cyrilzakka/clinical-trials huggingface dataset:
Magnetic Anchoring Guided Endoscopic Submucosal Dissection for Early Gastric Caner

This study uses magnetic anchored guidance system to treat early gastric cancer by endoscopic mucosal dissection to test the advantages of magnetically anchored guidance system for surgical field exposure during endoscopic mucosal dissection.

Gastric cancer is the second most common malignant tumor in China, with the highest mortality rate among all types of malignant tumors. Surgical resection is still the most effective treatment for gastric cancer. Minimally invasive surgery breaks the traditional surgical concept that the laparotomy must be performed by laparotomy. It can complete the operation that required a large incision with minimal incision trauma, and has the advantages of less trauma, faster recovery and fewer complications. At present, the application of gastroscopy and laparoscopy for early gastric cancer has reached consensus at home and abroad. Endoscopic mucosal resection of early gastric cancer is suitable for patients with intramucosal cancer and no lymph node metastasis. However, the unclear exposure of the surgical field during the operation causes difficulty in operation or conversion to open surgery is a difficult problem facing this technique. The project designed a magnetic pulling unit that can be connected through an endoscope, including external abdominal magnets, internal abdominal magnets, connecting hooks, and micro surgical tweezers. Using magnetic anchoring technology, the magnetic pulling unit is anchored to the abdominal wall, and micro surgical tweezers are used. The tumor tissue is pulled indirectly, so that the mucosa is lifted up, which is beneficial to the peeling of the submucosa. This method increases the operating space of the main hand of the endoscope, and at the same time, the magnetic clamp is used to connect the clamps so that they can move in all directions, so as to achieve the desired traction of the tumor tissue site, fully expose the surgical field, and facilitate surgical anatomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients are diagnosed as of gastric cancer by a preliminary endoscopy or biopsy sampling

Exclusion Criteria:

* Patients with a cardiac pacemaker or severe cardiac and/or pulmonary diseases
* Patients without informed consent
* Patients with other malignant tumors
Diagnostic Value of ICG in Endometriosis

This study evaluates the diagnostic value of the addition of indocyanine green and near infrared fluorescence imaging during laparoscopy in patients with suspected endometriosis.

Endometriosis is a public health problem with an increasing incidence and various symptoms. Surgical treatment reliefs pain and improves fertility by radically removing endometriotic lesions. However, peritoneal endometriotic lesions may vary significantly in their appearance in standard white light laparoscopy and therefore may be difficult to be identified. Because endometriosis is associated with hypervascularisation the visualization of tissue perfusion by additional use of near infrared (NIR) fluorescence imaging with indocyanine green (ICG) may improve the detection of peritoneal endometriotic lesions.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Be premenopausal (menopause is defined as amenorrhea lasting one year or longer)
* Patients should be in follicular phase
* Have chronic pelvic pain and/or Infertility and be willing to undergo planned endometriosis resection procedure.

Exclusion Criteria:

* Known or suspected allergy to iodine, shellfish, or ICG dye
* Hyperthyroidism
* Severe renal insufficiency
* Simultaneous therapy with beta-blockers
* Women who are pregnant (positive HCG in the blood) or breast feeding
* Intention to become pregnant during the course of the study
* Inability to follow the procedures of the study (due to language problems, psychological disorders, dementia)
* Active pelvic infection (positive vaginal or cervical smears for bacteria or elevated markers of infection in the blood)
* Previous history of radiation therapy of the pelvis
* Presence of medical conditions contraindicating general anesthesia or standard laparoscopic surgery
Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders

This study will examine the effect of offering information sessions to a randomized group of patients with OCD spectrum disorders. Psychoeducation is a component of first line treatment; though intended to be informative in nature, these psychoeducation services can have a positive effect on quality of life, sense of self-efficacy, functioning and a person's readiness to engage in long term treatment. However, no studies have dismantled and tested the independent effect of psychoeducation from standard treatment such as Cognitive Behavioural Therapy. This study aims to directly test the potential effect of one aspect of CBT that if found to be helpful, can become a distinct early intervention component of care so that as people await services, they can profit from the early benefits associated with attending these information sessions. This study therefore sets out to examine the potential early benefits of providing education about the illness on symptom functioning, quality of life and readiness to engage in more formal treatment. We will offer 4 structured information sessions to individuals allocated to a wait list for services related to the treatment of OCD and OCD Spectrum Disorders in order to directly test the benefit of adding a didactic structured psychoeducation program to our services. The study will be a randomized trial where subjects (N=50) will be randomly assigned to receive either 1) 4 educational sessions covering information on diagnosis, treatment, available resources and self care for OCD and OCD Spectrum Disorders or 2) wait list as per usual with no additional information sessions. The experimental design is a 2 (treatment condition) by 2 (assessment phase) repeated measures factorial design. It is hypothesized that subjects participating in the psychoeducation group compared to the wait list control group will see greater reductions in self-reported measures of symptom severity and improvement in other measures of quality of life, level of functioning, self-efficacy and readiness to engage in treatment. If this study can demonstrate that the addition of a short structured informative intervention of 4 sessions can confer early benefits for those suffering with OCD and OCD spectrum disorders, then it provides another route by which patients can improve this condition specifically while waiting for consultation and the opportunity to receive a more structured, evidence-based treatment.


Eligibility Criteria:
Inclusion Criteria:

* Referred for treatment services at the Frederick W. Thompson Anxiety Disorder Centre at Sunnybrook Health Sciences Centre
* Presenting with OCD or OCD Spectrum Disorders
* Ability to communicate in written and spoken English

Exclusion Criteria:

* Active substance abuse/dependence
* Suspected organic pathology
* Recent suicide attempt/active suicideality
* Active bipolar or psychotic disorder
Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer

This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in non-small cell lung cancer

This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus etoposide/cisplatin with concurrent radiotherapy in stage III non-small cell lung cancer with EGFR 19/21 Mutation, the primary endpoint is progression-free survival

Eligibility Criteria:
Inclusion Criteria:

* Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation
* No previous systemic anticancer therapy
* Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site
* ECOG Performance Status of 0 to 1

Exclusion Criteria:

* Prior treatment with anti-EGFR (the epidermal growth factor receptor) monoclonal antibody or small molecular compounds therapy such as gefitinib, erlotinib or cetuximab
* Evidence of clinically active Interstitial Lung Diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
* Known severe hypersensitivity to icotinib or any of the excipients of this product
Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)

Radiochemotherapy is a standard for the treatment of unresectable stage III non-small cell lung cancer. The investigators goal is to study the efficacy and the toxicity for a promising association of new agents (cetuximab and pemetrexed) with concurrent radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* non-squamous stage III non-small cell lung cancer
* measurable disease (RECIST 1.1)
* ECOG performance status 0-1
* normal organ and marrow function

Exclusion Criteria:

* prior chest radiation therapy
* history of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last five years.
* Prior therapy with known specific inhibitors of the EGFR.
* history of severe allergic reaction to prior therapy with monoclonal antibodies
[KJ-INT-002] BE Study

Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 after Oral Administration to Healthy Adult Male Subjects


Eligibility Criteria:
Inclusion Criteria:

1. Male aged between 19 and 45 years of age inclusive, at the time of signing the informed consent.
2. Body weight \>= 50 kilogram (kg) and body mass index within the range 18 - 29.0kg/m\^2 (inclusive).
3. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
4. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

Exclusion Criteria:

1. Patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system.
2. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator contraindicates their participation.
3. Systolic blood pressure ≥ 150 or ≤ 100 mmHg, Diasolic blood pressure ≥ 95 or ≤ 55 mmHg.
4. Gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational product.
5. Alanine aminotransferase, alkaline phosphatase \<=2x upper limit of normal (ULN) total bilirubin \> 2.0mg/dl and eGRF \<60mL/min/1.73m2
6. History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of \>21 units for males. One unit is equivalent to 10 gram of alcohol.
7. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days of the biological effect of the investigational product (whichever is longer).
Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies

The purpose of this clinical trial is to provide study medicine(s) and learn about their safety. This study is seeking participants who:

* Have benefited from ongoing study treatment as determined by the study doctor in a Pfizer-sponsored palbociclib Parent Study
* Must agree to follow the reproductive criteria
* Are willing and able to comply with all scheduled visits, treatment plans, and other study procedures
* Can give signed informed consent documents

Participants in this study will continue to receive treatment as they were in the parent study. The time by which participants will take part in this study is retrospective (after completed parent study). We will examine the experiences of people receiving the study medicine(s). This will help us determine if the study medicine(s) are safe. During this time, the participants will be monitored for the safety of the study medicine(s).

This is an open-label study to provide continued access to treatment for eligible participants who continue to derive clinical benefit as determined by the investigator from study intervention(s) in a Pfizer-sponsored palbociclib clinical study (Parent Study)

Eligibility Criteria:
Inclusion Criteria:

* Any participant who is receiving study treatment and deriving clinical benefit as determined by the investigator in a Pfizer-sponsored palbociclib Parent Study
* Participants must agree to follow the reproductive criteria
* Participants who are willing and able to comply with all scheduled visits, treatment plans, and other study procedures
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document and protocol

Exclusion Criteria:

* Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study
A Multi-Strain Probiotic Reduces the Frequency of Diarrhea in IBS-D Patients

The goal of this interventional clinical study is to study whether the consumption of QiMeiYan Probiotics in 25-35 young people with Mild irritable bowel syndrome (IBS Score 75 - 175) will reduce the frequency of Diarrhea.

140 eligible participants (70 males and 70 females) will be enrolled in two study sites and randomly assigned to two groups of products QiMeiYan Probiotics and placebo. All participants will consume assigned products once a day after meals and record the critical data such as photo of feces. Three site visits will be arranged and all clinical data will be captured and recorded into CTMS (Clinical Trial Management System) for statistical analysis.

Researchers will compare the two groups to validate if the daily consumption of QiMeiYan Probiotics will reduce the frequency of Diarrhea in the study population.


Eligibility Criteria:
Inclusion Criteria:

* Chinese males or females, age between 25-35, the ratio is 1:1;
* Mild irritable bowel syndrome diagnosed by IBS-SSS, IBS Score 75 - 175;
* Subjects agree not to take any other probiotics during the trial;
* Willing not to participate in other interventional clinical studies during the period of this trial;
* Fully understand the purpose, benefits obtained, possible risks and side effects of the study;
* Willing to comply with all research requirements and procedures;
* Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate.

Exclusion Criteria:

* In the treatment of gastrointestinal symptoms;
* Lactose intolerance;
* Suffering from other organic diseases currently that affect the intestinal function, such as history, colon or rectal cancer resection of gastrointestinal tract, inflammatory bowel disease, diabetes, thyroid function hyperfunction or decline, congenital megacolon, scleroderma, anorexia, etc.;
* Controlling diet, exercising more, or taking medications to control weight or affect appetite in the last 3 months;
* Subjects have any of the following medical history or have been clinically examined to have the following diseases that may affect the evaluation of the test effect: obvious gastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases;
* Abuse alcohol or other drugs, supplement or OTC drugs currently or in the past may cause bowel dysfunction or can affect test result evaluation;
* Take drugs frequently that may affect gastrointestinal function or the immune system according to PI's judgment;
* Use laxatives or other substances that promote digestion 2 weeks before the trial;
* Take dairy products or other foods containing prebiotics/bacteria 10 days before the trial.
Multicenter Unsustained Tachycardia Trial (MUSTT)

To determine the value of electrophysiologic (EP)-guided antiarrhythmic therapy in coronary heart disease patients at increased risk for sudden death. The study included a controlled clinical trial and a registry.

BACKGROUND:

Cardiac arrest (sudden cardiac death) occurs relatively frequently in asymptomatic patients who have had myocardial infarctions, have ejection fractions less than 40 percent, and non-sustained ventricular tachycardia. However, it is not possible to predict who will die suddenly or when cardiac arrest will occur. Current efforts to reduce sudden death in such long-term survivors of myocardial infarction or in patients with coronary disease have produced results that are not very encouraging.

Such patients may feel quite well. They survived their myocardial infarction and may have slight or even moderate reduction of exercise ability, but by 'pacing' themselves, such patients can lead relatively normal lives. They may be aware of their arrhythmia because of short periods of palpitations which may only trouble them transiently. Consequently, this group of patients, many still in the prime of their lives, are at relatively high risk of dying suddenly.

The multicenter trial may reveal the most effective treatment for such patients, the value of electrophysiologic studies in predicting who is most at risk of sudden cardiac death, and whether electrophysiologic studies can help select the best mode of treatment. The protocol for performing programmed stimulation and serial drug testing is designed to mirror those currently in use by many practicing electrophysiologists.

DESIGN NARRATIVE:

Randomized, non-blind. Patients were assigned to standard therapy or to an aggressive arm consisting of electrophysiologic-guided antiarrhythmic therapy. Patients in the aggressive arm whose ventricular tachycardia was suppressible or who were still inducible, but who were hemodynamically stable in ventricular tachycardia, were followed on drug therapy. Otherwise, patients in the aggressive arm received an implantable defibrillator. The primary endpoint was sudden cardiac death or cardiac arrest. Patients without inducible sustained ventricular tachycardia were followed in a registry. Recruitment ceased on October 31, 1996 after a recommendation from the DSMB.

The study completion date listed in this record was obtained from the "End Date" entered in the NIH Query View Report (QVR).

Eligibility Criteria:
Men and women patients with documented coronary artery disease, ejection fraction less than or equal to 40 percent, and nonsustained asymptomatic ventricular tachycardia.
Medication Abortion With Autonomous Self-Assessment Project

In this study, the investigators propose to create and pilot-test an asynchronous medication abortion provision service.

In this study, the investigators propose to create and pilot-test an asynchronous medication abortion (MA) provision service. The foundation of this service will be a website that provides information combined with a linked screening questionnaire. The questionnaire will be designed to collect the information recommended by current MA guidelines for history-based MA eligibility assessment. If the patient's responses meet specified criteria, the questionnaire will be sent to a study clinician, who will then determine whether a real-time clinical consultation or facility-based tests are needed. If the clinician decides that they are not, treatment will be provided accordingly. The primary goal of the study is to collect preliminary data on feasibility of the approach, abortion outcomes, and participant satisfaction. The investigators will use these data to determine whether to proceed with further development of asynchronous MA provision.

Eligibility Criteria:
Inclusion Criteria:

* • Has reviewed the study website

  * Can speak and read English
  * Has an address in a state where the study clinicians are licensed to practice medicine and where the service is legal
  * Is at least 18 years old
  * Is pregnant with a gestational age of ≤54 days from last menstrual period
  * Desires MA
  * Has not had an ultrasound in the current pregnancy (see below)
  * Has no symptoms of or risk factors for ectopic pregnancy
  * Has no medical contraindications to MA, specifically:

    * Hemorrhagic disorder or concurrent anticoagulant therapy
    * Chronic adrenal failure
    * Concurrent long-term systemic corticosteroid therapy
    * Inherited porphyria
    * Allergy to mifepristone or misoprostol, or other prostaglandin
  * Is comfortable obtaining the abortion pills without a pre-treatment ultrasound and without speaking by phone or video with the abortion provider.

Exclusion Criteria:

-
Circadian Health and Influential Factors

This study evaluates the quality of sleep of patients admitted to medical and intensive care units. All of them will have a clock placed to measure their circadian activity. Also, data will be recorded through questionnaires about the unit, patient habits and medical problems.

The investigators found an extensive bibliography related to the quality of sleep and its effects on health. However, it should be noted the literary emptiness in relation to the influential factors in it. Chronobiology is the science responsible for studying the rhythmic changes in living beings; where the investigators include the circadian rhythm. In this way, all the "cycles" will be influenced by a series of factors that allow its correct operation, being in this case the light-dark cycle (LD), together with the temperature compensation, these being the determinants that allow, or not homeostasis.

The sleep - wake pattern is one of the most important circadian rhythms that happen in the organism. The dream is an unconscious process by which, despite the muscular relaxation that occurs, it is accompanied by continuous brain activity along with sensitive perception, where several of the organ systems come into play. This cycle is composed of two factors: a homeostatic one directly proportional to the time we are awake, and another circadian, dependent on the secretion of melatonin and the body's regulation of temperature. This fact can be compromised by the appearance of both external and internal stimuli, altering normal functioning, which is translated into sleep deprivation, which, if extended over time, can have physical and mental consequences, Some of them are: deterioration of the immune function, an increase in the incidence of cardiovascular diseases, memory deficit, early aging, mood swings, difficulty in healing, greater probability of developing metabolic syndromes, cognitive, affective disorders and even some types of cancer

The results obtained will facilitate the elaboration of action protocols focused on improving sleep quality in hospitalized patients.

Eligibility Criteria:
Inclusion Criteria:

* subjects over 18 years of age, minimum duration of the hospitalization process of 96h, conscious and oriented with constancy in their clinical history (HC) and who give their consent.

Exclusion Criteria:

* personas con discapacidad visual y/o auditiva documentada en su HC, en el caso de los pacientes de Unidades de Cuidados Intensivos (UCIs) se excluirán a aquellos que obtengan una puntuación inferior a 8 en la escala Glasgow. Pacientes con cualquier tipo de aislamiento y aquellos incluidos en el plan de Cuidados Paliativos.