cyrilzakka/clinical-trials huggingface dataset:
Early Age-Related Hearing Loss Investigation Pilot Study

The purpose of this clinical trial pilot is to obtain feasibility and pilot data necessary to inform the hearing intervention being designed for a larger R01 clinical trial that seeks to determine whether best practice hearing aid intervention impacts hearing-related outcomes in adults with hearing loss aged 55 to 75 years.

Secondary purposes include: To determine what effects best practice hearing aid intervention has on physical, social, and quality of life outcomes in adults with hearing loss aged 55 to 75 years.

This is an observational pre-post intervention feasibility study. In addition to the objective finding that adults with hearing loss experience higher rates of cognitive decline, they also tend to report lesser degrees of physical activity and increased cognitive fatigue, which is the feeling of tiredness or having a lack of energy. Unfortunately, the mechanism by which hearing loss relates to physical activity and fatigue, and the effect of hearing aids as an intervention to improve these factors, is unclear. Thus, the purpose of this study is twofold: First, we will establish the feasibility of administering a best practices hearing aid intervention to a sample of adults from the target age range of 55 - 75 years old to inform the larger clinical trial; Second, we will collect pilot data to explore the relationships between hearing loss, physical activity, socialization, fatigue and hearing-related outcomes before and after hearing aid intervention.

There are no experimental or investigational devices or agents used in this study. We are providing best-practices standard of care hearing intervention including hearing aids. We are additionally tracking activity using the ActiGraph wGT3X-BT, an FDA-approved Class II medical device that tracks continuous, high resolution physical activity and sleep/wake information.

Participation involves a minimum of 6 in-office study visits. Intervention sessions occur approximately 2 weeks apart, with a final long-term outcome session occurring approximately 6-months post the baseline intervention session.

Significant others of participants are invited to join the study and contribute data related to their own quality of life and their observations of the effects of the hearing intervention on the participant.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 55 to 75 years old with little or no experience with hearing aids
* English or Spanish speakers

Exclusion Criteria:

* Unable to complete written questionnaires on a tablet without assistance
* Refer for cognitive screening score based on criteria using the Mini Mental State Examination
Examination of Occupational Justice, Activity Performance and Quality of Life in Homeless People

This concerns the participation of individuals experiencing homelessness, as a disadvantaged group, in meaningful and purposeful occupations, evaluated within the framework of occupational justice. Homeless individuals face numerous social and economic barriers that impact their full participation in societal occupations. However, since survival becomes the primary goal for homeless individuals, meaningful occupations often revolve around surviving on the streets. The aim is to identify problems and constraints to participation in daily life activities so that their participation can be enhanced.

"The data collection tools will be implemented during face-to-face interviews with participants. Interview durations will vary between 45 to 90 minutes. Interviews with individuals who accept the invitation to participate will be conducted in public places such as cafes, parks, and other community areas in the Beyoğlu district. The data collection process, initiated after ethical approval, will be concluded upon reaching a sufficient number of participants. Homeless individuals contacted through the 'Çorbada Tuzun Olsun Derneği' will be informed about the research and invited to participate. Individuals with neurological or psychiatric conditions that hinder communication and collaboration will not be included in the study. Fourteen homeless individuals aged 18 or older, literate, able to communicate and collaborate, and currently living on the European side of Istanbul will be included in the study. Data collection instruments for the study include a Demographic Information Form, Semi-Structured Interview Guide, Canadian Occupational Performance Measure, Occupational Justice Health Questionnaire, World Health Organization Quality of Life Scale Short Form, and Occupational Balance Questionnaire."

Eligibility Criteria:
Inclusion Criteria:

* Fourteen homeless individuals aged 18 or older, literate, able to communicate and collaborate, and currently living on the European side of Istanbul will be included in the study.

Exclusion Criteria:

* Individuals with neurological or psychiatric conditions that hinder communication and collaboration will not be included in the study.
Efficacy and Safety of Gynostemma Pentaphyllum(Dungkulcha) Extract on Alleviation of Chronic Stress-induced Strain

The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Gynostemma Pentaphyllum(Dungkulcha) on alleviation of chronic stress-induced strain. The investigators measured decrement of body fat parameters, State\&Trait version of STAI, Beck Anxiety Inventory(BAI), Hamilton Anxiety Inventory(HAM-A), and monitored their blood pressure.


Eligibility Criteria:
Inclusion Criteria:

• Age 20-65 years with chronic stress( S-STAI score 40\~60)

Exclusion Criteria:

* excessive physically chronic fatigue
* Subjects taking antidepressants, anxiolytics, hypnotics within the last 2 months prior to the study
* Cardiovascular disease
* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* Participation in any other clinical trials within past 2 months
* Renal disease
* Abnormal hepatic function
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* History of alcohol or substance abuse
* Pregnancy or lacting women etc.
Nutrition and Constipation at Inguinal Hernia Patients

There are lots of inguinal hernia risk factors determined in the literature. But the relationship between nutritional status and inguinal hernia were not examined yet. In this study the investigators evaluated the constipation scale and food consumption of the inguinal hernia patients. This Case-Control study was performed between March 2018- March 2019. The patients who admitted for operation with inguinal hernia were the case group (n:115) and the patients who were admitted to the same hospital without inguinal hernia were control group (n:88). The age, body mass index, alcohol and smoking habits, daily activity, frequency of food consumption and the Wexner constipation scoring were examined using questionnaire were noted.

Inguinal hernia is the most common type of abdominal wall hernias and the prevalence is estimated as 5-10% in United States. Although many risk factors have been defined for inguinal hernia, family history of inguinal hernia has been reported to be one of the most important factors. In addition to this, advanced age, male gender, smoking, chronic cough causing intraabdominal pressure increase, and chronic constipation are the risk factors. The hernias may recur according to the causes they originate from the reasons they originate in the early or late period after treatment.In this study, constipation and nutritional status of inguinal hernia patients were evaluated and it was aimed to examine the relationship between inguinal hernia and nutrition which has not been previously evaluated in the literature.

This Case-Control study was performed between March 2018- March 2019. The patients who admitted to the general surgery for operation with inguinal hernia were the case group of this study (n:115). Also, the patients who were admitted to the same hospital with such as eye, ear/nose/throat, dermatologic diseases or elective surgeries and did not have any inguinal hernia complaints, constipation and other chronic disease which could increase the intra abdominal pressure selected as control group (n:88).

Written informed consent was obtained from each participant. The numbers of cases and controls were matched based gender and age in each group. The age, gender, body mass index, alcohol and smoking habits, daily activity, frequency of food consumption and the constipation scoring according to Wexner constipation scoring were examined using questionnaire. The demographic data, nutritional status and the constipation scores were compared among individuals to identify differences between these two groups.

Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of Inguinal Hernia

Exclusion Criteria:

* Cancer
* Pregnancy
* Chronic liver diseases
* Previous abdominal surgery history
* Femoral hernia
* Bilateral inguinal hernia
* Weight loss above the 20% of the body weight in the last 6 months
Transdermal Buprenorphine Patch for Laparoscopic Cholecystectomy

Preliminary studies of the transdermal buprenorphine patch target chronic pain patients, and the pain relief effect and safety have been proven. There are previous reports that the transdermal buprenorphine patch is effective in acute postoperative pain control. However, no clinical studies have yet been reported on its application during laparoscopic cholecystectomy. Therefore, we designed this study to see if the use of a transdermal buprenorphine patch resulted in a better pain profile.


Eligibility Criteria:
Inclusion Criteria:

* 1) Patients 19 years of age or older who are expected to undergo laparoscopic cholecystectomy 2) ASA PS 1-3

Exclusion Criteria:

* (1) Patients with known hypersensitivity to buprenorphine, including patients with previous allergic contact dermatitis (2) Patients with drug resistance, opioid dependence, and treatment for drug withdrawal symptoms (3) Patients with severe respiratory dysfunction or respiratory depression (4) Patients currently taking other central nervous system depressants or muscle relaxants that may cause respiratory depression, hypotension, severe sedation, or lead to coma (5) If you are unable to read or understand the consent form (e.g. cognitive impairment, illiteracy, foreigners, etc.) (6) Other vulnerable subjects
Far Infrared Irradiation for Control, Management and Treatment of Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic Lateral Sclerosis (ALS, sometimes called Lou Gehrig's s Disease, or Maladie de Charcot) is a progressive, usually fatal, neurodegenerative disease caused by the degeneration of motor neurons, the nerve cells in the central nervous system that control voluntary muscle movement.

This study will investigate the use of far infrared radiation for the control, management and treatment of ALS.

As a motor neuron disease, ALS causes muscle weakness and atrophy throughout the body as both the upper and lower motor neurons degenerate, ceasing to send messages to muscles. Unable to function, the muscles gradually weaken, develop fasciculations (twitches) because of denervation, and eventually atrophy due to that denervation. The patient may ultimately lose the ability to initiate and control all voluntary movement except of the eyes.

Observations from our research studies indicate that, far infrared rays provide energy to the body, improve the autonomic functions of the nervous system, restore the functions of the endocrine system, strengthen the immune system, improve blood circulation and increase the level of oxygen in the cells and promote the regeneration of muscle cells, nerves and brain cells.

It is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly lead to complete rehabilitation of people who have ALS.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ALS

Exclusion Criteria:

* None
Promoting Success for Pre-K Teachers, Families and Children

The current study examines the impact of ParentCorps in high-poverty Early Education Centers in New York City (NYC). The study is conducted within the context of the NYC Department of Education (DOE) Pre-K Thrive initiative. As part of this initiative, the Center for Early Childhood Health and Development (CEHD) at NYU Langone Health is implementing services to strengthen family engagement and support parents and teachers in building safe, nurturing and predictable environments for young children. Services include resources to support social emotional learning (SEL) and family engagement (FE) for all Pre-K for All (PKFA) programs and all PKFA families; Professional Learning to support the use of evidence-based SEL and FE practices for teachers and leaders from 350 PKFA programs; and ParentCorps programs for PKFA children and families in 50 PKFA programs (which is a subset of PKFA programs receiving Professional Learning). The current study evaluates the relative value of Thrive Professional Learning plus ParentCorps compared to Thrive Professional Learning.

This study will include 158 pre-K teachers (teachers and teaching assistants) across 23 Centers (12 Centers receiving Thrive Professional Learning plus ParentCorps, 11 Centers receiving Thrive Professional Learning only). All teachers in the 23 Centers will be invited to complete 2 self-report surveys over a two-year period. A sub-set of teachers will be randomly selected to participate in 2 interviews during this period. In addition, teachers in sites randomized to ParentCorps (12 Centers) will be invited to consent to the use of weekly implementation surveys, observational data and semi-structured interviews about experiences with implementation, collected as part of standard implementation practice of ParentCorps, for the purposes of this study.


Eligibility Criteria:
Inclusion Criteria:

* Teachers who are teaching staff in the Pre-K classrooms in the 23 Centers.

Exclusion Criteria:

* Only Pre-K teachers from the 23 Centers will be invited to participate in the study. Leaders and other school staff from the Centers are excluded from the study.
* Family-level administrative data only on Pre-K families from the 12 Centers assigned to the Professional Learning plus ParentCorps condition will be obtained from the NYC DOE. Families in other sites are excluded from the request for family-level administrative data.
A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Efficiency and Safety of Intracranial Aneurysm Assistive Software in the Preoperative Assessment

the goal of this clinical trail is to evaluate the efficiency and safety of intracranial aneurysm assistive software in the preoperative assessment. The trail is designed as retrospective, multicenter, controlled clinical trail. Collecting probable cases images retrospectively according to inclusion criteria and exclusion criteria strictly. Controlling bias strictly, to make sure the efficiency and safety of intracranial aneurysm assistive software is evaluated reliably and precisely. In our trail, software-assisstant planning controls against experienced-surgeon-independent planning，which aims to avoid bias effictively and eliminate non-test interferences.


Eligibility Criteria:
Inclusion Criteria:

1. aged 18-80y, no gender limitation.
2. non-ruptured intracranial saccular aneurysm with specific intracranial CTA images; Target aneurysm has performed intravascular coiling treatment.
3. intracranial aneurysm diameter range from 3mm to 10mm.
4. the shape of aneurysm is regular without daughter sac or more than 2 lobulations.

Inclusion criteria of images:

1. the number of detector rows of Computed Tomography(CT) is more than 16 rows.
2. slice thickness ≤ 0.625mm, whole-brain image is considered.
3. Both plain scan sequences and enhancer sequence are required.

Exclusion Criteria:

1. combined with cerebral hemorrhage;
2. combined with cerevascular malformation or cerebral occupying lesion;
3. fusiform aneurysm or dissection aneurysm;
4. significant proximal stenosis of parent artery;
5. intracaverous internal carotid artery aneurysm;
6. target aneurysm has been performed flow-diverter stents treatment.

Exclusion criteria of images:

1. none DICOM format;
2. quality score less than 3 scores;
3. metal artifacts existance.
Uremic Toxins and Outcomes in Chronic Kidney Disease

The aim of this cohort study is:

To investigate the etiology and epidemiology of comorbidities in CKD; To find out risk factors associated with the mortality of CKD; To find out uremic toxins which are related to the mortality and comorbidities of CKD; To focuse on the association between uremic toxins and inflammation, oxidative stress and nutritional status in CKD.

To investigate the etiology and epidemiology of comorbidities in CKD; To find out risk factors associated with the mortality of CKD; To find out uremic toxins which are related to the mortality and comorbidities of CKD; To focuse on the association between uremic toxins and inflammation, oxidative stress and nutritional status in CKD.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years old;
* clinically diagnosed with chronic kidney disease, according K/DOQI criteria.

Exclusion Criteria:

* acute kidney injury
* history of kidney injury \<3 months
* malignancy
* pregnancy
* incomplete clinical data
Prognosis in UC After First Biological

To study the long-term clinical outcome of patients with ulcerative colitis treated with first trial of biological therapy.

UC patients treated with at least one biological in Tampere University Hospital between January 2009 and January 2020 were identified and reviewed from patient records.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated for ulcerative colitis for the first trial of biological

Exclusion Criteria:

* Age under 16 years
Preventing Acquired Resistance: Strengthen TB Treatment by Adding Amikacin in the First Treatment Week of Multidrug-resistant Tuberculosis

Acquired drug-resistance is a major challenge for tuberculosis (TB) care programs. The 2020 WHO guidelines recommends replacing second-line injectables by bedaquiline in rifampicin-resistant TB (RR-TB) treatment regimens. However, recent reports show too high rates of acquired bedaquiline resistance. This may be explained by the delayed onset of action of bedaquiline. The investigators will study whether high-dose amikacin (a second-line injectable), administered during the first week of RR-TB treatment, is safe in 20 patients treated for RR-TB in Rwanda. If safe, further studies will assess whether adding amikacin in the first treatment week protect against acquired bedaquiline resistance. This study is embedded in an ongoing "Master study" of the ShORRT (short oral RR-TB) treatment regimen in Rwanda, a before/after study, with a retrospective cohort (before; the previously recommended second-line injectable-containing RR-TB regimen) and a prospective cohort (after: the newly recommended ShORRT regimen).


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the Master SHORRT study
* Able and willing to provide written informed consent for the present substudy "Stake"

Exclusion Criteria:

* Any audiometry abnormality (grade 1 or higher) on baseline audiometry
* History of kidney disease or baseline creatinine clearance below or equal to 60ml/min
* Pregnant or breastfeeding women
* History of previous injectable based tuberculosis treatment (including with streptomycin)
* \< 18 years and \> 65 years old
* Patient on NSAID or on diuretics

Master ShORRT study

Inclusion criteria:

* Is willing and able to give informed consent to be enrolled in the research project and for follow-up
* Has bacteriologically or molecularly confirmed TB with evidence of resistance to at least rifampicin

Exclusion criteria:

* Is unable to take oral medication;
* Must take any medications contraindicated with the medicines in the MDR/RR-TB regimen;
* Has a known allergy to any of the drugs in the MDR/RR-TB regimen;
* Has a QTcF interval of ≥ 500 msec; at baseline that does not correct with medical management.
Vein Fitness System vs Compressive Therapy for Venous Ulcers: a Bayesian Adaptive Trial

The objective of this Bayesian Adaptive trial is to compare a control group versus a comprehensive ulcer healing protocol. The latter involves a combination of compressive therapy, miokinetic drainage and muscle strengthening for the entire lower extremity pump among patients with lower extremity venous ulcers. The investigators hypothesized that the combined therapy will have a higher closure rate as well as lower time to closure.

This is a Bayesian adaptive, randomized, controlled, parallel, two-armed Bayesian adaptive trial. Patients diagnosed with varicose ulcers through Doppler ultrasonography will be recruited at the Pro Circulation Clinic of Angiology and Vascular Surgery, Brazil. The active group will be the Vein Fitness system, a multimodal intervention comprising exercise, lymphatic drainage, and compressive therapy, while the control group will be standard compressive therapy and regular wound care. The researchers will measure closure of the wounds and the closure rate as the primary outcomes. The study was designed in accordance with the CONSORT statement.

Eligibility Criteria:
Inclusion Criteria:

* Venous ulcers due to chronic venous disease assessed by color duplex scan (CDS) examination in standing position. Reflux will be assessed using CDS over a longitudinal vein through the manual compression of the calf in a distant position from the examined area. Reflux will be considered pathological if: \>0.5 seconds (s) in the superficial venous system, or \> 1.0 s in the deep system, or \> 0.35 s in a perforator vein.

Exclusion Criteria:

* Investigators will exclude patients with ulcers from any other cause, including arterial insufficiency, with ankle-brachial pressure index (ABPI) \< 0.8. Also will be excluded patients who use immunosuppressive and chemotherapy drugs, who have allergies to compression materials, and wheelchair users (due to the impossibility of performing the exercises).
Using YouTube to Learn Anatomy: Perspectives of Mexican Medical Students

The study is aimed at exploring the popularity, impact, and usefulness of using YouTube in learning anatomy as perceived by Mexican medical students studying at different universities along the country


Eligibility Criteria:
Inclusion Criteria:

* Student of medicine

Exclusion Criteria:

* Not student of medicine