cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fed Condition

The purpose of this study is to determine the pharmacokinetics and bioequivalence of Lamotrigine formulations after administration of single doses to non-smoking, healthy males and females under fed conditions

A single-dose, two-way, bioequivalence study in up to 24 normal, non-smoking, healthy males and females will be utilized to evaluate the pharmacokinetics and bioequivalence of Lamotrigine chewable dispersible formulations under fed conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females at least 18 years of age inclusive.
* Informed of the nature of the study and given written informed consent.
* Have a body weight within 15% of the appropriate range as defined in the
* 1983 Metropolitan Life Company tables and weighing at least 100 lbs. (Appendix I and II).

Exclusion Criteria:

* Hypersensitivity to Lamotrigine' (Lamictal®), or similar compounds.
* Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
* Recent history (within 1 year) of mental illness, drug addiction, drug abuse or alcoholism.
* Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
* Received an investigational drug within the 4 weeks prior to study dosing.
* Currently taking any prescription medication, except oral contraceptives, within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing; This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
* Tobacco use (\>5 cigarettes per day) in the 3 months prior to study dosing.
* If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods. Females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
DARK STUDY "DysbetalipoproteinemiA and atheRoma Risk"

Dysbetalipoproteinemia (type III, Fredrickson's classification) is a rare metabolic disorder. It results from a defect in the clearance of VLDL and chylomicron remnants due to homozygous APOE2 variants or heterozygous APOE mutations, and there is an elevated plasma cholesterol and triglycerides.

As a consequence of the derangements in lipoprotein metabolism, dysbetalipoproteinemia predispose to the premature development of atherosclerosis.

However among this population there is heterogeneity in development of cardiovascular complications and the determinants remain unclear actually.

The aim of the investigators study is to evaluate the intensity of clinical atherosclerosis, and identify its determinants.


Eligibility Criteria:
Inclusion Criteria:

- apo E gene sequencing in CBE (Centre de Biologie Est / Hospices Civils de Lyon / France) laboratory in Lyon until December 2012

Exclusion Criteria:

* age \< 40 years
* refused participation
A Study to Investigate the Possible Causes of Secondary Effects During Use of Peripheral Midline Type Catheter in Patients Hospitalized in Different Care Settings

Although the use of peripheral venous catheters (CVP) with brachial insertion with echo-guide (Midline) has increased significantly over the last 5-10 years, there are no sensitive data concerning complications in the literature during their use, particularly as regards incidence of thrombotic complication.The prospective observational study will enroll all the patients admitted to Home Health Hospitalization service, Geriatric Department and Intermediate Care service, to whom a Midline-type CVP will be placed for infusional therapy and who will give their consent to participate.


Eligibility Criteria:
Inclusion Criteria:

* Subjects admitted to wards adhering to the study (Home Health Hospitalization service, Geriatric Department and Intermediate Care service)
* Subjects submitted to Midline type venous catheter insertion

Exclusion Criteria:

* History of deep venous thrombosis or pulmonary embolism
* Be hospitalized for less than a week
SleepHelsinki! CIRCADIAN SLEEP REGULATION IN ADOLESCENCE

Adolescence associates with alterations in sleep-wake organization, such as later circadian phase preference. Simultaneously external pressures, such as evening-driven social activities increase. These may lead to delayed sleep phase, which may cause serious problems for waking up at socially accepted times, and absenteeism from the school may follow. This project aims at tracking risk factors for later circadian regulation problems, characterizing interconnections of biological, psychological and behavioural mechanisms that maintain or induce poor sleep regulation in adolescence, and building a cost-effective, theoretically-based sleep intervention for adolescents with delayed sleep phase. This randomized control trial capitalizes on a new population-based cohort of 16-17-year olds.


Eligibility Criteria:
Inclusion Criteria:

* Late bedtime several times per week

Exclusion Criteria:

* Chronic disease that affects sleep. Ongoing therapeutic treatment relationship if considered overlapping by the participant
A Pharmacokinetic Interaction Study Between Apatinib Mesylate and Transporter Pgp Substrate Digoxin in Advanced Solid Tumor Subjects

Apatinib, an oral inhibitor of vascular endothelial growth factor receptor 2#VEGFR-2#, Induces Transporter Pgp function in vitro. This study in patients with advanced cancer evaluated the effect of Apatinib on Transporter Pgp function by comparing the pharmacokinetics of Transporter Pgp-specific probe drugs in the presence and absence of Apatinib. The probes used Substrate Digoxin.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of advanced solid tumors. 2. ECOG PS score: 0-1; 3. Expected survival ≥ 3 months; 4. Major organs must function normally, meeting the following criteria:

1. Hematology

   1. HB≥100 g/L;
   2. ANC≥1.5×109/L;
   3. PLT≥90×109/L;
2. Blood biochemistry:

   1. TBIL≤ 1.25×ULN;
   2. ALT and AST≤2.5×ULN;
   3. ALP≤2.5×ULN;
   4. Serum Cr ≤ 1.5 × ULN or endogenous CrCl ≥ 60 mL/min (Cockcroft-Gault formula);
   5. Albumin \> 30 g/L;
   6. K+\>3.0mmol/L; 5. Able to understand and sign an informed consent form (ICF).

Exclusion Criteria:

1. Primary liver cancer; gastric cancer;
2. Active brain metastasis (medically uncontrolled), carcinomatous meningitis, spinal cord compression;
3. Presence of clinically symptomatic third space fluid;
4. Uncontrolled hypertension (SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg despite optimal pharmacological treatment);
5. Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \>2 NYHA 2 congestive heart failure; (2) left ventricular ejection fraction (LVEF) \< 50% (3) heart rate \<60 (4) Grade II or greater myocardial ischemia or myocardial infarction(5) QTc interval ≥ 450 ms in males and ≥ 470 ms in females;
6. Abnormal coagulation function;
7. Prior radiotherapy, systemic chemotherapy (\< 6 weeks if chemotherapy including nitrosoureas or mitomycin), hormone therapy, surgery or target therapy within 4 weeks before the study drug administration, or any unresolved AEs \> CTC-AE Grade 1;
8. History of psychotropic substance abuse, alcoholism or drug abuse;
9. Use of study drugs in other clinical trials within 4 weeks prior to the first dose；
10. Use of a potent CYP3A4 inhibitor or inducer within 2 weeks prior to the first dose;
11. Use of any prescription or over-the-counter medication, vitamin products or herbs within 2 weeks before taking the investigational drug;
12. Other factors that may lead to the termination of the participation in the study at the discretion of the investigators.
A Disease Management Study Targeted to Reduce Health Care Utilization for Patients With Congestive Heart Failure

The aim of this study is to determine whether a nurse-managed telephone-based disease-management intervention can reduce healthcare utilization and improve self-assessed health status in patients with congestive heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ≥1 unplanned inpatient occasion with primary diagnosis of heart failure ( I50) during the last 12 months
* Heart failure grade NYHA II- III
* Accurate heart failure diagnosis
* Living in one of four Swedish counties where the trial is ongoing

Exclusion Criteria:

* Deceased
* In a moribund state
* Significant cognitive loss and therefore cannot provide consent
* Psychosis diagnosis
* Severe hearing impairment
* Language difficulties
* Participants in another study
ALICIA (Acalabrutinib in CLL Therapy)

This is a multicenter non-interventional observational study conducted with a single hand arm to collect real-world data. In this study, commercially available acalabrutinib will be used as prescribed treatment for CLL as per the treating physician's best clinical judgement. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.

A multi-center collaborative effort in 15 centers selected from regions within Russia will help capture more patients into the database, rather than limiting the data to a single institution. This will be critical for:

* increasing database sample size
* reducing bias (single institution bias)
* increasing result's generalizability to the whole Russian population Being an observational study, only data available from routine clinical practice and standard of care (SoC), in line with national and international laws and regulations, will be recorded.

Patients will be treated according to prescribing information, with visit frequency and assessments performed according to routine medical practice and SoC. Only data corresponding to these visits and assessments will be collected as part of the study.

Data for the study will be transcribed and entered into an electronic Case Report Form (eCRF) from the patient's medical records. The site investigator will be responsible for ensuring that all required data is collected and entered into the eCRF with the involvement of clinical research organization


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Confirmed diagnosis of CLL
* Patient started treatment with monotherapy acalabrutinib (prescribed by physician decision no more than 4 weeks ago before screening)
* Capability of providing written Informed Consent Form

Exclusion Criteria:

* Patients not corresponded to inclusion criteria
* Pregnancy
* Lactation
* Patients included in open-label trials
* Previous Bruton tyrosine kinase inhibitors (BTKI) treatment
Association Between Genetic Variant Scores and DOACs (DARES2)

The study's objective is to evaluate the predictive accuracy of Cipherome's algorithm in predicting and preventing serious adverse drug reactions (ADRs) experienced by patients while on direct oral anti-coagulants (DOACs).


Eligibility Criteria:
Inclusion Criteria:

* Any adult patient 18 years and older, who experienced a serious adverse drug reaction while taking a DOAC and is able to provide informed consent.

Exclusion Criteria:

* Failure to provide informed consent
Validation of ACS NSQIP Risk Calculator for Predicting Complications After Thoracic Surgery at University Hospital Basel

This single-center retrospective research project aims to evaluate whether and what is the significance of the National Surgical Quality Improvement Program of the American College of Surgeons (ACS NSQIP) risk score in thoracic surgery at the University Hospital Basel.

Advances in medical and surgical therapies have enabled treatment for polymorbid patients, who often have multiple chronic conditions. This has increased the need to accurately assess the risks of postoperative complications and mortality. Due to their complex health status, these patients are more susceptible to adverse outcomes following surgery, necessitating precise risk prediction to guide clinical decision-making and optimize outcomes.

This single-center retrospective research project compares the preoperative risk assessments by the National Surgical Quality Improvement Program of the American College of Surgeons (ACS NSQIP) risk calculator with actual complications (graded according to the Clavien-Dindo classification) observed in patients who underwent thoracic surgery at the University Hospital Basel between May 1, 2021, and March 1, 2022.

The ACS NSQIP risk calculator, a web-based tool, uses 21 preoperative risk factors to predict 13 perioperative outcomes, including serious complications, infections, and mortality. By evaluating these predictions against real patient outcomes, this research project aims to validate the calculator's accuracy specifically in the context of thoracic surgery.

The results of this research project could optimize patient care by better identifying high-risk patients and improving preoperative preparation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with signed general research consent
* Patients who underwent surgery in our department for the period from 01.05.2021 to 01.03.2022
* Patients with preoperative ACS NSQIP Risk score

Exclusion Criteria:

* Patients who have clearly stated that they would not agree in providing their clinical data for scientific purposes
Use of the Efisiotrack System for Monitoring Patients With Shoulder Orthopedic Injuries

To evaluate the effect on clinical variables of monitoring exercises prescribed for shoulder injury rehabilitation with the eFisioTrack platform in patients of the Rehabilitation Service at University Hospital of Elche.

Patients who be referred to the rehabilitation service of the University Hospital of Elche (Spain) for physiotherapy treatment (manual therapy, exercise, stretching, and electrotherapy) after suffering orthopedic injury or surgery in the shoulder joint complex will be considered for enrollment in the study.

Patients will performed the prescribed physical therapy treatment, at least three times per week in sessions of 45 minutes in the hospital setting (application of manual therapy and physical modalities as ultrasound, heat/cold, laser, magnetic field therapy) together with completion of the exercise program for functional recovery of the upper extremity (exercises for muscle strength, scapular stability, joint mobility, and proprioception).

Following baseline examination, patients will be randomly assigned to either physiotherapist-supervised exercise (control group) or monitoring by the eFisioTrack system (experimental group) to perform active exercises as part of their shoulder rehabilitation. These will be performed independently by each patient in a hospital room without supervision by the physiotherapist.

The following patient-reported outcome measures will be used to assess participants' shoulder pain and function: the Disabilities of Arm, Shoulder and Hand (DASH) score and the Constant-Murley (CM) score.

All participants will be assessed at baseline on their first visit to the physical therapy area and at one-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old and be able to read and understand Spanish.
* Suffer a traumatic or degenerative shoulder injury, with or without surgical treatment.
* Have a prescription for rehabilitative physical therapy that includes active exercises.

Exclusion Criteria:

-Had a concomitant injury on an upper extremity or the cervical spine at the time of participation or sequelae of previous injuries in the area.
Closing the Loop in Adolescents During Non-compliance Behaviours

The ultimate goal of the investigators ongoing research is the development of a closed-loop system for insulin delivery, which can help people with type 1 diabetes (T1D) attain a tight glucose control avoiding the risk of hypoglycaemia. The main components of the system are a continuous glucose monitor (CGM), an insulin pump and a computer-based 'model-predictive algorithm', which computes the amount of insulin to be given by the insulin pump according to the CGM values. In the studies performed thus far the efficacy and safety of closed-loop glucose control was evaluated both overnight and over a prolonged period of time including the day-time in children and adolescents with T1D. The results showed that closed-loop improved control of blood glucose and prevented nocturnal hypoglycaemia, as compared to the conventional insulin pump therapy.

The objective of the current study is to test the performance of closed-loop further, by evaluating the system during common non-compliant behaviours in the administration of meal insulin doses in adolescents with T1D. This will pave the way for a more comprehensive use of closed loop systems to control glucose levels in T1D under various "real-life mimicking" common circumstances. The present study adopts an open-label, randomised, 2 period cross-over design whereby closed-loop insulin therapy will be compared with the conventional insulin pump therapy in 12 adolescents with T1D.

Participants aged 12 to 18 years will be randomised for two 24 hour studies in a clinical research facility, during which glucose levels will be controlled by either the computer-based closed-loop algorithm (intervention arm) or by conventional insulin pump therapy (control arm). On both occasions, participants will under-estimate and omit the meal-related insulin dose for the evening-meal and lunch, respectively. The study will take place at the Wellcome Trust Clinical Research Facility (WTCRF), Cambridge with participants recruited from paediatric diabetes clinics in England.


Eligibility Criteria:
Inclusion Criteria:

* Aged 12-18 years
* Type 1 diabetes diagnosed for \> 1 year
* Insulin pump treatment for at least 3 months
* HbA1c between 8 and 12%
* Subject willing to perform reduction/omission of meal insulin boluses during clinical studies

Exclusion Criteria:

* Non-type 1 diabetes mellitus
* Physical or psychological disease likely to interfere with the normal conduct of the study
* Current treatment with drugs known to interfere with glucose metabolism
* Known or suspected allergy against insulin
* Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy
* Total daily insulin dose \>= 2 IU/kg/day
* Pregnancy, planned pregnancy, or breast feeding
Study Evaluating Safety and Efficacy of INCB050465 Combined With Bendamustine and Obinutuzumab in Relapsed or Refractory Follicular Lymphoma (CITADEL-102)

The purpose of this study is to evaluate the safety and efficacy of parsaclisib when combined with bendamustine and obinutuzumab in subjects with relapsed or refractory follicular lymphoma (FL).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed FL.
* Documented CD20+ FL.
* Relapsed or refractory to any prior rituximab-containing regimen.
* Previously treated with a maximum of 4 cancer-directed treatment regimens.
* At least 1 measurable lesion \> 1.5 cm in at least 1 dimension by computed tomography or magnetic resonance imaging.
* Must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Exclusion Criteria:

* Clinical evidence of transformation to a more aggressive subtype of lymphoma or Grade 3B FL.
* History of central nervous system lymphoma (either primary or metastatic).
* Allogeneic stem cell transplant within the last 6 months, or active graft-versus-host disease following allogeneic transplant or autologous stem cell transplant within the last 3 months before the date of the first dose of study drug administration.
* Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug.
* Prior treatment with a selective PI3Kδ inhibitor or a pan PI3K inhibitor.
* Prior treatment with bendamustine (within 12 months of the start of study treatment). Subjects with prior bendamustine treatment (\> 12 months before the start of study treatment) are eligible if they meet the following criteria:

  * Did not discontinue because of tolerability concerns.
  * Achieved either partial or CR to the bendamustine regimen of at least 12 months in duration before relapse/progression.
  * Experienced progression following a regimen containing an alkylating agent.
* Received prior obinutuzumab.
* Received rituximab within 4 weeks of study start.
* Prior treatment-related toxicities that have not resolved to ≤ Grade 1 before the date of study drug administration except for stable chronic toxicities (≤ Grade 2) not expected to resolve (eg, stable Grade 2 peripheral neurotoxicity).
* Received any prior monoclonal antibody (except an anti-CD20 antibody) within 90 days before the date of study start.
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (eg, subjects in whom re-administration with rituximab would be contraindicated for safety reasons).
Intestinal Wall Remodeling (Infliximab Therapy) in Crohn's Disease Patients Undergoing Serial Computed Tomography (CT) Enterography

Anti-TNF therapy induces intestinal wall remodeling that correlates with clinical response and can be detected in patients undergoing serial computed tomography enterography (CTE).

We will retrospectively identify Crohn's disease patients who underwent serial CTE imaging between 2004 and 2008. Approximately 4500 CTEs were performed over this period. We estimate a sample size of 50 Crohn's disease patients who have had CTE performed before and after infliximab therapy was initiated. We will analyze each CTE for the presence of penetrating disease, number of inflammatory lesion, length of each lesion, and severity of each lesion (degree of enhancement, wall thickness, stratification, vascular engorgement, fatty proliferation, and symmetry). Degree of enhancement and thickness will be graded on a 5-point scale. Stratification, vascular engorgement, fatty proliferation, and symmetry will be treated as dichotomous variables (yes/no). Only small bowel lesions will be described. A GI radiologist (JGF), blinded to the clinical information and previous imaging results, will provide the readings. Comparisons between CTEs will be performed to determine responders (all lesions improved), mixed responders (not all lesions improved), and refractory (no lesion improved). A descriptive pattern of healing will also be recorded for each lesion. Clinical data to be recorded include indication for CTE, time between CTE, dates of each CTE, date on first infliximab infusion, dose of infliximab, interval between infusions, history of penetrating disease, history of surgery, clinical status at imaging (remission, flare, or uncertain), medication usage, age, and disease duration. Clinical status at time of imaging will be based on the ordering clinician's global assessment at the time of repeat CTE. This will be determined by a review of the medical record by a gastroenterologist (DHB).

Eligibility Criteria:
Inclusion criteria

* Established Crohn's disease
* CTE before and after initiating infliximab
* Underwent at least 2 CTEs between 1/1/2004 and 12/31/2007
* At least 6 months between CTEs

  \*off-label use of infliximab by either increased dose or shortened interval will be included in the study Exclusion criteria
* Small bowel surgery occurring before repeat CTE imaging
* Episodic infliximab therapy (intervals greater than every 8 weeks)