cyrilzakka/clinical-trials huggingface dataset:
BGS Neonatal Pilot Study

This is a pilot, randomized, safety and efficacy study of an investigational device (i.e. BabyGentleStick™; BGS, Actuated Medical, Inc). The primary study objectives are to obtain subject feedback, assess device performance; and ascertain potential harm in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Medically stable late preterm/term neonates with a gestational age at birth of \> 35 weeks gestation at birth
* Sex: male or female

Exclusion Criteria:

* Congenital anomalies or conditions at birth impacting central nervous system functioning and autonomic measurements
* Known risk for bleeding (i.e. Hemophilia, blood clotting or protein disorders)
* Prolonged labor or delayed birth with evidence of perinatal depression (e.g. Infant Apgar scores below 5)
* Identified maternal opiate dependency during pregnancy placing the infant at risk for opiate withdrawal, also known as neonatal abstinence syndrome (NAS)
* Critical illness in the mother preventing the ability to obtain informed consent from parents
Special Drug Use-results Surveillance of Scemblix Tablets

Uncontrolled, central registration system, all-case, multicenter, special drug use-results surveillance.

The objective of this study is to collect data on the occurrence, severity, clinical courses of the safety specifications of asciminib, identify factors etc. involved in occurrence and assess its clinical safety inresistant/intolerant chronic myelogenous leukemia patients during an observational period of 48 weeks from the start of treatment with asciminib.

Eligibility Criteria:
Inclusion Criteria:

* patients treated with asciminib in Japan.

Exclusion Criteria:

NA
Optimum Length of Catheter in the Epidural Space for Labor Analgesia in Non-obese Women: a Randomised Controlled Trial of 4 Cm Versus 5 Cm

Epidural analgesia was introduced to the world of obstetrics in 1909 by Walter Stoeckel. Over the following 100 years it has developed to become the gold-standard for delivery of intra-partum analgesia, with between 60 and 75% of North American parturients receiving an epidural during their labor. Effective labor analgesia has been shown to improve maternal and fetal outcomes. One aspect of catheter insertion that has not been fully evaluated, and with very little recent work undertaken, is the optimal length of epidural catheter to be left in the epidural space. Dislodgement or displacement of epidural catheter remains a significant cause for failure with analgesia. Novel methods of fixation may further reduce the risk of catheter migration. Another factor is the direction of travel within the epidural space, only 13% of lumbar catheters remain uncoiled after insertion of more than 4 cm into the epidural space.

Hypothesis: The investigators hypothesize that catheters inserted to 4 cm will have a lower rate of failure when compared to those inserted to 5 cm.

Objective: This study aims to evaluate the difference in quality of labor analgesia delivered by epidural catheters inserted to either 4 or 5 cm into the epidural space.

This study will be conducted as an interventional double-blinded randomised control trial to establish best practice.

Effective labor analgesia has been shown to improve maternal and fetal outcomes. It is of paramount importance to the obstetric anesthesiologist to optimize the quality of labor analgesia and identify any factors leading to ineffective epidural analgesia. One aspect of catheter insertion that has not been fully evaluated, and with very little recent work undertaken, is the optimal length of epidural catheter to be left in the epidural space.

Previous studies have advocated, for varying reasons, different lengths of catheter to be left in the space; these range from 2cm to 8cm. Longer epidural lengths in the space can be associated with foraminal escape, leading to unilateral block, and intravascular insertion, prompting additional manipulation. Shorter lengths have previously been associated with more frequent dislodgement. The directionality of the epidural catheter once in the space has been demonstrated to correlate with misdirection.

The aim of the study would be to standardize practice in how much epidural catheter is threaded into the epidural space.

Eligibility Criteria:
Inclusion Criteria:

* All women aged 18 years and above.
* In established second stage of labor.
* 3-7 cm dilation at time of insertion.
* Women with BMI \< 40 kg/m2

Exclusion Criteria:

* Known contraindication to epidural insertion.
* Inability or unwillingness to provide written consent.
* Previous difficult epidural insertion.
* Previous failed epidural.
* Imminent instrumental or operative delivery.
* Dural puncture.
* Combined spinal epidural analgesia.
* High BMI \> 40 kg/m2
A Novel Patient Engagement Platform Among Patients With Gastrointestinal Malignancies

A randomized control trial to evaluate the feasibility of implementing a patient educational platform (PEP) for patients with gastrointestinal malignancies undergoing active chemotherapy treatment.

Patients will be randomized in a 2:1 ratio.

Patients in the experimental arm will receive automatically generated personalized educational videos (PEV) and questionnaires regarding side effects and quality of life (QOL) to either their cell phone or email. The videos will be personalized to each patient based on their demographics, specific medical instructions and treatment plan. Data collected regarding side effects and QOL in the experimental arm will be used in order to facilitate real time intervention through real time provider alert system.

A link to the first PEV will be sent before the first chemotherapy cycle, addressing the diagnosis and type of malignancy, chemotherapy protocol, common side effects and their management. Side effects questionnaire will be sent every week while QOL questionnaire will be sent every 6 weeks.

Patients will be followed from recruitment through three weeks after completion of the planned treatment protocol. If treatment is discontinued prior to completion of the protocol, follow-up will end three weeks after the last administered treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals with a newly diagnosed gastrointestinal malignancy, treated at the outpatient clinic of the Institute of Oncology at the Sheba Medical Center
2. Individuals planned to receive one of the following cytotoxic chemotherapy protocols:

   1. FOLFOX - a combination of 5-fluoruracil, leucovorin and oxaliplatin.
   2. FOLFOIRI - a combination of 5-fluoruracil, leucovorin and irinotecan.
   3. FOLFIRINOX - a combination of 5-fluoruracil, leucovorin, oxaliplatin and irinotecan.
   4. De Gramont - 5-fluoruracil and leucovorin.
3. Ability to read and comprehend Hebrew language text.
4. Ability to see computer or cell phone screen (i.e., no visual impairment).

Exclusion Criteria:

1. Eastern Conference Oncology Group (ECOG) performance status greater than 2.
2. Cognitive deficits that would preclude understanding of consent form and/or questionnaires.
3. Inability to read and comprehend Hebrew language text.
4. Current participation in a therapeutic clinical trial.
Optimizing Psychological Treatment for Pain After Breast Cancer

The present study aims to optimize psychological treatment for pain after breast cancer by identifying active treatment components. Specifically, a factorial design will be used to evaluate the efficacy and change processes of three psychological treatment components, which have been shown to be efficacious in the treatment of pain after breast cancer.

There is a need for optimization of psychological treatment of pain after breast cancer. Optimization relies on knowledge about the active components of existing treatments. Guided by the Multiphase Optimization Strategy (MOST), the present study aims to address this challenge by identifying active contemporary cognitive behavioral therapy components for breast cancer-related pain. Consistent with the Optimization phase of the MOST framework, a full factorial design will be used to evaluate the efficacy and change processes of three selected treatment components.The overall hypothesis is that the three components will target key maintaining psychological factors in pain, thus leading to reductions in the primary outcomes of pain intensity and -interference. The treatment components and their hypothesized mechanisms of action are as follows:

1. Mindful attention practices will increase attentional control (i.e., the ability to intentionally focus and intentionally shift one's attention), thereby reducing pain hypervigilance, leading to reductions in pain intensity and -interference.
2. Decentering practices will reduce fusion with thoughts (i.e., getting caught up in one's thoughts, feelings and inner experiences), thereby reducing pain catastrophizing, leading to reductions in pain intensity and -interference.
3. Values and committed action (i.e., behavior congruent with one's values) will increase acceptance of discomfort and reduce avoidant behavior, leading to reductions in pain intensity and -interference.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary breast cancer stage I-III
* Min. 6 months post primary treatment (i.e., surgery, chemotherapy, and/or radiotherapy). Endocrine treatment, e.g., Letrozol or Tamoxifen, and/or Zoledronic acid and/or Herceptin treatment is allowed during study participation
* Pain corresponding to a pain score of \>= 3 on pain intensity and/or pain interference measured by 11-point Numeric Rating Scales (NRSs)
* Sufficient ability to communicate in Danish
* Sufficient ability to participate in an online-delivered intervention

Exclusion Criteria:

* Non-curable breast cancer (stage IV)
* Breast cancer recurrence
* Bilateral breast cancer
* Other current cancer disease
* Other primary pain condition (e.g., fibromyalgia)
* Current severe psychiatric disorder (e.g., psychosis) hindering study participation
* Insufficient ability to communicate in Danish
* Insufficient ability to participate in an online-delivered intervention
Do High Doses of Protein Supplements Affect Serum Lipid Profiles?

Protein supplements are widely used among people going to the gym. The effects of these substances on blood biochemical, hematological, inflammatuary, glucose metabolism markers and lipid profile is not well known. The previous studies on this issue give inconclusive results. So the investigators aimed to investigate this subject and compare the blood tests between subjects using and not using protein supplements.

As more people are doing regular exercises, people using protein supplements are also increasing. The effects of these substances on blood lipid profiles, biochemical, hematological parameters, inflammatory and glucose metabolism markers are not well known. So the investigators of this study planned to search the effects of these substances on blood tests. Totally 69 subjects going to the gym for at least three preceding months were included to the study. They were divided into two groups: the ones using protein supplements and the ones who never used these substances. Demographic and clinical characteristics were recorded. Dietician assessed the dietary habits of the subjects. Blood was drawn for the tests mentioned above from all of the subjects. And the results were compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

- Going to the gym for at least three preceding months

Exclusion Criteria:

* Any kind of acute or chronic illness
* Abnormality on electrocardiography
* Body-mass index\>30 kg/m2
* Use of any kind of drugs
* Hypertension at the time of recruitment
Indocanine Green as Tracer for Lymph Nodes Dissection in Station 253

This is a prospective randomized controlled study. investigators will randomly assign patients to the indocanine green (ICG) group and control (CL)group to compare the differences of lymph nodes dissection in station 253 between the two groups.

ICG is a registered and FDA-approved non-specific fluorescent probe for optical imaging in clinical settings. The properties of ICG ,which is a water-soluble amphiphilic molecule with a molecular weight of 775 Dalton and a hydrodynamic diameter of 1.2nm ,render it an excellent lymphatic contrast agents if injected into the lymphatic system. ICG near-infrared(NIR) fluorescent imaging has achieved satisfactory results in the localization of sentinel lymph nodes in patients with breast cancer,non-small cell lung cancer,and gastric cancer. Liang et al have suggested that 253 lymph nodes dissection in rectal cancer is technically demanding ,and that learning curve for laparoscopic 253 lymph nodes dissection requires minimally 20 procedures. Currently,it was still controversial about 253 lymph nodes dissection in rectal cancer surgery. However, lymph node involvement is a major prognostic factor for survival after rectal cancer surgery. Therefore, it is necessary to harvest more station 253 nodes for the better long-term survival and the more precise staging.

In this study, investigators will randomly assign patients to the indocanine green (ICG) group and control (CL)group. Number of harvested station 253 lymph nodes, number of positive station 253 lymph nodes, will be evaluated and compared. Investigators will also evaluate patients, operative time, blood loss, post-operative hospital stay and complications.

Eligibility Criteria:
Inclusion Criteria:

(1)18-80 years of age (2)American Society of Anesthesiologists (ASA) class 1-3 (3)single rectal or sigmoid colon carcinoma confirmed pathologically by endoscopic biopsy (4)planned laparoscopic radical resection (5)Written informed consent

Exclusion Criteria:

1. previous abdominal tumor surgery
2. women who are pregnant or breast feeding
3. emergency patients with obstruction or perforation
4. T4b cancer evaluated by CT or MRI or endoscopic ultrasonography
5. pelvic or distant metastasis
6. T1 cancer planned local excision
7. allergic constitution patients
A Study of HSV Testing Among Pregnant Women

The objective of the study is to evaluate the acceptance and effect of type- specific HSV serologic testing of pregnant women on sexual behavior at the end of pregnancy.

The study hypothesis is that women with antepartum testing who are identified as susceptible to HSV-1 or HSV-2 will have reduced unprotected coital activity and reduced unprotected oral-genital activity compared to those who did not receive antepartum testing. The objective of the study is to evaluate the acceptance, and effect of type-specific HSV serologic testing of pregnant women on sexual behavior at the end of pregnancy.

Upon enrollment, study participants will be randomized into either of two type-specific HSV serologic testing and counseling regimens:

* Group 1: Antepartum and postpartum testing. Subjects will be made aware of their antepartum testing results.
* Group 2: Antepartum blood draw and postpartum testing. Subjects' specimens will be tested at the same time.

Women in group 2 will receive information about herpes infection and how to decrease their chance of acquiring infection during pregnancy. Subjects will be asked to keep a diary of sexual activity and return to the clinic every 4 weeks until delivery.

Eligibility Criteria:
Inclusion Criteria:

* 14 years of age or older
* Pregnant less than 28 weeks at time of enrollment
* No previous HSV serology within the past year
* able to comprehend english

Exclusion Criteria:

* History of genital herpes
* HIV seropositive
* Any contraindication for sexual activity during pregnancy
Effect of Intradialytic Exercises in Chronic Kidney Disease Patients

the purpose of this study is to compare between intradialytic aerobic versus resistive exercises on immunity response in patients with chronic kidney disease.

The patients of this study will randomly assigned into three equal groups (n=20)

1. Study Group A (20 patients) will receive intradialytic aerobic exercise and medical treatment.
2. Study Group B (20 patients) will receive intradialytic resistive exercise and medical treatment.
3. Control Group C (20 patients) will receive medical treatment only (HD session and drugs) Each patient will receive the treatment program three times per week for three months.

Eligibility Criteria:
Inclusion Criteria:

* Sixty men chronic kidney disease (grade III RF). They received regular hemodialysis sessions at least one year ago, each one for four hours, three times per week.
* They had a history of type II Diabetes more than five years.
* Their age will be ranged from 50-60 years old.
* They are Fit for exercise by functional assessment using six minute walk test.
* Their Hemoglobin level more than 10 g\\dl.
* Their Body Mass Index (BMI) will be ranged from "18.5" to "24.9".

Exclusion Criteria:

* Severe cardiac disorders.
* Severe orthopedic problems (for example fractures).
* Hepatic encephalopathy.
* Preexisting neuromuscular diseases (e.g. myasthenia gravis). •Severe chest diseases.
* Spinal cord injuries involved the phrenic nerve.
* Uncontrolled diabetes or hypertension
* Patients receiving inefficient hemodialysis session.
* Patients with other cause for inflammation e.g. malignancy and autoimmune disease.
* Active bleeding as alveolar hemorrhage, hemoptysis.
* Physical limitation that would limit cycling.
Provoked Craving Relief Study by NRT

This study is designed to assess the ability of the mint nicotine mouth strip to relieve provoked cigarette craving in light smokers compared to nicotine lozenge and nicotine gum.


Eligibility Criteria:
Inclusion Criteria:

* Smoking Status: Current cigarette smokers who have smoked regularly for at least a year and smoke their first cigarette more than 30 minutes after waking up.

Exclusion Criteria:

* Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to nicotine (or closely related compounds) or any of the stated ingredients in formulation.
* Prior Concomitant Medication: a. Treatment with known enzyme altering agents (e.g. carbamazepine, phenytoin, cimetidine, sodium valporate) within 30 days of the craving provocation visit. b. Use of any prescription psychoactive medication (such as but not limited to antidepressants, antipsychotics, anxiolytics) within 14 days of the craving provocation visit. c. Use of any over-the-counter (OTC) medication that affects central nervous system such as antihistamines, sedating agents, or any compound that would have a sedating effect within 24 hours of the craving provocation visit. d. Use of any nicotine replacement therapy or any other treatment for smoking cessation (e.g. bupropion or varenicline) within one month of screening visit. e. Use of any nicotine containing products at any time during the Provocation/Treatment visit. f. Use of any medications noted in the exclusion criteria, or use of any product that would, in the opinion of the investigator, jeopardize the safety of the subject or impact on the validity of the study results.
* Any disease that, in the opinion of the investigator, may interfere with the absorption, metabolism or excretion of the study product. A medical history that, in the opinion of the investigator, might jeopardise the safety of the subject or the validity of the study results. For example, recent myocardial infarction or cerebrovascular accident (within 12 weeks of the screening visit), phenylketonuria, unstable or worsening angina pectoris, Prinzmetals angina or severe cardiac arrhythmia.
* Expired Carbon Monoxide (CO): Any subject whose CO level rises during the sequestration period (i.e., the subject's expired CO assessments immediately prior to the provoked craving paradigm are higher than the mean baseline CO assessment) and, in the opinion of the investigator, may have smoked during that time.
* Alcohol: Consumption of any alcoholic beverage within 24 hours of the craving provocation visit, as indicated by a positive breath alcohol test.
Survey: Clinical Outcome After Bowel Resection in Women Due to Endometriosis

Endometriosis is one of the most frequent benign diseases that can affect women in their reproductive age. In severe form, the colon or rectum may be involved. It has been shown that the surgical treatment improve typical symptoms like pain and dyspareunia. The investigators evaluated the functional results and quality of life after laparoscopic colonic resection for endometriosis

A clinical analysis of thirty women with typical symptoms including pelvic pain, infertility and endometriotic bowel lesions who underwent laparoscopic surgery including colonic resection performed from 2009 to 2012. Quality of life and pain was documented postoperatively. We conduct a telephone survey, which starts at May 2014.

Eligibility Criteria:
Inclusion Criteria:

* •Clinical diagnosis of endometriosis

Exclusion Criteria:

* Unwillingness to participate on the survey
Resveratrol and Exercise to Treat Functional Limitations in Late Life

The purpose of this research study is to evaluate the effects of combining physical exercise with a resveratrol supplementation on the physical function of older adults.

This investigation is a pilot study to investigate the potential of resveratrol, a commercially-available nutritional product, to enhance the efficacy of physical exercise in improving physical function among older adults with functional limitations. The overarching objective of this project is to evaluate the safety and efficacy of an intervention combining resveratrol supplementation and physical exercise among sedentary persons aged \> 65 years objectively-measured functional impairments. A total of 60 participants will be recruited to participate in this three month intervention study. All participants will engage in a center-based exercise program 3/days per week and will be randomly assigned to consume 1) placebo, 2) 500 mg/day resveratrol, or 3) 1000 mg/day resveratrol. This study will provide critical information regarding the influence of the combination of resveratrol and exercise on objectively-measured and self-assessed indices of physical function. The study will also provide novel biologic information regarding the relative effects of the interventions on skeletal muscle mitochondrial function.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand study procedures and to comply with them for the entire length of the study
* Willingness to be randomized into either treatment group
* Age 65 years and older
* Physical limitations evidenced by \>290 seconds needed to complete long-distance corridor walk test
* Sedentary lifestyle, defined as \<150 min/wk of moderate physical activity as assessed by CHAMPS questionnaire

Exclusion Criteria:

* Failure to provide informed consent
* Regular consumption of a resveratrol supplement
* Current involvement in supervised rehabilitation program
* Absolute contraindication(s) to exercise training according to American College of Sports Medicine guidelines
* Pain classification \> Grade 3 on Graded Chronic Pain Scale
* Peripheral vascular disease; peripheral neuropathy; retinopathy
* Severe cardiac disease, including:

NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina

* Myocardial infarction or stroke within past year
* Significant cognitive impairment, including:

known dementia diagnosis or a Mini-Mental State Examination exam score \<24

* Progressive, degenerative neurologic disease (e.g., Parkinson's Disease, multiple sclerosis, ALS)
* Severe rheumatologic or orthopedic diseases (e.g., awaiting joint replacement, active inflammatory disease)
* Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen
* Hip fracture, hip or knee replacement, or spinal surgery within past 4 mos.
* Other significant co-morbid conditions that would impair ability to participate in the exercise-based intervention
* Simultaneous participation in another intervention trial