cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of Transcranial Magnetic Stimulation of Supplementary Motor Area (SMA) in Patients With Bladder Hypersensitivity and Bladder Pain

The main hypothesis of this study is that transcranial magnetic neuromodulation can correct the symptoms of hypersensitivity and bladder pain. The investigators assume that under the influence of transcranial magnetic stimulation, both the subjective state of patients assessed by standardized questionnaires and the objective parameters assessed by invasive and non-invasive urodynamic studies will be improved. In this study, two protocols for magnetic stimulation of the supplementary motor area (SMA) will be compared with each other and with placebo. The investigators expect to determine the dependence of the therapeutic effect on the applied stimulation protocol.

The aim of the study is to test the hypothesis that the use of the magnetic stimulation method SMA in patients with symptoms of bladder hypersensitivity and bladder pain will help to reduce the clinical and urodynamic signs of these pathological conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years;
2. Signed informed consent;
3. The presence of OAB symptoms: urinary frequency, nocturia, urgency and urge incontinence; discomfort during filling the bladder, pain in the projection of the bladder over the womb.
4. Resistance to standard therapy for bladder hypersensitivity and bladder pain.

Exclusion Criteria:

1. The patient, who have been implanted devices that control physiological functions (a pacemaker, a device for deep brain stimulation and chronic epidural brain stimulation, a cochlear implant).
2. Convulsive attacks in the anamnesis;
3. Taking medications that may trigger the risk of seizures;
4. Pregnancy or suspicion on it;
5. The presence in the patient's body of metal elements or objects made with the use of ferromagnets (joint prostheses, eye prostheses, tattoos made using metal ink, surgical clips, staples and other metal suture materials, etc.)
6. Chronic cardiovascular and cerebrovascular diseases in the stage of decompensation or recent acute conditions (myocardial infarction, brain stroke, etc.)
7. A history of injuries associated with impaired conduction along the pathways of the brain and spinal cord;
8. The presence of detrusor hyperactivity patterns according to the preliminary multichannel urodynamic study;
9. The presence of infravesical obstruction in men, determined by uroflowmetry (obstructive urination curve according to the Liverpool nomogram);
10. The postvoid residual volume (more than 100 ml);
11. The presence of urinary tract infection;
12. A history of cancer;
Dose Ranging Study in Elective Total Hip Replacement Surgery

The primary objective is to:

* demonstrate the efficacy of SR123781A in the prevention of venous thromboembolism (VTE) by the demonstration of a dose-response in patients undergoing total hip replacement surgery.

The secondary objectives are to:

* evaluate the safety of SR123781A in the prevention of VTE after elective total hip replacement surgery; and
* to assess the SR123781A pharmacokinetic profile in patients undergoing elective total hip replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo elective total hip replacement surgery or a revision of at least one component of a total hip replacement performed \> 6 months prior to study entry

Exclusion Criteria:

* Pregnant or nursing women, or women of childbearing potential who are not using an effective contraceptive method and who do not have a negative pregnancy test performed immediately before randomization
* Known progressive malignant disease
* Ischemic stroke in the last 3 months
* Myocardial infarction (MI) in the last 3 months
* Any major orthopedic surgery in the 3 months prior to study start
* Clinical signs or symptoms of DVT or PE within the last 12 months or symptoms of post phlebitic syndrome (these conditions may confound DVT/PE assessments)
* Treatment with other antithrombotic agents within 7 days prior to surgery
Comparison of a Prophylactic Intraligamentary Injection of Piroxicam Versus Mepecaine of Post-endodontic Pain

to evaluate the effect of a single intraligamentary injection of piroxicam on postoperative pain associated with endodontic procedures.

The pain after endodontic treatment is commonly severe in the first 24 hours after treatment, then it will reduce gradually until commonly disappearing after 7-10 days in most cases. Since piroxicam has a half-life of 50 hours in the plasma, it will be effective in controlling the most intense pain which occurs after endodontic treatment It appears that optimal clinical benefits can be achieved by administering drugs such as local anesthetics and NSAIDs before the onset of postoperative pain. Administering these drugs before a surgical or an endodontic procedure may be of benefit for longer procedures or for minimizing peripheral sensitization, which is a result of the cascade of inflammatory mediators that are released by tissue injury and fuel the subsequent inflammatory process

Eligibility Criteria:
Inclusion Criteria:

* • Medically free patients

  * Patient's age between 25-50 years.
  * Molar or premolar teeth diagnosed clinically and radiographically with irreversible pulpitis and symptomatic apical periodontitis.
  * Positive patient's acceptance for participation in the study.
  * Sex include both male and female.
  * Patients who can understand Numerical Rating Scale (NRS)
  * Patients able to sign informed consent.

Exclusion Criteria:

* • Pregnancy or lactation in female patients

  * Medically compromised patients.
  * Patient with multiple teeth that required endodontic treatment to eliminate the possibility of pain referral.
  * Patient with fracture or mobile or mutilated teeth.
Prevalence of NNSH in a Group of Egyptian Children Aged 3-8 Years Old in Giza Governorate: A Cross Sectional Study.

1. Prevalence of non-nutritive sucking habits (NNSH) in a group of Egyptian children aged 3-8 years old in Giza Governorate.
2. Assessment of factors associated with NNSH.

Several studies have reported on the prevalence of non-nutritive sucking behaviors among infants and young children in different populations. Non-nutritive sucking is regarded as a normal part of development, and early studies of its prevalence generally found that 70-90% of children had some history of a non-nutritive sucking habit. Like these early studies, most recent studies have used retrospective methods to assess the prevalence of non-nutritive sucking habits.

Prolonged duration of non-nutritive sucking behaviors may have consequences in regard to the developing orofacial structures and occlusion. Little is known as to why some children have sucking habits beyond the first 2 to 3 years of life.

Prevalence of NNSH and associated factors in Egyptian children might be different.

Eligibility Criteria:
Inclusion Criteria:

* 3-8 years old children.
* Children free of systemic diseases.
* Positive patient/parents acceptance for participation in the study.
* Both sexes will be included.

Exclusion Criteria:

* Disabled children.
* Children with cleft lip \& palate.
* TMJ disorders.
* Children undergoing orthodontic/orthopedic treatment.
* Participants who were exposed to thumb sucking prevention programs.
Primary Care Validation in French of a Single-question Screening Test for Unhealthy Alcohol Use.

Unhealthy alcohol use (UAU) is a very important public health concern. In France UAU is the second cause of avoidable death after tobacco smoking. In 2014, 31% of the French adult population presented with unhealthy alcohol use. Primary care practitioners have access to validated questionnaires in French such as the Alcohol Use Disorder Identification Test (AUDIT) and the Fast Alcohol Consumption Evaluation (FACE). These tests are not often used because of their length.

In 2009 a study by Smith et al in the USA compared a single question with the AUDIT-c (a short version of the AUDIT). The single question was "How many times in the past year have you had X or more drinks in a day?" Where X is 7 for men and 6 for women. This study found that the single question had a comparable sensitivity and a specificity, respectively 81,8% and 79,3%.

The aim of the study is to validate this question in French. First the question has been translated from English to French following the WHO method. The aim of the present study is to validate the French translation by comparing it with the AUDIT and the FACE. A questionnaire will be given to patients with inclusion criteria in general practitioners waiting rooms (15 different locations). This questionnaire will be composed of the single question, followed by the AUDIT and FACE, and three socio-demographic questions. The questionnaire will be anonymous.


Eligibility Criteria:
Inclusion Criteria:

* Consulting in a general practitioner's office
* Over 18 years Old

Exclusion Criteria:

* Less than 18 years old
* Pregnant women or breast-feeding mothers
* People under legal protection
Impact of Competency-Based Training and Technical Assistance Employment Outcomes of Individuals With ID/DD

Currently, there are no national pre-requisites for training to become or to be hired as an ES (Employment Specialist). Staff providing employment services have a broad range of educational and training backgrounds. Some individuals have a masters and have completed an ACRE approved course to earn a ACRE (Association of Community Rehabilitation Educators) Basic Employment Certificate in Employment Services while others may have a high school diploma and have not received any additional training. The first phases of the study were important in identifying if the currently identified ACRE competencies are relevant and if the ACRE approved online training course does impact knowledge.

The final phase of the study aims to identify if the addition of technical assistance to the current course not only impacts knowledge of participants but also their self-reported engagement in skills that are outputs of their knowledge acquisition. Additionally, the third phase will link participation in the course and TA (technical assistance) to employment outcomes of individuals with ID/DD (individuals with intellectual and/or developmental disability). These additions address large gaps in the extant literature and research on employment specialists, training, and its impact on employment outcomes.

While, evidence-based practices in SE (Supported Employment) exist, research indicates that these practices are not often put into practice. Furthermore, of the few studies that have explored ES(Employment Specialist) training and its effectiveness, very few have identified if training impacts the employment outcomes of individuals with disabilities. Employment specialists and their skill directly impact the successful employment of individuals with ID/DD. Despite the introduction of SE into the field over four decades ago as well as legislative support, employment outcomes of individuals with remain dismally low. It is necessary to begin to gather evidence of the impact of training as well as feasibility and dosage in order to identify how to prepare employment service providers to better support individuals with disabilities to access employment.

Eligibility Criteria:
Inclusion Criteria:

* Use the VCU RRTC listserv
* Residing or working in the United States
* 18 and older
* have not participated in ACRe training
* Currently providing or will be providing employment services to individuals with ID/DD

Exclusion Criteria:

* Unable to consent
* Under 18
* Pregnant women
* Prisoners
Alveolar Echinococcosis: Parasite Viability and Innovative Markers for the Follow-up of Patients Treated With Albendazole

Study design to define improved management of patients with hepatic alveolar echinococcosis treated with albendazole and especially make appropriate and timely decision of treatment withdrawal .

Based on exploratory analysis of existing and newly developed biological and imaging exams, for diagnosis and follow-up, and study of the relationship of these markers to the viability of the parasite and/or the activity of the parasitic lesions The study included two series of patients: operated on (curative hepatectomy) // non-operated on

Close follow-up of the patients, based on WHO guidelines (Brunetti, Acta tropica 2010), including albendazole bloods levels determination.

Clinical exam, sampling and storing (biobank) of blood specimens at inclusion, M1, M3, M6, M9, M12, M18, M24, M30, M36, M44, M48.

Additional sampling for operated on patients : M15 and M21.

Imaging each year (US, CT, PET-CT \& RMI).

Preservation of operative specimens samples at -80°C: samples taken at different location (center and periphery of the lesions) and in distant non-infected liver, for further studies of the immune response, RNA detection, and albendazole dosages.

Eligibility Criteria:
Inclusion Criteria:

* hepatic alveolar echinococcosis
* without antiparasitic treatment or with antiparasitic treatment and hepatectomy programmed

Exclusion Criteria:

* Patients with exclusively extra-hepatic form of alveolar echinococcosis
* Women without effective contraception (Contraindication to benzimidazoles)
* The immunosuppressed patients or receiving an immunosuppressive treatment will not be the object of a stop of the post-operative treatment by albendazole on 1 year after the intervention of radical resection; they can be included in the study but will receive the albendazole during 2 years; this exclusion applies to the patients treated by liver transplant.
MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma

Objective: In preparation of a randomized controlled trial, the investigators aim to assess pilot data on technical feasibility and safety of laser interstitial thermal therapy (LITT) at Radboud University Medical centre and to assess practical feasibility of a randomized study in patients with primary irresectable glioblastoma, as compared with standard of care.

Study design: Prospective randomized pilot study. Randomization stopped (amendment September 2nd, 2021),

Study population: 20 patients aged \>= 18 with radiologically suspected diagnosis of primary glioblastoma and contra-indication for surgical resection.

Intervention: Patients will be randomized to receive either (i) biopsy and LITT (n=10) or (ii) biopsy alone (n=10).


Eligibility Criteria:
Inclusion criteria

In order to be eligible to participate in the study, a patient must meet all of the following criteria:

* Informed consent, age \>18-year-old
* Supratentorial localization
* Maximal volume \<=70cc on post-contrast T1 MRI
* Safe trajectory/trajectories possible for ablation of 70% of the tumour, avoiding eloquent structures or transgression of a ventricle or vessel .
* Karnofsky Performance Status (KPS) \>= 70

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Contra-indication for general anaesthesia or MRI
* Lesion \>70cc on post-contrast MRI on the day before intervention.
* Non-glioblastoma diagnosis as per frozen section analysis
* Pregnancy
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.

This is an international, multicenter, randomized, open-label, active-controlled, phase 3 clinical trial. The purpose of this trial is to compare the safety and efficacy of palazestrant (OP-1250) as a single agent to the standard of care endocrine therapy: either fulvestrant or an aromatase inhibitor (anastrozole, letrozole, or exemestane).

This trial is seeking adult participants with ER+, HER2- advanced or metastatic breast cancer whose disease has relapsed or progressed on 1 or 2 prior lines of standard-of-care endocrine therapy for metastatic breast cancer. Prior lines of therapy must include one line of endocrine therapy in combination with a CDK 4/6 inhibitor. In the dose-selection part of the trial, approximately 120 participants will be randomized to one of the two doses of palazestrant or to the standard-of-care endocrine therapy. Thereafter, approximately 390 participants will be randomized to palazestrant at the selected dose or to the standard-of-care endocrine therapy.

Eligibility Criteria:
Key inclusion criteria:

* Adult female or male participants.
* ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.
* Evaluable disease (measurable disease or bone-only disease).
* Previously received a CDK4/6 inhibitor in combination with an endocrine therapy in the advanced setting. One additional line of ET as a monotherapy is allowed. Duration of the most recent prior ET must be at least 6 months.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate hematologic, hepatic, and renal functions.
* Female participants can be pre-, peri- or postmenopausal.
* Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.

Key exclusion criteria:

* Symptomatic visceral disease, imminent organ failure, or any other reason that makes the participant ineligible for endocrine monotherapy.
* Previously received chemotherapy in the advanced/metastatic setting.
* Previously received treatment with elacestrant or an investigational estrogen receptor-directed therapy.
* History of allergic reactions to study treatment.
* Any contraindications to the selected standard-of-care endocrine therapy in the local prescribing information.
* Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.
* Clinically significant comorbidities such as significant cardiac or cerebrovascular disease, gastrointestinal disorders that could affect absorption of study treatment.
Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma

In patients with cholangiocarcinoma therapeutic effects have been reported for Gemcitabine/Oxaliplatin. Furthermore, photodynamic therapy (PDT) has significantly improved patients survival in two randomised trials. PDT induces tumor necrosis only in an area of few millimetres, while tumor parts which are located beyond this area remain untreated. An additive effect could result from PDT as a local therapy in combination with systemic chemotherapy.

Patients entered in the study receive a sequential therapy consisted of photodynamic therapy followed by systemic chemotherapy (Gemcitabine/Oxaliplatin) 4 weeks later. Systemic chemotherapy every 2 weeks is scheduled 9 times in each cycle. Thereafter, another cycle of PDT followed by chemotherapy is intended.

Eligibility Criteria:
Inclusion Criteria:

* Histologic/cytologic verified cholangiocarcinoma or cholangiocarcinoma-typical findings in \>= 2 diagnostic methods
* Bile duct stenoses which are technically successful treated with biliary drainage
* Irresectability/inoperability
* Karnofsky-Index \>= 60%
* Age \>= 18
* Written consent

Before chemotherapy:

* Bilirubin \<= 5 mg/dl
* GOT/GPT \< 5x upper standard
* Creatinine \< 2x upper standard
* Thrombocytes \> 100 G/l
* Neutrophils \> 2,00 G/l
* Haemoglobin \> 9 g/dl
* No occurence of complications during endoscopic procedures (abscess, bilioma, cholecystitis, cholangitis, pancreatitis, biliary leakage)

Exclusion Criteria:

* Implantation of a metal stent in the bile duct
* Previous PDT or chemotherapy
* Neoplasia
* Porphyria
* Pregnant or breastfeeding women
* Women of childbearing age and potent men who are not using highly effective contraceptives
Relationship Between Red Cell Distribution Width (RDW) and HbA1C in Patients With Type 2 Diabetes Mellitus After Glycemic Control

Diabetes mellitus (DM) is an epidemic disease, with approximately 463 million persons diagnosed with it. Of those, 90% are patients with type 2 DM (T2DM). Some estimates indicate that 700 million cases of DM will be reported in 2045. T2DM develops due to insulin resistance, leading to reduced insulin secretion. DM has a number of associated complications, such as nephropathy, neuropathy, and cardiovascular disease.

The health status of normal individuals and patients with various diseases is commonly monitored using the complete blood count (CBC). In patients with T2DM, the CBC can be used as a follow-up test, which will help in reducing complications associated with the disease. Some CBC parameters have also been used as prognostic markers for T2DM. One of these markers is the red cell distribution width (RDW), which measures the variability in the sizes of red blood cells (RBCs) and is considered an indicator of their heterogeneity. The evidence associating RDW with a higher risk of mortality has been expanding since the initial report of its prognostic utility in heart failure patients. Multiple studies have shown that elevated RDW values are associated with many human diseases, such as cancer, cardiovascular disease, and diabetes, and are also associated with disease activity or complications of diseases. The RDW can be used diagnostically in patients with T2DM and other illnesses, as patients with T2DM frequently show alterations in various hematological properties, including changes in the structure, metabolism, and function of blood cells. These alterations can be caused by different factors, such as excessive levels of reactive oxygen species (ROS), leading eventually to oxidative stress and the dysfunction of RBCs.

The relationship between RDW and T2DM has been studied for several years, and there are no consistent results.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed to have Uncontrolled type 2 diabetes mellitus (HbA1C more than 7%)

Exclusion Criteria:

1. Patients diagnosed to have type 1 diabetes.
2. Patients are diagnosed to have secondary diabetes.
3. Clinical states associated with increased RDW:

   * Anemia (Female Hb less than 12, Male Hb less than 13) either due to hemolysis, or in response to ineffective red cell production, which can be caused by deficiencies in iron, vitamin B12 or folate.
   * After blood transfusions
   * Pregnancy, thrombotic thrombocytopenic purpura and inflammatory bowel disease.
Heart Rate Variability of Patients With Bipolar Disorder in Subsyndromal Depressive Phase

The purposes of this study were: (1) to compare heart rate variability between bipolar patients in subsyndromal depressive phase and healthy controls (2) to evaluate the relation between the severity of subsyndromal depressive symptoms and reduced heart rate variability.


Eligibility Criteria:
Inclusion Criteria:

1. Bipolar group:

   * DSM-IV bipolar disorder
   * Montgomery-Åsberg depression rating scale (MADRS) score for last one month : ≤ 10
   * Clinical Global Impression severity (CGI-S) for last one month : ≤ 3
2. Healthy controls group: Subjects had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist.

Exclusion Criteria:

* Psychiatric disorder except bipolar disorder
* Neurological symptoms or signs
* History of head trauma
* History of cardiovascular diseases
* Any medication except psychiatric medication.