cyrilzakka/clinical-trials huggingface dataset:
Comparison of Bioactive Glass Ceramics Spacer and PEEK Cages in Posterior Lumbar Interbody Fusion: A Prospective, RCT

The authors aimed to compare the clinical efficacy and safety of CaO-SiO2-P2O5-B2O3 glass ceramics with PEEK cage that is widely used for posterior lumbar interbody fusion (PLIF) surgery in the clinical field.


Eligibility Criteria:
Inclusion Criteria:

* patients aged between 30 and 80
* patients who required one-level PLIF between L1 and S1 among those who required an extensive laminectomy or facetectomy to correct severe disc extrusion or severe spinal stenosis or those who required PLIF due to grade I or II spondylolisthesis
* those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form.

Exclusion Criteria:

* osteoporosis patients with average T-scores of L1-L4 at \<-3.0 in DEXA bone density tests
* women with positive pregnancy tests before the trial or who planned to become pregnant within the following 3 years
* patients with a history of malignant tumor or malignant diseases (but the cases of cured disease with no relapse for the past 5 years were included in the present study)
* patients with abnormal blood potassium and phosphorus levels;
* patients with liver disease, kidney disease, respiratory disease, metabolic disease, or psychological disease;
* patients deemed to have less than 1-year life expectancy;
* patients with mental retardation or whose parents or legal guardians were older or had mental disabilities;
* other patients viewed as inappropriate by the staff
Computerized Cognitive Training for Schizophrenia in Brazil

The purpose of this study is to investigate the effect of a neuroplasticity-based computerized cognitive training for people with schizophrenia in the Brazilian population.

Cognitive impairments are important determinants of functional outcome in schizophrenia, which are inadequately treated by antipsychotic medication. Neuroplasticity based computerized cognitive trainings have been emerging for the last two decades and are an attempt to help patients with their cognitive impairments and global functioning.

The aim of this study is to perform a computerized cognitive training to improve attention, concentration, learning, clinical symptoms and quality of life in patients. The investigators are interested in testing the differential efficacy between a specific visual versus auditory computerized cognitive training and explore the biological markers that may be involved in these neuroplasticity based training processes.

The investigators will conduct a 40 hours computerized, adaptable, perception specific, cognitive training program in patients with schizophrenia. Patients will come for 1 hour, daily, and perform a visual or auditory training, or control games for about 2 months. Visual and auditory exercises are chosen to be the equivalent of one another and target cognitive domains such as divided attention, working memory and social cognition. Clinical, cognitive, emotional and biomarker data will be collected before the training, half way through, and after the training, to assess progress in several aspects of their functioning and biology.

The investigators hypothesize visual and auditory trainings will be effective as compared to the control games. They also expect that auditory training to be more efficient compared to the visual training because it targets sensory functions that are mostly impaired in schizophrenia, due to auditory hallucinations patients experience. The investigators also hypothesize that both trainings will improve clinical symptoms and quality of life. On a more exploratory analysis, the investigators expect to identify new biological markers of cognitive neuroplasticity, which they expect will differentiate visual and auditory paths.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of schizophrenia or schizoaffective disorder based on DSM-IV criteria
* age 18- 60 years
* Portuguese as primary language (learned before age 12)
* no major medical or neurological disorder that precludes participation in the study

Exclusion Criteria:

* IQ score \<70
* active substance dependence (DSM-IV criteria)
Patient Satisfaction and Clinical Experience of Dentists

Rehabilitation of the edentulous patients has always been a challenge. The success of this treatment modality is not only affected by the patients' acceptance of his new dentures, but on his ability to use them which depends to a great extent on the quality of those dentures. It is strongly believed that the success of dental treatments is affected by the experience of a dentist. The aim of this study was to compare patient satisfaction with complete dentures provided by forth and fifth year dental students and prosthodontists at the University of Jordan Hospital one week and 8 weeks post insertion

After obtaining the ethical approval, questionnaires were distributed to a total of 60 patients who accepted to participate in this study. The 60 patients consisted of 2 groups. The first group included patients treated by fourth and fifth year students, the second group consisted of patients treated by prosthodontists with a minimum of 5 years of experience. The questionnaire was distributed to those patients 8 weeks post insertion of complete upper and lower dentures. The questionnaire was divided into 3 parts. the first part included demographic and contact information questions for the patient. The second part included examination to the upper and lower dental arches and a third part included questions that probed the patient's satisfaction with his upper and lower dentures in general. Furthermore, the questionnaire included questions about the patient's comfort with his dentures, whether he is satisfied with the esthetics, phonetics, retention, efficiency in mastication, and ease of cleaning. This part of the survey was adapted from the Oral Health Impact Profile (OHIP-EDENT) questionnaire.

Eligibility Criteria:
Inclusion Criteria:The study population was completely edentulous patients attending the undergraduate students' clinic and specialty Prosthodontic clinics at the Jordan University Hospital in need of conventional complete dentures.

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Exclusion Criteria:

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Treatment of Impaired Glucose Tolerance in Pregnancy

The purpose of this study is to evaluate if treatment (insulin or diet) of pregnant women with impaired glucose tolerance (75-g OGTT with a fasting P-gluc \<7.0 mmol/l and 2 h P-gluc \>10.0 and \<12.2 mmol/l) close to normoglycemia reduces children´s birth weight and neonatal morbidity. There will be a focus on treatment according to specific goals and separate follow-up regimes for the children and women post partum.


Eligibility Criteria:
Inclusion Criteria:

* Women with 75g OGTT result : fasting capillary plasma \<=7.0 mmol/l and/or 2 h value \>= 12.2 mmol/l

Exclusion Criteria:

* Multiple pregnancy
* Pregestational Diabetes
Application of Intra-operative Prophylactic Antibiotics/Antiseptics in Chinese Breast Reconstruction Patients

The study aims to investigate different approaches of local application of antibiotics/antiseptics intraoperatively in Chinese patients undergoing post-mastectomy implant based breast reconstruction, and aims to single out an intervention method that limits the use of antibiotics and maintains low rates of surgical site infection and capsular contracture. Patients who undergo post mastectomy breast reconstruction in the breast reconstruction department in Tianjin Medical University Cancer Institute and Hospital are eligible to enter the study.

There is an ongoing trend towards implant based breast reconstruction in post-mastectomy patients in China. In 2015, more than 60% of patients undergoing breast reconstruction in Tianjin Medical University Cancer Institute and Hospital opted for implant based breast reconstruction. One of the major complications in implant based breast reconstruction is infection, which could cause implant explantation, delay the time to adjuvant therapies in breast cancer patients, and inflict adverse psychological effects. Although empirical intravenous and/or oral antibiotics are suggested peri-operatively, local applications of antibiotics/antiseptics and their combinations are applied differently in many medical centers worldwide, and some even suggest against the use of intraoperative local antibiotics. Furthermore, there is no consensus as to the local application of antibiotics intraoperatively for breast reconstruction patients in Chinese population. We therefore designed an open-label prospective randomized control trial in our Chinese patient population to investigate the effects of three different approaches of intraoperative surgical site intervention with antibiotics and or antiseptics. In each groups, all peri-operative interventions are standardized to best reduce bias. Short-term infection rate and long-term capsular contracture rate will be observed in the hope of singling out the best modality in our medical center to integrate into the overall comprehensive treatment for female breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent mastectomy and eligible for implant-based breast reconstructions
* Karnofsky Performance Status (KPS) larger than 70
* No severe deficiency in hematological, cardiovascular system, no immunodeficiency, no severe abnormal liver or kidney function

Exclusion Criteria:

* Metastatic breast cancer
* Local or systemic infection within 30 days prior to breast reconstruction surgery
* Local, oral or systemic administration of any form of antibiotics within 30 days prior to breast reconstruction surgery
* Pre-operative complete blood count shows white blood cell (WBC) count \>10\*10\^9/L, Neutrophil cell (N) count \> 7.5\*10\^9/L or N%\>80%
* Pre-operative blood procalcitonin (PCT) higher than upper limit of the normal range
* Past history with injection breast augmentation
Ambulatory Pessary Trial

The purpose of this study is to compare two methods for assessing patients with pelvic organ prolapse for occult stress urinary incontinence. Urodynamic testing is the most widely accepted and well-studied method for diagnosing occult stress urinary incontinence preoperatively, but an ambulatory pessary trial is a less expensive option that is available to a wider group of practitioners and evaluates patient while they are engaged in their daily activities.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Patients planning to undergo pelvic organ prolapse surgery and preoperative urodynamic testing within 6 months of recruitment.
* Stage 2 or greater pelvic organ prolapse on pre op POP-Q exam
* Negative stress test on clinical exam
* Cognitive capacity to complete questionnaires and voiding diary

Exclusion Criteria:

* Stress incontinence during provocative stress test on pre-operative exam.
* Occult stress urinary incontinence demonstrated on pre-operative physical exam
* Known ability to retain a pessary for the 3 day trial
* \< age 18
* History of bladder augmentation or artificial sphincter
* Known neurologic disease effecting bladder (spinal cord injury, Multiple Sclerosis, Parkinson's Disease, etc.)
* Non ambulatory patients
* Active infections of the vagina or pelvis (Pelvic inflammatory disease, infectious vaginitis, etc.)
* Occult stress urinary incontinence demonstrated on pre-operative physical exam
* Known ability to retain a pessary for the 3 day trial
* \< age 18
* History of bladder augmentation or artificial sphincter
* Known neurologic disease effecting bladder (spinal cord injury, Multiple Sclerosis, Parkinson's Disease, etc.)
* Non ambulatory patients
* Active infr
Comparing Two-time Points of Thyroid Hormone Replacement During the Holy Month of Ramadan

Muslims all over the world fast during the month of Ramadan from dawn until dusk. There is little data regarding the best timing of levothyroxine intake during the month of Ramadan where taking it on an empty stomach represents a challenge to most patients.This study aims to compare two-time points of levothyroxine intake during Ramadan in terms of change in thyroid stimulating hormone (TSH), compliance and convenience.

Hypothyroidism requires regular replacement with levothyroxine to achieve euthyroidism (thyroid hormone status within the normal range). Usually, levothyroxine is taken orally in the morning on a daily basis. In clinical practice, the investigators have observed that this levothyroxine replacement is sub-optimal resulting in higher levels of thyroid stimulating hormone. Based on this observation, the investigators conducted this study to examine whether timing of oral intake of levothyroxine during the holy month of Ramadan will affect achievement of euthyroidism. They recruited 96 hypothyroid patients taking levothyroxine, attending Hamad endocrine outpatient clinics, who were fasting during Ramadan( May-June 2017)and for whom there is no clinical contraindication to fasting. Patients were randomly assigned to two time points for taking levothyroxine:

A. 30 minutes before the Iftar meal B. 30 minutes before Suhour The primary outcome was the change in thyroid stimulating hormone (TSH) before and after Ramadan. The null hypothesis is that there is no difference in TSH between the two groups.

The findings from the study will help in the clinical care of patients with hypothyroidism in Ramadan. Hypothyroidism is common worldwide and many Muslims will require the appropriate advice regarding management of hypothyroidism in Ramadan.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Primary hypothyroidism who had stable TSH over the last 6 months prior to the study period
* Age between 18-70 years old
* Patients who planned to fast during Ramadan.

Exclusion Criteria:

* Patients with any end organ damage
* Pregnant ladies
* Patients with thyroid cancer
* Patients not adhering to medications
* Patients who had a clinical contraindication to observe fasting.
The Effects of COVID-19 Infection on Respiratory Muscle Strength and Core Stabilization

World Health Organization (WHO) Novel-19 Corrosion Disease (COVID) in 2019 without being used by a pathway caused by the SARS-CoV-2 virus. After the acute period in COVID-19 patients, muscle weakness may continue in breathing, weakness, and training. The effects on core stabilization, pulmonary functions, respiratory muscle strength, physical activity scores and quality of life in healthy adults who do not have COVID-19 who do regular exercise may be higher than in healthy adults who do regular exercise with COVID-19.

The type of our study was planned as Case-Control. 50 exercises will be included in our study. The first COVID-19 (n= 25) is healthy, and the second group will come from the successful group without COVID-19 (n=25). Between February and April, a student will accept participating in the clinic at Bezmialem Foundation University. After being informed about it, the attached form will be signed. In addition, participants will be asked to fill in our attached document, including demographic and clinical studies, in a face-to-face interview. All body exercises, breathing muscle test, six-minute walking test, McGill core endurance test, short-form test, and quality of life test were planned in our two groups. The results of these tests will be evaluated by testing and checking.

Eligibility Criteria:
Inclusion Criteria:

1. To be between the ages of 18-50,
2. Volunteering to participate in the research,
3. Those who have done aerobic exercise at least three days a week in the last three months

Exclusion Criteria:

1. Neurological deficits in the upper or lower extremities,
2. Fractures or orthopedic problems in the upper or lower extremities,
3. Cardiovascular diseases that prevent rehabilitation,
4. Systematic rheumatic disease (rheumatoid arthritis, ankylosing spondylitis),
5. History of surgery in the last three months,
6. Patients with spine problems,
7. Smokers,
8. Patients with chronic respiratory problems.
Evaluation of Sound Processor for a Transcutaneous System

A single center study evaluating the performance of an externally worn sound processor for a transcutaneous bone anchored hearing system using audiological outcomes measures such as aided thresholds and speech intelligibility and self evaluation questionnaires.

Bone conduction hearing systems use the body's natural ability to transfer sound through bone conduction. The sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). Thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. Bone conduction devices currently on the market are divided into three types; transcutaneous direct drive, percutaneous (skin penetrating) direct drive and transcutaneous skin drive bone conduction devices. This evaluation focus on a sound processor used for a transcutaneous system.

Eligibility Criteria:
Inclusion Criteria:

* Subjects implanted with the Bridging Bone Conductor (BBC) implant
* Subjects that have completed one year follow up in Osseofon BCI (Bone Conduction Implant) study
* Subjects available for 6 months study procedures without affecting the follow ups in the Osseofon BCI study
* Active user of the BCI SP

Exclusion Criteria:

* Inability to participate in follow-ups
* Unsuitable as judged by the principle investigator or the sub-investigator
Rituximab and Involved Field Radiotherapy in Early Stage Follicular Lymphoma

Combination of involved field radiotherapy for the control of macroscopic disease and CD20 antibody Rituximab for the control of microscopic remainders in other regions in patients with early stage nodal follicular lymphoma /grade I or II). Evaluation of DFSl and toxicity.

The MIR (Mabthera(R) and Involved field Radiation) study is a prospective multicenter trial combining systemic treatment with the anti CD20 antibody Rituximab (Mabthera(R)) in combination with involved field radiotherapy (30 - 40 Gy). This trial aims at testing the combination's efficacy and safety with an accrual of 85 patients.Primary endpoint of the study is progression free survival. Secondary endpoints are response rate to Rituximab, complete remission rate at week 18, relapse rate, relapse pattern, relapse free survival, overall survival, toxicity and quality of life.

More details: Witzens-Harig M, Hensel M, Unterhalt M, Herfarth K. Treatment of limited stage follicular lymphoma with Rituximab immunotherapy and involved field radiotherapy in a prospective multicenter Phase II trial-MIR trial. BMC cancer. 2011; 11: 87.

Eligibility Criteria:
Inclusion Criteria:

* verified follicular lymphoma grade 1 or 2
* only nodal involvement (incl. Waldeyer) clinical stage I or II
* largest tumor ≤ 7 cm
* adequate bone marrow reserves

Exclusion Criteria:

* ECOG \>2
* Follicular lymphoma grade 3
* buky disease (\>7 cm)
* involvement of the spleen
* neoplasia in PMH (except: basalioma, spinalioma)
* Immunodeficiency syndromes, viral hepatitis, connective tissue disease
* severe psychiatric disease
* pregnancy or breast feeding
* known allergies against foreign proteins
The Amenorrhea With Etonogestrel Implant

The etonogestrel subdermal implant has been available worldwide for more than 15 years. The action of etonogestrel subdermal implant is principal via suppression of ovulation, but it also has effects on cervical mucus and in some women induces suppression of endometrial proliferation. Several studies have confirmed its high efficacy and convenience. The uterine bleeding problems and in particular irregular bleeding and amenorrhea are major side effects of etonogestrel subdermal implant. A considerable number of patients request early removal due to bleeding changes. Amenorrhea occurs in about 22% in etonogestrel subdermal implant users. Despite the presence of many studies that reported the prevalence of etonogestrel subdermal implant-associated bleeding, little is known about the predictive factors affecting menstrual bleeding patterns especially amenorrhea after etonogestrel subdermal implant insertion. These predictive factors should be provided prior to the etonogestrel subdermal implant insertion which may improve acceptance and continuation of etonogestrel subdermal implant.


Eligibility Criteria:
Inclusion Criteria:

1. Women aged between 18 and 40 years.
2. Women who are not lactating.
3. Non-pregnant women
4. Women have regular menstrual cycles every 21-35 days with a typical cycle length variation of no more than 5 days.
5. Women who will ESI only for pregnancy prevention for at least 12 months.
6. Have not any medical or gynecologic problems.

Exclusion Criteria:

1. Women with any contraindications for progesterone-only contraception in accordance with WHO eligibility criteria.
2. Refuse participation in the study.
Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia

The regions which are assumed to underlie the pathophysiology of schizophrenia, namely hypoactivity at the prefrontal level and pathological hyperactivity of the associative regions of the language located in the left temporoparietal region.

To assess the efficacy of tDCS on auditory hallucinations, the investigators performs an randomized double blind versus placebo trial. In each arms patients will receive two tDCS sessions a day during two weeks.

Hearing hallucinations are one of the major symptoms of schizophrenia. In 30% of patients they are resistant to common psychotropic treatments. tDCS (Transcranial Direct Current Stimulation) is a technical of brain stimulation, non-invasive, painless that modulates brain activity by the transcranial administration of a low-intensity electric current, via two electrodes (an anode and a cathode). Several scientifics studies have reported a beneficial effect of tDCS in the treatment of pain, depression and especially hearing hallucinations in schizophrenia.

The main study purpose is to evaluate the effectiveness of tDCS on resistant auditory hallucinations in patients with schizophrenia.

Then, to evaluate the effectiveness of tDCS on global schizophrenic symptomatology and to assess the impact of tDCS on patients' quality of life.

Also the study, evaluate the impact of tDCS on cortical excitability. We measure the change in serum BDNF (Brain Derived Neutrophic Factor) before and after tDCS stimulation. Indeed, to evaluate the impact of tDCS on neurocognitive functions.

Patients will receive either active tDCS or placebo tDCS randomly. All patients will have two tDCS/day sessions, one hour apart, for 2 working weeks. The stimulation parameters will be consistent with the literature data, namely: Intensity = 2mA; duration of sessions = 20 minutes; total number of sessions = 20 (2 daily sessions for two working weeks).

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia according to DSM-V.
* Refractory auditory hallucinations(despite two antipsychotics trials).
* Right-handed patients.
* Written informed consent.

Exclusion Criteria:

* Presence of other psychiatric disorders than schizophrenia (except addiction to tobacco or caffeine ).
* History of severe head trauma or coma.
* History of epilepsy or neurological disorder or a general medical condition.
* Presence of intracranial metallic objects or pacemaker.
* Hospitalized patients without consent.
* pregnant women .
Electromyography in Thoracic Outlet Syndrome

Record the ENMG data carried out systematically in patients treated by rehabilitation for thoracic outlet syndrome in order to assess their characteristics and judge the relevance of these data in the context of the diagnosis and their possible modifications following the rehabilitation treatment.


Eligibility Criteria:
Inclusion Criteria:

* Inpatient rehabilitation for thoracic outlet syndrome
* Patients' agreement

Exclusion Criteria:

* \< 18 years old
* Not able to consent
* Pregnancy
* Musculoskeletal disorders of the upper limbs
* Acute cardiac, pulmonary, metabolic or neurological diseases