cyrilzakka/clinical-trials huggingface dataset:
Exercise and Parkinson's: Comparing Interventions and Exploring Neural Mechanisms

Parkinson disease (PD) is characterized by substantial disability and reduced quality of life, both of which can be attributed in large part to difficulties with walking. Evidence suggests that exercise may be an important addition to traditional treatments, particularly with respect to addressing walking problems. In particular, dance and treadmill training have been individually shown to improve walking performance and quality of life. At present it is not clear whether dance or treadmill training have similar effects or if one is superior to the other. Furthermore, our understanding of the means by which these exercise interventions convey benefits is extremely limited. This study aims to address these knowledge gaps by directly comparing dance, treadmill training and stretching (control group). The primary area of interest is the effects on gait, with secondary measures of disease severity, balance, and quality of life. The investigators will determine not only the effects of the interventions on walking performance, but will also investigate the effects of the interventions on connections between different parts of the brain and on brain function during imagined walking tasks using functional magnetic resonance imaging (fMRI). Participants will be randomly assigned to dance, treadmill training, or a stretching/flexibility control group. Participants will be assessed over a period of 6 months at 3 different time points. The investigators hypothesize that both dance and treadmill training will lead to improvements in forward walking, but that dance will result in greater improvements in backward walking compared to treadmill training. Furthermore, the investigators hypothesize that the tango and treadmill interventions will have different effects of brain function and brain connections. The investigators expect dance to enhance the activity and connections of particular brain regions and treadmill training to enhance activity and connections of different brain regions. The investigators do not expect changes in brain activity or connections in the control group.


Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of Parkinson disease
2. at least grade 3/5 strength and normal joint ranges of motion in both legs,
3. vision corrected to 20/40 or better,
4. able to walk independently for 10 feet with or without an assistive device, 5) normal gross somatosensory function in the feet (2-point discrimination, vibration, joint kinesthesia, and light touch),

6) no history of vestibular disease, 7) no evidence of dementia

Exclusion Criteria:

1. medical condition for which exercise is contraindicated,
2. evidence of abnormality other than PD-related changes on brain imaging,
3. history or evidence of neurological deficit other than PD that could interfere, such as previous stroke or muscle disease,
4. history or evidence of orthopedic or muscular problem,
5. failed to pass magnetic resonance imaging screening procedure
Phase II Study of AP0302 5% Versus a Vehicle Comparator

This study is designed to evaluate the analgesic safety and efficacy of study drug (AP0302) applied topically every 6 hours as compared to a vehicle, in subjects experiencing delayed onset muscle soreness.

The purpose of this study is to evaluate the efficacy and safety of S-Ibuprofen Topical Gel 5% in reducing pain/soreness associated with delayed onset muscle soreness (DOMS).

Eligibility Criteria:
Inclusion Criteria:

* no clinically significant medical conditions
* BMI between 18-30
* negative drug, alcohol, pregnancy screens
* other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* no upper extremity workout in last 6 months
* no job requiring heavy lifting
* history of muscle disorders
* allergy or intolerance to study drug
* history of recent pain medication use
* other protocol-defined exclusion criteria may apply
Safety and Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).

The study objectives are to assess any changes in visual acuity and visual field observed following the administration of RPh201 during an overall treatment period of at least 13 consecutive weeks with an option to extended the treatment phase to another 13 weeks (26 weeks total), and at the follow-up visit at 3 month after end of treatment in patients with optic nerve neuropathy.


Eligibility Criteria:
Inclusion Criteria:

1. Participants, either men or women are ≥ 18 years of age.
2. Diagnosis of ischemic optic neuropathy unilateral or bilateral:

   1. Traumatic Neuropathy
   2. Ischemic optic neuropathy - Non Arteritic Ischemic Neuropathy (NAION)
3. Corrected Visual acuity equal or worse than 6/60 or visual field of less than 15 degrees or both.
4. Field of view with a reduction from 10 degrees to one quarter situations functions.
5. Participant understands the nature of the procedure and provides written informed consent prior to any study procedure.
6. Women of child bearing potential must use adequate birth-control precautions.

Exclusion Criteria:

1. Glaucoma
2. Neuropathy caused by tumors.
3. Neuropathy caused by infections
4. Mitochondrial optic neuropathies
5. Nutritional, Radiation, Toxic optic neuropathies
6. Retinal diabetic complications
7. Hereditary optic neuropathies
8. Patients with complete SCOTOMA beyond three quarters.
9. Clinical evidence for presence of infection.
10. Patient is receiving, or has received within one month prior to enrollment corticosteroids, immunosuppressive drugs, cytotoxic agents, radiation therapy and chemotherapy.
11. Patient has a history of alcohol or drug abuse within the last two years.
12. Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception.
13. Participation in another clinical trial within 60 days prior to the Screening Visit or during this study.
14. Clinically significant and/or uncontrolled condition or other significant medical disease
15. Clinically significant uncontrolled retinal disease (AMD)
A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older

The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to work with smartphones/tablets/computers
* From the time of vaccination through 3 months after vaccination, participant agrees not to donate blood
* Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
* Before randomization, a participant must be: a. postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b. not intending to conceive by any methods
* Participants must sign an Inform Consent Form (ICF) indicating that the participant understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study

Exclusion Criteria:

* Has a serious clinically unstable condition, (example, end-stage renal disease with or without dialysis, clinically unstable cardiac disease), Alzheimer's disease, or any other condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise well-being) or that could prevent, confound, or limit the protocol specified assessments
* History of malignancy within 5 years before screening not in the following categories: a. Participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator; b. Participants with a history of malignancy within 5 years, which is considered cured with minimal risk of recurrence per investigator's judgement, can be enrolled
* Had major surgery (example, major cardiopulmonary or abdominal operations) as per the investigator's judgment within 4 weeks before vaccination, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study
* Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator, or an employee of the sponsor
* Contraindication to Intramuscular (IM) injections and blood draws (example, bleeding disorders)
* Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)
Use of Wharton Jelly Derived Mesenchymal Stem Cells for Knee Osteoarthrosis

Wharton Jelly derived Mesenchymal Stem Cells (WJMSC) will be injected in patients diagnosed with Knee osteoarthrosis

Ten patients from both genders diagnosed with Knee osteoarthrosis, will be enrolled according to strict inclusion and exclusion criteria. These patients will be injected with Wharton Jelly derived Mesenchymal Stem Cells. Then, they are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.

Eligibility Criteria:
Inclusion Criteria:

* Severe KOA stage III or IV by Laurance \& Kellgren staging as judged by Posterioranterior (PA) Xray of the knee joint.
* Willing to participate by signing the informed consent

Exclusion Criteria:

1. Sublaxation beyond 20 degrees of the bones of the knee joint
2. Oral anticoagulants or heparin therapy
3. Heart failure or arrhythmia
4. Body Mass Index \> 35
5. Uncontrolled Diabetes Mellitus.
6. Evidence of Infectious Diseases.
7. Active infection
8. Malignancy
9. Pregnancy
10. Anemia less than 11g/dl or thrombocytopenia less than 100,000 or leucopenia less than 3000.
11. Unreliable patients
12. Non-resident in Jordan
MSC for Treatment of cGVHD After Allo-HSCT

The purpose of this study is to evaluate the efficacy of mesenchymal stem cells in patients with chronic graft-versus-host disease.

Allogeneic hematopoietic stem cell transplantation(allo-HSCT) can cure many hematologic diseases. Although great progress has been made in the prevention and treatment of side effects associated with transplantation,chronic graft-versus-host disease(cGVHD) remains an important complication that occurs in about 50% patients. The mortality of cGVHD and its complication could reach up to 50%,and cGVHD seriously influence the quality of life. At present, the first line treatment of cGVHD remains in discussion.

Mesenchymal stem cells (MSCs) are a form of multipotent adult stem cells that can be isolated from bone marrow (BM), adipose tissue, and cord blood. Clinical applications of human MSCs are evolving rapidly with goals of improving hematopoietic engraftment, preventing and treating GVHD after allo-HSCT and so on. However, the efficacy of treatment of cGVHD remains undetermined.

In the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded MSCs in treating patients with cGVHD.

Eligibility Criteria:
Inclusion Criteria:

* A patient age of 18-65 years
* Recipients of allogeneic hematopoietic stem cell transplantation Patients with moderate/ severe cGVHD without systemic treatment
* Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Primary disease relapse
* Expected lifetime less than 3 months
* Patients with any conditions not suitable for the trial (investigators' decision)
Flurbiprofen Tablet vs Spray In Oral Soft Tissue Wounds

The amount of active ingredient in tablet form of flurbiprofen is higher than that in the oral spray form. Therefore, based on the hypothesis that the side effects that may occur depending on the dose can be reduced, this clinical study investigated whether tablet and spray form flurbiprofen would have similar effects on postoperative pain in primarily closed soft tissue wounds in the oral region.

In line with the number of patients obtained after sample size calculation, the study was completed on 40 patients who met the inclusion criteria. Patients were healthy, volunteer individuals who required excision of the epulis fissuratum or frenulum with the indication of preprosthetic surgery. 2 groups were formed by simple randomization with 20 patients in the tablet group and 20 patients in the spray group. After the surgical procedure, tablet and spray flurbiprofen were prescribed according to the groups. Apart from these, paracetamol, chlorhexidine gluconate + benzidamine hydrochloride mouthwash were prescribed to all patients as rescue analgesics. The tissue fragments removed from the patients who underwent epulis excision were sent for histopathologic evaluation and confirmed.

Eligibility Criteria:
Inclusion Criteria:

* Provided that those using removable prosthesis had discontinued using the prosthesis 1 month ago (in order to minimize the lesion to be excised), healthy or ASA Class I patients between 40 and 65 years of age, who had the indication of pre-prosthetic surgery due to excision of epulis fissuratum and frenulum

Exclusion Criteria:

* Pregnancy, lactation, and taking contraceptive pills; being allergic to the drug or other NSAIDs to be used in the study; had used steroids or analgesic drugs for any reason for the last 1 month; using psychiatric drugs; those with incomplete data and refused to sign the consent form; those who were extremely afraid and had a gag reflex; those with any gastrointesinal problems; smoking, ASA-2 and ASA-3 patients and those who smoked.
Gardasil Immunogenicity With Needle-Free Injection

1. Compare rates of seroconversion and GMTs generated following a 3-dose series of vaccine in women given low doses of vaccine by the ID route with the NFI (Group III) to those women given standard doses by the IM route with a needle and syringe (Group I) at 1 month, 6 months and 18 months following completion of the vaccination series.
2. Compare rates of seroconversion and GMTs generated following a 3-dose series of vaccine in women given standard doses of vaccine by the IM route with the NFI (Group II) to those women given standard doses by the IM route with a needle and syringe (Group I) at 1 month, 6 months and 18 months following completion of the vaccination series.

Primary hypotheses:

The primary goal of this study is to compare the vaccination groups. Using GMTs to measure immunogenicity of the 3 different vaccination regimens, we will test for non-inferiority between Group I and Group II and between Group I and Group III.

Our hypotheses are:

1. GMTs of antibodies to all 4 HPV types (6, 11, 16 and 18) following a 3-dose series of vaccine in women given low doses of vaccine by the ID route with the NFI (Group III) will be non-inferior to GMTs in women given standard doses by the IM route with a needle and syringe (Group I). Non-inferiority criteria will have been satisfied when the upper 95% confidence limit on the ratio of GMTs (GI/GIII) is less than 1.5 for all HPV types.
2. GMTs of antibodies to all 4 HPV types (6, 11, 16 and 18) following a 3-dose series of vaccine in women given standard doses of vaccine by the IM route with the NFI (Group II) will be non-inferior to GMTs in women given standard doses by the IM route with a needle and syringe (Group I). Non-inferiority criteria will have been satisfied when the upper 95% confidence limit on the ratio of GMTs (GI/GII) is less than 1.5 for all HPV types.
3. The proportions of baseline-naïve vaccinees seroconverting to all 4 HPV types (6, 11, 16 and 18) following a 3-dose series of vaccine in women given low doses of vaccine by the ID route (Group III) and standard doses of vaccine by the IM route (Group II) with the NFI will be non-inferior to the seroconversion rates in women given standard doses by the IM route with a needle and syringe (Group I). Non-inferiority criteria will have been satisfied when the upper 95% confidence limit on the difference in proportions is less than 10% for all HPV types.

Eligibility Criteria:
Inclusion Criteria:

1. Thai national
2. Woman
3. Age 18-26 years
4. Has had no more than 5 lifetime sex partners
5. HIV-uninfected
6. Able to complete all of the protocol visits and has signed the consent form

Exclusion Criteria:

1. Known contraindications to vaccination with Gardasil
The Effect of Applying Modified NUTRIC Scoring System to Evaluate the Nutrition Risk and Giving Different Types of Nutritional Support on Clinical Outcomes in Critically Ill Patients

Malnutrition is very common in critically ill patients. It is quite important to evaluate nutritional status precisely. Heyland et al firstly reported NUTRIC score including age, APACHE II score, SOFA score, number of commorbidities, days from hospital to ICU admission and IL-6. Because the IL-6 is not routinely checked at ICU. A modified NUTRIC score without IL-6 is more practical. Previous studies showed lower in-hospital mortality in higher nutritional risk patients with higher caloric intake compared with lower caloric intake. However, there is still controversial regarding the in-hospital mortality between full caloric feeding and permissive underfeeding in critically ill patients. Herein the investigators conduct a study to investigate what kinds of nutritional supplements will decrease in-hospital mortality in different nutritional risk patients.


Eligibility Criteria:
Inclusion Criteria:

* 1. Medical intensive care unit patients 2. age elder than 20 years old 3. Intubated with ventilator support patients 4. Predicted ICU stay longer than 72 hours

Exclusion Criteria:

* 1. NPO patients 2. Contraindication for enteral feeding 3. TPN use 4. Upper or lower GI bleeding patients 5. Feeding with gastrostomy or Jejunostomy patients 6. Metoclopramide related EPS or Torsades de pointes history
Self-help for Treating Social Anxiety Disorder: An Evaluation of a Mindfulness and Acceptance-based Approach

Social anxiety disorder (SAD) is the most common anxiety disorder, affecting up to 10% of the population and causing significant distress. Fortunately, there are effective interventions including cognitive behavior therapy (CBT) and acceptance and commitment therapy (ACT). However, only about a third of people with SAD seek treatment. There are a number of barriers to seeking treatment, including cost, availability, and stigma. Self-help may be one way to reach people who may not otherwise present for treatment. Research on self-help books for SAD based on CBT has yielded promising results. However, no research to date has examined the efficacy of ACT-based self-help for SAD. The primary purpose of the present study is to evaluate The Mindfulness and Acceptance-based Workbook for Social Anxiety and Shyness (Fleming \& Kocovski, 2013), an ACT-based self-help book. Socially anxious participants will be randomly assigned to receive the workbook or be placed on a waitlist. It is hypothesized that workbook participants will report significantly reduced social anxiety at the end of eight weeks compared to waitlist participants. The secondary purpose is to evaluate how the treatment works. Increases in mindfulness and acceptance have been shown to lead to reduced social anxiety. These same variables will be examined in the present study. Finally, this research aims to examine variables that can predict who may do well in treatment. Given that two-thirds of people who meet criteria for this disorder will not seek traditional treatments, it is important to develop and evaluate alternative treatments, including those based on self-help.


Eligibility Criteria:
Inclusion Criteria:

* must be seeking help for shyness/social anxiety

Exclusion Criteria:

-
Shock Wave Therapy for Lower Limb Lymphedema

This is a double-blind randomized clinical trial to compare the effect of shock wave therapy on lower limb lymphedema. There are two arms: A) complex decongestive therapy + extracorporeal shock waves therapy; B) complex decongestive therapy plus placebo extracorporeal shock waves.

This is a double blind, randomized, clinical trial. 30 patients with lower limb lymphedema will be randomized in 2 groups. One group will receive the habitual complex decongestive therapy (lymphatic manual drainage and compression) plus extracorporeal shock waves therapy. The other group will receive complex decongestive therapy (lymphatic manual drainage and compression) plus placebo extracorporeal shock waves.

Patients in the 2 groups will be instructed on skin care measures and kinesitherapy. The usual manual lymphatic drainage and compression will be applied to the 2 groups. The 2 groups will receive 10 treatment sessions, 2 weekly for 5 weeks.

Group complex decongestive therapy + shock waves. Patients will receive treatment with manual lymphatic drainage, compression, and shock waves.

Group complex decongestant therapy + placebo. Patients will receive treatment with manual lymphatic drainage, compression, and placebo shock waves.

Tolerance and possible adverse effects will be recorded by physiotherapist. Any adverse effect detected will be evaluated by the rehabilitation medical doctor.

Eligibility Criteria:
Inclusion criteria

* Patients with lower limb lymphedema
* Lymphedema of at least 6 months of evolution
* The lymphedema must affect at least the knee to the foot
* Moderate or severe lymphedema (grades 2 or 3)
* Sign the informed consent

Exclusion criteria

* Under 18 years of age
* Coagulation disorders (hemophilia, treatment with acenocoumarol, etc.)
* Current or previous deep vein thrombosis of the lower extremity
* Pregnancy
* Electronic implantable medical devices as pacemaker implants, medication pumps, etc
* Having received treatment with complex decongestive therapy or shock waves during the last 6 months
* Treatment with corticosteroids or radiotherapy in the area to be treated in the last 6 weeks
* Active oncological disease in the area to be treated
* Active infectious-inflammatory process in the area to be treated
* Cognitive or sensory deficits that prevent collaboration
* Inability to walk independently or inability to attend therapy
Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children

There is little epidemiological data in the literature on the therapeutic compliance of epileptic children. Yet it is a fundamental issue in the therapeutic education and balance of this pathology. To obtain more epidemiological precision on the observance of epileptic children and to propose, according to the factors involved, the improvement of practices (therapeutic education ..). Propose an evaluation of the quality of life of their children by a suitable self-questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* • Child aged 5 to 17

  * Child who has received complete information on the organization of the research and who has not objected to his participation and the exploitation of his data
  * Holder (s) of the parental authority present (s) having received the complete information on the organization of the research and not being opposed to the participation and the exploitation of the data of his child
  * Epileptic child
  * Follow-up at the neuro pediatric department of CHRU Nancy

Exclusion Criteria:

* epileptic encephalopathy
* Multiply handicapped child