cyrilzakka/clinical-trials huggingface dataset:
Tofacitinib for Inflammatory Eye Disease

Non-infectious inflammatory eye disease, such as uveitis and scleritis, is a chronic, auto-immune process that leads to vision loss. While steroids are effective in the short term, the side-effect profile of chronic steroid use necessitates the identification of effective steroid-sparing therapies. Tofacitinib is a small molecule that inhibits the signaling pathways of multiple inflammatory cytokines. The investigators plan to evaluate whether tofacitinib may have efficacy for patients with uveitis and / or scleritis.

This study is a prospective, single-site, open-label investigation of tofacitinib for refractory uveitis. The study will be for 24 weeks, with potential 1-year extension for treatment responders. The patients will self-administer the medication.

Eligible patients would be those patients with a diagnosis of uveitis who meet the following criteria:

1. Disease sufficiently severe to require treatment with systemic corticosteroids, and
2. Referred from Ophthalmology to Rheumatology or Uveitis specialist for a steroid-sparing agent

For patients naive to oral steroid-sparing therapy (e.g., methotrexate, azathioprine, or mycophenolate), tofacitinib will be initiated as monotherapy. For patients who have failed or had only a partial response to oral steroid-sparing therapy, tofacitinib will be initiated as an add-on therapy. For patients intolerant to a conventional agent, tofacitinib will be initiated as replacement monotherapy. For patients who have failed biologic therapy (e.g. adalimumab), biologic therapy will be discontinued and tofacitinib will be initiated as replacement therapy without change to concurrent conventional steroid-sparing agents. Study visits will occur at baseline/enrollment, and weeks 4, 8, 12, 16, \& 24 (+/- 2 weeks). Clinic visits may occur more frequently as determined by the treating physician. Laboratory monitoring (Table 1) will be obtained according to standard of care for drug toxicity monitoring. Clinical responses will be evaluated at 24 weeks, with the primary outcome defined as treatment failure.

All patients will undergo a predetermined oral steroid taper starting at 60mg of prednisone (or equivalent) and tapering over 14 weeks (Table 2). All patients will undergo a predetermined topical steroid drop taper starting at their current dose (Table 3).

Patients will have an ophthalmological evaluation by their treating ophthalmologist at Washington University. Steroid sparing therapy will be managed by rheumatologists or uveitis specialists at Washington University. All patients will be evaluated for an associated systemic rheumatologic condition.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of uveitis
* a clinical response to steroids
* active disease requiring at least 10mg of prednisone daily (or steroid equivalent)

Exclusion Criteria:

* suspected or confirmed ocular infection
* chronic or recurring infections, such as HIV
* renal insufficiency that would preclude safe administration of tofacitinib
Identification of a New Metabolite of Furosemide in Humans

Recent in-vitro and in-vivo studies performed by one of the investigators (ESO, ICMPE, UPEC, France) have recently allowed to synthetize a new and easy-to-synthesized chemical compound of the furosemide (pyridinium furosemide) during furosemide degradation by electro-Fenton or bioconversion. The biological properties of pyridinium furosemide are currently under investigation. Furosemide is a diuretics currently used in the treatment of patients with heart failure. The goal of the investigators is to assay pyridinium furosemide in urine of patients treated by furosemide to demonstrate that pyridinium is or not a metabolite of furosemide in humans. This study will contribute to assess the fate of pharmaceutical residues of furosemide in the environment.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Written informed consent
3. Affiliation to social security
4. Known heart failure
5. Treatment by furosemide

Exclusion Criteria:

None
A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients

This is a multicenter, randomized, open-label, 2-arm Phase 2 study to evaluate the efficacy and safety of Fluzoparib with Apatinib versus Fluzoparib alone, as treatment, in relapsed ovarian cancer patients. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 2 portion of the study.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically diagnosed high-grade serous or endometrioid recurrent ovarian,fallopian tube,or peritoneal cancer.
2. Patients must have received at least 2 previous platinum-containing regimens.
3. At least one target lesion.
4. ECOG performance status 0-1.
5. Adequate bone marrow, kidney and liver function.

Exclusion Criteria:

1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib.For exploratory cohort ，patients who received PARP inhibitor are eligible;
2. Prior malignancy unless curatively treated and disease-free for \> 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix allowed;
3. Radiation or anti-hormonal therapy or anticancer therapy within 14 days before first administration;
4. Known to be human immunodeficiency virus positive;
5. Known active hepatitis C virus, or known active hepatitis B virus;
6. Untreated and/or uncontrolled brain metastases;
7. Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 3 months prior to the first administration;
8. Pregnant or breast-feeding women.
Back Pain in Patients With Severe Osteoporosis

The purpose of this study is to compare the effectiveness of teriparatide versus therapies that decrease bone loss to prevent new or worsening back pain in patients with osteoporosis seen in clinical practice.

Study B3D-CR-B013 is a prospective observational study to compare changes in back pain among patients treated with teriparatide versus those treated with antiresorptives (raloxifene, daily or weekly bisphosphonates).

Eligibility Criteria:
Inclusion Criteria:

* Men and postmenopausal women who have a previous vertebral osteoporotic fracture that was sustained at least 6 weeks prior to joining the study.
* Patients who are free of severe or chronically disabling conditions other than osteoporosis.
* Patients who are not currently receiving and have not previously received teriparatide.
* Patients who agree to participate, return to follow-up visits, and who have signed informed consent to participate in the study.
* Patients, who in the opinion of the prescribing physician, are eligible to receive the intended treatment and comply with all the recommendations stated in the relevant product information.

Exclusion Criteria:

* Are investigator site personnel directly affiliated with the study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
* Are Lilly employees (that is, employees, temporary contract workers, or designees responsible for conducting the study). Immediate family of Lilly employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at a Lilly facility.
* Patients who have any contraindications according to the relevant product information in the country in which they are being treated.
* Patients who are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug.
Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid

A dose-escalation study to determine the optimum dose of Clavulanic Acid (CLAV) for effects on craving and efficacy.

This is a randomized, double-blind, placebo-controlled, parallel group inpatient study of clavulanic acid for 10 days in adults (18-65) seeking treatment for cocaine use disorder. For those subjects who can tolerate 500 mg/day for 3 days (or matched placebo), there will be a forced dose escalation to 750 mg/day for 3 days. Subjects who can tolerate 750 mg/day for three days will have a forced dose escalation to 1000 mg/day for 4 days until the study ends.

Thus, there are 3 Periods for each participant:

Period 1: 500 mg CLAV per day for days 1-3; Period 2: 750 mg per day for days 4-6; Period 3: 1000 mg/day for days 7-10.

Subjective, cognitive, and adverse effect assessments, blood pressure and pulse will be performed daily. Structural MRI, resting state MRI (rs-fMRI), functional MRI (fMRI) and Magnetic Resonance Spectroscopy (MRS) scans will be done at baseline and on Days 3, 6 and 10 of the study. At the time of each scan, safety of the subject to complete the scan will be re-assessed. fMRI was not done at baseline.

Eligibility Criteria:
Inclusion Criteria:

1. Be able to verbalize understanding of consent form
2. Be male or female adult volunteers ages 18-65 inclusive.
3. Have a Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of cocaine use disorder, moderate to severe in early remission
4. Have a Body Mass Index (BMI) of 17.5 to 39.9 kg/m2; and a total body weight of at least 45 kg (99 lbs.)
5. Have a history and brief physical examination that demonstrate no clinically significant contraindication for participating in the study, and/ or significant or unstable medical or psychiatric illness.

Exclusion Criteria:

1. Have a current DSM-5 substance use disorder, mild, moderate, or severe, on any drug of abuse other than nicotine, caffeine, and cocaine use disorder in early remission verified by Urine Drug Screen (UDS). Alcohol use disorder and marijuana use disorder, mild without withdrawal symptoms, will be permitted.
2. Have any previous medically adverse reaction to CLAV, Augmentin, penicillin, Ticarcillin, cephalosporin, or any beta-lactam drug.
3. Have any illness, condition, and use of medications, in the opinion of the principal investigator, sub-investigators which would preclude safe and/or successful completion of the study.
4. Report having human immunodeficiency virus (HIV) infection or test positive for HIV during screening
5. Be pregnant (females).
6. Unable to tolerate MRI scan for duration of 60 minutes for physical or psychological reasons.
Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis

The forecast of the spontaneous infection of the liquid of ascites (ISLA) at the cirrhotic patient is still burdened by a heavy mortality. The fast diagnosis of the ISLA is thus an essential stake to improve the forecast.

Investigators would so like to estimate the interest of the strip PeriScreen for the fast diagnosis of the ISLA at cirrhotic patients . Investigators plan to include 670 patients, what would allow to make out a will at least on ascites 2000 on about twenty centers for duration estimated of 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years
* Presence of ascites due to cirrhosis
* Hospitalization for a complication of cirrhosis (ascites first decompensation, gastrointestinal bleeding, encephalopathy, etc ...).

or

* Hospitalization to perform a paracentesis evacuated outpatient
* Patients on long-term antibiotic primary or secondary prophylaxis the spontaneous bacterial peritonitis and with clinical and/or biological signs that suggest spontaneous infection of ascite.

Exclusion Criteria:

* Patients with ascites urgently admitted to hospital for suspected infection receiving antibiotics for more than 12 hours.
* chylous ascites,
* Hemorrhagic Ascites
* Biliary Ascites (straw)
* Ascites heterogeneous appearance
* Ascites not related to portal hypertension (peritoneal carcinomatosis, pancreatic ascites, tuberculosis, etc ...)
* Patient receiving imipenem IV.
* Patients on long-term antibiotic primary or secondary prophylaxis the spontaneous bacterial peritonitis without clinical and/or biological signs that suggest spontaneous infection of ascite.
Well-Being and Health-Related Quality of Life in Cancer Patients and Survivors During the COVID-19 Pandemic

This study investigates the well-being and health-related quality of life in cancer patients and survivors during the COVID-19 pandemic. Using questionnaires may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing, isolation, seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.

PRIMARY OBJECTIVES:

I. Assess experiences during the coronavirus disease 2019 (COVID-19) pandemic (e.g., exposure, risk factors, testing, isolation, seropositivity, hospitalization, loss of family or friends); COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms); health, financial and social disruptions; perceived benefits and social support; and health-related quality of life (HRQoL) in a convenience sample of cancer patients and survivors.

II. Evaluate the extent to which COVID-19 experiences are associated with COVID-19-specific psychological distress, health, financial and social disruptions, perceived benefits and social support, and HRQoL.

III. Evaluate the extent to which resiliency factors such as social support and perceived benefits moderate the effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL.

OUTLINE:

Patients complete an online questionnaire over 10 minutes regarding the COVID-19 pandemic including testing, risks of exposure, whether people they know have acquired COVID-19, as well as questions on how the pandemic has impacted their quality of life.

Eligibility Criteria:
Inclusion Criteria:

* MD Anderson active patient (visit within past 5 years)
* ICD-10 confirmed cancer diagnosis
* Documentation of being alive per the cancer registry
* Patients who have signed consent for one of the following protocols: PA14-0241 or LAB03-0320
* Has an active email address and/or can be contacted via MyChart
* English or Spanish speaker

Exclusion Criteria:

* Non-active patient (i.e., no visit within past 5 years)
* Language other than English or Spanish
* Patients who have previously consented to the following protocols: 2012-0112, 2009-0976, 2005-0035, or PA15-0336, because they will be contacted through separate IRB protocols to complete this same survey
Fixation of the Orogastric Tube: Which Method for the Newborn ?

It is recommended to respect the perioral zone by fixing the feeding tube only on the newborn's cheek, in order to promote oral acquisition and avoid repeated dislodgment of probes (HAS). This rule is easily applicable for nasogastric tubes. The difficulty is found for orogastric tubes. The "mustache" is usually used to fix it, but this interferes with the perioral zone and must be changed more often than necessary.

To achieve a more sustainable orogastric tube's fixation to the cheek, a German team directed by W. Krämer developed and tested an orogastric tube's fixing technique that was subsequently approved and used.

Using this German method, a randomized, monocentric superiority study, including 30 newborns and premature babies requiring an orogastric tube, will compared german probe's fixation method to the mustache.

The aim of the study is to ensure a more effective orogastric tube's fixation to reduce the number of fixation changes, probe placements and negative oral stimulations in newborns.


Eligibility Criteria:
Inclusion Criteria:

* Newborns admitted to neonatal intensive care unit
* Express consent of the holders of parental authority
* Orogastric tube indication (enteral feeding, digestive aspiration)

Exclusion Criteria:

* Newborns over 2 months of age corrected
* Indication of nasogastric tube
* Port of gastrostomy
* Pathology resulting in hypersalivation or hyper sweating
* Swallowing disorder
* Genetic disease
* Severe neurological impairment
* Cleft lip and / or palate
* Other malformation in the oral sphere or perioral area
* Sedation with morphine analgesics
* Anticonvulsant treatment
* Palliative care
Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647)

This study aims to establish the safety, tolerability, and efficacy of Vytorin (R) (Ezetimibe + Simvastatin) (SCH 465981) on a select population of Filipinos with hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient men or women, age 18 years and above
* Patients with primary (heterozygous familial and non-familial) hypercholesterolemia

Exclusion Criteria:

* Known hypersensitivity to Ezetimibe and Simvastatin
* Moderate to severe hepatic insufficiency
* Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal
* Pregnancy or lactation
* Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine
An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence

This is a clinical investigation approved by US FDA and Canadian Health Authority to study the safety and potential effectiveness of the autologous muscle cells for the treatment of stress urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Patient has SUI with normal detrusor activity confirmed with urodynamics
* Patient has bladder capacity \>200 mL
* Patient's incontinence has not shown any improvement for at least -6 months
* Patient has failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)

Exclusion Criteria:

* Patient has known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability
* Patient has a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)
* Patient has uncontrolled diabetes
* Patient is pregnant, lactating, or plans to become pregnant during the course of the study
* Patient is morbidly obese (defined as 100 pounds over their ideal body weight, or BMI ≥40) and would not be expected to benefit from treatment
* Patient has current or acute conditions involving cystitis or urethritis
* Patient is scheduled to receive radiation treatment to the vicinity
* Patients with a history of radiation treatment to the urethra or adjacent structures
Study Comparing The Effect On Disease Activity When Reducing Or Discontinuing Etanercept In Subjects With RA

This study involves Rheumatoid Arthritis patients in regular clinical setting who are already on etanercept treatment and are in remission or in a low disease activity (LDA) state, and is intended to identify parameters that can serve as guidance in clinical settings. This study will consider the clinical and radiographic course in subjects when etanercept treatment is tapered or discontinued, and analyze the subjects' experience of disease worsening and the predictive values of clinical parameters, serum biomarkers and imaging on the clinical and radiographic course in different treatment groups. The effect of re-treatment with etanercept at treatment failure will also be studied.


Eligibility Criteria:
Inclusion criteria:

* Subject has a current DAS28 equal to or less than 3.2.
* Subject is currently receiving treatment with etanercept, either 25 mg twice weekly or 50 mg once weekly, for a minimum of 14 months at baseline
* Subject is currently receiving oral, sc or intramuscular methotrexate once weekly, 7.5 mg/week to 25 mg/week and at a stable dose for a minimum of 4 months at baseline.

Exclusion Criteria:

* Subject has earlier had an attempt of discontinuing etanercept for reasons of remission or low disease activity state.
* Subject has received any disease-modifying anti-rheumatic drug, other than methotrexate, within one month before baseline.
* Subject has had a dose of prednisone (or equivalent) \>7.5 mg/day or has received intra-articular, intravenous, intramuscular, or subcutaneous corticosteroid within one month of baseline.
Impact of Triple Combination CFTR Therapy on Sinus Disease.

The study's main goal is to observe how effective elexacaftor-tezacaftor-ivacaftor is for improving the symptoms and signs of CF-related sinus disease.

To determine if elexacfator-tezacaftor-ivacaftor improves the signs and symptoms of CF-related sinus disease, before and after initiation of triple combination therapy, each subject will undergo sinus CT scan and complete questionnaires related to signs and symptoms of sinus disease.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects from 18 to 89 years old.
2. Subjects with cystic fibrosis and comorbid chronic sinus disease (historic diagnosis based on physician assessment of signs and symptoms and medical record).
3. Subjects who clinically elect to initiate elexacaftor-tezacaftor-ivacaftor therapy and/or that are ineligible for CFTR modulator therapy based on their genotype, but have class I/II mutations based on sweat chloride \> 90 mmol/L.

Exclusion Criteria:

1. Subjects under the age of 18 or over the age of 89.
2. Subjects who do not elect to initiate elexacaftor-tezacaftor-ivacaftor for clinical reasons.
3. Subjects who had sinus surgery within the last 6 months or will have sinus surgery during the study period.
4. Subjects who have had a recent pulmonary exacerbation or viral infection within two weeks of initial visit.