cyrilzakka/clinical-trials huggingface dataset:
The First Failure Study

The purpose of this study is to look at two different antiretroviral treatment options in individuals who are about to commence their second antiretroviral treatment.

This study will assess important clinical and laboratory differences between these two therapeutic options. Potential differences include: differences in body fat distribution, in lipid parameters, in adherence and in neurocognitive (brain) function. This study is looking to show differences in body fat distribution between the two study treatment arms. Differences in lipids, viral load, adherence, cardiac and bone biomarkers and neurocognitive function will also be assessed. There is also a lumbar puncture sub study participants can also take part in.

The total duration of involvement in the trial will be up to 96 weeks (approximately 2 years) plus a screening visit 1 - 4 weeks prior to the start of the study. Including visit the clinic on 12 occasions (screening visit, baseline visit, weeks 2, 4, 8, 12, 24, 36, 48, 64, 80 and 96)


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected males or females
* over 18 years of age
* signed informed consent
* currently receiving a stable antiretroviral regimen comprising of:
* two or more licensed NRTIs
* one licensed NNRTI or boosted protease inhibitor
* no previous protease inhibitor resistance documented on HIV-1 genotypic resistance testing
* failure of current antiretroviral regimen due to:
* toxicity, intolerance or virological failure if receiving an NNRTI containing regimen at screening
* toxicity or intolerance if receiving a boosted-protease inhibitor regimen at screening (with plasma HIV RNA \< 400 copies/mL at screening)
* willing to modify antiretroviral therapy, in accordance with the randomisation assignment
* no previous exposure to etravirine
* subjects in good health upon medical history, physical exam, and laboratory testing in the opinion of the investigator
* have no serologic evidence of active HBV infection evidenced by negative hepatitis B surface antigen
* female subjects who are heterosexually active and of childbearing potential (i.e., not surgically sterile or at least two years post menopausal) must practice contraception as follows from screening through completion of the study:
* barrier contraceptives (condom, diaphragm with spermicide)
* IUD or Depo PLUS a barrier contraceptive
* female subjects of childbearing potential must have a negative pregnancy test.

Exclusion Criteria:

* current alcohol abuse or drug dependence
* pregnancy
* active opportunistic infection or significant co-morbidities
* current prohibited concomitant medication
* a likelihood of diminished response to any of the study treatment arms, in the opinion of the investigator, based on HIV genotypic resistance testing
Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)

This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5 years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of 13vPnC 1 year after the initial dose of study vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female aged 70 years or older.
* Documented vaccination with 1 dose of 23vPS at least 5 years previous.
* Healthy.

Exclusion Criteria:

* Receipt of more than one dose of 23vPS prior to enrollment.
* History of severe adverse reaction to a vaccine.
* Immunodeficiency.
Fetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I

Diaphragmatic hernia detected in fetal life carries a high risk for postnatal demise due to lung underdevelopment. Clinical experience from prospective controlled non-randomized case series with fetoscopic tracheal balloon occlusion has seen improved survival rates in contrast to untreated controls. Therefore, the purpose of this randomized clinical trial is to provide further evidence about the efficacy and safety of the prenatal interventional approach. Primary outcome measure is postnatal survival to discharge from hospital treatment.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women from European countries carrying fetuses with congenital right or left diaphragmatic hernias
* Normal karyotype, no further severe anomalies on prenatal ultrasound study
* Fetal liver herniation into the chest, Lung-to-head ratio of ≥0,40 ≤0,84 between 30+0 - 33+5 weeks+days of gestation

Exclusion Criteria:

* Any maternal disease or condition that would result in an increased risk to her personal health from the experimental procedure
* Abnormal fetal karyotype
* Further severe fetal anomalies on prenatal ultrasound
Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo

Vitiligo is a common acquired depigmentation disorder affecting approximately 2% of the world population. The purpose of this pilot study is to evaluate the effect and the safety of Tildrakizumab in adult participants with vitiligo.

Tildrakizumab is a monoclonal antibody against interleukin (IL) 23, specifically anti-IL23p19. It is approved in the USA, Europe and Australia for psoriasis. The psoriasis dose is 100mg administered subcutaneously at weeks 0, 4 and every 12 weeks. Recent research has shown medications used to treat psoriasis may be effective in other immune mediated or autoimmune diseases such as vitiligo. With studies underway assessing the effect of Janus Kinase (JAK) inhibitors in psoriasis and vitiligo, this study seeks to determine if an IL-23 inhibitor is beneficial in halting disease progression and inducing repigmentation in vitiligo. There is some data to indicate that a higher dose of Tildrakizumab is effective for other autoimmune diseases such as psoriasis and hidradenitis suppurativa. For psoriasis, 200mg dosage was more effective than 100mg dosage. For hidradenitis suppurativa, a dosage of 200mg every 4 weeks was shown to be effective. Patients included in this study will start Tildrakizumab at a dosage of 200mg every 4 weeks for 6 months. There is a total of 8 visits involved in this study. Tildrakizumab is provided during visit 2, 3, 4, 5, 6, 7. Visit 1is a screening visit. At visit 1 and visit 8 no study drug will be provided.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosis of vitiligo
* Clinically stable vitiligo: defined as no new vitiligo patches and no enlargement of existing patches in previous 3 months.
* Able to provide voluntary, written, informed consent

Exclusion Criteria:

* Clinically active vitiligo: defined as new vitiligo patches or enlargement of existing patches in previous 3 months
* Concurrent skin disease in the study area
* Immunocompromise
* Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 12 weeks after the last dose.
Quality of Cardiopulmonary Resuscitation Pre- and Intra Hospital

The survival after intrahospital cardiac arrest has been reported to 15%. In Norway this varies between 16 and 23%.). Many factors are associated with survival after cardiac arrest, both intra- and prehospital. Recent studies have not included information about individual patient factors and the outcome after cardiopulmonary resuscitation (CPR). In the current hospital, we are able to record patient specific information related to a cardiac arrest/CPR situation, and thereby be able to assess patient-related factors associated with both detection, treatment and outcome of CPR.

Several factors have been associated with survival, e.g. to monitor hands-off time(Odds ratio, OR, for 2.48, 95% KI 1.11-5.56, p=.03), monthly assessment of all cardiac arrest cases (OR 6.9, 95% KI 1.41-33.92), and includin av local coordinator for CPR (OR 2.93, 95% KI 1.08-7.94, p=.03), as well as depth of compressions. Nevertheless, information about cardiac arrests and CPR have not been assessed in relation to patient specific information. In the current hospital, we are able to record the CPR sequence, and see this in relation to other patient- and case- specific information such as initial cardiac rythm, time to first compression, hands-off time, quality of CPR, and factors affecting the treatment and outcome.

The hospital has 71 registered defibrillators used in CPR. The current study will both gather retrospective data- not seen in relation to patient specific information, and prospective data related to specific patients.

Eligibility Criteria:
Inclusion Criteria:

* cardiac arrest (all reasons)
* a defibrillator has been used
* over 18 years
* cardiopulmonary resuscitation has been conducted

Exclusion Criteria: N/A
Reducing Disparities in Diabetes Risk Through Lifestyle Changes in Community Settings

This study aims to design and test the effectiveness of a lifestyle diabetes risk reduction program, Live Well, Be Well, in reducing risk of diabetes in persons at risk with a focus on reaching lower-income, minority individuals.

To design and test the effectiveness of a lifestyle diabetes risk reduction program, Live Well, Be Well, to increase physical activity, decrease weight, and improve diet, offered in community-based settings to primarily lower income, minority persons aged 25 and older at moderate to high risk of diabetes. The design is a randomized controlled trial with the primary outcome being fasting plasma glucose; secondary outcomes are weight, physical activity, blood pressure, and other physiological risk factors as well as health-related quality of life. This project is a partnership between the University of California San Francisco and the City of Berkeley Division of Public Health.

Eligibility Criteria:
Inclusion Criteria:

* age 25 and older
* moderate- to high-risk score on a Diabetes Risk Appraisal (DRA) (assessing sedentary behavior, family history of diabetes, race/ethnicity, gestational diabetes, hypertension, and high cholesterol) and a fasting fingerstick glucose level of 95-140 mg/dL (indicating high risk of diabetes).
* conversant in English or Spanish

Exclusion Criteria:

1. diabetes, assessed by self-report of having ever been told by a physician that they have diabetes (other than gestational) OR use of an oral hypoglycemic medication or insulin, OR a fingerstick fasting glucose level of \>150 mg/dl;
2. unstable chronic or serious condition that could limit participation in unsupervised light to moderate physical activity (e.g. unstable angina, diagnosed with or hospitalized for chest pain, heart surgery, stroke, or myocardial infarction in the past 6 months);
3. uncontrolled hypertension (systolic \>180 mmHg or diastolic \>105 mmHg);
4. current pregnancy or attempting to conceive;
5. plans to move from the area within 1 year;
6. insufficient cognitive functioning to complete program procedures,
7. implanted defibrillator,
8. a hip or knee replacement in the past 3 months.
HDDO-1756 Bio Equivalence Study

For healthy adult volunteers, safety and pharmacokinetic properties are compared between the two formulations in the case of HDDO-1756 alone administration and HDDO-17561/HDDO-17562 combined administration.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult volunteers aged 19 or older during screening
2. A person who weighs more than 50.0 kg and has a BMI of 18.0 kg/m2 or less and 30.0 kg/m2 or less.

   ☞ BMI (kg/m2) = Weight (kg) / {Long (m)}2
3. A person who has no chronic disease or medical treatment and has no pathological symptoms or findings as a result of an internal examination;
4. A person who has been determined to be eligible for a clinical trial according to the characteristics of the drug during screening, such as serum tests, hematologic tests, hematological tests, urine tests, urine tests, etc. and vital signs (physical tests) and 12-lead ECG tests.

Exclusion Criteria:

1. Current or past history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, urinary system, cardiovascular system, digestive system, musculoskeletal disease, or mental illness, as well as those with the following symptoms or history:
2. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
3. Persons with a history of gastrointestinal diseases (cron disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of drugs;
Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers

Subjects who have completed study 6108A1-500, in which our experimental meningoccal B vaccine or placebo was administered, will be approached for inclusion into this study which is purely for blood draw. The sera will be used for assay development.

The purpose of this protocol is to analyze the collection of blood volumes (approximately 200 to 470 mL per bleed) from volunteer donors who previously completed study 6108A1-500. As such, the inclusion and exclusion criteria are consistent with the Australian Red Cross guidelines for blood donation.

The 6108A1-500 study is an ongoing, double-blind, ascending-dose, randomized, placebo-controlled trial to assess the safety and tolerability of ascending doses of rLP2086 with aluminum phosphate (AlPO4) adjuvant, in healthy adults aged 18 to 25 years. Upon completion of participation in the 6108A1-500 study, subjects will be approached to participate in this blood sampling study. The sites participating in this blood sampling study are the same sites participating in the 6108A1-500 study.

Eligibility Criteria:
Main Inclusion Criteria:

1. Completed study 6108A1-500.
2. Hemoglobin level ≥12.0 and ≤16.5 g/dL for female subjects and ≥13.0 and ≤18.5 g/dL for male subjects.
3. Body weight ≥45 and ≤120 kg.
4. Systolic blood pressure \>90 and \<180 mm Hg.
5. Diastolic blood pressure \>60 and \<100 mm Hg.
6. Able to be contacted by telephone.
7. For all female subjects: have a negative urine pregnancy test unless the subject is surgically sterile.

Main Exclusion Criteria:

1. Bleeding diathesis or condition associated with prolonged bleeding time.
2. Prior antibiotic use (within 14 days).
3. Any clinically significant chronic disease that, in the investigator's judgment may be worsened by blood draw.
Efficacy of ThermoProfen in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee

ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated with osteoarthritis. This study will evaluate ThermoProfen for the treatment of mild to moderate pain associated with osteoarthritis of the knee in adults.

The primary objective of the study is to compare the efficacy of ThermoProfen™ against two other experimental treatments.

The treatment may be ThermoProfen (Matrix Transdermal Ketoprofen Patch) or a patch that may or may not include ketoprofen and that may or may not provide heat.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 through 75 years of age
* Patient has radiographic evidence of osteoarthritis of the target knee obtained within the past year.

Exclusion Criteria:

* Patient has a known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs, including aspirin).
* Patient has asthma that has been induced or made worse by the use of aspirin or NSAIDs.
* Patient has a relevant history of serious gastrointestinal disease.
* Patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.
* Patient is taking warfarin, heparin, or low molecular weight heparin.
* Patient has received oral, intramuscular, intravenous, intra-articular, or soft-tissue administration of steroids within 1 month of study enrollment (or within 2 months, if in the target joint).
* Patient has received intra-articular visco-supplementation (in target joint) within 6 months of study enrollment.
Comparison of Different Frailty Assessment Tools

Feasibility and Comparison of the Impact of different Frailty Assessment Tools on the Outcome of Ventricular Assist Device Implantation and Heart Transplantation in advanced heart failure patients

Comparison of the feasibility and results of the following frailty assessment tools in advanced heart failure patients treated with ventricular assist device Implantation or awaiting heart transplantation in Eurotransplant-Status "high urgency":

* Evaluation of the muscle mass in the preoperative CT-Scan
* Bioelectrical Impedance Analysis
* 6 Minute Walk Test
* Grip Strength Measurement
* Questionnaires: EQ5D-5L, Rockwood Frailty Scale

The assessment will be conducted prior to surgery, after surgery and at 6 Month Follow-up

Eligibility Criteria:
Inclusion Criteria:

* Planned VAD Implantation/ HU-Status awaiting Heart Transplantation
* Signature on Informed Consent

Exclusion Criteria:

* \< 18 years old
* Informed consent not possible/not signed
* Pregnancy/Breastfeeding
Measuring Aided Language Development

The focus of the current study is to systematically investigate the psychometric properties of a range of aided language measures, which are based on the Graphic Symbol Utterance and Sentence Development Framework (Binger \& Kent-Walsh).

Our central hypotheses are: (1) psychometrically sound measures can be established to capture growth within and across different dimensions of language acquisition, and (2) some elicitation contexts will be better than others at capturing aided language growth. Specific Aim 1 identifies valid measures to characterize aided language progress. Aim 1A uses existing data to document the psychometric properties of a range of aided language measures for preschoolers at the early stages of aided communication acquisition who have received 4 months of aided language intervention. Aim 1B analyzes language progression for high-performing aided communicators who will receive 24 months of intervention; this allows for investigation across all phases of early aided language acquisition. Specific Aim 2 identifies elicitation contexts that demonstrate the most productive aided language use. Achievement of the aims will result in measures that demonstrate strong reliability, differentiate growth for different populations, describe different dimensions of language growth, and are clinically feasible.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Identification of Down Syndrome or Cerebral Palsy + Significant Speech Impairment
* Must Speak English as a Primary Language
* Must Be Able to Express At Least 25 Words (using any communication mode)
* Must Be Able to Accurately Select Picture Symbols on iPad Communication App with at Least 50% Accuracy
* Vision and Hearing within Functional Limits or Corrected to be within Functional Limits for Study Activities

Exclusion Criteria:

* Clinical Diagnosis of Autism or Social Communication Disorder
* Primary Language Spoken is A Language Other than English
Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Fed Healthy Volunteers

This trial is conducted in the United States of America (USA). The aim of this trial is to compare repaglinide and metformin as co-administered tablets and as a combination tablet.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers (female not pregnant, lactating or breastfeeding)
* BMI (Body Mass Index) between 19-29 kg/m\^2, both inclusive
* Fasting plasma glucose from 70-115 mg/dl
* Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data

Exclusion Criteria:

* Any clinically significant disease history, in the opinion of the Investigator, of systemic or organ disease
* Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening
* Positive results on screening for Hepatitis B surface antigen, Hepatitis C antibody and HIV (human immunodeficiency virus) antibody
* Positive results on the drug abuse/alcohol screen
* Any regular use of prescription or nonprescription drugs, including mega-vitamin or herbal supplement regimens, other than contraceptives, that cannot be stopped at least 1 week prior to Visit 2 (trial product dose administration) and for the duration of the study
* Subject is currently a smoker (more than one cigarette per day or equivalent)
* Use of grapefruit or grapefruit juice within 7 days of trial product dose administration
* Blood donation, surgery or trauma with significant blood loss (500 mL) within the last 2 months prior to dosing
Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

• Male or female patients aged 40 years or over with moderate to severe chronic obstructive pulmonary disease (COPD) plus

* 20 pack-year smoking history
* Signed informed consent
* Post-bronchodilator forced expiratory volume in 1 second )FEV1) ≥ 30% and \< 80% predicted FEV1/FVC (forced vital capacity) \< 70%

Exclusion Criteria include:

* History of asthma
* Prior exposure to indacaterol
* Active cancer or history of cancer
* Patients with concomitant pulmonary disease
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged
* Patients unable to successfully use a dry-powder inhaler device or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria applied to the study.
Effects of Involvement in a Group-based Creative Expression Program on Psychotropic Drug Use in Persons With Dementia

This project, a small-scale pilot study, will attempt to determine if involvement in a group-based creative expression program may correlate with a reduction in use of psychotropic drugs for persons with dementia.

The study site has two skilled-nursing dementia Special Care Units. One unit will serve as a control with residents receiving the standard care activity program. The other unit will receive the standard care activity program as well as the TimeSlips storytelling program (two hour-long sessions per week for six weeks). The behavioral symptoms and psychotropic drug usage for both cohorts will be studied for eight months, the first four months with no intervention and the last four months with or without the six-week TimeSlips intervention.

Eligibility Criteria:
Inclusion Criteria:

* residence in one of two dementia special-care skilled nursing units at the study site
* clinical diagnosis of dementia