cyrilzakka/clinical-trials huggingface dataset:
The Effects of Atorvastatin on the Nitrogen Oxide-system in Patients With Type 2 Diabetes and Nephropathy

It has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. This effect can partly be related to a reduction in cholesterol levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. The purpose of this study is to investigate the effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular variables in patients with type 2 diabetes with nephropathy.

Subjects will be examined on two examination days. 4 days prior to each examination day subjects are treated with either atorvastatin or placebo. During treatment periods subject are given a standardized diet.

On the examination days subject are given L-NMMA(L-NG-monomethyl Arginine citrate), a NO inhibitor, 6 mg bolus infusion followed by continuous 4 mg/kg/hr infusion for 1 hour. Renal function, central hemodynamic and vasoactive hormones are evaluated prior, during and after L-NMMA infusion.

Renal function is measured by renal clearance of 51Cr-EDTA and urinary sodium, potassium and albumin concentration. Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC) will be measured to evaluate channel activity in the nephron.

Central blood pressure, pulse wave analysis, and augmentation index are measured using SphygmoCor® from Atcor.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* minimum 40 years
* Chronic Kidney disease
* Estimated GFR (eGFR) between 30 and 90 ml/min
* Diabetes Mellitus type II

Exclusion Criteria:

* Nephrotic Syndrome
* Anamnestic or clinical signs of significant heart, lung, lever, kidney and brain disease
* Neoplastic disease
* Alcohol abuse,
* Drug abuse
* Pregnancy or nursing
* Blood donation within a month before examination
* Hgb \< 6,0
A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)

This is a Phase 3, open-label, 1-year study of the safety, tolerability, and need for re-treatment with SAGE-217 in adult participants with MDD.

This study was previously posted by Sage Therapeutics. In July 2024, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Inclusion Criteria:

1. Participant has a diagnosis of MDD as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Clinical Trial Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period.
2. Participant is in good physical health and has no clinically significant findings, as determined by the Investigator, on physical examination, 12-lead electrocardiogram (ECG), or clinical laboratory tests.
3. Participant has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥28 and a HAM-D total score of ≥20 at Screening and Day 1 (prior to dosing).

Exclusion Criteria:

1. Participant has attempted suicide associated with the current episode of MDD.
2. Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
3. Participant has had vagus nerve stimulation, electroconvulsive therapy, or has taken ketamine (including esketamine) within the current major depressive episode.
CAPITAL: Carotid Artery Plaque Intravascular Ultrasound Evaluation

To assess the safety and feasibility of Volcano Corp Eagle Eye Gold Catheter system to correlate the presence and characteristic of carotid artery atherosclerotic disease with anatomic and histologic analysis.

A Phase , single center, prospective safety and feasibility study in patients diagnosed with carotid artery disease requiring intervention (carotid endarterectomy(CEA) or carotid artery stenting (CAS) with distal protection) as determined by the attending physician per standard treatment guidelines. At the time of the procedure, patients will undergo peri-operative assessment of their carotid artery disease with the study device.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Patient must be:

Symptomatic with lesions \>/= to 50% stenosis, or Asymptomatic with lesions of \>/= to 75% stenosis in at least one carotid artery, specific to the internal carotid artery, common carotid artery or bifurcated region; documented through acceptable ultrasound studies, completed within 30 days of recruitment.

* For patients with bilateral carotid disease- procedures need to be staged greater than 30 days apart. The lesion that has a greater degree of stenosis will be considered as the index procedure.
* Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment.
* The patient is able to give informed consent.

Exclusion Criteria:

* The patient is experiencing a new (acute) neurologic event or has experienced a stroke within the last 30 days prior to enrollment.
* The patient has intracranial tumors, arterial vascular malformations \>5mm, aneurysms or severe intracranial stenosis distal to the target lesion.
* Presence of thrombus at the target site or loose 'floating' debris as determined by duplex analysis and/or angiography.
* Existing hemorrhagic disease or coagulation problems creating inability to obtain homeostasis at entry site.
* The patient has an allergy to, or is unable to tolerate, heparin, concomitant medications (clopidogrel or ticlid, aspirin) or to nitinol metal.
* The patient has a history of or known reaction to radiocontrast agent (radiopaque dye) and is unable to be premedicated.
* Coumadin treatment that has continued during the 48 hours prior to enrollment and an INR above hospital normals (i.e. in the event of atrial fibrillation or prosthetic valve replacement).
* Hemodynamic instability at the time of intervention.
* Severe chronic renal insufficiency (plasma/ serum creatinine\> 2.5 mg/dL) at the time of intervention, except in patients on dialysis.
T Cell Responses to Various Levels of Exercise Stress

The objective of this project is to quantify the immunoendocrine response to acute stress events combining both physical and psychological challenges. This work will serve as a pilot project examining differential stress induction in response to exercise. Participants will have an instructor with prior military training lead a two-hour training session for 10 recreationally fit male volunteers. You will be randomly assigned to a high-intensity training group to participate in the "military style" training and a low-intensity training group who will participate in a low-intensity cardiovascular training protocol. Blood samples will be collected from you prior to and following the exercise session and these samples will be analyzed for endocrine measures as well as markers of immune function to include chemokines and cytokines.


Eligibility Criteria:
All subjects will be screened using a health-history questionnaire for contradictions to exercise by American College of Sports Medicine (ACSM) guidelines

Inclusion Criteria:

* Recreationally active
* Between the ages of 18-40,
* Healthy
* Non-obese (BMI \<28 kg/m2)
* Non-smoking
* Free of metabolic or cardiovascular diseases.

Exclusion Criteria:

* Unhealed Fractures
* Thrombophlebitis (blood clots)
* Recent Surgery (within the last three months)
* Recent Uncontrolled Bruising
* Osteomyelitis (acute or chronic bone infection)
* Myositis Ossificans (hardened scarring in muscle tissue of the thigh).
Feeding Malnourished Children Different Types of Fatty Acids to Promote Neurocognitive Development

An appropriate balance of omega-6 and omega-3 fatty acids is important for support of neurocognitive development in healthy infants and toddlers. In young children recovering from severe acute malnutrition (SAM), excess omega-6 intake depletes omega-3 fatty acid status. This research will evaluate how novel ready-to-use therapeutic foods (RUTF) with balanced fatty acids improve the metabolic and neurocognitive effects in young children in Malawi recovering from SAM, yielding new knowledge that also has implications for development of well-nourished children.


Eligibility Criteria:
Inclusion Criteria:

* 6-59 months
* An acceptable appetite defined by the ability to consume 30 grams RUTF within 20 minutes
* Mid Upper Arm Circumference \<11.5 cm, weight-for-height z-score \< -3, or bilateral pitting edema on the dorsum of the feet

Exclusion Criteria:

* Participation in any other ongoing study or supplementary feeding program
* Children with a chronic medical condition, including cerebral palsy, static encephalopathy, congenital heart disease, gastrointestinal disease, or peanut allergy
Effect of Prophylactic Antibiotics on Intra-Operative Culture Results

Subjects will be consented and then determined randomly whether they will receive antibiotics prior to their surgery or during their surgery. Each patient will have cultures taken before and during their surgery from the infected hip or knee. Results will be compared after completion of the study.

It is unknown whether giving pre-operative antibiotics affects the results of intraoperative bacterial cultures. This is an important question as antibiotics are often not given prior to surgery out of concern that accurate culture results will not be obtained. It is important to obtain accurate cultures so that targeted antibiotic therapy can be used. However, delaying the administration of antibiotics also delays the onset of treatment. Currently, the optimal course of action is unknown. The purpose of this study is to resolve this issue and determine if prophylactic antibiotics affect intra-operative culture results in patients undergoing revision hip or knee arthroplasty surgery for infection.

This is a prospective randomized clinical study to determine if prophylactic antibiotics affect intra-operative culture results in patients undergoing revision hip or knee arthroplasty surgery for infection. Pre-operatively, patients will have their affected joint aspirated and this fluid will be sent for cultures. Patients are then randomized to receive prophylactic antibiotics (Vancomycin and Ancef) within one hour prior to surgery or to have pre-operative antibiotics withheld. Every patient then has their affected joint cultured intra-operatively. All samples will be evaluated for the presence of aerobic bacteria, anaerobic bacteria, mycobacteria, and fungus. Pre-operative and post-operative cultures in both study populations are compared to determine the effects of pre-operative antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* prior arthroplasty surgery of the hip or knee
* presentation to clinic with infected joint
* scheduled for revision surgery

Exclusion Criteria:

* patients who have received antibiotics for any reason within 4 weeks of their pre-operative culture
* infected native joints
* septic patients
* refusal of participation
Evaluation of the Six Minute Walk Test and Other Instruments in Heart Failure

The purpose of this study is to assess functional capacity, quality of life and functioning of the autonomic nervous system in heart failure patients on beta-blocker treatment. The study hypothesis is that subjects who walk less distance, have lower quality of life and reduced heart rate variability during the six minute walk test.

Heart failure and its treatment result in symptoms such as pulmonary or systemic congestion causing impairment to the effort, psychological and social commitment, and impact on quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes
* Different etiologies of Heart Failure
* Functional class I - III (NYHA)
* Left ventricular ejection fraction (LVEF) ≤ 50%
* No history of previous cardiac surgery
* In return for medical evaluation at the Amelio Marques Clinic, Hospital de Clinicas, Federal University of Uberlândia scheduled for the period from October 2012 to January 2013
* Clinical stability observed by: heart rate, respiratory rate, blood pressure and arterial oxygen saturation

Exclusion Criteria:

* Bad cognition compromising the understanding of tests
* Physical disability that compromise the performance in walk test
* Aortic aneurysm or any aortic deformity
* Patients with signs or symptoms of transient myocardial ischemia with angina pectoris and/or class IV by the Canadian Cardiovascular Society Classification
* Anomalous pressure behavior with hypertension \> 180/100 mmHg
* Orthostatic hypotension (decrease \> 15 mmHg ) with symptoms
* Arrhythmia with presence of complex ventricular extra systoles
* Tachycardia sinus at rest (HR \> 120 beats/min)
* Atrioventricular block of 2nd or 3rd degree
* Subjects with pacemakers or implantable cardioverter-defibrillator (ICD)
* Functional class IV by the New York Heart Association
* Chronic organ dysfunction such as renal failure, respiratory or liver disease
* Active neoplasia over the past five years
* Commitment as general weakness, fever, other limiting factors (psychological, musculoskeletal)
* Feeling sick before the beginning of the Six minute walk test: intolerable angina or dyspnea, cramps in legs, staggering gait, excessive sweating (diaphoresis), pallor or ashen skin or SpO2 below 85%
* Voluntary desire of the patient to withdraw from research
Comparasion of the Immediate Effect of Myofascial Relaxation Technique and Kinesiology Taping

As a result of glycation of collagen fibers in diabetes mellitus, an increase in thickness and stiffness is observed in the plantar fascia, which is a connective tissue. These changes in the plantar fascia affect the windlass mechanism of the foot, normal range of motion and foot plantar pressure distribution. These biomechanical effects may cause the development of diabetic foot ulcers in the later stages of the disease. We hypothesis that myofascial release technique and kinesiology taping methods have an effect on plantar fascia stiffness and plantar pressure distribution in diabetic patients. The aim of this study is to investigate the immediate effects of the two methods on the stiffness of the plantar fascia and foot sole pressure distribution in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Those with diabetic foot ulcer development risk groups 1 and 2 according to the International Working Group on the Diabetic Foot (IWGDF)
* Those who have diabetes for at least 5 years
* Ambulation independently without using an assistive device

Exclusion Criteria:

* Those with foot posture deformity
* Having another disease that will affect connective tissue properties
* Presence of orthopedic or neurological disorders that will affect plantar load distribution
* History of surgery and fractures from the ankle-foot in the last 6 months
Observational, Non-interventional Use of LIPUS to Mitigate Fracture Non-union in Patients at Risk

This study is one of three separate studies of the Bioventus Observational Non-interventional EXOGEN Studies (BONES) program. Eligibility for each study is determined by fractured bone.

The prospective arm of this non-interventional, observational study is designed to collect real world evidence from patients at risk of a fracture non-union across the US receiving EXOGEN treatment. Patients will be followed for 9 months post fracture. As a non-interventional study, the treating clinician will continue to provide routine care without research intervention or dictation by a protocol. A medically staffed Direct-to-Patient Contact Center will serve as a central investigational site with scheduled and structured direct-to-patient contacts via phone/email/text/web based surveys to obtain informed consent and collect data directly from the patient. For all prospective patients, primary effectiveness data will be obtained directly from the medical records of the treating physician.

The comparator arm of this study will be a retrospective cohort of patients within a national health insurance claims database. An extract of this database will be taken and eligible controls derived via propensity score analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Must be willing to provide voluntary informed consent
2. Male or female age 21-80 on fracture date
3. Must be willing to sign for release of medical insurance claim billing records from the treating clinician, pertaining to the fracture and fracture treatment
4. Fluency in English and/or Spanish
5. Prescriptive initiation of therapy with the EXOGEN Ultrasound Bone Healing System (Model number 71034400) for a specified fracture
6. Bone specific fracture

Exclusion Criteria:

1. Patient report of treatment with an electrical bone growth stimulation device (e.g., pulsed electromagnetic field (PEMF) or capacitive coupling (CC) based devices) for bone fracture in 9-months pre-index period up to baseline phone contact
2. Pregnant on fracture index date
3. Evidence that prescription for EXOGEN has been written to treat a fracture non-union or mal-union (i.e, ICD-10-CM code with seventh character modifier of K, P or S).
4. Evidence that prescription for EXOGEN has been written to treat a pathologic fracture (ICD-10-CM code M80. or M84.) or neuropathic bone (ICD-10-CM code M14.6)
5. Patient with a concurrent fracture of the other bones of interest
6. Patients who are or anticipate living or receiving fracture treatment outside of the US during the post-index fracture period
7. Patient report of history of primary or metastatic bone cancer
8. Patient report of bone infection or osteomyelitis of index fracture at baseline contact
9. Patient report of prior bone specific fracture in 9-months pre-index period
10. Patient prescribed EXOGEN as part of a Worker Compensation claim
Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Zemplar® (Paricalcitol Injection) in the Treatment of Patients Suffering From End-stage Renal Disease and Severe Over-reactivity of the Parathyroid Glands

This observational study will evaluate the clinical benefit of Zemplar (paricalcitol injection) in daily routine practice in end-stage renal disease patients with severe over-reactivity of parathyroid glands. Participants will be followed for 6 months. Data will be collected from participants initiated on Zemplar therapy according to standard of care. The time to achieving the maintenance dose of Zemplar (paricalcitol injection), the proportion of participants achieving target parathyroid hormone levels, and prevalence of elevated serum calcium and phosphate levels will be evaluated.

Prospective data collection started at initial dosing with Zemplar (paricalcitol injection) and ended up to 6 months later. If available, retrospective data on vitamin D treatment as well as on the incidence of hypercalcaemia and hyperphosphataemia in the 6 months leading up to paricalcitol treatment were also collected. Eight visits were planned for documentation of prospective data. In accordance with the non-interventional character of the study, only diagnostic and monitoring procedures were applied which are part of the routine medical care of secondary hyperparathyroidism.

Eligibility Criteria:
Inclusion Criteria:

Based on the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection), the patient is entitled to treatment with paricalcitol injection and:

1. ≥ 18 years of age,
2. Willing to sign the patient information and informed consent form,
3. Chronic kidney disease (CKD) stage 5 patient receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT), whose intact parathyroid hormone (iPTH) level is:

   * between 500-800 pg/mL with at least two abruption of conventional vitamin D therapy due to elevated serum calcium level (i.e. \> 2.4 mmol/L) in the medical history, or
   * higher than 800 pg/mL and parathyroidectomy is contraindicated.
4. The patient is planned to receive paricalcitol treatment independently from his/her participation in this study.

Exclusion Criteria:

Patients cannot be enrolled in the study if any of the following exclusion criteria apply:

1. The patient is already treated with Zemplar (paricalcitol injection),
2. Any contraindication exists as stated in the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection),
3. Patients who decline to participate in the study or decline to sign the patient information/informed consent form.
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo

The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream with or without phototherapy in adolescent and adult participants with non-segmental vitiligo for whom vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of nonsegmental vitiligo with depigmented area including all of the following:

  1. ≥ 0.5 F-VASI on the face
  2. ≥ 3.0 T-VASI (body areas not including the face)
  3. Total body vitiligo area (facial and nonfacial) not exceeding 10% BSA.
* Agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.

Exclusion Criteria:

* No pigmented hair within any of the vitiligo areas on the face.
* Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders.
* Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
* Previous adverse reaction to NB-UVB phototherapy that caused discontinuation of therapy.
* Lack of response (little or no repigmentation) to prior NB-UVB phototherapy.
* History of thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, ischemic stroke, myocardial infarction).
* Any other skin disease that, in the opinion of the investigator, would interfere with the study cream application or study assessments.
* Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox) within 1 week before baseline.
* Any serious illness or medical, physical, or psychiatric condition(s) that pose a significant risk to the participant; or interfere with interpretation of study data.
* Recent use of topical or systemic medications (including biologics or JAK inhibitors), or laser or phototherapy to treat vitiligo. Note: Recent may be defined differently for different treatments.
* Specific protocol-defined chemistry, hematology, and serological lab values.
* Those who are pregnant, lactating or considering pregnancy during the period of study participation.