cyrilzakka/clinical-trials huggingface dataset:
Orelabrutinib Followed by Response-adapted Ultra-low Dose 4Gy Radiation as First-line Treatment of MALT Lymphoma

Investigate the efficacy and safety of Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation in the treatment of local-stage MALT lymphoma

This prospective, multicenter trial is trying to evaluate the efficacy and safety of Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation as first-line treatment of local-stage mucosa associated lymphoid tissue extranodal marginal zone lymphoma

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Histologically confirmed mucosa-associated lymphoid tissue (MALT) lymphoma
* Lugano stage I-II
* ECOG 0-2
* Signed informed consent
* Having sufficient organ function: a) Hematopoietic function: Neutrophils ≥ 1.0 × 109/L, PLT ≥ 50 × 109/L, Hb ≥ 80g/L; b) Liver function: bilirubin ≤1.5 times the upper limit of normal (ULN), ALT and AST\<3 x ULN, serum albumin ≥ 30 g/L; c) Renal function: serum Cr\<1.5 × ULN, creatinine clearance rate ≥ 50mL/min (calculated according to the standard Cockcroft Gault formula, if renal dysfunction is caused by tumor compression, creatinine clearance rate ≥ 30mL/min); d) Coagulation function (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant therapy at the time of screening): International standardized ratio (INR) ≤ 1.5 x ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.

Exclusion Criteria:

* Recent major surgery (within 4 weeks prior to enrollment), except for diagnostic surgery
* Have uncontrolled intercurrent diseases (cardiovascular and cerebrovascular diseases, coagulation disorders, severe infectious diseases) including but not limited to: severe acute or chronic infection requiring systemic treatment, symptomatic congestive heart failure (NYHA III-IV) or symptomatic or poorly controlled arrhythmias, arterial hypertension (systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥100mmHg) that is not controlled even with standard treatment, unstable angina, active peptic ulcer or bleeding disorder;
* Severe concomitant diseases that interfere with treatment
* Active interstitial pneumonia
* Active chronic hepatitis B infection (defined as HBV DNA positive; patients with latent or prior hepatitis B infection (defined as positive for hepatitis B surface antigen or hepatitis B core total antibody) can be included if HBV-DNA is undetectable at screening. The above-mentioned patients must voluntarily undergo regular DNA tests and receive appropriate antiviral therapy as prescribed)
* Positive hepatitis C test result (for patients who are positive for HCV antibodies, only polymerase chain reaction (PCR) shows a negative HCV RNA can participate)
* Patients with active HIV and syphilis infections;
* Pregnant or lactating women
* Patients with multiple factors affecting oral medication (such as dysphagia, nausea, vomiting, chronic diarrhea, and intestinal obstruction)
* The researcher determined that patients are not suitable to participate in this study.
Effect of Montelukast Therapy in Obstructive Sleep Apnea(OSA) Children

The investigators leading hypotheses are:

* Oral therapy with montelukast may lead to improved sleep study findings in children with mild to moderate Obstructive Sleep Apnea Syndrome (OSAS) who require surgical removal of adenoids and tonsils for OSAS.
* A significant proportion of the children with OSAS treated with montelukast will show reduced severity of OSAS, and this will remove the need for surgical intervention.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for inclusion in the study will be symptomatic snoring children \>2 years of age and \< 10 years of age, who snore and have an apnea hypopnea index (AHI) \>2/hrTST (hour total sleep time), and in whom T\&A is therefore contemplated. Also among these, we will include children referred for evaluation for snoring who have a history of allergic rhinitis.

Exclusion Criteria:

* Exclusion criteria will include: Hypersensitivity to montelukast, immunodeficiency or immunosuppressant therapy, craniofacial, neuromuscular, syndromic or defined genetic abnormalities, acute upper respiratory tract infection, systemic corticosteroid therapy or antibiotic therapy in the 2 weeks previous to the study, and children who already had adenotonsillectomy. In addition, children chronically receiving oral antihistamine preparations or nasal decongestants will be required to continue using these medications throughout the duration of the study. Patients receiving immunotherapy will continue on the same regimen without escalation of dose and frequency throughout the duration of the study. In addition, patients with severe OSA who in the opinion of their treating physicians require early surgical intervention for their OSA will be excluded from eligibility to the study.
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09

JY09 is a glucagon-like peptide-1 (GLP-1) mimetic generated by genetic fusion of a Exendin-4 dimer to human immunoglobulin Fc.

In this Double-blind, randomized, placebo-controlled trial, 41 healthy subjects received placebo or escalating doses of JY09 on day 1 in the first cohort, and on days 1 and 22 in the following sequential cohort 2-4, and on days 1, 15, and 30 in the cohort 5: cohort 1: 0.3 mg; cohort 2: 0.3 + 0.7 mg; cohort 3: 0.7+1.5 mg; cohort 4: 0.7+3.0 mg; and cohort 5: 0.7 + 1.5 + 6.0 mg. The primary endpoints were the incidence of adverse events and serious adverse events related to JY09. Secondary endpoints included pharmacodynamics and pharmacokinetics parameters, as well as anti-JY09 antibody incidence and titers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Male's mass is ≥50 kg, female's mass is ≥45 kg, have a body mass index between 18 and 26 kg/m\^2
* Subjects or their legal representative signed informed consent
* agree to use instruments of contraception from the time of the first dose until 6 months after the last dose of investigational drug, avoid pregnancy make yourself or your mate
* Able to keep good communication with investigator and comply with the requirements of the clinical trials

Exclusion Criteria:

* Smokers,quitting time less than 3 months , or can't quit smoking during the trial
* Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing,or being treated for a direct lower gastrointestinal or using steroids
* Participation in any clinical investigation within 3 months prior to dosing
* Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing
* Significant illness within 2 weeks prior to dosing,and investigator judge doesn't fit to participate in this trial
* A history of clinical significance of abnormal ECG
* A history of diabetes, hyperuricemia and hyperlipidemia
* A history of acute or chronic bronchial spasms
* Have clinical significant gastrointestinal diseases
* Have serious, progressive, or uncontrolled organ or system diseases
* Abuse of drug or alcohol within 12 months before first dosing
* People who are pregnant, nursing mothers, or in the near future plan to be pregnant,or show pregnancy test positive before into group
* Subjects who, in the opinion of the investigator, are in any way unsuitable to participate in the study
Eating Behaviors in Shift Workers

This study will compare eating behaviors and measures of hunger and fullness between day and night workers in order to better understand why night workers are at increased risk for obesity and related diseases.


Eligibility Criteria:
Inclusion Criteria:

* Work \~ 8-hour shifts during day or night on 3 or more consecutive days of the week
* BMI 19-35 kg/m\^2
* Age 20-55 years of age
* Metabolically healthy
* Weight stable over previous 3 months
* Lives in New York City area

Exclusion Criteria:

* Pregnant or less than 1 year postpartum at time of study
* Smoking
* History of drug or alcohol abuse
* Rotating shift work
* Habitual sleep duration of more than 6 hour per night
* Obstructive sleep apnea
* Transmeridian travel
* Type 2 diabetes
* Cardiovascular disease
* Hypertension
* Participation in diet or weight loss program in the 3 months prior to enrollment
* Psychiatric or sleep disorder
* Food allergies or intolerances
* Dislike of or unwillingness to eat test foods
A Study of Quantitative Assessments of Angle Width in Chinese Patients With Open-angle Glaucoma and/or Ocular Hypertension

This study will assess angle width in Chinese patients with Open-angle Glaucoma and/or Ocular Hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Of Chinese descent
* Open-angle Glaucoma or Ocular Hypertension in each eye

Exclusion Criteria:

* History of a narrow-angle or angle closure glaucoma
* Angle abnormalities in either eye
Prevalence of Polycystic Ovary Syndrome (PCOS) in Obese Premenopausal Women

Between 40% and 85% of women with Polycystic Ovary Syndrome (PCOS) are overweight or obese and obesity is closely linked to the development of PCOS. Although it is well established that obesity increases the severity of the clinical features of PCOS, data regarding the prevalence of PCOS in obese women and the change in body weight in women with PCOS over time are scares. In a prevalence study it was investigated whether obesity increases the risk of PCOS in the general population and they demonstrated that the prevalence rate of PCOS in underweight, normal-weight, overweight, and obese women were 8.2, 9.8, 9.9, and 9.0%, respectively, similar to that observed in the general population. These results suggest that the risk of PCOS is only minimally increased with obesity. On the other hand, in a Spanish prevalence study among overweight and obese subjects, they demonstrated a 28.3% prevalence of PCOS, which is markedly higher compared with the 5.5% prevalence of PCOS in lean women in Spain.

First the investigators aim to estimate the prevalence/probability of PCOS among obese, premenopausal women (between 18 and 50 years) with no symptoms of classic menopausal symptoms in Sweden. Secondly, to elucidate whether women diagnosed with PCOS respond to standard weight reduction regime to the same extent as women without PCOS.


Eligibility Criteria:
Inclusion Criteria:

PCOS diagnostic criteria should be the presence of both clinical and/or biochemical hyperandrogenism and/or oligo-/amenorrhea and/or polycystic ovaries (PCO).

Exclusion Criteria:

1. Exclusion of other endocrine disorders such as hyperprolactinemia (s-prolactin \< 27µg/L), nonclassic congenital adrenal hyperplasia (17-hydroxyprogesterone \< 3nmol/L), and androgen secreting tumors.
2. Pregnancy or breastfeeding the last 6 months.
3. Any sign of climacteric symptoms.
4. Language barrier or disabled person with reduced ability to understand information.
5. Oral contraceptives and insulin sensitizing agents is commonly used among women with PCOS since it may interfere with hormone profile. As the prevalence of PCOS can be assumed to be increased among women using oral contraceptives and insulin sensitizing agents, they are included but analyzed separately.
Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women

Depomed's Gabapentin Extended Release is an investigational, extended release formulation of Gabapentin that is being studied for the treatment of Hot Flashes/Hot Flushes in postmenopausal women

The primary study objective is to assess the efficacy of G-ER dosed at 1800mg daily (600mg AM, 1200mg PM), compared to placebo in reducing the average daily frequency and severity score of moderate to severe hot flashes in postmenopausal women at weeks 4 \& 12 of the efficacy treatment period, compared with baseline.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, postmenopausal women who seek treatment for hot flashes
* Patients using hormone replacement therapy(HRT) must be willing to discontinue treatment
* Patients must be experiencing moderate to severe hot flashes
* Patients must be able to sign the informed consent
* Patients must be able to enter simple commands and complete questionnaires on the frequency and severity of their hot flashes using an electronic diary

Other inclusions apply.

Exclusion Criteria:

* Patients with hypersensitivity to Gabapentin
* Patients with severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss
* Patients treated with estrogen pellets or injectable progestin drug therapy within 6 months.
* Patients currently treated with Gabapentin or Pregabalin for any indication, including vasomotor symptoms

Other exclusions apply.
Thymoglobulin in Cadaver Donor

To determine the efficacy and Security of Thymoglobuline in cadaveric donor Efficacy: To demonstrate that in cadaveric donor, Thymoglobuline diminished graft alloreactivity by decreasing expression of inflammatory markers in graft biopsies Security:To demonstrate that the administration of Thymoglobulin does not have side effects in renal recipients.

This is randomized controlled Multicenter phase II clinical trial promoted by members from IdiPAZ. At least two hospital (La Paz and Santa Maria from Lisbon, will be involved. A per nature pilot study will recruit 10 cadaver donors from each hospital, and randomized half-to-half per center, for study and control groups.

The RCT initiated in 2009 and finished in 2013.

Cadaver donor from the study group will receive 3 mg/kg iv. Thymoglobulin 3-6 hours prior to organ procurement. The randomization process recruits 1:1 study/control donors.

Kidney biopsies will be taken from each kidney before transplantation to examine the expression of pro-inflammatory and HLA molecules (anti-DR, VCAM, ICAM, E-selectin) at tubular cells by immunohistochemical techniques under blinded conditions.

Recipients will be managed as usual and expressly followed up for one year, recording the incidence of delayed graft function and rejection and graft survival at the first year.

A comparison between the results obtained in kidney biopsies and patients transplanted in each group will permit differentiate whether Thymoglobulin administered in cadaver modifies the expression of antigens by kidney tubular cells and the results obtained with transplantation, in terms of graft function, rejection and survival.

Eligibility Criteria:
Inclusion Criteria:

* Accepted adults cadaveric donors for renal transplant from University Hospital La Paz( Madrid) and from University Hospital Santa Maria (Lisbon)
* Informed consent from relatives for including in the study

Exclusion Criteria:

* Known allergy to the rabbit proteins
* Non accepted grafts
* Family refusal to consent
Hereditary Tubulointerstitial Nephritis

The aim of this study is to identify families with hereditary chronic tubulointerstitial renal diseases , characterize the phenotype and screen for mutations in known genesis (UMOD, REN, TCF2, NPHP1). Genome wide analysis will be performed in families without mutations identified.

* Inclusion of affected subjects with familial history of chronic renal failure, early gout ,renal cysts in several hospital in France
* Characterization of the phenotype; dosage of the urinary uromodulin in all subjects
* Collect DNA samples
* Screen for UMO mutations first
* Then for REN or TCF2 depending on the phenotype
* Validate the use of the dosage of urinary uromodulin for the diagnosis of UMOD associated disease.
* Identify new genes responsible for hereditary HTIN (Hereditary Tubulointerstitial Nephritis).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* HTIN of unknown cause
* Chronic renal failure defined by a eGFR (estimated Glomerular Filtration Rate) estimated according to MDRD (Modification of the Diet in Renal Disease) \< 60ml / min / 1,73m2.
* At least two siblings affected by gout before 40 years or by chronic renal failure.
* Affiliated or benefiting from a national insurance
* Signature of the enlightened consent.

Exclusion Criteria:

* Endstage renal failure before the age of 18 years in all affected subjects of the family.
* Microscopic or macroscopic persistent hematuria, or proteinuria \> 1gramme / 24hours.
* Other potential cause of TIN (Tubulointerstitial Nephritis): pyelonephritis, drug toxicity.
* High blood pressure known for more than 10 years before the discovery of the renal disease.
* Major cardiovascular before the discovery of the renal disease.
* Chronic auto-immune or infectious disease.
* Polycystic kidney disease with increased of the size of the kidneys
An Evaluation of Virtual Psychiatric Transition of Care Offered in Behavioral Health

The primary objective is to evaluate the effectiveness of a post inpatient discharge virtual psychiatric care team compared to standard care, to reduce 30-day all cause non-elective acute care utilization (Emergency Department (ED), observation, and inpatient encounters).

The foundational idea for the Virtual Psychiatric Transition of Care (VPTC) program came from the Atrium Health Hospital at Home care model which has garnered wide acclaim and financial support in the acute care world. A behavioral health care team comprised of licensed clinicians (Behavioral Health Professionals), health coaches, a consulting psychiatric pharmacist and psychiatric providers follow patients for 45 days or more depending on patient need after their acute care encounter. Patient enrolled in the VPTC program will receive the following core components: Introduction to the patient follow-up process, psychosocial assessment, tracking and treatment recommendations for (residential movement, nutrition, sleep hygiene, stress management, pain management, perinatal/postpartum mood disorders, substance abuse), tracking and treatment recommendations for behavioral health symptoms (depression, anxiety, suicidal ideation, etc.), placement into an appropriate case management program if needed, navigation to additional psychiatric or substance use services if needed, and motivational interviewing and brief therapeutic recommendations if needed.

For patients that have attempted suicide, they will begin the VPTC program following the zero suicide pathway. The Atrium Health Behavioral Health Service Line created the 'Zero Suicide pathway', in 2019 for those patients identified as "high risk" for suicide when leaving inpatient units. Zero Suicide is a national movement sponsored by the 2012 National Strategy for Suicide Prevention, National Alliance for Suicide Prevention, Suicide Prevention Resource Center and the Substance Abuse and Mental Health Services Administration (SAMHSA). It is a programmatic approach to keep patients from falling through the cracks in a fragmented and disconnected healthcare system and is based on the belief that suicide is preventable, and suicide deaths are not fated. Since access to mental health services is constrained in our community, patients often fall through the cracks when transitioning between points of care.

Eligibility Criteria:
Inclusion Criteria:

* Residency or shelter in North Carolina
* 18 years of age or older on the day of discharge
* Access virtual care (phone/video)
* Discharged from a behavioral health hospital or a behavioral health unit

Exclusion Criteria:

* None
Acute Exercise on Brain Insulin Sensitivity

Dementia is a leading cause of death in the United States among aging adults. Brain insulin resistance has emerged as a pathologic factor affecting memory, executive function as well as systemic glucose control. Regular aerobic exercise decreases Alzheimer's Disease (AD) risk, in part, through changes in brain structure and function. However, there is limited data available on how exercise impacts brain insulin resistance in aging. This study will test the effect of acute exercise on brain insulin sensitivity in middle-aged to older adults. The study will also examine cognition and cardiometabolic health in relation to brain insulin sensitivity.

Obesity, hypertension, high blood glucose (e.g. prediabetes/type 2 diabetes), and physical inactivity is thought to worsen brain insulin resistance and reduce cerebral blood flow. This suggests lifestyle approaches may be necessary to counteract declines in brain health. Regular aerobic exercise decreases Alzheimer's Disease (AD) risk, in part, through changes in brain structure and function. Moreover, exercise-related structural changes in the brain, namely increased hippocampal volume, is linked to improved memory. However, there is limited data available on how exercise impacts brain insulin resistance in aging. It is also unclear if one bout of exercise may help improve brain insulin responses to insulin before fitness gains or weight loss in people at risk for dementia, type 2 diabetes and cardiovascular disease. Because single bouts of exercise are established to improve metabolic and vascular insulin sensitivity in people with obesity, the investigators anticipate exercise to raise brain insulin sensitivity in relation to cognition and cardiometabolic health.

Eligibility Criteria:
Inclusion Criteria:

* Male or female \>40 and \<80 years old.
* Has a body mass index \>25 and \<45 kg/m2.
* Physical Activity (\<150 min of moderate/high intensity exercise per week)

Exclusion Criteria:

* Subjects who have not been weight stable (\>2 kg weight change in past 3 months)
* Subjects who are smokers or who have quit smoking \<1 years ago
* Subjects with abnormal estimated glomerular filtration rate (eGFR).
* Hypertriglyceridemic (\>400 mg/dl) and hypercholesterolemic (\>260 mg/dl) subjects
* Hypertensive (\>160/100 mmHg)
* Subjects with a history of significant metabolic, cardiac, congestive heart failure, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or cancer that in the investigator's opinion would interfere with or alter the outcome measures or impact subject safety.
* Pregnant (as evidenced by positive urine pregnancy test) or nursing women
* Subjects with contraindications to participation in an exercise
* Current Pregnancy
* Currently taking active weight suppression medication (e.g. phentermine, orlistat, lorcaserin, naltrexone-bupropion in combination, liraglutide, benzphetamine, diethylpropion, phendimetrazine)
* Subjects currently taking medications that affect heart rate and rhythm (i.e. Ca++ channel blockers, nitrates, alpha- or beta-blockers).
* Known contraindications for MRI imaging
Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting or Switching to Biphasic Insulin Aspart 30 Treatment

This study is conducted in Europe. The aim of this study is to investigate safety and efficacy in subjects with type 2 diabetes mellitus starting or switching to biphasic insulin aspart 30 (NovoMix® 30) treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes