cyrilzakka/clinical-trials huggingface dataset:
Effect of Bile Acids on GLP-1 Secretion

The purpose of this study is to describe the physiological, pathophysiological and potentially therapeutic implications of bile-induced glucagon-like peptide-1 (GLP-1) secretion in human glucose homeostasis.

The investigators hypothesize that even modest increments in endogenous GLP-1 secretion will elicit important antidiabetic effects of GLP-1. To evaluate whether bile acids have such effects, the investigators plan to perform intraduodenal infusion of two different bile acids and placebo.

Eligibility Criteria:
Patients with type 2 diabetes

Inclusion Criteria:

* danish caucasian ethnicity
* normal haemoglobin
* BMI \> 25 kg/m2
* HbA1c \< 9%
* informed consent

Exclusion Criteria:

* liver disease(ALT and AST \> upper reference limit)
* gastrointestinal disease
* liver and biliary tract disease
* nephropathy (serum creatinine \> 150 μM, and/or albuminuria)
* treatment with insulin, glp-1 analogues and/ or DPP-4 inhibitors
* treatment with medicine that can not be paused for 12 hours
* previous abdominal surgery eg. cholecystectomy
* BMI \< 18,5 kg/m2 or \> 35 kg/m2

Healthy Volunteers

Inclusion Criteria:

* danish caucasian ethnicity
* normal haemoglobin
* HbA1c \< 6,0 (American Diabetes Association guidelines)
* informed consent

Exclusion Criteria:

* liver disease(ALT and AST \> upper reference limit)
* gastrointestinal disease
* liver and biliary tract disease
* nephropathy (serum creatinine \> 150 μM, and/or albuminuria)
* treatment with medicine that can not be paused for 12 hours
* previous abdominal surgery eg. cholecystectomy
* BMI \< 18,5 kg/m2 or \> 35 kg/m2
* first degree relatives diagnosed with diabetes
* previously diagnosed with diabetes, or treated with antidiabetic agents
18F-2-fluoro-2-deoxy-D-glucose in Positron Emission Tomography Computed Tomography

The study objectives are as follows:

* To determine the safety of trial 18F-2-fluoro-2-deoxy-D-glucose, produced by a new manufacturer, by surveillance for adverse events in patients having Positron Emission Tomography Computed Tomography scans in a comprehensive program for indications including, but not limited to, oncology, neurology, cardiac and infectious/inflammatory processes.
* To determine the efficacy of 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography in differentiating benign from malignant solitary pulmonary nodules and calculate sensitivity, specificity, and accuracy using pathologic confirmation as the gold standard when available, or greater than 6 month follow up stability on Computed Tomography scan when not.

The purpose of performing this clinical trial is to provide local access of 18F-2-fluoro-2-deoxy-D-glucose to the patients of Newfoundland and Labrador. This product has been offered to patients over the last three years by transporting from facilities outside of the province. There have been significant delays in access and in fact, times where 18F-2-fluoro-2-deoxy-D-glucose has not been available through this process. This has caused delays and limitations of treatments for patients who rely on Positron Emission Tomography Computed Tomography scans for diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Known or suspected disease for which 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography Computed Tomography is appropriate for the investigation of. This includes, but is not limited to: Known or suspected cancer, neurological disorders (dementia or epilepsy), cardiac conditions (inflammation or myocardial viability), known or suspected presence of infection/inflammation process

Patients must satisfy all the following:

* Able to provide written informed consent, or consent obtained from appropriate guardian
* Able to tolerate the physical and logistic requirements of completing a Positron Emission Tomography Computed Tomography scan

Exclusion Criteria:

* Pregnant women: if there is any possibility of pregnancy, a blood Beta Human Chorionic Gonadotropin level will be obtained as per Eastern Health policy.
* Patients unwilling or unable to stop breast feeding for 12 hours
* Patients who are too medically unstable to tolerate the uptake period or lie flat for the duration of the scan
* Patients who exceed the safe weight limit of the Positron Emission Tomography Computed Tomography scanner bed (500 lbs.) or who cannot fit through the bore (70 cm diameter)
* Patients unwilling to proceed with scan (I.e. claustrophobia) prior to injection
* If patients inability to follow staff direction causes a safety hazard prior to injection
Improvements in Dynamic Contrast-Enhanced MR Angiography and Perfusion and Non-Contrast MRI

This study evaluates if technical improvements in MRI can be used to provide improved performance contrast-enhanced MRI as used for angiography and perfusion as well as in non-contrast MRI.

PRIMARY OBJECTIVE:

I. To study how a variety of technological approaches in MRI can be used to provide improved performance contrast-enhanced MR imaging as used for angiography and perfusion as well as in MR image acquisition without the use of contrast material.

OUTLINE: This is an observational study.

Participants undergo a non-contrast MRI on study and may optionally undergo a second non-contrast MRI on study. Participants may also undergo blood sample collection on study.

Eligibility Criteria:
Inclusion Criteria:

* Adults

Exclusion Criteria:

* Standard exclusion criteria for clinical MRI; e.g. cardiac pacemaker, claustrophobia, an implanted device that has been determined to be MR conditional at 1.5T but not at 3T, anticipated considerable susceptibility artifact from hip prosthesis, etc.
CAR-NK Targeted CD19 for r/r B-cell Malignancies

This is a single-centre, single-arm and open-label study to investigate the safety and efficacy of JD010 in adult patients with relapsed or refractory B cell hematologic malignancies. JD010 injection is a CD19-targeted chimeric antigen receptor modified natural killer cells (CAR-NK) derived from a healthy donor


Eligibility Criteria:
Inclusion criteria:

1. Age ≥ 18 years old, no gender or race;
2. Expected survival period ≥ 3 months;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
4. Confirmed relapsed/refractory B-cell malignancies and tumor cells expressing CD19;
5. Adequate organ function:

   A. Liver function: ALT≤3×ULN, AST≤3×ULN, total bilirubin≤2×ULN; B. Coagulation function: international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN; C. Renal function: serum creatinine≤1.5×ULN or creatinine clearance rate ≥30mL/min; D. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%;
6. Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.;
7. Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

1. Central nervous system involved;
2. Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide;
3. Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids);
4. Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis.
5. History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines;
6. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment;
7. Women who are pregnant (urine/blood pregnancy test positive) or lactating;
8. Suffering from a serious autoimmune disease or immunodeficiency disease; 9 Suffering from mental illness;

10. Known alcohol dependence or drug dependence; 11. According to the investigator's judgment, the patient has other unsuitable grouping conditions.
Making Calories Count: Information Format and Food Choice

The purpose of the study is to better understand how individuals make decisions regarding the meals they order. Participants' ordering decisions at lunchtime at a chain restaurant will be recorded over several weeks to study ordering habits over time. Lunch menus will be provided by the study, and the menu format will vary the way in which information on caloric content is displayed.

The impact of different labeling formats on total calories in the chosen meal will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Customers of two chain restaurants

Exclusion Criteria:

* Unable to read a written menu
Could Bisphenol-A Have a Role in the Etiology of Neural Tube Defects

Our aim in this study is in patients with a diagnosis of neural tube defect; is the measurement of BPA levels in maternal blood and amniotic fluid.

This prospective observational study was conducted with 92 patients aged 18 - 45 years who had amniocentesis at 15 - 22 weeks of gestation at Bursa Yüksek İhtisas Training and Research Hospital between April 15, 2021 and April 15, 2022. Patients were divided into two groups according to amniocentesis indications. Group 1: patients with abnormal maternal serum screening test or prenatal diagnosis test, patients with abnormal ultrasonography findings (45 patients), Group 2: patients with pre-diagnosis of NTD (47 patients). During the amniocentesis procedure, the first 5cc amniotic fluid and maternal serum samples were collected from the patients. The obtained samples were stored at -80°C until the end of the study. After all samples were collected, BPA values were measured by ELISA method.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had a single pregnancy, had a pre-diagnosis of neural tube defect or had amniocentesis between 15 and 22 weeks of age with other indications
* patients had an uncomplicated pregnancy before the procedure
* patients had no vaginal infection

Exclusion Criteria:

* Multiple pregnancies,
* pregnant women who developed complications due to amniocentesis
* pregnant women with known infective or autoimmune diseases before pregnancy
* those whose spouses or themselves worked in the plastics industry
* patients who could not obtain enough amniotic fluid despite meeting the study criteria during the study
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05693 (P05713)

The objective of follow-up study P05713 is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of monofollicular growth in women who underwent ovulation induction (OI) in base study P05693 (NCT00697255) is safe for pregnant participants and their offspring.

Base study P05693 (NCT00697255) was planned to include two separate stages (Ia+Ib and II).

Stage Ia was open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose recombinant Follicle Stimulating Hormone (recFSH) would provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.

Stage Ib was open-label and uncontrolled in a small cohort of women (n=3) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose Human Chorion Gonadotropin (hCG) would provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.

Stage II was planned to be open-label and randomized (n=40) to evaluate whether the intended dosing regimen of corifollitropin alfa followed by low dose recFSH (n=20) or hCG (n=20) would provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.

P05713 is a follow-up (FU) study to prospectively monitor pregnancy, delivery, and neonatal outcome of women who became ongoing pregnant during base study P05693 (NCT00697255). For this trial, no study specific assessments will be required and no treatment will be administered, but information as obtained in standard practice will be used. Enrollment will begin when the first ongoing pregnancy resulting from the base study has been established (ultrasound ≥ 10 weeks after bolus injection of hCG).

Eligibility Criteria:
Inclusion Criteria:

* Participants who participated in base study P05693 (NCT00697255) and received at least one dose of corifollitropin alfa
* Ongoing pregnancy confirmed by ultrasound at least 10 weeks after bolus injection of hCG in base study P05693
* Able and willing to give written informed consent (informed consent is

incorporated in the informed consent form of protocol P05693)

Exclusion Criteria:

* None
An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (RELEVANT)

This prospective observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in patients with metastatic colorectal cancer. Data will be collected from patients receiving Avastin in combination with chemotherapy according to registered indication in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Metastatic colorectal cancer
* Prescribed to receive Avastin according to registered indication

Exclusion Criteria:

* Patients not eligible for Avastin treatment according to the Summary of Product Characteristics
Evaluation of the BOKS Before-school Physical Activity Program

BOKS, Build Our Kids' Success, is a before-school physical activity program that has been implemented in over 2,000 elementary and middle schools. Students participate in the program for 12 weeks, two or three mornings per week for about 1 hour per session. This study if a non-randomized control trial seeking to 1) examine the extent to which participation in the before-school BOKS program improves, health, well-being, and performance, and 2) compare the results of a two-day-per-week versus a three-day-per-week program.


Eligibility Criteria:
Inclusion Criteria:

* Participating school
* Child age 5-14 years

Exclusion Criteria:

* No valid parental consent
* Missing group assignment
Human Breastmilk in Children Receiving a Bone Marrow Transplant

The investigators hypothesize that children receiving human milk will maintain a greater diversity of helpful bacteria in their gut and have lower levels of inflammatory proteins in the blood compared with children not receiving human milk.

The investigators hypothesize that the gut microbiota during bone marrow transplant could be influenced by administration of enteral donor breast milk. This study will attempt to address this hypothesis, by feeding donor breast milk to young children undergoing transplant, and serially comparing the gut micobiota in children receiving human milk, with those receiving conventional feeding.

Eligibility Criteria:
Inclusion Criteria:

* Children less than 5 years old receiving transplant (autologous or allogeneic)
* Parents must give informed consent

Exclusion Criteria:

- Failure to meet inclusion criteria
Effects of Hypnosis on Skin Temperature

Hypnotic glove anesthesia is a hypnosis technique wherein the patient, following the suggestions of the hypnotherapist, is mentally capable to create a loss of sensation in areas of the hand that would be covered by a glove. We investigated the effects of hypnotic glove anesthesia on skin temperature measured by thermography.

After 20 min installation and temperature equilibration (T0), the subject skin temperature was recorded in 5 regions of both hands (1 = distal hand, 2 = proximal hand, 3 = wrist, 4 = distal forearm, 5 = proximal forearm) using infrared thermography.

After 10 min of latency, skin temperature was recorded again in both hands (T1).

A first noxious stimulus (NOX1) is then applied by the hypnotherapist by pinching the webbing between the thumb and index fingers of the dominant hand between the thumb and the index. Pain intensity is assessed on a 0-10 (0 = no pain, 10 = maximal pain imaginable) numerical rating scale (NRS1).

The hypnotic glove is then mentally created by the subject on his dominant hand following the suggestions of the hypnotherapist (T2). To assess the efficacy of the hypnotic glove, a second noxious stimulus (NOX2) is applied similarly to NOX1 and the NRS was recorded (NRS2).

The subject is then invited to mentally wear off the glove (T3). Skin temperature is then recorded in both hands, and a third noxious stimulus (NOX3) is applied similarly to NOX1 and NOX2 to verify the disappearance of hypnotic anesthesia.

A last record of skin temperature in both hands is performed 5 min after the glove is withdrawn (T4).

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged from 18 to 75

Exclusion Criteria:

* Neurologic or psychiatric disorder
* Upper limb amputation
* Microcirculation abnormalities (e.g. Raynaud syndrome)
Metatranscriptomic Next Generation Sequencing in First Trimester Trophoblast With Increased Fetal Nuchal Translucency (METAHCN)

The study is based on the hypothesis that increased nuchal translucency may be associated with a materno fetal infection and that the pathogen responsible for this infection could be identify with metatranscriptomic next-generation sequencing in the trophoblast tissue.

Nuchal translucency \> 3.5 mm in the first trimester of pregnancy is due to fluid accumulation in the subcutaneous tissue in the nuchal area. This is seen in around 1% of all pregnancies. Increased nuchal translucency is explained by a chromosomic abnormality (mainly Down syndrome) in 30 to 40% of cases. Therefore, the state of the art is to perform an array CGH on chorionic villi sampling. Cases of nuchal translucency that are not explained by a chromosomic abnormality may be associated: with fetal defect (heart, congenital diaphragmatic hernia) in 10% of cases, with genetic disease in 4% of cases or with miscarriage or fetal death of unknown etiology in 18% of cases.

The etiology of increased nuchal translucency remains unknown in more than 50% of the cases. It could be linked to inflammation or reflect an infection but this latter association has been rarely studied. This association was suggested in a study reporting serology of CMV, toxoplasmosis or B19 parvovirus primary infections in pregnant women carrying a fetus with increased nuchal translucency. In those rare cases, the microorganism was not searched directly in the trophoblast tissue. In the investigators' center, the investigators describe in a context of maternal primary infection, one case of increased nuchal translucency with a positive CMV PCR in the trophoblast tissue collected at 12 weeks. Other pathogens yet not identified might be associated with increased nuchal translucency.

Metatranscriptomic next generation sequencing (mNGS) allows to search for any pathogens without a priori. It is therefore a powerful technic to study this potential association between increased nuchal translucency and infection.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Singleton pregnancy
* First trimester (11 GA+0D to 13 GA+6D)
* Carrying a fetus with a nuchal translucency \> 3.5 mm for which a chorionic villi sampling is performed OR a suspicion of genetic abnormalities for which a chorionic villi sampling is performed
* Delivery planned at Necker hospital
* Not opposed to participation

Exclusion Criteria

* Age \<18 years
* no health insurance
* difficulties in understanding the French language
* chronic infection (HIV, HBV, HVC and HTLV-1)
The Effects of Cervical Spine Manipulation On Postural Control

The purpose of this study is to test the effect of high velocity low amplitude (HVLA) chiropractic cervical manipulation on the patient's postural control as measured by a force plate.


Eligibility Criteria:
Inclusion Criteria:

* Students
* Normal healthy adults

Exclusion Criteria:

* Previous or ongoing foot, ankle, or hip problems
* Experiencing vertigo, visual difficulties and other disorders that would make it difficult to balance for a set period of time.
* Anyone with high risk for injury due to cervical manipulation
* Anyone with training in areas of activity that require superior balance
* Body mass index over 30
Evaluation Study for a Non-Contact Biometer

The purpose of this study is to determine whether a new non-contact biometer, is as accurate as the the available gold-standard.

The features of a not yet commercial available new biometer will be compared to available contact and non contact biometers in different patient groups.

Eligibility Criteria:
Inclusion Criteria:

1. 18 year or older
2. Normal eye
3. Cataract
4. Corneal abnormality (scar, opacity, transplant)
5. refractive corneal surgery
6. Pseudophakia
7. Aphakia
8. Silicon oil
9. refractive IOL

2.-9. (at least one yes)
D2212C00002 J-Phase II Study

The purpose of the study is to evaluate the safety and tolerability of multiple-doses of tralokinumab in Japanese patients with Idiopathic Pulmonary Fibrosis.

This is a phase II, multicenter, blinded within cohort, dose-escalation study to evaluate the safety and tolerability of two ascending doses of tralokinumab in Japanese patients aged ≥ 50 years with mild to moderate Idiopathic Pulmonary Fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Confirmed IPF diagnosis for ≤ 5 years prior to Visit 1 (screening). Confirmation of diagnosis of IPF
* Mild to moderate IPF to include all of the following at Visit 1

  1. FVC ≥ 50% and ≤ 90% predicted normal
  2. Partial pressure of oxygen in arterial blood (PaO2) of ≥ 55 mmHg on room air, or oxygen saturation by pulse oximetry (SpO2) of ≥ 90% on room air at rest
  3. Hemoglobin-corrected diffusion capacity for carbon monoxide (DLCO) ≥ 30% and ≤ 90% predicted normal

Exclusion Criteria:

* History of clinically significant environmental exposure (eg, domestic and occupational) to a known cause of pulmonary fibrosis
* Diagnosis of connective tissue disease or drug toxicity as the likely cause of the interstitial disease
* A suspected IPF exacerbation not fully resolved and treatment completed ≤ 14 days prior to Visit 1
* A suspected IPF exacerbation during the screening period
* A FEV1/FVC ratio \< 0.70 at the time of Visit 1 (postbronchodilator)
* The extent of emphysema on the HRCT is greater than the extent of fibrosis