cyrilzakka/clinical-trials huggingface dataset:
COVID-19 and Social Isolation and Loneliness Trial

Social isolation and loneliness worsen older peoples' quality of life, risk of dementia, and contributes to 45,000 deaths/year in Canada - as much as smoking. Isolated people use the health care system more often, but have worse outcomes. Effective, inexpensive interventions exist but unfortunately they have not been implemented in Canada.

We partnered with the Australian developer of HOW R U?, an effective and feasible intervention that uses specially trained, older, hospital volunteers to provide peer support to combat isolation and loneliness in isolated older peers.

Little is known about older people's preferences for virtual care (telephone vs. video) nor their relative effectiveness. Thus we will compare two ways of delivering HOW R U: telephone support and a tested, secure user-friendly video conferencing app, aTouch Away® to a common control arm.

We also partnered with Emergency Medicine, Family Medicine, Geriatrics and Psychiatry to identify people who will benefit from peer support; and with Volunteer Services to recruit volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Any community-dwelling person 70 years of age and older receiving care from the ED, Family Medicine, or Geriatric clinics at our two participating sites (MSH and NYGH) will be eligible.

Exclusion Criteria:

* age less than 70 years; communication problems (critically ill, unconscious, language barrier, speech impairment or otherwise unable to provide consent), or admission to a hospital for \> 72 hours. Patients with severe cognitive impairment or those living in nursing homes who are dependent on others for their activity of daily living will be excluded. To target the intervention for older people with loneliness a baseline de Jonge loneliness scores of 2.0 will be required for participation in the trial.
Effectiveness and Safety of Topical Hyaluronic Acid of Different Molecular Weights in Xerotic Skin Treatment

The goal of this clinical trial is to compare 0,1% topical low molecular weight (7 kDa) hyaluronic acid with 0,1% high molecular weight (1.800 kDa) hyaluronic acid as therapy of xerotic skin in elderly

This clinical trial is conducted to compare the effectiveness and safety between moisturizers containing 0,1% low molecular weight hyaluronic acid, 0,1% high molecular weight hyaluronic acid, and its vehicle on skin hydration of elderly with xerotic skin. It is designed to answer following questions:

1. Is the skin capacitance in the elderly after using moisturizers containing low molecular weight hyaluronic acid higher than high molecular weight hyaluronate acid and vehicle?
2. Is the transepidermal water loss in the elderly after using moisturizers containing high molecular weight hyaluronic acid lower than low molecular weight hyaluronate acid and vehicle?
3. Is the dry skin score (SRRC) in the elderly after using moisturizers containing low molecular weight hyaluronic acid lower than high molecular weight hyaluronate acid and vehicle?
4. Is there any difference in occurence of side effect in elderly between the use of moisturizers containing low molecular weight hyaluronic acid, high molecular weight hyaluronic acid, and vehicle?

Eligibility Criteria:
Inclusion Criteria:

* Female or male diagnosed with xerotic skin
* 60-80 years old
* Willing to participate in clinical trial and sign informed consent

Exclusion Criteria:

* History of hypersensitivity to moisturizer
* Dermatitis or any dermatosis on intervention area in the leg
* Score of erythema and crack more than 2, based on SRRC scoring
Neutrophil Phenotypic Profiling and Surgical Site Infections in Surgical Patients

Surgical site infections (SSIs) are one of the major hospital acquired infections and responsible for the most cost among the hospital acquired infections. The objective of this study is to assess the neutrophil functional profiles and their associations with SSIs.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for an elective open gastrointestinal surgical procedure or spine fusion surgery

Exclusion Criteria:

* On chronic immunosuppressive drugs such as chronic corticosteroid use
* preexisting immunodeficiency diseases
Adipokines and Ghrelin Concentrations in Different Stages of Anorexia Nervosa

The aim of this study is to determine serum concentrations of adiponectin (ApN), leptin and ghrelin in different stages of anorectic patients and to evaluate their relationships between biochemical, hormonal and anthropometric parameters.

Objective: The aim of this study is to determine serum concentrations of adiponectin (ApN), leptin and ghrelin in different stages of anorectic patients and to evaluate their relationships between biochemical, hormonal and anthropometric parameters.

Design: The study group is composed of four groups. Group1: Treatment-naïve patients with a recent diagnosis of AN (n:19), Group 2: The weight recovered (10 % increase in body weight compared with baseline weight) subgroup of group 1 at the end of a mean 117.72±98.14 days of follow-up (n: 12), Group 3: Recovered patients with a previous history of AN but normal menstrual cycles and body weight at the present time (n:10), Group 4: Control group: constitutionally thin healthy young women with normal menstrual cycles (n:10). Venous blood was obtained for measurements of biochemical parameters, ApN, leptin and ghrelin and body composition was determined by bioimpedance analysis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of anorexia nervosa for Group 1-3
* Constitutionally thin healthy subjects for Group 4

Exclusion Criteria:

* Medical or psychiatric diagnosis other than anorexia nervosa,
* History of gastrointestinal disease for Group 1-3
* History of eating disorder or gastrointestinal or psychiatric disease for control group
Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers

The aim of this study is to investigate whether a supplementation of 20 µg Vitamin D3 per day for 12 weeks can be used to normalize vitamin d-Status

It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to normalize insufficient vitamin d status and reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* age between 18 and 70 years
* informed consent

Exclusion Criteria:

* use of antihypertensive medication
* use of vitamin d or calcium supplements
* known renal, inflammatory or malignant diseases
* hypercalcemia or hypercalciuria
* participation in other clinical studies
* use of tanning booths during the study
* pregnancy or lactating period
Truncal Blocks Versus Wound Infiltration for SICD

This is a single-center, randomized and prospective trial of all patients undergoing S-ICD implantation. Subjects will only be eligible for this study if they are ≥ 18 years of age and eligible to undergo S-ICD implant at Mount Sinai Morningside Hospital. They will be randomized to receive either surgical infiltration of local anesthetic or truncal blocks. Intraoperative and postoperative data will be collected including total opioid use, pain scores postprocedure, total postoperative narcotic need and length of stay.

This is a single-center, randomized and prospective trial of all patients undergoing S-ICD implantation. Subjects will only be eligible for this study if they are ≥ 18 years of age and eligible to undergo S-ICD implant at Mount Sinai Morningside Hospital. They will be randomized to receive either surgical infiltration of local anesthetic or truncal blocks. Intraoperative and postoperative data will be collected including total opioid use, pain scores postprocedure, total postoperative narcotic need and length of stay. The procedures involved for the study are the placement of the described truncal blocks or wound infiltration. Data to be collected are patient demographics, history of present illness, past medical history, and pain management techniques required (i.e non-narcotics and narcotics use). In addition, age, race, gender and BMI will also be collected. Intraoperative analgesia requirements, postoperative analgesia requirements, duration of procedure and length of stay will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Patients undergoing S-ICD placement

Exclusion Criteria:

* Allergy to amide local anesthetics
Early Pain Finding in Infants With Brachial Plexus Birth Injury

In Brachail Plexus Birth Palsy (BPBI), fractures, glenohumeral joint dislocation, torticollis and plagiocephaly, facial nerve palsy, phrenic nerve palsy, obesity, speech delay, integumentary system problems, and central nervous system disorders are common comorbidities. Clinical assessments such as observation, palpation, and radiologic imaging are commonly used to identify early period comorbidities after delivery .Since fractures or joint deformities may occur in the affected upper extremity due to high-energy trauma at birth, pain assessment in the early postnatal period is recommended and several objective assessment methods have been proposed. Due to the difficulty of pain assessment in early childhood, the assessment is mostly performed by palpation. Pain is suspected if the baby grimaces with light palpation of the neck and upper shoulder area.

Although some hospitals have adopted objective assessment of pain and objective assessment is recommended, the level of pain in early childhood has not been investigated. Therefore, the aim of our study was to determine the level of pain in BPBI in early childhood and to examine the relationship between pain and motor function. In addition, the second aim of the study is to determine the cut-off value of the pain level that may be a sign of fracture in patients with BPBI, in order to suspect a fracture in the shoulder region and request additional examinations.

The diagnosis of BPBI, determination of Narakas classification and evaluation of comorbidities were performed by a senior orthopedic surgeon. After the initial doctor's examination, patients are routinely referred to the physiotherapy clinic for a physiotherapy evaluation.In the assessment, active joint movement and pain assessments of children were used, and all of these assessments were performed by a hand and pediatric physiotherapist.


Eligibility Criteria:
Inclusion Criteria:

* Having diagnosis of Brachial Plexus Birth Injury (BPBI),
* Being initial evaluation and not having started treatment before,
* Being in the age range of 15-90 days old,
* Consent to participate in the study.

Exclusion Criteria:

* Children with BPBI who are older than 90 days or younger than 15 days,
* Starting regular physical therapy or home program before applying to our hospital,
* Pseudo-paralysis that are diseases that may show symptoms similar to BPBI (clavicle or humerus fracture only, pseudo-paralysis not BPBI injury, glenohumeral joint septic arthritis, arthrogryposis multiplex congenita (AMC), cerebral palsy, spinal cord ischemic injury, spinal cord congenital aplasia, spinal tumor, congenital radial palsy).
SIGnificance of Routine Hysteroscopy Prior to a First 'in Vitro Fertilization'(IVF) Treatment Cycle

BACKGROUND: Despite the numerous advances in the field of in vitro fertilisation/intracytoplasmic sperm injection (IVF/ICSI), there still exists a maximum implantation rate per embryo transferred of about 30%. Next to the physiological and physic burden that comes with every IVF treatment cycle, implantation failure also adds up to the considerable costs associated with ART. Studies have shown, that minor intrauterine abnormalities can be found in 11-40% of the infertile women with a normal transvaginal sonography. Detection and treatment of these abnormalities by office hysteroscopy have led to a 9-13% increase in pregnancy rate. Therefore, it is increasingly advocated to screen all infertile women on intracavitary pathology prior to the start of IVF/ICSI.

OBJECTIVE: The aim of the proposed study is to assess whether diagnosing and treating unsuspected intrauterine abnormalities by saline infusion sonography and/or routine office hysteroscopy prior to a first IVF/ICSI treatment cycle improves the cost-effectiveness of the fertility treatment.

STUDY DESIGN: Multicenter randomized intervention study. POPULATION: Asymptomatic women, indicated for a first IVF/ICSI treatment cycle and a normal transvaginal ultrasonography.

INTERVENTION: Participants will be randomized for a (SIS and) hysteroscopy with treatment-on-the spot of predefined intrauterine abnormalities versus no diagnostic work-up. In both groups standard IVF/ICSI treatment will be initiated.

PRIMARY OUTCOME MEASURE:

Cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)

SECONDARY OUTCOME MEASURE:

* Cumulative implantation rate achieved within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)
* Cumulative miscarry rate within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)
* Cost calculations of, SIS, hysteroscopy procedures and the IVF treatment
* Patient preference and tolerance of a SIS and diagnostic/therapeutic hysteroscopy procedure
* Prevalence of unexpected intrauterine abnormalities
* Diagnostic accuracy of SIS in diagnosing intrauterine abnormalities


Eligibility Criteria:
Inclusion Criteria:

* Women indicated for a first IVF/ICSI treatment
* Primary or secondary infertility
* Normal Transvaginal Ultrasound, performed in the follicular phase of the menstrual cycle

Exclusion Criteria:

* Recurrent miscarriage
* Prior hysteroscopy treatments
* Meno-metrorrhagia (defined as any intermenstrual loss of blood)
APACC Study:Prospective Study on Aspirin Efficacy in Reducing Colorectal Adenoma Recurrence

Experimental and epidemiologic studies have suggested that aspirin intake reduces the risk for colorectal cancer. In the APACC study we randomly assigned 291 patients to daily Aspirin or Placebo for 4 years. However, the available data are not sufficient to serve as the basis for firm recommendations

The APACC Study is a prospected, randomized, double-blind, placebo-controlled multicentre clinical trial design to test the efficacy of regular low-dose aspirin administration in reducing the recurrence rate of colorectal adenomatous polyps. The study involved 49 gastroenterology centers from various parts of France. Patients were eligible if they had either at least 3 adenomas irrespective of size, or at least one measuring 6mm in diameter or more histologically confirmed colorectal adenomatous polyp by the local pathologist, and 2 independent pathologists, underwent a complete colonoscopy with polypectomy and were then confirmed free of polyps, were aged between 18 and 75 years at recruitment, and were be able to conform to the protocol during the study period. During a 4-week run-in period before enrolment, all subjects took 300 mg aspirin per day to test tolerance and compliance with the treatment. They were then randomized to either of the following three groups: placebo, aspirin as acetylsalicylate of lysine 160 mg/day or aspirin as acetylsalicylate of lysine 300 mg/day. Information on compliance, tolerance of the treatment and concomitant disease is obtained at regular clinical visits every 4 months. Informations on factors such as smocking habits, previous medical history was recorded at enrollment. The primary outcomes were defined as the proportion of subjects in whom at least one new adenoma was detected, and the adenomatous polyp burden calculated as the sum of the diameters of these adenomas at the follow-up colonoscopy 1 and 4 years after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Patients are aged between 18 and 75 years At least 3 adenomas irrespective size or at least one measuring 6mm or more All subjects had a clean colon at the study entry

Exclusion Criteria:

* No personal history of colon cancer, no inflammatory bowel disease, no familial adenomatous polyposis, no regular use of aspirin
Cognitive Training With and Without tDCS to Improve Cognition in HIV

The purpose of this study is to develop pilot data on the potential efficacy of computer-based cognitive training or the combination of computer-based cognitive training with transcranial direct current stimulation (tDCS) in improving cognitive function in persons with HIV-related mild neurocognitive disorder (MND).

The purpose of this study is to develop pilot data on the potential efficacy of computer-based cognitive training or the combination of computer-based cognitive training with transcranial direct current stimulation (tDCS) in improving cognitive function in persons with HIV-related mild neurocognitive disorder (MND). tDCS is a noninvasive brain stimulation technique in which a small direct current (1-2 mA) is applied to the scalp during a cognitive or motor activity, inducing a very small current that affects specific neural circuits related to the site at which electrodes are placed. tDCS has been judged safe and has shown significant treatment effects in studies with other populations, but has not been extensively studied in individuals with HIV infection. tDCS has been shown to facilitate learning in a number of studies, suggesting that it may improve or enhance learning in those with cognitive problems. As HIV infection is associated with decrements in a number of cognitive skills, including working memory, executive functions, and psychomotor speed that are related to individuals' functional status and medication adherence, the demonstration of a technique to enhance the effects of cognitive training in this population would have substantial clinical benefits as well as scientific value.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Fluent in English
* Meets Frascati criteria for mild neurocognitive disorder

Exclusion Criteria:

* Left handed
* Presence of dementia
* Use of specific psychotropic medications including antidepressants, antipsychotics, and sleep-promoting medications
Comparison of Clipping Via Keyhole Versus Traditional Approaches and Coiling for Ruptured Aneurysms

Endovascular coiling has become a strategy of choice of intracranial aneurysms due to its minimally invasiveness. However, there has few prospective randomized controlled studies on the comparison of therapeutic effect between endovascular coiling and microsurgical clipping, especially the latter via keyhole approaches, which has been widely used in recent years. Based on the data of a single center, a randomized controlled study was conducted on patients with ruptured anterior circulation aneurysms suitable for both endovascular and extravascular treatment, including endovascular coiling, microsurgical clipping via conventional craniotomy and keyhole approaches, in order to compare the efficacy of the above strategies and provide more objective basis for treatment selection for operators.

Consecutive patients of a single center will be screened. If spontaneous subarachnoid hemorrhage (SAH) is confirmed by head computed tomography (CT), a diagnostic CT angiography (CTA) or digital subtraction angiography (DSA) will be carried out emergently. A patients harbored a single intracranial aneurysm of anterior circulation that resulted in SAH will be concerned. Based on the assessment of condition, the patient will enrolled into this study without indication of decompressive craniectomy. The enrolled patients will be divided randomly into 3 groups, who experienced endovascular coiling, microsurgical clipping via conventional craniotomy and via keyhole approaches. All of these treatment will be conducted by a same senior neurosurgeon. CTA or DSA were followed up regularly. The occlusion rate, operative period, hospitalization duration and cost, surgical complications were compared and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Single intracranial anterior circulation aneurysm diagnosed by CTA or DSA
* CT showed that subarachnoid hemorrhage originated from the rupture of the aneurysm and was confirmed during operation
* No indication of decompressive craniectomy (Hunt-Hess grade ≤ 4, Glasgow Coma Scale ≥ 7, no brain herniation; CT showed midline displacement \< 5mm)
* The aneurysm is suitable for both endovascular treatment and microsurgical clipping

Exclusion Criteria:

* The patients and their families did not agree to join the study
* Patients with unruptured anterior circulation aneurysms
* Patients with posterior circulation aneurysms
* Patients with multiple intracranial aneurysms
* Those who cannot receive treatment due to serious concomitant diseases
Induction of Migraine Aura With Sildenafil

In a double blind placebo-controlled cross-over study the effect of Sildenafil on aura and migraine headache induction is tested in patient with migraine with aura.


Eligibility Criteria:
Inclusion Criteria:

* Migraine with aura
* Minimum of 2 attacks/year

Exclusion Criteria:

* Any other type of headache, except tension-type headache \< 4 days per month
* History of cardio- or cerebrovascular diseases
* Hypertension or hypotension
* Any daily intake of medication, including prophylactic migraine treatment, except oral contraceptives
* Pregnancy and lactation
Exposure, Dose, Body Burden and Health Effects of Lead

This is a study of the effects that lead has on the health of the central nervous system (for example, memory), peripheral nervous system (for example, sensation and strength in the hands and fingers), kidneys, blood pressure, and the blood forming system. A total of 803 lead workers and 135 persons without occupational lead exposure are being studied in South Korea. Lead in the body is being assessed by measurement of blood lead, chelatable lead (an estimate of lead in the tissues), and lead in bone. Subjects are tested three times each over three years. Several genetic factors are also being assessed for the role they play in the health effects of lead. These genes are known to differ among individuals. We are interested to know whether different forms of the same genes can modify the effect lead has on health.


Eligibility Criteria:
Lead workers in South Korea in one of 26 specific lead-using facilities.

Population controls in South Korea.
Lenalidomide Based Immunotherapy in the Treatment of DLBCL

This study is to evaluate the efficacy related molecular biomarker of Lenalidomide plus RCHOP or RICE in the treatment of de novo or Refractory and Relapsed DLBCL patients


Eligibility Criteria:
Inclusion Criteria:

Histologically diagnosed as diffuse large b-cell lymphoma and may provide a desirable lymph node tissue sample (10 paraffin sections or rolls) or lymph node biopsy sample (15 paraffin sections or rolls)

Previously treated with Lenalidomide plus RCHOP regimen in de novo DLBCL or Lenalidomide plus RICE regimen in relapse refractory DLBCL.

No history of stem cell transplantation.

Written informed consent.

Exclusion Criteria:

Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.

Clinically significant active infection.

Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.

Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.

Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.

Patients who are pregnant or breast-feeding.

HIV infection.