cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered in Patients With Renal Failure

The intent of this clinical study is to answer the questions:

1. Is the proposed treatment safe
2. Is treatment effective in improving the disease pathology of patients with Renal Failure and clinical outcomes

Adipose-Derived Stromal Cells (ASCs) are a novel therapy for patients suffering from Renal failure. By injecting ASCs, these regions may become populated with the ASCs, thereby potentially restoring kidney function. ASCs are a patient-derived ("autologous") cell transplantation technology that is delivered to the patient. The therapy is composed of cells derived from a patients' own adipose tissue that are isolated within approximately 1 hour and immediately delivered back to the patient.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females between Age 18 and 80 years.
* Chronic Kidney Disease(CKD) patients of stage III, IV, or V
* Patient should be afebrile 24 hours prior to procedure.
* Up to date on all age and gender appropriate cancer screening per American Cancer Society.

Exclusion Criteria:

* Acute Renal Failure
* Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores.
* Hemoglobin level below 6g/dl or at the discretion of the physician depending on patient's overall condition.
* Chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders.
* Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
* Life expectancy \< 6 months due to concomitant illnesses.
* Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
* Active infectious disease. Patients known to have tested positive for Human immunodeficiency virus (HIV), Human T-lymphotropic virus(HTLV), Hepatitis B (HBV),Hepatitis C (HCV), Cytomegalovirus (CMV) and/or syphilis will be evaluated by an expert as to patient eligibility based on the patient's infectious status
* Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
* Patients on chronic immunosuppressive transplant therapy
* Systolic blood pressure (supine) ≤90 mmHg or greater than 200mmHg
* Resting heart rate \> 100 bpm;
* Active clinical infection within one week of enrollment.
* Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
* History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
* Unwilling and/or not able to give written informed consent.
Extension Study of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration (AMD)

This is a Phase III, open-label, multicenter extension study of intravitreally administered ranibizumab in subjects with primary or recurrent subfoveal choroidal neovascularization (CNV) secondary to AMD who have completed the treatment phase of a Genentech sponsored Phase I or Phase I/II ranibizumab protocol (FVF1770g, FVF2128g, or FVF2425g).


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent and authorization of use and disclosure of protected health information
* Age \>=50 years
* Completion of the treatment phase of a Genentech sponsored Phase I or I/II ranibizumab protocol (FVF1770g, FVF2128g, or FVF2425g)

Exclusion Criteria:

* CNV in either eye due to other causes such as ocular histoplasmosis, trauma, or pathologic myopia
* Active intraocular inflammation (grade trace or above) in the study eye
* Current vitreous hemorrhage in the study eye
* Subretinal hemorrhage in the study eye that involves the fovea, if the size of the hemorrhage is either \>=50% of the total lesion area or \>=1 DA in size
* Intraocular surgery (including cataract surgery) in the study eye within 1 month preceding Week 0
* Uncontrolled glaucoma in the study eye (defined as intraocular pressure \>=30 mmHg despite treatment with anti-glaucoma medication)
* Premenopausal women not using adequate contraception
* Laser photocoagulation (subfoveal, juxtafoveal, or extrafoveal) in the study eye within 30 days preceding Week 0
* Prior treatment with external-beam radiation therapy or transpupillary thermotherapy (TTT) in the study eye
* Previous treatment with verteporfin in the study eye within 30 days preceding Week 0
* Treatment with verteporfin in the non-study eye within 7 days preceding Week 0
* History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
* Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs other than ranibizumab (e.g., pegaptanib, anecortave acetate, protein kinase C inhibitors, etc.)
* Previous participation in any studies of investigational drugs within 1 month preceding Week 0 (excluding vitamins and minerals studies)
* Discontinuation from a ranibizumab study due to an adverse event judged by the investigator to be possibly or probably related to ranibizumab
* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications
* Inability to comply with study or follow up procedures
A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis.

This study will investigate the safety, efficacy and pharmacokinetics of R3421 in patients with moderate to severe chronic plaque psoriasis. Patients will be randomized to one of 3 treatment groups to receive once daily oral treatment with a)R3421 20mg, b)R3421 120mg, or c)placebo. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-70 years of age;
* medically stable, moderate to severe chronic plaque psoriasis.

Exclusion Criteria:

* any skin condition which may interfere with evaluation of the effect of study medication on plaque lesions;
* confounding or concomitant condition or treatment.
Reducing Residual Albuminuria in Subjects With Diabetes and Nephropathy With Atrasentan

Prospective, randomized, double-blind, placebo controlled, 12-week, multicenter study. The objective of the study is to evaluate the efficacy and safety of once daily administration of atrasentan tablets compared to placebo in reducing residual albuminuria in Japanese Type 2 diabetic patients with nephropathy who are treated with the maximum tolerated labeled dose for hypertension of a RAS (renin angiotensin system) inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Patient has Type 2 diabetes and has been treated with at least one anti-hyperglycemic medication within the 12 months prior to the screening period.
* Patient is receiving a maximum tolerated labeled dose of an ACEi (Angiotensin Converting Enzyme inhibitor) or ARB (Angiotensin II Receptor Blocker)(Renin Angiotensin System (RAS) inhibitor). Estimated GFR (Glomerular Filtration Rate) is greater than or equal to 30 and less than or equal to 75 mL/min/1.73m2 by the CKD (chronic kidney disease)
* Epidemiology Collaboration (EPI) formula.
* UACR (Urinary Albumin to Creatinine Ratio) is greater than or equal to 200 mg/g as determined by the geometric mean of the three morning void urine specimens obtained at Run-in period.
* Serum albumin is greater than or equal to 3.0 g/dL. BNP (B-type Natriuretic Peptide) is less than or equal to 200 pg/mL.
* SBP (Systolic Blood Pressure) is greater than or equal to 110 mmHg and less than or equal to 160 mmHg. HbA1c (Glucosylated Hemoglobin A1c) is less than or equal to 12% and serum potassium is less than or equal to 5.5 mEq/L.

Exclusion Criteria:

* Patient has a history of moderate or severe edema, facial edema unrelated to trauma, or a history of myxedema in the prior 6 months to screening.
* Patient is receiving loop diuretics greater than or equal to 120 mg QD (Once Daily) of furosemide or greater than or equal to 3.0 mg QD (Once Daily) of bumetanide or greater than or equal to 150 mg QD (Once Daily) of ethacrynic acid or greater than or equal to 60 mg QD (Once Daily) of torasemide.
* Patient has a documented history of Stage C or Stage D heart failure, defined ACC/AHA (American College of Cardiology/ American Heart Association Practice Guidelines).
* Patient is receiving any of a combination of an ACEi (Angiotensin Converting Enzyme inhibitor) and ARB (Angiotensin II Receptor Blocker) or rosiglitazone or aliskiren or an aldosterone antagonist and patient is receiving pioglitazone and edema is present.
The Positive Piggy Bank - A Positive Activities Intervention for Improving Functional Status in Patients With Back Pain

Investigators will conduct a randomized controlled trial of a 30-day positive activities intervention, Positive Piggy Bank, compared to a Wait-List control group (Figure 2). Prior to their scheduled appointment to undergo epidural steroid injection, all patients meeting study criteria will be contacted by research staff to be invited to participate in this study. Those interested will be asked to arrive 45 minutes before their regularly scheduled appointment. At that time they will learn more about the study and provide informed consent if they choose to participate. Participants will then complete the study questionnaires and be randomized 1:1 to the Positive Piggy Bank condition (n=100) or the Wait List control group (n = 100). All participants will receive the usual treatment provided at the Back \& Pain Center at the University of Michigan, Department of Anesthesiology (e.g., maintenance of medication regimen, standard office visits). Post-intervention (Day 30) and 2 months after that (Day 90), participants will complete the same questionnaires by mail. The primary outcome will be improved functional status, while secondary outcomes will be symptomatic (i.e., pain, fatigue and sleep) and related to mood and well-being. After the study period, the patients in the Wait List control will be offered the Positive Piggy Bank intervention and will be asked to complete one more set of questionnaires at 30 days by mail.


Eligibility Criteria:
Inclusion Criteria: Primary diagnosis of back pain and schedule to undergo an epidural steroid injection. :

1. ages 18 to 80;
2. able to read/understand English and give consent;
3. willing and able to comply with all aspects of study procedures;
4. if on antidepressants, medications stable for ≥4 weeks prior to study;
5. no plan to initiate a new non-pharmacological pain intervention during the 30-day study period (e.g., back surgery, physical therapy, cognitive-behavioral therapy);
6. if on pain medications, medications stable for ≥4 weeks prior to study and no plans to switch medications during the 30-day study period.

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Exclusion Criteria: Participants may meet all criteria above, but will be excluded under the following additional conditions:

1. having a known psychotic disorder or the presence of another psychiatric condition (e.g., severe depression, suicidal ideation) or cognitive impairment (e.g., severe dyslexia, traumatic brain injury) limiting ability to give consent and/or participate fully in the study;
2. currently undergoing psychotherapeutic care at the Back \& Pain Center;
3. other factors that at the discretion of the investigators would adversely affect study participation. We will not exclude participants who undergo unanticipated changes in treatment, but will handle these data as described later.

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An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis

Phase 2 study of RPT193 in adults with atopic dermatitis

Randomized, placebo-controlled Phase 2 study of RPT193 in adults with moderate-to-severe atopic dermatitis

Eligibility Criteria:
Inclusion Criteria:

* Clinically confirmed diagnosis of active atopic dermatitis (AD), according to the revised Hanifin and Rajka criteria
* 12-month history of AD and had no significant flares in AD for at least 4 weeks before screening
* inadequate response to a ≥1 month treatment with topical medications
* Atopic dermatitis covering ≥10% of the body surface area
* EASI score ≥16
* Validated Investigator Global Assessment (VIGA) ≥3
* Use of emollient(s) at least 2x daily for 1 week prior to baseline
* Negative coronavirus disease (COVID)-19 results at screening

Exclusion Criteria:

* Uncontrolled moderate-to-severe asthma
* Uncontrolled diabetes
* Stage III or IV cardiac failure
* Severe renal condition
* Major surgery within 8 weeks of screening
* Immunodeficiency and/or receipt of immunosuppressive drugs within 4 weeks of baseline
* Use of systemic Janus kinase (JAK) inhibitor within 8 weeks of baseline
* Received live or live-attenuated vaccine within 4 weeks of baseline
* Prior receipt of RPT193
Trifecta™ Long Term Follow-Up (LTFU) Study

The Trifecta™ LTFU Study is a single-arm, multi-center, prospective, non-randomized, post-market study conducted in the United States and Canada to collect long-term safety and effectiveness data through 10 years after implant of the Trifecta™ aortic bioprosthetic valve. The Trifecta™ is a tri-leaflet stented pericardial valve designed for supraannular placement in the aortic position. The Trifecta™ LTFU Study is an extension of the Trifecta™ Investigational Device Exemption (IDE) Study (NCT00475709) conducted to support United States Food and Drug Administration (FDA) approval of the Trifecta™ valve. All Trifecta™ LTFU Study subjects received Trifecta™ valve implants during participation in the Trifecta™ IDE study and subsequently consented to extended annual follow-up through 10 years under the Trifecta™ LTFU protocol.

This clinical study was designed as an extension of the Trifecta™ IDE Study supporting FDA approval of the Trifecta™ valve. A total of 11 Trifecta™ IDE Study investigational sites in the United States (n=9) and Canada (n=2) participated in the Trifecta™ LTFU Study. Study enrollment included 329 subjects implanted from 2007 through 2009 at these 11 sites during the IDE Study who consented to participate in continued annual follow-up through 10 years post-implant. Of these 329 subjects, 140 also participated in the FDA-mandated Trifecta™ Post-Approval Study (PAS, NCT01514162) prior to consenting to additional annual follow-up under the Trifecta™ LTFU protocol. The remaining 189 subjects entered the Trifecta™ LTFU Study directly from the Trifecta™ IDE Study.

The Trifecta™ LTFU Study database subsumes all data collected in the 329 participants under the Trifecta™ IDE and Trifecta™ PAS protocols and extends these data through 10 years from each subject's original date of implant in the Trifecta™ IDE Study. The Trifecta™ LTFU Study data thus encompass 10 years of continuous annual post-implant follow-up in the 329 participants as well as their pre-implant Baseline Visit data. Data collected includes adverse events, assessments of heart failure symptoms by New York Heart Association (NYHA) functional classification, and echocardiographic assessments of Trifecta™ valve function.

Eligibility Criteria:
Inclusion Criteria:

1. Patient currently has a Trifecta™ aortic valve that was implanted at one of the U.S. or Canadian investigational sites during the Trifecta™ IDE study.
2. Patient met eligibility criteria prior to enrollment in the Trifecta™ IDE study.
3. Patient agrees to complete all required follow-up visits.
4. Patient provided written informed consent prior to any study related procedure, as approved by the governing Institutional Review Board (IRB) or the Ethics Committee (EC) of the investigational site.

Exclusion Criteria:

1. Patient is currently participating or planning to participate in any other study unless approved by the Sponsor.
Effective Rehabilitation of Patients Operated With Total Knee Arthroplasty

The purpose of this study is to investigate the effect of maximal strength training (MST) compared to standard rehabilitation in patients operated with total knee arthroplasty. Previous studies report reduced physical function and muscle strength despite successful surgery inserting an artificial implant.

Furthermore, great loss of muscle strength has been found in these patients in the early postoperative phase.

The study is a randomized controlled trial. The investigators hypothesize that MST will increase muscle strength and physical function more than standard rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* unilateral osteoarthritis,
* \< 75 years

Exclusion Criteria:

* disease(s) that compromise testing/training,
* unable to understand written and verbal instructions and information,
* osteoarthritis in the contralateral leg that needs treatment.
The V-Wave Shunt: FIM Safety and Feasibility Study

The V-Wave atrial-septal shunt implant is intended for the reduction of elevated left atrial filling pressures ('Left Atrial Decompression') in chronic, New York Heart Association (NYHA) class III -IV, Heart Failure (HF) patients. This is a First In Man (FIM) study, aimed to enable a first evaluation of the safety and performance of the V-Wave shunt implant when implanted in Chronic Heart Failure patients. Prospective, open label, single-arm study with intra-patient comparisons (i.e. subjects' status will be compared to their pre-implant (baseline) status.

V-Wave Ltd, an Israeli based medical device company, has developed the V-Wave atrial-septal shunt, a permanent implant indicated for Heart Failure (HF) patients with elevated Left Atrial filling Pressures (LAP). The V-Wave shunt, developed by V-Wave Ltd, has been designed specifically to meet the needs of an interatrial shunt and thus represents a dedicated device, to be implanted percutaneously in the interatrial septum creating an interatrial communication.

This study aims to enable a first evaluation of the safety and performance of the V-Wave shunt implant when implanted in Heart Failure patients with elevated LAP. Study endpoints were then chosen to portray both safety (device related Major Adverse Cardiac And Neurological Events) as well as preliminary performance as assessed by a well characterized measure (e.g., LAP which is known to be associated with the general state of the disease and most importantly left ventricular ejection fraction and cardiac function in general).

Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 and \< 85 years old
* Patient has chronic ischemic or non-ischemic cardiomyopathy NYHA Class III or ambulatory Class IV heart failure despite optimal medical therapy
* Patient LVEF \> 15% and ≤ 40%
* Patient has elevated Left Atrial Pressure (LAP)
* Patient has normal Right Atrial Pressure (RAP)
* BNP or NTproBNP levels are \>300 or \>1500 pg/mL, respectively

Exclusion Criteria:

* Right Heart Failure
* Ongoing malignant disease
* Thromboembolic event within the last 6 months
* Acute or chronic renal insufficiency
* Congenital heart disease
* Severe pulmonary hypertension
* Atrial Fibrillation (persistent/permanent)
* Severe Mitral Regurgitation
* LA Thrombus or Deep Vein Thrombosis (DVT)
* Severe restrictive or obstructive lung disease
Evaluation of Oxygen Delivery Methods in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

To examine the effects of oxygen therapy methods applied as indicated in COPD acute exacerbations on blood gas results and spirometric measurements.

Patients requiring non-invasive ventilation will be divided into two groups: one group will receive NIMV in the form of Continuous Positive Airway Pressure (CPAP) or Bi-level Positive Airway Pressure (BiPAP). The other group will receive EzPAP® (a non-invasive positive airway pressure device). For both groups, blood gas results and hand-held spirometer parameters, including Forced Vital Capacity (FVC), Peak Expiratory Flow (PEF), and Forced Expiratory Volume in one second (FEV1), will be evaluated before and after the application.It is aimed to evaluate the effect of COPD noninvasive treatment methods on hospitalization and mortality processes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute exacerbation of COPD,
* Those without a history of trauma,
* Patients who have not undergone any lung surgery previously,
* Patients capable of providing written and verbal consent.

Exclusion Criteria:

* Patients without acute exacerbation of COPD,
* Pregnancy, suspected pregnancy,
* Those who have undergone any lung surgery previously,
* Patients with a history of trauma,
* Intubated patients and those not compliant with treatments,
* Patients unable to provide written and verbal consent.
Fluid Immersion Simulation (FIS) System Versus Air Fluidized Bed (AFB) System for Pressure Ulcers

The primary objective is to compare the efficacy of the FIS on closure rate to the AFB after 2 weeks of operative debridement and closure.

Secondary Objectives:

1. Compare the complication rate in each treatment group during the acute postoperative period (2 weeks).
2. Comparisons of the inflammatory and bacterial microbiomes of pressure ulcers following surgical therapy.
3. Comparisons of baseline patient characteristics and their relationship to both early and late pressure ulcer recurrence, and complication rates.
4. Assessment of outcomes and complications associated with flap technique and surgeon guided descriptions of the operative closure.
5. Compare the absolute costs associated with the FIS System against AFB system.
6. Compare the acceptance of each system by subjects and nursing staff, including the parameter of patient comfort at 7 and 14 days postoperative.
7. Assessing the incidence of complications and additional treatments needed following the two week study period.

Eligibility Criteria:
Inclusion Criteria:

1. will be admitted as an inpatient
2. is ≥ 18 years of age and ≤ 85 years of age at time of consent
3. is able to provide his/her own informed consent
4. is deemed by the investigators to be reasonably compliant
5. has a pressure ulcer meeting criteria for stage III or IV
6. has not participated in a clinical trial within the past 30 days
7. has a 30-day wound history available if the wound has been previously treated

Exclusion Criteria:

1. has a life expectancy of \< 12 months
2. is not healthy enough to undergo surgery for any reason
3. has a history of radiation therapy
4. is, in the opinion of the investigator, noncompliant
5. has a history of \> 3 closures of pressure ulcers in the same site
6. has a history of a bleeding disorder
7. has severe fecal incontinence
Shoulder Muscle Imbalance as a Risk for Shoulder Injury in Elite Adolescent Badminton Players

Background: To assess the impact of pre-season clinical measures and rotator muscles strength on the risk of significant shoulder injury (SSI) in elite adolescent badminton players Design: Prospective cohort study Participants: Nine elite adolescents badminton players were included and followed from September 2018 to May 2019.

Independent variables: A pre-season visit consisted in clinical and isokinetic shoulder strength testing. Isokinetic internal and external rotator shoulder muscles strength was tested at 60, 120 and 240°/s. Conventional and functional (eccentric-to-concentric) ratios (FR) were calculated. SSI collection was performed by an experienced sport physician.


Eligibility Criteria:
Inclusion Criteria:

* All the elite adolescent badminton players from a high-level club.

Exclusion Criteria:

* Players who had SSI in the 3 months prior to the isokinetic test or had shoulder surgery