cyrilzakka/clinical-trials huggingface dataset:
Effects of Body Awareness Therapy in Knee Osteoarthritis

The aim of this study is to investigate the effect of Body Awareness Therapy (BAT) on pain, balance and functional capacity in patients with knee osteoarthritis.

Individuals will divided into two groups: training group and control group. Both groups will receive exercise training as a home program. Individuals in study group will participate in BAT training 3 days for 6 weeks. Assessments will be made before and after the 6-week study program.

Symptoms such as pain, morning stiffness, and decreased muscle strength lead to a decrease in functional capacity and quality of life in knee osteoarthritis. It is estimated that 80% of patients with osteoarthritis have movement limitation and 25% are unable to perform significant daily activities. It is also stated that increases the risk of falls due to decrease proprioception in patients with knee osteoarthritis. In addition to physical symptoms, it is reported in the literature that symptoms such as sleep disturbance, depression and anxiety are seen and play a role in pain experience.

It is stated in the literature that hypersensitivity of the central nervous system causes painful perception of normal body functions in chronic osteoarthritis, which leads patients to compensatory and dysfunctional movement strategies.

Body Awareness Therapy (BAT) is a mind-body treatment approach directed towards awareness of body senses and how the body is used. The aim is to integrate the body and soul in the individual's experiences and to restructure body awareness and control.

The aim of this study is to investigate the effect of BAT on pain, balance and functional capacity in patients with knee osteoarthritis.

The study will consist of patients with stage 2-3 knee osteoarthritis according to Kellgren-Lawrence classification.

The individuals included in the study will be divided into two groups as training and control groups using a computer-based randomization program.

Both groups will be given a home program consisting of joint range of motion, stretching, strengthening and proprioceptive exercises. The control group will perform home exercise program and follow up will be made at once a week. The training group will participate in BAT for 3 days/week for 6 weeks in addition to home exercise program. Assessments will be made before and after the 6-week study program.

Eligibility Criteria:
Inclusion Criteria:

* Primary knee Osteoarthritis
* Stage 2 -3 according to Kellgren - Lawrence Classification

Exclusion Criteria:

* Previous surgery in the lower extremity
* Neuromuscular disease
* Vestibular pathology
* Physiotherapy intervention or intra-articular injection within the last 6 months
Osimertinib or Docetaxel-bevacizumab as Third-line Treatment in EGFR T790M Mutated Non-Small Cell Lung Cancer

Acquired epidermal growth factor receptor (EGFR) T790M mutation is the most common genetic change after resistant to first generation EGFR tyrosine kinase inhibitor (EGFR TKI) in non-small cell lung cancer. After a 10 to 14 months median progression-free survival with the treatment of first generation EGFR TKI, half of patients will get disease progression.For patients progression after treated with first line EGFR TKI and second line double bullets chemotherapy or chemotherapy then EGFR TKI, optimal third line therapy is quite critical important for benefit patients' survival. We conducted this study was aimed to compare the efficacy and toxicity between osimertinib and docetaxel-bevacizumab as the third line therapy in patients with local advanced or metastatic non-squamous cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* local advanced or metastatic non-small cell lung cancer
* large cell lung carcinoma or adenocinoma
* Previously treated by TKI-Chemotherapy or Chemotherapy-TKI
* EGFR T790M positive
* No uncontrolled hypertension
* No active bleeding or thrombosis in recent 6 months
* No previously treated with VEGF antibody

Exclusion Criteria:

* newly diagnosed thrombosis
* anti-coagulation therapy
* uncontrolled hypertension
* uncontrolled nephropathy
Citicoline in Non-Arteritic Ischemic Optic Neuropathy

The investigators tested the hypothesis whether the treatment with Citicoline in oral solution (OS-Citicoline) would increase or stabilize visual acuity, retinal ganglion cells (RGCs) function and neural conduction along the visual pathways (neuroenhancement), and/or induce preservation of RGCs fibers' loss (neuroprotection) in an human model of neurodegeneration: non-arteritic ischemic optic neuropathy (NAION).

The investigators enrolled 40 patients with bilateral or monolateral NAION and 20 age similar controls

Twenty NAION patients received 500 mg/day of OS-Citicoline for a 6-months period followed by 3-months of wash-out (19 patients completed the study, NC Group); 20 NAION patients were not treated (19 patients completed the studyNN Group) from baseline up to 9 months. In all subjects, at baseline, at 6 and 9-months of follow-up: Visual acuity (VA), Pattern Electroretinogram (PERG), Visual Evoked Potentials (VEP), retinal nerve fiber layer thickness (RNFL-T) and Humphrey 24-2 visual field mean deviation (HFA MD) were assessed. Mean differences were statistically evaluated by ANOVA between Groups, and correlations were verified by Pearson's test.

Eligibility Criteria:
Inclusion criteria:

1. Acute visual reduction episode from NAION occurring for more than 6 months
2. Typical defects of the visual field evidenced with the Goldmann perimetry or with Humphrey perimetry 30-2
3. Visual acuity not less than 1/10
4. Having suspended any potential neuroprotective therapies (e.g., Coenzyme Q10) for at least 6 months.

Exclusion criteria:

* Ocular surgery in the 3 months preceding the study, including surgery for cataracts in the previous three months.
* Cataract or maculopathy
* Known hypersensitivity to the study product
* Positive history for diseases of the optic nerve (retrobulbar optic neuropathy, glaucoma) or systemic diseases which could preclude the enrolment in the study according to the investigators' judgement
* Pregnant or nursing women, or women of potential childbearing age not using adequate contraception.
* Diabetes, SLE, rheumatoid arthritis, mixed connective tissue disease
A Dose Escalation Study of L-DOS47 in Recurrent or Metastatic Non-Squamous NSCLC

The primary purpose of this research study is to evaluate how safe, how well tolerated and how effective a range of doses of L-DOS47 in combination with standard doublet therapy of pemetrexed/carboplatin in patients with Stage IV (TNM M1a and M1b) recurrent or metastatic non-squamous Non-Small Cell Lung Cancer.

It is planned that patients will receive 4 cycles of combination treatment with L-DOS47 + pemetrexed/carboplatin. Patients who have not progressed following the 4 cycles of combination treatment and who have not experienced unacceptable toxicity will have the opportunity to continue to receive L-DOS47 treatment for as long as there is clinical benefit and it is well-tolerated, in the opinion of the Investigator, until disease progression. Patients who are unable to complete 4 cycles of L-DOS47 + pemetrexed/carboplatin combination treatment due to pemetrexed/carboplatin toxicity will have the opportunity to continue receiving L-DOS47 treatment following discontinuation of pemetrexed/carboplatin, for as long as there is clinical benefit and it is well-tolerated, in the opinion of the Investigator, until disease progression.

Eligibility Criteria:
Main Inclusion Criteria:

1. Male or female patient ≥ 18 years of age
2. Histologically or cytologically confirmed non-squamous NSCLC
3. EGFR-mutation positive patients must have progressed on or had intolerance to an EGFR small molecule tyrosine kinase inhibitor
4. Patients whose tumors harbor an anaplastic lymphoma kinase (ALK) translocation must have progressed on or had intolerance to an ALK inhibitor;
5. No prior adjuvant chemotherapy within 1 year of the first treatment day if there is recurrent disease
6. At least 1 site of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and minimum life expectancy of ≥ 3 months
8. Adequate bone marrow, renal and liver function

Main Exclusion Criteria:

1. Histologic evidence of predominantly squamous cell NSCLC
2. Brain metastasis and/or leptomeningeal disease (known or suspected)
3. Peripheral neuropathy \> CTCAE grade 1
4. Possibility of a curative local treatment (surgery and/or radiotherapy)
5. Previous chemotherapy except adjuvant treatment with progression of disease documented ≥ 12 months after end of adjuvant treatment
6. Having received treatment in another clinical study within the 30 days prior to commencing study treatment or having side effects of a prior study drug that are not recovered to grade ≤ 1 or baseline, except for alopecia
7. Concurrent chronic systemic immunotherapy, chemotherapy or hormone therapy
A Prescription Support Tool for Oral Antithrombotic Combinations

From a systematic review of international guidelines (2012-2018), a prescription support-tool synthesizing national and international guidelines on chronic management (≥ 1 month) of oral AT agents without considering in-hospital management and bridging therapy will be developed. Guidelines dealing with the use of oral ATs for non-valvular atrial fibrillation, coronary artery disease, ischemic stroke, valvular heart disease, peripheral artery disease and venous thromboembolism in adults will be included. These pathologies were selected because most prescriptions of ATs are related to neuro-cardiovascular diseases and because this study would provide a synthesis relevant for clinicians in charge of the follow-up of patients with oral AT combinations. Studies are needed to assess the impact of this tool on appropriate prescribing.

Oral antithrombotic (AT) drugs are widely implicated in serious and preventable bleeding events, which justifies the implementation of risk minimization actions. Avoiding inappropriate oral AT combinations is a major concern, particularly for patients with multiple chronic conditions. The first step is to provide fast and easy access to the latest recommendations. From a systematic review of international guidelines (2012-2018), a prescription support-tool synthesizing national and international guidelines on chronic management (≥ 1 month) of oral AT agents without considering in-hospital management and bridging therapy will be developed. Our main objective in this study is to evaluate the accuracy of this tool by measuring the appropriateness of oral AT prescriptions according to the most recent guidelines.

Methods and analysis: In this web-based randomized controlled trial, participating French general practitioners and cardiologists in the outpatient setting will be randomized by use or not of the prescription support-tool. They will be asked to provide the number of drugs, drug class, duration and dosage of ATs, within a time window of 10 minutes, for 3 different clinical situations presented as clinical vignettes (multiple-choice questions). The scientific committee has created and validated 30 clinical vignettes illustrating outpatient clinical situations for which the use of oral ATs (single, dual or triple therapy) is recommended or not according to the guidelines. All data will be treated anonymously.

Ethics and dissemination: If the prescription support-tool is associated with more appropriate prescription of AT combinations, its dissemination to further evaluate outcome data including haemorrhage, ischemic events, and death will be considered.

Eligibility Criteria:
Inclusion Criteria:

* French practicing physicians who are involved in outpatient settings, including general practitioners and cardiologists.

Exclusion Criteria:

* Physicians with an exclusive hospital practice.
Digital Addiction, Sleep Quality and Orexin-A Level

This study aims to determine the level of digital addiction in university students where technology use is quite common, and to evaluate the relationship between digital addiction and orexin and sleep quality.

The main question it aims to answer is:

* Are digital addiction trainings given to students effective on digital addiction levels?
* Are digital addiction trainings given to students effective on sleep quality?
* Is there a relationship between digital addiction level and orexin-A peptide?

The changes experienced in technology along with the developing world also bring about major changes in the lives of individuals. It is seen that technology is present in every aspect of life, especially the internet that enables widespread communication and the use of the tools and equipment developed accordingly is rapidly increasing especially in the young age group. It is stated that digital addiction is spreading very rapidly throughout the world and has many negative consequences on the daily life and health of the individual. Many health problems such as personality disorders, violence, increase in aggressive behavior, disruptions in the sleep-wake cycle, anxiety, and depression are associated with digital addiction. Orexins are hypothalamic neuropeptides that play a role in the regulation of many complex behaviors such as nutrition, sleep, and wakefulness. In recent studies, it is thought that orexin can cause behavioral addictions. Orexin plays a role in both the early and late stages of the addiction mechanism.

Eligibility Criteria:
Inclusion Criteria:

* Individuals studying at Amasya University,
* Those who agree to participate in the study,
* Individuals who do not have any communication barriers

Exclusion Criteria:

* Individuals who are not students at Amasya University,
* Individuals with communication disabilities.
Children and Adolescents With Dental Anxiety - Randomized Controlled Study of Cognitive Behavioral Therapy

The purpose of this study is to determine whether cognitive behaviour therapy is effective in the treatment of children and adolescents with dental anxiety. Our hypothesis is that children and adolescents who have been offered CBT shows significant better performance on outcome measures compared with patients in control group who have received treatment as usual.


Eligibility Criteria:
Inclusion Criteria:

* The patient and parents agree to participate in the research project
* A primary diagnosis of specific phobia (dental anxiety or needle phobia) can be established according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition.

Exclusion Criteria:

* The diagnostic interview shows that other psychiatric or developmentally related diagnoses should be consider as the primary diagnosis
* The patient undergoing psychiatric examination and/or psychotherapy
* The patient has no dental treatment needs or the dental treatment needs are of an emergency nature.
A Modified Constraint-Induced Movement Therapy Program in Rehabilitation of Arm Paresis in Children With Cerebral Palsy

The purpose of this study is to determine if a modified protocol of constraint-induced movement therapy (CIT) is effective in rehabilitation treatment of arm paresis in children with cerebral palsy. In these children one main problem the non-use of the affected arm. Many studies showed that the non-use phenomenon can by reversed by the CIT, a rehabilitation program consisting of 15 days of restraining the unaffected arm plus a daily intensive (6 hours/day) physiotherapy training of the paretic arm. The present study aims at evaluating if a shortened CIT protocol (restraining device plus only 2 weekly hours of physiotherapy) is effective in improving use and function of children paretic arm


Eligibility Criteria:
Inclusion Criteria:

* presence of mild-moderate arm paresis (after cerebral palsy) enabling to
* reach and grasp a pellet
* age between 1-10 years
* active participation during proposed activities
* parents consent for participation -

Exclusion Criteria:

* presence of severe behaviour disturbances
* presence of severe mental retardation (QI\<60)
Phase II Trial of Individualized Immunotherapy in Early-Stage Unfavorable Classical Hodgkin Lymphoma

The aim of the trial is to establish an individualized first-line treatment incorporating checkpoint inhibition for early-stage unfavorable cHL, which is effective and well tolerated.

Programmed cell death protein-1 (PD-1) blockade is highly effective and well tolerated in relapsed or refractory cHL and has also demonstrated efficacy in the first-line treatment of cHL in combination with doxorubicin, vinblastine, and dacarbazine (AVD) in the phase II GHSG NIVAHL trial. A relevant proportion of patients achieved an early metabolic complete remission (CR) with anti-PD-1 monotherapy and might not require standard chemo- or radiotherapy. Limiting therapy-associated short- and long-term side effects of these conventional treatments including impaired quality of life, second primary malignancies or organ damage is of utmost importance in the predominantly young cHL patients. This trial will hence further reduce treatment intensity and provide a chemo- and radiotherapy-free therapy to optimally responding patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 for the main trial cohort
* Age ≥ 61 years and eligible for AVD as determined by CIRS-G score and investigator for the exploratory cohort
* First diagnosis of treatment-naïve cHL
* Early-stage unfavorable disease (i.e. stage IA, IB and IIA with risk factors a-d, stage IIB with risk factors c-d):

  1. large mediastinal mass
  2. extranodal lesion(s)
  3. elevated erythrocyte sedimentation rate
  4. ≥ 3 nodal areas

     Exclusion Criteria:
* Presence of nodular-lymphocyte predominant Hodgkin lymphoma, grey-zone lymphoma and/or central nervous system involvement of lymphoma
Open Lung Approach Versus Standard Protective Strategies

The aim of this study was to compare the effects of adding a recruitment maneuver (RM) to low tidal volume (VT) ventilation, with or without an individualized post-RM positive end-expiratory pressure (PEEP) setting in lung-healthy patients during anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-III undergoing elective major abdominal surgery including pancreatic-duodenectomy, gastrectomy and liver resection

Exclusion Criteria:

* i) laparoscopic surgery, ii) patients with previous respiratory disease.
Improving the Application Skill of the Semmes-Weinstein Monofilament Test

The Semmes-Weinstein Monofilament Test is one of the most widely used and objective clinical tests for assessing the sense of touch. Some guides include standard instructions for the application of the Semmes-Weinstein Monofilament Test. With monofilaments applied correctly by the instructions, patients' threshold values can be determined accurately. However, there are disagreements about the accuracy of the pressure applied by the therapist who applies the monofilament to the patient. The investigators aimed to compare the application of the Semmes-Weinstein Monofilament Test to undergraduate students of the occupational therapy department by teaching it using classical methods and visual feedback.


Eligibility Criteria:
Inclusion Criteria:

* Being third or fourth-year undergraduate students of the Occupational Therapy Department
* Completing the Hand Rehabilitation course
* Being a volunteer to participate in the study
Endovascular Therapy for Renal Artery Stenosis in China

A multicenter prospective registry planned to recruit more than 5 000 patients with renal artery stenosis was carried out in China. This primary purpose of this study was to evaluate the safety and efficacy of renal artery revascularization in the real world. The secondary purpose was to investigate the etiologic distribution of renal artery stenosis and optimize the indications for renal artery revascularization.

Currently,the endovascular therapy of renal artery stenosis (especially atherosclerotic) remains in dispute. Some randomized control trials published in recent years (including ASTRAL and CORAL trials) showed the lack of additional benefit for renal artery revascularization compared with sole medical therapy. However,these randomized control trials presented a number of limitations including low numbers of patients and non-stringent inclusion criteria. Given clinical medical practice entering the era of big data, the large-sample real-word studies would be more objective to answer some pending issues of randomized controlled trial.Therefore,a multicenter prospective registry planned to recruit more than 5 000 patients with renal artery stenosis was carried out. This primary purpose of this study was to evaluate the safety and efficacy of renal artery revascularization in the real world. The secondary purpose was to investigate the etiologic distribution of renal artery stenosis and optimize the indications for renal artery revascularization.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 14 at the time of informed consent
2. Diameter reduction of renal artery or main branch of renal artery≥ 60%,and ≥2 of four following conditions met:1)systolic hyperemic pressure gradient \>20 mm Hg,2)captopril renoscitigraphy positive in the lesion side

   ,3)renin-angiotensin-aldosterone system significantly activated and 4)severe reduction (\>25%) of glomendar filtration rate in the lesion side
3. office systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg while receiving 3 antihypertensive drugs,or office systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg without antihypertensive drugs
4. Serum creatinine level\<264umol/L
5. Length of ipsilateral kidney ≥7.0 cm and glomendar filtration rate ≥10 ml／min
6. Urine protein \<2+

Exclusion Criteria:

1. Unable to provide informed consent
2. Unstable condition and unable to tolerate interventional therapy
3. intolerance to antiplatelet drugs or contrast medium
4. vascular anatomy not suitable for endovascular therapy
5. Pregnant, nursing, or planning to be pregnant
Pharmacist Counseling on the Health-related Quality of Life of Patients With Type 2 Diabetes Mellitus

The quality of life (QoL) of patients with type 2 diabetes mellitus (T2DM) is a measure of the successful outcomes of therapy. The program of management of chronic diseases "Program Pengelolaan Penyakit Kronis" (Prolanis) among patients with hypertension and T2DM is a new strategy of the Badan Penyelenggara Jaminan Sosial (BPJS), which is the Indonesian national health insurance system. The impact of pharmacist counseling interventions on health-related QoL (HRQoL) was analyzed in Prolanis T2DM patients.

A cluster randomized controlled trial that was designed to include two groups (control (n = 111) and intervention (n = 109) groups), and pre- and post-test procedures were conducted. The participants were Prolanis T2DM patients who attended four primary health-care centers (Puskesmas) in Makassar City, South Sulawesi, Indonesia from August 2017 to August 2018. The intervention group received systematic counseling for 6 months. The data were collected using the Bahasa Indonesia version of the European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire and were analyzed using EQ-5D preference weight for each health state with the Indonesian EQ-5D-5L value Set. Furthermore, the EQ-5D index and the EQ-5D VAS score were calculated and HbA1c levels were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Registration in the Prolanis at BPJS Makassar City,
* Age between 20 and 65 years,
* HbA1c level ≥6.5%, and
* Willingness to participate in research by signing an informed consent (for all T2DM patients with or without comorbidities)

Exclusion Criteria:

* Irregular control schedules,
* Incomplete medical record data,
* Circumstances that did not allow filling out the questionnaires (e.g., inability to speak, see, or hear)