cyrilzakka/clinical-trials huggingface dataset:
A Phase 1 Study of Novel GS-9973 Tablet Formulations to Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on GS-9973 Pharmacokinetics

This is a Phase 1, Open-Label, Adaptive Study of Novel GS-9973 Tablet Formulations to Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on GS-9973 Pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

* Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
* Must have a body mass index (BMI) range of approximately 19 to 30 kg/m2
* Must have a minimum weight of 45 kg
* Females of childbearing potential must have negative serum pregnancy tests at screening and baseline and must practice at least 1 reliable method of contraception as defined by the protocol

  * Female subjects who utilize hormonal contraceptive as 1 of their birth control methods must have used the same method for at least 3 months prior to study dosing
* Male subjects must agree to use condoms during heterosexual intercourse and avoid sperm donation from Day -1 until 90 days following the last dose of study medication
* Must refrain from blood donation throughout the study period
* Must, in the opinion of the Investigator, be in good general
* Must be a non- or light smoker, eg, less than 10 cigarettes per day

Exclusion Criteria:

* Pregnant or lactating subjects
* Use of prescribed or over-the-counter medications that affect gastric pH
* History of severe peptic ulcer disease, GERD, or other diseases requiring prolonged(\>6 weeks) medication or surgical therapy to modify gastric pH
* Have a history of clinically significant cardiac abnormalities or presence of clinically significant abnormality on 12-lead ECG.
* Have a history of any cancer requiring systemic chemotherapy or radiation
* Have a history of bleeding disorders
* Have a history of liver disorders
* Current acute infection or history of acute infection within 7 days
* Have a recent history of alcohol or illicit drug abuse and/or have a positive test for selected drugs of abuse
* Have a positive hepatitis screen or positive Human Immunodeficiency Virus antibody test
* Have participated in another clinical trial within 28 days
* Have received transfusion of blood or plasma products within 6 months
* Have donated \> 500 mL blood within 56 days
* Are unable or unwilling to comply with study restrictions, return for follow-up appointments, or other considerations, which in the opinion of the Investigator, would make the candidate unsuitable for study participation
* Current or historical medical condition that is deemed to be of medical significance by the Investigator
* Have used prescription medications, over the counter products, herbal remedies and nutritional supplements within 7 days
Percutaneous Endoscopic Tracheal Plug/Unplug for CDH (Congenital Diaphragmatic Hernia)

Congenital diaphragmatic hernia is an anatomically simple birth defect in which contents of the fetal abdomen migrate into the chest due to incomplete formation of the diaphragm. Herniation of viscera into the chest prevents the fetal lungs from developing and growing to normal size. In the most severe cases, there is significant morbidity and mortality at birth. For these fetuses, fetal intervention may improve outcomes by enabling the lungs to grow enough in utero that they are capable of sustaining life after birth. This unblinded, non-randomized trial will assess the safety and efficacy of the use of the Goldvalve balloon and MiniTorquer microcatheter to perform percutaneous temporary tracheal occlusion to treat severe CDH in utero. The primary outcome variable will be fetal lung growth due to successful 'plugging/unplugging' of the trachea, as determined by serial lung-head ratio (LHR) measurements. Secondary outcome variables include maternal, fetal and neonatal variables, specifically neonatal survival at 90 days of life. For infants who survive beyond 90 days post-delivery, their families will be offered follow-up (up to 2 years of age and possibly beyond) in the Long-term Infant-to-Adult Follow-up Evaluation (LIFE) Clinic at UCSF.


Eligibility Criteria:
General subject population: Pregnant women in the second trimester, at least 18 years of age, and of any and all ethnic backgrounds.

Inclusion Criteria:

* Confirmed diagnosis of CDH
* Normal fetal echocardiogram
* Normal karyotype
* Fetal liver herniated into the left hemithorax
* Lung-head ratio (LHR) is 1.0 or less, calculated between 24-26 weeks' gestation
* Fetus is between 26 and 28 weeks' gestation
* Singleton pregnancy
* Mother meets psychosocial criteria
* Pre-authorization from third-party payor for fetal intervention, or ability to self-pay.

Exclusion Criteria:

* Failure to meet all inclusion criteria
* Other congenital anomalies detected on ultrasound
* Contraindication to abdominal surgery or general anesthesia
* Allergy to latex
* Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor)
* Family unable or refuses to stay in San Francisco for duration of the tracheal occlusion period and for the duration of the pregnancy as medically necessary.
Postprandial Responses to Hydroxytyrosol-enriched Bread

The amelioration of postprandial glucose and insulin responses to bread is of great importance since it may have significant beneficial effects on health. A number of studies have shown that hydroxytyrosol may have positive metabolic effects. However, this compound presents high hydrophilicity which constitutes the major barrier to its potential application in foods. Microencapsulation arises as a technological strategy to protect it and increase its stability. Alpha-cyclodextrin besides being a great carrier molecule, seems to also be beneficial to postprandial glucose levels. Enrichment of bread with encapsulated hydroxytyrosol could examine potential postprandial benefits.

Ten healthy normoglycemic subjects will participate in the study and will be provided with either a solution of glucose (reference food) or white wheat bread or wheat bread enriched with a-cyclodextrin or wheat bread enriched with hydroxytyrosol encapsulated in a-cyclodextrin, with 1-week intervals in amounts that yielded 50 g of available carbohydrates. Venous blood samples will be collected before consumption and at 30, 45, 60, 90, 120 and 180 min postprandially. Postprandial glucose, insulin and appetite-related hormone responses as well as glycemic index (GI) and subjective appetite ratings will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Normal body mass index
* Stable body weight for at least 3 months before enrollment
* Normal exercise, eating and drinking habits

Exclusion Criteria:

* Pregnancy and lactation
* Chronic medical illness (diabetes mellitus, cardiovascular disease, chronic liver, kidney, polycystic ovary syndrome or untreated thyroid disease)
* Use of nutritional supplements
* History of drug and/or alcohol abuse
* Psychiatric disease
A Phase I Study of Intravenous Aflibercept in Combination With S-1 in Japanese Cancer Patients

The primary objective of this study is to determine the recommended phase II dose of AVE0005 in combination with S-1 in Japanese cancer patients.

The secondary objectives of this study are to assess the safety profile of AVE0005, to determine the pharmacokinetics of AVE0005, to make a preliminary assessment of antitumor effects.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed cancer patients without standard of care
* ECOG performance status 0, 1, or 2
* Adequate organ and bone marrow function

Exclusion Criteria:

* Need for a major surgery or radiation therapy during the study
* History of hypersensitivity to S-1
* Known dihydropyrimidine dehydrogenase deficiency
* Uncontrolled hypertension
* History of brain metastases
* Ascites requiring drainage
* Pregnancy or breastfeeding
* Patients who have previously been treated with AVE0005

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study

At an academic tertiary referral center, patients with pelvic floor dysfunction, scheduled for outpatient cystoscopy or urodynamic testing will be asked to participate in the study. Patients will be called one day after the examination and will be asked about pain and their general state of health.

The purpose of this study it to investigate pain perception in urogynecologic patients during outpatient cystoscopy and compare it with pain perception during outpatient urodynamic. The investigators will also investigate the difference between anticipated and actual pain perception. The investigators will test the null hypothesis that there is no difference in patients´ pain perception between outpatient cystoscopy and urodynamic testing. The secondary hypothesis will be that there is no difference between patients´ anticipated amount of pain and the actually experienced pain during cystoscopy and urodynamic testing.

According to power calculation, a sample size of 52 patients per group will be needed to detect a 2 cm difference in pain scores on the VAS - judged as a clinically significant difference - with 95% power and a two-sided significance level of 0.05.

Exclusion criteria are: age ≤ 18 years, insufficient ability to understand German, pregnancy and the participation in another clinical study at the same time.


Eligibility Criteria:
Inclusion Criteria:

* women undergoing cystoscopy or urodynamic testing at an academic tertiary referral center.

Exclusion Criteria:

* age ≤ 18 years
* insufficient ability to understand German
* pregnancy
* participation in another clinical study at the same time
Perceived Stress and Black Rice (Oryza Sativa L.) Extract Fermented With Lactobacillus

The investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects and tolerability of black rice (Oryza Sativa L.) extract fermented with Lactobacillus on patients with perceived stress for 8 weeks.

A previous animal study has indicated that black rice (Oryza Sativa L.) extract fermented with Lactobacillus relieved stressful situations in a 7-week-old C57BL/6 mice model. Therefore, the investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects and tolerability of black rice (Oryza Sativa L.) extract fermented with Lactobacillus on patients with perceived stress for 8 weeks; the safety of the compound is also evaluated. The Investigators examine stress response inventory (SRI), perceived stress scale (PSS), stress-visual analog scale (VAS), EQ-5D-5L, salivary cortisol, plasma cortisol, serotonin, dehydroepiandrosterone sulfate (DHEAS), cortisol/DHEAS ratio, adrenocorticotropic hormone (ACTH), glucose, lactate, free fatty acid (FFA), malondialdehyde (MDA) superoxide dismutase (SOD), heart rate, systolic blood pressure (BP), and diastolic BP at baseline and after 8 weeks of intervention. Eighty adults were administered either 1,000 mg of black rice (Oryza Sativa L.) extract fermented with Lactobacillus or a placebo each day for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

- the Perceived Stress Scale between 13-18

Exclusion Criteria:

* People with alcohol use/induced disorders
* Persons with brain disease or undergoing rehabilitation treatment for brain disease
* Patients with mental illnesses such as major affective disorder, post-traumatic stress disorder, uncontrolled obsessive-compulsive disorder, schizophrenia, dementia, drug addiction, etc.
* Those who have taken psychotropic drugs, sleeping pills, appetite suppressants, oral steroids, and corticosteroids within 1 month before starting the trial
* Those who have taken functional health foods recognized by the Ministry of Food and Drug Safety related to relieving tension caused by stress and improving sleep within 1 month before the start of the test
* Those who show withdrawal symptoms due to abstinence from drinking or smoking within 1 month before starting the trial.
Ask Questions (ASQ):Implementation of a Communication Intervention

This clinical trial implements a communication intervention to improve patient-oncologist communication in the outpatient medical oncology setting. A communication brochure called the ASQ brochure may help patients prepare for the doctor visit by thinking through the questions that patients and patients' family want to ask the doctor.

Patient-centered communication is critical to providing high-quality care. In patient-provider clinical interactions, providers are responsible for several aspects of patient-centered communication. However, to reach the goal of providing the best possible treatments, patients should also actively participate by asking questions and expressing their concerns. Question prompt lists, simple lists of questions provided to patients before clinic visits to help them prepare for the appointment, have been tested in several medical contexts and patient populations, including among an underserved, minority population in Detroit, and have been shown to contribute to improved outcomes related to better communication quality. Using a RE-AIM framework, this descriptive, mixed methods, single-arm intervention study assesses the implementation of an evidence-based communication intervention (question prompt list), the "ASQ brochure". The ASQ brochure is designed to improve patient-oncologist communication and other outcomes by improving patient self-efficacy for managing patient-physician interactions. Investigators will recruit 225 patients and implement the ASQ brochure at seven Karmanos Cancer Center network sites. Participants are newly diagnosed patients with (Stages I-IV) cancer for which systemic therapy is likely a recommended treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older
* Have a first appointment to see a medical oncologist at a Karmanos Cancer Institute (KCC) site for medical/systemic treatment for a new, confirmed diagnosis of stages I-IV cancer
* Speak and read English well enough to be able to understand consent documents
* Given the diverse population seen at KCI, we will make attempts to recruit a representative sample. Our strategy will be simply to ask recruiters to make special attempts to recruit a representative sample. If that strategy fails after the first 10 patients we will build in requirements that at least 25% of the patients self-identify as non-White

Exclusion Criteria:

* Not specified
Patterns of Use of Belatacept: Analysis of Data From the Collaborative Transplant Study

The primary purpose is to describe the pattern of Belatacept use at the time of transplant and up to three years post-transplantation for all Belatacept treated patients.

Time Perspective: Prospective design, Retrospective data collection and analysis

Eligibility Criteria:
Inclusion Criteria:

* Patients who received solid organ transplantation during study period in one of the transplant centers involved in CTS
An Elimination Diet Using a New Amino Acid Based Formula: Immunological and Clinical Effects in Cow's Milk Allergy

The purpose of this study is to evaluate whether a new version of an amino acid based formula improves tolerance to milk in cow's milk allergic infants/young children.

Infants with CMA cannot tolerate proteins contained in milk, although they are able to tolerate amino acids which are the 'building blocks' of proteins. Unlike standard infant formulas which are made from milk proteins, amino acid formulas (AAF) are made from nonallergenic aminoacids plus all the other nutrients required to support growth and development.

Eligibility Criteria:
Inclusion Criteria:

* Infants ≤ 8 months of age
* Infants sensitised to cow's milk and diagnosed with IgE mediated cow's milk allergy confirmed by milk challenge or diagnosis of anaphylaxis to milk within the last 3 months

Exclusion Criteria:

* Infants less than 2500 g at birth
* Infants less than 37 weeks gestation
* Infants with severe concurrent illness
* Use of anti- histamines, systemic corticosteroids, systemic antibiotics or anti-mycotic drugs, and immuno-modulatory drugs
* Infants consuming less than 500ml per day of their usual formula at study entry
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
Tele-rehabilitation in Children With Cerebral Palsy in the Covid-19 Pandemic

The investigators study aimed to observe the effect of motor learning-based tele-rehabilitation on quality of life in children with cerebral palsy during the Covid-19 pandemic.

Cerebral palsy; It is defined as a permanent, non-progressive disorder that occurs as a result of the effects of the developing fetal or infant brain for different reasons in prenatal, perinatal or postnatal periods. Children with cerebral palsy experience fundamental limitations in the postural control of static and dynamic tasks such as sitting, standing, and walking. However, children with cerebral palsy need rehabilitation. The COVID-19 pandemic prevents effective provision of rehabilitation services for children with cerebral palsy. However; Lack of access to rehabilitation services in individuals with cerebral palsy during the COVID-19 pandemic has increased the need for alternative and complementary methods. During the Covid-19 pandemic process, the tele-rehabilitation process will be able to achieve functional and social participation in children with cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

* Children with spastic cerebral palsy, ages 3-16
* To be at 1-2-3 levels according to GMFCS
* The tele-rehabilitation group is not receiving treatment in any center.
* Voluntary participation in the study with the consent of the parents

Exclusion Criteria:

* Application of muscle tone reduction 6 months before the start of the study (eg botulin toxin, baclofen pump therapy) or those undergoing orthopedic surgery.
The Effect of Music on Pain, Anxiety and Satisfaction During Mammography

This study was planned to determine the effect of music listened to during mammography screening on pain, anxiety and satisfaction.

The randomized controlled and experimental study will be conducted with 70 women who apply to the Cancer Early Diagnosis, Screening and Training Center for mammography screening. Women in the experimental group (n=35) will listen to music before, during and after mammography screening, and women in the control group (n=35) will undergo routine mammography screening. Information Form Containing Sociodemographic Information and Situational Anxiety Inventory will be used to collect data.

Eligibility Criteria:
Inclusion Criteria:

* Knowing how to read and write,
* Not having had a mammogram before,
* Being between the ages of 40-69,
* No hearing-related problems,
* Not having used analgesic or anesthetic medication within 24 hours before or during the procedure,
* Voluntarily participating in the study,

Exclusion Criteria:

- The woman has a cognitive and auditory problem
Symptom Preoccupation in Atrial Fibrillation (AF) and Its Role in AF-related Disability

A cross-sectional study (N=400) will investigate the prevalence of symptom preoccupation and its role in AF-related disability. Subjectively-rated assessments will be gathered from 400 AF patients.

In the present study we aim to investigate symptom preoccupation in patients with atrial fibrillation (AF) to further improve the understanding of the role of psychological factors in AF-related disability. A cross-sectional study (N=400) will investigate the prevalence of symptom preoccupation and its role in AF-related disability. Subjectively-rated assessments will be gathered from 400 AF patients.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Diagnoses with AF
* Able to read Swedish and access to computer

Exclusion Criteria:

-
Extended-release Guanfacine Hydrochloride in Children/Adolescents With Attention-deficit/Hyperactivity

A study to evaluate the long term maintenance of efficacy of using Guanfacine Hydrochloride (SPD-503) for the treatment of ADHD in Children aged 6-17 years in Europe, Australia, Canada and the US.

The SPD503-315 clinical program has studied the efficacy, safety, and tolerability of this product in treating symptoms of ADHD in children and adolescents aged 6-17 through short-term, placebo-controlled studies and long-termn, open-label studies. This study will more rigorously assess the long-term maintenance of efficacy using a placebo-controlled, randomised-withdrawal design. To date, all of the completed studies conducted as part of the SPD503 proigram have enrolled subjects from the US. This study is designed to evaluate the long-term maintenance of efficacy of SPD503 for the treatment of ADHD in children aged 6-17 years in Europe, Australia, Canada and US.

Eligibility Criteria:
Inclusion Criteria:

* male or female, aged 6-17 years at the time of consent/assent at Screening/Visit 1
* subject meets DSM-IV-TR criteria for primaru diagnosis of ADHD
* subject has a minimum ADHD-RS-IV total score of 32 at enrolment/visit 2
* subject has a minimum CGI-S score of 4 at Enrolment/Visit 2
* subject is able to swallow intact tablets

Exclusion Criteria:

* subject has a current controlled or uncontrolled, co-morbid psychiatric diagnosis.
* subject has a know history or presence of structural cardiac abnormalities
* subject with orthostatic hyupotension or a known history of controlled or uncontrolled hypertension
* current use of any prohibited medication or other medications, including herbal supplements that affet blood pressure, or heart rate or that have CNS effects or affect cognitive performance
* subject is significant overweight based on Centre for disease control and prevention BMI for age gender specific charts. Significantly overweight is defined as a BMI \>95 th percentile Children aged 6-12 years with a body weight ,25,0kg, or adolescents aged 13-17 years with a body weight \<43 kg or \>91 kg at screening/visit 1
* subject is currently considered a suicide risk in the opinion of the investigator
* history of failure to respond to an adequate trial of an alfa2-agonist for the treatment of ADHD.