cyrilzakka/clinical-trials huggingface dataset:
Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population

This study seeks to evaluate the clinical and subjective performance of a new daily disposable soft contact lens.


Eligibility Criteria:
Inclusion Criteria:

1. They are of legal age (17 years) and capacity to volunteer.
2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
6. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
7. They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They are aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
7. They are pregnant or lactating.
8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
10. They have diabetes.
11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation

The purpose of this study is to see if fecal microbiota transplantation (FMT) will prevent the future development of CDI. This is also known as fecal bacteriotherapy or stool transplant.

This is a randomized, open-label, controlled study designed to assess the efficacy of autologous fecal microbiota transplantation (auto-FMT) for prevention of Clostridium difficile infection (CDI) in patients who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT). Patients will be enrolled prior to allo-HSCT; feces will be collected and stored from all participating subjects prior to the initiation of conditioning regimens, analyzed by deep 16S rRNA gene sequencing, and tested by assay for intestinal pathogens including Clostridium difficile. Later in the course of transplantation, following engraftment (defined as the first day of three consecutive days, that the absolute blood neutrophil count is at above f 500 mm3), subjects will undergo fecal testing for presence of Bacteroidetes by 16S PCR. Subjects will be eligible for study if they have a microbiologically diverse pre-transplant colonic microbiota, and if the post-engraftment specimen contains Bacteroidetes at a prevalence equal to or below (0.1%)

Eligibility Criteria:
Inclusion Criteria:

* Planned to undergo allo-HSCT
* Age ≥ 18 years

Exclusion Criteria:

* As determined by the study investigators or consenting professionals, prolonged antibiotic treatment, as prevention or suppression of an ongoing infection, where treatment involves gut-perturbing antianaerobic antibiotics
* Has severe colitis of any etiology or a history of inflammatory bowel disease (IBD).
Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy

Esophagogastroduodenoscopy (EGD) is commonly performed in patients presenting with abdominal pain and dyspeptic symptoms, serving as a valuable diagnostic and therapeutic tool. While various methods are available for biopsy sampling when mucosal pathology is observed during EGD, the practice of obtaining biopsies from endoscopically normal mucosa remains controversial. Although there is literature suggesting that routine biopsies from the antrum and duodenum for surveillance purposes increase costs, pathological findings can sometimes be detected in areas that appear normal on mucosal examination, leading to potential changes in treatment approach if biopsies are obtained.

In this study, a retrospective evaluation of the prevalence of various pathologies detected in biopsies obtained from endoscopically normal mucosa in patients who underwent EGD was reported as normal.

Esophagogastroduodenoscopy (EGD) is a commonly used diagnostic tool in upper gastrointestinal system diseases. Its widespread use is facilitated by its minimally invasive nature, the possibility of therapeutic procedures, low complication rates, and broad applicability. Although there are numerous guidelines regarding approaches to endoscopic pathologies and diseases detected during esophagogastroduodenoscopy, the necessity of biopsy sampling from mucosal areas that are endoscopically normal remains controversial.

In this study, patients aged between 18 and 95 who underwent EGD at the Sisli Hamidiye Etfal Training and Research Hospital Surgical Endoscopy Unit between 2021 and 2023, with no pathology detected during the endoscopic examination and who underwent biopsy sampling, will be evaluated. History of upper gastrointestinal surgery, detection of the endoscopic pathology, and not having biopsy sampling will be considered as exclusion criteria. The rate of detection of histopathological findings in the obtained biopsies, severity and activity of gastritis, rate and density of Helicobacter pylori detection, and rate and extent of intestinal metaplasia will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18-95
* Endoscopically normal esophagogastroduodenoscopy
* Sampling biopsies must be obtained

Exclusion Criteria:

* History of upper gastrointestinal surgery
* Abnormal endoscopic findings such as gastritis, ulcer, hiatal hernia, pyloric deformity, alkaline reflux
* Not having biopsy
The Accumulative Effect of Cold Water Immersion in Football Athletes

Football is a sport with congested calendars, which requires muscle recovery strategies such as cold water immersion (CWI). This recovery technique is well spread through football clubs, although it lacks a profound physiologic investigation to understand its effects on athlete's body. Objectives: The main objective of this study is to evaluate the effect of a long-term CWI exposure in football athlete's.

Study Hypothesis:

H0: The application of Cold water immersion doesn't amend the biomarkers, electromyograph signal, power and perceived of recover when compared with control sample.

H1: The application of Cold water immersion amends the biomarkers, electromyograph signal, power and perceived of recover when compared with control sample.

In order to answer this question, the investigators performed a randomized clinical trial in 23 sub-20 football athletes. All subjects were randomly divided into two groups; a control group (10 minutes seated rest) and a CWI group (10 minutes in a 10 degree C) during seven days in a row. The investigators evaluated creatine kinase (CK) and lactate dehydrogenase (LDH) as molecular biomarkers for muscle damage. The blood samples were collected on the first, second, ninth and tenth days. Yet, the investigators assessed the peak of muscle activity and isometric strength of the knee flexors and extensors, potency of lower limbs, perceived exertion (PE) and total quality recovery perceived (TQRPer) in order to understand the treatment physiological effect on the subjects on the first and last day of experiments (before and after training).

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Soccer players

Exclusion Criteria:

* Neurological, vascular or systemic muscle disease
Quetiapine Augmentation of PE Therapy for the Treatment of Co-occurring PTSD and Mild Traumatic Brain Injury

A pilot study to evaluate feasibility for a full-scale merit application. Specifically, for veterans considering prolonged exposure (PE) therapy, following the model established by Foa et al, we need to establish safety, and feasibility of quetiapine compared to treatment as usual (TAU) which employs multiple medications commonly used for PTSD in the VA system.


Eligibility Criteria:
Inclusion Criteria:

1. All treatment seeking adult (≥ 18 years)
2. Veterans with mTBI who meet PTSD diagnosis and have a CAPS-5 score of 25 or greater. Diagnosis will be determined using the provisional PTSD diagnosis convention recommended by the National Center of PTSD which requires at least moderate ratings (2 or more) on at least 1 B item (items #1-5), 1 C item (items #6-7), 2 D items (#8-14), and 2 E items (items #15-20) of the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).

Exclusion Criteria: (1) Pregnant or lactating women and those of child-bearing potential not using a reliable method of contraception; (2) Individuals meeting DSM-5 criteria for schizophrenia, schizoaffective disorder, or neurocognitive disorder; (3) Individuals currently taking any typical or atypical antipsychotic medication or individuals using daily benzodiazepines including nonbenzodiazepine z-drugs for sleep as they have effects similar to benzodiazepines for sleep. (Note: benzodiazepine use is contraindicated as they may impair learning required for progress with PE) (4) Individuals with known intolerance to quetiapine or a history of clinically unstable heart, lung, liver, renal or endocrinological condition, diabetes mellitus, and/or seizure disorder. (5) Individuals with substance use disorder severe enough to require medical detoxification.

(6) Individuals who report suicidal or homicidal ideations in the past month severe enough to warrant inpatient admission.

(7) Individuals with current or known history of cardiac arrhythmia or QTc interval ≥ 450 milliseconds. (Note) Patients requiring other anti-arousal medication for general medical conditions such as antihypertensive medications, beta blockers etc., for hypertension, anti-thyroid medications for hyperthyroidism, and/or anti-epileptic medications, divalproex, levetiracetam, or carbamazepine for seizure disorder may be included if stable for at least 1 month before the screening visit.
PCOM2 - The Physician Communication Intervention, Version 2.0

Poor quality of primary care providers' vaccine recommendations lead to low adolescent human papillomavirus vaccination rates and hundreds of thousands of adolescents unnecessarily at risk for HPV-associated cancers and diseases. Though a previous provider communication intervention, called PCOM, was found to be effective for increasing adolescent HPV vaccination in primary care, its dissemination is limited by the need for significant research team involvement to teach providers how to use the intervention's components. To address this, investigators propose to develop and test a virtual version of PCOM, use mixed methods to assess contextual factors affecting its use compared to the original PCOM intervention, and develop an optimized version of PCOM for broad dissemination to increase adolescent HPV vaccination nationally.

The overarching goal is to develop a "Virtual" version of the PCOM intervention ("PCOM-Virtual") and compare its efficacy for increasing HPV vaccination among adolescents to that of the original PCOM intervention ("PCOM-Standard"). Using Dissemination \& Implementation (D\&I) science principles to develop and evaluate the PCOM-Virtual intervention for non-inferiority, investigators anticipate that to have a "shelf ready" intervention and associated "User Manual" that can be easily incorporated into practices broadly to improve the practice's adolescent HPV vaccination rates.

Specific Aims are to: (1) develop the "PCOM-Virtual" intervention using principles of D\&I Science; (2) compare the efficacy of "PCOM-Virtual" versus "PCOM-Standard" in improving adolescent HPV vaccine utilization; and (3) examine whether practice, patient and provider characteristics are associated with variability in the efficacy of PCOM-Virtual and PCOM-Standard.

Eligibility Criteria:
Inclusion Criteria:

* Parents: Have an adolescent between the ages of 9-17 years old and receiving adolescent care at an enrolled clinic
* Providers: All providers at participating study practices will be eligible to participate.

Exclusion Criteria:

* Parents: Does not have an adolescent between the ages of 9-17 years old and is not receiving adolescent care at an enrolled clinic
* Providers: Providers who are not at participating study practices
A Study of TAK-861 in People With Narcolepsy Type 1

The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms and daily life functions; and to learn about the safety of TAK-861.

The drug being tested in this study is called TAK-861. TAK-861 is being tested to evaluate its efficacy and safety in participants with narcolepsy with cataplexy (narcolepsy type 1 \[NT1\]).

The study will enroll approximately 93 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:

1. TAK-861
2. Placebo

The study drug will be administered for 12 weeks. This multi-center trial will be conducted globally.

Eligibility Criteria:
Inclusion Criteria:

1. The participant has a body mass index (BMI) within the range 18 to 40 kilograms per meter square (kg/m\^2).
2. The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) diagnosis of NT1.
3. The participant has greater than or equal to (≥)4 partial or complete episodes of cataplexy/week (WCR).
4. The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1\*06:02 or results from radioimmunoassay indicate the participant's cerebrospinal fluid (CSF) orexin (OX)/hypocretin-1 concentration is less than or equal to (≤)110 picograms per milliliter (pg/mL) \[or less than one-third of the mean values obtained in normal participants within the same standardized assay\].

Exclusion Criteria:

1. The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.
2. The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure; or (c) has any medical condition (such as unstable cardiovascular, pulmonary, renal or gastrointestinal disease).
3. The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
4. The participant has a history of cancer in the past 5 years.
5. The participant has a clinically significant history of head injury or head trauma.
6. The participant has a history of epilepsy, seizure, or convulsion.
7. The participant has any current unstable psychiatric disorder or current active major depressive episode (MDE) or an active MDE in the past 6 months.
A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

* Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) with no evidence of prior or active choroidal neovascularization (CNV) in both eyes

Exclusion Criteria:

Ocular Exclusion Criteria: Study Eye

* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
* Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
* Previous intravitreal drug delivery (intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation) Ocular Exclusion Criteria: Both Eyes
* GA in either eye due to causes other than AMD
* Previous treatment with eculizumab, lampalizumab and/or fenretinide
MK0249 for the Symptomatic Treatment of Alzheimer's Disease (MK0249-011)

The purpose of this study is to test the efficacy and safety of an investigational medication for improving symptoms of Alzheimer's Disease. Subjects will receive either active medication or placebo for 28 days. Tests of memory, concentration will be included. Safety will be monitored using routine clinical and laboratory tests.


Eligibility Criteria:
Inclusion Criteria:

* Male or females
* Age at least 55 years or older
* Mild-to-moderate Alzheimer's Disease, with Mini Mental State Examination (MMSE) between 18 and 26, inclusive, Modified Hachinski Ischemic Scale (MHIS) score =/\<4, Global CDR score of 1 or 2, and who have a reliable informant/caregiver to accompany patient to all clinic visits
* If using symptomatic Alzheimer's Disease treatments, patients must be on the medication for 3 months and on a STABLE DOSE for at least 2 months

Exclusion Criteria:

* Patients cannot be living in a skilled nursing facility
* Patients cannot have poorly-controlled hypertension
* Patients cannot have the following conditions within 6 months of screening: significant cardiovascular disorders, active major depressive disorder, gastroesophageal reflux disease (GERD), or clinically significant sleep disorder
* Various concomitant therapy restrictions
Imaging Acquisition and Analysis Methods for Optimization of MRI Radiation Oncology Simulation and Response Assessment

Magnetic resonance imaging (MRI) is currently one of the standard diagnostic imaging methods used to diagnose tumor stage before treatment in the Radiation Oncology Department. It is also used to check responses to radiation after treatment. However, MRI isn't traditionally used in planning for radiation treatment or in checking treated tumor and tissue changes during radiation treatment. The goal is to find out the possible benefits of MRI imaging techniques in these settings of radiation treatment. The research aims are to study the possibility of using devices with new abilities such as the MR-Linac. The MR-Linac combines a radiation treatment machine with a diagnostic MRI scanner. This device will improve the quality of MRI-guided radiation treatment. The MR-Linac has functions that are currently not available in other combined imaging and radiation delivery devices. The MR-Linac does not provide additional imaging capabilities that are not currently available in other imaging devices.

Participating in this study would NOT change the current treatment plans, this will allow the investigators to use the MRI methods in research and future patient care.

The purpose of this protocol is to demonstrate proof of concept and feasibility of new MRI or CT hardware, pulse sequences and data analysis software to plan and adapt radiotherapy treatment and to assess tumor response to radiotherapy (only FDA approved hardware are allowed in this study). Efforts to develop, modify and evaluate new or existing MR or CT imaging techniques must be a continuous practice with the goal of enhancing the use of MRI or CT during radiation therapy. The investigators therefore anticipate an ongoing need for such a protocol and believe the ability to perform such studies is critical to the translation of new imaging technologies from concept to routine clinical use. Under this protocol, modifications to the following items may be tested: pulse sequence programs, radiofrequency coils, reconstruction and processing software, other MR or CT system hardware and analysis software. A brief description of each of these items is described below. The potential risks associated with modifying each of these items, and the measures that will be taken to minimize these risks are described in subsequent sections.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 18 or older

Exclusion Criteria:

* Anyone who would be normally excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Diseases Screening Questionnaire
* Participants/volunteers with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
* Female participants/volunteers who are pregnant or nursing
* Participants/Volunteers who are unable to comply or complete the MRI exam due to claustrophobia or high levels of anxiety
* Participants/Volunteers from the vulnerable population, as defined by 45 CFR 46.
* Participants at higher risk due to age, frailty, or the emergent nature of their condition.