cyrilzakka/clinical-trials huggingface dataset:
Sustained Effects of a Non-glucidic Nutrient Preload on Glucose Tolerance in Type 2 Diabetes

The investigators aimed at evaluating the effects of a small non-glucidic nutrient preload on plasma glucose, insulin, C-peptide, glucagon-like peptide-1, and glucose-dependent insulinotropic polypeptide concentrations after the meal consumption and for 300 min after a 75 g glucose ingestion in diet-controlled type 2 diabetic patients.

As supported by experimental and clinical data, oral carbohydrate tolerance is influenced by the coingestion of nutrients through multiple mechanisms. The ingestion itself, the contact with the gastric mucosa, the arrival into the intestine and the subsequent digestion are known to produce neural reflexes, hormonal responses and plasma substrates gradients which, by modulating gastric emptying, insulin secretion and insulin clearance participate in the regulation of postprandial glycaemia. The size of this effect is influenced by a number of factors: the specific nutrient chemical characteristics (fat vs protein and composition) and their physical properties (solid vs liquid), the timing (pre-load vs coingestion) and finally the individual glucose tolerance status. The effect on 5 h glucose excursions of a combination of protein and fat given before carbohydrate is still unknown.

Eligibility Criteria:
Inclusion Criteria:

* Diet-controlled type 2 diabetic patients
* Subjects ≥ 18 and ≤65 years of age
* Lean, Overweight or Obese (BMI: 18 to 35 kg/m2)
* Normal liver and kidney function
* Normal thyroid function
* Read and understood the informed consent form and signed it voluntarily

Exclusion Criteria:

* Liver, heart, kidney, lung, infectious, neurological, psychiatric, immunological or neoplastic diseases.
* Type 1 or insulin treated diabetes.
* Pregnancy or lactation
* Illicit drug abuse or alcoholism
* Subjects taking anoretic drugs
* Subjects on steroid treatment
* Subjects after bariatric surgery.
Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. The safety of this treatment will also be studied.


Eligibility Criteria:
* Patients must have received either 2 or 3 prior chemotherapy regimens including adjuvant or neoadjuvant therapy.
* Prior treatment must have included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).
* Patients must have received a minimum cumulative dose of anthracycline or must be resistant to an anthracycline.
* Patients must be resistant to taxane therapy.
* Patients may not have any history of brain and/or leptomeningeal metastases.
* Patients may not have CTC Grade 2 or greater neuropathy (motor or sensory).
* Patients may have not have had prior treatment with an epothilone and/or capecitabine (i.e., Xeloda)
A Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered to Patients With Refractory Solid Tumors or Lymphoma

This is an open-label, multicenter, Phase I dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics (PK) of GDC-0917 in patients with refractory solid tumors or lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented, locally advanced or metastatic solid tumors or lymphoma for which standard therapy either does not exist or has proven ineffective or intolerable
* Life expectancy \>/= 12 weeks
* Adequate hematologic and end organ function
* For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use an effective form of contraception and to continue its use for the duration of the study.

Exclusion Criteria:

* Clinically significant history of chronic liver disease, active hepatic infection, evidence of hepatic cirrhosis or Grade \>/= 2 liver dysfunction not due to hepatic metastases of cancer, current alcohol abuse, active infections with hepatitis B virus, or hepatitis C virus
* Grade \>/= 2 fever or associated constitutional symptoms, or a clinically significant systemic infection within the last month
* Autoimmune disease
* History of clinically significant pulmonary disease
* Need for chronic and continuous systemic or topical corticosteroids or immunosuppressive therapy within 2 weeks prior to study entry or anticipated need of continuous systemic corticosteroids or immunosuppressive therapy during study participation.
* Allergy or hypersensitivity to components of the GDC-0917 formulation
* Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in Cycle 1
* Experimental therapy within 4 weeks prior to first dose of study drug treatment in Cycle 1
* Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment
* Prior anti-cancer therapy within 4 weeks before the first dose of study drug treatment in Cycle 1
* All acute drug-related toxicities must have resolved prior to study entry, except for alopecia and Grade 1 neuropathy
* Current severe, uncontrolled systemic disease excluding cancer
* History of clinically significant cardiac dysfunction
* History of malabsorption or other condition that would interfere with enteral absorption
* Any history of active GI bleeding within the past 6 months prior to screening
* Known HIV infection
* Uncontrolled ascites, due to diseases other than cancer, requiring weekly large-volume paracentesis for 3 consecutive weeks prior to enrollment
* Pregnancy, lactation, breastfeeding or unwillingness to use birth control during the study and for 3 months after the last dose of GDC-0917
* Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
Trial of the Ovicidal Activity of Three Head Lice Products (NeutraLice Lotion®, NeutraLice Advance® and Moov Head Lice Solution®) After a Single Application

The purpose of this study is to compare the ovicidal activity of three head lice treatment products.

The study population will consist of Queensland primary school-aged children (Grades 1 - 7) who have at least 20 live eggs on the hair and who have not used any head lice product in the four weeks prior to the study.

Enrollment will continue to achieve 30 subjects in each treatment group (total of 90 subjects).

Subjects will be examined for the presence of head louse eggs. Those subjects who have at least 20 live eggs will be randomised into one of 3 treatment groups: NeutraLice Lotion, NeutraLice Advance or Moov Head Lice Solution treatment groups.

Pre-treatment: 10 eggs will be removed from the head by cutting the single hair with the live egg attached, before the treatment.

Treatment: The subject will then receive a single treatment application according to manufacturers instructions. Then the treatment will be washed from the hair as per the manufacturer's instructions.

Post-treatment: At least 10 treated (live) eggs will be removed from the head by cutting the single hair with the egg attached, after the treatment.

All of the eggs will be held in an incubator for 14 days. The proportion of eggs which hatch after 14 days will be compared for the pre-treatment and post-treatment eggs. Demographic data will be collected for each subject (hair type, hair colour, hair length, subject age, subject sex) to investigate the affect of hair type on ovicidal efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Male or female primary school-aged children.
* Presence of at least 20 live head lice eggs on the hair. The presence of live head lice eggs will be determined from a visual inspection of the hair.
* Parent / Guardian have given written informed consent to their child's participation in the trial.

Exclusion Criteria:

* History of allergies or adverse reactions to head lice products or the components of the specific products being tested.
* Treatment with any head lice product in the 4 weeks prior to participation in this trial.
* Treatment with hair dyes and bleaches within 4 weeks prior to participation in this trial.
* Presence of scalp disease(s).
PRediction of Early PostoperAtive Right vEntricular Failure in Mitral Valve Replacement/Repair Patients

The PREPARE-MVR (PRediction of Early PostoperAtive Right vEntricular failure in Mitral Valve Replacement/Repair patients) Study aims to evaluate those preoperative factors which can predict the early postoperative right ventricular failure or determine the functional shift seen in right ventricular function after mitral valve replacement/repair. The PREPARE-MVR study focuses mainly on echocardiographic (both conventional and advanced) parameters and includes right heart catheterization intraoperatively and in the early postoperative period as gold standard method.


Eligibility Criteria:
Inclusion Criteria:

* patients admitted for mitral valve replacement/repair
* severe mitral valve insufficiency

Exclusion Criteria:

* preoperative right ventricular dysfunction
* cardiac surgery in medical history
* infective endocarditis
* primary cardiomyopathies
* congenital heart disease
* decreased left ventricular ejection fraction
* pulmonary embolism in medical history
* severe chronic obstructive pulmonary disease
* primary pulmonary hypertension
* any malignancy affecting right heart
Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From HCV-Infected Donors to Uninfected Recipients

This study is being done to find out the best time to start medication for Hepatitis C Virus (HCV) in HCV-negative recipients of HCV-positive (HCV D+/R-) kidney transplants. Participants will be randomized into one of two groups:

Arm 1 - Prophylaxis: This group will start the HCV medication before transplant and will take a shorter course of HCV medication for 2 weeks.

Arm 2 - Transmit and Treat: This group will start the HCV medication after transplant and will take the full course (12 weeks) of HCV medication.

In the past, HCV-positive (HCV+) kidneys were not given to HCV-negative recipients. But over the last few years, medications have been created that cure HCV in nearly 100% of patients. HCV+ transplants to HCV-negative recipients have become increasingly common now that HCV can be cured.

There are two approaches to giving HCV medication to recipients of these transplants. The first is a prophylaxis approach. With prophylaxis, HCV medication is started before transplant and continued for a shorter course after transplant. The second is a transmit-and-treat approach. With transmit-and-treat, HCV medication is started after transplant and continued for the full, recommended course. Both approaches have successfully cured HCV in HCV-negative recipients of HCV+ organs.

This research will use a study drug called sofosbuvir/velpatasvir (SOF/VEL). It contains two drugs for treating HCV in one pill. We will compare giving SOF/VEL for 2 weeks starting pre-transplant (prophylaxis) to giving SOF/VEL for 12 weeks starting no later than 14 days post-transplant (transmit-and-treat).

SOF/VEL belongs to a group of medications called direct-acting antiviral agents (DAAs). These drugs prevent HCV from multiplying and spreading in the human body. SOF/VEL are already approved and used for 12 weeks to treat HCV infection. The use of SOF/VEL for 2 weeks in preventing HCV infection has not been studied. The FDA is allowing SOF/VEL to be used in this study.

Eligibility Criteria:
Inclusion Criteria:

* Participant meets the standard criteria for KT at local center.
* Participant is able to understand and provide informed consent.
* Participant is ≥ 18 years old.

Exclusion Criteria:

* Participant has active HCV infection (detectable HCV RNA) at time of screening.
* Participant has cirrhosis or advanced liver fibrosis.
* Participant's aspartate aminotransferase (AST) or ALT \> 2.5 times the upper limit of normal (ULN), within 60 days of screen.
* Participant has human immunodeficiency virus infection (HIV), or active hepatitis B (HBV) infection.
* Participant is unable to safely substitute or discontinue a medication that is contraindicated with the study medication.
* Past or current medical problems, which may pose additional risks from participation in the study, interfere with the participant's ability to comply with study, or impact the quality of the data obtained from the study.
* Participant is pregnant or breastfeeding.
Effects of Medisinstart for Type 2 Diabetes

Medisinstart is a counseling service in pharmacies where patients who start taking a new medicine receive two follow-up appointments with a pharmacist. The aim of the service is to promote correct medication use and increase patient adherence. The effect of Medisinstart has previously been studied among patients starting a new cardiovascular drug. The aim of the project is to map the effects of Medisinstart among patients starting a new medication for type 2 diabetes. Knowledge about the effects of Medisinstart is important in order to maximize the benefits of the service for patients and society. The project is being conducted as a randomized controlled trial among adult patients starting a new medication for type 2 diabetes. The intervention group receives Medisinstart, while the control group only receives prescription dispensing as normal. Data collection includes HbA1c analysis in blood samples and responses to questionnaires. HbA1c is an established measure of glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Extracted a new drug/active substance (A10A/A10B) for type 2 diabetes
* Age ≥ 18 years
* The drugs are administered by the patient/relatives
* Good command of Norwegian, both written and spoken

Exclusion Criteria:

* Inability to understand and/or complete consent forms, questionnaires and/or other patient-oriented materials
* Not able to attend physical appointments in the pharmacy
* Not given written consent to participate in the study
* Diabetes medication is administered by a healthcare professional
* Known pregnancy
* HbA1c is unsuitable as an average measure of blood glucose at baseline
* Received initiation of medication for type 2 diabetes within the last year
* Ongoing participation in other studies involving similar interventions to increase adherence and ensure correct medication use
Haptoglobin and Preeclampsia

The purpose of this study is to show that a certain protein called haptoglobin protects against preeclampsia which is a common pregnancy complication.


Eligibility Criteria:
Inclusion Criteria:

* all women

Exclusion Criteria:

* women with hypertension
Promotion of Active Lifestyle in Pneumonia Patients

Patients who have suffered a pneumonia used to reduce their activity levels because of the symptoms and the fear to suffer breathlessness. These patients often have sequelae after the hospitalization that previous studies have associated with a lack of physical activity.

The main objective of this research is to investigate the efficacy of a rehabilitation program for promotion higher activity levels in quality of life and self-perceived discapacity of pneumonia patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes.
* Agreed to participate.
* Pneumonia patients meeting the diagnosis criteria for this disease.

Exclusion Criteria:

* Neurological or orthopaedic pathologies that limited voluntary movement.
* Cognitive impairment that prevented them from understanding and answering the questionnaires.
* Patients who don´t understand Spanish language
Evaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant Rejection

This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and prevent kidney transplant rejection. This study will evaluate the effect of Thymoglobulin induction therapy and reduced doses of calcineurin inhibitors on the incidence of liver rejection and will provide a basis for future evaluations of Thymoglobulin as an immunosuppressive agent to help decrease the incidence of liver transplant rejection. Subjects meeting all inclusion and exclusion criteria are eligible to participate in this study. Approximately 75 study subjects from up to 18 transplant centers in the United States and Canada will be enrolled in this 12-month study.


Eligibility Criteria:
Inclusion Criteria:

* Primary liver transplant recipient with Model for End-Stage Liver Disease (MELD) criteria documentation
* Serum creatinine \> 1.5mg/dL at the time of transplant, or based on the value used to calculate the most recent pre-operative MELD Score for liver allocation
* Ages greater than or equal to 18 years
* If female, must not be lactating; must have a negative serum beta-human chorionic gonadotropin (HCG) test within 7 days prior to Study Day 0 (Day of Transplant); and must agree to practice an acceptable and reliable form of contraception during the study
* Signed informed consent

Exclusion Criteria:

* Living donor or multiple organ transplants
* Prior solid organ or bone marrow transplant recipient
* Fulminant hepatic failure
* Status 1 transplants
* ABO incompatible transplants
* Transplants utilizing livers from non heart-beating donors
* Liver transplant candidates with \> 6 weeks of analysis
* Donor with positive serology for hepatitis B surface antigen (HBsAg)
* Evidence of human immunodeficiency virus (HIV)
* Autoimmune hepatitis
* History of chronic steroid or immunosuppressant use in the 90 days prior to transplant, except for inhaled corticosteroids to treat asthma
* Recipient of investigational therapy within 90 days prior to transplant procedure
* Known contraindication to administration of rabbit anti-thymocyte globulin
* Acute viral illness
* History of malignancy within 5 years, with the exception of adequately treated localized squamous or basal cell carcinoma of the skin without evidence of recurrence, and/or hepatocellular carcinoma
* Illness other than primary liver disease (e.g. severe ischemic heart disease, left ventricular dysfunction, or pulmonary disease), which, in the opinion of the investigator, may significantly increase the risk of the transplantation procedure
* Current drug and alcohol abuse that, in the opinion of the investigator, puts subjects at risk for poor compliance (no drug test required)
Bacteriological Differences Between Transanal and Laparoscopic Total Mesorectal Excision for Rectal Cancer.

The primary purpose of this study is to compare the differences of bacteriological in rectal cancer patients undergoing laparoscopic or transanal endoscopy radical resection. The secondary purpose is to compare the effects of two different surgical methods on postoperative complications.

Transanal total mesorectal excision (taTME) is a new surgical procedure for total mesorectal excision (TME) by dissociating the mesorectum from the bottom through transanal endoscopic. The characteristics of TaTME are mainly summarized as transanal reverse operation, no auxiliary abdominal incision, complete mesorectal excision and specimen removal through the anus. So taTME is a natural orifice specimen extraction procedure (NOSES). Compared with traditional laparoscopy, taTME has obvious oncological and technical advantages. However, similar to NOSES, the specific surgical approach to taTME may induces bacteriological safety concerns. Whether TaTME is safe and feasible still needs strong evidence-based medical evidence. However, there have been prospective studies related to bacteriology in NOSES surgery, but there is a lack of prospective clinical studies on the issue of bacteriological diffusion during taTME surgery. Bacterial contamination of the peritoneal cavity is common in laparoscopic surgery for colorectal cancer. Although the standard NOSES procedure avoids bacteriological problems through the use of antibiotics, surgical peritoneal irrigation, and the use of sterile specimen bags, its safety remains inconclusive. Therefore, compared with conventional laparoscopic colorectal cancer surgery, taTME not only takes specimens from the natural orifice, but also requires further prospective studies on whether the incision of the intestinal wall from the mucosa during the operation will violate the aseptic principle, the aseptic safety of taTME still needs further prospective studies to confirm. Therefore, the investigators conducted a randomized controlled study to collect the abdominal and pelvic irrigation fluids in the transanal and laparoscopic TME surgery for bacteriological examination, to clarify the influence of the two different surgical methods on the intraoperative bacterial diffusion. The purpose of this study was to clarify the influence of two different surgical methods on the intraoperative bacterial spread, and to provide more evidence-based medical evidence for the safety of taTME surgery.

Eligibility Criteria:
Inclusion Criteria:

* Primary rectal carcinoma
* Single lesion
* No metastasis

Exclusion Criteria:

* History of malignant tumors
* Acute bowel obstruction, bleeding or perforation
* Tumor over 6cm in diameter or in severe adhesion with surrounded tissues
* Severe other contradictions of surgery
* Pregnant women will be excluded
Standard Versus Transepithelial Corneal Crosslinking

The gold standard corneal crosslinking (CXL) technique involves the initial step of epithelial removal, in order to achieve a sufficient treatment effect (meaning: stabilisation of progressive keratoconus (KC). Our aim is to evaluate the effects of transepithelial CXL (TE-CXL), whereby the epithelium is left intact and the cornea is instead treated by a solution composed of 0.1% riboflavin, combined with enhancers, after which standard CXL is performed. This solution seems to facilitate riboflavin penetration into the corneal stroma through the intact epithelium. The investigators expect to achieve a similar effect of TE-CXL with the advantage of a faster healing time and less risk of infections.


Eligibility Criteria:
Inclusion Criteria:

* Documented progressive KC (by Pentacam and/or corneal topography imaging).
* A clear central cornea.
* A minimal corneal thickness of ≥ 400 µm at the thinnest corneal location (Pentacam imaging).
* Minimal Snellen corrected distance visual acuity of ≥ 0.4.
* Patient age of ≥ 18 years.

For this research study, the inclusion parameters will be the same as mentioned above, with the following additional inclusion criteria:

* Documented progression of KC, as demonstrated by anterior segment imaging and/or corneal topography:

  o Defined an increase in maximal keratometry, steepest keratometry, mean keratometry or topographic cylinder value by ≥ 0.5 D over the previous 6 months and/or a decrease in thinnest pachymetry
* Documented progression of KC defined by increase in refractive cylinder of ≥ 0.5 D over the previous 6 months

Exclusion Criteria:

* Presence of corneal scars.
* History of epithelial healing problems.
* Presence of previous ocular infection (such as herpes keratitis).
* Patients who are pregnant and/or breastfeeding.