cyrilzakka/clinical-trials huggingface dataset:
Musculoskeletal Non-tumoral Pathology Quantitative Perfusion

Study on quantitative perfusion parameters acquired on MR imaging of patients with non-tumoral pathology of the musculoskeletal system.

Patients referred for the MR imaging evaluation of non-tumoral musculoskeletal pathology (osteonecrosis, pseudarthrosis and compartment syndrome) will have their MR protocols complemented by a contrast enhanced perfusion study. In this patients standard clinical evaluation is already performed with contrast medium injection (Gadolinium) and no additional injection is required.

After post processing multiple quantitative perfusions parameters will be extracted (e.g. plasmatic volume, transfer constant, backflow constant, extra-cellular extra vascular space volume). The variation of these parameters in patients with and without the previously described conditions will be compared.

Eligibility Criteria:
Inclusion Criteria:

* affiliation to a social security regimen
* Signature of an informed consent
* Clinical suspicion of one of the studied conditions (osteonecrosis of the wrist, osteonecrosis of the femoral head, pseudarthrosis and compartment syndrome)

Exclusion Criteria:

* MR contraindications
* Contraindications to contrast injection
* Previous history of allergy to gadolinium containing contrast medium
* Presence of metallic hardware in the study zone
* Pregnancy
* Patients under tutelage
Study of the Functional Result of the Reinsertion of the Subscapular in Reverse Shoulder Prostheses According to the Healing of the Subscapular

This study is based on the hypothesis that the functional result is better if the subscapularis is reinserted and healed. The originality of the study therefore consists in systematically monitoring the healing of this tendon postoperatively, with sufficient follow-up, by ultrasound and by an intra-tendon marker, in order to differentiate the result depending on whether the tendon is healed or not.


Eligibility Criteria:
Inclusion Criteria:

* Men or women over 18 years old
* Patient with an indication of reverse prosthesis for cuff rupture, or eccentric omarthrosis, or omarthrosis without cuff rupture but with posterior eccentricity
* Patient with a normal subscapularis preoperatively
* Patient benefiting from a social protection insurance
* Patient having signed the free and informed consent

Exclusion Criteria:

* Patient with an indication of anatomical prosthesis
* Patient with an abnormal subscapularis preoperatively
* Patient operated for a revision of prosthesis
* Patient with an indication for prosthesis on fracture sequelae
* Patient with an indication for prosthesis on fracture
* Patient participating in another clinical study
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient woman
* Patient hospitalized without consent.
Feasibility of Collecting Quality of Life Data in Collaboration With the Stem Cell Therapeutic Outcomes Database

This is a multi-institution, non-randomized, prospective pilot study to evaluate the feasibility of collecting quality of life (QOL) data on a large cohort of pediatric and adult allogeneic Hematopoietic stem cell transplantation (HCT) recipients.

QOL data will be collected at baseline (pre-transplant), 100 days, 6 months, and 12 months post transplant. The transplant center will consent the patient and administer the baseline QOL surveys. The transplants center will then submit the competed baseline data and patient contact information to the Center for International Blood and Marrow Transplant Research (CIBMTR). The remaining surveys will be administered to the patient from the CIBMTR via paper surveys mailed to the patient.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (≥ 18 years), or pediatric (≥ 2 years and \< 18 years) allogeneic HCT recipient (related, unrelated, or CBU) at participating pilot study transplant centers.
2. Signed informed consent form from adult patient or parent/guardian of pediatric patient.
3. Patient must have a valid mailing address within the United States to receive QOL surveys.
4. Ability to speak and read English.
5. Patients with access to a telephone.
Efficacy Study of Low-dose Glucocorticoid Prophylaxis for Acute Graft-versus-host Disease(GVHD)

Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia. However, GVHD rate was still high after haploidentical HSCT.

It was found in our previous study that CD4/CD8\>=1.16、CD56bright NK\>1.9×106/kg in the graft was associated with higher risk of developing acute Graft-versus-host Disease (GVHD).

The study hypothesis:

Risk stratification-directed low-dose glucocorticoid prophylaxis for acute GVHD after unmanipulated haploidentical blood and marrow transplantation can reduce the incidence of acute GVHD

patients undergone haploidentical HSCT following day 5 post transplant were randomized to treated group(low-dose glucocorticoid) and controlled group(no intervention).

Eligibility Criteria:
Inclusion Criteria:

* no severe diarrhea no serious infection

Exclusion Criteria:

* serious diarrhea active,uncontrolled infection
Effects of Caloric Restriction in Obesity and Type 2 Diabetes

The study investigates whether a long-term 25% caloric restriction can prevent onset and/or progression of renal function deterioration, retinal involvement and cardiovascular complications in overweight/obese type 2 diabetic patients, trough the amelioration of concomitant metabolic abnormalities such as visceral obesity, insulin resistance, dyslipidemia, hypertension and inflammation.

The main aim of the study is therefore to evaluate the role of calorie restriction (CR) on subjects at risk of nephropathy. Secondary aims are to better understand the relationship between CR and the following aspects: renal disease and its associated metabolic abnormalities, retinopathy and cardiovascular complications, quality of life and treatment cost.


Eligibility Criteria:
Inclusion Criteria

* Age \>40 years;
* Type 2 diabetes (ADA criteria);
* UAE \<300 mg/24h;
* Body mass index (BMI)\>27kg/m2;
* Serum creatinine \< 1.2 mg/dL;
* No major changes in calorie, protein and sodium intake in the last 6 mos;
* No major changes in concomitant treatments with blood pressure, glucose or lipid lowering agents since 6 and 3 months respectively;
* Patients legally able to give written informed consent to the trial (signed and dated by the patient);
* Written informed consent.

Exclusion Criteria

* Concomitant non-diabetic renal disease or ischemic kidney disease;
* Primary or immune-mediated renal disease;
* Urinary tract obstruction or infection;
* Treatment with steroids and/or non-steroid anti-inflammatory agents;
* Treatment with thiazide or loop diuretics that, on the basis of the Investigator's judgment, might sustain hypovolemia and/or sodium depletion (with secondary kidney hypoperfusion/hypofiltration);
* Hearth failure and/or hemodynamically significant left ventricular systolic dysfunction, cirrhosis, uncontrolled hyperglycemia resulting in glycosuria, hyper/hyponatremia of any cause;
* Previous surgical procedures for weight loss;
* Previous episodes of depression, or suicide attempts;
* Chronic abuse of alcohol and drugs;
* Pregnancy, ineffective contraception or peri-menopausal age;
* Cancer or any chronic disease that might affect the completion of the study;
* Chronic obstructive pulmonary disease (COPD) in treatment with positive airway pressure;
* Unwillingness or inability to adhere to CR intervention over the entire 24-months intervention period;
* Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial;
* Evidence of an uncooperative attitude;
* Any evidence that patient will not be able to complete the trial follow-up;
* Inability to fully understand the potential risks and benefits of the study.
The Effects of Two Different Types of Exercise Programs to Increase Physical Activity in Patients With MS

Multiple Sclerosis (MS) is a chronic, inflammatory, neurodegenerative, autoimmune disease of the central nervous system. It is thought that MS, which is one of the main causes of non-traumatic neurological dysfunction in young adults, affects approximately two and a half million people worldwide. The annual cost caused by MS is reported to be between $ 8,528 and $ 54,244 per patient. Due to the destruction of the central nervous system, MS has a wide range of sensory, motor, cerebellar and cognitive dysfunctions. These dysfunctions may lead to a limitation of physical activity in people with MS. In addition, people with MS may limit their physical activity because they fear the worsening of their symptoms. Physical inactivity and sedentary life style are thought to be among the reasons that increase the risk of developing chronic diseases such as cancer, hypercholesterolemia, hypertension, arthritis, osteoporosis, obesity, type 2 diabetes, depression and cardiovascular diseases in people with MS. It is reported that these chronic diseases secondary to MS increase mortality by 1.7 times. In addition, these diseases have been associated with increased disability, decreased quality of life, and hospitalization. Physical inactivity can increase disability and mortality by aggravating health problems caused by the disease. For this reason, it is emphasized that there should be studies to increase physical activity in people with MS. Studies have shown that physical activity improves muscle strength, aerobic capacity, gait and balance and reduces fatigue in people with MS. In addition, it is stated that physical activity increases self-efficacy and improves positive perspective in patients with MS. When the literature is examined, it is seen that there are studies about physical activity in MS but they have methodological limitations. There are a limited number of studies on the effectiveness of the programs planned to increase the level of physical activity. The aim of our study was to investigate the effects of physical activity program and online training program on physical activity in patients with MS.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with Multiple Sclerosis
* Being between 25 and 60 age range
* Not having attacks during last 3 months
* Having ≤ 5.5 Expanded Disability Status Scale
* Not having received physiotherapy and rehabilitation sessions for at least 3 months
* Having internet access

Exclusion Criteria:

* Pregnancy
* Blurred vision
* Use of assistive devices for ambulation
* Having another diagnosis rather than Multiple Sclerosis
MASCOT - Post Marketing Registry

To collect post marketing surveillance data on patients receiving at least one Combo Bio-Engineered Sirolimus Eluting Stent when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Combo Stent in routine clinical practice.

The multicenter, multinational, prospective registry population consists of patients who undergo percutaneous coronary intervention (PCI) with (attempted) placement of at least one Combo Stent (according to the Instructions for use) as part of routine clinical care. Approximately 2,500 patients from 50 centers in Europe and Asia will be entered into the registry. Patients entered into the registry are followed for one year. The registry is considered finished when all patients have completed the 12 month follow-up.

A follow-up is scheduled at 30 days, 6 months and 12 months post procedure. Follow-up is obtained at a planned regular visit to the outpatient clinic, or by telephone contact with the patient.

Eligibility Criteria:
In general, consecutive patients are included in the registry. Patients are only excluded from registration if ANY of the following conditions apply:

1. Undergoing PCI for treatment of stent thrombosis
2. High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
3. Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned
4. A life expectancy of \<12 months
5. Explicit refusal of participation in the registry
Alvimopan Use in Polytraumatized Patients

To evaluate the efficacy and safety of Alvimopan(12 mg) in recovery of bowel function in an emergency trauma setting without the pre-operative dosage in patients that will receive abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 to 80
* Poly-traumatized patients
* Extubated patients after abdominal exploration
* Underwent Abdominal exploration, had colon resection with primary anastomosis with closure of abdomen

Exclusion Criteria:

* Mechanically ventilated patients
* Patient not expected to survive Glasgow Coma Scale = 3
* Pregnant patients
* Apache score \> 40 (observed mortality 100%) Saas Ahmed Naved et al 2011
* Vasopressor therapy
* Septic patients
* Thoracotomy
* Bogota bag
* Intravenous Drug Abuser (IVDA) as evidenced by urine toxicology upon admission to the Trauma Unit
* Patients with prior history of gastric surgery and/or colonic surgery
* Medical History: of severe cardiovascular disease, Renal diseases, Hepatitis C or Hepatic failure, Autoimmune disease, Crohn and Ulcerative Colitis (In view of the inflammation in the intestinal mucosal which may decrease optimal absorption of the medication) and or bowel obstruction
* Prior pancreatic anastomosis or gastric anastomosis; ostomy formation
* Chronic use of nonsteroidal anti-inflammatory drugs
Comparison of Dry Needling and Deep Friction Massage in Patients With Subacromial Pain Syndrome

This study was planned to investigate the effects of Trigger Point-Dry Needling Therapy (TP-DNT) on night pain and Shoulder Internal Rotation (SIR) in individuals with Subacromial Pain Syndrome (SPS).

Shoulder pain seen intensely in the general population, many methods has been used for the treatment which has not been fully proven to be superior to each other. Before considering surgical approaches, trying conservative approaches is emphasized. While literature showed us that nighttime pain is an important musculoskeletal symptom, may be associated with local inflammation, it is an important feature during the treatment planning. TP-DNT had positive effects on night pain and SIR in SPS. It was seen that the treatment satisfaction level of participants was high. Despite these positive findings, there is need for further studies in which sample size is increased, control group is added, and long-term follow-up is planned.

Eligibility Criteria:
Inclusion Criteria:

* To be able to read and speak Turkish well enough to give informed consent and follow the working instructions.
* Having complaints of unilateral shoulder pain for at least 6 months and being diagnosed with subacromial impingement syndrome.
* Having night pain
* Having active trigger point.

Exclusion Criteria:

* Bilateral shoulder pain
* If there is a contraindicated condition for needles such as fear of needles or infection
* History of bleeding disorder
* Shoulder fracture and / or dislocation history
* Symptoms of cervical radiculopathy and / or neuropathy
* The use of antiaggregants, anticoagulants, analgesics or antiinflammatory drugs or drug-like substances (1 week before or during treatment)
* Fibromyalgia syndrome
* Any neurological, motor, or sensory disorder in the upper extremity
* History of surgery on shoulder or neck
* Conservative or invasive physical therapy or infiltration for the shoulder region during the last 6 months
* Pregnancy
PRospective Study to Measure the Impact of MammaPrint on Adjuvant Treatment in Hormone Receptor-positive HER2-negative Breast Cancer Patients (PRIMe)

PRIMe is a prospective, case-only trial designed to measure the impact of MammaPrint on physician chemotherapy intention in the two discordant groups (ET/POOR, CT/GOOD) in stage 1 and 2 HR-positive HER2-negative breast cancer patients. The design also provides for assessment of several important secondary indicators. Eligible patients will have their tumor sample analyzed for MammaPrint, BluePrint and TargetPrint. Patients cannot start treatment before the MammaPrint result is received and taken into consideration for the adjuvant treatment plan.


Eligibility Criteria:
Inclusion Criteria:

* Women with histologically proven invasive stage 1 and 2 breast cancer
* Hormone receptor positive according to local standards
* HER2 negative - i.e. IHC 0-1+, or FISH or other ISH non-amplified (locally assessed)
* Axillary lymph node status: 0-3 involved (macro metastases i.e. \>2mm OR micro metastases i.e. \>0.2-2mm)
* ≥ 18 years of age at time of consent
* Patients must be eligible to receive adjuvant chemotherapy and endocrine therapy as defined by a good Karnofsky index, no hematological, cardiological or hepatic contraindications nor any impeding comorbidity
* Written informed consent

Exclusion Criteria:

* ≥4 involved axillary nodes
* Multi-centric disease with more than 2 clinically relevant lesions
* HR negative OR HER2 positive/amplified (locally assessed)
* Previous diagnosis of malignancy unless disease free for 10 years
* Metastatic disease
* Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
* Women who have started or completed adjuvant chemotherapy or neo-adjuvant chemotherapy for current breast cancer
Observational Study on Dynamic Changes of Blood Pressure During Post-epileptic Seizure Stage (OCBPS)

This article details a multicenter study on changes of blood pressure and heart rate during post-epileptic seizure stage.

In contrast to the well-documented changes in heart rate and respiration, post-seizure changes in blood pressure have received insufficient attention. Fluctuations in blood pressure may worsen brain injury and elevate the risk of Sudden Unexpected Death in Epilepsy (SUDEP), yet evidence regarding postictal blood pressure changes remains limited.

This multicenter study aims to investigate the changes of blood pressure and heart rate during post-epileptic seizure stage in epilepsy patients, providing high-quality evidence on postictal hemodynamic changes and laying the foundation for future interventions. The study will enroll 2000 seizure events from hospitalized epilepsy patients aged 14-80 years between October 2024 and October 2025. Data on blood pressure, heart rate and blood oxygen will be collected during multiple time intervals post-seizure, alongside clinical information such as seizure type, duration, and medication use.

Eligibility Criteria:
Inclusion Criteria:

1. Age 14-80 years old, male and female;
2. Meet the diagnostic criteria for epilepsy, including focal epilepsy and generalized epilepsy.
3. Patients diagnosed with epilepsy, with at least one seizure during the hospitalization.
4. Seizures lasting longer than 30 seconds (including convulsive and non-convulsive status epilepticus, if seizure cessation can be determined and medications were recorded, they can be included).
5. Hypertensive patients who are on antihypertensive medication and have well-controlled blood pressure are eligible.
6. Patients who agree to participate in the study.

Exclusion Criteria:

1. Patients with structural heart disease, coronary artery disease (CAD), cardiomyopathy
2. Patients with severe systemic diseases
3. Pregnancy
4. Preictal seizures or myoclonic seizures.
Physical Fitness in Elderly

Aging decreases the physical fitness levels in living beings. The environmental factors also have a major effect on the physical fitness levels. The objective of this study was to compare the physical fitness levels of nursing home residents and community-dwelling elderly people. This study employed 118 participants, who consisted of nursing home residents and community-dwelling elderly people. The physical fitness levels of the elderly people were measured by Senior Fitness Test. The physical fitness levels of the elderly people were measured by Senior Fitness Test. Chair stand test, arm curl test, 2-minute step test, chair sit and reach test, back-scratch test, 8-foot up and go test and body mass index were measured.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 65 and 85 years
2. Scored between 24 and 30 points in the Mini-Mental Status Examination (MMSE).
3. Living in nursing homes for at least six months (for nursing home residents) (6,7).

Exclusion Criteria:

1. Not able to communicate verbally
2. Not able to stand for at least 90 seconds and ambulated with assistance
3. Patients with severe visual impairment, neurological disorders and/or congestive heart failure
4. Individuals who are not advised exercise.
Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive

To evaluate safety and efficacy of CE/BZA in real practice in Korea


Eligibility Criteria:
Inclusion Criteria:

1. Severe post menopausal vasomotor symptoms with uterus
2. postmenopausal osteopenia

Exclusion Criteria:

* Women with undiagnosed abnormal uterine bleeding
* Women with known, suspected, or past history of breast cancer
* Women with known or suspected estrogen-dependent neoplasia
* Women with active deep venous thrombosis, pulmonary embolism, or history of these conditions
* Women with active arterial thromboembolic disease (for example, stroke, myocardial infarction) or history of these conditions
* Women who are receiving progestin, estrogen, or estrogen-agonists/antagonists
* Women with hypersensitivity (for example, anaphylaxis, angioedema) to estrogens, bazedoxifene, or any ingredients
* Women with known hepatic impairment or disease
* Women with known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders
* Pregnant women, women who may become pregnant, and nursing mothers
* Women with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.