cyrilzakka/clinical-trials huggingface dataset:
Task-oriented Training for Stroke: Impact on Function Mobility

Residual neurological deficits from stroke lead to gait inefficiencies, resulting in an extremely high energy cost of movement and contributing to overall disability and lower quality of life. Therefore, interventions targeting movement economy should be developed for those in the chronic phase of stroke recovery. This study is designed to compare the effect of two distinctly different exercise paradigms (a higher-intensity treadmill training program and a lower-intensity group exercise program) on economy of movement during over-ground walking and activities of daily living, as well as the extent to which gains in muscular strength, muscular endurance, and balance predict changes in movement economy.


Eligibility Criteria:
Inclusion Criteria:

* Stroke \> 6 months prior with residual hemiparetic gait in women or men aged 40-85 years.
* Completion of all regular post-stroke physical therapy
* Adequate language and neurocognitive function to participate in testing and training and to give adequate informed consent.
* Able to rise from a chair unaided.
* Able to walk 10 meters without human assistance.

Exclusion Criteria:

* Regular structured aerobic exercise (\> 2x week).
* Alcohol consumption \> 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report.
* Clinical history of

  * unstable angina,
  * recent (\< 3 months) myocardial infarction or congestive heart failure (NYHA category II),
  * hemodynamically significant valvular dysfunction,
  * Peripheral Arterial Obstructive Disease with claudication,
  * major orthopedic, chronic pain, or non-stroke neuromuscular disorders restricting exercise,
  * pulmonary or renal failure,
  * poorly controlled hypertension (\>190/110), measured on at least two separate occasions
  * recent hospitalization for severe disease or surgery
  * severe or global receptive aphasia which confounds reliable testing and training.
* Untreated major depression as documented by a Center for Epidemiological Studies-Depression score of \>16 and confirmed by clinical interview.
* Pregnancy.
Sustained HBsAg and Viral Response in Patients Achieved HBsAg Loss by Interferon Treatment

Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of cirrhosis and hepatocellular carcinoma (HCC).HBsAg loss/seroconversion is considered to be the ideal endpoint of antiviral therapy in both HBeAg-positive and HBeAg-negative patients, as well as the ultimate treatment goal in CHB. However, some patients who have achieved HBsAg loss would reverse back to HBsAg positive, or even become HBV reactive with recurrence of viremia. In current study, the viral and HBsAg response in patients who have achieved HBsAg loss by interferon (IFN) treatment will be observed for 96 weeks after the completion of IFN treatment. The primary analysis will be performed at the end of 96 weeks. Following the completion of the study period of 96 weeks, patients will be offered to participate in a long term study for further observation of additional 144 weeks (total of 240 weeks from the enrollment).

Chronic hepatitis B patients who have achieved HBsAg loss from interferon treatment will be enrolled and observed for 96 weeks. Serum HBV DNA, HBsAg, anti-HBs, HBeAg, and anti-HBe will be measured every 3 months during the observation period. Their liver function and chemistry tests are also performed every 3 months. The liver ultrasonic examination would be taken every 3-6 months. The primary measurement is the percentage of patients who have positive HBsAg and/or a detectable level of HBV DNA. Following the completion of the study period, patients will be offered to participate in a long term study for further observation of additional 144 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had chronic hepatitis B and achieved HBsAg loss by interferon treatment.

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver
Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil®

Considering the total number of thyroid procedures in Germany (100000 - 120000 cases per year), TachoSil® is a valuable tool to support surgical haemostasis, avoiding lymph leaks and support speech-nerve saving approaches. The aim of this study was to evaluate a patient and procedure profile where TachoSil® is most beneficial.


Eligibility Criteria:
Main Inclusion Criteria:

* Patients undergoing total or subtotal thyroidectomy

Main Exclusion Criteria:

* Contraindications, such as hypersensitivity to the active pharmaceutical ingredient or to another ingredient
Cognitive and Metabolic Effects of a Probiotic Supplement

To examine the cognitive and metabolic effects of a probiotic supplement that is readily and already available for purchase in public drug stores. This study is a double-blinded randomized cross-over placebo-controlled intervention study. Participants will be randomized to receive either the probiotic supplement or the placebo during the first intervention period which will last 2 weeks. This will be followed by a washout period, after which they will proceed to the second intervention period, also lasting 2 weeks and also followed by a washout period.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 18-28y
* Healthy (self-reported) and not on medication
* Non-smoking
* Normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported via diaries)
* Regular meal patterns with daily breakfast

Exclusion Criteria:

* Major illness
* Taking any serious medications
* Any sleep conditions (e.g. irregular bedtimes, sleep complaints)
* Any dietary issues with the food items provided
* Current or history of endocrine, neurological or psychiatric disorders
* Shift work in the preceding three months or for a long duration
* Time travel over a significant number of time zones in the preceding two months
* Too much weight gain or weight loss in the preceding three months
* Excessive intake of fermented dairy products
* Intake of probiotics
* Recent antibiotic treatment (last 6 months)
* Recent intake of certain dietary supplements
* Excessive caffeine (\>5 cups daily) or alcohol intake (\>2 alcohol units daily)
Effect of Back School-based Intervention on Non-specific Low Back Pain in Adults.

The study consists of a theoretical and practical intervention based on the Back School. This intervention will be carried out over 8 weeks with a frequency of two sessions per week, for a total of 16 sessions of 45 minutes duration. Of all the sessions, 14 had a practical focus (strength and stretching exercises) and the other two had a theoretical focus (self-management techniques and pain neuroscience education). In addition, they had an initial session and a session at the end of the of the intervention in which measurements of the different variables were taken (The Visual Analogue Scale; Roland morris disability questionnaire scoring; Short Form 36 Health Survey; Tampa Scale Of kinesiophobia).These variables will be measured on two occasions, at the beginning of the study and at the end of the intervention, an average of 2 months.

The clinical practice guidelines highlight the importance of neck pain prevention through exercise an education. There are previous studies of the effects of theoretical and practical programmes based on back school on the lumbar region but not on the cervical region. Therefore, the aim of this study is to investigate the effects of a BS-based intervention on low back pain and functionality as well as kinesiophobia and quality of life in adults. The hypothesis previously hypothesised that this BS-based intervention would have positive effects on pain, functionality, kinesiophobia and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age. With non-specific low back pain for at least three months, with pain intensity (30-70 on a VAS).

Exclusion Criteria:

* History of cancer, spine infection, rheumatologic diseases, history of spine fracture, history of trauma, red flag signs including unwanted weight loss (exceeding 10 percent of the total body weight) in the past six months and fever, history of psychological disease and history of spine surgery, radiculopathy, anatomical and congenital disturbance.
* Missing more than two Back School sessions.
* Not being able to attend the measurement sessions.
Effect of Muscle Energy Technique Versus Strain-counterstrain on Upper Trapezius Trigger Points

Aim of the study To determine the comparative effects of muscle energy technique and strain counter strain in upper trapezius trigger point.

A Randomized Controlled trial will be conducted after approval of synopsis. To enroll patients Purposive sampling technique will be used. Patients will be selected according to the pre-defined inclusion and exclusion criteria. The enrolled patients will be allocated into two groups, group A and group B. On Group A muscle energy technique will be applied for 30 seconds and repeat 3 to 5 times per on treatment session and Group B will be treated with strain counter strain for 20-30 seconds and repeat this process for up to five times. Assessment will be done at baseline, 2nd week, 4th week and 6th week of treatment. Follow up will be assessed 15 days after completion of treatment protocol. The patients' outcome will be measured by Visual Analog Scale for pain intensity and Neck Disability Index . Informed consent will be taken from each patient. Statistical Package of Social Sciences software, version 20 will be used for the analysis of data.

Eligibility Criteria:
Inclusion Criteria:

1. Participants who are 18 to 34 years old
2. In upper trapezius From 2 weeks Had mechanical neck pain and was diagnosed with active myofacial Trigger points
3. Subjects have to exhibit a tendor point in the upper trapezius muscle either on the left or right side
4. Local pain is greater than 3/10 on Visual Analog scale

Exclusion Criteria:

1. Patient with cervical radiculopathy
2. Patients with Fibromyalgia syndrome
3. Patients who had cervical spine surgery
4. Patient with myelopathy
5. Patients who had myofacial pain therapy
Economic and Clinical Benefit of Remote Monitoring Among Defibrillator Patients by Indication Subgroups (BENEFIT-RM)

Remote monitoring is now universally available for all cardiac implantable electronic devices (CIEDs), and it has become the standard of care for the management of patients with these devices. In many countries, it is being proven that patients with implantable defibrillator (ICD) or cardiac resynchronizing therapy (CRT) can benefit from remote monitoring (RM) both economically and clinically. From previous RM related clinical studies, it is reasonably accepted that hospitalization cost and mortality rate is comparably higher in defibrillator patients compared to pacemaker indicated patients.

However, it is yet to be discovered which group of defibrillator patients are the most beneficiaries using remote monitoring system. In this study, the investigators would further categorize defibrillator patients into different indication subgroups and compare both economic and clinical benefits among different indication. By comparing economic and clinical benefits of remote monitoring by different subgroups, the investigators might be able to set a guideline on which group of patients should be strongly suggested for remote monitoring utilization.

Therefore, the investigators perform a prospective study in Korean population to compare economic and clinical benefits of RM compared to conventional follow-up in overall study cohort and by different subgroups. (ICD \& CRT-D).

The investigators propose to prospectively recruit 556 patients with ICD or CRT-D implantation in 10 sites in Korea.

* Eligible patients should be enrolled in remote monitoring system 0 to 45 days after successful device implantation and then randomly assigned in a 1:1 ratio to the RM or conventional follow-up group.
* In the RM follow-up arm, the patients are not mandated to visit the clinic unless there is unscheduled call due to adverse event notification.
* In the conventional follow-up arm, the patients should be seen at the clinic according to each center's custom but no longer than 1 year between each visit. Follow-up should be continued accordingly until two-years of device implant.

Eligibility Criteria:
Inclusion Criteria:

1. All ICD and CRT-D patients who are over the age of 18
2. Ability to provide informed consent and to complete the study and required follow-up

Exclusion Criteria:

1. Those who refuse to participate in the trial.
2. Those who refuse to use remote monitoring system or who live in an environment where remote monitoring system cannot be utilized.
3. Patient who refuse to use or expected to use less than 75% of remote monitoring system.
Task-State-Based Temporal Interference Stimulation (TI) to Improve Depression in Patients With Bipolar Disorder

The purpose of this study is to investigate the efficacy and safety of temporal interference stimulation (TI) in improving depressive episodes of bipolar disorder, to analyze the therapeutic principle of TI in bipolar disorder depressive episodes based on task state MRI scanning, and to explore the abnormal regulation mechanism of anhedonia neural circuit.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 16-50 years, right-handed, and completed nine years of compulsory education;
2. Meet the diagnostic criteria for bipolar disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
3. HAMD-17: \>17 points , assessed the presence of rapture deficits;
4. Subject had not been treated with a mood stabilizer, or had previously used an antidepressants and currently off medication for ≥1 week;
5. The subject/legal guardian is willing to actively cooperate with the treatment and sign an informed consent form after being fully informed of the temporal interference stimulus (TI).

Exclusion Criteria:

1. Co-morbid other psychiatric disorders, including affective psychiatric disorders, anxiety spectrum disorders, mental retardation, substance dependence (abuse), etc.;
2. History of a serious physical illness or a disease that may affect the central nervous system;
3. Neurologic disorders or risk of seizures such as previous cranial disorders, head trauma, abnormal electroencephalograms, magnetic resonance evidence of structural brain abnormalities, or a family history of epilepsy;
4. Contraindications to magnetic resonance scanning or time-interference stimulation (TI), such as the presence of metallic or electronic devices in the body (intracranial metallic foreign bodies, cochlear implants, pacemakers and stents, and other metallic foreign bodies);
5. Those who have received or are receiving electroconvulsive therapy (ECT ), modified electroconvulsive therapy (MECT ), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neurostimulation treatments;
6. Pregnant and lactating women, and women of childbearing age with positive urine pregnancy.
A Long-Term Study of Aripiprazole in Patients With Major Depressive Disorder

This trial is a 52-week safety study to evaluate the safety of adjunctive aripiprazole in outpatients with major depressive disorder who have experienced an incomplete response to an ongoing antidepressant trial.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, 18 years or older
* Experiencing Major Depressive Disorder with a duration of minimally 8 weeks.
* Treatment history of an inadequate response to at least one and no more than four antidepressants
Use Misoprostol to Optimize Prevention of Cervical Cancer

This is a double-blind randomized controlled trial of 420 non-pregnant women undergoing cancer screening by visual inspection with acetic acid (VIA) who have Type 3 transformation zone (TZ) and randomized to receive either Misoprostol or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 3 TZ confirmed on exam prior to randomization
* Age 25 years or older

Exclusion Criteria:

* With Type 1 or 2 TZ prior to randomization
* Currently pregnant
* History of hysterectomy
* Any cancerous lesions
* Active cervicitis
Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus

Following a transplant for hepatitis C cirrhosis, the infection comes back in 70-90% of cases and over time causes fibrosis and eventually cirrhosis of the new liver. The aim of this study was to see if the frequency of liver fibrosis was different with cyclosporine microemulsion than tacrolimus


Eligibility Criteria:
Inclusion criteria

* Reason for transplant is end-stage liver disease due to hepatitis C cirrhosis
* Patients receiving a first liver transplant from a deceased or living donor
* Patients in whom biopsies will be possible

Exclusion criteria

* Recipients of a liver from an hepatitis C virus positive (HCV+), human immunodeficiency virus positive (HIV+) or hepatitis B virus positive (HBV+) donor
* Patients with any severe coexisting disease or suffering any unstable medical condition or co-infected with HBV or HIV
* Patients with co-existing alcoholic disease who have not been abstinent for at least 6 months
* Transplanted for liver cancer exceeding a pre-defined size
* Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply
Promoting Healthy Development With the Recipe 4 Success Intervention

10-session home visit intervention conducted within Early Head Start and designed to reduce low-income toddler's obesity risk and improve their self-regulation skills and parents' sensitivity.

Recipe 4 Success, the product of a university-community engagement collaboration, uses 10 tightly sequenced, structured, and scripted food preparation lessons, delivered as part of Early Head Start home visits, to help low-income parents learn to sensitively scaffold their toddler's self-regulation skills and establish more healthy eating habits. The intervention relies on an active coaching therapeutic approach to deliver content. Recipe 4 Success is focused on parents because their feeding practices influence children's diet, and interventions to prevent childhood obesity are most likely to have long-term effects when they emphasize positive parenting practices. Parents' sensitivity and constructive scaffolding behaviors are related to children's self-regulation skills, which are robust predictors of healthy eating habits and body mass index (BMI). For example, children who have difficulty with self-regulation by age 3 have a higher BMI through age 12. Importantly, these relations may be causal: Adults who are taught self-regulation skills appear more successful in maintaining healthy eating habits over time. As a preventive intervention, Recipe 4 Success is implemented when children are 2, the point at which deliberate self-regulation skills are starting to emerge and develop rapidly and taste preferences are being formed. Recipe 4 Success is designed for families living in poverty because parents are less likely to provide sensitive scaffolding and children are less likely to display well-developed self-regulation skills and healthy eating habits under conditions of economic adversity. Finally, Recipe 4 Success was created to be integrated into Early Head Start to expedite wide-spread dissemination and easy sustainability and to enhance the efficacy of this nation-wide home visit program. If successful, this will be one of the first preventive interventions to improve either toddler's self-regulation skills or their healthy eating habits and BMI.

Eligibility Criteria:
Inclusion Criteria:

* Family lives in York, Allentown, Williamsport/Lock Haven Pennsylvania
* Family enrolled in Early Head Start home visit program
* Target child 18-36 months old at beginning of study

Exclusion Criteria:

* Family considered "in crisis" by home visitor (i.e., not able to focus on new intervention lessons because of child custody, family violence, mental health, or housing issues that currently demand parents' full attention)
PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis

This is a pilot, single-arm, open label study to evaluate the ability of CYTALUX™ (pafolacianine) to help identify cancerous lesions in subjects with gastrointestinal cancers and peritoneal carcinomatosis during cytoreductive surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 years of age and older
* Have a primary diagnosis of primary gastrointestinal cancer (of adenocarcinoma), planned for cytoreductive surgery
* Female patients must have a negative serum pregnancy test at screening, followed by a negative urine pregnancy test on the day of scheduled study drug infusion, or day of surgery
* Female patients of childbearing potential, or less than two (2) years postmenopausal, agree to use an acceptable form of contraception from time of signing informed consent until 30 days after study completion
* Ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and disclosure of protected health information, and agree to abide by study restrictions

Exclusion Criteria:

* Previous exposure to CYTALUX™ (PAFOLACIANINE)
* Patients with known gastrointestinal cancer with carcinomatosis determined pre-operatively to be inoperable
* Any medical condition that in the opinion of the investigators could potential jeopardize the safety of the patient
* History of anaphylactic reaction
* History of allergy to any components of CYTALUX™ (PAFOLACIANINE), including folic acid
* Pregnancy, or positive pregnancy test
* Clinically significant abnormalities on ECG
* Impaired renal function defined as eGFR \<50 mL/min/1.73m2
* Impaired liver function defined as values \>3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin
* Received an investigational agent in another trial within 30 days prior to surgery
* Known sensitivity to fluorescent light