cyrilzakka/clinical-trials huggingface dataset:
Kinesio Taping Effects on Balance and Ankle Proprioception

Ankle injuries are among the most common musculoskeletal injuries, affecting both athletes and the general population. Various methods are used to prevent such injuries, but the effectiveness of different kinesio taping applications on joint position sense and balance remains unclear. This study aims to investigate the effects of different kinesio taping techniques on proprioception and postural stability in healthy young adults. By identifying changes in balance and proprioception before injuries occur, the findings may provide clinical insights into the potential role of kinesio taping in rehabilitation and injury prevention.

Ankle and foot injuries are among the most frequently observed musculoskeletal injuries, particularly in athletes and physically active individuals. Various preventive methods have been developed to reduce the risk of such injuries, including exercise programs, footwear modifications, and taping techniques. Kinesio taping (KT) is widely used to enhance proprioception, joint stability, and neuromuscular function, but its effectiveness in healthy young adults remains unclear.

This study aims to evaluate the impact of different kinesio taping applications on joint position sense and balance in healthy young adults. The ankle-foot complex is rich in mechanoreceptors and plays a crucial role in movement and postural control. However, proprioceptive deficits and balance impairments contribute to the risk of injuries such as chronic ankle instability (CAI) and lateral ankle sprains. While several studies have investigated the effects of KT in injured populations, research on its impact on proprioception and balance in uninjured individuals is lacking.

By analyzing changes in balance and proprioception among healthy participants, this study will provide valuable insights into the potential role of kinesio taping in injury prevention. Understanding these effects before an injury occurs could help refine rehabilitation strategies and improve clinical decision-making regarding the use of kinesio taping for both prevention and post-injury treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age: Participants must be between 18-25 years old.
* General Health: Participants must be generally healthy individuals, with no previously diagnosed chronic health conditions, musculoskeletal disorders, or history of injuries.
* Ankle Health: No ankle injuries or surgical interventions in the past six months.
* Informed Consent: Participants must voluntarily agree to participate and sign the informed consent form.

Exclusion Criteria:

* History of Injuries: Any lower extremity injury (ankle or knee) within the past year.
* Neurological Disorders: Any neurological condition that may affect balance or proprioception.
* Other Health Conditions: Presence of chronic diseases such as rheumatic diseases, diabetes, or musculoskeletal disorders that could impact the study outcomes.
Oral QLT091001 in Retinitis Pigmentosa (RP) Subjects With an Autosomal Dominant Mutation in Retinal Pigment Epithelial 65 Protein (RPE65)

The purpose of this study is:

* To evaluate whether 7-day treatment with oral QLT091001 can improve visual function in RP subjects with an autosomal dominant mutation in RPE65.
* To evaluate duration of visual function improvement (if observed) in RP subjects with an autosomal dominant mutation in RPE65 after 7-day treatment with oral QLT091001.
* To evaluate the safety of oral QLT091001 administered once daily for 7 days in RP subjects with an autosomal dominant mutation in RPE65.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will have RP caused by an autosomal dominant mutation in RPE65, as diagnosed by an ocular geneticist or ophthalmologist.
* Subjects who have a best-corrected standard ETDRS visual acuity of 3 letters or better (20/800 Snellen equivalent) or visible photoreceptor outer segments on OCT/FAF.

Exclusion Criteria:

* Subjects with any clinically important abnormal physical finding at Screening.
* Subjects who have taken any prescription or investigational oral retinoid medication (e.g., Accutane/Roaccutane® or Soriatane/Neotigason®) within 6 months of Day 0 and subjects who did not tolerate their previous oral retinoid medication will be excluded regardless of the time of last exposure.
* Subjects with a history of diabetes or chronic hyperlipidemia, hepatitis, pancreatitis, or cirrhosis.
* Subjects who have taken any supplements containing ≥10,000 IU vitamin A within 60 days of Screening.
Dismantling the U.S. Social Norm of the "Kids' Food" Archetype (REACH Project)

This project is the first stage of a health promotion campaign to shift social norms about marketing and feeding children ultra-processed foods. Embedded within a longitudinal ethnographic study using photo-elicitation techniques, mothers of preschool-age children will be randomly assigned to arts-based or traditional education about ultra-processed food.

1. At baseline, describe how mothers of preschool-age children characterize food for children in their home and local environment and describe their knowledge of ultra-processed food.
2. To test different ways of providing nutrition education for increasing knowledge about children's nutrition and ultra-processed foods. Hypothesis: Both groups will correctly identify more ultra-processed foods post-education.
3. To learn in depth from mothers of preschool children about their perceptions of the food environmental culture (markets, advertising, health messaging, community norms, cultural norms, social norms) in Newark, NJ, through a series of focus group discussions about the mothers' photographs of the local food environment pre and post project.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* African American or Black or bi-racial or multi-racial African American and Black mothers
* \>18 years
* Female
* Legal guardian of a preschool-age child (3-5 years) participating in the Leaguers, Inc.

Head Start programming.

Exclusion Criteria:

* Spanish-speaking
* Other racial and ethnic groups
* Fathers
0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy

To study that 0.075% capsaicin lotion is safe, well tolerated and provide significant pain relief in patients with PDN compared with placebo lotion as a randomized, double- Blind, crossover, placebo-controlled trial

Neuropathy is one of the most common complications in both type 1 and type 2 diabetes mellitus. The most common symptom is a symmetrical, chronic, axonal, length-dependent sensorimotor polyneuropathy.

Topical capsaicin formulations are widely used to manage pain. Low-concentration creams, lotions, and patches intended for daily skin application have been available in most countries since the early 1980s.

We study 0.075% capsaicin lotion is safe, well tolerated and provide significant pain relief in patients with PDN compared with placebo lotion as a randomized, double- Blind, crossover, placebo-controlled trial for 20 weeks throughout the study in 42 participants. All participants are provided both 0.075% capsaicin lotion and placebo lotion. Each agent will be applied for 8 weeks then stop for 4 weeks, after that another agent will be used for 8 weeks. We keep following up all of them by calling and appointment to get information in effectiveness and adverse effect at 0,2,4,8,12,14,16,20 week, respectively.

Eligibility Criteria:
Inclusion Criteria:

1. DM type 2 over 1 year
2. Clinical presentation of peripheral sensory such as burning pain
3. DN4 score from 4 points
4. Good consciousness to tell their score with informed consent agreement
5. No adding dosage of previous pain control medications at least 4 weeks
6. HbA1C 6.5-9.0%

Exclusion Criteria:

1. Improper application site of skin for topical drugs such as abrasion wound.
2. Allergic history of Capsaicin
3. No intention to join the study with any reasons
4. Other previous medications used that effect to peripheral neuropathy such as Carboplatin, Cisplatin, Colchicine, Dapsone, Etoposide, Ethambutol, Indomethacin, Isoniazid, Lithium, Metronidazole, Phenytoin, Pyridoxine, Statins, Stavudine (d4T) or conditions worsening peripheral nerves following that poor nutrition, kidney failure, chronic alcoholism, vitamin deficiency, Hypothyroidism
Food Effect Study of a Single Dose of ZD4054 (Zibotentan)

The purpose of the study is to assess the effect of food on the pharmacokinetics of a 10 mg single oral dose of ZD4054 (Zibotentan)


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18 and 30 kg/m2
* Medical and surgical history and physical examination without any clinically significant findings
* Able to consume standard FDA specified high-fat breakfast.

Exclusion Criteria:

* Definite or suspected personal history or family history of hypersensitivity to drugs that are endothelin antagonists; ie, ambrisentan, artrasentan, sitaxsetan and bosentan
* Medical diagnosis of migraine with an attack during the 12 months prior to Screening
* Use of prescription medication within 2 weeks before dosing
Evaluation of Anti-mullerian Hormone(AMH) Levels as a Predictive Factor of Response to Weight Loss Treatment in Obese Infertile Women With Poly Cystic Ovary(PCOS)

This study is a prospective before \& after clinical trial to compare the basal and 3 months after diet anti-mullerian hormone levels between responders and non-responders to weight loss diet in obese infertile women with PCOS population

The study population comprised of all obese infertile PCOS patients aged 20-40 years which underwent 3 months weight loss diet in royan institute, Tehran Iran.

The study is conducted over 12 wk energy restriction. All subjects have the same dietary protocol. At baseline, week 12 the levels of AMH,Follicular Stimulating Hormone (FSH), Lutienizing Hormone(LH),Prolactin (PRL), androgens, sex hormone-binding globulin (SHBG), glucose, and insulin were measured and Free Androgen Index (FAI) and Insulin Resistance (IR) indices is calculated. The laboratory tests are determined by radioimmunoassay in the Laboratory of Endocrinology of Royan institute. AMH is measured in duplicate using an ultrasensitive ELISA kit (AMH-ELIZA Kit; Beckman Coulter, Marseilles, France) according to manufacturer instructions. All measurements are performed using a single kit and at the same time in the Laboratory of clinical Immunology of Royan institute.

Data collection will be performed by using questionnaire to be filled as per the available records and laboratory results. Data analysis will be done through descriptive and perceptive statistical methods.

Eligibility Criteria:
Inclusion Criteria:

- 1- diagnosis of PCOS, according to the Rotterdam Consensus Workshop Group, by 2 of the following 3 criteria: menstrual irregularity (cycle length\<26 d or \>31 d or variation between consecutive cycles of \>3 d); clinical (hirsutism assessed by a Ferriman-Gallwey score \> 8) or biochemical \[free androgen index (FAI) \> 5.4 or testosterone_1.4 nmol/L\] hyperandrogenism; or positive ultrasound presentation of polycystic ovaries by transvaginal scan.

2- Age between 18 -40

Exclusion Criteria:

- 1. Body mass index (BMI; in kg/m2) \< 30, 2. Type 2 diabetes mellitus and related endocrinopathic disorders \[identified by assessment of thyroid-stimulating hormone (TSH), prolactin, and 17_hydroxyprogesterone\].

3. Regular exercise activities during the study. 4. Cases of alcoholism and smoking. 5. The use of endocrine hormonal treatment or insulin-sensitizing agents is not permitted during either phase of the study, and the use of oral contraceptives is not permitted during of the study. Subjects are required to cease taking oral contraceptives 4 wk and hormonal treatment or insulin-sensitizing agents 2 wk before commencement of the short-term study phase.
Decompressive Craniectomy Combined With Hematoma Removal to Treat ICH

Decompressive craniectomy has been reported for the treatment of patients with intracerebral hemorrhage. But no prospective randomised controlled trials have yet been undertaken to confirm its effect.The purpose of the study is to determine whether decompressive craniectomy post hematoma removal surgery after intracerebral hemorrhage will reduce the chances of a person dying or surviving with a long term disability.

Intracerebral hemorrhage (ICH) is one of the most serious subtypes of stroke, affecting approximately 2-3 million people worldwide each year. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Hematoma removal (HR) surgery is the primary treatment for ICH which volume is more than 30ml. But whether decompressive craniectomy (DC) should be employed during the HR surgery still has considerable controversy. Outcomes in this study will be measured at 3 months after surgery via a postal questionnaire including the Glasgow Outcome scale, Modified Rankin Scale, and Barthel index. Two hundred patients will be recruited to the trial over 36 months. Follow-up will take three months with analysis and reporting taking one year.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of a spontaneous lobar and basal ganglia ICH on CT scan
* Patient within 72 hours of ictus
* Best score on the GCS of 5-13.
* Volume of hematoma between 30 and 100ml \[Calculated using (a x b x c)/2 method\]
* The history of hypertensive

Exclusion Criteria:

* Clear evidence that the hemorrhage is due to an aneurysm or angiographically proven arteriovenous malformation.
* Intraventricular hemorrhage of any sort
* ICH secondary to tumour or trauma.
* If the hematological effects of any previous anticoagulants are not completely reversed.
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration

Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (axitinib implant) in Subjects with Neovascular Age-Related Macular Degeneration


Eligibility Criteria:
Inclusion Criteria:

* Treatment naïve for Neovascular Age-Related Macular Degeneration (nAMD) in either eye at screening.
* Are at least older than 50 years of age at Day 1.
* Have Best Corrected Visual Acuity (BCVA) of at least 84 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximate 20/20 Snellen equivalent) at Day 1; OR have an increase of at least 10 ETDRS letters of Best Corrected Visual Acuity (BCVA) from Screening (Visit 1) BCVA

Exclusion Criteria:

* Monocular subjects or a Best Corrected Visual Acuity (BCVA) score of 20/200 in fellow eye at screening.
* Have evidence of a scar, fibrosis, or atrophy of \> 50% of the total lesion in the study eye.
Evaluation of the Ability of CT-based Finite Element Analysis (CTFEA) to Predict Fractures in Patients With Metastases: a Randomized Controlled Study.

Patients with metastases to proximal femur, who are evaluated fr the risk of pathologic fracture in order to decide on preventive fixation vs follow-up constitute the study population. The patients will be randomized in two arms. First arm - the decision of treatment will rely on conventional decision algorithm including specialist judgement and Mirels' score. Second arm- the decision on treatment will be supported by CTFEA analysis of bone structure and quantitative simulation-based estimate of fracture risk, in addition to the conventional decision algorithm. Operation rates, pathologic fracture rates and additional secondary outcomes will be compared between the two study arms.


Eligibility Criteria:
Inclusion Criteria:

1. Metastatic bone disease of femur
2. Patients who undergo a CT scan (soft tissue kernel/filter, 120 kVp), and have at least 2/3 of both femurs visible in the CT scan. If CT scan is performed at the Sourasky medical center it must be according to the protocol in Appendix A.

Exclusion Criteria:

1. Ipsilateral previous surgery with or without implants
2. Low quality CT scan or CT does not include at least 2/3 of the femurs.
3. History of fractures, radiation or surgeries in lower limbs.
4. Inability to provide informed consent
High Versus Low Dose Supplemental External Radiation With Pd-103 for Prostate Cancer

Objective: The objective of this study is test the hypothesis that delivering a higher percentage of the radiation dose as external radiation versus implant will lead to higher tumor control rates.

Research design A total of 600 patients with AJC clinical stage T1-T2 prostatic carcinoma (Gleason grade 7 to 10 and/or PSA 10 to 20 ng/ml) will be randomized to treatment with 44 Gy versus 20 Gy external radiation plus a Pd-103 implant boost (90 Gy versus 105 Gy, respectively).

Objective: The objective of this study is test the hypothesis that delivering a higher percentage of the radiation dose as external radiation versus implant will lead to higher tumor control rates.

Research design A total of 600 patients with AJC clinical stage T1-T2 prostatic carcinoma (Gleason grade 7 to 10 and/or PSA 10 to 20 ng/ml) will be randomized to treatment with 44 Gy versus 20 Gy external radiation plus a Pd-103 implant boost (90 Gy versus 105 Gy, respectively).

Methodology: Patients will be randomized by the method of random permuted blocks.

Cancer status will be monitored by serial serum PSA at 6, 12, 18 and 24 months and yearly thereafter. Treatment-related morbidity will be monitored by personal interview, using standard American Urologic Association and Radiation Therapy Oncology Group criteria at 1, 3, 6, 12 and 24 months. The primary endpoint will be based on serum PSA. A value above 1.0 ng/ml two years after treatment will be considered to have residual or recurrent cancer and to have failed therapy.

Findings: 566 patients have been randomized and the study was closed due to slowing accrual. A preliminary analysis shows similar morbidity between the treatment arms, and nearly identical cancer control rates between randomization arms.

Eligibility Criteria:
Inclusion Criteria:

* Males
* Prostate cancer
* PSA 10-20
* Gleason score 7-10

Exclusion Criteria:

* Lymph nodes positive
Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease

To explore the safety, feasibility and net symptomatic effects of multiple (3x/week, for 4 weeks) intermittent hypoxia treatment sessions in individuals with PD. Secondary outcomes include exploring induction of relevant neuroprotective pathways as measured in serum.

Intermittent hypoxia therapy is a non-pharmacological intervention used by athletes and individuals with cardiovascular disease, amongst others. The safety and feasibility of (intermittent) hypoxia therapy and its short-term effects on Parkinson's disease (PD) symptoms were assessed in a previous exploratory phase I trial. However, the net effects of multiple hypoxia treatment sessions on PD symptoms are unknown. The results of the previous phase I trial informed the study design of the newly proposed phase 1b-2a safety and efficacy trial.

45 minutes of normobaric intermittent hypoxia (FiO2 0.16 for 5 minutes interspersed with 5 minutes normoxia) will be delivered via a hypoxicator (a device that titrates decreased fractional oxygen from room air) through an oxygen mask in the hospital and subsequently at participants' homes. Interventions will be conducted 3 times a week, for 4 weeks in total.

Eligibility Criteria:
Inclusion criteria

* Informed consent
* Clinical diagnosis of Parkinson's disease by a movement disorder specialized neurologist.
* Hoehn and Yahr staging 1 to and including 3 (indicating mild to moderate PD).

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Individuals with diseases leading to restrictive and obstructive pulmonary diseases, sleep apnea and cardiac output deficits, such as pulmonary fibrosis, COPD, sleep apnea or excessive alcoholic intake, and congestive heart failure respectively
* Individuals with coronary artery disease NYHA classes III and IV
* Arterial blood gas abnormalities at screening procedure
* Individuals with shortness of breath or other airway or breathing-related inconvenience related to lack of dopaminergic medication
* Inability for in-clinic measurements in OFF phase
* Individuals with active deep brain stimulation
A Phase I/II Study of Mis-Matched Immune Cells (AlloStim) in Patients With Advanced Hematological Malignancy

The purpose of this study is to determine the safety and anti-tumor effects of an experimental immunotherapy drug, called AlloStim, which is intentionally mis-matched immune cells which are designed to elicit the same anti-tumor mechanism that occurs in allogeneic bone marrow/stem cell mini-transplant (BMT) procedures, without the toxicity associated with graft vs. host disease (GVHD).

AlloStim is combination biological drug and medical device formulation consisting of allogeneic immune cells that have been expanded and differentiated ex-vivo. These cells are conjugated to monoclonal antibody coated microparticles prior to infusion. The immune cells are living CD4+ memory Th1-like T-cells (T-Stim) that are differentiated from precursors purified from normal donor blood. AlloStim is a composition of T-Stim cells conjugated to paramagnetic epoxy covered microparticles (4.5micron) with covalently bound anti-CD3/anti-CD28 monoclonal antibodies (Dynabeads® ClinExVivo™ CD3/CD28) at a 2:1 bead:cell ratio. The T-Stim cells are intentionally mismatched to the recipient.

The graft vs. tumor (GVT) effect that occurs after allogeneic bone marrow transplant (BMT) is a curative therapy for advanced hematological malignancy but the clinical application of GVT is severely limited by graft vs. host disease (GVHD) toxicity. AlloStim is designed to elicit the "mirror" of the GVT/GVHD effects in the host immune system. Rather than trying to separate these effects, we have proposed that the effects could remain associated and "mirrored" onto the host immune system creating linked host vs. tumor (HVT) and host vs. graft (HVG) effects. We hypothesized that allogeneic Th1 memory cells activated at time of infusion to produce type 1 cytokines and express CD40L would elicit HVT/HVG "mirror effects" in immunocompetent cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed hematological malignancy
* unresponsive to chemotherapy and/or recurrence after autologous transplant
* adequate kidney, liver, lung and heart function

Exclusion Criteria:

* prior allogeneic transplant
* immunosuppressive therapy for concurrent medical condition
* active viral infection