cyrilzakka/clinical-trials huggingface dataset:
Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence

In clinical practice, many patients are not able to modify their habits to achieve a high level of diuresis and fluid intake and therefore are at an elevated risk for stone recurrence.

The investigators think that Ure-Na (osmotic agent) taking could help to increase urine volume and decrease urine concentration, which would be of benefit in the prevention of kidney stones.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 60 years of age
* High risk for recurrence (1 or more of) Bilateral or complex stones, Recurrent stones, Family history (1st degree relative), Non-calcium stones, Solitary kidney or anatomical abnormality, Nephrocalcinosis, Systemic disease with risk of stones (tubular acidosis, cystinuria, etc.)
* Diuresis \< 1.8 L/24 hours despite recommendations from physicians and/or nutritionist at the kidney stone clinic (as documented in the previous 6 months)

Exclusion Criteria:

* Patient does not meet 1 of the 3 inclusion criteria
* Pregnancy or breastfeeding
* Lack of understanding about the protocol and effects of Ure-Na
* Expected inability to adequately increase fluid intake on Ure-Na
Compassionate Use of Pozelimab

Provide compassionate use of pozelimab

Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Peri-operative Foot CT Perfusion in CLI Patients

To investigate the clinical value of quantitative analysis of peri-operative foot supply through CT perfusion in patients with critical limb ischemia


Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years old;
* CLI patients with Fontaine grade III-IV or Rutherford grade 4-6 and underwent a successful revascularization;
* Patients completed both pre- and post-operative CTP workups;
* Patients signed the informed consent form and be able to complete the clinical follow-up for 12 months.

Exclusion Criteria:

* Patients has participated in other clinical studies;
* Patients with Heart failure (NYHA III/IV)/right to left shunt heart disease/severe aortic and mitral insufficiency/acute coronary syndrome/malignant arrhythmia/severe pulmonary hypertension (pulmonary artery pressure at least 90 mmHg)/moderate to severe renal insufficiency (creatinine clearance rate\<60 ml/min)
* Any allergic constitution;
* Pregnancy and childbirth;
* Life expectancy\<12 months.
Drug-Eluting Balloon Angioplasty Versus Bypass Surgery as First-Line Strategies in Infrageniculate Arterial Disease for Critical Limb Ischemia in Type 2 Diabetic Pacients: a Randomised Controlled Clinical Trial

The aim of this study is to evaluate the outcomes of drug-eluting balloon angioplasty and vein bypass surgery in diabetic patients with critical limb ischemia due to infrapopliteal arterial disease.

Objective: To consider the clinical outcomes of drug-coated ballon angioplasty and vein bypass surgery in terms of amputation-free survival, overall survival, relief of symptoms, quality of life and to determine if limb revascularization contributes to diabetic peripheral neuropathy (DPN).

All patients with type 2 diabetes mellitus and severe limb ischemia reffered to multidisciplinary diabetic foot team or endocrinology or vascular units can be considered.

To be eligible for randomization, peripheral arterial occlusive disease must be located infra-popliteally; patients must have adequate inflow and outflow to support infrapopliteal interventions; have a good superficial vein for bypass surgery. If the patient is suitable for both treatment arms, they will be invited to enter the trial.

If patient is suitable for both revascularization techniques randomization will be performed after diagnostic angiogram submission

Patient will be randomised to one of the following groups:

A. Vein bypass surgery first strategy B. Endovascular treatment first (drug coated balloon angioplasty) strategy

Outcomes will be recorded at 1, 3, 6, 9, 12, 18, 24 month after revascularisation procedure. Information collected will include further interventions (vascular, non-vascular), hospitalisations (for whatever reason), other health problems, clinical and haemodinamic status of limbs, funcional status, quality of life, neuropathy.

Eligibility Criteria:
Inclusion Criteria:

* Patient with type 2 diabetes mellitus
* Severe limb ischemia (Rutherford class \>=4) due to infrapopliteal, +/- popliteal disease \[ a.tibialis anterior, tr.tibioperonealis, a.peronea, a.tibialis posterior, a.dorsalis pedis stenosis or occlusion (50%-100%; \>40mm in length); leasion may involve a.poplitea P1-P3 segment; have adequate inflow and outflow to support infrapopliteal intervention (diagnostic imaging); suitable for both vein bypass and best endovascular treatment following; angiography diagnostic imaging and ultrasound examination of vein conduit.\]

Exclusion Criteria:

* Requires primary limb amputation
* Acute limb ischemia
* Anticipated life expectancy of \<2 years
* Unsuitable for either revascularisation strategy
* Severe concomitant disease (acute coronary ischemic event, brain ischemic event, cognitive disorder, active oncology process)
3D MRE-Based Evaluation of Meningioma Mechanical Properties and Histological Features

This prospective single-center study aims to evaluate the feasibility and clinical utility of three-dimensional magnetic resonance elastography (3D MRE) in assessing tumor stiffness and adhesion in patients with meningioma undergoing surgical resection. By correlating preoperative MRE-derived stiffness and adhesion maps with intraoperative findings and histopathological features, the study seeks to determine whether MRE can serve as a noninvasive imaging biomarker for surgical planning, risk stratification, and prediction of tumor behavior.

Meningiomas are the most common primary intracranial tumors and are often surgically resectable. However, the intraoperative texture and adhesion of the tumor to surrounding structures vary widely and directly impact the surgical approach, difficulty, and outcomes. Current preoperative imaging lacks the ability to quantitatively assess biomechanical properties such as stiffness and adhesion, which are critical for neurosurgical planning.

This prospective clinical trial investigates the application of 3D magnetic resonance elastography (MRE) in characterizing the biomechanical properties of meningiomas. Specifically, it aims to quantify tumor stiffness and adhesion using MRE-derived shear modulus maps and correlate these measurements with intraoperative surgeon-assessed stiffness/adhesion scores and postoperative histopathology. The study will also assess the diagnostic performance of MRE in predicting challenging resections, high tumor adhesion, and histological subtypes.

Approximately 300 patients with radiologically confirmed meningioma scheduled for elective resection will be enrolled. Participants will undergo standard MRI and additional 3D MRE scanning. Intraoperative findings including tumor stiffness, adhesion, blood supply, and resection difficulty will be systematically recorded. Postoperative pathological analysis will include tumor grade and histological subtype. Statistical analyses will evaluate correlations, diagnostic accuracy, and potential prognostic value.

Findings from this study may support the use of 3D MRE as a valuable noninvasive tool in preoperative assessment of meningiomas, helping optimize surgical strategies, reduce complications, and inform treatment decisions.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing meningeoma resection surgery are eligible for inclusion in the study cohort.

Exclusion Criteria:

* Patients with metallic implants or foreign bodies in their bodies (pacemakers, artificial metallic heart valves, metal joints, metal implants, and those who can not remove dentures, insulin pumps, or contraceptive rings)
* Pregnant women in the first trimester (within three months)
* Patients with severe claustrophobia or anxiety
* Patients with severe fever
* Patients who can not tolerate MRE
* Patients with vascular malformations and aneurysms.
* Patients who do not sign an informed consent
Palatal Versus Buccal Protraction Using Plates Assisted With Facemask in Growing Class III Patients

to compare Palatal and buccal protraction using plates assisted with facemask in growing class III patients

A randomized controlled clinical trial was adopted in this study. A total of 20 growing Class III patients were selected from patients seeking orthodontic treatment. The participants were recruited from the department of Orthodontics at Faculty of Dentistry, Mansoura University. No active advertisement was used for participant recruitment, and instead, a convenience sample was formed. Prior to participating in the study, the purpose of the study was explained to the parents of the children and informed consents and assents were obtained according to the guidelines on human research adopted by the Research Ethics Committee Faculty of Dentistry, Mansoura University

Eligibility Criteria:
Inclusion Criteria:

* Growing patients with age ranged between 8-13 years old.
* Patients should have examination: Class III malocclusion due to maxillary retrusion as verified by clinical and radiographic examination; SNA \<79 and ANB angle \< -1.
* Good likelihood of recall availability.

Exclusion Criteria:

* Vertical skeletal mal relationship.
* History of previous orthodontic/orthopedic treatment.
* Bad habits that may jeopardize the appliance.
* Patients with systemic diseases
* Congenital deformities such as cleft lip and/or palate.
Volunteering as an Intervention to Reduce Depression Among Adolescents

The purpose of the present study is to test in a preliminary manner an innovative strategy for treating depression among adolescents (alongside existing therapy) using community volunteerism.

The purpose of the present study is to test in a preliminary manner an innovative strategy for treating depression among adolescents (alongside existing therapy) using community volunteerism. In addition, this study will test a potential mechanism by which volunteering might decrease depressive symptoms: increasing psychosocial assets, specifically decreasing self-orientation and increasing an orientation toward others. This will be measured through self-report as well as using functional magnetic resonance imaging (fMRI). This study will be the first study to explore how neural response patterns are potentially altered by intense experiences with volunteerism among depressed adolescents.

Eligibility Criteria:
Inclusion Criteria:

* age 14-20
* new mild to moderate depression diagnosis (single episode)
* new mild to moderate anxiety diagnosis
* new adjustment disorder diagnosis
* have been in treatment for \< 8 months
* right-handed

Exclusion Criteria:

* history of recurrent depressive, anxiety or adjustment disorder episodes
* have been in treatment \> 8 months
* left-handed
* expressing suicidal ideation
* claustrophobia
* any contraindications for completing an MRI scan
Corticosteroids Therapy and Pneumocystis Jirovecii Pneumonia (PCP)

To explore the effects of corticosteroid therapy on pulmonary fibrosis and potentially pneumothorax in patients with mild PCP (pO2 \>70mmHg) combined with the standard of care treatment of antibiotic therapy.

Although the development of highly active anti-retroviral therapy has substantially reduced the incidence of Pneumocystis jirovecii pneumonia (PCP) among HIV-infected individuals, PCP remains one of the most common presenting opportunistic infection among this population. The use of adjunctive corticosteroids in the treatment of patients with moderate to severe PCP has resulted in a significant improvement in the development of respiratory failure and mortality.

Past studies have demonstrated no clinical benefit in patients with mild disease (pO2\>75 torr on room air). This may have been due to the fact that few patients with mild disease develop either respiratory failure or die during the course of the acute illness so that a statistical difference could not be demonstrated.

However, considering parameters other than mortality, there is some evidence to suggest that patients with high pO2 concentrations benefit from adjunctive corticosteroids. PCP is associated with the development of pulmonary fibrosis and this can have significant consequences. Pathological studies have shown the development of interstitial fibrosis late in the course of acute illness. Studies have documented the presence of diffuse interstitial pneumonitis five months after the onset of acute illness. Therefore, patients with PCP infection, regardless of their pO2 level on presentation may benefit from corticosteroid therapy.

The current standard of care therapy for patients with PCP does not involve the addition of corticosteroids to standard antibiotics in those patients with pO2\>70 mmHG. This study propose to conduct a randomized, prospective, un-blinded clinical trial to explore the effects of corticosteroid therapy on pulmonary fibrosis in patients with mild PCP who are admitted to the George Washington University Hospital.

Eligibility Criteria:
Inclusion Criteria:

* HIV Infection,
* Hospital admission for suspected PCP,
* Confirmatory test for PCP (bronchoscopy with bronchoalveolar lavage), pO2\>70 mmHg or pO2\<70 mmHg while breathing room air,
* 18 years or older

Exclusion Criteria:

* Contraindications to corticosteroid therapy,
* Unable and or unwilling to perform PFTS or to return for follow-up evaluations,
* Underlying lung disease such as emphysema, untreated active tuberculosis, Uncontrolled diabetes (fasting glucose \> 250 mg/dL,
* Uncontrolled hypertension (160/95 mmHg),
* Pregnancy
Frozen Red Blood Cell Transfusions in Trauma Patients

The purpose of this study is to look at red blood cell (RBC) transfusions in trauma patients and evaluate for any differences between the age of the RBCs and how they were stored. The investigators will specifically look for the following differences between study groups:

1. the transfused red blood cells' ability to delivery oxygen to the tissues
2. differences in biochemical markers in subjects and units transfused, and
3. how the subject's internal organs are working and if they develop any infections


Eligibility Criteria:
Inclusion Criteria:

* Trauma Service with an Injury Severity Score \> 4
* Require a blood (PRBC) transfusion
* Transfusion is not emergent
* Able to obtain consent from patient or appropriate 3rd party prior to 1st transfusion

Exclusion Criteria:

* Inability to adhere to blood age randomization due to limitations of the blood bank inventory
* Bilateral hand injuries that prevent StO2 measurements
* Age \< 15
* Pregnancy
* Massive transfusion (=/\> 10 units in 24 hours) in last 3 months
* Hemodynamically unstable or need for transfusion in \< 3 hours
IVL for Stent Underexpantsion

The IVL-Dragon Registry was a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL in high-volume PCI centers. The primary efficacy endpoint was clinical success, defined as a reduction of stent underexpansion to \<30% with no evidence of in-hospital device-oriented composite end point (DOCE) (defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction).


Eligibility Criteria:
Inclusion Criteria:

* stent underexpansion treated with intravascular lithotripsy (IVL)

Exclusion Criteria:

* no
PrEP (Pre-exposure Prophylaxis) Stigma and Women Ethnodrama Pre-Test Phase

The investigators will develop and pre-test an ethnodrama intervention designed to transform community member beliefs about and foster support of young cisgender women (YCW) using PrEP.

In Aim 1/Year 1, the investigators will develop the ethnodrama intervention; no data collection activities are included. In Aim 2/Year 2, the investigators will pre-test the ethnodrama intervention with invited groups of young women and members of young women's socio ecology (i.e., male partners, female peers, healthcare providers, informal community leaders, and family members).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Young cisgender women who have taken or are taking PrEP
* Male partners of young women
* Female peers of young women
* Healthcare providers
* Informal community leaders
* Family members of young women

Exclusion Criteria:

None
Corticosteroid And Ozone Injection In Patıents With Carpal Tunnel Syndrome

There are a limited number of studies on the use of ozone in CTS.The aim of this clinical study is to compare the effectiveness of corticosteroid injections and ozone injections added to splint and exercise therapy in mild-moderate CTS patients..

106 patients included in the study were randomized and divided into three groups. During the follow-up, a total of 90 patients, 30 patients in each group, completed the study.

106 patients included in the study were randomized and divided into three groups.

During the follow-up, a total of 90 patients, 30 patients in each group, completed the study.

Neutral hand-wrist rest splint and tendon-nerve gliding exercises were given to 30 patients included in the control group.

In addition to the treatment given to the first group, 40 mg (1 ml) triamcinolone acetonide was injected under USG guidance to 30 patients included in the corticosteroid group.

In addition to splint and exercise therapy, 3 cc ozone (O2-O3), 10 micrograms were injected under USG guidance to 30 patients in the ozone group.

Patients in all three groups were evaluated at the beginning of treatment, 6 weeks and 3 months after treatment.

Evaluation methods include provocative tests (Tinnel, Phallen, Flick tests), visual analogue scale (VAS) numbness day/night and VAS pain scores, sensory tests (two-point discrimination and Semmes Weinstein monofilament test (SWMT)), hand and finger grip strengths. measurement, Boston carpal tunnel syndrome questionnaire (BCTA), median nerve cross-sectional area (MSCA) measurement with USG and electrophysiological parameters were used.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-70, male or female.
* Clinically and electrophysiologically diagnosed with mild or moderate CTS
* Having symptoms for 1 month or longer
* No contraindications for corticosteroid and ozone application
* Patients whose consent was obtained to participate in the study

Exclusion Criteria:

* Under 18 years old and over 70 years old
* Having a severe CTS
* Having thenar atrophy
* Those with diabetes, thyroid and kidney disease and CTS developing secondary to this
* Those with previous traumatic nerve injury, peripheral nerve injury or surgery
* Those with a diagnosis of polyneuropathy
* Having rheumatic disease
* With known radiculopathy
* are pregnant
* Known G6PD deficiency, hyperthyroidism, thrombocytopenia, severe cardiovascular instability
* Those who have infection, burns, cuts or skin integrity in the skin area to be treated
* Cognitive disorder, severe psychiatric illness
* Those with diabetes, thyroid and kidney disease and CTS developing secondary to this
* Patients who have not received corticosteroid or ozone injection in the last 3 months
Physical Fitness in Celiac Disease Patients - the Effect of a Gluten Free Diet

Evaluating the effect of Celiac disease (CD) and gluten free diet (GFD) on physical fitness parameters among CD subjects. The CD subjects will be compared to healthy controls.

This is a prospective observational cohort study. The study would take place at Meir Medical Center (Kfar-Saba, Israel), a secondary-level academic hospital. The investigators will enroll 50 newly diagnosed CD subjects. The diagnosis will be in accordance with the European Society for Gastroenterology Hepatology and Nutrition guidelines for the diagnosis of CD from 2012 (6). The investigators will also enroll 50 control subjects. The control subjects are children visiting the pediatric gastroenterology clinic. Before enrollment the investigators will rule out chronic conditions involving the gastrointestinal tract including CD.

All subjects will be enrolled after providing an informed consent and signing the consent form.

The investigators will obtain the following measurements and evaluations at and 6 months after enrollment:

1. Anthropometric measurements: Height, weight, body mass index (BMI) and total body fat will be evaluated using a TANITA scale. The z-score for each parameter will be recorded.
2. A Godin leisure-time exercise questionnaire (7) will be filled by the subjects and their parents
3. Evaluation of physical fitness by the Eurofit fitness testing (8). This series of physical fitness tests was developed to evaluate speed, stamina and strength in school-aged children.

   1. Flamingo balance test
   2. Seat and reach test
   3. Standing broad jump test
   4. Handgrip test
   5. Sit-ups test
   6. Bent arm hang test
   7. Twenty meter endurance shuttle run test
   8. Wingate anaerobic fitness test
4. Bone speed of sound test will be performed by a bone sonometer - a non-invasive ultrasound based measurement of bone density.
5. CD subjects will be evaluated for adherence to GFD via questioning by a pediatric gastroenterologist and a clinical dietitian and by serum tissue transglutaminase immunoglobulin A (IgA) level (or serum deamidated gliadin peptide immunoglobulin G level in IgA deficient subjects). This is part of the normal follow-up of CD patients.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 4-18y visiting the pediatric gastroenterology clinic
2. Signing a consent form

Exclusion Criteria:

1. Family history of cardiovascular diseases or sudden death before age 50y
2. Chronic condition limiting the ability to perform the physical fitness tests (e.g. juvenile idiopathic arthritis)
3. Failure to complete the measurements and evaluations by 2 months from the date of the visit at the clinic
PAS for Lower Extremity Rehabilitation in Tetraplegic Patients

The investigators have recently shown in incomplete SCI patients that long-term paired associative stimulation is capable of restoring voluntary control over some paralyzed muscles and enhancing motor output in the weak muscles (1,2). In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete cervical level SCI and investigate its effectiveness for lower extremity rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* cervical incomplete SCI

Exclusion Criteria:

* epilepsy
* metal inclusion in the head area
* pacemaker
* hearing device
* high intracranial pressure