cyrilzakka/clinical-trials huggingface dataset:
Work and Iron Status Evaluation

This project seeks to understand how changes in the health of an individual affects the economic and social prosperity of the individual, family and community. The study involves providing iron supplements to a sample of participants in Central Java Indonesia and following those respondents for three years. They are compared with a control group who do not receive the supplement.

The goal of the study is to pin down the causal effect of improvements in health on the economic and social prosperity of individuals and their families. Particular attention will be paid to the dynamics underlying the effect of health on labor outcomes; older adults are more likely to experience transitions in health and economic status and so will be emphasized.

Beginning in 2002, about 4,000 households will be interviewed every four months for about 3 years. The first two waves of the survey will serve as baselines. After the second wave, households will be randomly assigned to one of two groups. Iron supplements will be provided to all members of households assigned to one of those groups. Household members in the 2nd group will receive an identical-looking placebo. Participants will take the supplements (or placebo) on a weekly basis for a year. The study will measure the effect of supplementation on the well-being of individuals and their families.

Data will be collected at the individual, household and community level. Individual level data will cover time allocation including work and participation in community activities, earnings, self-reported and physical health and cognition. All adult household members will be interviewed; questions about children will be answered by a caretaker. Data on wealth and consumption will be collected at the household level. Community resources, services and infrastructure information will be gathered along with detailed price data.

Eligibility Criteria:
Inclusion Criteria:

* Resident in village in study area in Purworejo District, Central Java, Indonesia

Exclusion Criteria:

* None
Airway Management Study to Evaluate the C-MAC Video Laryngoscope as an Alternative to the Direct Laryngoscopy

The purpose of this study is to evaluate the C-MAC video laryngoscope in difficult airway situations.

Unanticipated difficulties during tracheal intubation and failure to intubate are among the leading causes of anaesthesia related morbidity and mortality. Using the technique of video laryngoscopy, the alignment of the oral and pharyngeal axis to facilitate endotracheal intubation is obsolete. In this study we evaluate the C-MAC video laryngoscope (STORZ, Tuttlingen, Germany) for endotracheal intubation in difficult intubation situations (Cormack \& Lehane (CL) grade 3 and 4) validated by Macintosh laryngoscope. We hypothesize that endotracheal intubation is possible using the C-MAC in patients after failed direct laryngoscopy. We also examine whether visualisation of the glottis is improved with this device compared to direct laryngoscopy and possible complications such as soft tissue injury.

Eligibility Criteria:
Inclusion Criteria:

* Unexpected difficult airway

Exclusion Criteria:

* History of difficult or impossible mask ventilation
* Age \< 18 years
* ASA grade \> 3
* Emergency surgery
Protein Supply in Elderly

Stimulating overnight muscle protein synthesis, might augment muscle hypertrophy, increase mitochondrial mass, and/or improve muscle tissue repair. The goal of this proposal will be to provide further insight into the responsiveness of the muscle protein synthetic machinery to food intake in relation to age.


Eligibility Criteria:
Inclusion Criteria:

* Males
* Age between 65 and 80 years
* BMI \< 30 kg/m2

Exclusion Criteria:

* Type 2 diabetic patients
* Use of medication
* All co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. artrosis, arthritis, spasticity/rigidity, all neurological disorders and paralysis).
* Use of anticoagulants, blood diseases, allergy for lidocain.
* Contra indications for the use of a nasogastric tube: high risk of aspiration, gastric stasis, gastro-oesophageal reflux, upper gastrointestinal stricture, nasal injuries and base of skull fractures.
* Patients suffering from PKU (Phenylketonuria).
Effect of Daily Consumption of Vitamin B12 Fortified Yoghurt on Vitamin B12 Status in Older Adults

Older adults are recommended to meet their daily vitamin B12 (B12) requirements by consuming foods with added B12 and/or taking B12 supplements (i.e. sources of free B12) because of an age-related decreased digestion and absorption capacity for food-bound B12. Currently, B12 is not added to foods in Canada, except for simulated dairy and meat products. Yoghurt with added B12 is a novel dairy product that could fill a gap that presently exists in the Canadian market and has the potential to provide Canadian older adults with an alternative dietary source of B12 that could help improve their B12 status. Thus, the objective of this study was to assess the efficacy of the daily consumption of one serving of yoghurt fortified with B12 versus unfortified yoghurt for 8 weeks on the B12 status of healthy older adults, assessed using serum total B12. The primary hypothesis of this study was that the daily consumption of B12-fortified yoghurt would increase serum total B12 concentration of older adults compared to the consumption of unfortified yoghurts.


Eligibility Criteria:
Inclusion Criteria: Non-smoking and apparently healthy female and male volunteers aged 50-75 years, who are comfortable speaking, reading and understanding English.

Exclusion Criteria:

* Chronic health conditions, especially those related to B12 metabolism and the digestive tract. Chronic health conditions include diabetes, cancer, liver disease, psychiatric illnesses (depression, bipolar disorder, schizophrenia, anxiety disorder, eating disorder), cardiovascular disease, renal impairment, pancreatic dysfunction, gastrointestinal diseases (such as, Crohn's disease, Irritable Bowel Syndrome, Colitis, pernicious anemia, Celiac disease, acid indigestion, constipation, diverticulitis/ diverticulosis, gastroesophageal reflux disorder, or atrophic gastritis), total or partial gastrectomy, gastric bypass or other bariatric surgery, ileal resection or organ reconstructive surgery.
* Use of prescription or over-the-counter medications that may interfere with B12 status, i.e., Metformin, anti-cancer treatment, antibiotics, proton pump inhibitors, antacids; the use of high-dose B12 supplements for the last 1 month (e.g., 1000ug of B12 per day); intramuscular B12 injections in the last 1 month; vitamin supplements containing B-vitamins over the past three months; or Brewer's yeast over the past three months.
* Individuals who are unwilling to consume one daily serving of yoghurt for 8 weeks, provide blood samples and measures of height and weight, enroll and start the study in early 2019, or come to the University of British Columbia (UBC) or the BC Children's Hospital Research Institute (BCCHRI) site for study visits.
* Participants with deficient or high serum total B12 concentrations (\<148 and \>400pmol/L)
* Individuals with allergies or sensitivities to any ingredients of yoghurt (i.e. dairy)
* Individuals who smoke or consume more than one drink containing alcohol each day
Sleep Apnea in Elderly Male Twins

To conduct a genetic analysis of anatomic risk factors for sleep apnea in a well-characterized United States population-based registry of elderly male twins who have been successfully followed for the past 30 years.

BACKGROUND:

The contribution of genetic factors to sleep disorders has been demonstrated in twin and family studies, and further understanding of the genetic underpinning of sleep disorders is considered an important area of research. Many of the suggested risk factors for sleep apnea (e.g.,craniofacial morphology, obesity) have genetic determinants. However, a formal genetic analysis of these anatomical risk factors with sleep-recorded physiological measurements has not so far been conducted.

DESIGN NARRATIVE:

The investigators recruited a subsample of pairs from the NAS-NRC World War II Twin Registry in which at least one of the twin brothers reported sleep apnea symptoms and a subsample of control pairs in which both twins reported no symptoms. They monitoring the subgroup of twin pairs with overnight sleep recording. They also collected anthropometric measurements of weight, height, neck circumference, and craniofacial morphology and blood samples for determination of zygosity and DNA extraction for future molecular studies.

The twin design is most powerful for estimating the genetic and/or environmental overlap between physiological measurements such as sleep-recorded disordered breathing, obesity, and craniofacial morphology. The investigators chose to focus on an elderly male twin sample for which a wealth of data relevant to this study had been previously collected. Twin pair concordance or discordance for monitored sleep-disordered breathing allowed the full characterization of genetic/familial and individual environmental factors associated with the expression and severity of this condition.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Reproducibility of the Array-Based Comparative Genomic Hybridization (aCGH) System Using Whole Blood Samples

The objective of this study is to validate the performance characteristics of the GeneTrait CGH Microarray System DX. Reproducibility among sites, lots, and operators will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to donate at least 10 mL of whole blood
* Must be able to provide consent, or parental consent and patient assent (if applicable)
* Must be currently followed as a patient of a genetic clinic or counselor at one of the recruiting sites
* Must have at least one chromosomal change that is detectable by the GeneTrait CGH Microarray System DX as determined by karyotype and/or fluorescence in situ hybridization (FISH) analysis (within any of the 73 critical regions)

Exclusion Criteria:

* Unable to donate at least 10 mL of whole blood
* Unable to provide consent, or parental consent and patient assent (if applicable)
* Not currently followed as a patient of a genetic clinic or counselor at one of the recruiting sites
* Does not have at least one chromosomal change that is detectable by the GeneTrait CGH Microarray System DX as determined by karyotype and/or FISH analysis (within any of the 73 critical regions)
Efficacy of CeraVe® Moisturizing Cream on Skin Pruritus in Elderly Patients

The goal of this clinical trial is to evaluate the CeraVe® moisturizing cream's efficiency on the improvement of skin barrier in patients with chronic elderly pruritus. The main questions it aims to answer are:

type of study: clinical trial participant population:in patients with chronic elderly pruritus \[question 1\] Evaluate the CeraVe® moisturizing cream's efficiency on the improvement of skin barrier in patients with chronic elderly pruritus, including improvements of redness, dryness/squamation, itching, burning, tingling, tightness and other factors.

\[question 2\] Evaluate the tolerance of CeraVe® Moisturising Cream. \[question 3\] Evaluate the product experience of patients who were utilizing CeraVe® Moisturising Cream.

This trial utilizing simple randomization, the left and right calves of paticipants were randomly divided into test side(applicating CeraVe® Moisturising Cream ) and control side (applicating Standard Cream)according to random number representation. Grouping results were double-blinded.


Eligibility Criteria:
Inclusion Criteria:

* patients age≥60 years old(male or female).
* Clinician evaluates dry pruritus or patient complains of pruritus, which lasts for more than 1 month.
* Patients informed consent to the purpose and content of the research, willing to cooperate with follow-up observation. Have good communication and understanding skills.
* Patients are willing to share photos for medical research purpose.

Exclusion Criteria:

* Patients with bacterial and/or viral infections in the acute phase of skin inflammation
* The affected area is complicated by other skin diseases that may affect the efficacy evaluation
* Those who are allergic to the ingredients of this product or with allergic constitution
* Patients who have severe heart, brain, lung, or liver damage.
* Those who have received systemic or local antiallergic drug treatment within 2 weeks before enrollment of this study.
* Those who attending other clinical drug trials within 4 weeks before enrollment of this study.
* Patients with a history of alcohol or drug abuse.
* Patients who are unwilling to sign the informed consent form, and those who are unwilling to cooperate.
Impact of Postoperative Pyuria on Treatment Outcomes After PVP

The aim of this study was to identify serial changes in the incidence of postoperative pyuria after the Photoselective Vaporization of the Prostate (PVP), to determine whether the presence of postoperative pyuria could be correlated with surgical outcomes after surgery and to identify predicting factors that influence on persistent pyuria after the PVP.


Eligibility Criteria:
Inclusion Criteria:

* men who underwent photoselective vaporization (PVP) using 80 watt potassium-titanyl-phosphate (KTP) laser or 120 watt high-power-system (HPS) laser for benign prostatic hyperplasia refractory to medical treatment
* sterile urine on urinalysis and urine culture before surgery
* absence of indwelling urethral catheter before surgery

Exclusion Criteria:

* previous diagnosis of prostate carcinoma or bladder cancer
* co-existence of urinary stone
* any antibiotic treatment within 2-weeks before surgery
Robot Assisted Total Hip Arthroplasties

This is a randomized controlled, multicenter study. According to the inclusion criteria, volunteers were recruited from patients undergoing total hip arthroplasty. After signing the informed consent, the subjects were assigned to the experimental group and the control group through the central randomization system. The researchers will complete the total hip arthroplasty for patients in the experimental group with the assistance of surgical robotic system. The patients in the control group do not use the surgical robotic system. The proportion of acetabular abduction angle and anteversion angle in the lewinnek safe area is the primary outcome measurement. The operation time, WOMAC score, Harris score, SF-36 and dislocation rate are the secondary outcome measurements. The incidence of complications, devices and other adverse events were recorded.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of primary hip osteoarthritis(OA), fracture of femoral neck (FFN),or secondary hip osteoarthritis due to developmental dysplasia of the hip (DDH), hip avascular necrosis (AVN), rheumatoid arthritis (RA), ankylosing spondylitis (AS), and coxa plana

Exclusion Criteria:

* Severe vascular diseases of the lower extremity Neuromuscular diseases Infectious diseases Severe dysfunctions of major organs Severe neurosensory deficiencies caused by spinal diseases Unable to receive CT/MRI scans
Use of Fentanyl Patch in Partial Doses Than the Original

Fentanyl is considered a potent synthetic opioid widely used in anesthesiology, for short and long-term pain management, and for sedation. The fentanyl patch is constructed like a matrix, a system based on a polyacrylate net with fentanyl that attaches directly onto the skin. The doses available today are from 12µg/h, 25, 50, 75, to 100 µg/h. Despite the variable doses available, often in certain patients as the elderly or children, there is a need for slower titration than the 12 µg/h currently available.

In this study, the investigators aim to evaluate pain control and to examine the blood fentanyl concentration of patients on a fix dose of fentanyl patch up to 100 µg/h every two or three days, and compare it with pain control and concentration levels obtained from a similar dose patch, but after cutting the patch into two.

The study will take place at the pain clinic of Clalit Health Services-South District (CHS-SD), and the Negev home palliative care unit. In CHS-SD there are approximately 300 patients treated regularly with opioids and about 120 patients in the home palliative care unit. A sample of 95 patients will be recruited. Once consent form is signed, blood samples will be collected twice: 1. At the time of the visit; 2. After 144 hours (about 6 days) from the first sample, and at least 36 hours after replacing the cut patch. Pain management will be evaluated at both visits using the Brief Pain Inventory (Hebrew version) - BPI questionnaire, and rescue doses used before and after the cutting of the patch. The blood samples will be transferred to the laboratory for testing of fentanyl concentration levels.


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from chronic pain on a fixed dose of fentanyl patch for over two weeks, with a maximum dose of 100 µg/h every two or three days, and have given their informed consent will be included in the study.

Exclusion Criteria:

* Patients with cognitive problems
* non-Hebrew speaking
* patients that their medical condition prevents them from participation in the study.
Specified Drug Use-results Survey of Graceptor in Patients With Kidney Transplantation (Switching From Cyclosporine)

To evaluate the safety and efficacy of Graceptor ® in patients with kidney transplantation when converted from cyclosporine


Eligibility Criteria:
Inclusion Criteria:

* Patients who are converted to Graceptor® from cyclosporine in the maintenance phase after kidney transplantation.
* Patients who meet one or more of following criteria

  1. Decrease in kidney function: GFR (or eGFR) less than 60 mL/min, or investigator's decision
  2. Hypertension: systolic/diastolic blood pressure 130/80 mmHg or more or treatment with an antihypertensive drug
  3. Hyperlipidaemia: LDL cholesterol 120 mg/dL or more, or treatment with an antihyperlipidemic drug
  4. Rejection: antibody mediated rejection by Banff classification borderline changes or more severe, or investigator's decision
  5. Other adverse events and patients who cannot continue cyclosporine treatment based on investigator's decision
Vaccination Efficacy With Metformin in Older Adults

With aging the immune system gets weaker. This makes older adults more susceptible to influenza (flu). Vaccinations help to prevent infection from the flu virus, however the immune system of older adults do not respond as well to vaccines compared to young adults and thus, aren't as well protected from the complications from the flu. This research is being done to determine if Metformin, an FDA-approved diabetes medication, is effective at enhancing immune responses to flu vaccine in older men and women. Participants will be randomly assigned to either metformin or placebo treatment for a total of 22 weeks. Participants will be vaccinated with high-dose flu vaccine after 12 weeks of treatment. Immune responses will be evaluated throughout the study at 6 time points.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 65 years and older
* Willingness to provide consent and participate in all aspects of the trial including randomization to the intervention group and receiving this year's flu vaccine
* Received previous year's seasonal influenza vaccine

Exclusion Criteria:

* History of severe renal impairment and/or eGFR ≤ 45 mL/min/1.73m2
* Excessive alcohol use (more than 14 alcoholic drinks/week) or clinical/laboratory evidence of hepatic disease (via medical history and/or AST and/or ALT ≥ 3 times upper limit of normal at screening)
* Acute or chronic metabolic acidosis (via medical history and/or low serum bicarbonate (\< 22mEq/L), increased anion gap (\> 10 mEq/L))
* History of B12 deficiency within the last 10 years
* Known type 2 diabetes or screening of prediabetic (HbA1c 5.7-6.4%) or diabetic (HbA1c ≥ 6.5%)
* Currently taking metformin or other diabetes medications
* Unwilling or unable (due to significant cognitive impairment) to provide informed consent
* Terminal illness with life expectancy less than 12 months
* Advanced neurological disorder (Parkinson's, ALS, MS, dementia)
* Cancer or history of cancer in the past 2 years (excluding non-melanoma skin cancer) or any history of metastatic (stage 4) cancer
* Significant co-morbid disease (severe chronic obstructive pulmonary disease, active rheumatologic diseases, chronic infection (HIV, tuberculosis), severe congestive heart failure (NYHA class 4), myocarditis, etc)
* Myocardial infarction, stroke or hospitalization for heart failure in the last 12 months
* Severe active psychiatric disorder (e.g. bipolar, schizophrenia)
* Unable to complete physical performance testing due to medical conditions (at discretion of the PI)
* Uncontrolled hypertension (systolic/diastolic blood pressure \>150/90 mmHg)
* Unintentional weight loss \>10% in past 12 months
* Allergy or history of adverse reaction to flu vaccine or any ingredients in flu vaccine, including eggs
* History of Guillain-Barre syndrome following vaccination
* Immunosuppressive disorders or taking immunosuppressive medications (including oral prednisone \> 10mg/day)
* Current participation in another interventional study
* Refusal to receive flu vaccine