cyrilzakka/clinical-trials huggingface dataset:
VIVIFRAIL Program in Improving the Frailty and Physical Function in the Elderly

The global population is aging, and Taiwan has become an aging society. The aging population continues to rise. When the physical function and mental state of the elderly gradually decline, it is easy for the elderly to enter a state of physical weakness. Weakness is the decline in the reserve capacity of the physiological system. It is also related to geriatric syndrome, causing falls, hospitalization, disability, death, and increased medical costs, burden on primary caregivers, and reduced quality of life for the elderly.

Physical exercise training has been considered to be an effective strategy to prevent and delay disability and frailty, so this study uses the Vivifrail program for the elderly. A family-based 12-week exercise program, including: resistance, strength, balance, flexibility and cardiorespiratory endurance exercise training, performed five days a week, at least 45-60 minutes each time, so that the elderly can exercise at home, It can also improve physical function and improve the quality of life.

This study adopts a randomized controlled trial (RCT) with a one-group pretest-posttest design, with pre-frail and frail elderly as the research objects, and uses comprehensive assessment of the elderly to understand the physical function of the elderly Status, Vivifrail for the elderly was provided for abnormal physical function items, and post-test evaluation was carried out 4 weeks and 12 weeks after the intervention. In Taiwan, there is no research on Vivifrail for the frail elderly. In view of this, it is hoped that through the Vivifrail program and the follow-up of case managers, multi-faceted and continuous integrated care can be provided. Improve and maintain the physical function of the frail elderly for reference in the daily care of the elderly in the future.


Eligibility Criteria:
Inclusion Criteria:

1. ≧65 years old and above.
2. Pre-frail and frail cases assessed by Frail Fried's frail phenotype.
3. Clear consciousness, willing to accept interviewers, able to communicate in Chinese and Taiwanese.
4. Those who can cooperate with physical activities and have ADL ≥ 60 points.

Exclusion Criteria:

1. Those who cannot cooperate with the interventional care plan.
2. Elderly who are seriously ill or terminally ill.
3. People living in institutions.
4. Incompatibility and exclusion: acute myocardial infarction or recent unstable angina, poorly controlled atrial or ventricular arrhythmia, dissected aortic aneurysm, severe aortic stenosis, endocarditis/acute cardiac Capsulitis, uncontrolled hypertension, acute thromboembolism, acute or severe heart failure, acute or severe respiratory failure, uncontrolled postural hypotension, acute incompensated diabetes mellitus, or uncontrolled hypoglycemia, past month There is a fracture (muscle strength training).
Singida Nutrition and Agroecology Project

The purpose of this study is to test if a participatory, agroecological peer farmer-led education intervention can be effective at improving legume production, food security, and infant and young child feeding practices in Singida District, Tanzania.

Approximately 40% of under five children in Tanzania are stunted, with higher levels in rural areas. Our inception research in Singida identified five pressing issues faced by smallholder farmers that may contribute to this high rate of stunting. They are (A) hierarchical, or "top down" farmer education, (B) low soil fertility and little knowledge of agroecological solutions, (C) high levels of gender inequality and high workloads for women, (D) food insecurity and low dietary diversity, and (E) sub-optimal infant and young child feeding. Singida Nutrition and Agroecology Project (SNAP) is a randomized effectiveness trial of a participatory, agroecological peer farmer education intervention. Each intervention village will choose 2 mentor farmers, 1 man and 1 woman, who will participate in a field visit to and training by existing mentor farmers in Malawi and a two week long follow-up and refresher trainings in Tanzania integrating agroecology, climate change, nutrition, and gender equality. Mentor farmers will then conduct monthly visits to participating households and support the households in conducting experimentation with agroecological practices and/or new behaviors regarding nutrition and gender equality. Quarterly meetings among mentor farmers and biannual meeting of participating farmers within each village will be held to discuss progress and challenges of peer education and household experimentations.

Eligibility Criteria:
Inclusion Criteria:

* Are among the most vulnerable, as indicated by food insecurity
* Have a child who will be \<= 1 year old in February 2016
* Are farmers who have regular access to the same farms/plots (but they do not need to own the land per se)
* Female headed households are acceptable, so long as not more than half the selected households in the village are female headed (to be able to detect change in gender equity)
* Willing to stay in study for 3 years, i.e. do not plan to move
* Interested in experimenting with new farming techniques

Exclusion Criteria:

* Refuses to take part
Assessment of I-PRF Versus Nano MTA Combined with I-PRF Scaffold in Vital Pulp Therapy in Mature Mandibular First Molars

Assessment of I-PRF versus Nano Mineral trioxide aggregate Combined with I-PRF in pulpotomy in mature Mandibular First Molars

Clinical and Radiographic Assessment of I-PRF versus Nano Mineral trioxide aggregate Combined with I-PRF Scaffold in Vital Pulp Therapy in Mandibular First Molars with Closed Apices: "Randomized Controlled Trial"

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars only will be involved.

  * Patients of either gender aged from 15-30.
  * Tooth should give positive response to cold test.
  * The tooth is restorable
  * Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
  * Patients who will agree to the consent and will commit to follow-up period.
  * Patients with mature root.
  * Patients with no internal or external resorption and no periapical lesions.
  * Soft tissues around the tooth are normal with no swelling or sinus tract.

Exclusion Criteria:

* Patients with immature roots.

  * Haemostasias after 10 minutes can not be controlled after total pulpotomy
  * Patients with periapical lesions or infections.
  * Pregnant females.
  * Patients with fistula or swelling
  * Patients with necrotic pulp.
Time-Restricted Eating and Muscle Hypertrophy

The purpose is to examine the effects of time-restricted eating (TRE; consuming all calories within an 8-hour period each day) vs. normal eating (CON; consuming same kcals and protein as TRE, but during a 10-13 hr eating window each day) during 8 weeks of resistance exercise on body composition and muscle mass (whole muscle and single fiber), muscular performance, anabolic protein signaling, single muscle fiber characteristics, and the gut microbiome in well-trained young men and women.

The primary goal pertains to muscle hypertrophy (not fat loss), thus all participants will be placed in a 10% caloric surplus.

Eligibility Criteria:
Inclusion Criteria:

* 18-35 years old with \<25% (men) or \<30% (women) body fat
* have experience in resistance exercise for the whole body and performed resistance exercise at least 3 times per week the last 12 months
* be able to perform all necessary exercises with safe technique and no pain
* be able to squat 1.5x (men) or 1x (women) body weight
* be able to bench press 1.1x (men) or 0.55x (women) body weight
* be on a non-specialized, mixed macronutrient diet
* have a lifestyle which enables a reasonably consistent 7+ hours of sleep per night
* be free of any current joint, musculoskeletal, and/or neuromuscular injuries

Exclusion Criteria:

* have any known current illness, prohibitive muscular or neuromuscular problem, hypertension, cardiac, pulmonary, liver, kidney, insulin or any other metabolic disorders (e.g. Type I or Type II diabetes)
* are lactose intolerant or unable to consume whey protein for any reason
* are on any medications known to affect protein metabolism
* have taken antibiotics in the last 6 months
* cannot refrain from consuming any alcoholic beverages, nicotine, or marijuana (or derivative) for a period of 48 hours prior to data collection (pre and post testing)
* consume alcohol \>2x per week
* consume any analgesic or anti-inflammatory drug(s), prescription or non-prescription, chronically or within 48 hours of data collection
* consume any recreational drug(s), prescription or non-prescription, legal or illegal, chronically or within 30 days of data collection
* consume any caffeine or food within 12 hours of data collection
* cannot refrain from physical exercise (outside of activities of daily living) outside of what is prescribed by the research team for the duration of the study
* cannot refrain from using recovery methods such as electric stimulation, hot/cold therapy, massage, chiropractic, or personal air/water devices (Normatech, etc.)
* have utilized any anabolic steroid, currently or in the past
* cannot refrain from consumption of any supplementation (creatine, multivitamin, fish oil, protein powder, BCAA, pre-workouts, etc.) outside of what is provided
* cannot refrain from consuming any supplemental pro or prebiotics or other items that intentionally alter the gut microbiome
* fail to adhere to the nutritional guidelines or miss \>3 of the exercise sessions
* were recently pregnant, trying to become pregnant, or are currently breastfeeding
Microbiome Derived Metabolism and Pharmacokinetics

The investigators will perform single-dose pharmacokinetic (PK) studies in humans following administration of drugs with known microbiome derived metabolism (MDM) in parallel with preclinical studies. By directly comparing laboratory measurements to clinical results, the investigators will be able to confirm the relevance of MDM in vivo, create microbiome-dependent PK profiles of the MDM positive drugs, and establish methodology to capture the contribution of MDM to inter-individual variability in clinical drug PK profiles.

The human gut microbiome has been shown to play an important role in the observed inter-individual variability in therapeutic response, including both efficacy and toxicity. One of the mechanisms by which the gut microbiome exerts these effects is through the direct biochemical transformation of orally administered drugs into more or less active or toxic metabolites, termed herein microbiome-derived drug metabolism (MDM). Recent systematic studies have revealed an enormous and largely unexplored biochemical capacity of human gut bacteria - cultured in ex vivo microbial communities or as single isolates - to metabolize dozens of orally administered drugs but the clinical relevance of the observed MDM remains unmapped. This gap in knowledge is a result of overt disconnect between preclinical and clinical studies: MDM studies performed in the laboratory are removed from direct clinical comparisons, and human studies performed during drug development and therapeutic interventions almost completely ignore microbiome contribution. Moreover, there is currently a lack standardized experimental methods and mathematical models to start incorporating MDM into clinical decisions. Our PK studies are aimed at developing such strategies into clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age
* Body mass index between 18.5 - 29.9 kg/m2

Exclusion Criteria

* Estimated creatinine clearance \< 50 mL/min
* Liver impairment (liver enzymes \> 2 times upper limit)
* Antibiotics in the past 3 months
* History of gastrointestinal disease
* History of autoimmune disorder
* Chronic viral infection
* Smoker
* Alcohol intake (defined as having up to 1 drink per day for women and up to 2 drinks per day for men)
* Use of immune modulating medications
* Diabetes mellitus
* Any history or contraindication to the study medications
* Additional exclusion criteria will be based on the FDA approved prescribing information for selected drugs (i.e., contraindications)
Adult Patients Undergoing Open Colectomy MA402S23B303

This study is designed to compare the standard of care against EXPAREL(R) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospitalization costs.

This is a phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with EXPAREL compared with postsurgical administration of standardized intravenous (IV) morphine sulfate or sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing open colectomy with general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age and older.
* Patients scheduled to undergo open segmental colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy.
* Ability to provide informed consent, adhere to study visit schedule, and complete all assessments.

Exclusion Criteria:

* Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioid, or propofol.
* Patients who abuse alcohol or other drug substance.
* Patients with severe hepatic impairment.
* Patients currently pregnant or who may become pregnant during the course of the study.
* Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.
* Patients who have participated in an EXPAREL study within the last 30 days.
* Patients who have received an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the patient's participation in this study.
* Patients who undergo any concurrent surgical procedure during the ileostomy reversal surgery

In addition, the patient will be ineligible if he/she meets the following criteria during surgery:

* Patients who have any concurrent surgical procedure.
* Patients with unplanned multiple segmental resections or large intestine.
* Patients who have unplanned, temporary or permanent colostomies, ileostomies, or the like placed.
* Patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or an other analgesic, local anesthetics, or anti-inflammatory agents.
* Patients who receive Entereg(R).
Effects of Dynamic Stabilizatıon Exercises and HVLA Manipulatıon in Low Back Paın

Our aim is to contribute to the literature by comparatively examining the effects of DNS exercises and chiropractic HVLA manipulation on pain, pain-related functional impairment (disability), physical competence level, dynamic fitness level of core muscles and postural deviations in patients with chronic nonspecific low back pain.

Sixty volunteers aged between 20 and 45 years will participate in this study. Before starting the study, anthropological measurements (height, weight, body mass index) were made. After these measurements, the participants will be randomly divided into four groups.

The groups will be formed as chiropractic manipulation (CM) group (n=15), dynamic neuromuscular stabilization (DNS) group (n=15), CM + DNS group (n=15) and control group (CG) (n=15).

The KM group will receive 8 sessions of High Velocity Low Amplitude (HVLA) chiropractic manipulation twice a week for 4 weeks and the DNS group will receive 8 sessions of (DNS) exercise twice a week for 4 weeks and each session will last 50 minutes. The KM+DNS group will receive a total of 8 sessions of DNS exercises and HVLA chiropractic manipulation twice a week for 4 weeks.

Participants will be assessed a total of 3 times during the study; just before the intervention starts, 2 weeks after the intervention starts, after the 4th session, 4 weeks after completing the intervention, after the 8th session.

Participants will be assessed with Visual Analog Scale (VAS), Roland Morris Disability Questionnaire (RMDQ), Dynamic Neuromuscular Stabilization - Heel Slip Test (DNS-HS), Oswety Disability Index (ODI) and posture assessment will be performed using PostureScreen Mobile application.

Eligibility Criteria:
Inclusion Criteria:

* 7 points in Oswetry Disability Index (ODI)
* Participants should be between the ages of 20 and 45
* Normal radicular tests
* Being diagnosed with low back pain 6 months
* Not having perception problems and being able to cooperate well
* Signing the voluntary consent form

Exclusion Criteria:

* Pregnancy
* History of previous spinal canal surgery
* Presence of neurological deficits
* Presence of cancer
* Having an inflammatory or rheumatologic disease
* Spinal deformities (due to infection or trauma, compression fracture)
Long-Term Non-Interventional Latanoprost Study

This is a non-interventional, prospective, longitudinal cohort study. A total of 150 pediatric subjects with glaucoma or elevated intraocular pressure, including 75 latanoprost-treated subjects and 75 non-topical prostaglandin analogue treated subjects, will be enrolled from ophthalmic hospital clinics and academic ophthalmic centers. As a non-interventional study, the study subjects' continued use of latanoprost and assessments of ocular events will be obtained through the routine medical follow-up with treating ophthalmologists or other designated members of the medical care team.

At least 40 subjects in each of the following age groups: 1-\<5 years and 5-\<18 years. No minimum required numbers in the \<1 year age group.

Eligibility Criteria:
Inclusion Criteria:

* Male or female \<18 years of age (neonates must be at least 36 weeks gestational age).
* Diagnosis of pediatric glaucoma or elevated intraocular pressure.
* Evidence of a personally signed and dated informed consent document indicating that the subject (and/or a legally acceptable representative) has been informed of all pertinent aspects of the study. A signed and dated assent will be required where applicable according to local laws.

For treated subjects only:

* Continuously treated with latanoprost for at least 1 month within the year prior to the baseline examination.

For untreated subjects only:

* Continuously treated with latanoprost or other topical prostaglandin analogues for less than one month prior to the baseline examination (based on the best knowledge of treating ophthalmologists), and unlikely to be treated with latanoprost or other topical prostaglandin analogues during the three-year study period; OR
* No prior treatment with latanoprost or other topical prostaglandin analogues, and unlikely to be treated with latanoprost or other topical prostaglandin analogues during the three-year study period.

Exclusion Criteria:

* Unable/unwilling to comply with protocol.
* Pregnant or nursing females at baseline.
* For treated subjects only: a history of allergy or hypersensitivity to any of the ingredients contained in latanoprost (e.g., hypersensitivity to benzalkonium chloride).
Psycho-Spiritual Management for Patients With Advanced Cancer and Their Family Caregivers

The goal of this behavioral research study is to learn about the effects of two different supportive care programs on patients' and their family caregivers' psychological wellbeing and overall quality of life.

To enhance the accessibility and scalability for future research, both the interventions (FFM and AC) will be delivered via videoconferencing. To increase the generalizability of the findings, a multi-site enrollment recruitment strategy will be used to enroll a diverse (including underserved) patient population. The program will be delivered in both English and Spanish and a varied social economic population will be enrolled in the program.

Eligibility Criteria:
Inclusion Criteria:

* Be diagnosed with a metastatic (stage IV) breast, thoracic, gastrointestinal, gynecological, or genitourinary cancer
* Be without disease progression for at least 3 months based on surveillance CT imaging
* Have an ECOG performance status of ≤2
* Have a family caregiver willing to participate

Both patient and caregiver must meet all the following criteria:

* Be ≥18 years old
* Be able to read and speak English or Spanish.
* Be able to provide informed consent

Additionally, either the patient and/or caregiver must:

• Have a NCCN Distress Thermometer score of ≥4

Exclusion Criteria:

A patient who meets the following criteria will be excluded from participation in this study:

• Have cognitive deficits that would impede the completion of self-report instruments as deemed by their attending oncologist

3.3 Vulnerable Populations This study is designed for individuals who are at least 18 years of age, and there is no upper age limit. Children under the age of 18 will not be included. First and foremost, it is unlikely that a minor is diagnosed with a metastatic solid tumor. It is also unlikely that a minor serves as the primary family caregiver of a patient with cancer. Additionally, the intervention is designed for adults, and the assessment tools are not validated for minors. While pregnant caregivers (self-identified) are study eligible, we will also exclude pregnant patients (medical notes).

3.4 Recruitment/Screening Process Eligible study participants (i.e. cancer patients) will be identified using the electronic clinic appointment systems on their tumor characteristics (i.e. cancer type and stage) and date of birth (i.e. minimum 18 years old). Potential patients and caregivers will be approached during patients' appointment at an outpatient oncology appointment, screened for eligibility, and consented. Since this is a family-based intervention, it is possible that caregivers will not be present during the patients' clinic visits. If so, patients will be asked for permission to contact the caregiver via phone to obtain consent.
Management of a Giant Lymphocele Following Varicose Vein Surgery - A Case Report

A 48-year-old female presented to the plastic surgery outpatient department (OPD) with a history of painful, progressive swelling of the right groin and medial aspect of the right thigh for 4 months. After investigation, it was diagnosed as a giant lymphocele. A pedicled gracilis muscle flap was used to reconstruct and obliterate the cavity. There was no recurrence of the swelling. : Lymphocele is a common complication after extensive vascular surgeries. In the unfortunately case of its development, prompt intervention must be done to prevent its growth and ensuing complications.


Eligibility Criteria:
Inclusion Criteria: diagnosed case of lymphocele -

Exclusion Criteria: none

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