cyrilzakka/clinical-trials huggingface dataset:
Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS)

Hypothesis: Intravenous administration of bone marrow-derived autologous adult human mesenchymal stem cells is a safe novel therapeutic approach for patients with multiple sclerosis.

Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS) is a phase I/IIA trial designed to establish the safety of intravenous administration of bone marrow-derived autologous adult human mesenchymal stem cells to patients with multiple sclerosis.

Disease under investigation: Multiple Sclerosis

Phase: I/IIA

Number of patients: 10

Design: 18 month cross over, single treatment at 6 months

Intervention: Administration of bone marrow-derived autologous mesenchymal stem cells

Route of administration: Intravenous

Dose: Up to 2,000,000 Mesenchymal Stem Cells per kilogram

Source of patients: Referrals accepted from Neurologists in East Anglia and North London, UK

Referral Criteria: (all 3 required)

1. Clinically definite multiple sclerosis
2. Expanded Kurtzke Disability Status Score 2.0 - 6.5 (inclusive)
3. Evidence of optic nerve damage by

   * history of optic neuritis, or
   * relative afferent pupillary defect, or
   * optic atrophy on fundoscopy, or
   * abnormal visual evoked potential from either or both eyes suggestive of demyelination

Primary Objective: Establish the safety of intravenously administered bone marrow-derived autologous mesenchymal stem cells at a dose of up to 2,000,000 cells/kg over 12 months by monitoring adverse reactions.

Secondary Objectives: Explore the efficacy of intravenously administered bone marrow-derived autologous mesenchymal stem cells at a dose of up to 2,000,000 cells/kg over 12 months on visual function by clinical, neurophysiological, and imaging assessments.

Outcome Measures:

1. Primary

   * Adverse events
2. Secondary

   * Visual function (acuity and colour)
   * Visual evoked potential latency
   * Optic nerve Magnetisation Transfer Ratio
   * Retinal nerve fibre layer thickness (by optical coherence tomography)
   * Brain lesion Magnetisation Transfer Ratio
   * MRI brain T1 hypointensity load
   * T cell response suppression
3. Tertiary

   * Multiple Sclerosis Functional Composite Score
   * Expanded Kurtzke Disability Status Score

Eligibility Criteria:
Inclusion Criteria:

* Clinically definite multiple sclerosis
* Expanded Kurtzke Disability Status Score 2.0 - 6.5 (inclusive)
* Evidence of optic nerve damage by:
* history of optic neuritis, or
* relative afferent pupillary defect, or
* optic atrophy on fundoscopy, or
* abnormal visual evoked potential from either or both eyes suggestive of demyelination
* Prolonged visual evoked potential P100 latency with preserved waveform
* T2 lesion on MRI optic nerve
* Retinal nerve fibre layer thickness on optical coherence tomography \> 40 microns

Exclusion Criteria:

* Age \< 18 years
* Age \> 65 years
* Patient lacks capacity to give informed consent
* Presence of a severe bleeding disorder
* Planning a pregnancy during the trial period
* Current MS disease modifying therapy
Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes

The investigators will compare plasma kinetics of two marker drugs in individuals with different genetic variations in the MDR1-gene. The hypothesis is that one group will have higher exposure than the other.


Eligibility Criteria:
Inclusion Criteria:

* - Healthy volunteer ≥ 18 years of age
* Normal kidney function as measured by GFR according to Cockroft-Gault (70-120 ml/min)
* Normal P-potassiumvalue (3,6-4,6 mmol/L)
* HF\>50 and no AV-block on resting ECG. No other significant abnormalities as judged by the investigator.
* Subject giving written informed consent
* Subject capable of understanding instructions

Exclusion Criteria:

* - Pregnancy
* Ongoing infection
* Intake of medication, including natural remedies (for example St John´s wort), within one month prior to starting study except for paracetamol.
* Active drug or alcohol abuse
BASIS-T Efficacy Trial

For the approximately one in five children with social, emotional, and behavioral (SEB) challenges, accessible evidence-based prevention practices (EBPPs) are critical. In the United States, schools are the primary service setting for children's SEB service delivery but EBPPs are rarely adopted or implemented by educators (e.g., teachers) with sufficient fidelity to see effects. Given that individual behavior change is ultimately required for successful implementation, focusing on individual-level processes holds promise as a parsimonious approach to enhance adoption. Beliefs and Attitudes for Successful Implementation in Schools for Teachers (BASIS-T) is a pragmatic, multifaceted pre-implementation strategy targeting volitional and motivational mechanisms of educators' behavior change to enhance implementation and student SEB outcomes. This study protocol describes a hybrid type 3 effectiveness-implementation trial designed to evaluate the main effects, mediators, and moderators of the BASIS-T implementation strategy in the context of Positive Greetings at the Door (PGD), a universal school-based EBPP previously demonstrated to reduce student disruptive behavior and increase academic engagement.


Eligibility Criteria:
Inclusion Criteria:

* Being a K-5th grade teacher at an elementary or K-8 school, and not a teacher in a special education-only classroom

Exclusion Criteria:

* Having been trained or supervised on delivering PGD in the past 5 years
Effect of Short Term Versus Long Term Treatment With Seton Prior to LIFT Surgery for Complex Anal Fistula

The aim of this study is to compare short term (3 week) with long term (6 months) treatment with seton prior to LIFT surgery. The main end-points are recurrence rates and complication rates after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 65 years
* Complex anal fistula defined as

  * anterior fistulas in women
  * branched fistulas
  * fistulas in patients with anal incontinence
  * fistulas traversing more than 30% of the anal sphincter and therefore unsuitable for simple division.

Exclusion Criteria:

* Crohn's disease in the rectum
* Previous LIFT surgery on same side
* Patient already treated with seton \> 3 weeks
* Not able or willing to sign informed consent
Trial of Prophylactic Tamsulosin for Postoperative Urinary Retention in Primary Total Hip and Knee Arthroplasty Patients

The study aims to evaluate the efficacy of prophylactic tamsulosin in reducing the incidence of postoperative urinary retention in primary total knee and hip arthroplasty patients.

Prophylactic administration of tamsulosin will be compared to a placebo to evaluate the effectiveness in reducing the incidence of postoperative urinary retention in total hip and knee arthroplasty patients.

Eligibility Criteria:
Inclusion Criteria:

* Men age 35 or older
* Primary total hip and knee arthroplasty patients (general, spinal, or epidural anesthesia
* No current use (\>1 month) of alpha-blockers
* Community ambulator
* Adequate organ and marrow function as defined below:

leucocytes at least 3,000/µL, absolute neutrophil count at least 1,500/µL, platelets at least 100,000/µL, creatinine within normal institutional limits

* Ability to understand, and the willingness to sign, a written informed consent

Exclusion Criteria:

* History of radical prostatectomy
* Receiving any other investigational agents
* Revision hip and knee arthroplasty patients
* Severe liver or kidney disease
* Taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir, or conivaptan)
* Being on alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, phenoxybenzamine, or silodosin)
* Being of 5-alpha reductase inhibitors (finasteride, dutasteride)
* History of allergy or sensitivity to tamsulosin or other alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, or phenoxybenzamine)
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Taking Sildenafil,Tadalafil, or Vardenafil
The Effects of a Multi-factorial Rehabilitation Program for Healthcare Workers Suffering From Post-COVID-19 Fatigue Syndrome

The SARS-CoV2 pandemic has kept the world in suspense for over a year now. Almost 100 million people around the world have contracted COVID-19 to date and over 2 million people have died of COVID-19 by the end of January 2021.

Despite the tragedy of these deaths, it must be pointed out at this point that the number of COVID-19 survivors is significantly larger. These COVID-19 survivors are now the focus of interest in rehabilitation measures, as it has been shown that survival of the disease does not go hand in hand with a complete cure. Thirty-five percent of all COVID-19 survivors and 87% of the COVID-19 survivors who were hospitalized in the course of their illness suffer from after-effects that are currently summarized as post-COVID fatigue syndrome also known as "Long-COVID".

As health care workers are at higher risk of contracting SARS CoV2 and furthermore, considering their central role in the overcoming of this pandemic, a COVID-19 rehabilitation program for healthcare workers of the Medical University of Vienna, Austria as well as the General Hospital of Vienna, Austria - together the second-largest university-clinic in the world - was developed as part of workplace health promotion. Nowadays, the fatigue syndrome is primarily known as a side effect of cancer treatment and thus from the rehabilitation of cancer patients. Cancer-related fatigue is a massive limiting side effect for patients and the currently most effective treatment strategy against cancer-associated fatigue syndrome is physical training.

The idea for this current project is, that physical exercise might have similar effects on post-SARS-CoV2 fatigue as it has on cancer-related fatigue.

The current study evaluates the effects of this primarily exercise-based rehabilitation program on Long-COVID fatigue.

Employees of the Medical University of Vienna, Austria and the General Hospital of Vienna, Austria who survived a SARS-CoV2 infection will be invited to take part in an eight weeks post-COVID-19 rehabilitation program which is part of a workplace health promotion measure. This program consists of eight weeks of exercising (twice per week supervised resistance training + individual, heart-rate controlled endurance training recommendations) with a sports scientist and a sports medicine specialist, complemented by one session of nutrition consultation with a nutritionist and two sessions of psychological consultation with a clinical psychologist.

Parallel to this workplace health promotion program, the scientific evaluation of this intevention will be undertaken via this study.

Eligibility Criteria:
Inclusion Criteria:

* Employees of the Medical University of Vienna, Austria or the General Hospital of Vienna, Austria
* survived COVID-19 infection

Exclusion Criteria:

* acute COVID-19 infection
* serious, uncontrolled diseases of the cardiovascular system
* insufficient language skills to complete the study requirements
Developing and Testing Interventions to Address Conscientious Objection to Abortion Care in Mexico and South Africa

The primary purpose of this research is to develop strategies and interventions to mitigate the impact of conscientious objection on women's access to safe abortion care in Mexico and South Africa using a user-centered design approach and test the feasibility and effectiveness of these interventions.

Conscientious objection (CO) is emerging as a growing barrier to abortion care, and evidence suggests that it is being incorrectly used as a justification for public sector medical providers and institutions to exempt themselves from their duties to provide essential reproductive health services for women. Given this, it is essential to better understand and address this misuse of CO and find ways to improve women's access to safe abortion services to prevent them from using unsafe methods which risk their health and lives.

This study will conduct formative research to more fully understand the problem of CO in Mexico and South Africa and use these findings to develop interventions and strategies to mitigate the impact of CO on women's access to safe abortion care using a user-centered design approach. Rapid randomized controlled trials will then be used to assess effectiveness of the interventions. The specific aims of this study are:

1. Improve our understanding of CO and its impact on access and quality of abortion care from providers' and facility mangers' perspectives in Mexico, and South Africa.
2. Develop strategies and interventions to mitigate the impact of CO on women's access to safe abortion care. Using the data collected, a multi-disciplinary Innovation Team will develop strategies and interventions to respond to the challenges posed by CO using a user-centered design approach.
3. Rapid-test intervention prototypes. We will test selected strategies (prototypes) in Mexico, and South Africa with assessments to determine successes, and the feasibility of scaling up these approaches.

Eligibility Criteria:
South Africa

Inclusion Criteria:

* All staff currently working in selected health facilities
* Able to provide informed consent

Exclusion Criteria:

* Unable to provide informed consent

Mexico

Inclusion Criteria:

* Doctors/anyone eligible to be an abortion provider working in selected health facilities
* Able to provide informed consent

Exclusion Criteria:

* Unable to provide informed consent
Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System

This is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart System with CCM therapy.

The Continued Access study is a prospective, non-randomized, multi-center study designed to allow controlled access to the Optimizer Smart System until the PMA order has been issued by the FDA.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are 18 years of age or older
2. Subjects who have a baseline ejection fraction greater than or equal to 25% and less than or equal to 45% by echocardiography.
3. Subjects who, in the opinion of the Investigator (based on the current guidelines for clinical practice), have been treated for heart failure for at least 90 days and are currently receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure.
4. Subjects who are in New York Heart Association functional Class III and IV at the time of enrollment.
5. Subjects who are willing and able to return for all follow-up visits.

Exclusion Criteria:

1. Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
2. Subjects receiving any form of inotropic support within 30 days before enrollment, including subjects on continuous IV inotrope therapy.
3. Subjects hospitalized for decompensated heart failure requiring acute treatment with intravenous loop diuretics, IV inotropes or hemofiltration within 30 days before enrollment and baseline testing.
4. Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 PVCs per 24 hours on baseline Holter monitoring.
5. Subjects having a PR interval greater than 375ms.
6. Subjects who are scheduled for a CABG or a PTCA procedure, or who have undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of enrollment.
7. Subjects who have a biventricular pacing system, an accepted indication for such a device, or a QRS width of 130ms or greater.
8. Subjects who have had a myocardial infarction within 90 days of enrollment.
9. Subjects who have mechanical tricuspid valve.
10. Subjects who have a Left Ventricular Assist Device or prior heart transplant.
11. Subjects on dialysis.
12. Subjects who are participating in another experimental protocol.
13. Subjects who are unable to provide informed consent.
Thrombus Aspiration in STEMI Patients With High Thrombus Burden

This is a prospective, multicenter, open-label, randomized, controlled, parallel group study, in which ST-segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(TIMI thrombus grade ≥3) are included. Patients are randomized to be treated with or without manual thrombus aspiration(TA) during primary percutaneous coronary intervention(PPCI) by a ratio of 1:1.

This study is intended to explore the efficacy of thrombus aspiration (TA) in ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden who received primary PCI within 12 hours after the onset of symptoms, reducing the incidence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization within 180 days or stroke in 30 days.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. STEMI patients undergoing primary PCI within 12 hours after the onset of symptoms;
3. High thrombus burden after guidewire passes the lesion (TIMI thrombus grade ≥3);
4. Informed consent must be voluntary;

Exclusion Criteria:

1. Haemodynamic instability or cardiogenic shock;
2. After thrombolytic therapy;
3. The predicted survival time is less than 6 months due to non-cardiac disease;
4. History of coronary artery bypass grafting;
5. Participate in other researches within 30 days;
6. Preoperative gastrointestinal bleeding or contraindications to dual antiplatelet therapy;
7. Patients were considered unsuitable by other researchers.
Skin Cancer Screening and Education at Beaches

This study was an evaluation of the Dana-Farber Cancer Institute Blum Family Resource Center Van's existing skin cancer screening and education program. This program occurred over 2 summers. This study will fill a critical gap in the investigators' knowledge about how best to address the high-risk behaviors that regularly occur during the summertime at beaches. The investigators randomized beaches to receive different combinations of the van program components in order to determine how services should optimally be configured to maximize impact. The investigators hypothesized that providing all three components (1-Skin cancer prevention education; 2-Biometric feedback using a Dermascan Analyzer that illustrates skin damage due to sun exposure and Ultra Violet (UV) Reflectance Photography; and 3-Dermatologist skin exam) will maximize knowledge and behavior change, relative to education alone.


Eligibility Criteria:
Inclusion Criteria:

* Beachgoers eligible to participate in the study included:

  * those who were 18 years and older
  * Caucasian
  * able to understand, speak and read English
  * ability to give informed consent
  * had not already enrolled in the study at another participating beach
A Comparative Study to Assess the Prevention of Surgical Site Infection (SSI's) in Revision Total Joint Arthroplasty Patients Treated With Single-Use Negative Pressure Wound Therapy (PICO™) or Standard Care Dressings (AQUACEL® Ag SURGICAL Dressing)

The aim of this study is to assess the prevention of incision healing complications in patients undergoing revision TKA and THA treated with either Single-Use NPWT (PICO) compared to standard of care dressings (AQUACEL Ag Surgical Dressing). All patients undergoing a revision TKA and THA who consent to taking part in the study, and meet the eligibility criteria will be included onto the study. Patients will be followed up for a period of up to 3 months to determine if there are any latent incision healing complications


Eligibility Criteria:
Inclusion Criteria:

1. Patient ≥18 years old
2. Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
3. Subjects undergoing revision total knee arthroplasty or revision total hip arthroplasty
4. Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information
5. Subjects deemed able to understand and comply with study visit schedule and procedures

Exclusion Criteria:

1. Wounds that require daily inspection
2. Active bleeding within the surgical site
3. Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception
4. Subjects on warfarin therapy. Resulting in increased exudate and prolonging hospital stay following surgery to achieve therapeutic INR levels
5. Skin integrity issues that preclude the use of Negative Pressure Wound Therapy (NPWT)
6. Subjects undergoing primary total joint procedures
7. Subjects with a known history of poor compliance with medical treatment
8. Subjects who have participated in this trial previously and who were withdrawn 9 . Subjects with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing)
COVID-19 and Obstetric Transmission

The aim of this study is to capture data, laboratory markers, and clinical outcomes of obstetric and neonatal outcomes in cases of COVID-19 during pregnancy and of pregnancies exposed to a COVID-19 vaccine in Cuyahoga County.

A review of the 55 cases of obstetric COVID-19 cases world-wide demonstrate the following fetal complications of COVID-19: miscarriage (2%), intrauterine growth restriction (IUGR; 10%), pre-eclampsia, and pre-term birth (39%). In Wuhan, China, nine women who were COVID-19 positive were surveilled for vertical transmission and overall obstetric and early neonatal outcomes. Amniotic fluid, umbilical cord blood, and neonatal throat swabs were collected at the time of delivery, and breastmilk samples were collected after lactation commenced. There was no viral detection of COVID-19 demonstrated.2 However, two neonates in the United Kingdom have tested positively for COVID-19 after delivery from an infected mother. Most recently, antibodies were detected (IgM and IgG) in the serum of a neonate born via cesarean delivery to a known positive mother. Therefore, vertical transmission has not been completely ruled out.

Additionally, infection at varying times of pregnancy has not been well delineated or correlated to neonatal or maternal outcomes at time of delivery. Therefore, there is a need to continue surveying and documenting clinical findings in obstetric COVID-19 cases.

This study will follow pregnant women who are diagnosed during any point of their pregnancy with COVID-19 and those who were vaccinated. during pregnancy. The aim will be to evaluate maternal and neonatal specimens for the presence of COVID-19 virus, immune and cellular response.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 infection at any time of the pregnancy, or presumed case by symptoms and direct contact with a positive case
* Pregnancy documented by ultrasound

Exclusion Criteria:

* COVID-19 infection before or after pregnancy
* Person under investigation, but not a presumed or known positive case
Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings

The goal of this study is to provide gait parameters as a new objective method to assess total knee arthroplasty outcome between patients with fixed- and mobile-bearing, using an ambulatory device with minimal sensor configuration.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from a primary unilateral knee osteoarthritis and requiring a knee replacement
* Informed consent