cyrilzakka/clinical-trials huggingface dataset:
Exploratory Study of Propofol and Fentanyl Pharmacodynamics

Exploration of the hypothesis that general anesthesia is not a singular threshold but is a continuum of central nervous system depression dependent on interpretation of nociceptive stimuli.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesia (ASA) classification score I-II male and female volunteers
* Normal healthy individual by medical history and physical examination
* Uncomplicated airway anatomy
* Body Mass Index (BMI) between 18-29
* Subject willing to give consent and comply with evaluation and treatment schedule
* 18-55 years of age (inclusive)
* Negative durg screen for marijuana, cocaine, ecstasy, phencyclidine (PCP), amphetamines, benzodiazepines, opiates and methamphetamines
* Woman of childbearing age byst be utilizing reliable means of contraception
* Able to read, speak and understand English

Exclusion Criteria:

* Physical of psychological condition which would impair study participation as determined by the principal investigator
* Known or suspected neurological pathologies as assessed by the principal investigator
* History of significant alcohol or drug abuse, a history of allergy to opioids or propofol, or a history of chronic drug requirement or medical illness that is known to alter pharmacokinetics or pharmacodynamics of fentanyl and/or propofol
* Known or suspected hypersensitivity to any study drug
* Taken any medication within 2 days prior to study drug administration, with the exception of oral contraceptives
* Baseline tolerance above 50 mA on TES
* Pregnancy or lactation
* Consumed food within 8 hours or liquids within 4 hours prior to study drug administration
* Participation in any other investigational device or durg study within 30 days of enrollment
* Diagnosis of sleep apnea
* Current prescription to anti-depressant or anti-anxiety medication
Yoga for Breast Cancer

The purpose of this study is to examine the use of Eischens yoga for 8 weeks in one cohort of 20 women with stage I and II breast cancer receiving radiation therapy treatment, while a second cohort of the same type of and number of patients who, instead of yoga will receive standard supportive therapy, Questionnaire measuring cancer-related quality of life (FACT-G instrument) and fatigue (Brief Fatique Inventory) will be given to patients at several points.


Eligibility Criteria:
Inclusion Criteria:

* Stage I and II breast cancer patients undergoing active radiation therapy
* Above the age of 18
* Must sign informed consent form
* Must speak English
* Only women are eligible

Exclusion Criteria:

* Patients with medical restrictions that may interfere with yoga participation per their physicians' decision
* Those who have smoked in the last 6 months because smoking can interfere with the breathing and relaxation techniques of yoga.
* Those who have regularly taken yoga in the last 6 months, because they would not come to the intervention with the same baseline as other participants.
Impact of Counselling and Visual Aid on Anxiety in Endoscopic Patients

A single blind randomized controlled trial was conducted to compare the effect of counselling and visual aid on the anxiety levels in patients undergoing endoscopy and to investigate the superiority of visual aid over psychological counselling and preparation for the procedure in an informed patient.

A single blind RCT was conducted to assess level of state anxiety between two interventional groups; counselling group and video group. 232 consecutive patients were enrolled from the outpatient department who were scheduled to undergo either a gastroscopy or a colonoscopy (diagnostic or therapeutic). The patients were randomly allocated to one of the two intervention groups (A and B) at the time of endoscopy scheduling. All of the patients received regular instructions regarding gut-preparation at the time of appointment and were also provided with written clear instructions. A gastroenterologist provided information about endoscopy, including the exact preparation instructions and information on the importance of bowel preparation and the adverse effects of the agents used.

Depression Anxiety Stress Scale-42 was administered at baseline. Intervention group A (counselling group) was counselled about the procedure, complications and the post-procedure recovery phase and Group B (video group) was also counselled and shown a 5 minutes animated video of the respective procedure in separate room by gastroenterologist. Endoscopies were carried out by trained doctors (endoscopists) with a minimum experience of 1000 endoscopic procedures. Patients in both the groups were interviewed again after the intervention using Depression Anxiety Stress Scale-42.

Eligibility Criteria:
Inclusion Criteria:

* both genders (male or female) with a minimum age of 18 years
* Able to comprehend questions being asked in Urdu language
* Mentally competent at signing the consent form

Exclusion Criteria:

* Patients who were diagnosed cases of psychiatric illnesses
* Undergoing emergency endoscopy (whether diagnostic or therapeutic)
* End stage renal disease
* Hearing difficulty
* Senile dementia
* Pregnant or diagnosed cases of malignancy
* Signs of hepatic encephalopathy
Doppler at the Diagnosis in Predicting Perinatal Outcomes in Early and Late-onset Fetal Growth Restriction

When a FGR is diagnose, the challenge in his monitoring is to assess the benefit-risk balance between continuing the pregnancy in order to limit complications related to prematurity and birth in order to minimize any risk of fetal death in utero. By able to know the characteristics of fetal deteriorations and its relationship with fetal and neonatal outcomes could be a thankful help in this decision. The placental insufficiency is by far the most common cause of FGR (32)(miller 2008). This effect can be documented thanks to ultrasound examinations to study fetal growth and Doppler of umbilical arteries for the placenta, the middle cerebral artery for the brain perfusion and the Ductus Venosus for the cardiac effects of placental dysfunction. The apparition of Doppler abnormalities suggests a deterioration of the disease and leads to several changes in clinical FGR management. Nevertheless, at this time, very few studies allow us to predict the time util the degradation and their impact on perinatal outcomes.

The primary aim of this study was to evaluate the performance of the Doppler at the time of diagnosis in predicting the outcome of pregnancies. The secondary aim was to evaluate the performance of Doppler performed at any time during pregnancy and studied independently in predicting outcome of pregnancies


Eligibility Criteria:
Inclusion Criteria:

* Fetal growth restriction of antenatal diagnosis

Exclusion Criteria:

* Twin pregnancies, non-isolated IUGR, post-natal diagnosis of FGR and incomplete records
Multi-points and Full-thickness Biopsy in the Diagnosis of cCR After Neoadjuvant Therapy for Rectal Cancer

Background There is currently no reliable means to restage rectal cancers after neoadjuvant chemoradiation. There are still no reliable methods to identify patients with pCR before radical surgery. As a result, clinical complete response (cCR), defined as no clinical detectable tumor by physical examination, endoscopic evaluation, and imaging, is designed as a surrogate endpoint for pCR. However, the concordance between cCR and pCR varies from 22% to 96% in different reports, which questions the clinical value of such strategies. Therefore, based on rectal diginal examination, serum CEA, MRI, endoscopy examination, we suggested to add multi-points and full-thickness biopsy technique to further improve the accuracy of cCR.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and female, between 18 and 80 years old;
* Colonoscopy biopsy pathology confirmed colorectal adenocarcinoma;
* The distance from the lower margin of the tumor to the anal margin ≤12 cm (endoscope) or to the anorectal ring ≤8 cm;
* The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesia;
* Initial local MRI stage was T2 or T3A or T3B, N0-2, negative for extramural vascular invasion (EMVI), circumferential ential resection margin (CRM), and no peripheral iliac, common iliac, obturator, or abdominal aortic lymph node metastasis;
* CCR patients evaluated after neoadjuvant therapy (no mass or ulcer found on digital rectal examination;Endoscopic examination showed no other changes except flat scar, telangiectasia or pallor of mucosa.MRI or rectal ultrasound showed no residual tumor in the primary site and lymphatic drainage area.Serum carcinoembryonic antigen (CEA) was normal.
* Signing informed consent for surgery.

Exclusion Criteria:

* Previous history of malignant colorectal tumor;
* Patients complicated with intestinal obstruction, intestinal perforation, intestinal bleeding and other patients requiring emergency surgery;
* Unresectable lymph node metastasis;
* Recently diagnosed with other malignant tumors;
* Patients who had participated in or were participating in other clinical trials within 4 weeks prior to enrollment;
* ASA rating ≥IV and/or ECOG physical status score ≥2 points;
* Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious basic diseases cannot tolerate surgery;
* a history of serious mental illness;

  - pregnant or lactating women;
* Those with uncontrolled infection;
* Patients with other clinical or laboratory conditions considered by the investigator should not participate in the study
An Observational Study in Differentiated Thyroid Cancer Which is Radioactive Iodine (RAI) Refractory to Assess the Use of Multikinase Inhibitors

The purpose of the study was to assess the use of Multikinase Inhibitors (MKIs) in the treatment of patients with a progressive differentiated thyroid carcinoma (DTC) refractory to radioactive iodine (RAI) who do not have any symptoms.

The primary objective of this study was to compare time to symptomatic progression (TTSP) from study entry in asymptomatic patients with RAI-refractory progressive DTC for whom there is a decision to initiate MKIs at study entry with that of asymptomatic patients with RAI-refractory progressive DTC for whom there is a decision to not initiate MKIs at study entry.

Eligibility Criteria:
Inclusion Criteria:

* Histologically/cytologically documented DTC (papillary, follicular, Hurthle cell, and poorly differentiated carcinoma)
* DTC refractory to RAI
* Radiological progression and preferably according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* No symptoms due to DTC
* \>/=1cm diameter of lesion confirmed by radiological exam
* Life expectancy of at least 6 months

Exclusion Criteria:

* Plan to be treated according to a clinical trial protocol for intervention including a locoregional therapy or systemic therapy
* Previous treatment with MKIs for advanced disease
* Hospice patients
Efficacy and Safety of Posiformin 2 % Eye Ointment in the Treatment of Blepharitis

This is a multicentre, randomised, double-masked, parallel-group, phase IV comparison of Posiformin 2 % eye ointment (active substance: bibrocathol) in the treatment of blepharitis.

Reduction of signs and symptoms of blepharitis

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* ambulatory male and female patients 18 years of age or older
* summarised score of signs and symptoms of blepharitis of 15 or more at baseline

Exclusion Criteria:

* different ocular conditions
* different system conditions
* several concomitant medications
Urinary miRNA in Endometrial Cancer Study

This study is a prospective feasibility study with the addition of a retrospective cohort study on the the expression of microRNA in urine in endometrial cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of endometrial cancer
* Age: 18 years or older

Exclusion Criteria:

* Prior or coexisting other malignancies
* Autoimmune disorders (other than diabetes mellitus)
CT Perfusion Changes in GI Cancer During Adenosine Vasodilation Test

The aim of this study was to investigate changes in abdominal tissue perfusion during adenosine vasodilation. Our hypotheses were that CT perfusion measurements are altered by changes in the circulatory system mediated by adenosine, and a more differentiated assessment of the circulatory capacity of abdominal tumours could be achieved by sequential rest and adenosine vasodilation CT perfusion measurements.


Eligibility Criteria:
Inclusion Criteria:

* Tumour larger than 1.5 cm on diagnostic CT
* Normal serum creatinine
* Age above 18
* Informed written and oral consent.

Exclusion Criteria:

* Contrast allergy or contrast induced nephropathy
* BMI \> 40
* Asthma or Chronic Obstructive Lung Disease
* Heart failure (NYHA III+)
* Heart conduction disorder
* Atrial fibrillation
* 2nd/3rd Heart block
* Long QT syndrome
* Wolf Parkinson White Syndrome
* Moderate / severe aortic stenosis
* Haemodynamic contraindications for adenosine, systolic pressure below 90
A Study of the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise (MK-8835-003, VERTIS MONO)

This trial will evaluate the efficacy and safety of ertugliflozin monotherapy in the treatment of participants with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on diet and exercise. This trial consists of a run-in period of 3 to 11 weeks, a 26-week placebo-controlled treatment period (Phase A), and a 26-week active treatment period (Phase B). The primary hypotheses of the trial are that at Week 26, the mean reduction from baseline in hemoglobin A1c (A1C) for 15 mg ertugliflozin is greater than that for placebo and the mean reduction from baseline in A1C for 5 mg ertugliflozin is greater than that for placebo.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T2DM in accordance to American Diabetes Association guidelines
* Participants with no prior allowable oral anti-hyperglycemic agents (AHA) for at least 8 weeks prior to study participation or participants on a single allowable oral AHA at the start of study participation
* Participants on a single allowable AHA must be willing to discontinue this medication at the Screening Visit (S2) and remain off this medication for the duration of the trial. Allowable oral AHAs for discontinuation are metformin, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, glinides or alpha-glucosidase inhibitors.

Exclusion Criteria:

* History of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, or New York Heart Association (NYHA) functional class III-IV heart failure within 3 months of study participation
* A clinically significant electrocardiogram abnormality
* A history of malignancy ≤5 years prior to study participation, except for adequately treated basal or squamous cell skin cancer or in situ cervical cancer
* A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2) inhibitor or metformin
* On a blood pressure or lipid altering medication that have not been on a stable dose for at least 4 weeks prior to study participation
* A surgical procedure within 4 weeks prior to study participation or planned major surgery during the trial
* Donation of blood or blood products within 6 weeks of study participation or plans to donate blood or blood products at any time during the trial
* Pregnant or breast-feeding, or is expecting to conceive during the trial, including 14 days following the last dose of study drug
A Study of TQ-B3525 Tablets in Subjects With PIK3CA and/or PIK3R1/2 Gene-altered Recurrent/Metastatic Advanced Gynecologic Tumors

This is a study to evaluate the efficacy and safety of TQ-B3525 in subjects with recurrent / metastatic advanced endometrial cancer, cervical cancer and ovarian cancer with PIK3CA and / or PIK3R1 / 2 gene-altered (mutation or amplification). Endometrial cancer, cervical cancer and ovarian cancer are divided into three cohorts, each cohort administrated TQ-B3525 tablet orally once a day.


Eligibility Criteria:
Inclusion Criteria:

* 1. Pathologically confirmed malignant gynecological neoplasm. 2. Has PIK3CA and/or PIK3R1/2 Gene-altered. 3.Unresectable, locally advanced recurrent and/or metastatic tumors, has at least 1 measurable lesion.

  4.Failed with standard treatment or has no effective treatment. 5. 18 years and older, Eastern Cooperative Oncology Group(ECOG) performance status score of 0 to 1, Life expectancy ≥ 3 months.

  6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.

  7.Understood and signed an informed consent form.

Exclusion Criteria:

* 1.Has untreated or active central nervous system metastases. 2.Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration.

  3. Insufficient hematopoietic function of bone marrow. 4. Dysfunction of liver and kidney. 5. Bleeding risk. 6. Dysfunction of gastrointestinal tract. 7.Dysfunction of heart and cerebral vessels. 8.Has received PI3K, AKT, mTOR inhibitor. 9.Has participated in other clinical trails within 30 days. 10. Has received surgery, or unhealed wounds within 4 weeks before the first administration.

  11. Has received organ grafting, or hematopoietic stem cell transplantation within 60 days before the first administration, or host versus graft reaction.

  12. The patients required immunosuppressor, or the whole-body, or absorbable local hormone therapy for immunosuppression purposes and continued to use within 7 days before the initial administration (daily dose of glucocorticoid \<10 mg, except metacortandracin or other therapeutic hormones and so on).

  13. Has active infections. 14. Has human immunodeficiency virus (HIV). 15. Pregnant or lactating women. 16. Has psychotropic substances abuse or a mental disorder. 17. Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.

  18. Patient's compliance is inadequate.
Efficacy of Cap-assisted Chromoendoscopy as a Screening Test for Colorectal Neoplasm Using Web-based Research Network

The investigators plan to conduct a multi-center, randomized controlled trial to investigate the efficacy of cap-assisted chromoendoscopy as a screening test for detection of colorectal polyp. This study will be performed using web-based research network, e-VELOS in Korea.

Various endoscopic tools have been tried to reduce polyp missing rate which has been reported to be 20-25%. Transparent cap-assisted colonoscopy has been suggested to improve visualization of the lesion that are difficult to access, such as tangentially located lesions and those located within a limited luminal space. Chromoendoscopy with indigocarmine spraying was reported to increases the detection rates of polyp, especially in right colon and rectum. However, there also have been mixed results regarding polyp detection rates of the endoscopic methods. Moreover, there is no data regarding the impact of the screening tools on longterm recurrence rate of colorectal polyp. Therefore, in this study, we intend to perform a multi-center, randomized controlled trial to investigate the efficacy of cap-assisted chromoendoscopy as a screening test for detection of colorectal polyps. This study will be performed using web-based research network, e-VELOS in Korea.

Eligibility Criteria:
Inclusion Criteria:

* All asymptomatic colonoscopic examinees

Exclusion Criteria:

* Familial history of hereditary colorectal cancer
* History of colorectal cancer
* Patients had received colonoscopy examination before
* Familial or past history of FAP(familiar adenomatous polyposis)
* Colonic polyposis syndrome
* Prior colonic resection of any part of the colon
* Allergy to indigo carmine
* Inflammatory bowel disease
* Pregnancy
* Inability to provide informed consent
Testing the Feasibility and Acceptability of Social Media and Digital Therapeutics to Decrease Vaping Behaviors

Use of vaping products (e.g., electronic nicotine delivery systems, e-cigarettes) has been increasing rapidly, particularly among teens and young adults. With limited information on the long-term effects of vaping products, health information about vaping has been somewhat unclear in regards to associated health risks. Teens and young adults may be reluctant to disclose their use of vaping products to parents or health providers and instead turn to social media to share and seek out information regarding vaping risks and cessation supports. Thus, our current proposal outlines the use of social media to identify teens and young adults socially networking about vaping, the use of an online chatbot screen to evaluate individual cessation support needs, and the use of a digital intervention system to support vaping cessation. The mobile intervention used in this study is based on a widely-used evidence-based mobile intervention for combustible smoking (i.e., quitSTART) and has been adapted for vaping and young adults to include an in-app chatbot to guide users to tailored content and to motivate and encourage their cessation efforts. We aim to integrate our social media recruitment and online screening approach to connect individuals with this mobile app intervention, and will conduct a randomized controlled trial to evaluate user engagement with and preliminary efficacy of the digital intervention on reducing vaping behaviors among teens and young adults.


Eligibility Criteria:
Inclusion Criteria:

* US Resident
* English Speaking
* Have daily access to a smartphone
* Current vaping product user (P30D)
* Identified as socially networking about a desire to quit vaping and/or experiencing negative health outcomes due to vaping
* Vaping product user only (i.e., not using vaping as a means to support combustible smoking cessation)
Patients Undergoing Percutaneous Coronary Intervention (PCI) Through Optimal Platelet Inhibition

The purpose of this study is to assess the the 1-year rates of ischemic and bleeding complications in patients whose dual antiplatelet therapy regimen post-PCI has been determined with the use of a clinical algorithm that includes both clinical risks and platelet reactivity while on chronic clopidogrel therapy.

Prospective multicenter registry. Patients already on chronic dual antiplatelet therapy with aspirin and clopidogrel will be assessed for (1) clinical risks factors for future bleeding and ischemic complications, and (2) on-treatment platelet reactivity as measured by the VerifyNow P2Y12 assay (Accumetrics, Inc., San Diego, CA, USA). These will be considered by utilization of a clinical algorithm to determine the dual antiplatelet regimen post-PCI (aspirin in combination with 1. clopidogrel, 2. prasugrel 5mg daily, or 3. prasugrel 10mg daily).

Eligibility Criteria:
Inclusion Criteria:

* The subject has provided informed written.
* The subject must be ≥ 18 years of age (or minimum age as required by local regulations) at the time of enrollment.
* Patient is established on chronic clopidogrel therapy when he/she returns for PCI, and the components of DAPT are determined by the clinical decision algorithm as local standard of care.
* The subject is willing and able to cooperate with the study procedures and required follow-ups.

Exclusion Criteria:

* Patients with cardiogenic shock will be excluded.
* The subject is participating in an investigational device or drug study. Subject must have completed the follow up phase of any previous study at least 30 days prior to enrolment in this study.
* Pregnant women.