cyrilzakka/clinical-trials huggingface dataset:
Low-fiber Diet for Colorectal Cancer Screening Colonoscopy

This trial will compare the efficacy of 2 different sets of dietary recommendations to be followed before colon cleansing for colorectal cancer screening colonoscopy.

There is no enough evidence in the literature to recommend a low-fiber diet for screening colonoscopy. Although evidence of benefit of a liquid diet is minimal and there is a growing body of evidence about the benefits of a liberalized diet, a high degree of heterogeneity in the clinical trials comparing the diet modifications before colonoscopy prevents a formal recommendation in current guidelines. A low-fiber diet the day before colonoscopy may result in same efficacy of bowel cleanliness, with an improved tolerability and acceptability.

All consecutive patients of a population-based colorectal screening cancer program referred for a colonoscopy will be invited to participate in the study. After obtaining informed consent, they will be randomized to one of the groups: liquid diet or low-fiber diet. The will be interviewed by a registered research nurse, and they will be provided with written instructions for bowel preparation and questionnaires for registering the data of the study. The day of the colonoscopy, questionnaires will be collected and endoscopists blinded for the study bowel preparation will perform the colonoscopy. Patients will be contacted for adverse events and a general satisfaction questionnaire, 3 days after colonoscopy.

Eligibility Criteria:
Inclusion criteria:

* Consecutive patients referred for a colonoscopy in a population-based colorectal screening program.

Exclusion criteria:

* Unwillingness to participate.
* Inability to follow instructions
* Active inflammatory bowel disease
* Incomplete colonoscopies for technical reasons or contraindication as evaluated by the endoscopist
An Internet-based Dialectical Behaviour Therapy-informed Skills Training for Reducing Alcohol Consumption and Improving Psychological Distress of Adult Smokers.

1. To determine the feasibility, acceptability, and preliminary effects of an internet-based DBT-ST for promoting smoking abstinence/reduction and improving psychological distress/emotional regulation in adult smokers
2. To explore the participants' experiences and perceptions (e.g., perceived benefits/weaknesses) towards the proposed intervention


Eligibility Criteria:
Inclusion Criteria:

* Hong Kong Chinese aged 18-64 years
* Had smoked at least one cigarette per day over the previous three months
* Indicate psychological distress as measured by the Depression, Anxiety, and Stress Scale-21
* Have an intention to stop smoking
* Have an electronic device and are willing to receive interventions via the internet

Exclusion Criteria:

* Experiencing psychotic disorders/cognitive impairment/communication problems
* Participating in other smoking cessation programs or related psychosocial interventions
E-Sense® Normal Values of Urodynamic Pressures Using E-Sense® Catheters

In this post-market observational study, subjects referred to urodynamic testing will be approached to enroll in a clinical study to define the normal range of pressure values utilizing e-Sense® catheters. Urodynamic test results using the study devices will be provided back to the study sponsor for test interpretation and to publish. The urodynamic information collected using the study devices will be used in the UDS test interpretation for each subject enrolled, unless there is a reason to believe the test should be repeated (i.e. inconclusive results).

Subjects who are referred to undergo a Urodynamics will be recruited to participate. Initial resting pressures will be measured/recorded using the e-Sense® and water-filled catheter (dual-catheterized) in lying, sitting, and standing positions for each subject. The study will collect various urodynamic pressure values at regular intervals during bladder filling. The detrusor pressures before filling will then be compared with the pressures collected during bladder filling to determine normal pressure value ranges. Urethral pressures will also be measured using e-Sense® and water-filled catheters, and the values compared. The goal is to provide users of the e-Sense® catheter as to what values should be expected when good quality measurements are being made.

Eligibility Criteria:
Inclusion Criteria:

* Subjects medically indicated for Urodynamic procedure between ages 20-35 or \> 50 years old (equally split male and female)
* Due to aging and giving birth significantly affecting the urethra:
* Female subjects 20-35 should be nulliparous.
* Female subjects \> 50 years old should have given birth to at least one child vaginally. Further caesarian births would not mean exclusion from the study.
* Subjects with range of BMI values
* Subject provides written authorization and/or consent per institution or geographical requirements

Exclusion Criteria:

* Subjects with cognitive or psychiatric conditions that interfere with or precludes direct and accurate communication regarding the study, giving informed consent
* Any anal / rectal symptoms and/or surgery
* Pregnant women
* Subjects with active untreated bladder infections (not including patients with asymptomatic bacteruria)
* Subjects having greater than 300 mL post void residual on the clinic visit uroflowmetry test
Prospective Multi-omics Observational Study of Gynecological Rare Pathological Tumors

The goal of this observational study is to draw the characteristic maps of genomics, transcriptome, proteomics, metabolomics, etc. in 600 patients with gynecological rare pathological types of malignant tumors. Then it is planned to explore the molecular mechanism and find some new targets for diagnosis and treatment, and design and establish the database system of the above rare tumors.


Eligibility Criteria:
Inclusion Criteria:

* 1)Pathological diagnosis: clear cell carcinoma (ovary, uterus), nerve small-cell carcinoma (ovary, uterus), carcinosarcoma or sarcoma (ovary, uterus), cervical gastric adenocarcinoma, ovarian germ cell tumor, ovarian sex cord stromal tumor, trophoblastic tumor, perivascular epithelioid cell tumor (PECOMA) and other rare gynecological tumors; 2)Received pathological results from tumor surgery; 3)The patient voluntarily participated in this research project with good compliance and was able to complete the enrollment according to the experimental requirements; 4)Sign the informed consent form and consent to the collection and use of their data, and consent to genomics, transcriptome and other tests.

Exclusion Criteria:

* 1)Patients with malignant tumors in other parts of the body; 2)Suffering from uncontrollable neurological diseases, psychiatric diseases, or psychiatric disorders; 3)Poor compliance and inability to cooperate and describe treatment responders.
A Study to Determine the Effects of Multiple Doses of Mipomersen (200 mg SC) on the Pharmacodynamics and Pharmacokinetics of Single-dose Warfarin

The purpose of this study is to assess how blood clotting and thinning time is effected when a single dose of warfarin is given alone and when a single dose of warfarin is given with mipomersen; to assess the blood levels of a single dose of warfarin, a single dose of mipomersen, and a single dose of warfarin when given with mipomersen; and to assess the safety of mipomersen when given with or without warfarin.

This will be a Phase 1, open-label, single-sequence, 2-period, crossover study to determine the effect of multiple doses of mipomersen (200 mg SC given every other day for a total of 4 doses) on the PD and PK of warfarin and to evaluate the PK of mipomersen when administered alone and in combination with warfarin. Subjects will be admitted to the clinic on Day -1 until discharge from the clinic on Day 18 and return for outpatient visits on Days 19, 20, and 78. All subjects will receive a single 25-mg oral dose of warfarin given alone on Day 1 (designated the reference treatment). All subjects will then receive 200-mg SC doses of mipomersen given every other day on Days 8, 10, 12, and 14 (total of 800 mg mipomersen) with a single 25-mg oral dose of warfarin also given on Day 14 (combination designated the test treatment).

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent before any study-related procedure is performed.
* Body mass index (BMI) between 18 and 32 kg/m2, inclusive.
* No clinically significant abnormalities based on medical history, laboratory assessments, vital sign, 12-lead electrocardiogram (ECG) results, and physical examination.
* Subjects willing and able to follow a prescribed diet.
* Subjects have not consumed nicotine or nicotine-containing products for at least 6 months before Screening.
* Subjects are nonpregnant and nonlactating, surgically sterile, postmenopausal, abstinent, or the subject or partner is willing to use a reliable method of contraception during the study and for 5 months after mipomersen dosing.

Exclusion Criteria:

* Poor metabolizer of warfarin as determined by CYP2C9 genotype testing.
* Clinically significant PT, aPTT, INR, protein C, protein S, or platelet count results or hematuria.
* Abnormal prolongation of skin bleeding time or a personal or family history of coagulation or bleeding disorders, vascular malformations including aneurysms, or venous thromboembolism.
* Active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease.
* Active malignancy of any type other than nonmelanomatous skin malignancies.
* Use of any prescribed or over-the-counter concomitant medications within 14 days before the first dose of investigational product without approval of the Investigator and Sponsor.
* Positive test result for drugs of abuse, alcohol, or cotinine or history of alcohol abuse or drug addiction.
* Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or HIV.
Exploration of Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease

This is a prospective study conducted on patients with Cerebral Small Vessel Disease, dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given Stellate Ganglion Block. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index.

This study is conducted for Exploration of Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease. This is a prospective study conducted on patients with Cerebral Small Vessel Disease, dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given Stellate Ganglion Block. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years.
* Meeting the diagnostic criteria for cerebral small vessel disease.
* Dysphagia confirmed by Videofluoroscopic Swallowing Study
* Mini-Mental State Examination (MMSE)\<27, indicating the existence of cognitive impairment.
* No history of prior stroke.
* Stable vital signs.

Exclusion Criteria:

* Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
* Cognitive impairment that might be caused by other diseases, such as Alzheimer's disease, Parkinson's disease, brain injury, etc.
* Neurological blockade contraindications such as bleeding tendency, blocked site infection.
* Unable to successfully finish the assessment of this study.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
* Pregnant or nursing females
From Administration of Oral Medicines by Nurses to Controlled Self-administration: Impact on Safety of Administration During Hospitalisation

Medication administration practices during patient hospital stay tend to improve patient autonomy. Several studies have concluded that self-administration of medication programs in hospital centers have a beneficial effect on patients' knowledge of their medications, their compliance and the safety of administration. Nevertheless, few studies have been carried out in France on this subject. The aim of this study is to evaluate the impact of the change of nurses administration practices from the administration of each drugs to supervision of self-administration by the patient under a self-administration program.


Eligibility Criteria:
Inclusion Criteria:

* Care in the rehabilitation unit of Hospital in Valenciennes, France
* Patient with a planned stay of 7 days or more
* Patient on chronic treatment before admission to hospital ;
* Patients taking their treatment alone at home;

Exclusion Criteria:

* Age \< 18 years old
* Patients with poor compliance
* No chronic treatment
* Unstable disease
* Major cognitive, memory or depressive disorders
* Swallowing disorders
* Prehension problems
* Patient under legal protection
* Patient under guardianship or curatorship
* Patient included in another trial
Measurement of the Pancreas Function in Patients With More Than One Pancreas After Liver and Small Bowel Transplantation

Under chronic immunosuppressive and corticosteroid therapy, transplant patients have a tendency to develop in the long-term diabetes. Patients who have received extra pancreatic tissue with their liver and small bowel transplantation have not yet developed insulin resistance or diabetes mellitus. We would like to investigate to which level insulin secretory capacity the extra pancreas together with the native pancreas has in these transplant patients using the hyperglycemic clamp. These data will be compared with the data obtained from healthy controls.

The glycemic control in type 1 diabetic recipients of islet cell grafts is correlated with the ß-cell mass. In the standard technique for liver/small bowel transplant procedure previously described by Grant et al, the pancreas was removed. This surgical method was modified by Sudan et al and the donor pancreas was transplanted intact in these non-diabetic patients. Under chronic immunosuppressive and corticosteroid therapy, these patients with extra ß-cell mass have not developed insulin resistance or diabetes mellitus. To which level insulin secretory capacity the extra pancreas allograft together with the native pancreas has in these transplant patients are not yet known.

Among the measures of pancreatic ß-cell-secretory capacity, the first-phase and steady state insulin secretion from the hyperglycemic clamp studies are believed to give the most robust estimates. Moreover, the hyperglycemic clamp and the euglycemic clamp yield comparable estimates of insulin sensitivity and, so that under appropriate conditions, the hyperglycemic clamp technique may be used to assess both insulin sensitivity and insulin secretion in the same individual in a single experiment.

Eligibility Criteria:
Inclusion Criteria:

* Liver/small bowel transplant patients with partial or whole pancreas
* Solitary small bowel transplant patients
* Insulin independent (no diabetes mellitus)
* Maintenance IS with Tacrolimus/Azathioprine
Genetic Substudy of the Alternans Before Cardioverter Defibrillator (ABCD) Trial

The ABCD clinical study (ClinicalTrials.gov Identifier NCT00187291) was designed to determine if a T-Wave Alternans (TWA) test is equivalent to an Electrophysiology Study (EPS) in predicting life-threatening heart rhythms in patients with ischemic heart disease, left ventricular dysfunction, and non-sustained tachycardia. The purpose of the ABCD Genetic sub-study is to identify genetic markers that predict TWA status and arrhythmia risk in this same population.

The primary objective of this study is to test the hypothesis that therapy directed primarily by a T wave alternans (TWA) test, measured non-invasively during exercise, is equivalent to therapy directed by an electrophysiological study (EPS) in predicting spontaneous ventricular tachyarrhythmic events (VTEs) in patients with ischemic heart disease, left ventricular dysfunction, and asymptomatic non-sustained ventricular tachycardia (NSVT). In the absence of any previous life-threatening ventricular arrhythmia (i.e., for primary prevention), ICD implantation is currently indicated in patients with ischemic heart disease, left ventricular dysfunction, asymptomatic non-sustained ventricular tachycardia, and a positive EPS. The objective of this study is to demonstrate that a TWA test directed therapy is equivalent to EPS directed therapy in guiding ICD implantation for the purpose of primary prevention of sudden cardiac death (SCD) in patients with ischemic heart disease, left ventricular dysfunction, and asymptomatic non-sustained ventricular tachycardia.

Eligibility Criteria:
Inclusion Criteria:

Subjects previously enrolled in the ABCD trial sponsored by St. Jude Medical (ClinicalTrials.gov Identifier NCT00187291)

* patients with ischemic heart disease
* left ventricular ejection fraction (LVEF) \< 40%
* non-sustained ventricular tachycardia

Exclusion Criteria:

Individuals who were not previously enrolled in the ABCD trial are not eligible for this genetic sub-study.
Breast Cancer Outreach Among Primary Care Patients

This project aims to evaluate different approaches to increase breast cancer screening among primary care patients at Penn Medicine through a centralized screening outreach program. In a pragmatic trial, the investigators will evaluate different approaches to increase completion of screening among eligible patients, including ordering mammograms in bulk prior to outreach, sending personalized text reminders, and endorsing of the communication by the primary care provider.

While mammograms are recommended by guidelines for early detection of breast cancer, mammogram rates are significantly lower now than they were prior to the initial COVID-19 pandemic surge in early 2020. In this project, the investigators will evaluate different ways of reaching out to eligible patients to encourage them to participate in breast cancer screening. Through letters, texting, and the electronic health record portal (MyPennMedicine (MPM)), the investigators will compare mammogram bulk orders, text messaging, and primary care provider endorsement to traditional outreach messaging with the goal of increasing breast cancer screening uptake.

Eligibility Criteria:
Inclusion Criteria:

1. Women ages 40-74
2. Followed by Primary Care with a Penn Medicine PCP listed and at least one visit in the last 2 years
3. Health Maintenance due (default biannual screening starting at age 50 or edit modifier based on input by clinician)

Exclusion Criteria:

1. Currently scheduled for a mammogram
2. History of bilateral mastectomy
Citalopram Versus Citalopram Plus Pindolol in Major Depressive Disorder

The purpose of this study is to examine whether the speed of the clinical antidepressant action of citalopram can be accelerated by administering double doses of pindolol (15 mg/day, tid) which presumably should lead to increased 5-HT1A autoreceptor occupancy.

Design, Settings, and Participants. A randomised, double-blind, placebo-controlled trial with MDD patients allocated to two treatment arms: citalopram + pindolol versus citalopram + placebo. Participants: outpatients with a depressive episode (DSM-IV criteria) were selected from a general hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a depressive episode
* HDRS score \> 18
* Written informed consent

Exclusion Criteria:

* suicidal risk \> 3
* severe organic illness
* other psychotropic drugs
Drug Use Study With Intuniv® in Australia

This study will evaluate and analyze prescribing behaviors of physicians and determine whether Intuniv was correctly prescribed in Australia.

This is a drug utilization study using retrospective database analysis where study will combine data from two sources of patient-level drug utilization data for Intuniv:

i) NostraData database: longitudinal participant level prescription database ii) Physician survey: de-identified participant data provided by representative physicians in Australia

In the NostraData database, actual prescription data are collected, which allows generation of information on drug usage. However, these prescription data do not contain patient variables such as age and indication needed to monitor potential off-label use. Therefore, these data must be supplemented with another data source. The physician survey will provide the data not included in the NostraData database.

Eligibility Criteria:
Inclusion Criteria:

* Is indicated for the treatment of ADHD in children and adolescents 6 to 17 years old, as monotherapy.
* Must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.

Exclusion Criteria:

* Use for participants with a diagnosis other than ADHD.
* Use for children less than 6 years of age.
* Use in adults (greater than or equal to \[\>=\] 18 years of age)
* Prescribed overdose greater than (\>) 7 milligram per day (mg/day) for participants \> 12 years, or \> 4 mg/ day for children lesser than or equal to (\<=) 12 years.
* If monotherapy with Intuniv, no prior treatment with stimulants or atomoxetine.