cyrilzakka/clinical-trials huggingface dataset:
Stable Sleep Pattern Before Sleep Loss

Sleep is now recognized as important for disease prevention. Too little or too much sleep contributes to cardiovascular disease. Leading health organizations recommend adults sleep 7-9 hours per night for optimal health. This recommendation is based on research that finds reductions in sleep duration elevate blood pressure and impair vasodilation of blood vessels. One question raised in a recent NIH Workshop report (PMID:36448463) is whether stable sleep patterns, irrespective of a person's sleep duration, could mitigate the adverse effects of insufficient sleep on vascular function. This project will address this question in midlife adults using a randomized, crossover designed study.

Purpose and hypothesis The aim of this study will be to test the hypothesis that stable sleep, as defined by a consistent (low variability) bedtime and wake-time schedule, will diminish the negative effect of sleep deprivation on vascular function.

Study design and procedures Thirty adults (15 men, 15 women) will complete a 6-week study that will involve five study visits. The first visit will include informed consent, collection of demographic data, sleep- and health-related surveys, and familiarization with study procedures. Participants will then be block randomized to either habitual sleep followed by stable sleep, or stable sleep followed by habitual sleep - each sleep condition will lasts two weeks. In the habitual sleep condition, participants will be asked to follow their normal routine without concern about their sleep duration. In the stable sleep condition, participants will be asked to keep the same bedtime and wake-time schedule without deviation. Bedtime and wake-times will be determined by the researchers, but individualized for each participant so that their usual sleep duration (based on self-report) is met. Sleep will be monitored throughout the study using research-grade motion sensors worn at the wrist. Resting blood pressure, blood vessel vasodilatory function, and cardiovascular responses to exercise will be our main outcome variables. These variables will be measured before (on day #13) and after (on day #14) one night of sleep deprivation. Total sleep deprivation is a well-established experimental model to understand the acute effects of insufficient sleep on vascular function in humans.

Eligibility Criteria:
Inclusion Criteria:

* Women and men
* 35-64 years of age

Exclusion Criteria:

* obese based on BMI \>29 kg/m2
* night-shift work
* prior diagnosis of sleep apnea
* signs of insomnia using the Insomnia Symptom Questionnaire
* a 'poor sleeper' (global score ≥5) based on the Pittsburgh Sleep Quality Index
* taking medications that alter sleep
* personal history of stroke, coronary heart disease, diabetes mellitus
* taking antihypertensive medications
* smoker (including vaping)
Efficacy Study of Oral Seliciclib to Treat Non-Small Cell Lung Cancer

A phase 2 study to evaluate efficacy of oral seliciclib in treating non-small cell lung cancer (NSCLC).

A randomized Phase II study of an experimental anti-cancer drug called seliciclib with objectives of evaluating safety and efficacy in patients with non-small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with histologically-confirmed recurrent non-small cell lung cancer have had at least two prior systemic treatment regimens
* Must have measurable disease according to RECIST
* Eastern Cooperative Oncology Group performance status 0-1
* Adequate bone marrow, hepatic and renal function
* Ability to swallow capsules
* At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, at least 7 days from prior radiation therapy and have recovered from prior toxicities
* At least 3 weeks from major surgery

Exclusion Criteria:

* Non-small cell cancer histology contains a component of small cell lung cancer
* Previously untreated CNS metastasis or progressive CNS metastasis
* Prior treatment with a CDK inhibitor
* Currently receiving radiotherapy, biological therapy, or any other investigational therapy
* Uncontrolled intercurrent illness
* Having other cancers that have been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer or basal cell skin cancer
* Pregnant or lactating women
* Known to be HIV-positive
* Active hepatitis B and/or hepatitis C infection
Analgesic Efficacy of Surgeon-administered Transversus Abdominis Plane Blocks for Caesarean Section.

The purpose of this research study is to evaluate whether or not adding a Transversus Abdominis Plane Block (TAP block) improves pain control for patients having a cesarean section. A TAP block is a type of nerve block where at the end of the surgery an injection of a long acting local anesthetic is made into the abdominal wall. In studies in patient's having other abdominal surgeries this has reduced the amount of narcotics patients need for pain control. This may also led to patients being more active after surgery and maybe spending less time in hospital.

Randomized clinical trial of Transversus Abdominis Plane Block (TAP block) at Cesarean Section.

Eligibility Criteria:
Inclusion Criteria:

* ASA status II to III
* All patients undergoing elective CS under regional anesthesia at any gestational age.

Exclusion Criteria:

* - Known drug allergy to local anesthetics
* Planned general anesthetic
* NSAID use contraindicated post partum
* Chronic pain disorder or chronic narcotic use/dependence
* Planned vertical abdominal incision
* Planned Cesarean Hysterectomy.
* Placenta Previa or suspected Placenta Accreta
AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects

Phase 1, open label, single dose, 3 way crossover study to evaluate the bioavailability of a solid dose formulation of PF 04965842 relative to a suspension formulation under fasting conditions and the effect of food on the bioavailability of the solid dosage formulation of PF 04965842 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Subjects who received within 7 days prior to the first dose of study medication or are likely to receive during the study any moderate strong inhibitors of CYP3A4, eg, itraconazole, erythromycin, ketoconazole, protease inhibitors, verapamil, or diltiazem.
* Subjects who received within 28 days or are likely to receive during the study inducers of CYP3A4, eg rifampin.
Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Volunteers Under Fasted Condition

An open-label, randomized, two-period, two-group, crossover study was conducted in 26 healthy Chinese volunteers under fasted conditions to assess the bioequivalence between two formulations of Anastrozole.

Anastrozole is currently used as first-line treatment in locally advanced or metastatic breast cancer. A generic anastrozole tablet was developed to offer an alternative to the marketed tablet formulation.The aim of the current study was to evaluate the bioequivalence between the test and reference formulations of anastrozole in a single-dose, 2-period, 2-sequence crossover study with a 21-day washout interval. A total of 26 healthy Chinese female volunteers were enrolled and completed the study, after oral administration of a single dose of 1.0-mg test and reference formulations of anastrozole. Blood samples (3 mL) for pharmacokinetic analysis were collected predose and 20min, 40min, 1, 1h20min, 1h40min, 2, 2h20min, 2h40min, 3, 3.5, 4, 7, 12, 24, 48, and 72 hours postdose and were determined by a fully validated high-pressure liquid chromatography-tandem mass spectrometry method. The evaluated pharmacokinetic parameters, including Cmax, AUC0-t, AUC0-∞, were assessed for bioequivalence based on current guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Postmenopausal volunteers aged between 18 and 65 years old.
* The body mass index is in the range of 19.0-28.0 kg/m2 (including the critical value). The weight is not less than 45 kg.
* The subjects have no family planning within 6 months and could select contraceptive method.
* Subjects who had not any medical history of cardiovascular, digestive, respiratory, nervous, haemal diseases or hepatic/renal impairment.

Exclusion Criteria:

* Meet the diagnostic criteria for osteoporosis.
* Subjects with vaginal bleeding.
* blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening.
* any use of other prescription drugs (including contraceptive) 28 days prior to medication for this study.
* any history of alcohol abuse in the recent 2 years or moderate drinkers (drink more 2 units per day or 14 units per week);
* smoking more than 5 cigarettes per day during the 3 months prior to screening;
Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy

This study investigate the progression of labour in 144 normal weight pregnant women (BMI \<30) and 144 obese pregnant women (BMI \>30) , not in labor admitted for induction of labor. These women are to be investigated for success of induction of labor.

* This prospective study will be conducted for 144 obese and 144 non obese ), post date (\>41 wks), not in labor.
* Woman is classified as obese if BMI \>=30.
* Prolonged pregnancy was defined as delivery on or after (41+0 weeks) of gestation.
* First informed consent will be obtained.
* Determination of gestational age
* Proper history taking, general and abdominal examinations will be done then digital examination will be performed to determine bishop score.
* And obstetric U/S scan will be done and by which the following data will be obtained :

  * Fetal biometry
  * Fetal heart activity
  * Presentation
  * Localization of the placenta.
  * Amount of amniotic fluid.
  * Exclude multifetal pregnancy.
* Induction of labor will be done using vaginal misoprostol according to the estimated Bishop score.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman.

  * Post date \>= 41 weeks.
  * Absent onset of labor.
  * Patient acceptance to join the study after signing an informed consent.

Exclusion Criteria:

* Placenta previa and or vasa previa.
* Previous caesarean section(CS).
* Multiple gestation
* Any patient who will refuse to be a part of the study.
* Intra- uterine fetal death (IUFD).
Perioperative Nutrition in Gastric Bypass Surgery

The aim of this study is to demonstrate the influence of peri-operative nutrition on the preservation of lean body mass after gastric bypass, as well as it's influence on postoperative complications.

Outcome measures:

* Lean body mass
* Length of hospital stay
* Weight loss
* Postoperative complications
* Cost

Eligibility Criteria:
Inclusion Criteria:

* RYGBP surgery planned
* Age over 18
* Informed consent

Exclusion Criteria:

* Previous bariatric surgery
A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo

This is an observational study of the long term safety and efficacy of ICM-203.

Subjects who have received ICM-203 or matching placebo from ICM-203 clinical studies will be enrolled. Subjects will be contacted annually to collect safety and efficacy outcomes until 5 years after the last dose of ICM-203 or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Previous receipt of ICM-203 or matching placebo

Exclusion Criteria:

* None
The Application of Indocyanine-Green(ICG) Fluorescence Imaging in Hepatocellular Carcinoma

This study aims to evaluate the feasibility of indocyanine green (ICG)-based fluorescence imaging in the detection of liver tumors. By correlating the ICG fluorescence patterns with pathologically confirmed tumors , it would be possible to use fluorescence navigation system in helping promoting oncology treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18 years≤ Age ≤70 years
* Compling with the diagnosis criteria of hepatic carcinoma.
* Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled.
* Preoperative liver function is Child - Pugh grade A or B.
* The patients are volunteered for the study.

Exclusion Criteria:

* Patients with mental illness.
* Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc.
* The patients refused to take part in the study.
* There are other co-existed malignant tumors.
* Benign liver diseases.
* Indocyanine green allergy
Survival, Quality of Life and Resectability in Locally Advanced Pancreatic Cancer

This study aims to assess overall survival, quality of life and resection rates in locally advanced pancreatic cancer

This is a multicenter pragmatic prospective observational study including Nordic hospitals treating patients with borderline resectable and locally advanced pancreatic cancer. Eligibility will be assessed at regional multidisciplinary tumor boards. Patients with borderline resectable and locally advanced (non-endocrine) pancreatic cancer according to the National Comprehensive Cancer Network (NCCN) and the International Study Group of Pancreatic Surgery (ISGPS) are eligible for inclusion. The study is observational. Quality of life will be assessed in all study participants. The primary outcomes are exploration rates, resection rates and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed or suspected invasive pancreatic primary tumor
* Tumor classified as borderline resectable or locally advanced disease according to NCCN guidelines

Exclusion Criteria:

* Suspected endocrine tumor
* Suspected non-pancreatic periampullary tumor
* Distant metastasis
* Age \< 18 years
* Patient unable to understand verbal or written information interfering with informed consent or treatment
* Mental or organic disorder interfering with informed consent or treatments
DermAI to Evaluate Human Factor of Testing

The purpose of this research is to improve how well remote patch allergy testing works and make sure they are easy and practical for people to use from home.


Eligibility Criteria:
Inclusion Criteria:

- Willing and able to provide informed consent.

Exclusion Criteria:

* Has used topical or oral steroids two weeks prior to patch testing.
* Currently taking immunosuppression agents or is immunocompromised due to medical condition.
* No sunburn or rash at site of testing.
* Women who are breastfeeding or pregnant.
* Treatment with ultraviolet (UV) light (including tanning) during the two weeks prior to visit.
* Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting patch test area from excess moisture due to showering).
Safety and Efficacy of CC-4047 in Subjects With Metastatic Hormone Refractory Prostate Cancer (HRPC)

Phase II randomized open-label, two-arm study of safety and efficacy of CC-4047 in subjects with metastatic hormone refractory prostate cancer (HRPC)


Eligibility Criteria:
Inclusion Criteria:

* Understand and voluntarily sign an informed consent form
* Adult male subjects, age 18 or older at the time of signing the informed consent form
* Able to adhere to the study visit schedule and other protocol requirements
* Histologically confirmed adenocarcinoma of the prostate with radiographic evidence of metastases and PSA progression following hormonal therapy for metastatic disease. Subjects must have evidence of progression of disease as demonstrated by 2 consecutive rises in PSA (an absolute change of at least 1ng/ml) separated by at least 28 days.
* Antiandrogen therapy must have been stopped at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide or nilutamide) prior to entering study with evidence of a rising PSA (from baseline) measured x 2 at least 2 weeks apart Testicular androgen suppression must be maintained with either LHRH therapy of bilateral orchiectomy.
* Must use barrier contraception (latex condom) when engaging in reproductive activity with women of child-bearing potential throughout the course of study treatment and for 4 weeks following the discontinuation of study treatment.
* May have had only one prior regimen of chemotherapy for prostate cancer. The chemotherapy must have been stopped at least 4 weeks prior to study entry.
* Disease-free of other malignancies for greater than 5 years with the exception of curatively treated basal cell, squamous cell carcinoma of the skin of Ta transitional cell carcinoma of the bladder.
* ECOG performance status of 0 or 1.
* Serum creatinine greater than or equal to 2.0 mg%
* Adequate hematologic functions: Granulocytes greater than or equal to 1800 mm3 and platelets greater than or equal to 100,000 mm3.
* Adequate hepatocellular function: AST\<2 x normal and bilirubin\<1.5mg/dl
* No active unresolved infection

Exclusion Criteria:

* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study or confounds the ability to interpret data from the study.
* Use of any other experimental drug or therapy within 28 days of baseline.
* Any prior use of CC-4047 of Thalidomide
* Tumors containing small cell or sarcomatoid elements
* Symptomatic bone metastases.
* Concurrent use of any other anti-cancer agents.
* Known brain disease that is symptomatic, is currently being treated with corticosteroids, or has not been previously irradiated.
* Non-PSA producing tumors
Japanese Assessment of Indication Based Programming

The purpose of this clinical investigation is to assess the programming behavior of the physicians in the patient cohort. Furthermore, the acceptance level of specific programming recommendations based on the patient's clinical needs and primary indications will be evaluated by comparing parameters determined by the feature IBP to daily life programming chosen by physicians.


Eligibility Criteria:
Inclusion Criteria:

* Implanted with a single or dual chamber ICD or CRT-D device approved in Japan capable of using the IBP feature.
* Geographically stable patients who are available for follow-up at a study center .
* Age 20 years or above.
* Patients, who do receive all leads that are supposed to be used with a certain type of device (i.e. no dual chamber ICD / CRT-D device without an atrial lead or CRT-D devices with only one ventricular lead).

Exclusion Criteria:

* Inability or refusal of the patient to give approval to collect/store/process personal health information at the sponsor.
* Pregnant women or women, planning to become pregnant .
* Any kind of previous CRM device therapy (no replacements, no upgrades, no new implants after complete system removals ).
* Enrolment in another clinical trial or clinical investigation without prior notification of the sponsor .
* Estimated life expectancy of less than six months per judgment of the physician.
Non-Invasive Distractor During Knee Arthroscopy

Patients will be prospectively recruited for knee joint distraction who are undergoing knee arthroscopy. Patient demographics, operative factors, and rates of medical comorbidities will be collected and evaluated. Intraoperative arthroscopic images will be evaluated by the attending Orthopaedic surgeon with standard and testing mechanism and a measuring device will be used to measure the distance between the femur and tibia in the medial and lateral compartments.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age who have capacity to provide informed consent. Eligible participants will include existing patients of Dr. DiStefano who are scheduled to undergo knee arthroscopic surgery to address meniscal pathology. Study risks, benefits and description will be provided and informed consent will be obtained.

Exclusion Criteria:

* Patients with prior history of neurovascular deficiency or history of prior injury
* Patients with a prior history of knee surgery
* Patients with diagnosed knee ligament laxity or knee instability.
* Patients that are not cleared for knee arthroscopy
A Study to Evaluate the Effect of Thymoglobulin and Reduced Doses of Steroids to Prevent Renal Transplant Rejection

This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant rejection.

This study will evaluate the effect of Thymoglobulin and reduced doses of steroids to prevent renal transplant rejection and will provide a basis for future evaluations of Thymoglobulin as an immunosuppressive agent to help prevent renal transplant rejection.

Subjects meeting all inclusion and exclusion criteria are eligible to participate in this study. In addition to standard treatment, study participants will receive either Thymoglobulin with rapid discontinuation of steroids or steroids per hospital standards for at least the first 90 days after transplant. The treatment assignment is random and is not chosen by the subject or their physician.

Subjects will be monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurs at Months 1, 3, 6 and 12 following the transplant.

Approximately 150 study subjects from 15-20 transplant centers in the United States will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Adult living donor renal transplant recipient
* Age greater than or equal to 18
* If female and of childbearing potential: a) must not be lactating; b) must have a negative serum B-human chorionic gonadotropin (HCG) test within 24 hours prior to Study Day 0 (Day of Transplant) and; c) must agree to practice an acceptable and reliable form of contraception during the study; and
* Signed informed consent

Exclusion Criteria:

* Human Leukocyte Antibody (HLA) identical matched living donor transplant recipient
* \> 2 previous transplants
* Current panel reactive antibody (PRA) \> 20%
* History of a positive cross-match with the donor
* Active donor or recipient serology positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV)
* Loss of first kidney transplant in \< 1 year
* History of noncompliance in clinical trial(s)
* History of chronic CS or immunosuppressive use except for inhaled CS to treat asthma
* Use of any investigational products during the 90 days prior to screening
* Requirement for multiple organ transplant
* Patient without a functioning urinary bladder prior to transplant (e.g. patients with self catheterization will be excluded)
* Known contraindication to administration of rabbit antithymocyte globulin
* Currently abusing drugs or alcohol
* In the opinion of the investigator, at high risk for poor compliance
* In the opinion of the investigator, has a significant medical or psychosocial problem or unstable disease state that warrants exclusion from the study. Examples of significant problems include, but are not limited to morbid obesity and severe cardiac disease.