cyrilzakka/clinical-trials huggingface dataset:
Calcineurin Inhibitor-Free Immunosuppression in Renal Transplant Recipients at Low Immunogenic Risk

To compare renal function (51Cr-EDTA clearance) 12 months posttransplant, in primary renal allograft recipients (from cadaveric donor) at low immunogenic risk, 0 DR mis-match, receiving immunosuppressive therapy with A) Zenapax® (5 doses), CellCept® (1.5 g bid., aiming for TDM for total trough concentrations of 2-6 mg/L) and prednisolone or B) Sandimmun Neoral® (full dose), CellCept® (1.0 g bid.) and prednisolone.

Primary Objective To compare renal function (51Cr-EDTA clearance) 12 months posttransplant, in primary renal allograft recipients (from cadaveric donor) at low immunogenic risk, 0 DR mis-match, receiving immunosuppressive therapy with A) Zenapax® (5 doses), CellCept® (1.5 g bid., aiming for TDM for total trough concentrations of 2-6 mg/L) and prednisolone or B) Sandimmun Neoral® (full dose), CellCept® (1.0 g bid.) and prednisolone.

Secondary Objectives To compare the two treatment groups with regard to: patient and graft survival (12 months), biopsy-proven and presumptive rejection episodes (3 and 12 months), posttransplant (12 months) incidence and severity of hypertension, hyperlipidemia, glucose intolerance, incidence of infection and tolerability and "success rate" of TDM guided CellCept® dosing in a calcineurin inhibitor-free immunosuppressive protocol over 12 months.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients of either gender above 18 years of age. 2. Patients who are recipients of primary, 0 DR mis-matched renal allografts from cadaveric donors (aged between 10 and 70 years).

  3. Patients who are single organ recipients (kidney only). 4. If the patients are women of childbearing potential, they must use safe contraceptives.

  5. Patients not previously treated with Zenapax® or Simulect®. 6. Patients must be capable to understand the information given about the study, including purpose and risks, and they must sign a statement of informed consent in accordance with the Helsinki declaration.

  7. Patients with white blood count greater than 2.5 x 109 /L (IU), platelet count greater than 100 x 109 /L (IU) or haemoglobin greater than 6 g/dL at the time of entry into the study.

Exclusion Criteria:

* 1. Patients who are recipients of HLA-identical renal transplants. 2. PRA positive (\>20%) patients at any time the alst 6 months. 3. Patients who are unable to stay outside hospital as outpatients for 3 months.

  4. Patients who are unable to receive oral medication. 5. Patients with active peptic ulcer disease. 6. Patients with active infection. 7. Patients with disorders which might interfere with their ability to absorb oral medication, such as severe diarrhoea or patients with previously diagnosed diabetic gastroenteropathy.

  8. Patients who are pregnant or nursing mothers. 9. Patients with ongoing malignancies, excluding adequately treated skin carcinoma.

  10. Patients not able to adhere to the investigational immunosuppressive therapy.

  11. Patients receiving bile-acid sequestants.
De-Escalation Protocol Of HPV Mediated Oropharyngeal Squamous Cell Carcinoma

The purpose of this study is to evaluate the effects, good and/or bad, of treating participants with HPV-mediated oropharyngeal cancer, with less treatment, using the new staging system. The investigators believe this treatment will provide the same effectiveness as the usual treatment, but decrease the side effects. The radiation doses, chemotherapy doses, and the type of surgical approaches that will be used in this treatment protocol have all been previously investigated. Previous research suggests that this can be done safely, but there has not been a study done basing treatment on the new staging system.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have newly diagnosed, histologically, or cytologically confirmed HPV positive, squamous cell carcinoma of the base of tongue, tonsil, oropharyngeal cavity or unknown primary.
* Participants must have tumors staged using AJCC TNM 8th edition Staging for Head and Neck cancers.
* Participants must have an exam by a Head and Neck Oncologist within 6 weeks before registration.
* Participants must not have any evidence of distant metastatic disease.
* Participants with other active malignancies may be eligible, at the discretion of the investigator, as long as the treatment plan for the head and neck cancer outlined in this protocol can still be followed. The potential effect of the treatment and disease progress of the second active malignancy should also have minimal or no impact on the toxicities being monitored on this study.
* Participants must not have any uncontrolled intercurrent illnesses, psychiatric illnesses, psychosocial problems, or social situations that would limit the patient's compliance with the study or ability to successfully complete the study treatment safely.
* Participants with inconclusive pathology after biopsy; who are found to have HPV positive SCC following standard of care surgery are eligible to enroll.
* Participants who require additional surgery to complete staging with known HPV+ SCC are eligible to enroll.

Exclusion Criteria:

* Participants must not be receiving or planning to receive any other clinical trial therapy or intervention.
* Participants with an unknown primary tumor who are both HPV positive and EBV positive are NOT eligible for this protocol.

These additional evaluations must be performed on participants with T0 (unknown primary site) P16+ squamous cell carcinoma of the head and neck prior to registration.

* Flexible laryngoscope
* Ultrasound guided Fine-needle aspirate (FNA) of the known site of disease with the following analysis:
* Human papilloma virus (HPV); p16 Immuno-Histo-Chemical Staining. If negative, complete high risk HPV Fluorescence in-situ Hybridization (FISH).
* Epstein Barr Virus (EBV): Epstein Barr Virus Encoded RNA (EBER) in-situ Hybridization.
* Direct Laryngoscopy with directed biopsy of bilateral base of tongue, bilateral palatine tonsillectomy, and dental extraction, as needed.

If a participant is both HPV positive and EBV positive, he/she is not eligible.
The Effect of Bifocals in Children With Down Syndrome

Visual acuity at near improves in children with Down syndrome using bifocals

The accommodation is consistently reduced in 50 to 100% of children with Down syndrome and does not improve with age.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Down syndrome (DS)
* Accommodation lag \>0.5 Dioptres for children with DS \<12 years and \>0.75 Dioptres for children older than age 12 or Visual acuity at near is worse than at distance and \>0.1
* Age range 2-14 years
* Speaks Dutch as the first language
* Must be verbal or able to understand instructions
* Must be able to perform a task sitting on a chair and working at a table

Exclusion Criteria:

* Visual acuity at near \< 0.1
* Not able to do vision tests at age over 5
* Has worn bifocals already
* Other significant eye diseases, such as keratoconus, cataract or high myopia (\>S-6.00).
* Diagnoses of any neurological, sensory or behavioural disorders such as autism, microcephaly or significant hearing loss.
* Prematurity, born premature after a pregnancy term less than 36 weeks
* Born after severe perinatal problems
Revascularisation of Autotransplanted Teeth

Retrospective Analysis of a Study cohort that experienced autotransplantation of mature teeth with simultaneous root end resection

Note: The study was registered on Clinicaltrials.gov after termination of study.


Eligibility Criteria:
Inclusion Criteria:

* Male and female consenting and judicious young people and adults
* Written consent of the participant and, if applicable, of the legal guardian after education
* Planned tooth transplantation with advanced or completed root growth

Exclusion Criteria:

* Contraindications for magnetic resonance imaging (MRI): (pronounced metal restorations, running orthodontics with metal, fixed appliance in the target jaw)
* Current or past antiresorptive therapy with bisphosphonates
* Further anamnestic general or local risk situation, among others: Anti-angiogenic therapy, History of local radiation therapy, severe coagulation disorder, unadjusted diabetes mellitus, malignant diseases
* Acute gingivitis or advanced periodontitis
* Participation in an ongoing drug trial (various drugs may distort the result, such as bisphosphonates, cortisone, chemotherapeutics, angiogenesis inhibitors)
* heavy smokers (\> 10 per day)
* Acute or chronic infections (osteomyelitis) at the surgical site
* metabolic diseases (diabetes, hyperparathyroidism, osteomalacia)
* Severe kidney dysfunction, severe liver disease
* Patients with high-dose corticosteroid therapy
* prolonged corticosteroid or radiotherapy in the oral cavity
* autoimmune diseases
* Pregnant or breastfeeding women
CD34+ Enriched Transplants to Treat Myelodysplastic Syndrome

This study will evaluate whether processing blood stem cell transplants using an investigational device (the CliniMACS system) results in fewer complications for patients who undergo transplant to treat a blood malignancy (cancer) or blood disorder.

The CliniMACS system will be used to remove immune T-cells from the transplant donor's blood. Immune T-cells contribute to graft versus host disease (GVHD) - a serious complication that can happen after transplant. GVHD occurs when a patient's immune system attacks the donor's cells. The study aims to reduce the number of the donor immune T-cells thereby preventing or reducing the severity of GVHD.


Eligibility Criteria:
Inclusion Criteria:

* Myelodysplastic syndrome (MDS): Refractory anemia/refractory anemia with ring sideroblasts/refractory cytopenia with multilineage anemia (RA/RARS/RCMA) with high-risk cytogenetic features or transfusion dependence, as well as Refractory Anemia with Excess Blasts Type 1 and 2 (RAEB-1 and RAEB-2)
* Karnofsky (adult) Performance Status of at least 70%
* Adequate organ function measured by:
* Cardiac: asymptomatic or if symptomatic then left ventricular ejection fraction (LVEF) at rest must be 50% and must improve with exercise.
* Hepatic: \< 3x upper limit of normal (ULN) aspartate aminotransferase (AST) and: 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia or if the hyperbilirubinemia is directly caused by the disease in which the patient is receiving a transplant \[e.g., acute myeloid leukemia (AML) Chloroma obstructing the biliary tree\]. Patients with higher bilirubin levels due to causes other than active liver disease is also eligible with Pl approval e.g., patients with paroxysmal nocturnal hemoglobinuria (PNH), Gilbert's disease or other hemolytic disorders.
* Renal: serum creatinine: \<1.2 mg/dL (normal range 0.7-1.3) or if serum creatinine is outside the normal range, then creatinine clearance (CrCl) \> 5940 mL/min (measured or calculated/estimated).
* Pulmonary: asymptomatic or if symptomatic, diffusion capacity of lung for carbon monoxide (DLCO) 50% of predicted (corrected for hemoglobin).
* Willing to participate and must sign an informed consent form

Exclusion Criteria:

* Pregnant or breast-feeding
* Active viral, bacterial or fungal infection
* Patient seropositive for human immunodeficiency virus (HIV)-I /II; human T-lymphotropic virus (HTLV)-I /II
* Presence of leukemia in the central nervous system (CNS)
Intra-Articular Dexmedetomidine: A Treatment for Chronic Knee Pain

Chronic knee osteoarthritis (KOA) is a painful condition with limited treatment options. Non-pharmacological approaches often fall short, leading to decreased quality of life. Ozone therapy, a simple and affordable treatment, has shown promise for pain relief. Dexmedetomidine (DEX), a sedative and analgesic, has been used successfully as an adjuvant to anesthesia and local anesthetics. Given its potential for pain management, exploring DEX as a treatment for KOA could offer a new and promising approach.


Eligibility Criteria:
Inclusion Criteria:

* Patients were not assigned for surgical intervention;
* Patients were free of exclusion criteria

Exclusion Criteria:

* Patients were assigned for surgical intervention;
* Patients who had uncontrolled hypertension and/or diabetes mellitus;
* Patients who had uncompensated cardiac, renal, or hepatic diseases;
* Patients with coagulopathy, spinal deformity, allergy, or contraindication for the used drugs;
* Patients who refused to sign the informed consent were excluded from the study.
Phase III Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy

The PolarisDMD study is a Phase 3, global study to evaluate the efficacy and safety of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Male patients from 4-7 years of age (up to 8th birthday) will be enrolled.

Edasalonexent is an orally administered small molecule that inhibits NF-kB, which is the key link between loss of dystrophin and disease pathology and plays a fundamental role in the initiation and progression of skeletal and cardiac muscle disease in DMD.

The study includes a 52-week, randomized, double-blind, placebo-controlled period, followed by a 2-week follow- up. Approximately 125 boys with DMD will be enrolled in this trial, with 2 boys receiving edasalonexent for every 1 boy receiving placebo.

Following completion of the treatment period, patients may elect to continue in a separate open-label extension study.

Eligibility Criteria:
Inclusion Criteria:

* Written consent/assent by patient and/or legal guardian as per regional and/or Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements
* Diagnosis of DMD based on a clinical phenotype with increased serum creatine kinase (CK) and documentation of mutation(s) in the dystrophin gene known to be associated with a DMD phenotype
* Able to perform stand from supine without assistance in ≤ 10 seconds
* Able to perform the 10MWT and 4-stair climb
* Followed by a doctor or medical professional who coordinates Duchenne care on a regular basis and willingness to disclose patient's study participation with medical professionals

Exclusion Criteria:

* Use of corticosteroids within 24 weeks prior to Day 1; use of inhaled, intranasal, and topical corticosteroids is permitted
* Use of another investigational drug, idebenone, or dystrophin-focused therapy within 4 weeks. Exception: Patients who have received at least 24 weeks of a stable dose of eteplirsen prior to Day 1, and expected to continue treatment, will be eligible
* Use of the following within 4 weeks prior to Day 1: immunosuppressive therapy, warfarin, phenytoin, S mephenytoin, cyclosporine, dihydroergotamine, ergotamine, fentanyl, alfentanil, pimozide, quinidine, sirolimus, tacrolimus, or paclitaxel
* Use of human growth hormone within 3 months prior to Day 1
* Other prior or ongoing significant medical conditions
A Research Study to Evaluate the Safety and Effectiveness of MK0217 to Prevent and Treat Bone Loss (0217-193)(COMPLETED)

A research study to see how safe and effective MK0217 is when taken weekly for the prevention and treatment of steroid induced bone loss.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged 18 to 80 years, being treated with oral glucocorticoid (steroid), without vertebral fracture or prior osteoporotic fracture

Exclusion Criteria:

* Mentally or legally incompetent, pregnant, alcohol or drug dependence, history of heart disease, kidney disease, hypertension, upper gastrointestinal disease, cancer, being treated with hormone replacement therapy, or life expectancy of less than 3 years
Urdu Version of Maastricht Upper Extremity Questionnaire Reliability Validity Study.

In this study, the examiners will investigate the reliability and validity of Mastrict Upper Extremity scale in Urdu language in Pakistani patients with Carpal tunnel syndrome.

The objective of this study is to translate as well as culturally adapt the Mastrict Upper Extrimity scale (MUEQ) into Urdu language and to test its reliability and validity in patients with Carpal Tunnel Syndrome. This cross-sectional survey will use convenience sampling technique to enroll the participants on a pre-defined criteria.

The outcomes of this study will help in finding the reliability and validity of MUEQ in patients with CTS. The reliability of this scale will be examined using internal consistency and test-retest methods. The internal consistency will be checked by Cronbach's alpha value. The test-retest reliability will be analyzed using an interclass correlation with patients.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who had to execute computer jobs in office.
* Individuals who have been working in present position for minimum 6 months
* Individuals who have been working for at least 4 hours or more in a day

Exclusion Criteria:

* Individuals who had Severe phsycytric and behavioral complaint
* Individuals who had prior injury of upper extremity
* Individuals who had any surgery of upper extremity
Dermatologic Research Evaluation and Monitoring of Sleep in Moderate-to-Severe Psoriasis

Getting enough sleep is important for maximizing health and well-being. When it comes to health, sleep is as vital as regular exercise and eating a balanced diet. Not getting enough sleep can lead to health problems like heart attacks, diabetes, and even cancer. Since individuals with psoriasis have these same health problems, getting better sleep may help to keep them happier and healthier. This study will look at how individuals with psoriasis sleep and if their sleep is different than indivuduals without psoriasis.

A growing body of literature has revealed that individuals with psoriasis are more likely to report sleep disturbance when compared to the general population. The cross-sectional study presented here will allow the investigators to objectively and rigorously measure sleep architecture in psoriasis patients and compare it to healthy controls, If sleep dysfunction is confirmed in this population, then clinical interventions such as screening for sleep disturbance or promoting sleep hygiene could lead to meaningful improvements in patients' health, longevity, and overall quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a diagnosis of moderate to severe plaque type psoriasis confirmed by the principal investigator. Moderate to severe psoriasis will be defined as affected BSA ≥3%. Healthy controls will be age and sex matched (see below) subjects with no prior or current history of psoriasis.
2. Are at least 18 years of age
3. Psoriasis has been stable over the last 3 months
4. Psoriasis is either untreated or treated only with topicals at the current time (see exclusion criteria for washout times)
5. Subjectively reported poor sleep quality using the Pittsburg Sleep Quality Index (PSQI) (defined as a global score \>5)
6. Fluent in English
7. Demonstrate understanding of the study and willingness to participate as evidenced by voluntary informed consent

Exclusion Criteria:

1. Patients with guttate, erythrodermic, or pustular psoriasis subtypes
2. Having a previous diagnosis of obstructive sleep apnea (OSA) or another medically defined sleep disorder or fall into the intermediate or high-risk groups for having OSA as calculated by the STOP-BANG questionnaire
3. Subjects who have used the following treatments for psoriasis: phototherapy (UVB) in the last 2 weeks, photochemotherapy (PUVA) in the last 4 weeks, oral systemic treatments in the last 4 weeks, biologic immunomodulating agents in the last 12 weeks, or have had exposure to any other investigational drug/device within 30 days prior to study entry
4. Subjects who have used any over the counter or prescription sleep aids within five half-lives of the agent in question.
Effects of Antiplatelet and Antioxidant Agents on Drusen Progression: A Pilot, Prospective Cohort Study

The aim of this clinical trial is to evaluate the effect of low doses of antiplatelet medications (aspirin 81 mg/day or clopidogrel 75 mg/day) with or without a combination of antioxidants (N-acetylcysteine 600 mg/day) in a dry AMD patient with large drusen.

Participants will divided in to three groups.

* Participants who were already taking low dose antiplatelet medications.
* Participants who take the antiplatelet drug mentioned above in addition to the antioxidant prescribed by the investigator
* Participants does not use any medications.


Eligibility Criteria:
Inclusion Criteria:

* Dry AMD with at least 1 large drusen. According to the AREDS study, large drusen have a size of more than 125 micron.
* Patients can evaluate SD-OCT (Spectral domain optical coherence tomography), OCT angiography, and best-corrected visual acuity.
* Age range: 50-85 years
* Patients who have previously used antiplatelet drugs.

Exclusion Criteria:

* Patient with advanced AMD, such as geographic atrophy, neovascular complications (choroidal neovascularization)
* Patient with additional retinal diseases that affect visual acuity, e.g., retinal detachment, diabetic macular edema.
* Patient with a history of intravitreal anti-VEGF injection or macular laser.
* Patient using SSRIs, SNRIs, azole, NSAIDs, dual antiplatelet, anticoagulant medications.
Protein Ingestion on BMM Response in Endurance Runners

The goal of this clinical trial is to investigate the effects of protein ingestion post-exercise on bone turnover markers. The main questions it aims to answer is:

Does protein ingestion independently influence the bone metabolic response to exercise in endurance runners?

We will compare dietary protein to a placebo (water) to detect changes in bone turnover markers.

Participants will:

In a within-subject design, participants will perform an exhaustive run and take either protein or placebo immediately post-exercise.

Track physical activity and diet before each arm of the intervention and during the washout period.

Endurance athletes are at increased risk for bone loss and injury due to high-volume training, muscle weakness, and elevated nutritional demand. Dietary practices influence short- and long-term bone health and nutrition supplementation post-exercise may improve the short-term response of bone to exercise and benefit musculoskeletal recovery. However, we have a limited understanding of which dietary practices are most beneficial to optimize bone health in athletic populations. Protein supplementation has long been recommended for muscle adaptation and athletic performance but its potential for bone health has not been thoroughly investigated in endurance athletes. The purpose of this study is to is to investigate the acute independent effects of dietary protein ingestion on bone metabolism in healthy adults aged 18-35 years participating in high-volume endurance running.

Eligibility Criteria:
Inclusion Criteria:

* 18-35 years of age
* Healthy-range body mass index (BMI) (18.5-24.9 kg/m2)
* Competitive runner for at least one season (minimum 40 km/week for the past 6-months)
* Can read, speak, and understand French and/or English

Exclusion Criteria:

* Disease or medication known to affect bone metabolism
* Disease (e.g., uncontrolled thyroid disease, malabsorptive or inflammatory disorder, metabolic bone disease)
* Medication (e.g., hormonal contraceptives the past 3 months, glucocorticoids, anti-hypertensive drugs, anti-epileptic drugs, osteoporosis therapy)
* Orthopedic or musculoskeletal injury/disease that limits the capacity to exercise
* Current smoker or tobacco user
* Current diagnosis of an eating disorder
* Female participants with self-reported or diagnosed:
* Hypothalamic amenorrhea
* Polycystic ovarian syndrome
* Hyperprolactinemia
* Primary ovarian insufficiency
* Pregnant or breastfeeding
* Donated blood within the past two months