cyrilzakka/clinical-trials huggingface dataset:
MEAL TIMING Study: Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes

One in three American adults have prediabetes, and up to 70% of adults with prediabetes eventually develop type 2 diabetes. With the high cost of treating diabetes, cost-effective approaches are needed to reduce the incidence of diabetes. One new strategy may be to change when people eat. Studies in rodents suggest that a form of intermittent fasting that limits eating to a short time period each day and involves fasting for the rest of the day (time-restricted eating; TRE) improves blood sugar control and cardiovascular health. Preliminary studies suggest that TRE also improves blood sugar, weight loss, and cardiovascular health in humans. This study will be the first full-scale, controlled feeding trial to determine whether TRE can improve 24-hour blood sugar control, 24-hour blood pressure, and cardiovascular disease risk factors even when food intake is matched to the control group. This clinical trial will also determine whether the benefits of TRE depend on the time of day that people eat. Participants will be assigned to one of three groups: (1) 'Early TRE' (eat between \~8 am-3 pm), (2) 'Mid-day TRE' (eat between \~1 pm - 8 pm), or (3) Control Schedule (\~8 am - 8 pm) for 8 weeks. All food will be provided and matched between groups.


Eligibility Criteria:
Inclusion Criteria:

* Aged 30-70 years old
* Prediabetic as determined by HbA1c between 5.7-6.4% or fasting glucose between 100-125 mg/dl with HbA1c \>= 5.1%
* Fasting insulin less than 100.0 mU/l and, if HbA1c \<5.7%, must also have fasting insulin \>= 8.0 mU/l
* BMI between 30-60 kg/m\^2
* Wake up at a regular time between 5-8 am

Exclusion Criteria:

* Been diagnosed with diabetes or on diabetes medication or any medication known to affect glucose or 24-hour rhythms in blood pressure
* On weight loss medication
* Change in the dosage of a chronic medication within the past 2 months
* Have a clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)
* Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones
* Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise the participant's safety or data validity
* Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years
* Pregnant or breastfeeding
* Diagnosed psychiatric conditions
* Sleep disorder, circadian disorder, or regularly sleep less than 6 hours per night
* Major change in health or medical history in the past 3 months
* Currently perform overnight shift work
* Regularly eat within a \<10.5-hour period each day
* Lost or gained more than 4% of weight in the past 2 months
* Traveled more than 2 time zones away in the 2 months prior to enrolling in this study
* Will travel outside the Central time zone in the 2 weeks prior to testing
* Will travel more than 1 time zone away during this study
* Behavioral factors or other circumstances that may make it difficult for you to follow the study requirements
Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD

A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation.

A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral geographic atrophy (GA) age-related macular degeneration (AMD). All subjects will be assigned to HUCNS-SC transplantation. All subjects will be followed for efficacy and safety for 12 months. An independent data monitoring committee (IDMC) will review adverse events for the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

* GA associated with AMD in both eyes. Total area of GA determined by fundus autofluorescence.
* BCVA of 20/320 or better in each eye at screening assessment

Exclusion Criteria:

* Prior or concurrent choroidal neovascularization in either eye by clinical exam and/or fluorescein angiography as determined by the investigator or the reading center.
* Retinal or macular disease of any other cause in either eye.
* Diagnosis of glaucoma in either eye.
* Uncontrolled intraocular pressure in either eye
* Compromised renal function defined as eGFR \<60mL/min and urine protein-to-creatinine ration \>0.3 is spot urine collection.
* History of or active autoimmune disease.
* Previous organ, tissue or bone marrow transplantation.
* Seropositive for HIV, hepatitis B or C, or CMV IgM
Impact of Desflurane and Sevoflurane on Postoperative Delirium in Elderly Patients

Advanced age is a consistent risk factor for the incidence of postoperative cognitive decline, which is associated with longer hospital stays, decreased quality of life, and increased mortality. Anaesthetic drugs can also affect postoperative cognition, as their residual effects can alter central nervous system activity. Desflurane and sevoflurane are widely used volatile anesthetics. Choice anesthetics may influence the occurrence of postoperative delirium. However, evidence in this aspect is conflicting.

With increasing life expectancy, more and more patients aged 65 or older will receive general anesthesia. Rapid recovery from anesthesia may reduce the incidence of many postoperative complications, such as postoperative delirium and cognitive dysfunction. Using inhalational anesthetics is the mainstay of general anesthesia. Since they pass readily into the brain, anesthetics are usually recognized as the important cause of postoperative cognitive dysfunction. Studies have shown that inhalation anesthesia may increase the risk of postoperative delirium in elderly patients compared to propofol, but such studies mostly focus on isoflurane and sevoflurane. Concentrations isoflurane caused aggregation of amyloid peptides in cell cultures, indicating that they brought cytotoxicity to the brain; sevoflurane also showed the same cytotoxic effect. However, some studies showed that inhalational anesthetics had a protective effect on postoperative cognitive function. Desflurane is currently known to be the least biotransformation inhaled anesthetic, whose blood-gas partition coefficient is only 0.42. Desflurane is increasingly used in elderly patients in clinical practice. However, it is not clear whether general anesthesia maintained mainly by desflurane reduces postoperative delirium and early cognitive dysfunction compared with sevoflurane-based general anesthesia

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 65 years and \< 90 years;
2. Scheduled to undergo non-cardiac or non-neurosurgery with an expected duration of 2 hours or more, under general anesthesia;
3. Agree to participate, and give signed written informed consent.

Exclusion Criteria:

1. Preoperative history of schizophrenia, epilepsy, parkinsonism or any diseases of central nervous system;
2. Inability to communicate in the preoperative period (coma, dementia, language barrier, impaired hearing or vision);
3. Severe diseases in cardiovascular, respiratory, liver, kidney, or preoperative American Society of Anesthesiologists physical status classification ≥ IV;
4. Alcoholism and drug dependence;
5. Other reasons that are considered unsuitable for participation by the responsible surgeons or investigators (reasons must be recorded in the case report form).
Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy

Gabapentin is a nerve medication that treats pain. The specific aim of the study is to compare the difference in the postoperative use of no gabapentin, 300 mg gabapentin 3x daily, or 300 mg gabapentin once at night. Our hypothesis is that higher doses of gabapentin will correlate with decreased pain at the incision and chest tube sites and decreased opioid consumption.

The purpose of this study is to determine the effectiveness of various dosages of gabapentin, as part of an ERAS protocol, for postoperative analgesic control after open thoracotomy and additionally determine if there is a correlation of the dosage of gabapentin with pulmonary complication and impaired cognition postoperatively.

Given the widespread use of gabapentin and the huge variability in dosing, our study aims to simplify ERAS protocols for thoracotomy by figuring out the optimal dosing of gabapentin and whether its use overall decreases postoperative opioid consumption and complications.

The specific aim of the study is to compare the difference in the postoperative use of no gabapentin, 300 mg gabapentin 3x daily, or 300 mg gabapentin once at night.

Eligibility Criteria:
Inclusion criteria:

* Pt undergoing open thoracotomy at Indiana University Hospital
* ASA 1,2,3 or 4
* Age 18 or older, male or female

Exclusion criteria:

* History of substance abuse in the past 6 months which would include heroin, marijuana or any other illegal street drugs
* Patient on home dose of gabapentin or pregabalin
* Patient staying intubated after surgery
* Patient above 70yo
* Patient (home dose) taking more than 30mg PO morphine equivalent (PME) per day
* Known allergy or other contraindications to the study medications, which include gabapentin
* Patient unable to receive post-op epidural
* BMI above 40
* Creatinine clearance less than 30
Vaginal Dilator Therapy Among Women With Gynecologic and Breast Cancers Experiencing Dyspareunia

In this randomized controlled trial, the investigators will assess the difference in mean patient-reported pain scores and sexual function between women with gynecologic or breast cancers experiencing dyspareunia (painful intercourse) who are assigned to vaginal dilator use with vaginal moisturizer (Intervention Group, n = 29) compared to vaginal moisturizer alone (Control Group, n = 29) over 16 weeks.

Between 2012 and 2016, approximately 94,000 women were diagnosed with a gynecologic cancer annually and over 1.2 million women with breast cancer between 2013 and 2017. It is well known that gynecologic and breast cancers, and their treatments including surgery, adjuvant chemotherapy and endocrine therapy, and radiation, result in significant effects on the female reproductive system which can lead to sexual dysfunction. In the U.S., sexual dysfunction among gynecologic oncology patients has been reported to be as high as 90%, and over 70% among breast cancer patients. Patients who receive chemotherapy and/or endocrine therapy commonly experience dyspareunia, vaginal dryness, and challenges with desire and orgasm due to a low estrogen state. In fact, among patients with breast cancer, unaddressed sexual side effects from adjuvant endocrine therapy are one reason for early discontinuation. Hysterectomy and oophorectomy, including for ovarian cancer risk-reduction, can cause similar physical symptoms in addition to psychologic effects like anxiety related to sexual intercourse.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older
* English or Spanish speaking
* Patients currently or previously treated for:

  * Gynecologic cancer (surgery, chemotherapy, adjuvant vaginal brachytherapy)
  * Breast cancer (chemotherapy, aromatase inhibitors, or selective estrogen receptor modulators; surgical menopause)
* Current desire for penetrative sexual activity
* Endorsement of at least one of the following in the last 6 months:

  * Dyspareunia during penetrative sexual activity
  * Reported sensation of penetrative object (partner's penis, sex toy) not fitting in the vagina
  * Avoidance of penetrative sexual activity due to fear of pain
* Physically able to insert a vaginal dilator by themselves
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients with prior primary or upfront pelvic radiation
* Patients with whole pelvic radiation at any time
* Patients with a history of chronic pelvic pain
* Patients with vulvodynia as noted on baseline pelvic exam with \> 5/10 pain score during an external exam with a cotton swab
* Patients with prior vaginal dilator use for any indication
Hypothalamic Functional Magnetic Resonance Imaging (fMRI) Response to Nutrients

The purpose of this study is to identify how certain parts of the brain that control appetite respond to changes in dietary carbohydrate and fat.

To measure fMRI signal change in hypothalamic and brainstem centers associated with control of food intake and energy expenditure in response to IV glucose, fructose, and saline. The fMRI response to these nutrients will then be compared in obese vs. lean subjects. Frequently timed blood samples will be obtained for measurement of nutrients (i.e., glucose) and blood levels of other factors (i.e., insulin, ghrelin, lactate) during these infusion protocols, and to test associations between these levels and the fMRI response.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 year to 45 years of age
* BMI 18 to 25 kg/m2 (25 subjects) and 30 to 40 kg/m2 (25 subjects), matched for age and sex.
* At maximal lifetime weight.
* Weight stable for at least 3 months.

Exclusion Criteria:

* Those with a major medical illness or who require prescription medication, including: cancer, coronary artery disease, hypertension, and diabetes.
* Subjects taking psychiatric or centrally-acting (CNS) medications, or who are diagnosed with a psychiatric or neurological illness, including: depression, anorexia, bulimia, and seizure disorder.
* Subjects who have lost weight as a result of dieting, pharmacological treatment, or bariatric surgery.
* Weight \> 350 lbs or girth \> 60 inches (the limits of the MR machine)
* Exercise \> 30 minutes, 3 times a week.
* Alcohol consumption \> 2 drinks / day.
* Weight \> 300 lbs (150 kg) (weight limit for MR machine).
* Blood glucose \> 100 mg/dL, abnormal creatinine or liver function tests.
* Illicit drug use.
* Pregnancy.
* Extreme dietary habits as determined by a GCRC nutritionist: very high or low dietary carbohydrate, protein, or fat intakes.
* Those with a contraindication to exposure to strong magnetic fields: presence of metal in the body such as body piercing, shrapnel, cardiac pacemakers or aneurysm clips.
* Those with claustrophobia.
The Study to Compare the Cordis SMART™ Stent System With the Bard® Luminexx™ Stent

This study will look at the performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System for the treatment of TASC C \& D superficial femoral artery long lesions (up to 22 cm) in comparison with the Bard® Luminexx™ 6F Vascular Stent as determined by the primary patency rate at 6 and 12 months post procedure.

This is a German multi-center prospective, randomized, two-arm study evaluating performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System as compared to the C.R. Bard® Luminexx™ 6F Vascular Stent. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 200 patients will be entered into the study.

The study population will consist of approximately 200 symptomatic peripheral vascular disease patients with TASC C \& D SFA lesions. The disease will consist of symptomatic, long de novo or restenotic lesions (\> 70% stenosis) and occlusions (5 - 22 cm) on diagnostic imaging. The lesion must not extend into the distal SFA and the popliteal artery. At least one distal popliteal artery must be patent as well as one calf vessel. Reference vessel diameter must be \>= 4.0 to \<= 6.0 mm.

Trial participants will be randomized to the Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System or to the Bard® Luminexx™ 6F Vascular Stent.

Patients will be followed for twelve months post-procedure. Study examinations will be done at screening, procedure time, discharge, six, and twelve months post procedure.

This study will be conducted over up to 15 investigational sites in Germany.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic leg ischemia by Rutherford classification (category 2, 3, 4 or 5); duration of intermittent claudication (category 2-3) should be at least 3 months.
* One superficial femoral artery de novo or restenotic lesion (more than 70% stenosis or occlusions), with a lesion length of more than 5 to less than 22 cm.
* Patent popliteal artery on the index side, i.e., single vessel runoff or better with at least one of three vessels patent to the lower 1/3 of the calf prior to the day of the procedure.

Exclusion Criteria:

* Revascularisation involving the same limb within 30 days prior to the index procedure or a planned revascularisation within 30 days after the index procedure.
* Patients having total occlusions of the iliac artery on the same side must be excluded.
* Previously implanted stent(s) in the to be treated artery at the same site.
* Requiring stent placement in the distal superficial femoral artery and the popliteal artery.
Efficacy of Combination of Trastuzumab to Gemcitabine - Platinum Advanced or Metastatic Urothelial Carcinoma

A multicenter, randomized, Phase 2 trial to study the effectiveness and feasibility of association of trastuzumab with combination chemotherapy in advanced or metastatic bladder cancer patients. Combining monoclonal antibody therapy with combination chemotherapy may improve treatment efficacy on tumours overexpressed HER 2.


Eligibility Criteria:
Inclusion Criteria:

* Transitional cell carcinoma of the urothelium or bladder histologically proven stage IV AJCC \[locally advanced (T4b and / or N + M0) unresectable or metastatic (M1)\]
* Tumor and / or metastasis overexpressing HER2 immunohistochemistry (IHC 3 +) or IHC 2 + and FISH +. Centralized analysis.
* Measurable disease with at least one lesion with a diameter\> 2 cm for conventional methods (clinical examination, CT or MRI) or\> 1 cm for the helical scanner. In case of single metastasis, metastatic disease should be histologically proven
* Age ≥ 18 years and ≤80 years
* Life expectancy\> 3 months,
* Index performance status \<2 according to ECOG PS,
* No prior chemotherapy other than adjuvant and / or neoadjuvant chemotherapy, without Herceptin ® and complete for more than 6 months (naive to any previous chemotherapy in the metastatic setting)
* No radiotherapy within 4 weeks prior to inclusion,
* Normal cardiac function as measured by ejection fraction (LVEF\> 50%),
* Blood and liver satisfactory constants:

Hematological criteria: - Neutrophils\> 1.5 x 109 / L, - Chips\> 100 x 109 / L - Hemoglobin\> 10 g / dL, Liver function: - Alkaline phosphatase (unless bone metastases) \<2 x N - Total bilirubin \<1.5 x N - transaminases (AST, ALT) \<1.5 x N, renal Constants: - Creatinine clearance \> 30 ml / min (Cockcroft and Gault, cf. Annex XV protocol)

- Patient's written consent after full information.

Exclusion Criteria:

* Concurrent treatment with an experimental drug, participation in another clinical trial within \<30 days
* Patients previously treated with Herceptin ®, or another treatment targeting growth factors EGF (eg Iressa ®, Tarceva ®)
* Existence of a severe pulmonary disease, liver or kidney is likely to be exacerbated by the treatment,
* Other medical conditions: congestive heart failure or angina pectoris even if medically controlled failure, history of myocardial infarction before entering the trial, hypertension or uncontrolled arrhythmias, significant valvular disease,
* Patient with dyspnoea at rest or requiring oxygen therapy or with respiratory failure,
* Presence of a severe infection requiring antibiotics,
* Presence of CNS metastases or meningeal
* History of another malignancy uncured or cured for less than 5 years (except basal cell carcinoma, papillary thyroid carcinoma in situ of the cervix treated)
* Pregnant or lactating or not using effective contraception Women,
* For Cisplatin only: carrying a serious neurological disease, current events devices\> NCI grade 2 neuropathy, hearing loss, creatinine clearance \<60 ml / min, the patient can not support a patient hydration.
The Efficacy of Intravenous Immunoglobulin Therapy for Severe 2019-nCoV Infected Pneumonia

In this single-center, randomized, open-label, controlled study, the investigators will evaluate the efficacy and safety of Intravenous Immunoglobulin (IVIG) in combination with standard care for severe 2019 novel coronavirus (2019-nCoV) pneumonia.

In December 2019, viral pneumonia caused by a novel beta-coronavirus (2019-nCoV) outbroke in Wuhan, China. Part of patients rapidly progress severe acute respiratory failure with substantial mortality, making it imperative to develop an efficient treatment for severe 2019-nCoV pneumonia besides the supportive care.

Intravenous immunoglobulin (IVIG) has been shown to improve the treatment effect and prognosis of severe infection over the past decades with its capacity of proving passive immunity and anti-inflammatory, immunomodulatory effect. We hypothesized that IVIG therapy would improve the prognosis of severe and critically ill patients with 2019-nCoV.

This single-center, randomized, open-label, controlled trial will evaluate the efficacy and safety of IVIG therapy in patients with severe or critically ill 2019-nCoV respiratory disease.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged \>=18years old;
* Laboratory (RT-PCR) confirmed 2019-nCoV infection in throat swab and/or sputum and/or lower respiratory tract samples;
* The interval between the onset of symptoms and randomized is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used;
* Meet any of the following criteria for severe or critical ill conditions:

  1. Respiratory rate \>=30/min; or
  2. Rest SPO2\<=90%; or
  3. PaO2/FiO2\<=300mmHg; or
  4. Respiratory failure and needs mechanical ventilation; or
  5. Shock occurs; or
  6. Multiple organ failure and needs ICU monitoring;
* Sign the Informed Consent Form on a voluntary basis.

Exclusion Criteria:

* Exist of other evidences that can explain pneumonia including but not limited to:

influenza A virus, influenza B virus, bacterial pneumonia, fungal pneumonia, noninfectious causes, etc.;

* Allergy to Intravenous Immunoglobulin or its preparation components;
* Patients with selective IgA deficiency
* Women who are pregnant or breast-feeding;
* Researchers consider unsuitable.
Evaluation of the Accuracy and Precision of Flash Glucose Monitoring Sensors in Different Sites

On the first of July 2016, reimbursement for the Freestyle Libre Flash Glucose Monitoring (FGM) was introduced by the Belgian healthcare authority by means of a new diabetes convention. Making this the only way to receive the device in Belgium. Since then, many type 1 diabetes (T1D) patients switched to FGM. But some patients found the sensor on the upper arm too visible. Abbott does not recommend to place the sensor on a different place of the body than the back of the upper arm, because no tests were done yet (besides on the upper arm) to make an accuracy claim. With this study, we want to evaluate the accuracy and the precision of the Freestyle Libre FGM by using three FGM sensors simultaneously on different places of the body and perform regular self-monitoring of blood glucose (SMBG) tests.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of T1D for more than 6 months
* Adult patients ≥ 18 years
* Signed informed consent form

Exclusion Criteria:

* Pregnancy
* Patients with severe cognitive dysfunction or other disease which makes FGM use difficult.
* History of allergic reaction to any of the FGMs materials or adhesives when in contact with the skin.
* History of allergic reaction to chlorhexidine or alcohol anti-septic solution.
* Abnormal skin at the anticipated glucose sensor insertion sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
* Presence of concomitant pathology that might cause edema at the insertion sites (such as heart failure, liver failure, kidney failure defined as eGFR \< 45 ml/min).