cyrilzakka/clinical-trials huggingface dataset:
Hyperbaric Oxygen for Ulcerative Colitis

The investigators aim to prospectively study the feasibility and clinical impact of hyperbaric oxygen therapy in acute hospitalized moderate to severe ulcerative colitis flares as an adjunct to standard medical treatment. Specifically, we will investigate the impact of hyperbaric oxygen therapy on clinical response/remission and serum and mucosal inflammatory markers. The investigators expect that hyperbaric oxygen therapy will improve patient responsiveness to steroids and avoid progression to second line therapy during hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* known or newly diagnosed moderate to severe ulcerative colitis with a Mayo score of greater than 6
* Mayo endoscopic sub-score of greater than or equal to 2
* Risk score of greater than or equal to 4 points

Exclusion Criteria:

* Complication requiring urgent surgical intervention (in the opinion of the investigators)

Clinically significant cardiac, renal, neurological, endocrine, respiratory or hepatic impairment in the opinion of the investigator, including but not limited to:

* Pulmonary i. COPD with CO2 retention; Previous/current imaging showing hyperinflation/air trapping/bullous disease/blebs (opinion of investigators) ii. Current pneumothorax or previous spontaneous pneumothorax iii. Bronchogenic cyst(s)
* Cardiac i. Uncontrolled HTN (systolic \>160 or diastolic \>100) ii. Unstable angina or myocardial infarction within the previous 3 months iii. Ejection fraction \< 35% iv. Current or previous amiodarone use v. ICD in place vi. Pacemaker in place not approved for chamber use
* Hematological/Oncological i. Current chemotherapeutic drug use, and past history of bleomycin use. ii. Hereditary Spherocytosis iii. Sickle cell anemia
* Gastrointestinal and Infectious Disease i. Known or suspected Crohn's disease ii. Previous infection with mycobacterium, fungus, HIV, Hepatitis B or C iii. Gastrointestinal or systemic infection including, but not limited to, --Clostridium difficile iv. Current capsule endoscopy or previously non-retrieved capsule Endocrinology i. Uncontrolled hyperthyroidism

Neurological and Psychological i. Vagal or other nerve stimulators

ii. Uncontrolled seizure disorder

iii. Medications or medical conditions that lower seizure threshold (in the opinion of the investigator) iv. Drug or alcohol abuse/dependence v. Current treatment for alcohol cessation with disulfiram vi. Current or recent (within past week) use of baclofen Head and Neck i. Previous middle ear damage, surgery or infection(s) which may increase the risk for needing ear tubes (in the opinion of the investigator) ii. Current or previous retinal detachment or optic neuritis iii. Retinal or vitreous surgery within the past 3 months Miscellaneous i. Implanted devices not on the approved list for use with HBOT

Women who are pregnant or nursing. Women with childbearing potential were required to use effective birth control if not surgically sterile or postmenopausal for \>2 years.
Efficacy of Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation in Hemodialysis Patients

The purpose of this study is to examine the effect of 6 months of daily beta-hydroxy beta-methylbutyrate (HMB) supplementation on the physical function and the health of bones, arteries and heart in hemodialysis patients.

Patients with renal failure receiving hemodialysis experience an increased rate of skeletal muscle protein catabolism which is associated with a number of co-morbid conditions including declines in muscle mass and strength, significantly increased fall risk, and reduced quality of life (QOL. Therefore, interventions to prevent muscle loss in hemodialysis are needed. Pharmacological agents have been investigated to treat muscle loss in dialysis patients; however, many of these treatments are expensive and have undesirable side effects. As a result, low-cost interventions designed to attenuate losses in muscle mass and strength in hemodialysis patients are needed.

Beta-hydroxy beta-methylbutyrate (HMB) represents a potential low-cost nutritional intervention to attenuate muscle loss in hemodialysis patients. HMB is a metabolite of the amino acid leucine that has been shown to safely increase muscle mass in other clinical populations with prevalent muscle loss, such as the elderly, cancer, and AIDS patients primarily through reductions in skeletal muscle protein catabolism. The primary purpose of the trial is to determine if oral supplementation with HMB attenuates muscle loss, improves muscle strength, physical function, fall risk and QOL in hemodialysis patients. Alterations in protein and gene expression associated with skeletal muscle protein turnover will be measured to investigate the mechanism for changes in our primary outcomes. We hypothesize that HMB supplementation will attenuate declines in muscle size and strength in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Must be receiving hemodialysis treatment.
* Must be willing to be randomized to HMB or placebo for 6 months
* Must receive physician clearance to participate

Exclusion Criteria:

* Bodyweight \> 350 lbs
* Currently taking an HMB supplement or HMB containing products (eg. Ensure)
Post-market Study of Multi-Vector Left Ventricular Lead Performance in Chinese Patients With Chronic Heart Failure

The purpose of this clinical study is to observe the safety and efficacy of the multi-vector left ventricular (LV) lead in Chinese patients that are indicated for Cardiac Resynchronization Therapy (CRT).

This is a multi-center, non-randomized observational study.

The total duration of the study is expected to be 2.5 years. The clinical study will be conducted in no more than 15 centers in China. Approximately 120 subjects will be enrolled in this study. Subjects will be followed up at 3, 6, 12 months and every 6 months afterwards. All subjects need to be followed for at least 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Meets the current European Society of Cardiology (ESC) or American College of Cardiology Foundation (ACCF)/American Heart Association (AHA)/Heart Rhythm Society (HRS) Class I or Class IIa indications for CRT implant (including upgrades from single or dual chamber Implantable Cardioverter-Defibrillators (ICDs))
* Are ≥ 18 years of age at the time of enrolment.
* Are able to provide written Informed Consent prior to any study related procedure.

Exclusion Criteria:

* Patient who is unable to comply with the follow-up schedule.
* Patient who has any medical conditions that in the opinion of the investigator will not be appropriate to participate in the study .
* Patient has a life expectancy of less than 1 year due to any condition.
* Patients, who has a CRT device implanted
Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care

The purpose of this study is to determine whether, for individuals in inpatient opioid detoxification, linking to outpatient Suboxone treatment increases treatment adherence and reduces relapse to illicit opioid use.

In this randomized trial, consenting individuals seeking inpatient opioid detoxification will be assigned to one of two groups. The first group will receive a tapering schedule of buprenorphine during inpatient detoxification to alleviate acute withdrawal symptoms, and referral to a community medical and substance abuse treatment providers (DETOX). The second group will also receive buprenorphine to relieve withdrawal symptoms, but will maintain a stable dose of buprenorphine through inpatient discharge and linkage to an appointment with a primary care provider within a week of discharge (LINKAGE). All participants complete study assessments at baseline, 1-month, 3-months and 6-months post-enrollment.

The SSTAR inpatient detoxification program based in Fall River, Massachusetts will serve as the recruitment site of this trial. SSTAR's program has 38 beds and is a 24-hour medically and psychiatrically supervised treatment facility that provides evaluation and withdrawal management. The SSTAR Family Healthcare Center is a 330 Federally Qualified facility also in Fall River that provides primary care and behavioral health services to residents of Community Health Network Area 25 (Fall River, Somerset, Swansea and Westport, Massachusetts). Dr. Bailey, Director of Research at SSTAR, will oversee the provision of buprenorphine treatment to study participants during detoxification and serve as liaison to the primary care providers at the Family Healthcare Center.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older;
* opioid dependent;
* interested in initiating maintenance buprenorphine treatment;
* opioid positive on urine toxicology;
* willing to establish primary care with a buprenorphine-waivered physician at SSTAR.

Exclusion Criteria:

* Patients unable to provide informed consent due to acute illness, cognitive impairment, or psychosis;
* probation/parole requirements that might interfere with protocol participation (1% of SSTAR inpatients);
* inability to provide two contact persons to verify location;
* not able to complete assessments in English;
* currently enrolled in a methadone or suboxone maintenance program;
* plans to leave the area within the next 6 months;
* current DSM-IV diagnosis of substance dependence for sedative/hypnotic drugs, cocaine, or alcohol;
* current suicidality on the Modified Scale for Suicidal Ideation;
* chronic pain requiring ongoing opioid use or anticipated major painful event (significant surgical procedure) in the coming 6 months;
* pregnancy;
* history of allergic reaction to buprenorphine or naloxone.
Nicotine Patch Safety Study

The purpose of this study is to evaluate the safety profile of a repeated application of a new transdermal patch compared to a reference product during 3 weeks, in a large population.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged more than 18 years
* Regular smoker motivated to stop tobacco consumption
* Current smoker of \> or = 20 cigarettes/day and \< or = 25 cigarettes/day or Fagerström score \> or = 5 (for smokers between 10 to 20 cigarettes/day)

Exclusion Criteria:

* Any visible skin disorder, abnormal skin pigmentation or other dermatologic disease which, in the opinion of the investigator would interfere with the assessment of the different parameters
* Current or past serious chronic cardiovascular, renal, hepatic, gastrointestinal (including duodenal or gastric ulcer), endocrine, hematological, neuropsychiatric, immunosuppressive condition or allergic disease, myopathies, epileptic seizures, bleeding tendency, cancer
* History of angina pectoris, myocardial infarction or stroke in the previous 3 months, coronary artery vasospasm, cardiac arrhythmia, acute stroke
* Clinically relevant abnormal findings on the physical examination (e.g large scars on the application zone)
A Trial of Doxycycline in Renal Disease

The goal of this trial is to evaluate whether subantimicrobial-dose of doxycycline (20mgBID) will affect serum and urine biomarkers of fibrosis in patients with pre-dialysis chronic kidney disease.

This is a Phase I, placebo-controlled, randomized crossover trial to determine the effects of 4-week treatment with subantimicrobial-dose doxycycline on serum and urine biomarkers of fibrosis in patients with pre-dialysis chronic kidney disease (eGFR\<30ml/min/1.73m2). Doxycycline is a matrix metalloproteinase inhibitor and is approved for use as an anti-fibrotic in the setting of gum and skin disease at low doses (20mgBID). At such a dose, serum levels are too low for antimicrobial effect and chronic usage is not thought to lead to tetracycline resistance. Investigators hypothesize that doxycycline will ameliorate cardiac and renal fibrosis and thus investigators will detect a decrease in fibrotic markers during treatment with doxycycline.

Eligibility Criteria:
Inclusion Criteria:

* CKD pre-dialysis (eGFR\< 30 ml/min/1.73m2 not on dialysis);
* local 415/650/510 area codes;
* primary language English or Spanish

Exclusion Criteria:

* eGFR worsening by greater than 5ml/min/1.73 m2 during the last 6 months;
* Systolic blood pressure less than 100mmHg or greater than 170 mmHg;
* pregnancy;
* ejection fraction less than 45%;
* NYHA class III or IV HF;
* myocardial infarction or hospitalization for HF within 4 months;
* liver disease;
* moderate or severe chronic obstructive pulmonary disease or pulmonary fibrosis;
* current infection;
* chemotherapy;
* major surgery within last month;
* bilateral dialysis access precluding lab draw;
* self-reported use of IV drugs or cocaine within the last 6 months.
A Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus

Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). In a previous small sample trail performed by the investigator's group, the investigators found that the Low-dose IL-2 was effective and well tolerated in active SLE, and the effect was associated with selective modulation of CD4+ T cell subsets.

This clinical study will confirm the efficacy and safety of low dose IL-2 treatment in SLE.

The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in SLE.The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for Systemic lupus erythematosus by randomized controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).

Each SLE patients (n=60) with Scores\>=8 on SLEDAI received low-dose IL-2 or placebo (active group: placebo group =1:1, 1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3 cycles. The end points were safety and clinical and immunologic response.

Eligibility Criteria:
Inclusion Criteria:

* Meet the American College of Rheumatology criteria for the diagnosis of SLE，1997.
* Under standard treatment (≥ 2 months) at the time of inclusion
* Background treatment failed to control flares or to permit prednisone tapering
* With at least one of the following manifestations: thrombocytopenia, disease-associated rash, mouth ulcer, non-infectious type of fever, active vasculitis, renal disorder(proteinuria\>0.5g/day), neuropsychiatric SLE.
* Positive for at least one of the following laboratory tests: ANA\>1:160, anti-dsDNA, immunoglobulin\>20g/L, decreased C3 or C4, leukopenia\<3×10\^9/L, thrombocytopenia\<100×10\^9/L;
* SLE disease activity index(SLEDAI) ≥ 8.
* Negative HIV test.
* Negative for hepatitis B and C virus.
* Negative urine pregnancy test.
* Written informed consent form.

Exclusion Criteria:

* Sever chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases\> 3N) )
* Serious infection such as bacteremia, sepsis;
* Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma);
* High-dose steroid pulse therapy (\>1.5mg/kg) or IV bolus of corticosteroids in the last 2 months.
* History of administration of rituximab or other biologics;
* Purified protein derivative (tuberculin) \>10mm
* Mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information;
* Inability to comply with IL-2 treatment regimen.
CoreHip - Post Market Clinical Follow-Up Study

The study is designed as a prospective, non-interventional multicentre cohort study. The product under Investigation will be used in Routine clinical practice and according to the authorized Instructions for Use (IfU). Aim of this observational study is to collect clinical and radiological results of the CoreHip® endoprosthesis system in a Standard Patient Population and when used in Routine clinical practice.

The CoreHip® System has a range of different stem designs to address most of the indications and anatomical conditions met in Primary THA patients within one implant and Instrument System.

Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥ 18 years
* Indication for THA with a CoreHip® stem
* Written informed consent

Exclusion Criteria:

* Pregnancy
* Patient age \< 18 years
* Patient not able to regularly participate at the follow-up examinations
Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally

The pathophysiology of sickle cell disease (SCD) manifestations, are complex with interactions of intracellular hemoglobin, membrane and endothelial activation but the hallmark remains recurrent and painful vaso-occlusive episodes (VOC). These painful episodes are thought to result from ischemia caused when small blood vessels are occluded by misshapen, inflexible erythrocytes. Painful episodes are the most common cause of hospitalization, morbidity, and impairment for SCD patients. There is no therapy that completely prevents or directly aborts painful events for all patients. Consequently, treatment for acute VOC is primarily supportive using hydration and medicinal pain control. Every pain medication has the potential to relieve pain but is associated with significant limitations and side effects.

The primary hypothesis to be tested in this double blind, randomized controlled trial is that Nalbuphine is equivalent to morphine for pain control and patients will suffer fewer episodes of acute chest syndrome. The investigators also expect subjects will report fewer side effects from respiratory depression, abdominal distention from reduced peristalsis, reduced histamine release causing pruritis and still be provided adequate pain control. Further hypotheses to be tested is ability to recruit patient participants while being treated in the Emergency Department and that continuous infusion of Nalbuphine with accompanying patient controlled analgesia (PCA) is safe and effective in controlling pain, requiring less total opiates consumption, while decreasing length of hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Patients with sickle cell disease (SS, SC, SβThal) who are hospitalized for acute painful episodes
* 6 years old and \< 19 years old
* Normal baseline chest radiograph
* Normal renal and hepatic function within the previous 12 months

Exclusion Criteria:

* Previous patient participation in this clinical trial
* Any patient on chronic transfusion Any patient with pulmonary infiltrate on chest radiograph on admission
* Any patient with DSM diagnosis, excluding those with Attention Deficit Disorder, on or off treatment
* Any patient with documented allergy to either study drug
* Any patient with known evidence of an underlying disease that would interfere with evaluation of a therapeutic response such as:

  * Hepatic dysfunction (3x ALT),
  * Renal dysfunction (Cr \> 1 children/adolescents, Cr \>2 adults),
  * Pulmonary Hypertension (TRJ \>3.0),
  * Cardiac dysfunction.
  * Any patient with symptoms of an acute stroke.
  * Any patient known or suspected to be pregnant.
  * Any patient with priapism
  * The patient or guardian who will not give consent or assent to be randomized.
Timing of Intrauterine Insemination (IUI) 24 or 48 Hours After Spontaneous Luteinizing Hormone (LH) Peak

The aim of the present study is to prospectively evaluate whether performing an intra-uterine insemination 24 hours after the spontaneous LH peak may result in significantly higher ongoing pregnancy rates compared to 48 hours.


Eligibility Criteria:
Inclusion Criteria:

* below 39 years of age on the day of LH peak
* donor semen
* natural cycle (without CC)
* cycle with less than 3 follicles reaching 15 mm of diameter or more.
* with basal hormonal values of progesterone ( \< 1,2 ng/dl)

Exclusion Criteria:

The patients excluded are women

* who underwent more than 6 intrauterine inseminations,
* with tubal infertility
Survival Rate and Cost-effectiveness of Conventional vs ART Restorations in a School Setting

This study will investigate the performance and cost-effectiveness of glass-ionomer restorations placed in school children in an outreach setting in rural areas in South Africa over a 2-year period, when placed using either ART (in a classroom) or conventional (in a mobile clinic) cavity preparation.

Access to dental care in South African townships is very limited, as indicated by a caries prevalence of 84% and severity of 4.9 (dmft) in 6 year olds. To tackle this burden school-based tooth-brushing programs have been suggested to be cost-effective while reducing inequalities in accessibility. However, despite their efforts, the caries burden remains high.

Alternatives are mobile dental services or treatment techniques that do not require extensive equipment such as Atraumatic Restorative Treatment (ART). Mobile dental services are more cost-effective than stationary clinics, but the costs of acquiring, outfitting, and running a mobile dental truck are factors that may hamper the broader use of this model. ART on the other hand is easy to execute with minimal equipment and monetary resources. But the drawback is a typically lower survival rate of ART restorations compared to conventional placed restorations.

This study aims to further assess and compare the performance and cost-effectiveness of glass-ionomer restorations when placed using either ART (in a classroom) or conventional (in a mobile clinic) cavity preparation in South African school children stemming from a periurban area. The results of this research may help to assess and implement future oral health care programs.

Eligibility Criteria:
General Inclusion Criteria:

* Children (4-8 years of age)
* Guardians have given informed consent
* Child is cooperative and assented

Inclusion criteria for teeth

* Cavity \> 1 mm
* Tooth has no pathological mobility
* Tooth has no preexisting developmental defects
* Tooth has no pulp exposure or is indication for endodontic treatment
* No pain, fistula or abscess related to the selected tooth

Exclusion criteria for teeth

* Cavity \> 1 mm
* Tooth has no pathological mobility
The Validation of New Photographic Technology for Assessing Skin Lesions

The purpose of this study is to determine the validity of a new photographic technology in a dermatologic setting. The digital picture uses high levels of resolution to look at skin biopsy lesions. These photos will be compared to current standard-of-care with hematoxylin and eosin histologic analysis by board-certified dermatologists.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ages 18 and older.
* Able to comprehend procedures, risks, and informed consent.
* Have a skin lesion the practitioner believes, and subject agrees, should be biopsied.
* Lesion on a non-revealing part of the body (none on areas that would be recognizable, nor on groin nor breasts).
* Willingness of subject to share the results of the biopsy pathology.

Exclusion Criteria:

* Lesion on a revealing part of body.
* Unable to understand the procedures, informed consent.