cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial Comparing Short-Term Efficacy and Safety of Exubera and Lantus

To compare short-term efficacy and safety of Exubera vs Lantus in patients with type 2 diabetes mellitus


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus Type 2

Exclusion Criteria:

* Severe Asthma, severe COPD
* Smoking
Comparison of Effects of Activity Base Therapy vs Strength Training on Gait Performance in Chronic Stroke

Stroke is a leading cause of disability worldwide affecting both male and female especially in older people. Functional independence and locomotion are hampered in stroke, therefore, affecting their quality of life. Objective: To find the comparative effects of activity base therapy vs strength training on gait performance in chronic stroke patients.

It was a randomized controlled trial, conducted in physical therapy department of Sir Ganga Ram Hospital. 20 chronic stroke patients were equally divided into two groups. In group-A patients were treated with activity base therapy and in group-B patients were treated with strength training. Patients were treated for a total of 6 weeks (12 sessions), 1 hour in a day, 3 times per week. Patients were assessed using Timed Up and Go (TUG) test and Fugl Meyer Examination-Lower Extremity (FME-LE). SPSS 25 was used toanalyze the dat

Eligibility Criteria:
Inclusion Criteria:

* Participants were at least 6 months post stroke.
* Ability to walk independent or with help of walking aids
* Ischemic stroke patients included in study.
* Mini mental state examination patients fully understand the commands

Exclusion Criteria:

* Presence of orthopaedic problems.

  * Neurological disorders.
  * Psychological problems.
  * Cognitive issues.
  * People with severe visual issues.
  * Participants with other medical complications foot ulcers, orthopaedic or other neurological impedance
Propofol-fentanyl-ketamine (PFK) Combination Versus General Anesthesia Using Propofol and Fentanyl in Patients Undergoing Endoscopic Procedures.

Conscious sedation provides adequate control of pain and anxiety for the majority of routine endoscopic procedures as well as adequate amnesia. Sedation practices vary widely, with some colonoscopists advocating sedation only for the most difficult cases of colonoscopy, while others prefer using deep sedation or general anaesthesia for colonoscopy. However, many physicians are still using moderate sedation for the majority of patients.

The use of propofol, a short acting anesthetic agent, for conscious sedation provides a considerably more rapid onset of action and shorter recovery time, for which it is believed to be a safe drug of choice for patients undergoing endoscopic procedures. Although propofol cannot be used as a single agent for moderate sedation, it can be effectively titrated to moderate sedation after administration of small doses of narcotics and sedatives.

The aim of this study is to compare between general anesthesia and deep sedation using propofol-fentanyl-ketamine (PFK) preparation in terms of perioperative vital signs, intraoperative awareness, post-operative pain scores, and the use of analgesia postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* patients who were admitted for endoscopic and colonoscopic procedures.
* ASA (American Society of Anaesthesiologists physical status) score from 1 to 3.

Exclusion Criteria:

* patient refusal.
* urgent and emergency cases, which were not elective procedures.
* Surgeries that were expected to take a long duration (more than 1.5 hour).
Development of Imaging, Clinical and Biochemical Bio-Markers for Parkinson's Disease

We propose to build on preliminary data evaluating non-dopaminergic/non-motor clinical biomarkers to more fully assess these markers at the threshold of Parkinson disease (PD).

Development of reliable biomarkers for both dopaminergic and non-dopaminergic manifestations of Parkinson disease (PD) and related disorders may dramatically accelerate research on PD etiology, pathophysiology, and therapeutics. Biomarkers are broadly defined as characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. Specific biomarkers may be useful at the onset of neurodegeneration, the onset of disease, and/or to mark disease progression.

Two hundred patients who have undergone neurological evaluation by their general community neurologist and have a questionable diagnosis of PD will be recruited to participate in this study. Subjects will be referred by the neurologists to the Institute for Neurodegenerative Disorders (IND) in New Haven, CT.

All subjects will be clinically evaluated at IND by a two movement disorders experts. At the baseline visit all subjects will also undergo \[123I\]ß-CIT SPECT ANAM, voice acoustics, olfactory, Spiral and biochemical testing. Each movement disorders expert will make an initial clinical diagnosis at baseline and again within three months follow-up. At the three month visit one movement disorder expert will be provided the DAT imaging data and will review that data with the subjects and referral physician. The other movement disorders physician will remain blind to the imaging and all other biomarker data. The blinded movement disorders expert will provide a final clinical diagnosis at the 12 month follow-up visit, which will represent the 'gold standard' diagnosis in this study. Statistical analysis to determine the sensitivity and specificity of ANAM, voice acoustics, olfactory, Spiral and biochemical testing compared to \[123I\]ß-CIT SPECT, and the gold standard clinical diagnosis will be completed. All subjects with DAT deficit and 10% of those without DAT deficit will be asked to return for repeat evaluation at 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Older than 21
* Any parkinsonian symptoms
* Referral by community neurologist
* Parkinsonian symptoms for less than 2 years duration.
* Willingness to follow the study plan.

Exclusion Criteria:

* Pregnancy
* Significant medical disease including abnormalities on screening biochemical or hematological labs or abnormal electrocardiogram (ECG - tracing of the electrical activity of the heart)
Optical Stimulation in Peripheral Nerves for Select Rhizotomy Procedures

The purpose of this study is to determine the safe and effective levels of optical stimulation in peripheral nerves of humans otherwise undergoing nerve lesioning in surgery.

The purpose of this study is to determine the safe and effective levels of optical stimulation in peripheral nerves of humans otherwise undergoing nerve lesioning in surgery, namely children undergoing selective rhizotomy for treatment of medically refractory spasticity.

Eligibility Criteria:
Inclusion Criteria:

* Children over the age of 3 and younger than 17 years
* Children who have failed appropriate medical therapy and are recommended for selective rhizotomy to treat spasticity by the pediatric neurosurgeon
* Children who would normally undergo electrodiagnostic testing including EMG monitoring for physiologic testing during surgery
* Surgery must be performed at the Vanderbilt University Children's Hospital

Exclusion Criteria:

* Patients in which a segment of the nerve (up to 2cm) cannot likely be identified at the time of surgery as determined by the pediatric neurosurgeon
* Children not undergoing routine selective rhizotomy for medically refractory spasticity as determined by the pediatric neurosurgeon
* Children who are medically unstable to tolerate an additional 20 minutes of experimental testing during the surgery
* Women who are pregnant will be excluded from this study
Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With Epilepsy

Multidose, Open-label, Multi-center Study to examine the steady state pharmacokinetics of TPM XR, as well as, safety and tolerability of repeated oral dosing in pediatric subjects with epilepsy.


Eligibility Criteria:
Inclusion Criteria:

1. Able to provide written IAF, as appropriate, with written informed permission (including ICF where required by regional laws or regulations) from the parent or LAR.
2. Male or female aged 4 to 17 years, inclusive, with a current diagnosis of partial onset or primary generalized epilepsy.
3. Current AED therapy including a stable dose of TPM IR as either adjunctive or monotherapy. All AED therapy (including a Vagal Nerve Stimulator) must have been initiated more than one month prior to Visit 1 and doses must be stable for at least two weeks prior to Visit 1.
4. No diagnosis of a progressive neurological disorder based on previous imaging.
5. Weight within the 25 - 80% weight-for-age percentiles based on the National Center for Health Statistics Growth Charts, and not less than 15.0kg.
6. Able and willing to swallow whole capsules.
7. FOCP should either be sexually inactive for two weeks prior to the first dose and throughout the study or, if sexually active, will be using an effective birth control method.

Exclusion Criteria:

1. A documented history of status epilepticus in the past year or seizures secondary to conditions other than epilepsy.
2. Use of either phenytoin or carbamazepine as current AEDs.
3. Diagnosis or an electroencephalogram consistent with a diagnosis of seizure disorders other than partial onset or primary generalized epilepsy.
4. Current diagnosis of Major Depressive Disorder or any history of suicide intent and/or attempt.
5. History or presence of clinically significant, chronic medical condition which, in the opinion of the Investigator, would preclude the subject from entering the study.
6. History of substance abuse or dependence.
7. Females who are pregnant or lactating.
8. Use of an investigational drug or device or participation in an investigational study within 30 days prior to the first dose of SM.
Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Androgen Resistant Metastatic Prostate Cancer

PRIMARY OBJECTIVES:

Determination of safety and toxicity of vaccination with mRNA transfected DC (based on blood samples, and adverse events).

SECONDARY OBJECTIVES:

Determine immunological response to the vaccine (induction of specific T-cell response) and assessment of tumour response.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 45 years of age.
* Must have histologically confirmed adenocarcinoma of the prostate.
* Must have evidence of disease progression while on LHRH agonist, or orchiectomy, with or without an antiandrogen for advanced prostate cancer. All patients will be maintained on the hormone regimen throughout this protocol that they were receiving at the time of entry or recent progression. Increasing PSA in three subsequent analysis.
* Must be ambulatory with a ECOG performance score of \<2
* Lab.values as following :ANC ( 1.5 x 109/L; platelets ( 100 x 109/L, Hb ( 9 g/dL (( 5.6 mmol/L). Creatinine ( 140 µmol/L (1.6 mg/dL); if borderline, the creatinine clearance ( 40 mL/min, Bilirubin \< 20% above the upper limit of normal, ASAT and ALAT ( 2.5 the upper limit of normal. Albumin ( 2.5 g/L).
* Prior radiotherapy: a minimum of 4 weeks (8 weeks in case of extensive prior radiotherapy) must have elapsed between the end of the prior radiotherapy and entry into the protocol.
* Prior chemotherapy: a minimum of 4 weeks must have elapsed prior to entry in the study.
* If the patient has received strontium-89 and alpha-radin, at least three months must have elapsed prior to entry in the study.
* Informed consent and expected cooperation of the patients for the treatment and follow-up must be obtained and documented according to the ICH-GCP Guidelines.

Exclusion Criteria:

* History of prior malignancy other than prostate cancer, clinically evident within the 24 months preceding enrolment into the study, except curatively-treated basal cell or squamous cell carcinoma of the skin.
* Active infection requiring antibiotic therapy.
* Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
* Autoimmune disease treated with steroid(s)
* History of asthma, anaphylaxis or other serious adverse reactions to vaccines.
* History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis/dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
* Chemotherapy or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination.
* Impending untreated spinal cord compression or urinary outlet obstruction.
* Any reason why, in the opinion of the investigator, the patient should not participate.
A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)

The purpose of this study is to determine if vimseltinib is safe, tolerable and works effectively to treat adults with active moderate to severe cGVHD. Participants will be treated with vimseltinib in 28-day treatment cycles for approximately 2 years.


Eligibility Criteria:
Inclusion Criteria:

1. Must be allogeneic hematopoietic stem cell transplant (HSCT) recipients with moderate to severe cGVHD requiring systemic immune suppression.

   a. May have persistent active GVHD (aGVHD) and chronic GVHD (cGVHD) manifestations (overlap syndrome).
2. Participants with active cGVHD who have received and failed at least 2 prior lines of systemic therapy.
3. Stable dose of systemic corticosteroids is permitted but not required. If being taken, participants should be on a stable dose of corticosteroids for at least 2 weeks prior to starting study drug treatment.
4. Adequate organ and bone marrow functions.
5. Participants of reproductive potential agree to follow the contraception requirements.
6. Karnofsky Performance Scale (KPS) of ≥60.

Exclusion Criteria:

1. Has aGVHD without manifestations of cGVHD.
2. Prior use of colony-stimulating factor 1 receptor (CSF1R) inhibitor for cGVHD.
3. History or other evidence of severe illness, uncontrolled infection, or any other conditions that would make the participant unsuitable for the study.
4. History of malignancy except for:

   1. Underlying malignancy for which the transplant was performed
   2. Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to enrollment and felt to be at low risk for recurrence.
5. Malabsorption syndrome or other illness that could affect oral absorption.
Randomized Control Trial on Seprafilm and Guardix in Preventing Ileus

The purpose of the study is to evaluate the efficacy of Seprafilm and guardix in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs) associated with the use of Seprafilm and guardix occurring within 30 days postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of GI cancer
* Operable

Exclusion Criteria:

* Withdrew consent
* Pregnant
* Ascites
* Distant metastasis
* Liver dysfunction (serum total bilirubin \>2.0 mg/dL)
* Renal failure (serum creatinine \>1.5 mg/dL)
* A past history of small bowel obstruction.
Changes in Brain Activity During Mirror Therapy and Virtual Reality Therapy

The purpose of this study is to compare electroencephalographic activity in upper limb rehabilitation with mirror therapy and virtual reality rehabilitation.

This is an experiment measuring EEG to healthy adult probands during mirror therapy and VR mirroring therapy in the upper limb. The experiment will be supplemented by haptic contact and stimulation of the upper limb with a foam roller. According to the instructions, the participants will perform a predetermined movement with one upper limb - clenching the fist. In one part with the mirror, in the other part the sensor for sensing the movement of the hand detects the movement, the software creates the illusion that the patient performs the same movement with the dominant and non-dominant upper limb. The patient sees on the screen the illusion of movement of both of his upper limbs. During therapy, the other upper limb will be tactively stimulated haptically and with a foam roller. Data collection will take place by measuring the electrical activity of the brain using an EEG device. The obtained data will then be processed and evaluated with the help of the sLORETA program. The aim of this work is to compare the brain activity from the above therapies with the resting state of the proband and to focus on the activity of mirror neurons.

Eligibility Criteria:
Inclusion Criteria:

* a healthy individual with a valid medical examination.

Exclusion Criteria:

* Having a stroke or other illness that is related to a disorder of movement of the upper limbs. Severe visual or auditory deficit and decompensated epilepsy due to screen movement tracking. Persons with acute (especially infectious) diseases did not participate in the research.
The Influence of EMG-triggered Robotic Movement on Function and Mobility of Stroke Patients

Rehabilitation of lower limbs after a stroke supported by robots aims to return to independence and minimize disability caused by the incident, but the results have been mixed. Objective of the study was to assess the changes in gait capabilities, muscle tone and daily activities in patients after a recent stroke who underwent a 6-week supervised rehabilitation process using exercises on the LUNA EMG neurorehabilitation robot. A total of 60 participants with impaired motor function and gait after subacute stroke were included in the study. Each patient was randomly assigned to an intervention (robot) or control group (RG or CG). All patients, except standard therapy, underwent 1 session of therapy per day, 5 days a week for 6 weeks. People with RG had 30 minutes of training sessions on the Luna EMG robot, while CG received exercises on the lower limb rotor. Patients were evaluated before the start of the study, and then after 2, 4 and 6 weeks of therapy using the Ashworth scale, Rivermead mobility index (RMI), Repty functional index, Time Up and Go test (TUG) and muscle circumference on the thigh.


Eligibility Criteria:
Inclusion Criteria:

* ischemic stroke,
* not later than 6 months ago,
* muscle strength of extensors and knee flexors on the Lovetta scale below 3,
* functional disorders of the lower limb,
* patient's condition allowing full understanding of commands
* continued/uninterrupted rehabilitation process for 28 days

Exclusion Criteria:

* cognitive impairment-lack of or poor cooperation between the patient and the therapist,
* stroke (more than 6 months after the incident),
* unstable clinical condition,
* muscle strength of knee extensors and flexors on the Lovett scale greater than or equal to 3,
* rigid fixed contractures within the lower limb,
* significant spasticity (Ashworth scale of 3 and above)
Study of DA+LDD in the Treatment of Femoropopliteal Occlusive Disease

This study will evaluate the effectiveness and safety of directional atherectomy plus local drug delivery using balloon catheter system in the treatment of femoropopliteal occlusive disease. Patients of femoropopliteal occlusive disease will randomly receive directional atherectomy plus local drug delivery using balloon catheter system and dilation using drug-coated balloon. Their clinical outcomes (e.g. 12-month late lumen loss rate, 1-year patency rate of target vessel) in 1 year after the treatment will be compared.

Femoropopliteal occlusive disease is a common type of peripheral arterial disease. Endovascular treatment has been the first-line treatment of femoropopliteal occlusive disease. However, the in-stent re-stenosis has been a major limitation of well long-term patency rate after stent implantation. The chronic inflammation induced by stenting could be a main reason of re-stenosis. Then the concept "leave nothing behind" is proposed, and some novel treatment methods and devices, such as paclitaxel-coated balloon dilation, directional atherectomy, are developed. Directional atherectomy can effectively remove the atherosclerosis plaque but leave the inflammatory reaction along the atherectomy route. Here, we propose the hypothesis that using local drug delivery with balloon system can relieve the inflammation induced by atherectomy. Therefore, 40 patients of femoropopliteal occlusive disease will be randomly allocated into the group "directional atherectomy+local drug delivery with balloon system" or "drug-coated balloon only". The 1-year patency rate, incidence of complications, imaging parameters will be compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* age of 18-80 years old
* patients of femoropopliteal occlusive disease (Rutherford 2-4)
* length of lesion ≤ 20cm
* have signed the informed consent

Exclusion Criteria:

* serum Cr \> 150 umol/L
* patients with acute thrombosis
* received endovascular treatment for femoropopliteal disease in recent 6 months
* less than 1 run-off vessel
* allergic to aspirin, heparin, clopidogrel, paclitaxel, contrast medium
* pregnancy and lactation
* relatively easy bleeding
* malignancy or irreversible organ failure
Polaprezinc Treatment for Enzalutamide- or Abiraterone-resistant CRPC

The purpose of this study is to evaluate clinical safety and efficacy of a gastric ulcer drug, polaprezinc (POL), with the AR-inhibitor abiraterone in Chinese patients with castration-resistant prostate cancer (CRPC).

Prostate cancer (PCa) is a major disease that affects 14.1% male population worldwide with a 6.8% mortality rate in 2020 (https://gco.iarc.fr/). In China, the PCa incidence rate is lower than in Europe and the US but increases rapidly. Androgen deprivation therapy (ADT) has been the most used treatment for men with advanced prostate cancer for decades. Despite the initial favorable response, nearly all patients progress to castration-resistant prostate cancer (CRPC) and subsequently succumb to the disease within 1-3 years.

Zinc-L-carnosine (ZnC), also called polaprezinc (otherwise known as PepZin GI™), is a chelated compound that contains L-carnosine and zinc. Some reports indicated that POL is effective in restoring the gastric lining, healing other parts of the gastrointestinal (GI) tract, improving taste disorders, improving GI disorders, and enhancing skin and liver. The primary mechanisms of POL action are identified as anti-inflammatory and antioxidant pathways. We have identified PRDX5 as a therapeutic target and repurposed polaprezinc (POL) as its inhibitor for the treatment of CRPC.

CRPC patients will be enrolled with their fully informed consent. Patients will be on abiraterone/prednisone, abiraterone/prednisone plus polaprezinc granules, or with other treatments according to patients' wishes in consultation with physicians. Polaprezinc will be 75 mg b.i.d., for 6 months. A standard regimen will be used for other treatments. PSA will be measured every month. ECT will be taken before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Male patients were older than 18 years of age.
2. Patients with measurable disease were required to have documented disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) (28) with at least one bone metastatic lesion. Patients with non-measurable disease were required to have at least two consecutive increases (relative to a reference value measured at least a week apart) in serum PSA.
3. Patients had been taking abiraterone or enzalutamide for at least three consecutive months and showed a persistent rise in PSA.
4. Life expectancy \>6 months

Exclusion Criteria:

1. Patients had taken polaprezinc previously.
2. Patients had cancer therapy (other than ADT) within 4 weeks before enrolment.
3. Patients had malignancies other than prostate cancer.
4. Patients had uncontrolled severe illness or medical conditions.