cyrilzakka/clinical-trials huggingface dataset:
Pre-probiotic Supplementation for Post-covid Fatigue Syndrome

The goal of this randomized controlled double-blind parallel-group interventional trial is to evaluate the effects of of dietary supplementation with a pre-probiotic on patient- and clinician-reported outcomes, and brain tissue metabolism in patients with post-covid fatigue syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65 years
* Covid-19 positive test within last 3 months (as documented byvalid PCR or antigentest
* Moderate-to-severe fatigue (20-MFI test total score \> 43.5)
* At least one of additional covid-19 related symptoms (anosmia,ageusia,breathingdifficulties,lungpain, body aches, headaches, difficulties concentrating etc.)

Exclusion Criteria:

* Other pulmonary and cardiovascular conditions
* History of dietary supplement use during the past 4 weeks
* Organic gastrointestinal (GI) disorders such as inflammatory bowel disease, coeliac disease, eosinophilic disorders, or current infection of the GI tract.
* Bowel surgery or short bowel syndrome.
* Medication or supplement which can impact the gut microbiome, including: antibiotics, antimicrobials, or antifungals in the two months
* Probiotic or prebiotic supplements in the last 4 weeks
Time-dependent Improvement of Functional Outcome Following Oxford Medial Unicondylar Knee Replacement

The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first six years following Oxford Medial Unicondylar Knee prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest.

The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first six years following Oxford Medial Unicondylar Knee prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest. Thats it!

Eligibility Criteria:
Inclusion Criteria:

* patients with medial knee osteoarthritis
* admitted for unicondylar knee replacement
* age 50-80 years

Exclusion criteria

* rheumatoid arthritis
* previous knee infection
A Phase I Study of Monoclonal Antibody TB-402 in Healthy Male Volunteers

Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody directed against FVIII, versus placebo in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Males 18 to 45 (Groups 1-9) or 55 to 75 (Group 10) years of age
* No clinically important abnormal physical, laboratory, ECG findings
* Normal (or abnormal but ncs) supine blood pressure (BP) and heart rate (HR)

Exclusion Criteria:

* Self or family history of cardiovascular or pulmonary disorder, coagulation or bleeding disorders or reasonable suspicion of vascular malformations eg cerebral haemorrhage, aneurysm or premature stroke.
* Any autoimmune disease.
* Previous allergic reaction to immunoglobulin.
* Present, or history of, severe allergy, for example asthma or anaphylactic reactions or allergy requiring treatment.
* Consumption of aspirin, other non-steroidal anti-inflammatory drugs or other drugs known to affect platelet function or any other aspect of coagulation within 14 days before drug administration.
* Abnormal platelet function or clinically significant out of range values for any coagulation tests.
* History of important bleeding episodes eg haematemesis, rectal bleeding, severe or recurrent epistaxis, haemoptysis, haematuria or intracranial haemorrhage.
* Screening FVIII:C \< 50%.
Young Houston Emergency Opioid Engagement System

The Houston Emergency Response Opioid Engagement System for Youths and Adolescents (Young HEROES) is a community-based research program integrating assertive outreach, medication for opioid use disorder (MOUD), behavioral counseling, and peer recovery support. The objective is to compare differences in engagement and retention in treatment for individuals with opioid use disorder. The investigators also intend to understand the prevalence of opioid overdoses and OUD among youth in Houston.

The Houston Emergency Response Opioid Engagement System for Youths and Adolescents (Young HEROES) is a non-randomized cohort study based at the University of Texas Health Science Center of Houston. This study recruits participants through three avenues: assertive community outreach with a peer coach and paramedic following and opioid overdose, community referrals, and emergency department referrals. The study explores the effect of the combination of assertive outreach, same-day induction into medication for opioid use disorder, ongoing maintenance treatment, behavioral counseling, peer recovery support, and paramedic follow-up on patient outcomes. The primary outcome is engagement and retention in outpatient treatment. Secondary outcomes include quality of life assessment as well as subsequent relapses and overdoses. The hypothesis is that patients with earlier induction into MOUD treatment who receive routine follow-up, are more likely to engage and remain in treatment long-term.

Eligibility Criteria:
Inclusion Criteria:

* In otherwise good health based on physician assessment and medical history
* Drug screen positive for opioids
* Patients express a willingness to stop opioid use
* Meet Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV-TR) criteria for opioid dependence
* Patients must be able to speak English
* Be agreeable to and capable of signing the informed consent and assent (parent or guardian must consent, minor must assent)

Exclusion Criteria:

* Non-English-speaking patients
* Have a known sensitivity to buprenorphine or naloxone
* Be physiologically dependent on alcohol, benzodiazepines, or other drugs of abuse that require immediate medical attention. Other substance use diagnoses are not exclusionary.
* Have a medical condition that would, in the opinion of the study physician, make participation medically hazardous, including unstable cardiovascular disease, neurological deficits, trauma, acute hepatitis, stroke, and liver or renal disease)
* Be acutely psychotic, severely depressed, and in need of inpatient treatment, or is an immediate suicide risk
* Be a nursing or pregnant female
Digital Health Weight Management Among Public Housing Residents

This research will test the efficacy of a weight management intervention through a three-group randomized trial: mHealth only, mHealth+Community Health Worker (CHW) support, versus control group, among residents of Boston's public housing developments. The mHealth group consists of a 1-year text messaging program to promote diet and physical activity behavior changes and the CHW support consists of monthly phone counseling delivered by a CHW to support the text messaging program. Our hypothesis is that the mHealth+CHW group will be more effective in bringing about weight loss compared to mHealth alone or the assessment only control group. The findings are expected to inform future health promotion efforts among residents in public housing developments.


Eligibility Criteria:
Inclusion Criteria:

* Current resident of Boston public housing development
* No plans to move within the next 6 months and no plan on leaving the country for more than 2 months over the next year
* Able to read and speak in English or Spanish
* Has cell phone with a plan that allows for unlimited text messages
* Willing to wear a device to track physical activity during assessment periods

Exclusion Criteria:

* Currently enrolled in a comprehensive weight loss program or a research study about weight that is incompatible with study participation
* Currently on a medically prescribed diet or fast that is incompatible with study participation
* Currently has a diagnosis of bipolar disorder, mania, manic-depressive disorder, schizophrenia, or psychosis and is not on any medications to treat the condition
* Precontemplation stage of change for making healthy eating or physical activity changes
* Pregnancy
* Medical contraindications to physical activity. Self-reported presence of any of the following:

  * Can not walk without help from someone else
  * Regularly needs to use the following special equipment to walk or get around: wheelchair, scooter, walker, or extra oxygen
  * Gets short of breath even when using special equipment at a very low level of physical activity such as walking around the home, making a bed, or taking a bath
  * Advised by a healthcare professional not to exercise and or if diagnosed with a bone or joint problem, it could get worse.
  * Frequently gets pains in the heart or chest
  * Had a heart attack in the past 6 months
  * Often feels faint or has spells of severe dizziness
  * Has very high blood pressure that is often over 175 or the bottom blood pressure number is often over 110
  * Has a good physical reason not to follow an activity program even if they wanted to
Improving Walking With Heel-To-Toe Device

Introduction: The purpose of this study is to test the efficacy potential of using real-time positive auditory feedback to improve gait pattern in people with Parkinson's Disease (PD). The components of walking are commonly affected in patients with PD. Gait training for PD is usually based on verbal cues from the therapist that are only moderately effective. Based on good principals of gait and neuroplasticity, the Heel-To-Toe (Heel2Toe) sensor was developed to provide real-time auditory feedback during walking training. Methods: A two-group, randomized feasibility trial is planned with repeated measures of gait parameters and walking outcomes. Participants will be assessed at baseline, 3 and 6 months. Outcomes after the 5 training days will be obtained directly from the Hee2Toe device for both groups (with and without auditory feedback). The primary outcome is walking capacity measured by the Six-Minute Walk Test and the Standardized Walking Obstacle Course. Gait parameters will be captured by the Heel2Toe device Expected Contributions: Gait training using the Heel2Toe sensor will be potentially effective for improving walking pattern in people with PD.

As this is a feasibility study, the main analysis will focus on within-group change over the intervention period of 3 months using indices of reliable change(36). This method assesses the number of people who changed in each of the groups based on the magnitude of change relative to pre-post variability and correlation. We will estimate the proportion of people with reliable change. Estimates from the pilot study will be used to plan the main trial if the pilot demonstrates feasibility. For the maintenance period, reliable change from baseline will also be estimated and used to identify the proportion of people who maintained reliable change or who gained/lost this status.

The study is designed to detect a minimal important within-group change of moderate magnitude or greater (effect size ½ standard deviation) with adequate precision. A sample size of 20 in the intervention with completed follow-up will provide a 95% confidence interval with precision that excludes an effect size of 0.03.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson Disease and be independent in ambulation without use of walking aid

Exclusion Criteria:

* exercising three or more time per week;
* Had any additional illness that restricted their function
* Showing difficulty reading, understanding or speaking either French or English
Magnetic Resonance Imaging (MRI) Interpretations for Lumbar Spinal Stenosis (LSS)

The objective of this study is to establish a relationship between the degree of radiologically established anatomical stenosis and the severity of self-assessed outcome measures in patients that have undergone and MRI.

Magnetic Resonance Imaging(MRI) has become the gold standard of evaluation of lumbar spinal stenosis (LSS. LSS is defined as the narrowing of the spinal canal. Thus far, there has been no formal grading system in literature. Physicians, particularly radiologists, in their interpretations, currently describe the degree of stenosis at each level as normal, mild, moderate or severe. Unfortunately, there is no consensus on criteria of these definitions. Treatments and surgical plans are based primarily on this information. Consequently, the reliability and accuracy of this information is critical in terms of optimizing outcomes.

In this study 50-100 MRI studies of patients diagnosed with symptomatic lumbar spinal stenosis will be collected, de-identified, and assigned a study identification number for tracking purposes. Three "raters" from Upstate and three "rater" from outside the institution, that have experience reviewing MRI's will be asked to review the MRI's and classify the LSS at all lumbar levels as normal, mild, moderate or severe in the central canal, lateral recesses and the neuroforamen. The raters will not have any information about the patients. The MRI's will then be given a new identification number, and the patient's self-assessment questionnaires (which are also de-identified and given the study id number) will be given to the raters, for a second review. The raters will have the patients gender, age and outcomes scores from Short form 36, Visual Analog Scale, Oswestry Disability Index and Zurich Claudication Questionnaires. The raters will classify the MRI, as normal, mild, moderate or severe using the outcomes and information supplied.

The data from both ratings will be compiled and compared to assess the reliability of the radiologically established anatomical stenosis when compared with the subjects outcome scores.

This study is for current patients in Upstate Orthopedics office.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 21 years of age
* Must be able to undergo or have undergone an MRI of the Lumbar spine
* Must be able to read/understand English
* Must be a current patient in our practice

Exclusion Criteria:

* Prisoner
Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Postsurgical Patient Deterioration.

The primary aim of the current study is to assess the effect of continuous wireless vital sign monitoring with generation of real-time alerts, compared to blinded monitoring without alerts on the cumulative duration of any severely deviating vital signs in patients admitted to general hospital wards after major surgery.

We hypothesize that continuous vital signs monitoring, and real-time alerts will reduce the cumulative duration of severely deviating vital signs.


Eligibility Criteria:
Inclusion Criteria:

* Admission for acute or elective major abdominal (laparotomy/laparoscopy), major orthopedic, major urologic, or arterial vascular surgery.
* Estimated duration of surgery ≥2 hours and at least two expected overnight stays.
* Randomization and commencement of continuous wireless monitoring possible within 24 hours postoperatively

Exclusion Criteria:

* Patient expected not to cooperate with study procedures.
* Allergy to plaster or silicone.
* Impaired cognitive function (in uncertain cases assessed by a Mini Mental State Examination\] score \< 24)
* Patients admitted for palliative care only (i.e. no active treatment).
* Planned admission to unit using continuous vital sign monitoring (i.e. an intermediary care/telemetry unit).
* Patients previously enrolled in the medical WARD RCT.
* Patients with a pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
* Inability to give informed consent.
Prevalence, Risk Factors and Consequences Related to Cesarean Scar Defect (Defect in Cesarean Scar)

The rates of cesarean section (CS) are rising all over the world. Worldwide the number of CS is millions every year. CS is one of the most frequently performed operation for women. As a consequence many women have a scar in their uterus. Cesarean scar may be associated with complications in later pregnancies. In recent years there have also been a few reports indicating that cesarean scar could potentially be associated with menstrual disorders and infertility. The impact of cesarean scar defect on long term welfare or quality of life is not clear.

In some women with a history of CS it is possible to recognise a defect in the site of previous uterotomy years after the performed CS by sonographic examination. This defect in the scar, also called as a niche, is a consequence of incomplete healing of the scar in the lower part of uterus. To date there is uncertainty relating to the factors that lead to poor healing of cesarean scar. Also impact of cesarean scar defect on later well-being and later pregnancies are not properly known.

The purpose of this study is to investigate the prevalence and the risk factors of cesarean scar defect. Also the impact of cesarean scar defect on women´s menstrual health, fertility, further deliveries and quality of life will be investigated.

This study is a prospective observational cohort study. Women at the age of 18-45 years who will give birth by elective or emergency CS will be asked to participate. Women are recruited within two days of CS. Women with known uterus anomaly or von Willebrand disease will be excluded.

The prevalence of scar defect will be evaluated by transvaginal sonography and contrast-enhanced sonohysterography using saline infusion. Both 2-dimensional and 3-dimensional sonography will be used. Sonographic evaluation will take place 6 months after the CS.

The following definition for CS scar defect will be used: myometrial discontinuity with a depth of ≥2 mm at the site of cesarean scar that communicates with the uterine or cervical cavity as seen on transvaginal sonography with or without saline infusion.

The prevalence of menstrual disorders will be evaluated 12 months after the CS. The subjects will be asked to report the number of menstrual bleeding days once a month during 3 consecutive months. Postmenstrual spotting is defined as ≥2 days of brownish discharge at the end of menstruation with total bleeding days of ≥7 or non-cyclic bleeding not related to menstruation.


Eligibility Criteria:
Inclusion Criteria:

* Women who gives birth by cesarean section whether it will be an elective surgery or an emergency surgery during labour

Exclusion Criteria:

* Uterus anomaly or von Willebrand disease
* Informed consent not provided
Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function

A large body of evidence confirm the cholesterol lowering effect of red yeast rice, phytosterols and L-tyrosol. Because their mechanisms of action mime the ones of chemical statins and cholesterol absorption inhibitors, it is plausible that their association will provide a more relevant (and safe) LDL cholesterolemia reduction.

European Food Safety Authority approves some health claim related to the cardiometabolic effects of some nutraceuticals, and in particular of red yeast rice, phytosterols and L-tyrosol.

In a previous study the investigators have already demonstrated the synergistic effect of red yeast rice and phytosterols in term of lipid-lowering activity.

Preliminary data suggest that these nutraceuticals could also exert a positive effect on vascular health beyond the direct effects on serum lipids.

No data are available on the combined effects of these dietary supplement in humans.

Eligibility Criteria:
Inclusion Criteria:

* Suboptimal LDL level (115-160 mg/dL)
* TG\<400 mg/dL
* Signed informed consent form

Exclusion Criteria:

* Patients already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk\> 10 years
* LDL-C\<115 mg/dL or \>160 mg/dL, TG\>400 mg/dL
* Obesity (BMI\>30 kg/m2) or diabetes mellitus
* Assumption of lipid lowering drugs or dietary supplements, or drugs potentially affecting the lipid metabolism
* Antihypertensive treatment not stabilized since at least 3 months
* Known current thyroid, gastrointestinal or liver diseases
* Any medical or surgical condition that would limit the patient adhesion to the study protocol
Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma

The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma.

The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years.

In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses.

The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old, who must understand and voluntarily sign an Informed Consent.
* Patients must have documented diagnosis of Multiple Myeloma and have measurable disease.
* Patients must have undergone prior treatment with ≥ 2 treatments lines, of anti-myeloma therapy.
* Patients must have either refractory or relapsed and refractory disease.
* Patients must have received at least 2 consecutive cycles of prior treatment that include lenalidomide and bortezomib, either alone or in combination regimens.
* Patients must have received adequate alkylator therapy

Exclusion Criteria:

* Prior history of malignancies, other than Multiple Myeloma.
* Previous therapy with Pomalidomide, hypersensitivity to thalidomide and lenalidomide or dexamethasone.
* Patients who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant.
* Patients who are planning for or who are eligible for stem cell transplant.
* Patients who received major surgery and any anti-myeloma drug therapy within the last 14 days of starting study treatment.
* Patients with a current disease that can interfere with protocol procedures or study treatment.
* Patients unable or unwilling to undergo antithrombotic prophylactic treatment.
* Pregnant or breastfeeding females.