cyrilzakka/clinical-trials huggingface dataset:
The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes

TITLE: How GLP-1 Analogues prevent steroid-induced diabetes (The GAPSID Study)

DESIGN: A double-blind study evaluating how GLP-1 analogues, compared with metformin, prevent hyperglycaemia in response to a 7-day course of dexamethasone (DEX) 6 mg once daily. This is a mechanistic experimental medicine study.

AIMS: To evaluate the mechanisms by which GLP-1 analogues reduce steroid-induced hyperglycaemia compared to metformin.

OUTCOME MEASURES:

* Primary: Glucose tolerance in response to standardised mixed meal test (MMT) lasting for 240 minutes, measured in all participants at baseline and on day 7 DEX.
* Secondary: Indices of insulin resistance (M-value), beta-cell function (acute insulin response to glucose) and disposition, as measured by a combined IV glucose tolerance test and hyperinsulinaemic-euglycaemic clamp, performed at baseline and on day 7 DEX.
* Exploratory: Tissue specific changes in adipose AMPK determined from adipose and muscle biopsies, taken from a subset of approximately 8 individuals in each group.

ELIGIBILITY: People living with pre-diabetes or lifestyle controlled diabetes

STUDY DURATION: This study will take place over 3 weeks for each partcipant. Study procedures include 10 days of baseline continuous glucose monitoring (CGM) followed by 7 days of dexamethasone with GLP-1, metformin or placebo. Participants will attend a follow-up visit 3-5 days after completing the 7-day course of study drug. The study will run over a period of 3 years.

ANTICIPATED IMPACT: Mechanistic evidence for the use of GLP-1 analogues, compared with metformin, in the treatment of steroid-induced diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years;
* Male or female;
* Pre-diabetes (HbA1c ≥42 and \<47 mmol/mol, or lifestyle-controlled diabetes (HbA1c ≥48 and ≤52 mmol/mol); measurements within range on two separate occasions ≥90 days apart)
* Body mass index ≥22.5 kg/m2

Exclusion Criteria:

* Prior treatment with any diabetes medication within 90 days;
* Current or planned pregnancy, or current breastfeeding;
* Previous treatment with GC (topical, oral, injected) within 30 days or 90 days for extended-release injected GCs (e.g. Depo-Medrone);
* Continuing requirement for GC treatment (e.g. for steroid replacement, chronic inflammatory or immunological condition);
* Treatment with medications altering DEX pharmacokinetics (e.g. phenytoin, carbamazepine, ritonavir).
* History of pancreatitis, renal disease (eGFR \<30), severe hepatic impairment, gallbladder disorders, or GI disease (e.g. IBD), heart failure, history of medullary thyroid cancer (MTC), or previous skin reactions.
* History of bleeding disorders of anticoagulant therapies (exclusion from the biopsy substudy only)
* History of giving blood or having taken part in another non-related study in the last three months
* History of any other medical, psychological condition, or use of any medications, which, in the opinion of the investigators, would either interfere with the study or compromise the safety of the participant.
Getting Biased Treatment Study: How Psychotherapy and Antidepressants Change Brain Activity in Chronic Depression

The purpose of this study is to determine how psychotherapy and pharmacotherapy respectively change brain activity in patients suffering from chronic depression.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Depression (Double Depression, Chronic MDE, MDE with incomplete remission)
* HAMD-24\>20

Exclusion Criteria:

* Concurrent Psychotherapy or Psychopharmacotherapy
* Previous Non-Response to Duloxetine
* Non-Response to three Antidepressants of two different groups given at adequate doses or Non-Response to two empirically tested forms of Psychotherapy in the current Depressive Episode
* Serious Psychiatric comorbidity
* Serious Neurologic comorbidity
* Contraindications to Duloxetine
* Contraindications to fMRI
Study of CS-3150 in Patients With Severe Hypertension

To examine antihypertensive effect and safety of administration of CS-3150 in patients with severe hypertension (Grade III).


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 20 to 80 years at informed consent
* Subjects with severe hypertension, who do not receive any antihypertensive drugs or receive antihypertensive drug (except for potassium-sparing diuretics) during run-in period (Sitting SBP ≥ 180 mmHg or Sitting DBP ≥ 110 mmHg)

Exclusion Criteria:

* Patients who are suspected hypertensive emergency
* Secondary hypertension or malignant hypertension
* Diabetes mellitus with albuminuria
* Serum potassium level \< 3.5 or ≥ 5.1 mEq/L (≥ 4.8 mEq/L if receive RA inhibitor)
* eGFR \< 60 mL/min/1.73 m\^2.
Cancer Experience Registry (CER) for Cancer Patients and Caregivers

The Cancer Experience Registry®: An Online Survey Research Study to Understand the Experiences of Those Impacted By a Cancer Diagnosis. The Registry is a web-based platform to distribute cross-sectional and longitudinal surveys. Study surveys are designed based on input from advisor experts, including patients and caregivers, and focus on the social, emotional, physical, financial and decision-making experiences of those who have been diagnosed with cancer and their caregivers. Findings contribute toward enhancing care for patients, survivors and caregivers via programming and policy initiatives.

The aims of the Registry are to: 1) better understand the psychosocial experiences and needs of people who have been impacted by cancer, including patients, survivors and caregivers; 2) inform the research community, healthcare providers, patient advocates and policy makers around gaps in care and the psychosocial challenges of people affected by cancer; 3) use the findings to develop and disseminate tailored (data-guided) programs and services that will address the emotional and social needs and ultimately improve the long-term quality of life of people affected by cancer; 4) link registrants to cancer related resources and programs via an online, modifiable platform; and 5) provide collaborating sites (e.g., hospitals/health networks/CSC affiliates) with aggregated reports on quality and needs of members or customers to enhance or improve quality of care.

Findings from the Registry are disseminated online at https://www.cancersupportcommunity.org/sites/default/files/file/2020-07/CSC_Registry_Report_June_2020.pdf

Eligibility Criteria:
Inclusion criteria:

* Have received a cancer diagnosis or have been a family caregiver or informal caregiver (i.e., a relative or friend) for someone diagnosed with cancer
* Live in United States, a US territory, or Canada
* Able to read and understand English

Exclusion criteria:

* None
Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis

The purpose of this study is to assess the microbiological cure rate of doripenem in the treatment of patients with complicated urinary tract infection or pyelonephritis. The study will also characterize the safety and tolerability of treatment with doripenem in patients with complicated urinary tract infection or pyelonephritis.

Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multi-center, prospective, open-label, single-arm study of doripenem in the treatment of complicated lower urinary tract infection or pyelonephritis in adults. Patients are hospitalized, but subsequently, patients may treated as outpatient or through home-based therapy at the discretion of the investigators. Conventional laboratory data will be collected from patients at specified times throughout the study. The primary endpoint is microbiological response measured at test of cure visit. The patients will receive doripenem with duration of therapy up to 10 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of complicated lower urinary tract infection or pyelonephritis

Exclusion Criteria:

* Women who are pregnant, nursing or of child-bearing potential and not using a medically accepted, effective method of birth control
* History of moderate or severe hypersensitivity reactions to antibiotic medications
CIRSE Registry for SIR-Spheres in France (CIRT-FR)

Selective Internal Radiation Therapy (SIRT), also known as radioembolisation, is a minimal invasive, endovascular treatment for primary and secondary liver tumours. In France, SIR-Spheres are listed as reimbursable by the national health authorities (Haute Autorité de Santé \[HAS\]). In order to evaluate the reimbursement after five years, all patients treated with SIR-Spheres will be entered into a registry that collects data on the real-life clinical application of SIRT and reports to the national authorities.

Selective internal radiation therapy (SIRT), also called radioembolisation (RE), with SIR-Spheres microspheres is an endovascular procedure, included within the interventional oncologic technologies to treat primary and secondary liver tumours. Using a microcatheter, a precise dose of resin microspheres is released in the hepatic artery, where they are carried into the arterioles and selectively lodge in the tumour microvasculature. The microspheres are loaded with the radioactive yttrium-90, a high-energy beta-emitting isotope with a half-life of 64.1 hours. Following administration, 94% of the radiation is delivered in 11 days.

In France, SIR-Spheres are listed as reimbursable by the national health authorities (Haute Autorité de Santé \[HAS\]). In order to evaluate the reimbursement after five years, all patients treated with SIR-Spheres will be entered into a registry that collects data on the real-life clinical application of SIRT and reports to the national authorities.

The goal of the research project is to gain a better understanding of the real-life clinical application of radioembolisation with SIR-Spheres and the impact of the treatment in clinical practice. Secondary objectives will be to assess the observed treatment outcomes of SIRT with SIR-Spheres Y-90 resin microspheres in terms of safety, effectiveness, quality of life, technical considerations and diagnosis and treatment-related considerations.

To better understand the palliative aspect of the treatment, acquisition of the change in quality of life is included by means of EORTC's validated quality of life questionnaire QLQ C30 with accompanying HCC module to measure quality of life in patients with hepatocellular carcinoma.

Besides data collection on the initial treatment, it will be advised to collect follow-up data and quality of life data every three months for a minimum of 24 months after treatment.

CIRT-FR is a post-market, prospective, non-randomized, observational study. Patients are only asked to be enrolled when they are treated with SIR-Spheres microspheres as part of their treatment determined by the treating clinician. In no way will participation of the patient in the registry impact their treatment plan, or influence the quality of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Primary or secondary liver tumours
* Treatment of liver tumours with SIR-Spheres
* Signed informed consent form

Exclusion Criteria:

- Consent denied
Adoptive Transfer of iNKT Cells for Treating Patients With Relapsed/Advanced HCC

This study enrolls patients who have relapsed/advanced hepatocellular carcinoma (HCC, BCLC stage C). The HCC tumor relapsed or metastasized through the body after standard treatment or the patients cannot receive standard treatment under current conditions. This research study uses special immune system cells called iNKT cells, a new experimental treatment.

The purpose of this study is to find the biggest dose of iNKT cells that is safe and tolerance, to see how long they last in the body, to learn the immunoresponse in the body, to learn the side effects are and to see if the iNKT cells will help people with relapsed/advanced hepatocellular carcinoma (HCC).

PBMCs of enrolled patients were collected and then further separated by density gradient centrifugation. After washing three times, the cells were resuspended in serum-free medium with recombinant human IL-2 and α-GalCer. Restimulation with α-GalCer-pulsed autologous DCs was done on days 7. After 14 days of cultivation, the iNKT cells were harvested, washed thrice, and then resuspended in saline. The frequency of iNKT cells before and after cultured in vitro were determined by flow cytometry analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years.
* Patients with hepatocellular carcinoma (BCLC, stage C) proved by histopathology or proved by CT or MRI imaging system, relapsed after previous therapy and no effective therapies known at this time.
* Life expectancy of ≥ 12 weeks.
* WBC\>3.5×10\^9/L, LYMPH\> 0.8×10\^9/L, Hb\>85g/L, PLT\>50×10\^9/L, Cre\<1.5×the upper limit of normal value.
* iNKT\>10/mL in peripheral blood mononuclear cell (PBMC).
* Able to understand and sign the informed consent.

Exclusion Criteria:

* Any uncontrolled systematic disease: hypertension, heart disease, and et al.;
* Portal vein tumor thrombus, central nervous system tumor metastasis, or combined with other tumors;
* Receiving radiochemotherapy, local therapy, or targeting drugs within 4 weeks prior to this treatment;
* Unstable immune systematic diseases or infectious diseases;
* Combined with AIDS or syphilis;
* Patients with history of stem cell or organ transplantation;
* Patients with allergic history to related drugs and immunotherapy;
* Patients with complications associated with liver diseases: moderate or severe pleural effusion, pericardial effusion, ascites, or gastrointestinal hemorrhage;
* Pregnant or lactating subjects;
* Unsuitable subjects considered by clinicians.
Interactions of Brain Regions in Visuomotor Adaptation

The purpose of this study is to better understand the roles the cerebellum, basal ganglia, and thalamus play in motor learning. Patients undergoing High Intensity Focused Ultrasound (HIFU) treatment will be receiving an ablation procedure to their thalamus as a part of their medical procedure. Participation in this study will include completing a behavioral task before and after the procedure to see how motor learning task performance differs with and without the thalamus. Similarly, patients undergoing Deep Brain Stimulation (DBS) treatment will have an electrode implanted in their thalamus as a part of their medical procedures. Participation in this study will include completing the motor learning task performance "on" and "off" thalamic electrical stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Be a patient receiving either high intensity focused ultrasound treatment or deep brain stimulation treatment for Tremor
* Able to provide informed consent and complete study procedures
* Must speak English
* Age 18-85

Exclusion Criteria:

* Not receiving one of the specified inclusion criteria
* Unable to provide consent or complete study procedures
* Women who self-report pregnancy
* Patients who are currently incarcerated
Evaluation of the Effectiveness of the Combined Psychological Resilience and Self-efficacy Intervention for Improving Resilience and Self-efficacy and Reducing Anxiety and Depression of Oesophageal Cancer Surgery Patients

The goal of this clinical trial is to evaluate the effectiveness of the combined psychological resilience and self-efficacy intervention in oesophageal cancer surgery patients. The main question it aims to answer is:

Is the combined psychological resilience and self-efficacy intervention program more effective than the single psychological resilience intervention in improving psychological resilience and self-efficacy and reducing anxiety and depression in patients undergoing oesophageal cancer surgery? Researchers will compare the combined psychological resilience and self-efficacy intervention program to the single psychological resilience intervention and routine care to see if the combined intervention can improve psychological resilience and self-efficacy and reduce anxiety and depression in oesophageal cancer surgery patients.

Participants will receive the combined psychological resilience and self-efficacy intervention program in the combined intervention group, the single psychological resilience intervention in the single intervention group and routine care in the control group.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with oesophageal cancer by pathological biopsy.
* Received surgical treatment.
* Native Chinese speakers and age≥18 years old.

Exclusion Criteria:

* Prior to or during the first evaluation, patients who had end-stage illnesses or other chronic ailments including kidney failure, heart failure, etc..
* Undergoing further supplementary therapies such as neoadjuvant chemotherapy or radiotherapy.
* Undergoing other systematic psychological therapies.
* Possess a background of psychopathy or cognitive problems.
* Patients\&#39; baseline anxiety and depression subscale scores are less than 8 points each.
DHFR 19 bp Deletion Polymorphism and Folic Acid Utilization

A genetic variation in the gene for the protein dihydrofolate reductase (DHFR) that is necessary to utilize folic acid (a synthetic form of the B vitamin folate found in supplements and fortified food), increases the risk for breast cancer in multivitamin users and, when present in mothers who used folic acid supplements during pregnancy, increases the risk for cancer of the eye of their children. The aim of the proposed research is to understand how a common genetic variation in the gene for DHFR affects the function of this protein and the ability of the body to use folic acid.

A 19bp deletion polymorphism of intron 1 of dihydrofolate reductase (DHFR 19bpdel) increases the risk for breast cancer, and retinoblastoma of the offspring, in folic acid supplement users. Folic acid is a synthetic form of folate present in fortified foods and supplements that must be converted to tetrahydrofolate by DHFR to enter the metabolism. Individuals homozygous for DHFR 19bpdel have higher prevalence of unmetabolized folic acid in plasma and lower incorporation of folic acid into tissues. How the DHFR19bpdel (17% homozygosity in US) affects DHFR activity and folate metabolism to increase cancer risk is not understood. Studies on this topic are urgent in the light of mandatory folic acid fortification in the US and other countries. The objective of this project is to characterize the effect of DHFR 19bpdel on DHFR activity and folate pathway reactions and to determine if the effect of DHFR 19bpdel can be alleviated with folinic acid, which is a folate source that need not be converted by DHFR. The specific aims of this project are to 1\] Determine expression of DHFR mRNA and protein, splicing of intron 1 and enzyme activity in white blood cells from 3 DHFR genotypes. 2\] Determine the effect of DHFR 19bpdel and folic acid or folinic acid concentration on cell growth, and folate pathway reactions in white blood cells in homozygotes for DHFR 19bpdel and those who lack the polymorphism. Results of this study will guide measures to reduce this modifiable cancer risk associated with DHFR 19bpdel.

Eligibility Criteria:
Inclusion Criteria:

* Adult premenopausal women aged 21-45 in general good health, non-pregnant, minimum weight of 110 pounds.

Exclusion Criteria:

* Smoking, a terminal illness, any known chronic illness, rheumatoid arthritis, heart, kidney, liver or gastrointestinal disease requiring treatment, antifolate medications, metformin use.
* More than 2 drinks a day.
* Pregnant women have different metabolism when compared to other adults hence they will not be included in the study.
* Non-English speaking subjects will be excluded since the study involves a computer based diet history questionnaire in English. The budget for this project does not include the cost of an interpreter.
Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer.

Rivaroxaban or placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer: a randomized, double blind, placebo-controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Objective diagnosis of colorectal cancer;
* Elective laparoscopic surgery for colorectal cancer
* Whatever the stage of cancer
* Antithrombotic prophylaxis with LMWH administered for 7±2 days after surgery

Exclusion Criteria:

* Age \< 18 years
* Surgery for non-cancer disease
* Duration of surgery \< 45 min
* Conversion to open surgery
* Other indication for anticoagulant therapy
* Known cerebral metastases
* Kidney or liver failure
* Known hemorrhagic diathesis or high risk for bleeding
* History of intracerebral bleeding or neurosurgery within 6 months
* History of heparin induced thrombocytopenia
* Pregnancy or lactation
* Refusal of informed consent.
Health Coaching for Back Pain After Emergency Department Discharge

The goal of this two-group randomized trial is to determine the feasibility and acceptability of a remotely-delivered health coaching intervention offered in conjunction with usual care for patients with an acute exacerbation of chronic low back pain who present to the emergency department (ED).

The main questions this feasibility trial aims to answer are:

* Is our health coaching intervention and randomized trial methodology feasible to conduct?
* Is our health coaching intervention acceptable to participants and ED providers?

Participants will be randomized to one of two groups (usual ED care plus health coaching or usual ED care plus education) and complete outcome assessments at 3 and 6 months after ED discharge. Participants and ED providers will also complete an interview.

This study is a two-group randomized feasibility trial of usual ED care plus either remote health coaching or remote education in patients with acute exacerbation of chronic low back pain presenting to the ED. We hypothesize that our health coaching intervention and randomized trial methodology will be feasible and that our health coaching intervention will be acceptable to participants and ED providers.

Forty participants will be randomized (20 per group), with 36 (90%) retained in the trial up to 6 months follow-up. Eligible patients presenting to the ED with a chief complaint of acute exacerbation of chronic low back pain will be randomized. Patients will be enrolled during or shortly after their ED visit, asked to complete a baseline questionnaire, and then randomized. Randomized participants will receive 8 calls from either a health coach or education provider, and be asked to complete assessments at 3 and 6 months after ED discharge. Interviews will be conducted with randomized participants and 15 ED providers asking about their experience with the intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Chief complaint of musculoskeletal LBP
2. Meets NIH-supported chronic LBP criterion (e.g., pain greater than 3 months that has resulted in pain on at least half the days in the past 6 months)
3. Age 18 years of age or older
4. English-speaking

Exclusion Criteria:

1. Requires hospitalization for an acute medical condition or active comorbidity
2. In the opinion of the investigator has a severe psychiatric or behavioral diagnosis or substance use disorder that would interfere with the ability to perform the intervention and complete follow-up
3. Involved in litigation related to the LBP condition