cyrilzakka/clinical-trials huggingface dataset:
A Study of LY3050258 in Healthy Participants

The main purpose of this study is to evaluate the safety and how well the body will handle a single dose of increasing strength of study drug LY3050258. Each participant will receive LY3050258 or placebo once, in each of 2 dosing periods. At least 7 days will pass between doses. This study will last approximately 45 days for each participant. Screening is required within 28 days before the start of the study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or healthy postmenopausal females, including Japanese participants
* Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m\^2)

Exclusion Criteria:

* An abnormal sitting blood pressure as determined by the investigator
* Any abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, places the participant at an unacceptable risk for study participation
* Current use of statins within the last 3 months prior to dosing
* Current or previous use of anabolic steroids in the preceding 6 months prior to dosing
* Use of dehydroepiandrosterone, other potential over-the-counter (OTC) steroidal supplements, or other nutritional products intended to have weight-reduction and/or performance-enhancing effects within 21 days prior to dosing
Tolerance and Safety of a Duodenal Probe Monitoring the Microcirculation

For Intensive Care Units (ICU) patients, Multiple Organ Dysfunction Syndrome (MODS) is a very common complication yielding high morbidity and mortality. Inadequate regional perfusion of certain organs (gut, kidney, liver, etc) often caused by shock is the main cause of MODS. Current practice uses cardiac output data and blood pressure to manage shock but there are still lacks of information about the regional perfusion. This leads to late MODS diagnostics preventing the implementation of adequate treatment.

Gut perfusion monitoring seems to be a good target to assess the microcirculation but, nowadays, no practical methods or devices are available to measure the gut perfusion, and the current monitoring methods are not specific (CO, BP, OPS-SDF, PCO2, etc).

"MC Monitor" trial is a prospective, multi-center pilot study, enrolling 10 patients.

The probe will be used by intensivists on ICU patients with a risk of shock and requiring mechanical ventilation.

The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist (standard procedure for post-pyloric tubes placement). This procedure will be used to assess the status of the gut mucosa prior to the placement of the APD probe.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or more,
* Male or female,
* ICU patient, on vasoactive amines, under mechanical ventilation,
* Stable hemodynamic status,
* Life expectancy expected to exceed 72 hours,
* Length of ICU stay greater than 5 days,
* Willing to participate and signed informed consent,
* Affiliation to the French social security system.

Exclusion Criteria:

* Pregnant or lactating woman,
* Ongoing enteral nutrition,
* Risk of gastrointestinal ischemia,
* History of pharyngeal surgery surgery, esophageal surgery, radiotherapy of mediastinal area,
* Known ear-nose-throat malignant disease,
* Unexplored dysphagia,
* Known recent gastrointestinal suture,
* Esophageal varices,
* Abdominal pain,
* Unstable cervical fracture,
* Moribund patient,
* Active participation in another investigational protocol within the past 30 days,
* Subject legally protected, under legal guardianship, deprived of his/her liberty by judicial or administrative decision.
Intrathecal Therapy for Adult Tuberculous Meningitis: Impact on Clinical Outcomes

Tuberculous meningitis (TBM) is the most lethal form of tuberculosis (TB). While anti-TB regimens remain the cornerstone of treatment, spinal injection of dexamethasone is considered a potentially effective adjuvant therapy. However, its impact on mortality and disability remains uncertain. This study analysed all TBM patients admitted to Beijing Chest Hospital affiliated with Capital Medical University from January 1, 2010 to December 31, 2023. Patients were categorised into two groups based on whether they received standard anti-TB therapy with dexamethasone via spinal canal administration (intrathecal therapy group) or standard anti-TB therapy alone (non-intrathecal therapy group). Propensity score matching was used to balance baseline characteristics, and one-year mortality and severe disability rates were statistically compared between the groups.


Eligibility Criteria:
Inclusion Criteria:

* 1. A positive pathogenic diagnosis of tuberculous meningitis, or clinical diagnosis of tuberculous meningitis, refer to the 《2019 Chinese guidelines for the diagnosis and treatment of central nervous system tuberculosis》; 2. Complete patient information can be found, included patients' demographic characteristics, medical histories, presenting signs and symptoms, clinical course, laboratory test results, diagnostic studies, treatments, complications; 3. Patients can be collected from the time of diagnosis and medication to 12 months.

Exclusion Criteria:

* 1. HIV positive patients (as HIV positive patients in China require diagnosis and treatment in specific healthcare systems); 2. Patients who are unable to collect complete demographic information, diagnostic and treatment information, or treatment outcomes.
Long-term Cardiovascular Risk Following Successful Renal Transplantation

Mineral metabolism disturbances occur early during the course of chronic kidney disease and eventually affect most patients. For how long such disturbances persist after a successful renal transplantation is mainly unknown. This study will investigate the prevalence of such disturbances in patients more than 10 years following a successful renal transplantation. The patients will be recruited from an existing registry in Norway.


Eligibility Criteria:
Inclusion Criteria:

* Registered in the Norwegian Renal Registry
* Documented elevated iPTH at Tx and 10 weeks post-tx
* Well functioning transplant 10 years following tx
* Signed informed consent

Exclusion Criteria:

* Lack of ability to comply with the protocol
* Refused written informed consent
Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)

Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE).

The primary objective of this study is to assess the efficacy of rifaximin SSD plus lactulose versus placebo plus lactulose for the treatment of overt hepatic encephalopathy (OHE). The secondary objectives of this study are to assess the safety of rifaximin SSD in subjects with OHE and to assess the effects of treatment with rifaximin SSD on key secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18 to 75 years of age (inclusive) at the time of screening.
* Females of childbearing potential, defined as a female who is fertile following menarche, must have a negative serum pregnancy test at screening and agree to use an acceptable method of contraception throughout their participation in the study.

Note: Female subjects who have been surgically sterilized (e.g., hysterectomy or bilateral tubal ligation) or who are postmenopausal (defined as total cessation of menses for \> 1 year) will not be considered "female subjects of childbearing potential".

* Subject is hospitalized with liver cirrhosis and/or OHE and has a confirmed diagnosis of OHE at Baseline.
* Subject has a Grade 2 or Grade 3 HE episode according to the HE Grading Instrument (HEGI) following 8 to 12 hours of intravenous (IV) hydration and lactulose treatment.

Exclusion Criteria:

* Subject has an uncontrolled major psychiatric disorder including major depression or psychoses as determined by the investigator.
* Subject has been diagnosed with an infection for which they are currently taking oral or parenteral antibiotics, which cannot be discontinued at time of enrollment. Note: Subjects currently taking Rifaximin are not excluded
* Subject shows presence of intestinal obstruction or has inflammatory bowel disease.
* Subject has uncontrolled Type 1 or Type 2 diabetes. Note: Subjects with controlled diabetes may be enrolled if they are on stable doses of oral hypoglycemic drugs for at least 3 months prior to screening, and demonstrate clinically acceptable blood glucose control at Baseline, as determined by the investigator.
* Subject has an active malignancy (exceptions: non-melanoma skin cancers).
Epidural Steroid Following Discectomy for Herniated Disc Reduces Morbidity

Focus of this study is evaluation of the outcome, neurologic impairment and safety of epidural steroide following lumbar discectomy for herniated disc disease.

Methylprednisolone might enhance recovery after discectomy for herniated disc disease without apparent side effect.

Convalescence after discectomy for herniated disc disease is dependent on pain and the inflammatory response. In arthroscopic and abdominal surgery steroids reduce the inflammatory response and enhance recovery.

200 patients with herniated disc disease are randomly allocated to receive epidural methylprednisolone 40 mg or none.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary lumbar herniated disc disease who had received and performed standardized conservative treatment program with intensive exercises
* Patients more than 18 years old

Exclusion Criteria:

* Patients with central or lateral spinal stenosis due to spondylosis or disc degeneration who needed bilateral decompression, laminectomy or fusion
* Patients with cauda equina syndrome who needed acute operative treatment
* Lack of informed consent and inability to read and understand Danish
Precision Nudging Drives Wellness Visit Attendance at Scale

The purpose of the present randomized controlled trial is to explore the effectiveness of a 12-month well woman digital health intervention leveraging Precision Nudging - the application of behavioral science and reinforcement learning to create individualized, tailored health messaging at scale that matches the right message to the right person at the right time - in promoting behavior change. Specifically, it is hypothesized that scaling behavioral science through reinforcement learning will be more effective at motivating participants to engage with well woman messages and to schedule and to attend a well woman visit compared to a standard of care message.


Eligibility Criteria:
Inclusion Criteria:

* Patient of health care system.
* Visit with OBGYN office in the last 36 months.
* OBGYN office provider is a Women's Wellness group approved provider.

Exclusion Criteria:

* Completed a women's wellness within the last 366 days.
* Upcoming women's wellness appointment.
* Had a childbirth episode (e.g., C-section vaginal delivery, or other event, including stillbirth) within the last 3 months or has a pregnancy due date in the future.
* Unsubscribed.
Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation

This study will enroll participants with myelodysplastic syndromes (MDS) with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have not received treatment with a hypomethylating agent previously. Participants will be randomized to receive either ivosidenib (IVO) alone or azacitidine (AZA) alone. IVO will be administered daily throughout the 28-day treatment cycle and AZA will be administered for the first 7 days of each 28-day cycle. Study visits will be conducted every week during Cycle 1 (Days 1, 8, 15, and 22), and Day 1 of each cycle thereafter. After the last dose of treatment, participants will attend an safety follow-up visit and participants will be followed to assess overall survival. Study visits may include a bone marrow aspirate, physical exam, echocardiogram (ECHO), electrocardiogram (ECG), blood and urine analysis, and questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HMA naive IDH1 R132 mutated MDS defined according to WHO criteria (5th edition):
* Moderate high, high and very high-risk MDS per IPSS-M score will be eligible regardless of blood counts and with blast counts 0-19%.
* Low and moderate low-risk MDS per IPSS-M score must:
* Have cytopenias related to MDS, defined as: \<100 platelets/microliter, or absolute neutrophil count (ANC) \<1000/mm3, or hemoglobin \<10g/dL AND
* Have a blast count between 5-19% AND
* Be eligible for HMA therapy (very low risk participants are to be excluded)
* Locally or centrally confirmed IDH1 R132 C/G/H/L/S mutation

Exclusion Criteria:

* Received prior anticancer/disease modifying treatment for MDS (including HMA's, cytotoxic chemotherapy, investigational agents, bcl-2 inhibitor based-regimens, hematopoietic stem cell transplant (HSCT), IDH1 inhibitors). For LR-MDS patients, prior treatment with growth factors, luspatercept, lenalidomide, and imetelstat are allowed.
* \>20% blasts by morphology or immunohistochemistry on screening bone marrow aspirate/biopsy
The Effect of Calcifediol (Hy.D 25 SD/S) and Vitamin D3 on Muscle Strength in a Frail Elderly Population

In an ageing population, the need for interventions to help older people remain healthy, active and independent for as long as possible, increases. Although several studies suggest a beneficial effect of vitamin D3 on maintaining or improving muscle strength and physical functioning, particularly in vulnerable populations, results are contradicting. Randomized, placebo-controlled trials are needed to further establish the effect of vitamin D on muscle strength in the frail elderly population.The primary aim of this study is to determine the effect of daily supplementation with two different forms of vitamin D on muscle strength in frail elderly people over a period of 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 25(OH)D levels 20-50 nmol/L.
* age 65 or older.
* physically frail (pre-frail or frail, based on the criteria designed by Fried et al.) (30). Frailty will be defined as a clinical syndrome in which one or more of the following criteria are present: unintentional weight loss (4.5 kg in past year), self-reported exhaustion (CES-D questionnaire), weakness (grip strength), slow walking speed and low physical activity (Minnesota questionnaire). More details on these criteria are described in chapter 6.3.2.
* body mass index between 18.5 and 35 kg/m2.
* willingness and ability to comply with the protocol, including performance of the knee extension strength test.

Exclusion Criteria:

* Medical Illness:

  * malabsorption syndrome: known intestinal malabsorption, celiac diseases, inflammatory bowel disease;
  * diseases that may enhance serum calcium concentration: sarcoidosis, lymphoma, kidney stone in the last 10 years, primary hyperparathyroidism;
  * abnormal indices of calcium metabolism, uncontrolled hypocalcaemia;
  * diagnosed renal insufficiency;
  * diagnosed cancer; currently diagnosed or undergoing treatment.
* Hypercalcemia: serum calcium adjusted for albumin of \> 2.6 nmol/L.
* Medication: interfering with vitamin D metabolism and vitamin D supplementation (bisphosphonate, PTH treatment, tuberculostatica, anti-epileptica).
* Subject not able (when medically necessary/ advised) or not willing to stop the use of vitamin D containing supplements during the study.
* (Expected) increase in exposure to sunlight (e.g. travelling to a sunny resort) during intervention period.
* Patient heavily consumes alcohol containing products defined as greater than \> 21 drinks of alcoholic beverages per week.
* Planned surgery which can affect study measures (taking into account duration of hospitalisation and recovery).
* Participation in another clinical trial.
Atazavanir/Ritonavir-based HAART in Children

There are no data on efficacy, safety and pharmacokinetics of ATV/r-based HAART in HIV-infected Asian children. Therefore, the investigators aim to evaluate the pharmacokinetics, efficacy and safety of ATV/r-based HAART in Thai HIV-infected children.

Non-nucleoside reverse transcriptase inhibitor (NNRTI)-based HAART have been commonly prescribed as the first-line HAART for HIV-infected children in resource-limited settings. Protease inhibitor (PI)-based HAART are the recommended second-line regimen after failing NNRTI-based HAART. The most commonly used PI in Thailand is lopinavir/ritonavir (LPV/r). However, the metabolic complications of lopinavir/ritonaive (LPV/r) such as hyperlipidemia and lipodyrtrophy are common and a concern for HIV-infected children as it may contribute to the development of cardiovascular disease in the longer term. There are data on efficacy, safety and pharmacokinetics of ATV/r-based HAART in HIV-infected adults but none in children. Furthermore, many studies in both adults and children have shown that different ethnicities can result in different pharmacokinetic response to antiretroviral drugs. As a result of this, this study investigated the efficacy, safety and pharmacokinetics of ATV/r-based HAART in HIV-infected Asian children.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-infected children
2. Age from 6- 18 years old
3. Body weight ≥ 25 kg at screening visit
4. ARV history, the children can be categorized in one of these 2 groups
5. ALT \<200 IU/L at screening visit
6. Total bilirubin \< 3 mg/dL at the screening visit
7. Can swallow capsule
8. Written informed consent from caregivers and assent (from children aged 7-17 years who know their HIV status)

Exclusion Criteria:

1. Active opportunistic infection
2. Relevant history or current condition, illness that might interfere with atazanavir/ritonavir absorption, distribution, metabolism or excretion.
3. Use of concomitant medication that may interfere with the pharmacokinetics of ATV/r (i.e. efavirenz, indinavir, proton pump inhibitor, antacids, cisapride, clarithromycin, rifampin etc.)
4. Pregnancy or lactating at screening visit
5. Liver diseases e.g. hepatitis B carrier, chronic hepatitis, cirrhosis
6. Inability to understand the nature and extent of the study and the procedures required.
Intraperitoneal Versus Extraperitoneal Colostomy

This is a prospective randomized trial of intraperitoneal versus extraperitoneal techniques for construction of terminal iliac fossa colostomies.


Eligibility Criteria:
Inclusion Criteria:

* permanent colostomy

Exclusion Criteria:

* none
Study to Evaluate Safety, Efficacy of PBI-4050 & Its Effect on Relevant Biomarkers in T2DM Patients With Metabolic Syndrome

This is a Phase 2, multi-center, double-blind, placebo-controlled study of the safety and effect of PBI-4050 at doses ranging from 400 mg to 1200 mg on relevant biomarkers in subjects with inadequately-controlled T2DMS on stable background antidiabetic therapy.

This Phase 2 study will be performed by 15 sites in Canada. The total duration of study participation for each subject is approximately 20 weeks and comprises 6 study visits

A total of approximately 268 subjects will be enrolled in the study and randomly assigned to one of the following 4 treatment groups:

* PBI-4050 400 mg
* PBI-4050 800 mg
* PBI-4050 1200 mg
* Placebo

All subjects will receive the assigned study drug for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years of age or older.
2. Subject has signed written informed consent.
3. Subject has a clinical diagnosis of T2DM with an HbA1c level between ≥ 7.5% and ≤ 10%.
4. Subject has been receiving stable antidiabetic therapy (with or without basal insulin) for a minimum of 3 months before the screening visit.
5. Subject is able and willing to self-monitor blood glucose level at home.
6. Subject has a body mass index (BMI) of ≥ 27 kg/m2 and ≤ 45 kg/m2.
7. Subject has metabolic syndrome, having at least 3 of the 5 risk factors.

Exclusion Criteria:

1. Subject is using prandial insulin or pre-mixed insulin in addition to oral hypoglycaemic agents for blood glucose control.
2. Subject is taking basal insulin dose \> 1.0 U/kg/day.
3. Subject has recent or on-going infection requiring systemic treatment with an anti-infective agent within 30 days before screening.
4. Subject has a history of pancreatitis or diabetic ketoacidosis.
5. Subject has had at least one episode of severe hypoglycaemia in the past 12 months.
6. Subject has evidence of significant cardiovascular disease within 3 months before screening.
7. Subject has an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2.
8. Subject has uncontrolled hypertension.
9. Subject has a diagnosis of rheumatic or inflammatory disease; or other autoimmune or inflammatory disease.
10. Subject is concurrently taking and plans to routinely continue taking anti-inflammatory medications during the study.
11. Subject is currently using medications for the indication of (or at the doses indicated for) weight loss.
12. Subject has significantly elevated liver enzyme levels.
13. History of malignancy of any organ system, treated or untreated, within the past 5 years other than basal or squamous cell skin cancer.
14. Subject has a history of chronic alcohol or other substance abuse.
15. Subject has a history of an allergic reaction to PBI-4050 or any of its excipients.
Reducing PM-associated CV Health Effects for Seniors

The objective of this study is to investigate the effectiveness of air filtration at reducing personal-level exposures to fine particulate matter (PM2.5) and mitigating related cardiovascular (CV) health effects among older adults in a residential facility in a representative US urban location.

We enrolled 40 nonsmoking older adults into a randomized double-blind crossover intervention study with daily CV health outcomes and PM2.5 exposure measurements. The study was conducted in a low-income senior living apartment building in downtown Detroit, Michigan.

Participants were exposed to three 3-day scenarios separated by one-week washout periods: unfiltered ambient air (control), low-efficiency (LE) "HEPA-type", and high-efficiency (HE) "true-HEPA" filtered air using air filtration systems in the bedroom and main living space of each residence.

The primary outcome was brachial blood pressure (BP). Secondary outcomes included noninvasive aortic hemodynamics and pulse wave velocity and heart rate variability. PM2.5 exposures were measured in the participants' residences as well as by personal-level monitoring.


Eligibility Criteria:
Inclusion Criteria:

* 50 to 85 years old
* non-smoking healthy adults

Exclusion Criteria:

* smoke or anyone in your residence smokes.
* had a cardiovascular event within the past 6 months (such as myocardial infarction (heart attack), angina, cardiac or carotid surgery or stent, diagnosed peripheral arterial disease, aortic aneurysms, treated heart failure, any treated arrhythmia including atrial fibrillation)
* have renal disease requiring dialysis.
* have had medication changes in the past 6 weeks.
* use supplementary oxygen.