cyrilzakka/clinical-trials huggingface dataset:
GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection

This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b HCV Infection.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects 18 and older with chronic HCV infection
* Liver biopsy results (performed no more than 3 years prior to Screening) indicating the absence of cirrhosis
* Monoinfection with HCV genotype 1a or 1b
* Interferon ineligible or intolerant
* Body mass index (BMI) between 18 and 40 kg/m2
* Use of highly effective contraception methods if female of childbearing potential or sexually active male
* Screening laboratory values within defined thresholds
* Has not been exposed to any investigational drug or device within 30 days of the Screening visit
* Able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Exclusion Criteria:

* Prior treatment of HCV with any direct-acting antiviral (whether approved or experimental)
* Decompensated liver disease or cirrhosis
* Co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
* History of difficulty with blood collection and/or poor venous access
* Pregnant or nursing female or male with pregnant female partner
* Chronic liver disease of a non-HCV etiology
* Suspicion of hepatocellular carcinoma
* Clinically-relevant drug abuse
A Multicentre,Study of IBI133 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumours

This is a multicentre, open-label, first-in-human, phase 1/2 study of IBI133 in subjects with unresectable, locally advanced or metastatic solid tumours. Phase 1 section includes three parts, IBI133 dose escalation part, and IBI133 monotherapy dose expansion part. The objective of phase 1 section is to identify MTD/recommended dose for expansion (RDE) of IBI133 monotherapy . The objective of phase 2 section is to further explore efficacy, safety and tolerability of IBI133 monotherapy at RDE in specified tumour population. The treatment cycle of the study is defined as every 3 weeks (21 days).


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
2. Male or female subjects ≥ 18 years old;
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
4. Anticipated life expectancy of ≥ 12 weeks;
5. Adequate bone marrow and organ function.
6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumour that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;

Exclusion Criteria:

1. Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
2. Prior HER3 targeted treatment, including but not limited to monoclonal antibody, bispecific antibody, T cell engager, and antibody-drug conjugate.
3. Prior treatment with an antibody-drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g. DS-8201).
Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function

Pilot randomized, placebo-controlled trial of nulliparous postpartum women with a perineal laceration following a term vaginal delivery comparing vulvovaginal atrophy symptoms between women using vaginal estrogen in the postpartum period with those using placebo.

The overall goal of this study is to determine whether there are benefits to use of low-dose vaginal estrogen in the postpartum period. Dyspareunia and vaginal/perineal pain are well-known sequelae after vaginal delivery. However, the contribution of postpartum vaginal atrophy to these issues is largely unknown. Although the relationship between lactation, relative estrogen deprivation, and vulvovaginal atrophy has been established, there is a paucity of data regarding on the prevalence of vulvovaginal atrophy symptoms in the postpartum period. Additionally, although the benefits of vaginal estrogen in postmenopausal atrophy are well-established, the benefits in the postpartum period are unknown.

Eligibility Criteria:
Inclusion Criteria:

* females \>18 years old with at least one prior prenatal care appointment affiliated with The Ohio State University Wexner Medical Center; nulliparous; 1-2 days status post \>37 weeks and 0 day vaginal delivery with at least a second degree perineal laceration; English-speaking and able to provide informed consent.

Exclusion Criteria:

* allergies to estradiol cream or its constituents; a vaginal delivery associated with a intrauterine fetal demise or neonatal death; inability to complete questionnaires in English or comply with study protocol; and inability to apply vaginal cream independently. The following medical conditions and diagnoses are also exempted: undiagnosed abnormal vaginal bleeding, known or suspected estrogen-dependent neoplasia, active or history of deep venous thrombosis or pulmonary embolism, active arterial thromboembolic disease, known liver dysfunction or disease, known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
The Effect of an Intervention Based on Implicit Theories of Personality on the Prevention of Adolescent Dating Violence

This study evaluates the efficacy of an intervention based on the Implicit Theories of Personality (ITP) to prevent dating violence in Spanish adolescents. Half of participants received the ITP intervention, while the other half received an educational intervention.

Intimate partner violence is a problem arising in adolescence, which causes severe suffering. Since the first romantic relationships are established during adolescence, implementation of preventive interventions during this developmental stage opens a window of opportunity for the prevention of partner aggression. Previous prevention programs have shown efficacy in modifying cognitions and attitudes related to dating violence, although behavioral changes have been reported in very few cases. Recent innovative brief interventions based on changing entity theories of personality (i.e., the belief that people cannot change and personal characteristics are fixed; Miu \& Yeager, 2015) have provided good results for preventing depression and other behavioral problems in adolescents. Therefore, the principal aim of this study is to examine whether a brief one-hour intervention based on promoting the idea that people can change shows efficacy in the prevention of perpetration and victimization of dating aggressive behaviors (both online -cyber dating abuse- and traditional -face-to-face dating aggression-) in adolescents. Additionally, other objective of the project is to examine whether gender moderates the effects of the intervention in changes in dating violence. The study involves the evaluation of the intervention in a sample of around 400 adolescents (13-18 years), randomly allocated to experimental and control conditions. It is a field experiment conducted in high schools and involves multiple measures over time (self-reports and parent reports). In summary, the project aims to respond to the challenge of health and wellness in the population through a randomized controlled trial with multiple sources of measure and from a biopsychosocial perspective. The ITP intervention has the potential to become a universal intervention to help reduce the rates of adolescent dating violence.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent by the adolescents and their parents.
* To be fluent in Spanish.
Ketamine and Closed-Loop Anesthesia System

The objective is to evaluate the sparing effect of ketamine on the dose of propofol.


Eligibility Criteria:
Inclusion Criteria:

* patients with an American Society of Anesthesiology score 1, 2 or 3
* scheduled for a surgical procedure lasting more than 2 hours under general anesthesia

Exclusion Criteria:

* pregnancy
* chronic pain
* simultaneous general and loco-regional anesthesia
* contra-indication to to nonsteroidal anti-inflammatory drug
* contra-indication to Ketamine
* contra-indication to propofol, to remifentanil, to morphine
* history of central nervous system disease
* patients receiving a psychotropic treatment
* patients with a pace-maker
Evaluation of ExSpiron™ Measurements Derived Without Patient Specific Calibration

Previous studies have shown that the ExSpiron™ can provide non-invasive, real-time, accurate measurements of minute ventilation (MV), tidal volume (TV) and respiratory rate (RR) after calibration with a spirometer. The purpose of this study is to compare the MV, TV and RR values measured by the ExSpiron™ without prior spirometer calibration to values obtained with a spirometer calibration. In this study, the MV and TV values will be compared between the ExSpiron™ with and without prior patient-specific calibration of the ExSpiron™ to a spirometer

In order to evaluate the performance of the device under the range of conditions encountered in the clinical environment, the respiratory volume monitor (RVM) was tested throughout a range of respiratory rates and also during erratic breathing patterns. At 4 and 36 breaths per minute (the extremes of the rates anticipated to be encountered in the clinical setting), and during erratic breathing, RVM and spirometry measurements were found to be highly-correlated (r=0.98 ±0.01 (mean ±95%CI) at 4 breaths/min, 0.97 ±0.01 at 36, and 0.93 ±0.04 during erratic breathing). These studies also included calibration of the ExSpiron to the spirometer.

The primary objective of the study is to compare the minute ventilation (MV), tidal volume (TV) and respiratory rate (RR) measurements collected and reported by the ExSpiron, without prior ExSpiron calibration, against acquired MV, TV, and RR measurements from an ExSpiron with prior individual specific calibration to a spirometer using either a Wright Spirometer or a Morgan Flow Volume Loop (FVL) Pneumotachograph Spirometer. A secondary objective will be to confirm the PadSet functionality after 24 hours of wear in accordance with current labeling.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females aged 21-90
* Able to provide written informed consent
* Able to participate in a two day study

Exclusion Criteria:

* Men and Women aged \<21 years and \>90 years of age
* Inability to follow study and/or study staff instructions
* Inability to perform study procedures, e.g. spirometry
* Allergy to the electrodes or components of the electrodes
Pharmacokinetics (Drug Levels in Blood) of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants

The purpose of this study is to characterize the pharmacokinetics (the way the body absorbs, distributes and eliminates the drug) of BMS 986165 given in the form of various prototypes of solid tablets to healthy participants.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* In the opinion of the investigator, a healthy participant is determined by having no clinically significant deviation from normal in medical history, physical examination,electrocardiograms, vital signs, and clinical laboratory determinations.
* Body weight \>= 50 kg at screening
* Women and men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Any major surgery, per investigator's discretion, within 4 weeks of study drug administration
* Inability to tolerate oral medication
* History of allergy to BMS-986165 or related compounds

Other protocol-defined inclusion/exclusion criteria apply
Study to Evaluate the Safety and Pharmacokinetics of Topically Applied 40% Lidocaine Gel Compared With Placebo in Subjects With Acute Herpes Zoster (Shingles) Pain

Study 2022-HZ-011 will utilize a randomized withdrawal (RW), double-blind, placebo controlled design in which the PK and safety of CNTX 2022 (40% anhydrous lidocaine gel) will be evaluated in subjects with acute-onset herpes zoster pain.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is a male or female ≥ 18 years of age and ≤ 85 years of age.
2. Subject has brush-evoked allodynic pain intensity score ≥ 4 using the NPRS as determined by pain assessment during the physical examination at screening.

   a. Onset must have occurred ≤ 20 days prior to randomization
3. Subject has an average daily pain intensity score of ≥ 4 using the NPRS as determined by pain assessment during the physical examination at screening.
4. Subject must have a diagnosis of herpes zoster (shingles).
5. Subject has rash limited to trunk and limbs, with a total surface area of up to 300 cm2.

Exclusion Criteria:

1. Subject has an active herpes zoster lesion on the face, head, neck, genital or rectal areas.
2. Subject has rash limited to trunk and limbs, with a total surface area greater than 300 cm2.
3. Subject has a known history of allergic reaction, hypersensitivity, or clinically significant intolerance to lidocaine, ingredients of the study drug, or local anesthetics of the amide type.
4. Subject has target skin area (allodynic area and surrounding skin) that is not intact, is inflamed, or in the opinion of the Principal Investigator, consistent with rash due to acute herpes zoster.
5. Subject has any other form of pain that was not discernible from herpes zoster (shingles) allodynia.
6. Subject is taking Class I antiarrhythmic drugs (e.g., tocainide, mexiletine), or medications that could interact with the study drug or interfere with its evaluation.
A Study of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer

This clinical trial is evaluating AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer. The main goals of this study are to:

1. To evaluate the safety and tolerability of AC682
2. To evaluate the pharmacokinetic of AC682
3. To evaluate the preliminary anti-tumor activity of AC682

This is a Phase I, open-label dose-escalation study of AC682, an orally available estrogen receptor degrader, given as a single agent.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be ≥18 years-of-age at the time of signing of the ICF
2. Histologically and/or cytologically confirmed advanced estrogen receptor positive (ER+) human epidermal growth factor 2 negative (HER2-) breast cancer
3. Female patients must be postmenopausal
4. At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or at least 1 predominantly lytic bone lesion in the absence of measurable disease
5. Previously received at least 1 endocrine therapy regimen; concomitant use of cyclin-dependent kinase (CDK) 4/6 inhibitor(s) is acceptable; Previous chemotherapy is not required, but up to 2 prior regimens of cytotoxic chemotherapy is allowed.
6. Patients who have adequate organ functions at baseline

Exclusion Criteria:

1. Treatment with any of the following:

   systemic anti-cancer chemotherapy, biologic, or hormonal agent from a previous treatment regimen or clinical study within 4 weeks prior to the first dose of AC682; systemic small molecules from a previous treatment regimen or clinical study within 14 days or 5 half-lives (whichever is longer) prior to the first dose of AC682 (at least 10 days must have elapsed between the last dose of such agent and the first dose of study drug)
2. Received radiotherapy (including radioactive isotope therapy) within 4 weeks prior to the first dose of AC682
3. Major surgery (excluding placement of vascular access) within 4 weeks of first dose of AC682
4. With known metastasis to the brain
5. Any condition that impairs a patient's ability to swallow whole pills. Impairment of gastrointestinal function (GI) or GI disease or other condition at baseline that will interfere significantly with the absorption, distribution, or metabolism of AC682.
6. Use of prophylactic growth factors and blood transfusions ≤14 days prior to the first dose of AC682 and during dose limiting toxicity observation period
Glucose Response to a Formula for Patients at Risk of Hypoglycaemia

This study assesses the glycemic responses to several nutritional products.

During a study visit fasted subjects will consume one serving of the reference product or of the test products. Venous blood samples will be taken at baseline and at several time-points over a 6-hr period.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy individuals, 18 up to and including 50 years of age.
2. Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
3. Willing to avoid the consumption of alcohol, unusual food intake, unusual physical activity 24h prior to each study visit.
4. Willing to come to the study visit in the morning after an overnight fast of minimum 10 hours and maximum 14 hours (with water only).

Exclusion Criteria:

1. Blood glucose levels ≥ 7.8 mmol/L at screening (not fasted)
2. Known history of gastrointestinal disease (e.g., diverticulitis, Crohn's disease, coeliac disease etc.), bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the Principal Investigator either: 1) make participation dangerous to the subject (e.g. anaemia) or to others, or 2) affect the results.
3. Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the Principal Investigator either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
4. Use of medications known to influence gastric emptying (including but not limited to anticholinergics, nicotine, narcotic analgesics, ganglion blocking drugs, antacids and metoclopramide).
5. Use of anti-clotting medications.
6. Current tobacco smokers or smokers that quite smoking \< 1 month prior to screening (except for occasional (≤ 3) cigarettes/cigars/pipes per week on average over the past month).
7. Self-reported pregnancy or breastfeeding
Does Omeprazole Decrease Intestinal Calcium Absorption?

The purpose of this study is to measure the effect of omeprazole on intestinal calcium absorption in postmenopausal women.

Existing literature makes it unclear whether proton pump inhibitor therapy truly decreases intestinal calcium absorption. Up to 25 postmenopausal women will participate in this study. The primary study outcome is the change in intestinal calcium absorption following omeprazole therapy 40 mg daily for 30 days. The secondary outcomes include the change in urine n-telopeptide.

We will interview women and review their medical records to determine eligibility. Eligible subjects will undergo three calcium absorption studies. The first 2 studies will determine the monthly variation in calcium absorption, while the 3rd study will occur after taking 40 mg of omeprazole daily for 30 days. Women will present to the research unit in the early morning and receive an oral and intravenous calcium tracer with breakfast. Over the next 24 hours, we will collect all urine for measurement of its calcium content. During the first stay, we will measure each subject's gastric pH by collecting gastric fluid from a temporary nasogastric tube. In consenting subjects we will collect one tube of blood, isolate its DNA.

Eligibility Criteria:
Inclusion Criteria:

* Women at least 5 years past menopause, defined as the last date of menses

Exclusion Criteria:

* Allergy/Intolerance to orange juice
* Allergy/Intolerance to omeprazole or other PPI therapy
* Use of drugs that interact with omeprazole including oral anti-fungal agents, coumadin, diazepam, phenytoin \& tacrolimus
* Use of antacids, PPI or H2-blocker therapy within the past two months
* Intestinal conditions associated with malabsorption or low gastric acid levels including Crohn's Disease, ulcerative colitis, pernicious anemia, bacterial overgrowth, celiac sprue, chronic diarrhea or use of antibiotics within the past month
* Known Stage 4 or 5 Chronic Kidney Disease, defined as an estimated GFR \<30 cc/minute
* Use of medications known to interfere with calcium metabolism, including oral steroids or anticonvulsants
Seroepidemiology of Viral Hepatitis in Hong Kong

Immunisation policies have strong influences on the epidemiology of hepatitis A and B infection. In Hong Kong, vaccines against both viruses have been available through different channels and programmes in the past 3 decades. To evaluate the changes in the prevalence of hepatitis A and B in the general population, a seroepidemiology study is conducted involving a prospective cross-sectional survey followed for serology testing. Eligible members of 1327 spatially random households would be invited to join the study by completing a questionnaire and providing blood samples, either by dried blood spots or venesection, for determining the presence of antigen and/or antibody against hepatitis B, as well as antibody against hepatitis A. The main measures comprise a set of metrics on the prevalence of hepatitis A and B. Analysis would be conducted to examine the association of risk factors with the tested markers and describe the attitudes towards viral hepatitis vaccination. The results would allow us to understand the transmission potential of hepatitis A and B in the community would be influenced by the changing disease epidemiology and coverage of vaccination, which inform the development of new vaccination strategies in Hong Kong


Eligibility Criteria:
Inclusion Criteria:

* residents normally living in Hong Kong
* living in domestic households randomly selected from Building Groups
* Any age, while subjects below the age of 18 would require informed consent of their guardians for participation
* Any gender

Exclusion Criteria:

* unable to understand written Chinese or English,
* failure to give consent for participation
* living in institution or non-domestic housing,
* foreign domestic helpers,
* normally living in Hong Kong