cyrilzakka/clinical-trials huggingface dataset:
Reducing Vaginal Infections in Women

The purpose of this study is to see if taking medication once a month can help to decrease the risk of vaginal infections. Additionally, researchers will study whether personal habits, such as douching, bathing, and sexual practices can influence the risk of vaginal infections. Vaginal infections may influence the risk of becoming infected with HIV-1 and other sexually transmitted diseases (STDs). Study participants will include 400 female prostitutes ages 16 and older, living in Mombasa. Study procedures will include sexual behavior questions, physical examinations including pelvic exams, testing of vaginal and cervical secretions for STDs, urine collection and blood samples. Participants will receive 2 different types of pills to treat vaginal infections (metronidazole or fluconazole) or placebo (contains no medication). Participants will be involved in study related procedures for 1 year and will return to the study clinic at one month intervals.

Prospective studies in Africa have demonstrated that vaginal infections are associated with a significant increase in a woman's risk of infection with HIV-1. Further clinical and epidemiological research is needed to evaluate strategies for prevention and treatment of vaginal infections as a means of reducing HIV-1 acquisition. Developing a vaginal health intervention to reduce the risk of HIV-1 infection is a particularly important goal in sub-Saharan Africa, where female controlled strategies for reducing the risk of HIV-1 transmission may be an important means of decreasing the spread of the epidemic. This study will evaluate the efficacy of a regimen for reducing the rate of vaginal infections. The study is a double blind, randomized, controlled trial of monthly treatment with single-dose metronidazole and fluconazole as a means of decreasing vaginal infections and promoting normal vaginal flora in HIV-1 seronegative female sex workers (FSWs) in Mombasa, Kenya. Participants will be recruited from an existing cohort of HIV-1 seronegative FSWs followed at a municipal sexually transmitted disease (STD) clinic in Mombassa, Kenya, since February 1993. Participants will be randomized to treatment with metronidazole 2 grams plus fluconazole 150 mg once a month or placebo. All patients will be asked to return for follow-up after 1 month. All women in the study will be treated as indicated for symptomatic vaginal infections, other genital track infections and followed until they have completed 12 monthly follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Women who do not currently have symptoms of vaginal itching or discharge. Women with these symptoms may be treated and enrolled at a subsequent monthly visit when they are asymptomatic.
* Those who are currently menstruating may be enrolled after the completion of menses.

Exclusion Criteria:

* Pregnancy
* Lactation
* History of adverse reactions to the study medications
* Alcoholism or inability to abstain from alcohol for 48 hours following treatment
* Women who do not anticipate living in Mombasa for a year following enrollment.
Mapping the MoA Behind GI Protection From Bif195

The trial will investigate effects of daily intake of the bacterial strain Bif195 or placebo when co-administered to once-daily oral intake of 300 mg of Acetylsalicylic Acid (ASA).

The trial includes a run-in period of two weeks duration followed by a 4-week intervention period in which Bif195/placebo and ASA are co-administered. This period is followed by a 6-week wash-out period before a new 4-week period is performed with a cross-over Bif195/placebo intervention as well as ASA co-administration. Bif195 and placebo interventions are performed double-blinded in randomised order in a cross-over fashion for each subject.

Subjects will participate in the trial for a total duration of approximately 17 weeks including the run-in phase. Besides the screening visit, the trial will consist of 4 visits.

After having given their written informed consent, subjects will complete the screening procedures to evaluate their eligibility for participation in the trial and complete a run-in period of two weeks duration to washout possible pre-trial probiotics and/or use of medication. On the morning of day 4 after baseline assessments at Visit 2, all subjects will start daily intake of 300 mg ASA in combination with Bif195 or placebo in a ratio of 1:1 according to the randomisation performed at Visit 2.

At visit 2 - 5, all subjects will be biopsied from the upper small intestine and the ventricle during a gastroscopy procedure. At each of these 4 visits, 6 biopsies will be taken from pre-specified locations in the duodenum and 2 biopsies will be taken from the ventricle (approximately 5 mg each). Luminal fluids will also be collected during the gastroscopy (approximately 2 ml per visit). One venous blood sample (of 20 ml per visit) will also be collected at each of these visits.

The analysis on biopsies and luminal fluid samples will include a combination of transcriptomic, microbiome, proteomics and metabolomics analysis.

Eligibility Criteria:
Inclusion Criteria:

* • Written informed consent

  * Healthy and without any gastrointestinal discomfort/pain or other significant symptoms
  * Age ≥ 18 and ≤ 40 years
  * Willing to abstain from any other probiotic products and/or medication known to alter gastrointestinal function throughout the participation of the trial

Exclusion Criteria:

-
Remineralization Potential of Curodont Repair Flouride Plus Versus CPP-ACP in Management of White Spot Lesions: Randomized Clinical Trial

The goal of modern dentistry is to manage non-cavitated caries lesions non- invasively through re-mineralization process to prevent the disease progression and improve aesthetics, strength, and function. Re-mineralization is defined as the process that supplies calcium, phosphate and flouride ions from an external source to the tooth to convert ion deposition into crystal voids in demineralized enamel. White spot lesions should be managed using a multifactorial approach. The most important strategy is to prevent demineralization and biofilm formationand use of methodologies for remineralization of lesions .

Self-assembling peptide (P11-4) has shown great potential for natural repair of early caries lesions through emerging biomimetic re-mineralization properties. (Takahashi Fet al in 2015) This peptide forms a 3D matrix within demineralized carious lesions areas, which enables novo hydroxyapatite crystal formation facilitating the so-called guided enamel regeneration of the lost enamel structure. The peptide has shown encouraging results as a scaffold for enamel regeneration


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 35 years of age female and males
* Had received conventional periodontal therapy
* Active carious white spot lesions
* No systemic diseases or concomitant medication affecting salivary flow

Exclusion Criteria:

* - Participant in another trial
* Non carious lesion (enamel hypoplasia and dental flourosis)
* Presence of abnormal oral, medical, or mental condition.
* Participants who had evidence of reduced salivary flow or significant tooth wear.
* Allergy to MI paste
Modifiers and Mechanisms of Loneliness Interventions

A specific aim of this research is to identify the role of emotion regulation in response to social threat in caregivers' response to a behavioral coaching intervention for loneliness. A second aim of the study is to determine the benefit of a digitized, social engagement prioritization tool for improving coaches' intervention fidelity and caregiver outcomes. This study is funded through the Pilot Award Program of the Rochester Roybal Center for Social Ties \& Aging Research, a UR Center funded by the National Institute on Aging by grant P30AG064103.

The objective of this Stage III mechanistic study is to help identify additional modifiable targets and scalable approaches to support further development of highly effective, mechanistic-informed approaches to reducing loneliness and improving social connectedness in caregivers. This study is a Stage III, 19-month 2 (groups) x 2 (assessment timepoints) randomized clinical trial (RCT) aimed at identifying whether lonely caregivers' capacity, is associated with the degree to which loneliness is reduced in response to social engagement intervention (S-ENG). Further, the study will address whether a digitized, social engagement prioritization tool (C4C) used in the first session of S-ENG can improve intervention fidelity and

Eligibility Criteria:
Inclusion Criteria:

* Caregiver (age 50 or older) for a community-dwelling loved one with Alzheimer's disease or related dementia (ADRD), living with (or in close proximity to) the person with ADRD.
* Elevated caregiving distress: above population mean (\>11) on 10-item Perceived Stress Scale (PSS-10) and/or at least moderate caregiver strain (score \>= 5) on the Modified Caregiver Strain Index.
* Social disconnection: UCLA Loneliness Scale: Short Form score of \> 5.

Exclusion Criteria:

* Non-English speaking
* Significant cognitive impairment
* Major cardiovascular conditions that may interfere with reliable assessment of HRV (e.g., congestive heart failure, pacemaker, prior myocardial infarction).
A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)

The purpose of this study is to evaluate the efficacy, safety and tolerability of levetiracetam treatment used as adjunctive therapy in Japanese and Chinese epilepsy patients aged ≥16 years and with uncontrolled Generalized Tonic-Clonic seizures despite treatment with 1 or 2 anti-epileptic drugs.


Eligibility Criteria:
Inclusion Criteria:

* An epilepsy patient with generalized tonic-clonic seizures that are classifiable according to the ILAE classification of epileptic seizures (Epilepsia, 1981)
* A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to and during the combined baseline period

Exclusion Criteria:

* Presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures
* Diagnosis of Lennox-Gastaut Syndrome
* Confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imagining features
* A history of convulsive or non-convulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1
Protecting Kidneys Through a Low Protein Diet: A Stepwise Multiple-Choice System Approach

Nephrology care continues to progress and recommendations are now focused on delaying as much as possible the need for renal replacement therapy ("intent-to-defer"strategy). Protein restriction is a valuable tool for stabilizing chronic kidney disease (CKD) and retarding the need for renal replacement therapy, but the best diet to be prescribed is still matter of discussion. This study is aimed at identifying implementation strategies for nutritional management of advanced CKD.

The recent paradigm on dialysis start suggests that an intention to defer policy should be preferred to beginning dialysis early ("the earliest the best" strategy). This strategy is further supported by the consideration that patient profiles are changing with the increasing proportion of older and higher comorbidity patients. In high comorbidity patients, survival is not necessarily improved by dialysis.

Nutritional care, adapted to each patient's needs and preferences, could in part answer these demands. Indeed, renal function has a strict correlation with dietary patterns. Low protein diets may have two favourable effects: 1) slowing down kidney function decline and 2) delaying the need of replacement therapy (metabolic stabilizing). In dialysis, the nutritional state is the most important survival indicator, and nutritional follow-up should allow starting dialysis in a good nutritional status.

The study proposed here is an implementation study with a principal aim to improve the use of low protein diets in the clinical setting, by offering a multiple choice approach and by adapting the diets to the patients' needs.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients followed on the unit for advanced CKD, with Kidney disease stage 4-5 or stage 3 with fast progression and without contraindications.

Exclusion Criteria:

* Malnutrition or short life-expectancy
* Patients aged less than 18 years old
* Pregnant women,
* Incapacity to complete the free-consent form,
* Pateints refusing participation in the study,
* Patients without healthcare coverage.
Exercise and Muscle Protein Signalling

This study examines the muscle protein signalling response after resistance and endurance exercise. We hypothesize that the signalling response after endurance and resistance exercise will be partly similar.


Eligibility Criteria:
Inclusion Criteria:

* healthy men
* inactive

Exclusion Criteria:

* enrolled in a endurance and/or resistance training program
Using an Escape Room Game in Teaching the Critical Care Nursing Course

Critical thinking is one of the most desired outcomes of nursing education worldwide. The impact of game-based learning, including the use of an escape room game, on the development of critical thinking ability in nursing students remains uncertain. The main purpose of this study is going to evaluate an escape room game as a learning method in Critical Care Nursing course in improving senior nursing students' critical thinking dispositions and skills. In addition to the main purpose, this study also aims to investigate the effects of incorporating an escape room game into a Critical Care Nursing course in improving senior nursing students' knowledge about critical care nursing, learning motivation, and satisfaction with the learning method. This is a two-arm parallel randomized controlled trial conducted on senior nursing students at Tra Vinh University in Vietnam. Two teaching methods in the Critical Care Nursing course will be applied.

Critical thinking is one of the most desired outcomes of nursing education worldwide. The impact of game-based learning, including the use of an escape room game, on the development of critical thinking ability in nursing students remains uncertain.

The main purpose of this study is going to evaluate an escape room game as learning method in Critical Care Nursing course in improving senior nursing students' critical thinking dispositions and skills. In addition to the main purpose, this study also aims to investigate the effects of incorporating an escape room game into a Critical Care Nursing course in improving senior nursing students' knowledge about critical care nursing, learning motivation, and satisfaction with the learning method.

This a two-arm parallel randomized controlled trial conducted on senior nursing students at Tra Vinh University in Vietnam. Two teaching methods in the Critical Care Nursing course will be applied. A conventional class with an escape room game will be implemented for the intervention group while a conventional class with case-based learning will be the teaching method for the comparison group.

The study will be a repeated-measurement design with three time points. Mean, standard deviation, frequency, percentage, t-test, and chi-squared test will be conducted. Generalized Estimating Equations will be used to analyze the intervention effect and time effect on scores of critical thinking dispositions and skills, knowledge of critical care nursing, and learning motivation over three-time points. Generalized Estimating Equations will also allow us to explore the interaction between group and time, as well as control for any potential covariates. The intention of this study is that its findings will offer valuable insights for faculty members to consider incorporating escape room games into their teaching methodologies.

Eligibility Criteria:
Inclusion Criteria:

* Nursing students who are in their senior year in the bachelor program and take Critical Care Nursing which is a required course.

Exclusion Criteria:

* None
Combined Effects of Exercise Breaks and Rest Breaks on Fatigue and Musculoskeletal Discomfort in Static Workstation Office Workers

Musculoskeletal discomfort and work fatigue has enormous impact on quality of personal and professional life and increases health related economic burden on country due to increased cost of healthcare and reduced productivity in work. Upper limb and neck pain complains are the most frequent when evaluated in computer workers. The incidence of musculoskeletal discomfort in office workers is as high as 50%. While fatigue is also common due to its high prevalence and its relationship with dysfunctional disorders in office workers. The objective of this study is to compare and determine the effects of exercise breaks, rest breaks and exercise along with rest breaks on Fatigue and Musculoskeletal discomfort in static workstation office workers


Eligibility Criteria:
Inclusion Criteria:

* Both male and female
* Age: 25-45 years
* Those static workstation office workers using computer for at least 6 hours per day.
* Static workstation office workers screened by ROSA.

Exclusion Criteria:

* Discomfort from non-musculoskeletal origin
* Recent history of trauma and receiving any kind of treatment for the current condition.
* Severe orthopedic disease
* Any mental and physiological illness that could interfere in the exercise.
A Wearable Nerve Stimulator for Chronic Migraine/Headache and Mood Disturbance in Adolescents

The aim of this clinical trial is to test a wrist-worn nerve stimulator in adolescents with chronic migraine/headache and mood disturbance. The main question it aims to answer is whether this device is effective in relieving clinical symptoms including pain, anxiety, depression and sleep disturbance.

Participants will wear the device for twelve weeks and complete monthly surveys throughout the study.

The aim of this study is to evaluate the effectiveness of the Apollo Neuro Device on remediating clinical and physical symptoms of adolescents struggling with chronic migraine/headache with overlapping mood disturbance. This device is worn on the wrist and produces silent, low-frequency waves that feel like slight vibrations. An Apollo Neuro Device will be offered as part of a treatment plan to patients with chronic neurological symptoms. Patients will be placed in either a treatment or waitlist treatment group randomly. Those in the treatment group will immediately use the Apollo Neuro Device for twelve weeks and those in the waitlist group will follow the standard plan of care for twelve weeks. At twelve weeks the initial treatment group will conclude their time in the study and the waitlist group will begin use of the device for another twelve weeks. Patients will complete surveys when they are given the Apollo Neuro Device, monthly while using the device, and after twelve weeks of use. The waitlist group will also complete surveys upon enrolling in the study and monthly thereafter until the completion of their intervention. The findings of this study will further the understanding of autonomic dysfunction symptomology and recovery in the diagnosis of adolescent chronic headache/migraine and evaluate the effect of nerve stimulation as a means of mediating autonomic nervous system dysfunction and reducing symptoms in these patients.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of chronic headache/migraine
* The ability to follow simple instruction

Exclusion Criteria:

* Previous diagnosis of moderate or severe traumatic brain injury
* History of mild traumatic brain injury/concussion within the last six months
* History of schizophrenia or bipolar disorder
* History of epilepsy, cerebral palsy, or severe sensory disorders
* History of stroke or neurodegenerative conditions
Study of GX-I7 in Combination With Pembrolizumab in Refractory or Relapsed (R/R) TNBC Subjects(GX-I7-CA-006/KEYNOTE-899)

To evaluate the safety and tolerability of escalating doses GX-I7 in combination with standard dose pembrolizumab, and to evaluate objective response rate (ORR) in subjects with refractory or relapsed TNBC


Eligibility Criteria:
Key Inclusion Criteria:

1. Triple negative must be defined as guidelines of American Society of Clinical Oncology(ASCO)/ College of American Pathologist(CAP): Estrogen Receptor (ER) \< 1% positive tumor nuclei, Progesterone Receptor (PR) \< 1% positive tumor nuclei, and negative for HER2 by IHC 1+, 0 or negativity status confirmed by in situ hybridization (ISH).
2. Subject must have received anthracycline and taxane based chemotherapy for TNBC
3. Has measurable disease as defined by RECIST 1.1 as assessed by the the local site Investigator/radiology.
4. Female subjects, age ≥ 19 years at the time of consent.

Key Exclusion Criteria:

1. Known severe hypersensitivity (≥ Grade 3) to pembrolizumab, pembrolizumab formulation excipients or GX-I7 formulation excipients or cyclophosphamide formulation.
2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (ie, CTLA-4, OX-40, CD137) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial.
Safety Study to Evaluate the Cumulative Irritation Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA

This is a safety study to determine the cumulative skin irritation potential of ZuraPrep™ and ZuraPrep™ without Isopropyl Alcohol after repetitive patch applications to skin of human subjects.

This cumulative irritation evaluation is designed to determine the skin irritation potential of ZuraPrep™ and ZuraPrep™ without Isopropyl Alcohol (IPA) after repetitive patch application to skin of healthy human subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subjects may be of either sex, at least 18 years of age and of any race
* Subjects must be free of tattoos, sunburn, dermatoses, cuts, lesions or other disorders of the skin of the back.
* Subjects must be in good general health

Exclusion Criteria:

* Known allergies to latex, metals, tape and/or adhesives, soap, citric acid, methylene blue, methylparaben, propylparaben, chlorhexidine gluconate, isopropyl alcohol, and sodium lauryl sulfate.
* Exposure of the back region to antimicrobial agents, medicated soaps, medicated shampoos, medicated lotions, strong detergents, sun-tanning, use of tanning beds, or swimming or soaking in pools or hot tubs, in the 7 days prior to, or during the 3-week test period.
* Use of topical or systemic corticosteroid, antihistamine, or anti-inflammatory medications in the 7 days prior to, or during the 3-week test period.
* Current or recent severe illness such as asthma, diabetes, hepatitis, organ transplant, mitral valve prolapse, congenital heart disease, internal prostheses, or any immunocompromised condition such as AIDS or HIV positive.
* Pregnancy, plans to become pregnant, breast-feeding
* Any active skin rash or breaks in the skin of the back
* Any sunburn or tattoos on the skin of the back
* Current active skin disease or inflammatory skin condition including contact dermatitis
* Participation in a clinical study in the past 7 days or current participation in another clinical study
* Any medical condition or use of any medications that, in the opinion of the Principal Investigator, would preclude participation
* Unwillingness to fulfill the performance requirements of the study