cyrilzakka/clinical-trials huggingface dataset:
Oral AQX-1125 and Combination Oral Contraceptive Drug-Drug Interaction Study

This is an open-label, fixed sequence, 4 cycle, drug-drug interaction (DDI) study of AQX-1125 in healthy female subjects on combination oral contraceptives (COC).


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-45 years, inclusive, at time of signing Informed Consent
* Adult females of child bearing potential, who are non-pregnant and non-lactating, and must agree to use adequate additional contraception from the start of Treatment Period A until 90 days after the last dose of AQX-1125
* BMI 18.0 - 35.0 kg/m2
* Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG and vital signs, as judged by the investigator

Exclusion Criteria:

* Previous participation in the current study
* Any clinically significant history of breakthrough bleeding
* Using tobacco or other nicotine containing products within 12 months prior to the first study-specific COC-cycle intake
* History of alcohol abuse or drug addiction
* Positive drug and alcohol screen at screening and (each) admission to the clinical research center
* Average intake of more than 24 units of alcohol per week
* Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies
* Participation in a drug study within 30 days prior to screening. Participation in more than 2 other drug studies in the 10 months prior to (the first) drug administration in the current study
* Donation or loss of more than 100 mL of blood within 60 days prior to the start of Treatment Period A, on Day 1. Donation or loss of more than 1.0 liters of blood in the 10 months prior to the start of Treatment Period A, on Day 1
* Significant and/or acute illness within 5 days prior to Day 1 in Treatment Period A, that may impact safety assessments, in the opinion of the investigator
* Unsuitable veins for blood sampling
Comparison of Two Treatments for Strabismus Correction: Botulinum Toxin A Associated to Surgery and Surgery Alone

Two different treatments were given to large angle horizontal strabismus (eso and exotropia) adult patients who agree to participate of the study. Inform consents were required for participants. Group 1 (12 patients) received conventional recess-resect surgery plus intraoperative injection of botulinum toxin A (5U). Group 2 (11 patients) received only conventional recess-resect surgery. The patients were randomly located in one of the groups. The angles of horizontal deviation were compared between the groups before and six months after treatment.

Patients underwent recess/resection surgery on the non-fixating eye using conventional technique under local anesthesia. The extent of surgery was determined based on our usual amounts. Before re-attaching the recessed muscle to the sclera, 5 units of botulinum toxin in 0.1 ml of hyaline solution were, or 0.1 ml of hyaline solution alone were was injected into the posterior muscle belly by the surgeon who was unaware of the contents of each syringe.

Eligibility Criteria:
Inclusion Criteria:

* adults with large angle horizontal strabismus

Exclusion Criteria:

* oblique muscle disfunction
* previous strabismus surgery
* dissociated vertical deviation
* paretic or restrictive deviation
Indocyanine Green Lymphography in Management of Lingual Lymphatic Malformation

To elucidate the application of indocyanine green (ICG) fluorescence angiography in the treatment of childhood tongue cLM (clinically localized malignancy, presumed context here), providing a clearer scientific basis for subsequent targeted interventions.


Eligibility Criteria:
Inclusion Criteria:

* No previous intervention
* more than 6 months post-treatment follow-up
* Stage I or Stage IIa

Exclusion Criteria:

* History of iodine allergy
* Syndromic cLM
* Severe liver and kidney dysfunction
Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults

This study will gather and compare data about the effectiveness and safety of two different treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received previous chemotherapy. One treatment will use an investigational drug in combination with an FDA approved chemotherapy. The other treatment will use a combination of two FDA approved chemotherapy drugs.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent (patient's written understanding of and agreement to participate in this study).
* Patients with confirmed extensive small cell lung cancer (SCLC).
* No prior chemotherapy within 5 years of the diagnosis of SCLC.
* Presence of either measurable or non-measurable SCLC by X-ray or physical examination.
* At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient).
* At least 24 hours since prior radiotherapy. Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting.
* Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

Exclusion Criteria:

* Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids.
* Any active infection.
* Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk.
* Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC.
* Use of an investigational drug within 30 days before the first dose of study medication.
* Women who are pregnant or lactating.
* Patients of child-bearing potential who refuse to practice an adequate form of birth control.
* Patients with clinical evidence of any stomach or intestinal (GI) condition.
* Patients requiring treatment with the drug cyclosporin A.
A Study to Test the Safety and Efficacy of MK-8998 in Acutely Psychotic Participants With Schizophrenia (MK-8998-004)

A study to evaluate the safety and efficacy of treatment with MK-8998 as compared to placebo and olanzapine for acutely psychotic patients with schizophrenia. The primary hypothesis is that in participants undergoing an acute psychotic episode of schizophrenia, MK-8998 6 to 8 mg twice daily is superior to placebo in the treatment of symptoms of schizophrenia as measured by the mean change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 4.


Eligibility Criteria:
Inclusion Criteria:

* Patient's age is 18 to 55
* Patient meets DSM-IV/DSM-IV-TR criteria for a primary diagnosis of schizophrenia
* The duration of the patients schizophrenia diagnosis must be greater than 1 year
* Patient has an acute exacerbation of psychotic symptoms (of at least 3 days but no longer than 6 weeks) and marked deterioration of function

Exclusion Criteria:

* Patient currently has a clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder that would pose a risk to the patient in the opinion of the investigator if they were to participate in the study or that might confound the results of the study
* The patient has evidence of acute hepatitis, clinically significant chronic hepatitis, or impaired hepatic function
* The patient has a chronic organic disease of the central nervous system (other than schizophrenia) such as, tumors, inflammation, active seizure disorder, vascular disorder, Parkinson's disease, Alzheimer's disease or other forms of dementia, myasthenia gravis, or other degenerative processes. In addition, patients must not have a history of mental retardation or persistent neurological symptoms attributable to serious head injury
* Patient has a history of alcohol/drug dependence within 3 months or alcohol/drug abuse within 1 month of screening. Exceptions include caffeine and nicotine abuse/dependence
* Patient has a history of hypersensitivity to olanzapine OR poor response to olanzapine in the last 2 years OR intolerable side effects due to olanzapine OR patients current psychotic relapse occurred while consistently taking a therapeutic dose (10 mg or more) of olanzapine OR olanzapine is medically contradicted
* Patient is refractory to antipsychotic treatment
A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

The purpose of the study is to determine if Pegvisomant is more efficacious than Sandostatin LAR Depot in normalizing IGF-I levels in treatment naive patients with acromegaly.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acromegaly
* IGF-I levels \>=1.3xULN (upper limit of normal) at screening
* No history of radiotherapy or prior treatment with other drugs for acromegaly
* Minimum of two months must have elapsed post surgery prior to screening

Exclusion Criteria:

* Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations
* AST/ALT \>= 3xULN (upper limit of normal)
* Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI
* Visual field defects (except post surgical stable residual defects)
* Unable to self administer drug
Nutritional Intake and Gut Microbiome

Pediatric obesity has been increasing in prevalence, but concerns have been raised around the world because no treatment has been found. Recently, however, research on gut microbiome has begun to become a new alternative. It has been shown that changes in the microbiome in adults may induce obesity. However, the results on children are still scarce. Unlike adults, children have few external factors such as alcohol, tobacco, stress, and cancer, making them suitable for obesity-related gut microbiome studies. The investigators will use Illumina MiSeq platform for 16s rRNA metagenomics profiling in children. In this study, the investigators aimed to analyze the relationship between pediatric obesity, gut microbiome profile, blood biomarkers relevant to metabolic syndrome, and nutrient intake data.


Eligibility Criteria:
Inclusion Criteria:

* Obese children: Children ≥95 ‰ between age 7 and 12 years
* Non-obese children: 5‰\<BMI \<85 ‰ for children between the ages of 7 and 12 years

Exclusion Criteria:

* Taking antibiotics, probiotics, or steroids for a month before visit
* Taking probiotics-like products including yogurt for seven days before visit
* Having enteritis symptoms including diarrhea for a month before visit
* Chronic heart disease, chronic bowel disease, chronic liver disease, chronic kidney disease, endocrine disease, genetic diseases or congenital metabolic disorder
Repair of Inguinal Hernia

The aim of this study is to compare the outcomes of open versus laparoscopic approaches for inguinal hernia surgery and provide evidence-based guidance to the selection of the most appropriate operative technique.


Eligibility Criteria:
Inclusion Criteria:

Male patient \> 18 years of age

• Primary groin hernias requiring surgical intervention that are eligible for both open and laparoscopic repair.

Exclusion Criteria:

* Emergency procedures .

  * ASA score \> 2.
  * Irreducible inguinoscrotal hernia .
  * Local or systemic infection .
  * Other abdominal hernias being operated at the same time or planned operated during Follow up.

Previous surgery which has impaired the sensation in the groin area .

* BMI \> 40 kg/m2.
* Known disease which Impairs central or peripheral nerve function .
* Concurrent malignant Disease .
* Chronic pain which requires daily medication . • Mental disorder which requires daily medication .
The Effects of Sex and Age Differences on Gastric Cancer : a Retrospective Study

Gastric cancer (GC) is more prevalent in males than in females. One of these differences could be the effect of sex hormones such as estrogens. However, few reports have been reported regarding sex and age differences of incidence and survival of GC. The aim of this study was to evaluate the effect of sex and age on the incidence and survival of GC. And we would like to further analyze single GC and synchronous multiple GC, EBV, etc.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Gastric cancer

exclusion criteria:

* Gastric MALTOMA
* Gastric Lymphoma
* Gastrointestinal stromal tumors (GISTs)
Virtual Reality Simulation for Nursing Education

Today, thanks to the developing hardware technology, various distance education projects are carried out with virtual reality, augmented reality and even mixed reality glasses. The visual writing fields of the content they provide can be extended as much as necessary.

With this research, it is aimed to develop a virtual reality-based simulation program and to ensure its use in nursing education and research.

The universe of the research will consist of 219 students who are studying at Hacettepe University Faculty of Nursing in the Spring Semester of the 2021-2022 Academic Year and who have successfully completed the Internal Medicine Nursing course. As a result of the power analysis, it is aimed to reach a total of 100 people, with 50 students in each group. Our research was planned in a randomized controlled design. The data of the research will be collected through Student Information Form, Knowledge Tests, Perceived Learning Scale, General Self-Efficacy Scale, Satisfaction with Educational Methods Questionnaire and California Critical Thinking Disposition Scale. With this research, it is predicted that there will be an increase in nursing students' knowledge score, perceived learning, general self-efficacy, satisfaction with the education method, and critical thinking dispositions.

Eligibility Criteria:
Inclusion Criteria:

* Successfully completing the Internal Medicine Nursing Course
* Having internet access
* Volunteering to participate in the research

Exclusion Criteria:

* Not being able to communicate in Turkish
* Being in the intervention groups and not participating in the virtual simulation application
* Not participating in any of the pre-test, post-test, or follow-up tests
Post-operative Rehabilitation of Total Knee Arthroplasty With Applications on Smart Phone

This study is designed to estimate the effect of an application on rehabilitation for osteoarthritis patients after total knee arthroplasty.

Apart from surgical technique, the outcome of total knee arthroplasty (TKA) also largely depend on adequate rehabilitation and subsequent functional recovery after surgery.Rehabilitation affects or even determines various performance of post-operative knee, including knee range-of-motion (ROM), muscle strength, functional independence, all of which subsequently affect patients' quality of life. Conventional way of rehabilitation is exercise therapy, which rely on guidance of therapists and the self-efficacy of patients.

An application (APP) on smart phone was designed for people received TKA to play the role of guider and help improving patients' self-efficacy. This is a single-centre randomized clinical trial, with an anticipation of 200 patients with knee osteoarthritis enrolled, who will be randomly assigned into experiment group or control group. The patients in the experiment group will be introduced to this APP and requested to use it regularly, while the patients in the control group will receive pure conventional rehabilitation. Primary outcome includes Visual analogue scale (VAS) of pain, knee society score (KSS), ROM, ability of daily living (ADL) before operation and at 2 weeks and 6 weeks after surgery. All potential covariates of those two groups, such as age, sex, and pre-operative kellgren-lawrence scores would be matched by completely randomize.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as knee osteoarthritis with bearing X-ray
* Education level of middle school and above
* Prepared to take single-knee primary TKA

Exclusion Criteria:

* Severe varus/valgus (over 10 degree) of affected knee before surgery
* Stiffness of affected knee before surgery
Technical Validation of MR Biomarkers of Obesity-Associated NAFLD

The overall goal of this collaborative research program is to develop, validate and translate advanced quantitative magnetic resonance (MR) biomarkers of obesity-associated non-alcoholic fatty liver disease (NAFLD). This protocol represents the research plan for two distinct phases. The first phase is an optimization phase. The second phase is designed to complete a rigorous test of conventional and advanced MRE techniques. Complementary anthropometric, laboratory, and MR measures will also be collected to characterize the cohort and identify factors that affect MRE performance

The long-term objective of this research is to improve the health of the millions of Americans with or at risk for NAFLD, the most common chronic liver disease and most rapidly growing indication for liver transplantation in the United States. To achieve this objective, an advanced MR-based imaging method will be used to measure liver "stiffness" which is an early sign of disease. This technique has been previously developed and validated and ready to be used for further research. This current protocol will extend previous work by optimizing and validating advanced 2 dimensional and 3 dimensional-magnetic resonance elastography (MRE) methods as non-invasive biomarkers of hepatic inflammation and fibrosis in obese patients at risk for non-alcoholic steatohepatitis (NASH), the histologically more aggressive subset of NAFLD.

Per Amendment approved 4/8/22: MRE exams will be conducted using a PDFF Pocket Phantom purchased by the UCSD from Calimetrix. This phantom consists of vials with known fat fraction which are captured when taking images of the liver. The known fat fractions provide an independent reference and are used for quality assurance purposes.

Eligibility Criteria:
Inclusion Criteria (Phase 1 and 2 participants)

* Age of at least 18 years
* Severely obese (BMI ≥ 35 kg/m2) patient

Inclusion Criteria (Phase 2 participants only)

* Cleared for weight-loss surgery
* Willing and able to complete all safety and follow-up procedures
* Willing to allow for the banking of biological samples

Exclusion Criteria (Phase 1 and 2 participants)

* Contraindications to MRI
* Girth or weight that exceeds scanner capacity
* Women of childbearing potential that are pregnant or will be attempting to become pregnant during the study duration.

Exclusion Criteria (Phase 2 participants only)

* Known liver malignancies
* Regular \& excessive alcohol consumption within 2 years prior to recruitment
* Use of steatogenic or hepatotoxic drugs
* Clinical or laboratory evidence of liver disease other than Nonalcoholic fatty liver disease (NAFLD)/ Nonalcoholic steatohepatitis (NASH) (e.g. HCV Ab, HBV Ab, ceruloplasmin)
* The subject has increased bleeding risk (i.e., decreased platelets, von Willebrand disease)
BREAST Choice Decision Tool R21

Breast reconstruction is a critical component of breast cancer treatment because it restores quality of life and body image after mastectomy. However, Spanish-speaking Latina women are significantly less likely to undergo reconstruction (13.5% vs. 41% for non-Latina White or highly acculturated Latina), meet with a reconstructive surgeon (18.1% vs. 72.6% for non-Latina White), or receive adequate information. Spanish-speaking Latina breast cancer survivors who do not have reconstruction experience the highest rates of decisional dissatisfaction and regret, compared to any other group of breast cancer survivors.

Persons diagnosed with cancer who primarily speak Spanish and identify as Latin American (hereafter we use the term "Spanish-speaking Latinx/a cancer survivor") are less likely to receive guideline-concordant treatment and more likely to have poor cancer outcomes. One way to improve guideline-concordant treatment is through shared decision-making and decision support. When a decision is preference-sensitive (the right choice depends on the person's preferences), such as decisions about breast reconstruction after mastectomy, decision aids are effective. Unfortunately, most decision aids in the United States are written in English and developed or tested with few Latinx people.

The BREASTChoice decision aid, proven effective in two randomized controlled trials, addresses knowledge gaps in breast cancer survivors. This study focuses on developing a Spanish-language version of BREASTChoice, which was previously unavailable. For that reason, the Cultural and Linguistic Adaptation Framework (CLAF) incorporates qualitative and experiential data to adapt BREASTChoice. The adaptation process takes place in five steps: appraise, review, assess, solicit, and integrate.


Eligibility Criteria:
Inclusion Criteria for Survivors: (must meet all criteria)

* Female sex
* Adult at least 18 years of age
* Latina, Latino, or Latinx ethnicity - defined as born in or descending from South America, Mexico, Central America, other Spanish-speaking Caribbean islands
* Prefer to speak Spanish at home
* Have a history of breast malignancy (e.g., ductal carcinoma, DCIS) or high risk for breast cancer (e.g., BRCA mutation)
* Had breast surgery within the last 8 years
* Able to understand an IRB-Approved consent information sheet

Inclusion Criteria for Health Care Providers:(must meet all criteria)

* Provides breast cancer care (physicians, nurses, and advanced practice providers in breast surgery, reconstructive surgery, radiation oncology, medical oncology)
* Provides treatment to Spanish-speaking Latina breast cancer survivors
* Able to understand an IRB-Approved consent information sheet

Exclusion Criteria:

-