cyrilzakka/clinical-trials huggingface dataset:
Expanded Access for Bulevirtide

The goal of this study is to provide access to bulevirtide (BLV (GS-4438), Hepcludex®) to eligible participants with chronic hepatitis delta virus infection (CHD).


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosed with CHD as confirmed by medical records.
* Compensated liver disease with liver cirrhosis (defined by biopsy, Fibroscan, or clinically by the treating physician) and Child-Pugh score ≤ 6.
* Positive HDV RNA test within 6 months of initial EAP request (only applicable to patients who have not received treatment with BLV).

Key Exclusion Criteria:

* Coinfection with hepatitis C virus (HCV) (HCV viremia defined by polymerase chain reaction (PCR)) or uncontrolled HIV infection (CD4 \< 500 cells/mm\^3 and detectable HIV RNA).
* Current or previous (within last 3 months from screening) decompensated liver disease, including coagulopathy, hepatic encephalopathy, and esophageal varices hemorrhage.
* Significant medical diseases or conditions, that might decrease the benefit-risk ratio of participating in this program to an unacceptable level, as determined by the treating physician.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Grafting of Epidermolysis Bullosa Wounds Using Cultured Revertant Autologous Keratinocytes

The term epidermolysis bullosa (EB) is used to describe a group of genetic skin diseases associated with skin weakness, blisters, and chronic wounds. "Revertant mosaicism" means that there are two genetically different populations of cells due to spontaneous mutations. Some EB patients have normal, non-fragile skin patches which may be areas of revertant mosaicism. In the revertant areas, the proteins function normally, like non-EB skin. In this study, we plan to culture cells from the revertant areas and graft them on to the wounded areas.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of EB (simplex, junctional or dystrophic)
* Areas of revertant skin that has been confirmed by biopsy
* 18 years or older subject willing and able to give consent
* Confirmation of EB diagnosis by immunofluorescence (IF), electron microscopy (EM), and genetic testing confirming mutation
* At least 100 to 200 cm2 of open erosions on the trunk and/or extremities suitable for skin grafting
* Able to undergo adequate anesthesia to allow grafting procedures to take place

Exclusion Criteria:

* Medical instability limiting ability to travel to Stanford University Medical Center
* The presence of medical illness expected to complicate participation and/or compromise the safety of this technique
* Active infection with HIV, hepatitis B, or hepatitis C
* Active infection in the area that will undergo grafting
* Evidence of a systemic infection
* Current evidence or a history of skin cancer in the area that will undergo grafting
* Active drug or alcohol addiction
* Hypersensitivity to vancomycin or amikacin
* Receipt of chemical or biological study product for the specific treatment ofEB in the past six months
* Positive pregnancy test or breast-feeding
Oral Bedtime Melatonin in Critically Ill Patients

Oxidative stress is one of the main mechanisms causing harm in severe infection with septic shock, ischemia-reperfusion injury in resuscitated cardiac arrest and ischemic and hemorrhagic stroke.

Melatonin is a potent scavenger of the mediators of oxidative stress, oxygen and nitrogen-reactive species, which directly injure cell structures like walls and DNA and thus cause organ dysfunction.

In a previous study we have observed that high-dose oral bedtime melatonin (OBM) is associated with improved organ function in severe Covid-19 patients

This is a double-blind randomized, adaptive trial in the 4 indications mentioned above giving 100 mg of OBM or placebo.

Interim analyses with pre-specified stopping rules will be performed in each sub-study for specific outcome variables collected at scheduled timelines.

Comparative organ dysfunction score (Sequential Organ Failure Evaluation-SOFA) will be done at baseline, 7, 14, and 30 days and mortality evaluated at 30 and 90 days.

For the 3 study groups enrolling stroke and resuscitated cardiac arrest patients, the modified Rankin score and the CVC (Glasgow) at 30 and 90 days will be compared.

Eligibility Criteria:
Inclusion Criteria:

* ICU stay \>5 days

Exclusion Criteria:

* ominous prognosis
Effect of BMS-986165 on the Blood Levels of Metformin

The purpose of this study is to investigate the effects of BMS-986165 on the drug levels of metformin in healthy participants.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy, as determined by having no clinically significant deviation from normal in medical history, physical examination, electrocardiograms, vital signs, and clinical laboratory determinations
* Body mass index of 18.0 kg/m\^2 to 32.0 kg/m\^2, inclusive, and body weight ≥ 50 kg, at screening
* Must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease

Other protocol-defined inclusion/exclusion criteria apply
Qigong for Multiple Sclerosis: A Feasibility Study

This feasibility study explores a community-based qigong intervention for people with multiple sclerosis (MS). The primary aim is to assess the feasibility of weekly community qigong classes for people with MS. The secondary aim is to explore the effects of qigong on balance, gait, mood, fatigue, and quality of life.

Qigong, a traditional Chinese mind-body exercise, has been shown to improve balance and gait in several neurological conditions; however, community-delivered qigong has never been assessed for people with multiple sclerosis (MS). We assessed the feasibility of community qigong classes for people with MS and explored outcomes of balance, gait, and quality of life (QOL).

Twenty adults with MS were randomly assigned to 10 weeks of community qigong classes or wait-list control. Feasibility criteria included recruitment, retention, adherence, and ability to participate in qigong movements. Secondary outcome measures included physical tests of mobility, gait and balance, and participant-reported mobility, depression, anxiety, fatigue, and QOL.

Because this is a small feasibility study, the data collected are meant to be hypothesis-generating. Any clinically meaningful trends toward improvement will justify further exploration of qigong for MS in a larger clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Living in the Portland Metropolitan Area
* Self-reported diagnosis of multiple sclerosis (MS - any type)
* Demonstrated ability to walk 50 feet without assistance
* Stable on disease-modifying or balance medications three months prior to baseline

Exclusion Criteria:

* Pregnant or nursing
* Participated in qigong, tai chi, or yoga (\>1 month) within six months prior to baseline
* Had an MS relapse within 30 days prior to baseline.
Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus

Gestational Diabetes Mellitus (GDM) is one of the most common medical complications of pregnancy. Neonatal hypoglycemia is a common and well described complication for infants born to mothers with GDM and diabetes mellitus (DM) and studies have linked intrapartum maternal glucose levels with neonatal hypoglycemia. While guidelines exist to guide practitioners in how to best manage intrapartum maternal glucose levels among Type I and and Type II DM, there is a paucity of data guiding practitioners in the intrapartum management of blood glucose levels for women with GDM, particularly those treated with insulin antepartum. The goal of this project is to compare two protocols of intrapartum glucose management in women with GDM and investigate the impact on neonatal blood glucose levels.

Research objective- To compare "Tight" vs. "Less Tight" intrapartum glucose management

Hypothesis: Neonates born to mothers managed via the "Less Tight" intrapartum glucose management protocol will have lower mean glucose levels in the first 24 hours of life when compared to mean glucose levels among infants born to mothers managed via the "Tight" intrapartum glucose management protocol.

Study Design: Randomized trial

Population: English or Spanish speaking women with a diagnosis of GDM managed at the Diabetes in Pregnancy Program at Women \& Infants Hospital, with a plan to deliver at Women \& Infants Hospital

Once enrolled, patients will then be randomized to "Tight" or "Less Tight" intrapartum glucose control.

Once admitted to the labor floor for intrapartum management the appropriate power plan for glucose control will be initiated. The specifics of labor management will be left to the discretion of the provider.

Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking women with a diagnosis of GDM managed at the Diabetes in Pregnancy Program at Women \& Infants Hospital, with a plan to deliver at Women \& Infants Hospital

Exclusion Criteria:

* Pre-existing DM, multiple gestations, major fetal anomalies anticipated to require NICU admission, planned cesarean delivery, medications known to effect glucose metabolism other than insulin (i.e. metformin)
Comparing Autologous Blood, Corticosteroid, and Their Combined Injection for Treating Lateral Epicondylitis

The goal of this clinical trial is to compare autologous blood, corticosteroid, and their combined injection for treating lateral epicondylitis. The main question it aims to answer are:

• Which of these highly used drugs in treatment of lateral epicondylitis is more effective? Participants were randomly allocated into three equal treatment groups (AB versus CS versus their combination) with sealed envelopes prepared by a computer-based random number generator. Patients in the AB Group received 1 ml of autologous venous blood mixed with 2 ml of 2% prilocaine HCl, patients in the CS Group received 1 ml of 40 mg methylprednisolone acetate mixed with 2 ml of 2% prilocaine HCl, and patients in the Combined Group (AB+CS) received 1 ml of autologous venous blood, 1 ml of 40 mg methylprednisolone acetate mixed with 1 ml of 2% prilocaine HCl. Each group received an equal amount of (3 ml) injected material. PRTEE and HGS measurements were assessed before the injection (baseline values), on Day 15, Day 30, and Day 90, in the same manner by the senior author.

This study aimed to compare the efficacy of autologous blood (AB) and corticosteroid (CS) injections and their combination in treating lateral epicondylitis (LE), hypothesizing that the combined approach might offer immediate symptom resolution and lower recurrence. Methods: A total of 120 patients diagnosed with lateral epicondylitis were systematically distributed among three distinct therapeutic injection groups. Those in the AB group were administered 1ml of autologous venous blood mixed with 2ml of 2% prilocaine HCl. Participants in the CS category were given 1ml of 40 mg methylprednisolone acetate mixed with 2ml of 2% prilocaine HCl. Meanwhile, patients in the combined group received a mixture containing 1ml each of autologous venous blood and 40mg methylprednisolone acetate, along with 1ml of 2% prilocaine HCl. Prior to receiving their respective injections, a comprehensive assessment of all participants was carried out. Follow-up assessments were subsequently conducted on days 15, 30, and 90, utilizing metrics of patient-rated tennis elbow evaluation (PRTEE) and measurements of hand grip strength (HGS).

Eligibility Criteria:
Inclusion Criteria:

1-Patients with LE whose complaints persisted for more than 3 months

Exclusion Criteria:

1. Patients with a history of recent trauma,
2. Congenital or neuromuscular disease or abnormality of the upper limb
3. Previous upper limb surgery,
4. History of rheumatic disease,
5. History of cervical disc pathology or carpal tunnel syndrome
6. Systemic corticosteroid treatment
7. Any previous local injection treatment
8. Patients with a history of previous allergic reaction towards local anesthetics and corticosteroids
The Impact of Sepsis on Long-term Outcomes in Critical Ill Children With Sepsis

This study is conducted in critically ill children with sepsis with a five years follow-up. We aim to investigate the impact of sepsis on long-term outcomes including growth, neurodevelopment, survival rate, quality of life.


Eligibility Criteria:
Inclusion Criteria:

We included critically ill children with sepsis who successfully discharged from pediatric Intensive care units, age \< 16 years.

We also included age, sex, illness severity matched critically ill children as control group.

Exclusion Criteria:

We excluded children with underlying diseases, cancer, hematologic malignancy.
The Role of Ribose in Patients Diagnosed With Fibromyalgia

The purose of this research study is to determine the potential benefit of D-ribose, a nutritional supplement (a sugar), versus a placebo (another sugar) in people with fibromyalgia.

Two hundred to three hundred subjects (equally distribued between placebo and D-ribose) between 18-78 years of age will comprise this study. The final numbers enrolled will depend upon obtaining approximately 100 subjects that can display a high degree of compliance to TID dosing with approximately equal balance between the active and placebo arms.

Eligibility Criteria:
Inclusion Criteria:

* previous diagnosis of fibromomyalgia by a MD
* Has been diagnosed with fibromyalgia and are over 18 years of age
* Does live in the United States

Exclusion Criteria:

* does NOT have severe medication/chemical/supplement sensitivities
* does NOT have insulin dependent diabetes or other severe illnesses (cancer, hepatitis, congestive heart failure)
* does NOT have rheumatoid arthritis or gout
* previous use of ribose
Telemedical Versus Conventional Emergency Care of Hypertensive Emergencies

Comparison of telemedical prehospital emergency care and conventional on-scene physician based care of hypertensive emergencies and urgencies. The adherence to current Guidelines should be researched.

Telemedically guided cases of hypertensive emergencies (april 2014 - March 2015) and urgencies are compared with a historical control group of conventional emergency medical service physician care on-scene for these scenarios. The historical control group is a time period prior to implementation of the telemedicine system and after a research project with a precursor telemedicine system. No telemedical support but only conventional on-scene EMS physician care was available (November 2013 - March 2014).

Eligibility Criteria:
Inclusion Criteria:

* prehospital diagnosis of hypertensive emergency of hypertensive urgency

Exclusion Criteria:

Prehospital diagnoses of:

* pulmonary edema
* aortic dissection
* acute coronary syndrome
* acute stroke
* acute respiratory insufficiency
The Effect of Relaxation Response Training on Declarative Memory and Learning in High School Students

Stress contributes to health and behavioral issues in students, but will not be integrated into schools without evidence of benefit. This study was conducted to determine if a 6-week relaxation response (RR) curriculum improves cognitive performance in ninth grade students.

Stress contributes to health and behavioral issues in students, but will not be integrated into schools without evidence of benefit. This study was conducted to determine if a 6-week relaxation response (RR) curriculum improves cognitive performance in ninth grade students.

Eligibility Criteria:
Inclusion Criteria:

* a member of 9th grade at a residential preparatory school.

Exclusion Criteria:

* none
Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain

The goal of this study is to compare the effectiveness of two different medications used in intravaginal trigger point injections (injections into extremely painful areas of a muscle) to treat chronic pelvic pain. The study compares onabotulinumtoxinA (BOTOX®) (a drug prepared from the bacterial toxin botulin which temporarily paralyzes muscles) to Kenalog (a synthetic corticosteroid used as an anti-inflammatory agent).

Chronic pelvic pain (CPP) is a common and often debilitating problem among women. The musculoskeletal system is an important factor in chronic pelvic pain. Studies have demonstrated that women with CPP had more frequent musculoskeletal findings. On physical examination, myofascial trigger points have been found. Trigger points are hyperirritable bands of muscle that can be felt from the vaginal wall. They are often knot-like or taut and are painful when pressure is placed on them. Intravaginal injections of these trigger points using steroids including Kenalog (triamcinolone) have been done and produced decreases in pelvic pain. Trigger point injections of Onabotulinumtoxin A has also been shown to decrease pain in subjects with CPP. This study will compare these two drugs and assess pain (using subject questionnaires) at one, three and six months post injection.

Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent
* Healthy women \> age 18 regardless of menopausal status
* Willing and able to fill out study questionnaires. In patients that are unable to read, the research nurse will be available to assist.
* High-tone pelvic floor dysfunction on vaginal exam
* A pelvic pain score of \> 4 on screening Visual Analog Scale (VAS)
* Pain perceived to be in the pelvis that has been present for at least 3 months.

Exclusion Criteria:

* Patients that have had Botox to the bladder within the last 8 months
* Patients that have had Botox outside the bladder of \> 160 u within the last 12 weeks.
* Patients that have had transvaginal trigger point injections of any form (Botox or steroid) in the last 3 months
* Pregnancy
* Concomitant use of any narcotic drug, alcohol, or any illicit drug use during the study period that could be deemed unsafe in combination with study medication as judged by the investigators.
* Any evidence of vaginitis on wet mount slide at initial visit that is untreated.
* Subject with any other vaginal epithelial disorder that could affect absorption of medication as deemed by the investigators.
* Any indication/condition/medication that the investigators identify as contraindicated in conjunction with study medication.
* Systolic blood pressure \> 160 mm Hg on screening blood pressure
* Heart rate \> 110 beats/minute on screening heart rate
Efficacy of the Stroll Safe Outdoor Fall Prevention Program

This study examines the effectiveness of the Stroll Safe Outdoor Fall Prevention program, a 7-week group based educational intervention. Half of participants are assigned to the Stroll Safe program and half are assigned to a wait list control group that initially receives written information only on outdoor falls prevention.


Eligibility Criteria:
Inclusion Criteria:

Community-dwelling adults age 60 years or older, English speaking, cognitively competent (i.e. have a Montreal Cognitive Impairment score (MOCA) \>24), and able to walk outdoors independently with or without a mobility device. In addition, they must answer "yes" to one or more of the following questions: Have you fallen outdoors and hurt yourself in the past year?, Have you fallen outdoors 2 or more times in the past year?, Are you afraid that you might fall outdoors?, Have you had 2 or more stumbles, trips, or slips outdoors in the past month?

Exclusion Criteria:

Less than 60 years of age, living in an institutional setting (e.g. nursing home), non-English speaker, Montreal Cognitive Assessment Score \<24, requiring the assistance of another person to walk outdoors, non-ambulatory, an acute health condition that would interfere with participation(e.g. recent fracture, uncontrolled/poorly managed mental health condition, respiratory disease requiring supplemental oxygen), they reply "no" to all of the following questions: Have you fallen outdoors and hurt yourself in the past year?, Have you fallen outdoors 2 or more times in the past year?, Are you afraid that you might fall outdoors?, Have you had 2 or more stumbles, trips, or slips outdoors in the past month?
CARE Trial: Comparing Different Levels of Calorie Reduction for Weight Loss

This research study will compare two weight loss programs that provide different recommendations for how to reduce your energy (or calorie) intake to achieve weight loss in an effort to determine if fixed calorie reduction or varied calorie reduction is more effective for weight loss.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-75
* Body mass index (BMI) 30-50 kg/m2

Exclusion Criteria:

* Uncontrolled hypertension (blood pressure \>160/100 mm Hg)
* Any of the following other medical conditions: myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported HIV); chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; chronic lung diseases or orthopedic problems that limit physical activity
* Current use of any of the following medications: antipsychotic agents, monoamine oxidase inhibitors, systemic corticosteroids, antibiotics for HIV or TB, or chemotherapeutic drugs; prescription weight loss medications (past six months)
* Unwilling or unable to do any of the following: give informed consent; read English at the 5th grade level; accept random assignment; travel to the intervention site
* Likely to relocate out of the area in the next 2 years
* Participation in another randomized research project
* Weight loss \> 10 pounds in past six months
* History of bariatric surgery
* Major depressive or psychiatric disorder, or excessive alcohol intake
* Potential participants living farther than 30 miles driving distance from UAB will be excluded from the study.
* Potential participants (female) that are pregnant or plan to become pregnant in the next 18 months will be excluded from participation in the study. This is a weight loss study and weight gain/loss due to pregnancy and/or delivery would confound study results. Additionally, weight loss is not recommended for pregnant women.