cyrilzakka/clinical-trials huggingface dataset:
A Study of LY3475766 in Healthy Participants

This study will evaluate the safety and tolerability of LY3475766 when given to participants with high levels of blood fat called triglycerides. It will also investigate how the body processes the study drug and the effect of the study drug on the body. Information about any side effects will be documented. This study will last up to 16 weeks for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females, apart from dyslipidemia
* Male participants must agree to adhere to contraception restrictions
* Female participants must be of nonchildbearing potential and include those who are infertile due to surgical sterilization or those who are postmenopausal
* Have a body mass index (BMI) \>18.5 and \<40 kilograms per meter squared (kg/m²)
* Have clinical laboratory test results within normal reference range, or acceptable deviations per investigator discretion
* Have a fasting triglyceride (TG) level that is 135 to 499 milligrams per deciliter (mg/dL), inclusive, at both screening and Day -1
* Have a fasting low density lipoprotein cholesterol (LDL-C) level greater than or equal to (≥) 70 mg/dL, inclusive, at screening and Day -1
* Have had a stable body weight for the 3 months prior to randomization (\<5% body weight change)
* Have not modified diet or adopted any nutritional lifestyle modification within 3 months prior to randomization

Exclusion Criteria:

* Are taking or have started taking Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors within 3 months prior to randomization; or statins, fibrates, or niacin ≤1000 mg/day within 8 weeks prior to randomization; or niacin \>1000 milligrams per day (mg/day) within 16 weeks prior to randomization; or any other lipid-lowering agents within 1 month prior to randomization
* Are taking or have started taking a beta-blocker, antiarrhythmic, non-dihydropyridine calcium channel blocker, ivabradine, or any other heart rate lowering agent within 1 month or 5 half-lives prior to randomization, whichever is longer
* Have a diagnosis of diabetes mellitus (type 1 diabetes mellitus or type 2 diabetes mellitus) or have 1 of the following at screening: fasting plasma glucose concentration ≥126 mg/dL (7.0 millimoles per liter \[mmol/L\]) OR a glycated hemoglobin level ≥6.5% (48 millimoles per mole \[mmol/mol\])
* Have previously completed or withdrawn from this study or any other study investigating LY3475766, and have previously received the investigational product
* Have known allergies to LY3475766, related compounds, or any components of the formulation, or history of significant atopy
* Have a seated heart rate ≤50 beats per minute
* Have clinically significant abnormal electrocardiogram (ECG) results constituting a risk while taking the investigational product, as determined by the investigator
* Have an abnormal blood pressure (BP) as determined by the investigator
Study of Ro 205-2349 in Patients With Type 2 Diabetes Mellitus

The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes. Doses of 5 to 20 mg/day will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Age 35 to 75
* Type 2 diabetes for longer than 3 months
* HbA1c (glycosylated hemoglobin A1c) greater than 7.0% at screening
* FPG (fasting plasma glucose) greater than 126 mg/dL at screening
* BMI (body mass index) less than 40 kg/square meter

Exclusion Criteria:

* Type I diabetes
* Type 2 diabetes patients currently treated with insulin
* Type 2 diabetes patients currently or previously treated with Actos, Avandia or Rezulin
* FPG (fasting plasma glucose) greater than 270 mg/dL at baseline
* Impaired liver or kidney function
* Triglycerides greater than 600 mg/dL
* Uncontrolled hypertension
* Pregnant or lactating women
* Women not using adequate contraception
Amodiaquine+Artesunate for Uncomplicated Malaria Treatment

This is a phase IV one-arm study aiming at recruiting 50 patients to assess the efficacy of AQ+AS in patients with a positive RDT diagnosis of malaria in Nanoro, Burkina Faso.


Eligibility Criteria:
Inclusion Criteria:

* Males and Females aged 6 months and above.
* Body weight of 5 Kg and above.
* RDT positive test.
* Fever (axillary temperature at ≥ 37.5°C) or history of fever in the previous 24 hours.
* Signed (or thumb-printed whenever patients are illiterate) informed consent.
* Patients' willingness and ability to comply with the study protocol for the duration of the study.

Exclusion Criteria:

* Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.
* Known hypersensitivity to the study drugs.
* Severe malaria.
* Danger signs: not able to drink or breast-feed, vomiting (\> twice in 24hours), recent history of convulsions (\>1 in 24h), unconscious state, unable to sit or stand.
* Known intercurrent illness or any condition (cardiac, renal, hepatic diseases) which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.
* Severe malnutrition (defined as weight for height \<70% of the median NCHS/WHO reference).
Bile Acids in Acute Insulin Resistance

This is a prospective observational study with a primary goal of monitoring changes in circulating bile acid profiles and parameters of glucose and lipid metabolism prior, during, and after cancer treatment with agents that directly impair insulin action: PI3K inhibitors, AKT inhibitors, and mTOR inhibitors. Patients will not receive any cancer treatment specifically for the purposes of this study. Rather, this study will be based on treatment decisions made independently by participants' oncologists according to standard of care or other clinical trial protocol. This study seeks to enroll at least 25 participants each for PI3K inhibitors, mTOR inhibitors and, once available for open-label treatment, AKT inhibitors.

The primary objective of this study is to determine the effect of drug-induced acute insulin resistance (diaIR) on the ratio of 12α-hydroxylated bile acids (12-HBA) to 12α-hydroxylated bile acids (non-12-HBA) in cancer patients treated with phosphatidylinositol-4,5-bisphosphate kinase (PI3K) inhibitors (PI3Ki), mammalian target of rapamycin (mTOR) inhibitors (mTORi), and AKT inhibitors (AKTi) once possible. Specifically, this study will: (1) verify the induction of diaIR by monitoring changes in fasting ± postprandial blood glucose, insulin/c-peptide, and fructosamine; and (2) assess qualitative and quantitative changes in the circulating bile acid (BA) pool (including bile acid intermediary metabolites) by mass spectrometry in the fasting ± postprandial states prior to and then at 2 and 4 weeks after starting treatment. This study focuses in particular on determining changes in the 12α-hydroxylated bile acids to 12α-hydroxylated bile acids, as well as each of these subclasses and their individual substituents as a proportion of the overall BA pool.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Speaks English and/ or Spanish
* Any cancer diagnosis
* Planned for treatment with:

  * PI3K inhibitors

    * Alpelisib
    * Inavolisib
    * Any experimental PI3K inhibitor
  * AKT inhibitors (if these become available for open-label use during the study course)

    * Afuresertib
    * Capivasertib
    * Ipatasertib
    * Miransertib
    * Uposertib
  * mTOR inhibitors

    * Everolimus
    * Sirolimus
    * Temsirolimus
* Signed informed consent

Exclusion Criteria:

* Known dysglycemia
* Known diagnosis of diabetes mellitus
* Treatment with glucose-lowering medications at baseline

  * Insulin
  * Sulfonylureas or meglitinides
  * Metformin \>1000mg total daily dose
  * Thiazolidinediones
  * SGLT2 inhibitors
  * GLP-1 receptor agonists
  * DPP4 inhibitors
  * Amylin mimetics
  * Acarbose
* Significant biochemical evidence of liver dysfunction on lab tests within 30 days before starting drug that have not fallen to below the following thresholds prior to starting drug
* Significant functional or anatomical abnormalities of the small intestine
* Use of certain medications at baseline, within 7 days of starting cancer drug
* Allergy to cow dairy or soy (only excludes from MMTT, does not exclude from fasting blood draws)
* Inability to provide informed consent
The Effectiveness of a Proprietary of a Botanical Extract on Sleep Quality

The purpose of this study is to evaluate the efficacy and superiority of a botanical based sleep product on sleep quality as compared to melatonin, among healthy female participants.


Eligibility Criteria:
Inclusion Criteria:

Provision of signed and dated informed consent form Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study Self reported poor sleep quality Biological sex of woman; gender identification of female Aged 35 to 55, inclusive Good general health as evidenced by medical history and screening For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study Has an apple watch or similar device Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria:

Pregnancy, trying to conceive, or breastfeeding Currently smokes or vapes (i.e., tobacco, flavored items, marijuana, etc.) or has in the past year Has received medical diagnosis or treatment for any sleep disorder in the past year Has ever received a medical diagnosis of sleep apnea or narcolepsy Works a night shift, is "on-call" or performs any job requiring or potentially requiring work related responsibilities after 8pm Consumes \> 8 alcoholic beverages in an average week Is a primary caretaker for a child younger than 18 months of age Consumes any sleep aid, medication, diet, or supplement intended to improve sleep in any way Known allergic reactions to any components of the intervention Positive COVID-19 test within 30 days of the study period Recent dramatic weight changes (10% change in body weight in the last 6 months) Introducing a new investigational drug or other intervention within 60 days before the start of the study
The Comparisons of Effects of Core Stability Exercise and Tai Chi on Core Muscle Performances in Elderly

Core muscles and core stability has a key component in the postural control or balance. However, no clear evidence has been found for the positive relationship between core stability and postural control in the elderly, and the effects of core stabilizing training on postural control or balance in the elderly. The purposes of this project are to investigate the effects of core stability training program on muscle strength, muscle performance, and balance outcomes in elderly adults.

In this pretest, posttest design study, elderly adults enrolled and assigned to the core exercise group or Tai Chi exercise group, the core exercise group received core exercise intervention comparing to Tai Chi exercise group participated Tai chi exercise program as a control group.

The young adults group were also enrolled for a reference group, not received any exercise intervention and just only received the measurements once.

Participants in the two elderly group will receive 12-week, 36-session exercise-based core stability training class. The each 60 minutes core exercise class focuses on exercise for improving strength, endurance of core muscles and trunk stability.

Participants need complete baseline assessments of muscle performance, and balance ability measures 1 week prior and 1 week and 12 weeks following the intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Core exercise group and Tai Chi exercise group

   1. healthy community-dwelling older adults (60-74 years old)
   2. not received any core stability or Tai Chi Chuan training within the previous 6 months
   3. independent in basic daily living activities
   4. able to move freely without any assistance
2. Young adults group a. Their age should be ranged between 20 - 59 years

Exclusion Criteria:

All group

1. have a history of orthopedic surgery on spine or lower extremity
2. have any spine pathology (e.g., spondylolisthesis, disc herniation)
3. have a pain over back or lower limbs to affect the ability to perform activities of daily living
4. had a history of vestibular disease (e.g., Meniere' s disease)
Study of Birth Control Use After Childbirth

This study is a randomized controlled trial that will evaluate the impact of a brief educational script on the method of birth control that women receive at their 6-week postpartum visit. The one-minute script ("LARC script") is given to women in the hospital during their postpartum admission. It informs patients about long-acting reversible contraceptive (LARC) methods, specifically the contraceptive implant and the intrauterine device. The investigators hypothesize that women who are randomized to receive the LARC script will be more likely to report that they are using a LARC method, when queried immediately after their six-week postpartum visit.


Eligibility Criteria:
Inclusion Criteria:

* Women who are admitted to the postpartum unit at WakeMed Hospital
* Delivery of a live infant \>24 weeks gestational age
* Age 14-45 years
* Ability to speak either English or Spanish fluently
* Willing to be contacted by phone until at least 8 weeks after delivery

Exclusion Criteria:

* History of a tubal ligation or hysterectomy
* Partner has already had a vasectomy
* History of fertility treatment to conceive this pregnancy
* Previous randomization into the study
Keyhole Limpet Hemocyanin in Chronic Hepatitis C

In this study the investigators examine the safety and efficacy of Keyhole-limpet-hemocyanin in patients with chronic hepatitis c infection and liver cirrhosis. The investigators hypothesize that administration of keyhole-limpet-hemocyanin reduces the viral load in patients infected with hepatitis c.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Hepatitis C infection
* no previous therapy
* at least one contraindication to interferon therapy
* liver cirrhosis
* age between 18-80 y
* women of not childbearing age

Exclusion Criteria:

* Hypersensitivity against keyhole-limpet hemocyanin
* previous treatment against hepatitis c
* autoimmune disorders
* immunosuppression
* hepatocellular carcinoma or other malignancies
* coinfection with hepatitis b or HIV
* pregnancy
* cardiovascular event during the last 6 months (stroke or MCI)
* uncontrolled diabetes
* renal insufficiency (GFR \< 50 ml/min) or chronic hemodialysis
Behavioral and Educational Tools to Improve Epilepsy Care

The long-term goal of this research is to improve seizure control among patients with epilepsy, which has the potential to improve quality of life for thousands of people living with epilepsy and reduce health care utilization, social and economic costs, and epilepsy-related mortalities. Participants who are suffering from epilepsy will be randomized to receive usual care (UC), a smartphone-based self-management intervention called Management of Risks in Epilepsy (MORE), or MORE + telephone-based motivational interviewing (MI). Participants will be followed for 3 months.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. English- or Spanish-speaking
3. Partial (focal) or generalized epilepsy (as confirmed with epileptiform activity on an electroencephalogram)
4. Poor medication adherence
5. Willing and able to use a smartphone (provided by the study) to manage disease.

Exclusion Criteria:

1. Known or suspected psychogenic nonepileptic seizures as sole seizure type
2. Active psychotic disorder
The Effectiveness Of Atezolizumab In Patients With Locally-Advanced Or Metastatic Non-Small Cell Lung Cancer After Prior Chemotherapy

Hyperion Is A Prospective, Multicenter, Non-Interventional, Two-Cohort Study Collecting Primary Data In Patients With Locally Advanced Or Metastatic NSCLC Of Squamous Or Non-Squamous Histology After Prior Chemotherapy Being Treated With Atezolizumab In Routine Clinical Practice.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of locally advanced or metastatic NSCLC (histologically or cytologically confirmed stage IIIB/stage IV) and prior chemotherapy
* Decision to be treated with Atezolizumab according to Summary of Product Characteristics (SmPC) by treating physician, independent of this non-interventional study
* No contraindication to treatment with Atezolizumab

Retrospective Inclusion:

* Participants may be included retrospectively. Retrospective inclusion and documentation is limited to up to 9 weeks after initial start of therapy with Atezolizumab (corresponding to a maximum of 3 treatment cycles with drug administrations at 3-week intervals), corresponding to a maximum of 9 weeks prior to date of informed consent. Quality of life for this population will be captured and assessed retrospectively with a modified questionnaire for the period immediately prior to treatment start until study inclusion. participants who started Atezolizumab therapy more than 9 weeks prior to ICF being obtained may not be included in the study.
* Participants who give consent to be retrospectively enrolled but have already discontinued Atezolizumab for reasons such as loss of clinical benefit or toxicity may also take part in the study, given their first administration of Atezolizumab is within 9 weeks of consenting to take part, and they meet all other eligibility criteria.

Exclusion Criteria:

Patients not eligible for Atezolizumab treatment according to SmPC
Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices

(1) To compare cuff-less wrist wearable radial artery blood pressure measurements utilizing ViTrack(developed by Dynocardia) to the cuff based commercially available blood pressure device, in healthy volunteers with normal or high blood pressure.

(1) The ViTrack is strapped over the radial artery at the wrist. The ViTrack blood pressure cuff will be utilized to obtain blood pressure(BP) readings in the volunteers with normal or high blood pressure. The readings from the ViTrack will be compared with the readings of a cuff-based, commercially available BP measuring device placed on the same arm.

Eligibility Criteria:
Inclusion Criteria:

* Health volunteers 18 years and above; equal numbers of males and females to address Sex As a Biological Variable (SABV); and in sinus rhythm.
* Agree to commit to participate in the current protocol.
* Provide written informed consent prior to any study procedures being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read).

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Any other condition that would increase the risk of participation in the study in the opinion of the site Investigator.
* A difference of \>10 mm Hg in left versus right arm oscillometric systolic BP.
* Upper extremity arteriovenous hemodialysis shunt.
* Wrist distortion or pain from arthritis.
* Prior trauma or surgery at the radial artery monitoring site.
Cardiovascular Morbidities and Lung Cancer Treatment: a Prospective Registry

Therapeutic algorithms for lung cancer are mainly based on randomised controlled trials which excluded patients with severe co-morbidities. Smoking, the main risk factor for lung cancer, is associated with cardiovascular events that may impact on the therapeutic decision.

The aim of this registry is to determine if and how cardiovascular co-morbidities impact on the physicians' decision for anticancer treatment in lung cancer patients by comparing it to the European Lung Cancer Working Party (ELCWP) guidelines


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of lung cancer, either NSCLC or SCLC patients and carcinoid tumours
* Untreated lung cancer of any stage and any treatment (including palliative care only).
* Availability for participating in the detailed follow-up of the protocol.
* Signed informed consent.
* Age above 18 years.
* Presence of at least one co-morbidity:
* Any active or past cardiac ischemia
* Reduced left ventricular ejection fraction (\< 50%)
* Obstructive cardiomyopathy
* Valvular dysfunction (3 or 4/4; valvular replacement)
* Arrhythmia (atrial flutter or fibrillation, significant ventricular arrhythmia, 2nd-3rd degree auriculo-ventricular block, Wolf-Parkinson-White and other similar aberrant conduction, bifascicular block, arrhythmogenic right ventricular dysplasia)
* Uncontrolled hypertension (systolic blood pressure (BP) \> 160 millimeter of mercury (mmHg) or diastolic BP \> 100 mmHg on ≥ 1 hypotensive drug) or controlled hypertension on ≥ 2 concurrent hypotensive drugs
* Active or treated peripheral arteritis (grade 2 or more)
* Cerebrovascular events
* Pulmonary embolism and/or thrombophlebitis or patients at high risk of thrombophilia (homozygous Leiden factor...)
* Aortic aneurism

Exclusion Criteria:

* Thymoma and thymic malignancies, pleural mesothelioma.
* Patient previously treated for lung cancer.
* Tumours for which complete staging cannot be assessed.
* History of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumour (more than 5-year disease free interval).
Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader

This study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of BGB-16673 monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts


Eligibility Criteria:
Key Inclusion Criteria

1. Provision of signed and dated written informed consent prior to any study
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
3. Adequate organ function of coagulation function, liver function, renal function and pancreatic function and measure disease per disease-specific response criteria
4. Phase 1: Confirmed diagnosis of R/R Marginal Zone Lymphoma (MZL), Follicular Lymphoma (grade 1-3a), Waldenström Macroglobulinemia (WM), non-germinal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL), Richter's transformation to DLBCL, MCL, or CLL/SLL
5. Phase 2: Confirmed diagnosis of MCL, or CLL/SLL
6. Highly effective method of birth control during study treatment period, and for at least 90 days after the last dose of the study drug

Key Exclusion Criteria

1. Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer
2. Require ongoing systemic treatment for any other malignancy or systemic corticosteroid treatment
3. Receiving treatment with a strong CYP3A inhibitor or inducer ≤ 14 days before the first dose of BGB-16673, or proton-pump inhibitors ≤ 5 days before the first dose of BGB-16673.
4. Current or history of central nervous involvement
5. Prior autologous stem cell transplant unless ≥ 3 months after transplant, prior chimeric cell therapy unless ≥ 6 months after cell infusion, prior allogeneic stem cell transplant ≤ 6 months before the first dose of the study drug

Note: Other protocol defined Inclusion/Exclusion criteria may apply