cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Glucoregulatory Effects of Glucagon-like Peptide-1 Receptor (GLP-1 Receptor) Activation in Participants With Type 2 Diabetes Mellitus (MK-0000-222)

This was a four-period crossover study to assess the glycemic effects of a single dose of oxyntomodulin (OXM) on the glucose levels in participants with Type 2 diabetes mellitus (T2DM). Participants were randomly assigned to 1 of 6 treatment sequences consisting of 4 treatment periods, with a 7-day wash-out between each treatment period. The primary hypothesis was that during graded glucose infusion (GGI) oxyntomodulin (OXM) is neutral or better than placebo (Pbo) at lowering ambient plasma glucose levels, and at significantly enhancing insulin secretion.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) of ≤38.0 kg/m\^2
* Have a clinical diagnosis of Type 2 diabetes mellitus
* Have a glycated hemoglobin (HbA1C) at screening ≤9.0%; fasting plasma glucose should not exceed 300 mg/dL (16.8 mmol/L)
* Judged to be in good health

Exclusion Criteria:

* Have a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study
* Have a history of stroke, chronic seizures, major neurological disorder, clinically significant endocrine, cardiovascular, hematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases
* Have untreated hypertension with blood pressure of \>160/95 mmHg
* Have a history of neoplastic disease within the past 5 years
* Have a history of hypersensitivity to OXM, liraglutide, insulin or Haemaccel®
* Unable or unwilling to comply with restrictions around concomitant medications
* Consume excessive amounts of alcohol, coffee, tea, cola, or other caffeinated beverages daily
* Have had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks
* Have a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
* Currently a regular user (including use of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months
* Are unwilling or unable to consume the standardized meals during the study and/or is on a carbohydrate restricted diet (i.e., a diet \<100 grams per day of carbohydrate)
Fasting Study of Alendronate Sodium Tablets (10 mg) and Fosamax Tablets (10 mg)

The objective of this study is to investigate the bioequivalence of Mylan's alendronate sodium 10 mg tablets to Merck's Fosamax 10 mg tablets following a single, oral 40 mg (4 x 10 mg) dose administration under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study
The Effect of Preoperative Stoma Simulation on Anxiety and Postoperative Adaptation

The majority of patients (60-70%) develop high levels of anxiety before surgery. Surgical patients may experience feelings of anxiety due to insufficient information and counseling before surgery and potential changes in the body caused by surgery. Fears include (but are not limited to) not waking up from anesthesia, not being able to return to previous work and family life, and adaptation concerns regarding new processes after surgery. Patients with fear of complications experience preoperative anxiety four times more than other patients. Other factors affecting preoperative anxiety were determined to be waiting for a long time before surgery, not knowing what will happen during surgery, losing control of the body, not receiving sufficient social support, being exposed to medical errors, and encountering undesirable health outcomes after surgery. The changes that will occur in the body and lifestyle after stoma surgery scare patients and cause them to feel anxiety in the pre-operative period. Despite significant developments in stoma care products and the increase in the number of nurses specialized in stoma care in recent years, the majority of patients experience problems with compliance. For this reason, the compliance of stoma patients with stoma life is increasingly the subject of clinical trials and epidemiological studies. In our country, studies conducted to determine the problems experienced by stoma individuals regarding compliance with stoma and social life are limited. Nursing interventions are recommended to reduce patients' anxiety and increase their compliance with stoma after surgery. This study aims to evaluate the effect of stoma simulation performed preoperative surgery on the patient's anxiety level and postoperative stoma compliance.


Eligibility Criteria:
Inclusion Criteria:

* All patients who are planned for elective stoma surgery,
* Are between the ages of 18-65,
* Can speak Turkish,
* Can read and write,
* Are conscious,
* Are willing to participate in the study will be included.

Exclusion Criteria:

* Patients with speech or hearing impairments,
* Those who have had urostomy surgery,
* Those who have a psychological diagnosis or are taking medication,
* Those who need intensive care after surgery,
* Those whose stoma was closed during the study,
* Those who have complications in the peristomal area,
* Patients who have had stoma surgery before will be excluded from the study.
ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation

In this study the prognostic value of ABCB5 in survival of the limbal stem cell transplantation expanded in vitro on amniotic membrane for corneal surface reconstruction in patients with limbal stem cell deficiency will be analyzed.

There are several diseases that cause the cornea to lose its clarity and directly affects the vision of the individual, therefore, the use of limbal stem cells has been having increasing acceptance in the field of medical therapy. An open clinical study is running with patients with limbal stem cell deficiency, performing a limbal stem cell transplantation expanded in vitro on amniotic membrane and the value of ABCB5 as a prognostic factor in the survival of transplant will be determined. The corneal surface status will be the primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

1. Bilateral limbal stem cell deficiency of any etiology.
2. Corneal impression cytology positive for goblet cells.
3. Ocular ultrasound results within normal parameters.
4. Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Active immunological diseases.
IJobs - an Internet Intervention for the Unemployed

The current study aims to test the efficacy of iJobs, an online intervention for the unemployed. iJobs is an online adaptation of the JOBS program.

The current study is a two-arm randomized controlled trial that will test the efficacy of iJobs (a web-based adaptation of the JOBS program) against a waiting list control group. Participants from the control group will be enrolled in iJobs 2 weeks after the experimental group finishes the program. iJobs is a 2-week intervention consisting of 5 modules focusing on discovering job skills, job search strategies, preparing effective resumes, exercising different types of interviews, and overcoming setbacks in the job search process. iJobs was previously tested in a feasibility and acceptability trial.

Eligibility Criteria:
Inclusion Criteria:

* Unemployed and looking for a job
* Work as volunteers and are looking for a paid job
* Have a PC or laptop and basic digital competencies

Exclusion Criteria:

* They don't have internet access and are not available during the two weeks of the program
Evaluation of Multidisciplinary Palliative Care on Terminal Cancer Patients in Taiwan

The purpose of the study is to compare the quality of dying and death of terminal cancer patients from the perspectives of medical staff and main care giver (family). The hypothesis is that their view points will be different.


Eligibility Criteria:
Inclusion Criteria:

* Cognitively intact.
* Contact with the patient in the last month.

Exclusion Criteria:

* Cognitively not intact.
* No contact with the patient in the last month.
Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with placebo, in Non-alcoholic Steatohepatitis (NASH) participants with Stage 2, Stage 3 liver fibrosis.

This study is designed to assess response to treatment on measures of fibrosis and other efficacy parameters. It will also assess dose response and overall safety.


Eligibility Criteria:
Inclusion Criteria:

* Key Inclusion Criteria Diagnosis of non-alcoholic steatohepatitis (NASH) with presence of Stage 2, Stage 3 fibrosis based of the non-alcoholic steatohepatitis (NASH) Clinical Research Network (CRN) Histologic Scoring System and a nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) of 4 or higher

Exclusion Criteria:

- Key Exclusion Criteria

1. History or evidence of decompensated liver disease,
2. Hepatitis and fibrosis more likely related to etiologies other than non-alcoholic steatohepatitis (NASH).
3. Participant has urine ethyl glucuronide (EtG) \> 500 ng/mL at Screening.
4. History or positive screen for human immunodeficiency virus (HIV) infection or congenital or human immunodeficiency virus (HIV)-unrelated acquired immunodeficiencies (eg, common variable immunodeficiency \[CVID\]).
5. History of hepatitis B and/or hepatitis C.
6. History of malignancy within the last 5 years (exceptions: excised and cured basal/squamous cell skin carcinomas and cervical carcinoma in situ).
7. Pregnancy or lactation.
A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants

A phase 1, randomized, double blind, placebo controlled drug-drug interaction, pharmacokinetics and safety study of cefiderocol in combination with xeruborbactam in healthy adult participants

Qpex Biopharma, Inc. is developing xeruborbactam, a new boron-based beta-lactamase inhibitor with activity against both serine and metallo-beta-lactamases in combination with a beta-lactam antibiotic.

Cefiderocol is a cephalosporin antibiotic approved in the US for the treatment of complicated urinary tract infections including pyelonephritis, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 55 years of age (inclusive) at the time of signing the informed consent.
* Body mass index (BMI) ≥ 18.5 and 32 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive)
* Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile
* Voluntary consent to participate in the study.

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration
* Females who are pregnant or lactating
* Documented hypersensitivity reaction or anaphylaxis to any medication. History of any severe hypersensitivity, anaphylaxis, or allergic reaction to cefiderocol or any other beta-lactam antibacterial drugs, or any other excipients used in the formulation (eg, cephalosporins, penicillins, carbapenems, or monobactams)
Willingness to Participate in a Trial Comparing Standard Genetic Counseling Versus Personalized Genetic Counseling

This study evaluates patients willingness to participate in a trial comparing standard genetic counseling versus personalized genetic counseling. Collecting information from patients may help researchers learn why patients may or may not take part in the future study that compares standard genetic counseling to personalized genetic counseling.

PRIMARY OBJECTIVE:

I. To evaluate patients' willingness to participate in a future randomized trial comparing standard genetic counseling versus personalized genetic counseling based on Li-Fraumeni syndrome patient reported outcome (LFSPRO) ShinyApp data.

OUTLINE:

Patients complete a questionnaire over 15-20 minutes. Patients positive for a TP53 mutation complete an additional questionnaire over 15-20 minutes within 1 month after test results.

Eligibility Criteria:
Inclusion Criteria:

* Individuals age 15 or older OR parent/guardian of a patient younger than 15 years (if age 15-17, the patient will provide assent and parent/guardian will provide consent), pregnant women will also be allowed to participate
* English fluency
* Receive genetic counseling specifically for TP53 genetic testing and who consent to undergo TP53 genetic testing OR individuals whose genetic testing indicates a TP53 germline mutation

Exclusion Criteria:

* Individuals who are non-English speaking
* Individuals having low suspicion for a TP53 germline mutation during pretest counseling and test negative for a TP53 mutation
Imatinib Mesylate and Zoledronic Acid in Patients With Chronic Myeloid Leukaemia in Cytogenetic Response Without Molecular Response

Imatinib mesylate is standard treatment of Chronic myeloid leukaemia, complete cytogenetic response is obtained in most of cases but molecular response concerned only a small part of the patients. To increase molecular response ratio we decided to increase imatinib dose to limited resistance to this drug and to add zoledronate for it anti tumoral activity to increase anti leukemic effect. We plan to accrue 37 patients in 5 centers. We will analyse molecular expression of BCR-ABL transcript after 6 months of treatment, safety, duration of response, VEGF expression and LTgd production.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria: at registration· Chronic myeloid leukaemia Ph+ confirmed by cytogenetic analysis or BCR-ABL translocation by molecular biology· Chronic phase:-\<15% blast cells in blood and 5% in bone marrow-\<30% blast cells+promyelocyte cells in blood and bone marrow-\<20% basophils in blood-\>100.000 platelets· Without extra medullar attempt excepted hepatosplenomagalia· First line of treatment· Biology and biochemistry with normal levels· Male or female\>18 years old· Signed written consent· ECOG\<3At inclusion· Chronic myeloid leukaemia with cytogenetic response without molecular response after one year of treatment by imatinib and BCR-ABL transcript detected by RT-PCR

Exclusion Criteria:

* · Other cancer excepted basocellular or cervix carcinoma · Major surgery in last 2 weeks previous inclusion· Women who are pregnant or breastfeeding (are unable to use an acceptable method to avoid pregnancy of his partner for the entire study period)· Dementia or altered mental status that would prohibit the understanding or rendering of informed consent · Abnormal renal function with creatinine clearance \< 30 ml/ minuteAccording to Cockcroft-Gault : CrCl= \[\[140-age (years)\] x weight (kg)\]/ \[72 x serum creatinine (mg/dL)\] {x 0.85 for women}· Chronic myeloid leukaemia in acute phase or in pass to be in acute phase · Treatment with bisphosphonates in last 6 months previous inclusion · Intolerance to bisphosphonates: hypersensitivity, on course dental problem, including tooth or mandibular infection; dental traumatism or recent diagnosis or previous mandibular osteonecrosis, or dental extraction with cicatrisation delay or necessity to set bone evidence · Mandibular surgery in last 6 weeks or planned in the future during treatment (tooth extraction)· Serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy: diabetes, thyroid pathology, neuropsychiatric illness, myocardial infarction or congestive heart failure grade 3-4 according to " New York Heart association"· History of psychiatric or depressive pathology · HIV positivity known · Inclusion in other study investigating antineoplastic molecule in last 30 days previous inclusion
Comparing a Diagnostic and Treatment Strategy of Upfront CTCA With SOC in Patients With Chest Pain and Suspected CAD

Rationale:

Patients with chest pain usually undergo multiple diagnostic examinations to demonstrate or rule out atherosclerotic coronary artery disease (CAD). In addition to high healthcare costs, some of the examinations do not assess the presence of CAD, which means that patients may be undertreated and are at risk for myocardial infarction. A uniform diagnostic and treatment strategy that uses computed tomography coronary angiography (CTCA) as initial examination may reduce major adverse cardiac events (MACE) and may reduce healthcare costs. In addition, we hypothesize that this strategy improves angina-related health status and reduces the number of invasive coronary angiograms (CAG's).

Objectives:

* To show that the intervention is non-inferior to the control with regards to clinical outcomes
* To show superiority of the intervention with regards to clinical outcomes

Study design: National multicenter prospective randomized controlled trial.

Study population: Patients with suspected stable CAD.

Intervention: upfront CTCA to diagnose CAD and guide optimal medical therapy (OMT). Patients with obstructive CAD and refractory angina despite OMT will undergo non-invasive ischemia imaging to guide revascularization.

Control: Standard of care. Diagnosis and treatment are at the discretion of the attending cardiologist.

Main study end point: Composite of all-cause mortality and non-fatal myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years

Exclusion Criteria:

* Presentation with acute coronary syndrome
* Acute coronary syndrome within last 3 months
* History of obstructive coronary artery disease on imaging
* History of PCI and/or CABG
* Severe renal failure
* Severe allergy to ionidated contrast medium
* Known pregnancy
* Patients with an estimated life expectancy of less than 1 year
RCVS: The Rational Approach to Diagnosis and Treatment

This is a randomized clinical trial of short-acting nimodipine versus twice daily extended release verapamil to treat patients presenting with Reversible Cerebral Vasoconstriction Syndrome (RCVS).

Patients greater than 18 years of age presenting with clinical signs and symptoms consistent with RCVS (see inclusion criteria) will be enrolled. Neuroimaging (CT, Magnetic Resonance (MR), or 4 vessel angiogram) will be obtained along with a baseline transcranial doppler ultrasound (TCD). They will subsequently be randomized to receive nimodipine (every 4 hours) or extended release verapamil (twice daily). Mean cerebral blood flow velocities will be followed for reduction or normalization on daily TCD and medication dosing adjusted appropriately. Patients will be followed 90 days post-discharge at which time they will undergo repeat neuroimaging to confirm resolution of vascular abnormalities and repeat evaluation. To determine effectiveness, the investigators will evaluate both short-term (surrogate) in-hospital outcomes and long-term outcomes. Reduction of TCD velocities and headache severity will serve as our short-term surrogate outcomes; however, need for additional medications, blood pressure, new/recurrent stroke/Intracranial Hemorrhage (ICH) will also be evaluated along with modified Rankin score (mRS) on discharge, length of stay, and discharge disposition. At 90 days, the investigators will also assess headache control along with mRS.. Adverse events and their relation to the treatment arms will be assessed, and adherence to the medications will be evaluated.

Eligibility Criteria:
Patients 18 years of age or greater meeting the following inclusion criteria adapted from Singhal and colleagues 2 will be included:

1. presentation consistent with RCVS :

* acute thunderclap/severe headache and

  \*\*supporting clinical features should prompt increased clinical suspicion (eg., potential medication trigger, recent pregnancy, migraine history)\*\*
* evidence of beading/elevated velocities on imaging (Transcranial Doppler (TCD), angiogram, Computer Tomography Angiogram (CTA), MRA) and
* reversibility (by 90 days)-will not be required for inclusion but will be retrospectively adjudicated

Participants will be excluded from the study if they are:

* unable to consent AND no family present to consent, or
* have presence of aneurysmal, traumatic, or mesencephalic Subarachnoid Hemorrhage (SAH), or
* have presence of other supported diagnosis (eg., vasculitis- inflammatory lumbar puncture) or
* are currently pregnant or
* the use of nimodipine or verapamil is contraindicated for any reason (eg., allergy, breast feeding) or
* have limited TCD sonographic window

  * stroke or ICH/SAH on presentation will not be a contraindication to inclusion in the trial \*\*
Effects of Early Behavioral and Transaction Interventions on Preterm Infants' and Parents' Biopsychosocial Well-being

This randomized controlled trial will use a longitudinal repeated-measures design to examine the effects of two interventions, behavioral support interventions and a parent-infant transactional program, on parents' stress, PPD and sleep quality, parent-infant interactions, and their preterm infants' stress (saliva cortisol levels), sleep patterns, emotional regulation, and neurobehavioral developmental outcomes from 7 days to 2 years corrected age.

The proposed study has five specific aims:

1. to develop behavioral-support interventions for preterm infants who receive painful, stressful procedures in the NICU,
2. to develop a parent-infant transactional program (PITP) for parent-infant dyads with preterm infants in the NICU,
3. to determine the short-term effects of the behavioral-support interventions and PITP on infant stress (salivary cortisol levels) and sleep patterns,
4. to determine the short-term effects of the PITP on parental stress, depression, social support, and sleep quality during postpartum, and
5. to determine the long-term effects of the behavioral-support interventions and PITP on parent-infant interactions and infants' long-term emotional regulation and neurobehavioral outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age (GA) \> 28 weeks and \< 37 weeks
2. Postbirth age \>2 days
3. Stable condition (score\<20 on the Neonatal Therapeutic Intervention Scoring System \[NTISS\] for disease severity).
4. Parents are not diagnosed with mental illness or some other illness known to influence/confound the outcome variables
5. Parents are fluent in Chinese
6. Parents do not use drugs
7. Parents agree to participate in this study

Exclusion Criteria:

1. Congenital anomalies
2. Neurologic impairment including convulsion, intraventricular hemorrhage \> grade II or periventricular leukomalacia
3. Documented congenital or nosocomial (infection acquired at hospital after birth) sepsis
4. Surgery
5. Severe medical conditions requiring treatments such as cortisol supplementation, sedatives, muscle relaxants, antiepileptic, or analgesic drugs