cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Wearable Trackers and Telerehabilitation in Cerebral Palsy

The inadequate number of rehabilitation sessions and the difficulties in accessing rehabilitation services for people with cerebral palsy result in delayed progress and low levels of physical activity for these people. As a result, it is well known that daily life often hinders the implementation of prescribed home programmes, leading to neglect. In the rehabilitation of people with cerebral palsy, physiotherapists face difficulties in monitoring patients and ensuring compliance with home exercise programmes. Both people with cerebral palsy and their carers often experience dissatisfaction and lack of motivation regarding the monitoring and control of development and activity.

This study aims to evaluate the effectiveness of a telerehabilitation programme supported by a mobile application and a wearable activity tracker, in addition to a standard rehabilitation programme, on physical activity levels, quality of life, sleep quality, balance, activity participation and motivation, and patient satisfaction in people with cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 14 and 18 years old
* Diagnosed with cerebral palsy
* Currently enrolled in a regular rehabilitation programme
* Level 1-3 according to Gross Motor Function Classification System (GMFCS)
* No cognitive impairments affecting the understanding of exercise programmes
* Voluntary informed consent to participate
* No recent surgeries (e.g. botox, muscle relaxation) within the past 6 months
* No socioeconomic issues related to the use of smart devices

Exclusion Criteria:

* The impact of recent surgical procedures or medical interventions on physical performance.
* The influence of health conditions that affect the entire body and physical performance.
Autologous Bone Marrow Derived Stem Cells for Acute Myocardial Infarction

One of the important reasons for human dying is Ischemic heart disease (IHD). The most reason is coronary artery disease. Beside morbidity, IHD induce myocardial infarction and necrosis which due to congestive heart failure.

One therapeutic method is cellular cardiomyoplasty, which is to produce and substitute the cardiac cells with stem cell transplantation. Cell therapy is a potential therapeutic method to prevent ventricular remodeling after acute myocardial infarction. Human and animal studies have shown that stem cell trans plantation to myocardial infarcted zone can improve heart contractile function.

The aim of this study is to comparison the effects of BM-derived AC133 and MNC implantation in patients with myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* CABG candidate
* At least 4 akinetic segments
* First anterior heart attack within in 10 days to 3 month.
* St elevation MI defined by: Post Acute MI LVEF less than 45% as assessed by echocardiography.
* The target lesion had to be located in the left anterior descending (LAD) section.

Exclusion Criteria:

* History of prior anterior myocardial infarction:
* History of prior CABG
* Poor echocardiography window.
* Active infection or history of recurrent infection or positive test for syphilis (RPR), hepatitis B and C (HBSAg/ Anti HBc Anti - Hcv) HIV and HTLV-l
* Documental terminal illness or malignancy.
* Previous bone marrow transplant
* Autoimmune disease (e. g Lupus, Multiple sclerosis)
* Any contraindication for bone - marrow aspiration.
* Positive pregnancy test (in women with child bearing potential)
Teachable Moment Brief Intervention for Suicide Attempt Survivors in an Inpatient Setting

This study is looking at the helpfulness of a brief treatment targeting suicidality (Teachable Moment Brief Intervention \[TMBI\]) and experimental pain responses in an inpatient population as well as collecting comparison data from the community.

The proposed study will use an innovative one-session psychotherapeutic intervention called the Teachable Moment Brief Intervention (TMBI) for suicide attempters admitted to a psychiatric inpatient unit. A total of 60 patients will be recruited from the inpatient psychiatry unit at Laureate Psychiatric Clinic and Hospital and 30 healthy community members for the study. Informed consent will be obtained for all participants and administration of the baseline assessment battery will be completed prior to randomization for patients. Patients will then be randomized to either (a) an experimental group receiving TMBI or (b) a group receiving treatment as usual (TAU). The intervention will consist of no more than 90 minutes (expected mean is 45 minutes for the intervention based upon previous studies of the TMBI) of 1:1 interaction with a study clinician. All participants will complete a follow-up assessment immediately following TMBI, TAU, or a rest period. Further, patients receiving the experimental intervention will then be asked to complete a client satisfaction survey. The aim will be to assess whether TMBI affects psychological, experimental pain, and autonomic nervous system responses as compared to TAU and community controls.

Eligibility Criteria:
TMBI \& TAU (data collection at Laureate Psychiatric Clinic and Hospital \[LPCH\])

Inclusion:

-admitted to LPCH subsequent to a suicide attempt

Exclusion:

* acute psychosis,
* inability to read English, or
* taking narcotic or opioid pain medication

CCG (data collection in the Psychophysiology Laboratory for Affective Neuroscience \[PLAN\] on the University of Tulsa campus)

Exclusion:

* acute psychosis,
* current suicide ideation,
* history of self-harm,
* inability to read English, or
* taking narcotic or opioid pain medication
Rosuvastatin for Hepatitis C

Objective: Determine if maximum doses of rosuvastatin are safe in patients infected with hepatitis C and if the so called pleiotropic effects of rosuvastatin cause a decrease in the HCV viral load.

Primary study parameters: 1. to which extend causes rosuvastatin serious side effects like rhabdomyolysis and hepatotoxicity in patients chronically infected with hepatitis C? 2. does treatment with rosuvastatin in HCV infected patients lead to lower HCV-RNA viral load? 3. Is a decrease in LDL correlated to a decrease in HCV-RNA load?

Study design: it's a pilot study in which the patients form their own control group. A total of 10 patients will be included. To evaluate the effect of maximum doses of rosuvastatin on liver function and side effects, first 2 patients will be treated and evaluated. If they experience no serious adverse events then a further 8 patients will be included. The dose of rosuvastatin will be increased over a period of 4 weeks.

Intervention: based on experience in treating dyslipidemia, gradually increasing the dose of rosuvastatin diminishes the experienced side effects and decreases the chances of developing hepatotoxicity. Therefore in this study we chose to increase the dose (see flowchart). Patients will start with 5 mg a day wich will be increased after 1 week to 10 mg per day. After the second week of therapy a further increase to 20 mg per day is executed. This dose will be given for another 2 weeks. At week 4 of treatment a further increase to 40 mg is done.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65 years
* All patients with hepatitis C (all genotypes)
* negative for hepatitis B and HIV
* ALAT \< 2,5 x below the upper limit of normal
* serological evidence of hepatitis C infection with detectable HCV-RNA (with Bayer Versant HCV bDNA V3.0)
* failed current standard of care treatment with peginterferon and ribavirin
* WHO-score ≤1
* fertile women must have a negative pregnancy test in the week before start of medication. Use of contraceptives during the whole study-period
* physically and mentally able to attend outpatients clinics

Exclusion Criteria:

* Hepatitis C patiënts naive for (peg)interferon and ribavirin treatment
* Alcohol abuses (\> 20 grams per day) in the last year
* liver cirrhosis detected through liver biopsy or decompensated liver disease (child-pugh B or C)
* concomitant treatment with hepatotoxic medication / interfering with CYP450 system: anti-fungal medication (voriconazole), antibiotics (gentamycine, azitromycine, claritromycin, erytromycin), immuun-suppresive drugs (cyclosporine), anti-arythmia (diltiazem, verapamil) and tuberculostatic drugs (rifampicin).
* current statin use
* active pregnancy or wish of pregnangy
* use of grapefruit juice
* mentally not fit to participate in the study
* daily use of more than 2 grams of paracetamol
Turkish Adaptation, Validity and Reliability of Pound Satisfaction Scale in Patients With Stroke After Stroke Rehabilitation

The aim of this study is to adapt the Pound Satisfaction Scale (PSS) to Turkish society in stroke patients and to make its validity and reliability in Turkish. The PSS scale developed by Pound et al evaluates the patient's satisfaction with the received rehabilitation program and services received in stroke patients. The PSS scale will be filled in face-to-face with volunteer participants who have received a stroke rehabilitation program and meet the inclusion criteria. 130 participants will be included in the study. In order to assess the concurrent validity of the PSS, the SF-36 (short form) which evaluates the quality of life, and the Patient Satisfaction Scale in Physiotherapy (PSSP) which evaluates patient satisfaction will be used. Scales will be repeated after 15 days to assess test-retest reliability.

The reliability and validity of the scale will begin with language equivalence and cultural adaptation. The scale will be translated from English to Turkish by two people who are fluent in Turkish and English. A single Turkish translation will be obtained from these two Turkish translations with a common opinion. The scale, which has been translated into Turkish, will be translated into English by two other people who are fluent in Turkish and English. The scale translated into English will be compared with the original. If the developer of the scale approves the translation of the scale, participants will be recruited for the study. In the pre-trial phase, a preassessment will be conducted with 15 participants to test the intelligibility of the scale. Based on the results of the pre-test phase, the final version of PSS will be able to be modified. The PSS scale will be filled in face-to-face with volunteer participants who have received a stroke rehabilitation program and meet the inclusion criteria. 130 participants will be included in the study. In order to assess the concurrent validity of the PSS, the SF-36 (short form) which evaluates the quality of life, and the Patient Satisfaction Scale in Physiotherapy (PSSP) which evaluates patient satisfaction will be used. Scales will be repeated after 15 days to assess test-retest reliability.

Eligibility Criteria:
Inclusion Criteria:

* To benefit from Physiotherapy and Rehabilitation services,
* Mini mental state examination (MMSE) score\> 24
* Patients with stroke
* Native language being Turkish

Exclusion Criteria:

* Native language not being Turkish
* Patients with motor sequelae from other diseases and insufficient cognitive or educational level to complete the scale
* Mini mental state examination (MMSE) score \< 24
Lifestyle Intervention on Patients With Overweight or Obesity

This study aims to analyze the effects of a 3-month self-applied online program, focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on adults with obesity. Participants will be recruited by 8 doctors from 6 public Health Centers. These patients will be randomized allocated into two interventional groups: the experimental group will receive audiovisual instructions from their specialist doctor, and the control group from a doctor outside the patient. Assessment will include sociodemographic variables, body mass index, blood pressure, glycemic and lipid metabolism variables, physical activity level, adherence to the Mediterranean diet, therapeutic alliance, and health-related quality of life. The randomization process will be stratified according to BMI, therapeutic alliance, age, and sex.

Obesity or being overweight, even other associated comorbidities, involve a worrying public health problem. The evidence shows that healthy eating and regular physical exercise, monitored by different means (internet, face to face, exercise diaries), play an important prevention role to maintain health while ageing. In this way, Information and Communication Technologies (ICTs) have been demonstrated as a useful tool to promote health, working on barriers at the same time, such as low motivation and difficulties maintaining regular exercise and/or healthy eating habits. ICTs also allows to reach a wider audience at a lower cost, due to their good cost-benefit relationship and the possibility of increasing the efficiency of interventions. Therefore, this study aims to analyze the effects of a 3-month self-applied online program, focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on adults with obesity. Participants will be recruited by 8 doctors from 6 public Health Centers. These patients will be randomized allocated into two interventional groups: the experimental group will receive audiovisual instructions from their specialist doctor, and the control group from a doctor outside the patient. Assessment will include sociodemographic variables, body mass index, blood pressure, glycemic and lipid metabolism variables, physical activity level, adherence to the Mediterranean diet, therapeutic alliance, and health-related quality of life. The randomization process will be stratified according to BMI, therapeutic alliance, age, and sex.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or grade I obesity (BMI \> 25 and \< 35).

Exclusion Criteria:

* No access to the Internet or a smartphone.
* Not having visited their doctor at least once in the last 2 years.
* Meeting DSM-IV-TR criteria for an Eating Disorder.
* Having a diagnosed serious psychological disorder (psychosis, bipolar disorder, major depressive disorder, substance abuse disorder, etc.).
* Having any disability that prevents or hinders exercise and physical activity.
* Receiving any weight loss treatment at another center.
A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease

This is a multi-center trial to further extend the assessment of the safety and efficacy of taliglucerase alfa in adult subjects (≥18 years old) with Gaucher disease who have enrolled in Protocol PB-06-003. Subjects will continue to receive an intravenous (IV) infusion of taliglucerase alfa every two weeks. The duration of treatment will be a maximum of 21 months or until taliglucerase alfa is commercially available to the subject at the discretion of the Sponsor.


Eligibility Criteria:
Inclusion Criteria:

* Successfully completed Protocol PB-06-001 and enrolled in Protocol PB-06-003
* The subject signs an informed consent

Exclusion Criteria:

* Currently taking another investigational drug for any condition.
* Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the subject's compliance with the requirements of the study.
Assessment of the Effectiveness of Low-Level Laser Therapy on the Hands of Patients With Rheumatoid Arthritis

The purpose of the present study was to assess the effectiveness of low-level laser therapy on the reduction in pain and improvement in function in the hands of patients with rheumatoid arthritis

Rheumatoid arthritis (RA) is a chronic inflammatory disease of unknown etiology that basically compromises the joints in a generalized, symmetrical, additive and usually progressive manner. This clinical condition includes pain and altered functionality. Low-level laser therapy (LLLT) has been studied since the 1970s with regard to its therapeutic effects. The literature suggests that it offers analgesic as well as anti-inflammatory benefits.

A number of studies carried out in the laboratory and on animals have shown that LLLT contributes toward the treatment of inflammatory joint disease. However, studies on humans with RA have yielded controversial results. A large part of the authors researched state that further randomized double-blind controlled studies should be carried out to prove the effectiveness of LLLT on RA. Thus, the aim of the present study was to assess the effectiveness of LLLT on the reduction in pain and improvement in function in the hands of patients with RA.

Eligibility Criteria:
Inclusion Criteria:

* patients with RA
* inflammatory condition of at least two hand joints among the wrists, proximal interphalangeal (PIP) joint and metacarpophalangeal (MCP) joint
* visual analogue scale (VAS) for pain between 3 and 8 cm during activities of daily living
* and being of either gender

Exclusion Criteria:

* skin lesions at the application site
* other illnesses affecting the hands; physiotherapy for the hands in the previous three months
* joint injections in the previous three months
* change in disease-modifying anti-rheumatic drugs in the previous three months
* and change in corticosteroids in the previous month.
Efficacy of Cortex Stimulation in Neuropathic Pain

The pains chronic neurogeneses remain difficult to treat whatever are their origin and their localization. The pharmacological therapeutic arsenal answers only partially the symptomatology often very invalidating which these chronic painful patients present. Electric stimulations of the central nervous system currently validated, in particular of the posterior cords of marrow made a significant improvement in a certain number of indications. Nevertheless, considerable patients are not relieved significantly, in particular those presenting of the pains neurogeneses of central origin (syndromes thalamic for example). It is within this framework that recently the stimulation of the sensorimotor cortex developed.

Principal objective: evaluation of the technique of stimulation under cortical on neuropathic pains .

The pains chronic neurogeneses remain difficult to treat whatever are their origin and their localization. The pharmacological therapeutic arsenal answers only partially the symptomatology often very invalidating which these chronic painful patients present. Electric stimulations of the central nervous system currently validated, in particular of the posterior cords of marrow made a significant improvement in a certain number of indications. Nevertheless, considerable patients are not relieved significantly, in particular those presenting of the pains neurogeneses of central origin (syndromes thalamic for example). It is within this framework that recently the stimulation of the sensorimotor cortex developed.

Eligibility Criteria:
Inclusion Criteria:

* Neurofibromatosis,
* Rebel chronic neuropathic pain with duration \> 1 year and AVS \> = 4

Exclusion Criteria:

* Cancer
* Epilepsy
* Cognitive deterioration
Economic Evaluation of Stream™ Platform

This Economic Evaluation study is a multi-center, two-arm, non-randomized, interventional trial. The purpose of this study is to evaluate the economic and patient outcomes of using the Stream™ Platform for early detection of anastomotic leakage after gastrointestinal surgery. The trial will track patient outcomes and healthcare costs in two groups: the intervention group, where the Stream platform is deployed, and the control group, before the integration of the Stream™ Platform. The data collected from both groups will be compared to assess the impact of implementing the Stream™ Platform and early leak detection on overall patient outcomes and healthcare costs.This trial will include hepatobiliary, colorectal, and trauma/acute care patient populations.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years - Male or Female
* Subject understands and has voluntarily signed and dated the informed consent form (ICF).
* Subjects must be willing to comply with trial requirements
* Subject has performed an open or laparoscopic surgery with peritoneal or pelvic drainage

Exclusion Criteria:

* Subject is pregnant
* Subject will be discharged \< 8 hours post-surgery
* 24 or more have passed since the end of the subject's surgery
* Involvement in the planning and conduct of the clinical investigation
* Subject is allergic to contrast medium
* Participation in another investigational drug or device study which would interfere with the endpoints of this study
* Device does not attach to drain used on the subject
Managing Distress in Malignant Brain Cancer

To identify potential adaptations of the managing cancer and living meaningfully (CALM) intervention that will be required for service members, Veterans, their beneficiaries, and civilian cancer metastasis to the brain (bMET) populations.

Single-arm, mixed-methods, Phase IIa, proof-of-concept trial to inform CALM adaptations for service members (SMs), Veterans, their beneficiaries, and civilians with bMET.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of brain metastasis (bMET) confirmed via medical records, radiography or histopathology
* At least 2 weeks post-surgical cranial resection or cranial biopsy (if applicable)
* Score \> 20 on the TICS
* Report elevated depression (PHQ-9 score ≥ 10) OR death anxiety symptoms (DADDS score ≥ 15)
* Ability to read, speak, and understand English
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Major communication difficulties, which would prohibit psychotherapeutic interaction
* Inability to meet with interventionist via an electronic device for telehealth intervention sessions
* Inability to understand and provide informed consent
* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the participant's risk