cyrilzakka/clinical-trials huggingface dataset:
Rollover Study for Zerit (Stavudine) ER Studies (-096, -099)

The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release \[IR\]) formulations, each in combination with lamivudine (3TC) and efavirenz (EFV) in subjects who have completed Bristol-Myers Squibb (BMS) studies AI455-096 and AI455-099.


Eligibility Criteria:
Inclusion Criteria:

* Completed d4T studies AI455-096 or AI455-099
* Have demonstrated compliance with the study medication and treatment visits
* Provide written informed consent
* Agree to use a barrier method of birth control (such as condoms) during the study
* Have a negative pregnancy test within 72 hours prior to start of study medication

Exclusion Criteria:

* Are pregnant or breast-feeding
* Need to take certain medications that have systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential
* Have active alcohol or substance abuse which may prevent compliance or increase risk of developing pancreatitis
* Have certain other conditions or prior treatments that might interfere with study continuation
* Need to take certain medications that should not be taken with EFV
Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer

The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.


Eligibility Criteria:
Inclusion Criteria:

* Advanced ovarian cancer with positive BRCA1 or BRCA2 status
* Failed at least one prior chemotherapy
* In investigators opinion, no curative standard therapy exists
* Measurable disease

Exclusion Criteria:

* Brain metastases
* Less than 28 days since last treatment used to treat the disease
* Considered a poor medical risk due to a serious uncontrolled disorder
AI Assisted Detection of Chest X-Rays

This study has been added as a sub study to the Simulation Training for Emergency Department Imaging 2 study (ClinicalTrials.gov ID NCT05427838).

The Lunit INSIGHT CXR is a validation study that aims to assess the utility of an Artificial Intelligence-based (AI) chest X-ray (CXR) interpretation tool in assisting the diagnostic accuracy, speed, and confidence of a varied group of healthcare professionals. The study will be conducted using 500 retrospectively collected inpatient and emergency department CXRs from two United Kingdom (UK) hospital trusts. Two fellowship trained thoracic radiologists will independently review all studies to establish the ground truth reference standard. The Lunit INSIGHT CXR tool will be used to analyze each CXR, and its performance will be measured against the expert readers. The study will evaluate the utility of the algorithm in improving reader accuracy and confidence as measured by sensitivity, specificity, positive predictive value, and negative predictive value. The study will measure the performance of the algorithm against ten abnormal findings, including pulmonary nodules/mass, consolidation, pneumothorax, atelectasis, calcification, cardiomegaly, fibrosis, mediastinal widening, pleural effusion, and pneumoperitoneum. The study will involve readers from various clinical professional groups with and without the assistance of Lunit INSIGHT CXR. The study will provide evidence on the impact of AI algorithms in assisting healthcare professionals such as emergency medicine and general medicine physicians who regularly review images in their daily practice.


Eligibility Criteria:
Inclusion Criteria:

* General radiologists/radiographers/physicians who review CXRs as part of their routine clinical practice

Exclusion Criteria:

* Thoracic radiologists
* Non-radiology physicians with previous formal postgraduate CXR reporting training.
* Non-radiology physicians with previous career in radiology, respiratory medicine or thoracic surgery to registrar or consultant level
Comparative Study of Circulating microRNA Changes in Patients With Liver Injury and Healthy Subjects

The objectives are to:

1. validate a panel of tissue-specific miRNAs that are differentially expressed in the plasma of patients with and without liver injuries
2. investigate the physiological range of the circulating miRNA panel in Healthy Subjects and under stress
3. investigate the dysregulation of circulating miRNA panel and their prognostic and predictive values in clinical outcomes in identifying patients at high risk for mortality and acute liver failure.

This trial involves peripheral blood sampling from subjects at their earliest presentation and remaining stays in the hospitalization in the emergency department. The investigators will develop panels of miRNAs that are specific indicator of early onset of major organ failures, and correlate clinical outcomes with these miRNAs.

The ICU patients after surgery or under chemotherapies in sponsor's institutes will be enrolled in this observational cohort of investigation. Whole blood samples will be separated immediately into plasma for storage. The participants will have their 2nd and 3rd samples obtained at 24-48 hours and 48-72 hours respectively. The schedule of most of sampling schedule is designed in concordance with the ICU routines to avoid extra burdens on patients. The plasma samples will be used as prognostic markers in prognostic and predictive values in identifying patients at high risk for mortality and acute liver failure. Patients who are discharged will be tracked for any clinical recurrence of the diseases every 28 days to assess the diagnostic accuracy of the miRNA biomarkers that are measured.

The 2nd objective will be assessed by measuring the concentration of miRNAs in recruited healthy volunteers before and after a brief public speech. The circulating miRNAs will be detected directly from 1 - 5 ul of plasma samples with the miRFLP assay. This capillary electrophoresis-based miRNA quantification method detects multiple miRNAs in absolute copy number in smaller sample signature with negligible batch to batch variation, thus providing a standardizable miRNA detection method.

Eligibility Criteria:
Inclusion criteria for healthy controls:

Adults 18 years and above

Exclusion criteria for healthy controls:

Underlying chronic inflammatory condition (e.g. inflammatory bowel disease) Underlying autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus) Pre-existent liver disorder User of any prescribed medicine or over the counter drugs in prior 7 days.

Inclusion criteria for subjects:

Adults 18 years and above Has condition related to ICU enrollment cause

Exclusion criteria for subjects:

Age below 18 years Known pregnancy Treating physician deems aggressive care unsuitable Unable to provide informed consent or comply with study requirements
Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase

A randomised controlled open-label clinical trial to compare the outcome parameters after ovarian stimulation using recombinant-human FSH (follicle stimulating hormone), starting on day 2 of the cycle versus start in the late follicular phase of the cycle.

Objective: To determine whether late follicular stimulation using recombinant-human FSH has comparable outcomes to treatment using recombinant-human FSH in early follicular phase in a flexible GnRH (Gonadotropin-releasing hormone) antagonist protocol, in oocyte donor patients.

Design: Open label, phase 3 randomized trial using a two-arm design with 1:1 allocation ratio

Patients: Oocyte donors (aged 18-36 years)

Intervention(s): Reference group: Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.

Investigational group: Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle (evaluation trough ultrasound and hormonal assessment) onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH (Luteinizing Hormone) \> 10 IU/L, till day of trigger.

Oocyte maturation trigger with GnRH agonist (0.2mg Gonapeptyl) in both groups.

Eligibility Criteria:
Inclusion Criteria:

* oocyte donor patients
* Age from 18 to 36 years
* BMI 19 to 35
* Regular menstrual cycle length i.e. 24-35 days

Exclusion Criteria:

* Patients with AMH \<1.1 ng/ml and/or AFC\<7
* Patients with FNPO (Follicle Number Per Ovary) ≥ 19 and/ord AMH \>5ng/ml
* Endometriosis grade 3-4
* Oligo-amenorrhea
* Any untreated endocrine abnormality
Assessing the Team SA Instrument in Measuring the Effectiveness of Communication Across Disciplines During ICU Rounds

Assessing the utility of the Team SA instrument in measuring the effectiveness of communication across disciplines during ICU rounds.

Multidisciplinary rounds are events that occur daily in Intensive care units. During these events, practitioners from multiple disciplines meet at a pre-specified time to discuss current medical condition and plans of care. At the conclusion of these discussions, all practitioners are expected to understand the plan of care well enough to execute defined tasks, but also coordinate as circumstances change. In order to coordinate under changing circumstances practitioners must have a broader understanding of the current state of the patient and how likely certain deteriorations are. This synthetic understanding of patient risks across multi-provider groups has been described as anticipatory team situational awareness (Team SA). One instrument has been validated in the ICU as feasible and informative. This Team SA survey successfully identified that the time spent in "training" discussions improved Team SA across physician groups. The investigators' goal is to implement this survey across the investigators' medical ICU service to obtain a baseline estimate of how effective current communication patterns are for achieving concordant Team SA. If gaps in communication are encountered future interventions will be developed

Eligibility Criteria:
Inclusion Criteria:

* Nurses, primary clinicians (resident or NP) and Critical Care physicians (Staff or Fellow in Critical Care Medicine) will be approached for interview. All subjects will be approached individually and asked to participate outside of the presence of the other potential study subjects.

Exclusion Criteria:

* N/A
The Effect of Sugammadex Given Based on Ideal, Actual or Adjusted Body Weight on Reversal of Rocuronium.

The aim of this study is compare the reversal of rocuronium induced neuromuscular blockade in morbidly obese patients using three doses of sugammadex; based on ideal body weight, adjusted body weight, and actual body weight.

The aim of this study is compare the reversal of rocuronium induced neuromuscular blockade in morbidly obese patients using three doses of sugammadex; based on ideal body weight, adjusted body weight, and actual body weight. Reversal Time: time from administration of Sugammadex to train of four (TOF) ratio ≥ 0.9 will be used as primary outcome.

Time need for extubation (time from administration of sugammadex to extubation), and duration of stay in post anesthesia care unit (PACU), will be used as secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years and under 45 years,
* body mass index ≥ 40 kg/m2, with indication of bariatric surgery

Exclusion Criteria:

* Patients with comorbid including: neuromuscular disease, renal impairment, and patients with difficult airway were excluded from this study.
Validation of Structured Light Plethysmography - Health and Disease

Validation of Structured Light Plethysmography (SLP) in patients with conditions such as Chronic Obstructive Pulmonary Disease (COPD) that effect breathing and in healthy participants.

The investigators hypothesize that SLP may be a useful tool to differentiate between different respiratory diseases. To further examine differences in disease and health, and between diseases SLP measurements will be recorded in a range of diagnostic conditions that effect breathing and in healthy normal subjects.

This is a non-randomised observational study to validate Structured Light Plethysmography in two groups of participants: those with Respiratory condition such as COPD and a normal healthy group. Neither group will receive any clinical intervention. SLP data capture and spirometry (as part of the patients clinical care) will be performed by the patients. The data collected from this study will allow examination of different breathing patterns between patients with different diseases, to compare breathing patterns in patients to those in healthy individuals, and to compare breathing patterns within a healthy population.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 0 and 80 years

Exclusion Criteria:

* Any contraindication to spirometry (if performed) or a history of a myocardial infarction or chest surgery within 4 weeks
* Patient unable to sit in an upright (or supine in the case of infants) position for required period of time
* Patients with significant co morbidities (assessed by the clinician at screening only):
* Chest wall or spinal deformity e.g. scoliosis
* Obstructive Sleep Apnoea (OSA) Apnoea hypopnoea index \> 30 (if known)
* An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in the study
* BMI \> 40
* Inability to consent/comply with trial protocol
Are Sleeping Disorders Associated With Visceral Hypersensitivity in Irritable Bowel Syndrome Patients ?

Visceral hypersensitivity is frequent in IBS population up to 60% and is correlated with severity and altered quality of life. Sleeping troubles are most frequent in IBS population. Insomnia is a frequent disorder with an important cost for healthcare. Insomnia could decrease pain threshold.

Visceral hypersensitivity was never measure in patients with insomnia. The hypothesis is IBS patients with insomnia probably have lower visceral pain threshold.

The objective is to assess pain threshold during a barostat procedure in in IBS patients with or without insomnia in comparison with healthy volunteers or patients with insomnia.

If the hypothesis are confirmed, insomnia should be look at in IBS patients and its treatments could improve visceral hypersensitivity and IBS symptoms.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers

   - Person aged over 18 years with no IBS and no Insomnia
2. Patients with insomnia

   - Patient aged over 18 years with no IBS and no Insomnia
3. Patients with IBS

   - Patient aged over 18 years with IBS
4. patients with insomnia and IBS - Patient aged over 18 years with IBS

Exclusion Criteria:

* Active chronic organic disease
* Endometriosis
* Opioids consumption
* Change in chronic treatment in the last 30 days
* Hypersensitivity to Normacol
* Patient with blood dyscrasia disorder known or identified, anticoagulant or antiplatelet treatments
* Rectal pathology
* Intestinal occlusion
* Severe renal failure
* Sodium retention
* Anal pathology (anal fissure, hemorrhoidal thrombosis)
* Person with administrative or judicial decision or under legal protection measure
* Patient participating in another trial in the last 30 days
* Pregnant or breastfeeding women
* Impossibility to keep fasting for 12 hours
Management of Mixed-Phenotype Acute Leukemia in the East of France

Clinical presentation and management of Mixed-Phenotype Acute leukemia (MPAL) is heterogeneous. This descriptive observationnal study aims to review MPAL cases in the East of France based on a 10-year multicentre retrospective collection.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 18 years of age
* Diagnosis of biphenotypic acute leukemia or mixed-phenotype acute leukemia between 2008 and 2018
Cannabinoids in Bipolar Affective Disorder

Some people with bipolar disorder who use cannabis (marijuana) claim that it eases the symptoms of depression and mania. There are many chemicals (called cannabinoids) found in cannabis but two particular ones appear to have medicinal (therapeutic) effects. These two compounds are: delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). These cannabinoids appear to have mood, anxiety, and sedative effects as well as have antipsychotic and anticonvulsant properties. This study will try to find out if these cannabinoids can be of benefit as an add-on treatment in bipolar disorder and what effects it has on thinking power and memory.

This study will be a within-subject, random order, double-blind cross-over study with standard clinical and neuropsychological ratings. Duration is 13 weeks per subject. Clinical assessments including mood ratings will be performed weekly. Instructions and practice on the use of the spray will be given under supervision during a 2-week run-in period before baseline. Patients can control the dosage of cannabinoids according to their symptoms by administering up to a maximum of 48 pump-controlled sprays per day. Patients will be asked to abstain from using cannabis (other than the study drug) during the study. Patients will be treated for 4 weeks with either the sublingual THC:CBD spray or placebo spray. This will be followed by a 2-week washout period before another 4 weeks of treatment with whichever study medication was not initially used. Neurocognitive testing will be performed 3 times during the study. A mood diary will be completed daily by each patient at home.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients between the 19-60 years of age with a diagnosis of bipolar disorder.
* Women must not be currently pregnant and must use a reliable method of contraception for the duration of the study.
* Subjects must be on stable medication (4 weeks minimum) for their bipolar illness (symptomatic despite current treatment), must be able to provide written informed consent, must adequately understand written and verbal English.

Exclusion Criteria:

* Those not meeting the inclusion criteria and those not able to give informed consent.
* Women who are currently pregnant or nursing.
* Those at immediate risk of harming self or others;
* those who have a clinically significant medical illness or other significant psychiatric illness;
* currently abusing alcohol or drugs;
* currently being treated with an investigational medication or medication that is contraindicated with cannabinoids;
* have a known allergy to cannabis-based products.
Effectiveness of Frog Leg Technique in Management of Low Back Pain Due to Lumbar Lordosis

Condition in which lumbar region experiences stress or extra weight and is arched to point of muscle pain or spasms is called Lumbar hyperlordosis.The study findings compared the effectiveness of frog leg technique and standard exercise therapy in management of low back pain due to lumbar lordosis.

In adult population, a major health problem is Low back pain. Postural change is one of the risk factor. Abnormal posture causes strain on ligaments and muscles, as a result indirectly affects the curvature of the lumbar spine.Condition in which lumbar region experiences stress or extra weight and is arched to point of muscle pain or spasms is called Lumbar hyperlordosis.The study findings compared the effectiveness of frog leg technique and standard exercise therapy in management of low back pain due to lumbar lordosis.

Eligibility Criteria:
Inclusion Criteria:

* Females with age between 20 and 45 years
* Patients with low back ache due to lumbar lordosis

Exclusion Criteria:

* History of surgery
* Patients with discogenic backache.
* Backache in pregnancy.
* Patients with traumatic history.
* Patients with pain due to any reason other than lumbar lordosis.
Our Care Wishes - Dementia

This Our Care Wishes- Dementia pilot study is adapting an existing successful online advance care planning platform to the specific needs of persons living with dementia and shared decision-makers (SDMs) and testing the usability and acceptability among nursing home residents and SDMs.


Eligibility Criteria:
Inclusion Criteria:

* Eligible PLWD will be receiving short-or long-term care at a participating NH, have documented moderate to severe cognitive impairment as measured by the Cognitive Function Scale included in the Minimum Data Set 3.0, 65 and have an identified SDM.

Exclusion Criteria:

* Participants are not eligible discharged from participating NHs, or do not have access to a telephone or video chat.
Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus

Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes This study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used alone or added to other diabetes treatments.


Eligibility Criteria:
Inclusion Criteria:

* Men or women at least 40 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
* Diagnosis of type 2 diabetes.
* Established cardiovascular disease with at least one of the following: coronary artery disease, cerebrovascular disease, or peripheral arterial disease.
* HbA1c \>7.0% (53 mmol/mol) (based on the most recent documented laboratory measurement within 6 months).
* Able and willing to provide informed consent.

Exclusion Criteria:

* Severely reduced kidney function: eGFR \<30 ml/min/1.73 m\^2 (based on the last measured and documented laboratory measurement within 6 months) or renal replacement therapy.
* Use of a GLP-1 receptor agonist at Screening.
* Severe gastroparesis
* History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study.
* Personal or family history of medullary carcinoma of the thyroid or subject with multiple endocrine neoplasia type 2 (MEN-2). Personal history of pancreatic neuroendocrine tumours.
* Medical history which might limit the subject's ability to take trial treatments for the duration of the study or to otherwise complete the study.
* Breastfeeding, pregnancy, or planning a pregnancy during the course of the study. Note: a pregnancy test will be performed on all women of child bearing potential prior to study entry.
* Known allergy to any GLP-1 receptor agonist or excipients of albiglutide.
* Use of another investigational product within 30 days or according to local regulations, or currently enrolled in a study of an investigational device.
* Any other reason the investigator deems the subject to be unsuitable for the study.