cyrilzakka/clinical-trials huggingface dataset:
Mechanisms of Choroidal Blood Flow Changes During Dark/Light Transitions

There is evidence from a variety of animal studies that choroidal blood flow is under neural control. By contrast, only little information is available from human studies. Recent results indicate that a light/dark transition is associated with a short lasting reduction in choroidal blood flow. We have shown that during unilateral dark/light transition both eyes react with choroidal vasoconstriction strongly indicating a neural mechanism.

The present studies investigate this possibility by using pharmacological interventions. The pharmacological agents tested include a nitric oxide synthase inhibitor, an alpha-receptor agonist (as a control substance for the blood pressure increasing nitric oxide synthase inhibitor), a muscarinic receptor blocker, and a non-specific beta-blocker. These drugs were chosen on the basis of previous animal experiments, as the systems, which are specifically influenced by these substances, are likely involved in neural control of choroidal blood flow.


Eligibility Criteria:
Inclusion Criteria:

* Men aged between 19 and 35 years, nonsmokers
* Body mass index between 15th and 85th percentile (Must et al. 1991)
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropy \< 3 Dpt.

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term

The purpose of this study was to estimate the safety and efficacy of titrated oral misoprostol compared with vaginal route for labor induction at term.

Oral misoprostol absorption is more rapid and possible more predictable, with a peak serum concentration following oral administration of 34 minutes and a half-life of 20-40 minutes. Peak serum concentration for vaginal administration is 60-80 minutes, this level being sustained for up to four hours. Although the direct local effect of vaginal administration on cervical ripening may be advantageous, the shorter half-life of oral delivery may be beneficial in the event of uterine hyperstimulation.In order to avoid uterine hyperstimulation, it appears reasonable to suggest that oral misoprostol should be administered in small, frequent doses, titrated against the uterine response.

Eligibility Criteria:
Inclusion Criteria:

* 34 to 42 weeks of gestation
* live singleton
* Bishop score \< or = 6
* reassuring fetal heart beat pattern

Exclusion Criteria:

* nonreassuring fetal heart beat pattern
* parity ovr five
* any contraindication to labor and/or vaginal delivery
* uterine scar
* suspected placental abruption with abnormal FHR pattern
* vaginal bleeding other than "bloody show"
* cervical dilatation of \> or = 4 cm
* uterine contractions \> or = 3 in 10 minutes
* significant maternal cardiac, renal or hepatic disease
* hypersensitivity to misoprostol or prostaglandin analogs
Management of Postpartum Preeclampsia

The aim of this study is to assess the effect of a lower treatment threshold for antihypertensive medication and tighter blood pressure control, using remote blood pressure monitoring, on reducing Emergency Room visits for our postpartum patients with hypertensive disease.

The aim of this study is to assess the effect of lower treatment threshold for initiating antihypertensive medication and tighter blood pressure control, using remote blood pressure monitoring, on reducing Emergency Room visits for our postpartum patients with hypertensive disease.

The investigators will study and compare two cohorts of patients. The first is a retrospective cohort, including patients delivered at Robert Wood Johnson University Hospital and Cooperman Barnabas Medical Center. The second is a prospective cohort that will enroll patients immediately postpartum who are eligible for our treatment protocol.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hypertension, gestational hypertension, or preeclampsia.
* Delivery of a neonate after 20 weeks during their current hospitalization
* Able to consent
* 18 years old or above
* English or Spanish speaking
* Planning to follow up with a physician associated with Robert Wood Johnson University Hospital or Cooperman Barnabas Medical Center
* Ability to follow directions

Exclusion Criteria:

* Any medical condition that the providers feel is a contraindication to the MOPP algorithm.
* Planning to follow up with an outside institution.
* Unwillingness to take blood pressure at home.
Foot and Ankle Clinic Application for Liposomal Related Anesthetic

The purpose of this study is to review the use of surgeon applied liposomal release anesthetic (Exparel) for post operative analgesia.

Hypothesis: Surgeon applied use of liposomal related anesthetic provides excellent post operative analgesia. Immediated and 72 hour narcotic use will be significantly impacted by the use of this modality.


Eligibility Criteria:
Inclusion Criteria:

* Any patient scheduled for ankle arthrodesis, a tibiotalocalcaneal arthrodesis, hindfoot arthrodesis including subtalar, double, triple, or isolated talonavicular arthrodesis
* Patients over the age of 18
* The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study

Exclusion Criteria:

* \< 18 years of age
* Patients with a history of infection
* Patients diagnosed with neuropathy or any form of numbness or loss of feeling in the arms or legs due to damaged nerves
* Patients having surgery on both feet at the same time
* Patients having any other different type of foot and ankle surgery
MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis

The purpose of this study is to better characterize the fluctuations in multiple sclerosis symptoms and their relationship to medications, to length/extent of disease, and to a variety of physiologic measures.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old
* Live in the United States of America
* Read/write in English

Exclusion Criteria:

* None
An Extension Study of PEAK Trial

Double blind, three arm, comparative intervention trial for 24 weeks(PEAK study) with open label extension trial for 28 weeks followed by 2 year observational study.

PEAK trial is now undergoing (Multicenter, randomized, double blind, three-arm parallel group study to evaluate efficacy and safety of Alogliptin and Pioglitazone combination therapy on glucose control in type 2 diabetes subjects who have inadequate control with Metformin monotherapy in Korea, Takeda No. ALO-IIT-012).

Duration of combination treatment is 24 week in the PEAK trial. Long-term efficacy and safety of alogliptin + pioglitazone + metformin combination therapy is not defined in Korea yet.

Thus, extension of the PEAK trial for the longer treatment upto 1 year has been planned.

PEAK trial will be followed by another 28 week open-label treatment of the same drug as initial randomization (total duration of treatment as randomized 52 week), and followed by 2 year of observation.

During observation period, any antidiabetic medication can be added/changed when HbA1c of the subject is off target 7% with clinician's clinical decision.

After 3 years of initial randomization, durability of glucose control will be assessed between 3 treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Completed "ALO-IIT-012(PEAK study)", without major protocol deviations.
* Male, or female, 19 years to 75 years.
* Female with childbearing potential who has a negative urine pregnancy test result at study start and willing to continue practice appropriate birth control during the entire duration of study
* Subjects completed PEAK can be included within 30 days after End Of the Study
* Subjects completed PEAK can be included if their treatment is the same as randomized even after 30 days of End Of the Study.

Exclusion Criteria:

* eGFR(Epidermal growth factor receptor) \< 50mL/min
* AST(aspartate aminotransferase)/ALT(alanine aminotransaminase) \>2.5 upper limit of normal
* Pregnant or lactating women
* Subject who the investigator deems inappropriate to participate in this study
* Patients with a history of bladder cancer or patients with active bladder cancer
* Patients with uninvestigated macroscopic hematuria
* Patients with cardiac failure or a history of cardiac failure (New York Heart Association \[NYHA\] Stages 3 to 4)
* Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, since this study drug contains lactose
Bee Venom Acupuncture for the Treatment of Frozen Shoulder

The purpose of this study is to evaluate the effectiveness of combined bee venom acupuncture (BVA) and physiotherapy (PT) on frozen shoulder, and whether if the effect of BVA is dose effective.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of frozen shoulder by orthopedist
* Must have shoulder pain of more than VAS 5 over 1 month and under 12 months
* Marked limitation of active and/or passive motion range in one shoulder

Exclusion Criteria:

* history of major shoulder injury or surgery
* other musculoskeletal pain
* cervical neuropathy, paralysis, neurological disorder
* hypersensitivity reactions by bee venom skin test
* renal or hepatic disorders, hematologic diseases, cancer, mental disorders, inflammatory or infectious disorders
Glucose Uptake in Metabolic Tissues After Bariatric Surgery

The goal of this study is to provide a comprehensive evaluation of whole-body and tissue-specific glucose metabolism after consuming a mixed meal in lean people and people with obesity, before and after 20-35% weight loss induced by Roux-en-Y gastric bypass or sleeve gastrectomy surgery.

Obesity is associated with an impairment in postprandial glucose disposal, which is an important risk factor for type 2 diabetes (T2D). Weight loss improves postprandial glycemic control. The difficulty in achieving successful weight loss by using lifestyle therapy (diet and physical activity) has led to an increased interest in bariatric surgery, which is the most effective available weight loss therapy. Moreover, bariatric surgery procedures that bypass the upper gastrointestinal tract, such as Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG), have profound effects on glycemic control and cause remission in a large percentage of people with T2D. However, the effect of RYGB and SG surgery on postprandial glucose disposal among key metabolic organs has not been investigated and compared. The goal of this study is to provide a comprehensive evaluation of whole-body and tissue-specific glucose metabolism after consuming a mixed meal in lean people and people with obesity, before and after 20-35% weight loss induced by RYGB or SG surgery. Glucose uptake (GU) will be assessed by using: i) a combination of oral and intravenous stable isotopically-labeled glucose tracers to assess the delivery of ingested glucose into the systemic circulation and whole-body glucose disposal rate; and ii) positron emission tomography (PET) with magnetic resonance (MR) imaging to assess muscle, subcutaneous and visceral adipose tissue, liver, small intestine, and pancreas GU.

Eligibility Criteria:
Inclusion Criteria:

* BMI 35.0-50.0 kg/m2 for obese group and 18.5-24.9 kg/m2 for the lean group
* Must be scheduled for RYGB or SG surgery

Exclusion Criteria:

* Previous bariatric surgery
* Unstable weight (\>4% change during the last 2 months before entering the study)
* Significant organ system dysfunction (e.g., severe pulmonary or kidney disease)
* Cancer or cancer that has been in remission for \<5 years
* Conditions that render subject unable to complete all testing procedures (e.g. metal implants that interfere with imaging procedures; coagulation disorders)
* Use of medications that are known to affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued for this study
* Pregnant or lactating women
* Persons who are not able to grant voluntary informed consent
* Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits
Study of Ataluren (PTC124) in Cystic Fibrosis

The primary objective of this study is to determine the long-term safety and tolerability of ataluren in participants with nonsense mutation cystic fibrosis (nmCF) who completed participation in the double-blind study PTC124-GD-009-CF (NCT00803205), as assessed by adverse events and laboratory abnormalities. The secondary objective of this study includes the assessment of the efficacy of ataluren, as measured by forced expiratory volume in 1 second (FEV1) and pulmonary exacerbation rate, and other safety parameters (for example, 12-lead electrocardiogram \[ECG\] measurements, vital signs).


Eligibility Criteria:
Key Inclusion Criteria:

* Ability to provide written informed consent (parental/guardian consent and participant assent if less than \[\<\] 18 years of age).
* Evidence of completed participation in the double-blind study, PTC124-GD-009-CF (Study 009).
* Body weight greater than or equal to (≥) 16 kilograms (kg).
* Performance of a valid, reproducible spirometry test using the study-specific spirometer during the screening period.
* Confirmed laboratory values within the central laboratory ranges at screening.
* In male and female participants who are sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during the study drug administration and 60-day follow-up period.
* Willingness and ability to comply with all study procedures and assessments, including scheduled visits, drug administration plan, laboratory tests, and study restrictions.

Key Exclusion Criteria:

* Chronic use of systemic tobramycin within 4 weeks prior to screening.
* Evidence of pulmonary exacerbation or acute upper or lower respiratory tract infection (including viral illnesses) within 3 weeks prior to screening or between screening and randomization.
* Any change (initiation, change in type of drug, dose modification, schedule modification, interruption, discontinuation, or re-initiation) in a chronic treatment/prophylaxis regimen for CF or for CF-related conditions within 4 weeks prior to screening and randomization.
* Known hypersensitivity to any of the ingredients or excipients of the study drug.
* Exposure to another investigational drug within 4 weeks prior to screening.
* Treatment with intravenous antibiotics within 3 weeks prior to screening.
* History of solid organ or hematological transplantation.
* Ongoing immunosuppressive therapy (other than corticosteroids).
* Positive hepatitis B surface antigen, hepatitis C antibody test or human immunodeficiency virus (HIV) test.
* Known portal hypertension.
* Pregnancy or breast-feeding.
Percutaneous Minimal Invasive Pedicular Screw and Rod Insertion in Circumferential Lumbar Fusion

Convalescence after lumbar surgery is dependent on the extensiveness of the surgical procedure. Minimal invasive techniques in lumbar spine surgery are reported to achieve excellent clinical results with less pain, morbidity and disability.

To achieve lumbar fusion when there is no need for decompression of the neural structures a posterior midline approach and a left anterior retroperitoneal approach is used. The retroperitoneal anterior approach to the lumbar spine offers some benefits compared with the posterior approach. Dural injury and epidural scarring can be avoided, and an interbody fusion graft can be placed with minimal risk to the nerve roots. However, the extensive posterior midline approach with extensive muscle dissection is necessary to place the pedicular screws.

A report of a follow-up period of 2 years of a randomized trial of minimal invasive insertion of pedicular screws and rods in lumbar fusion.

Eligibility Criteria:
Inclusion criteria:

* Degenerative disc disease in one of the three lower lumbar levels.

Exclusion criteria:

* Previous fusion, metabolic bone disease, co-morbidity or psychological instability.
Veterans Coordinated Community Care (3C) Study

Veterans Coordinated Community Care (3C) Study will recruit 850 Veterans at risk for suicide post inpatient hospitalization. Each participant will be randomly assigned to treatment as usual (TAU) or TAU plus the Coping Long Term with Active Suicide Program (CLASP), with follow-up for 6 months after discharge. Outcomes include suicide-related behaviors (including deaths due to suicide, opioid overdose, or other substance-related accidents; and nonfatal suicide attempts) and suicidal ideation and functioning.

Suicide is a problem of great public health importance. The great majority of suicides occur among people with psychiatric disorders, and among psychiatric patients, those recently discharged from psychiatric hospitalization have highest suicide risk. Intensive post-discharge case management programs have been shown to reduce post-discharge suicides, but the rarity of these events even among recently-hospitalized patients makes it infeasible to argue for universal implementation of intensive post-discharge case management. Researchers propose to address this problem by carrying out a pragmatic trial among psychiatric inpatients in the Veterans Health Administration (VHA) healthcare system judged to be at high risk of post-discharge suicide (based on a validated prediction model). Researchers will evaluate the effects of a scalable remote post-discharge moderate intensity adjunctive intervention, the Coping Long Term with Active Suicide Program (CLASP), and carry out a heterogeneity of treatment effects (HTE) analysis to determine how these effects vary as a function of patient characteristics and features of the post-discharge treatment environment. Patients in the CLASP treatment will be asked to nominate a significant other (SO) to participate in the program with them. SO participation is optional. The aim of this research is to conduct a multi-site randomized controlled trial (N=850) of the CLASP intervention compared to treatment as usual for Veterans at risk for suicide post inpatient hospitalization. Assessments will occur at baseline and 6 months post discharge. Medical, administrative, and vital records will be obtained for each participant. The primary outcome of this study will be post-discharge suicide-related behaviors (including deaths due to suicide, opioid overdose, or other substance-related accidents; and nonfatal suicide attempts) in the 6 months post-discharge. Researchers will also evaluate secondary outcomes involving patient suicidal ideation and functioning.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient Veteran at high-risk for post-discharge suicide (as flagged by the study's validated prediction model)
* 18 years or older
* Access to a telephone after discharge.

Exclusion Criteria:

* Impaired decision-making capacity
* Limited or no English language proficiency
* Terminal illness
PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

The objective of current protocol is try improve the results of chemotherapy treatment in patients with ALL wich is not indicated the peripheral stem cell transplant in first remission, with an intensive consolidation follow by re-inductions.

Induction therapy:

Patients with standard risk receive vincristine (1,5 mg/m2)IV on days 1, 8, 15 and 22;daunorubicin (30 mg/m2)IV on days 1, 8, 15 and 22; oral or IV prednisone 60 mg/m2/day, days 1 to 27 and 30 mg/m2/day, days 28 to 35;asparaginase 10.000 UI/m2 IM or IV, days 10 to 12, 17 to 19 and 24 to 26;cyclophosphamide (500 mg/m2)IV days 1, 2 and 29; methotrexate, cytosine arabinoside and hydrocortisone, days 1 to 22.

Patients older than 55 years are not treated with asparaginase and cyclophosphamide.

Consolidation therapy (1):

Standard risk: Mercaptopurine 50 mg/m2, PO, days 1 to 7, 28-35 and 56-63; methotrexate (3g/m2)IV/24 hours, day 1, 28 and 56; VM-26 (150 mg/m2)/12 hours, IV, days 14 and 42; ARA-C (500 mg/m2)/12 hours, IV days 14-15 and 42-43; intrathecally treatment, days 1, 28 and 56.

Patients over 50 years: Mercaptopurine (50 mg/m2), PO, days 1 to 7, 28-35 and 56-63;methotrexate (1,5 g/m2) IV/24 hours, day 1, 28 and 56; VM-26 (150 mg/m2)/12 hours, IV days 14 and 42; ARA-C (500 mg/m2)/12 hours, IV days 14-15 and 42-43; intrathecally treatment, days 1, 28 and 56.

Consolidation therapy (2)/Reinduction: one cycle similar to induction. It starts one week after last dose of mercaptopurine.Dexamethasone 10 mg/m2/day,PO or IV, days 1-14 and 5 mg/m2/day, PO or IV days 15-21; VCR: 1,5 mg/m2 IV, days 1, 8 and 15; Daunorubicin 30 mg/m2 IV, days 1, 2, 8 and 9; cyclophosphamide 600 mg/m2/day IV, days 1 and 15; Asparaginase: 10.000 UI/m2 IM or IV, days 1-3 and 15-17;intrathecally treatment days 1 and 15

Maintenance therapy 1:administration of continuous chemotherapy (mercaptopurine and methotrexate) and reinductions until one year from diagnosis.

* Continuous chemotherapy:

  * MP 50 mg/m2/day PO
  * MTX 20 mg/m2/week IM
* Reinductions

  * VCR: 1,5 mg/m2 IV, day 1.
  * PDN: 60 mg/m2/day, IV or PO days 1 to 7
  * L-ASA: 20.000 UI/m2, IM or IV day 1.
  * Intrathecally day 1

Seven cycles, weeks 25, 29, 33, 37, 41, 45 and 49.

Maintenance therapy 2:administration of continuous chemotherapy (mercaptopurine and methotrexate) while second year from diagnosis (weeks 53 to 104).

* MP 50 mg/m2/day, PO
* MTX 20 mg/m2/week, IM.

Eligibility Criteria:
Inclusion Criteria:

* Adults (over 15 years) with ALL standard risk no prior antiblastic chemotherapy

Exclusion Criteria:

* Mature B-ALL (FABL3) or with cytogenetic ALL "Burkitt-like" alterations (t\[8;14\], t\[2;8\], t\[8;22\])
* Mixed forms of ALL
* Acute Leukemia no differentiate
* Patients with coronary disorders, valvular or hypertensive cardiopathy
* Patients with chronic liver disorders
* Chronic pulmonary disorders
* Renal insufficiency
* Neurologic disfunctions
* ECOG 3 and 4
* No signed consent form