cyrilzakka/clinical-trials huggingface dataset:
Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer

The purpose of this study is to determine if cisplatin and pemetrexed are effective in the treatment of patients with Small Cell Lung Cancer, extended disease.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of Small Cell Lung Cancer (SCLC).
* Functional stage from 0 to 2 of the ECOG functional scale
* No previous systemic chemotherapy, immunotherapy or biologic therapy for SCLC.
* Previous bone marrow radiotherapy less than 25% is allowed.
* There must be at least one measurable lesion that complies with the solid tumor response evaluation criteria.
* Appropriate organic function.
* Life expectancy estimated at 12 weeks minimum.
* Females must be surgically sterile, postmenopausal or follow approved medical contraceptive methods during the treatment period and 6 months afterwards. Males must be surgically sterile or use a contraceptive method during the treatment period and during 6 months after treatment.
* The patient must be compliant and located close to the trial area for appropriate follow-up.
* The patient or his/her legal representative must sign an informed consent document.
* Patients must be at least 18 years of age.

Exclusion Criteria:

* Having received treatment for the last 30 days with a drug that has not obtained regulatory approval.
* Having participated in a previous pemetrexed trial.
* Mixed histologic diagnosis of SCLC and NSCLC.
* Concurrent illness.
* Having an active infection.
* Severe cardiac disease.
* Having received recently or concurrently a vaccine against yellow fever.
* Having suffered a previous malignant process other than SCLC.
* Central nervous system (CNS) metastases require concurrent corticoid therapy. Treated and stable CNS metastases are allowed.
* Clinically relevant fluid accumulation in the third space.
* Significant weight loss (greater than or equal to 10%) within 6 weeks prior to trial inclusion.
* Concurrent administration of any other anti-tumor treatment.
* Severe renal failure.
* Unable to discontinue administration of non-steroidal anti-inflammatory (NSAIDS) agents.
* Inability or unwillingness to take folic acid and vitamin B12 supplements.
* Inability to take corticoids.
Wound Infiltration as Part of an Opioid Free Pain Management Pathway Following Cesarean Delivery

This study will investigate the effect of three types of wound infiltration on post Cesarean opioid analgesia consumption when used in conjunction with an opioid free postoperative analgesia pathway.

The subjects that meet the inclusion criteria of the study will be randomized preoperatively into three arms following a 1:1:1 ratio. During the intraoperative course one of three combinations of wound infiltration will be administered to subjects prior to the closure of the surgical incision. Subjects in Group I will receive a placebo of normal saline. Subjects in Group II will receive bupivacaine alone. Subjects in Group III will receive both bupivacaine and dexmedetomidine.

Eligibility Criteria:
Inclusion Criteria:

* All scheduled Cesarean deliveries with intrathecal or epidural anesthesia

Exclusion Criteria:

* Emergency Cesarean deliveries
* Multifetal gestation
* Subjects \<18 years old
* Subjects belonging to a vulnerable population (including subjects with a known opioid addiction, subjects with a history of mental illness and prisoners)
* Cesarean delivery with general anesthesia
* Known allergy or hypersensitivity to any of the study medications
* Subjects that can't comprehend the visual analog scale for quantitative pain assessment
Study of Oral ENMD-2076 Administered to Patients With Ovarian Cancer

The purpose of this study is to determine whether oral ENMD-2076 is effective in treatment of patients with platinum resistant ovarian, fallopian, or peritoneal cancer. Additional sites to be added.


Eligibility Criteria:
Inclusion Criteria:

* Have histologically documented diagnosis of ovarian, fallopian or peritoneal cancer that is platinum resistant.
* Have a pre-study echocardiogram or multigated acquisition (MUGA) scan with an actual left ventricular ejection fraction of greater than or equal to the institution lower limit of normal
* Greater than or equal to 18 years of age
* Have clinically acceptable laboratory screening results
* Have an ECOG performance status of 0 or 1
* Able to tolerate oral medications

Exclusion Criteria:

* Have uncontrolled hypertension (systolic blood pressure greater than 150mmHg or diastolic blood pressure greater than 100mmHg); require two or more antihypertensive medications to control hypertension (including ACE inhibitors, beta blockers, calcium channel blockers, or diuretics)
* Have chronic atrial fibrillation or QTc interval corrected for heart rate of greater than 470 msec
* Have active, acute, or chronic clinically significant infections or bleeding
* Have persistent 2+ protein by urinalysis or a history of nephrotic syndrome
A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)

The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy. The core study was followed by a 24-week open-label, multicenter extension study to assess the safety, tolerability, and efficacy of canakinumab in patients with gout who were given canakinumab at the time of gout flare.


Eligibility Criteria:
Core study

Inclusion Criteria:

* Signed written informed consent before any study procedure is performed.
* History of at least 2 gout flares in the year prior to Screening (Visit 1, based on patient history), thus, candidates for initiating uric acid lowering therapy.
* Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of arthritis of primary gout.
* Body Mass Index (BMI) ≤ 40 kg/m\^2.
* Willingness to initiate allopurinol therapy as urate lowering agent for their gout therapy or having initiated allopurinol therapy within ≤ 1 month before Screening (Visit 1) or willing to re-initiate allopurinol therapy if this was stopped \> 2 months before Screening (Visit 1) for reasons different to toxicity/ intolerance or lack of efficacy.

Exclusion Criteria:

* Acute gout flare within 2 weeks of Screening (Visit 1) and during the Screening period.
* History of allergy or contraindication to colchicine or allopurinol.
* History of intolerance to allopurinol or to oral colchicine in appropriate dose for prophylactic use.
* History of bone marrow suppression.
* Absolute or relative contraindication to both naproxen and oral prednisolone/ prednisone.

Extension study

Inclusion criteria:

* Patients who completed the core study. A patient is defined as completing the core study if he/she completed the study up to and including the last visit (Visit 9).
* Patients who have signed a written informed consent before any trial procedure is performed.

Exclusion Criteria:

* Patients for whom continuation in the extension study is not considered appropriate by the treating physician.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).

Other protocol-defined inclusion/exclusion criteria applied to the study.
Medtronic SCORE Study - Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty

The objective of this study is to measure the effect that the scraping and scoring of vertebral cancellous bone using the Kyphon® Curette has on vertebral body anatomy height restoration and angular deformity correction during a balloon kyphoplasty procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 50 years
* One painful VCF meeting all of the following criteria:

  * Fracture due to diagnosed or suspected underlying primary or secondary osteoporosis
  * VCF is between T5 and L5
  * VCF shows hyperintense signal on STIR or T2 weighted MRI
  * VCF has at least 15% height loss as visualized on plain radiograph
  * Identified painful VCF has at least superior and one normal vertebrae within 2 levels inferior.
  * Either the immediate superior OR the immediate inferior vertebral body (but not both) may have a chronic fracture that does not need treatment.
* Patient states availability for all study visits
* Patient is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent

Exclusion Criteria:

* Patient is unable to undergo MRI
* Patient shows evidence of edema in vertebral bodies other than index level on MRI
* Patient is unable to stand for pre-operative and post-operative x-rays
* Patient body mass index (BMI) is greater than 35 kg/m2
* Patient is pregnant, or of child-bearing potential and not using contraception
* Vertebral body (VB) morphology or configuration is such that balloon kyphoplasty is not technically feasible or clinically appropriate for the index VCF
* Index fracture is result of high-energy trauma
* Suspected or proven cancer inside any VB
* Disabling back pain due to causes other than acute fracture
* Spine stabilization beyond balloon kyphoplasty required for index VCF
* Pre-existing conditions contrary to balloon kyphoplasty, such as:

  * Irreversible coagulopathy or bleeding disorder. Note that patients on Coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re-initiation of anticoagulants.
  * Allergy to any device materials (e.g., bone cement) for balloon kyphoplasty. Note that in patients with allergy to iodine-based contrast, other marketed approved non-iodine contrast solutions may be used.
  * Any evidence of VB or systemic infection
Pilates Exercise Versus Proprioceptive Neuromuscular Facilitation in Shoulder Dysfunction Post Mastectomy

The purpose of the study was done to evaluate the therapeutic efficacy of Pilates versus PNF in treatment of shoulder dysfunction and limitation of range of motion after mastectomy

Mastectomy is the removal of the entire breast, with five types: simple or total mastectomy, modified radical mastectomy, radical mastectomy, partial mastectomy, and subcutaneous (nipple-sparing) mastectomy. Post-surgical pain and changes in breast shape can lead to side effects like wound infection, hematoma, seroma, shoulder pain, edema, and decreased range of motion. Mastectomy rates vary worldwide, with the highest rate in central and eastern Europe at 77%. Some women at high risk of breast cancer choose to have a mastectomy even when there's no sign of cancer.

Pilates improve flexibility, build strength, and develop control and endurance in the entire body. It emphasizes alignment, breathing, developing a strong core, and improving coordination and balance. The core, consisting of muscles of the abdomen, low back, and hips, is often called the "powerhouse" and is thought to be the key to a person's stability.

Proprioceptive Neuromuscular Facilitation (PNF) is a stretching technique used to improve muscle elasticity and has been shown to have a positive effect on active and passive range of motions.

Eligibility Criteria:
Inclusion Criteria:

Age range between 40-75 years.

* Only females will participate in the study.
* All patients have no diabetes or blood problems.
* All patients enrolled to the study will have their informed consent

Exclusion Criteria:

Age less than 40 or more than 75 years.

* Diabetes mellitus.
* Subjects suffering from active malignant tumors.
* Subjects treated with skin graft.
* Subjects with Mental illness.
* Subjects with skin diseases
* Subjects with any previous cause for shoulder dysfunction
Exploratory THS 2.1 Nicotine Pharmacokinetics and Safety Study

The main goal of this exploratory study is to evaluate the pharmacokinetic profile of nicotine for the candidate modified risk tobacco product THS 2.1 and for conventional cigarettes (CC).

This 2-period 2-sequence cross-over clinical study intends to explore the profile of nicotine uptake (rate and extent of nicotine absorbed and associated variability) in healthy smokers switching from (CC) to THS 2.1 (single or ad libitum use) compared to smokers continuing to use CC, as a comparator. This study will serve to optimize blood sampling schedules and sample size estimation for further studies. This study will also provide preliminary information on the relationship between nicotine absorption and urge to smoke/withdrawal symptoms when using THS 2.1 as compared to CC, as well as the safety profile, which is related to the use of THS 2.1.

After screening, enrolled subjects will be admitted to the clinic for 8 days. This study duration includes 2 consecutive periods. Each period consists of 1 day for single use of the product preceded by a 24-hour nicotine deprivation, and 1 day for ad libitum product use. After leaving the clinic, the subjects will be followed up for safety over a period of 7 days.

This clinical study will be conducted in compliance with International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH Good Clinical Practice), the Declaration of Helsinki as amended in 2008, and the applicable regulatory requirements.

Eligibility Criteria:
Inclusion Criteria:

* Subject has signed an informed consent form before commencement of study procedures
* Healthy Caucasian aged between 23 to 65 years
* Subject is current smoker for at least 3 years (based on self-reporting and biochemically verified), who, for the last 4 weeks, had smoked at least 10 commercially available non-mentholated CC per day, and is not planning to make a quit attempt within the next 3 months

Exclusion Criteria:

* As per Investigator judgment, the subject should not participate in the study for any reason (e.g. medical, psychiatric and/or social reason)
* The subject has a medical condition requiring smoking cessation, or has a clinically relevant disease / condition which could interfere with the study participation and/or study results
* The subject has participated in a clinical study within 3 months prior to the Screening Visit
* Pregnant or lactating woman, and for woman of childbearing potential, absence / refusal to use an acceptable method of effective contraception
Sedation Versus No Sedation for Detection Rates of Precancerous Lesions and Cancer

The influence of sedation on the endoscopic detection rate of the precancerous lesions and cancer of upper digestive system has not been assessed. In the daily medical routine of China, patients have the right to choose the sedation style according to his or her own situation, whose detailed endoscopic data of patients are recorded in the endoscopy quality control system. The aim of this research is to detect whether the use of sedation can help improve detection rate of precancerous lesions and cancer of upper digestive system.

The influence of sedation on the endoscopic detection rate of the precancerous lesions and cancer of upper digestive system has not been assessed. In the daily medical routine of China, patients have the right to choose the sedation style according to his or her own situation, whose detailed endoscopic data of patients are recorded in the endoscopy quality control system. The aim of this research is to detect whether the use of sedation can help improve detection rate of precancerous lesions and cancer of upper digestive system.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than 18 years with or without GI symptoms attending for endoscopy from 2012 to 2019.

Exclusion Criteria:

* Patients unable to cooperated the endoscopy or unable to complete it. People with endoscopy contraindications are naturally excluded.
Confocal Laser Endomicroscopy for Brain Tumors

Confocal Laser Endomicroscopy (CLE) could be a useful tool for real-time diagnosis of brain lesions (initial diagnosis or follow-up post resection to check for residual dysplasia) and real-time assessment of resections margins during surgery. Probe-based CLE using the CELLVIZIO® has never been used for glioma surgical guided resection. Before assessing the potential of this technique in improving surgical resection outcome, a feasability study has to be performed.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old
* Clinical signs and history of the disease in favor of a HGG, LGG
* MRI study in favor of a HGG, LGG, meningioma or brain metastasis
* Affiliated to or beneficiary of a social security system (or equivalent).
* Patients who have provided written informed consent for the study

Exclusion Criteria:

* - Allergy to fluorescein
* Previous life-threatening allergic reactions and known hypersensitivity
* Pregnant or lactating or not using effective contraception;
* Restricted renal function define by a creatinine clearance \< 30ml/min
* Patients under a beta-blockers treatment
* Contraindication to do an MRI (pace-maker)
* Contraindication to the use of 5-ALA : known hypersensibility to 5-ALA or to porphyrin, acute or chronic porphyria
* Minor or adult ward of court (under guardianship or trusteeship)
* No affiliation to a social security system (or equivalent).
* Patients who express opposition to participation in the study.
Serotonin, Impulsivity, and Cocaine Dependence Treatment

The purpose of this study is to compare the effects of citalopram versus placebo given in the context of contingency management for cocaine dependence.

Cocaine dependence continues to be a significant public health problem, for which there is no FDA approved pharmacotherapy. This study is a 12-week, double blind, placebo controlled trial of citalopram for cocaine dependence. The primary outcome measure is benzoylecgonine positive urines. Secondary measures of side effects and craving are also examined.

Eligibility Criteria:
Inclusion Criteria:

* male and female subjects age 18 to 50 who currently meet DSM-IV criteria for cocaine dependence.
* female subjects: a negative pregnancy test

Exclusion Criteria:

* current or past DSM-IV Axis I disorder other than substance abuse/dependence
* any serious non-psychiatric medical illness requiring ongoing medical treatment
* substance dependence other than cocaine within the last 3 months
* negative urine drug screen for cocaine at time of testing
* for female subjects: a positive pregnancy test
A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment

The study involves a single dose of a study drug called abemaciclib taken by mouth. The purpose of this study will be to measure how much study drug gets into the blood stream and how long the body takes to get rid of it when given to participants with mild, moderate, or severe liver impairment compared to healthy participants. In addition, the tolerability of the study drug will be evaluated.

This study will last approximately 3 weeks for each participant, including check-in and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Female participants must be of non-child-bearing potential
* Have a body mass index of 18 to 40 kilograms per square meter (kg/m²)

Exclusion Criteria:

* No history of cardiovascular, renal, respiratory, gastrointestinal, endocrine or hematological disorders
* Have known allergies to abemaciclib, related compounds, or any components of the formulation
* No human immunodeficiency virus (HIV) infection or antibodies
Risk Stratification and Early Prevention Strategies for Non-compaction of Ventricular Myocardium (CAPTAIN)

This study intends to retrospectively-prospectively enroll NVM patients from multiple centers to establish a natural population cohort of NVM patients. By collecting clinical data and biological samples from surgical patients, the investigators will construct a prognosis prediction system for NVM, optimize risk stratification, explore new strategies for the early prevention and treatment of NVM, and improve the efficiency of clinical treatment of NVM patients.

This study intends to retrospectively-prospectively enroll NVM patients from multiple centers to establish a natural population cohort of NVM patients. By collecting clinical data and biological samples from surgical patients, the investigators will construct a prognosis prediction system for NVM, optimize risk stratification, explore new strategies for the early prevention and treatment of NVM, and improve the efficiency of clinical treatment of NVM patients.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of nvm was confirmed by cardiac ultrasound, electrocardiogram, magnetic resonance angiography, pathological examination and gene sequencing.
* Patients or their families agreed to participate in the study and authorized informed consent.

Exclusion Criteria:

* Incomplete clinical data.
* Do not agree to the inclusion or refuse to authorize the informed consent.
Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH

This study will determine whether an 18-month practical tobacco smoking cessation program integrating weight management counseling and exercise will be superior to treatment as usual in achieving prolonged smoking abstinence in persons with serious mental illness.

The objective of this study is to perform a randomized clinical trial (TRIUMPH) in persons with serious mental illness to test the hypothesis that intervention participants will have higher rates of smoking abstinence at 18 months than participants in the treatment as usual arm. The intervention includes group and individual smoking cessation and weight management counseling tailored by a participant's readiness to quit, pharmacotherapy with either varenicline or buproprion plus nicotine replacement therapy prescribed in the community clinic, exercise, and text messaging supporting health behavior change.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or recurrent major depression meeting criteria for serious mental illness
* Fagerstrom Test for Nicotine Dependence of ≥3 and daily cigarette smoking for at least the past 6 months (on days that cigarettes were available)
* On stable psychotropic medication for mental illness for at least 30 days (i.e., antipsychotic medication for those with schizophrenia spectrum illness, mood stabilizer for those with bipolar disorder)
* Competent and willing to give informed consent
* Completion of baseline data collection
* Willing to participate in smoking cessation intervention that includes combination of evidence-based behavioral (group and individual sessions) and pharmacotherapeutic smoking cessation aids

Exclusion Criteria:

* Serious cardiovascular event (e.g. myocardial infarction, stroke) within the past 6 months
* Serious unstable medical condition that limits life expectancy
* Pregnant, breastfeeding, or planning a pregnancy during study period.
* Alcohol or illicit substance use disorder if not sober/abstinent for ≥ 30 days
* Planning to leave mental health program or move out of geographic area within 18 months Review by treating psychiatrist required for those with inpatient psychiatric hospitalization within six months of enrollment.