cyrilzakka/clinical-trials huggingface dataset:
Impact of Volunteer Peer-Led Intervention for Weight Control in Primary Care

The specific objective of this research proposal is to determine the short-term efficacy of a primary care-based weight control intervention in which successful volunteer peers deliver a group-based program.

The purpose of the study is to conduct a pilot randomized controlled trial (RCT) of a successful volunteer peer-led weight control program compared to a control condition to determine intervention efficacy at 3 months. Six peer leaders from 2 primary care clinics will be recruited and trained to conduct the intervention. Overweight and obese patients (n=80) will be recruited (randomized by individual) to determine weight loss at 3 months (primary outcome). The program consists of 12 weekly weight loss sessions led by a successful volunteer peer leader using an adaptation of the Diabetes Prevention Program to help participants lose weight.

The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. The initial weight loss session will be conducted by the peer leaders with oversight by the PI. This session will serve to introduce the program and give an overview of program. The remaining sessions, conducted by co-peer leaders, will utilize an adaptation of the Diabetes Prevention Program. This adaptation allows for use in a group setting and facilitation by a lay individual.

Control Condition: Participants in the control condition will be given written information at the baseline visit from the NIH website "Aim for a Healthy Weight" to provide a basic understanding of weight loss and access to basic online resources. We expect that use of the website may result in some weight loss. However, similar information-only interventions have had a very small effect, which is accounted for in the sample size calculation.

Eligibility Criteria:
PEER Inclusion Criteria:

* Successful at volitional weight loss, defined as at least 10% of their initial body weight and maintenance for ≥ 1 year
* Fluently speak and read English
* Willing to volunteer 1 hour each week as a group leader
* Able and willing to give informed consent.
* Must have internet access

Participant Inclusion Criteria:

* Fluently speak and read English
* Able and willing to give informed consent
* Body Mass Index \> 25 and \< 45
* Interested in participating in weekly group sessions for weight loss
* Must have internet access

Exclusion Criteria:

* Current or planned pregnancy within the next year
* Medical or other contraindications to weight loss, including, but not limited to, history of:

  1. Myocardial infarction
  2. Stroke
  3. Unstable angina
  4. Congestive heart failure
  5. Cancer (except non-melanoma skin cancer)
* History of gastric bypass surgery or scheduled surgery for this purpose
* Current use of prescription medication for weight loss
* Weight loss of \> 5% of current body weight in previous 6 months
* Contraindications to weight loss
* Evidence of severe cognitive impairment or major psychiatric illness
* Plans to move in the next 6 months
* Answering yes to any question on the Physical Activity Readiness Questionnaire (PAR-Q)
A Single Center Trial of Donor Site Wound Dressings After Split Thickness Skin Grafting.

The goal of this clinical trial\] is to compare different types of dressings used and there outcomes on STSG donor site wound. The main question\[s\] it aims to answer are:

* the effectiveness of different donor site dressings and their adverse outcomes
* the satisfaction of patients with the donor site dressing will be observed. Participants will randomly allocated different types of dressings for split thickness skin graft donor site wound which include alginate hydrocolloid hydrofiber silicon film guaze


Eligibility Criteria:
Inclusion Criteria:

* . Patients of aged 18 years and above of either gender underwent single donor-site wounds after split-skin grafting and surface area larger than 10 cm2 were included in the study

Exclusion Criteria:

* Patients on chemotherapy or corticosteroids were excluded from the study. Non-probability consecutive sampling was employed
HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN)

The Hydrocephalus Clinical Research Network (HCRN) has been established by philanthropic funding to conduct multi-institutional research (clinical trials and observational studies) on pediatric hydrocephalus. In addition to philanthropic funding, the HCRN has also received an NIH NINDS Challenge Grant to support the network infrastructure which allows for the conduct of this and other network studies. The HCRN consists of multiple Clinical Centers and the Data Coordinating Center (DCC). The HCRN Core Data Project will obtain data about all neurosurgical hydrocephalus events from the network Clinical Centers, and create a database to be used by HCRN investigators. The ongoing maintenance of the Core Data Project serves two main purposes: 1) it will help investigators understand the variability, progression, and current treatment practices for hydrocephalus in children, with an ultimate goal of better guiding and assessing therapeutic intervention and providing recommendations on patient care and, 2) it will provide pilot and descriptive data necessary for hypothesis generation and study design (i.e. preliminary power analyses, recruitment projections) for studies under development by the HCRN. This multi-institutional database will be maintained throughout the lifetime of the HCRN, and may be useful for tracking trends in pediatric hydrocephalus over time. The Core Data Project will be an invaluable resource to the HCRN and will help stimulate new research protocols, identify potential need for future expansion of the network to incorporate additional patient populations, and provide a descriptive understanding of children with hydrocephalus cared for within the network.


Eligibility Criteria:
Inclusion Criteria:

Information for all neurosurgical hydrocephalus patient events will be obtained from each HCRN Clinical Center and will be placed continuously into the Core Data Project. The first calendar year will be 2008, and data collection will continue for the duration of the existence of the HCRN. Neurosurgical hydrocephalus patient events include any operation for the treatment of documented hydrocephalus including the following:

* Ventriculoperitoneal shunt
* Ventriculoatrial shunt
* Ventriculopleural shunt
* Arachnoid cyst shunts
* Subdural shunts
* Lumboperitoneal shunts
* Shunts replaced after treatment of infection
* Shunts exposed during an operations but not revised
* Endoscopic third ventriculostomies
* Ommaya reservoir(s)
* Ventricular access devices/reservoirs
* Subgaleal shunts.

Exclusion Criteria:

The following temporary cerebrospinal fluid (CSF) diversion procedures will not be included in the Core Date Project:

• External ventricular drain(s)
Efficacy of Prophylactic Glycerin Suppositories for Feeding Intolerance in Very Low Birth Weight Preterm Infants: a Randomized Trial

To evaluate the efficacy of prophylactic glycerin suppositories will accelerate the elimination of meconium from the large intestine and thus reduce the incidence of feeding intolerance in very low birth weight (VLBW) infants


Eligibility Criteria:
Inclusion Criteria:

1. Preterm infants with birth weight \< 1250g.
2. Inborn or outborn infants
3. Less than 72 hours of age.

Exclusion Criteria:

1. Congenital malformations.
2. Acute abdomen needing surgical intervention.
3. Severity of illness such that death is likely in the first few days after birth.
4. Inability to get the parental consent.
Investigation of the Role of FHL-1 and Myostatin in Intensive Care Unit Acquired Paresis (ICUAP)

The primary hypothesis for this study is that Myostatin and FHL-1 are important in the development of ICUAP and that changes in activity levels of muscle will modify the levels of expression and activity of these proteins.

ICUAP is an increasingly recognised clinical problem associated with significant morbidity and mortality. However the pathogenesis of the diseae is poorly understood and as yet no treatment exists. We believe that both myostatin and FHL-1 will be important in the development of this disease. This is based recent research and that both these proteins are likely to be regulated by sepsis and immobility (two major risk factors for ICUAP. There is evidence from invitro work that the two are likely to interact. We have designed an interventional trial to investigate the above hypothesis. Patients admitted to ICU and at risk of developing muscle wasting will be selected and receive electrical muscle stimulation of the quadriceps muscle for 1 week. Physiological measurements of peripheral and respiratory muscle strength and quadriceps size will be made pre and post intervention. And muscle biopsies, blood and urine collected from both legs pre and post intervention. The relevant molecular pathways can then be examined.

Eligibility Criteria:
Inclusion Criteria:

* High risk patients admitted to AICU.

Exclusion Criteria:

* Pre existing neuromuscular disease.
Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk

Venous thromboembolism (VTE) is currently the second cause of death in women of reproductive age worldwide. The incidence of VTE during pregnancy is 1.2 to 1.4/1000 women, half of VTE occurring during postpartum and as PE in majority of cases, accounting for 8.8% of maternal deaths.

Majority of postpartum VTE occurs in women with one or more moderate risk factors (obesity, caesarean section, postpartum hemorrhage). For these women at intermediate risk, the efficacy and safety of thromboprophylaxis have not been assessed yet during postpartum and international guidelines for pharmacological thromboprophylaxis, based on data extrapolated from other populations, observational studies and small clinical trials are inconsistent across countries.

We designed an open-label, randomized, controlled trial, aiming to demonstrate the superiority of a pharmacological thromboprophylaxis strategy with LMWH (LMWH type chosen according to physician / patient's preference) during 6 weeks after delivery (the 6-weeks follow-up visit being matched with usual care) in women at intermediate risk, over no pharmacological thromboprophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Women at intermediate risk of VTE during post-partum= with a 3% or more risk of VTE based on a validated prediction model\* or International guidelines (ACCP 2012).
* Age over 18 years
* Delivery between 6 hours and \< 36 hours
* Written informed consent

  * Definition: Intermediate risk is defined as ≥ 3%, based on risk prediction model developed by Sultan et al taking in account: smoking, varicose veins, obesity, comorbidities, diabetes, pre-eclampsia, post-partum hemorrhage, postpartum infection, emergency or elective section or following ACCP guidelines: one major risk factor or two minor risk factors.

Exclusion Criteria:

* Previous personal history of VTE
* LMWH started during antenatal period
* Need for anticoagulation at curative dose
* Contraindication to LMWH (previous heparin induced thrombopenia, hemostatic impairment, known severe renal insufficiency)
* Women who received more than two doses of LMWH since delivery
* Unable or refusal to give informed consent
* Aspirin at a daily dose 100 mg or dual antiplatelet therapy
* Previous inclusion in Mum-VTE study
* Concomitant participation in another therapeutic study
Botulinum Toxin Type A Injection Into the Gastrocnemius Muscle for Treatment of Nocturnal Calf Cramps in Patients With Lumbar Spinal Stenosis

Nocturnal calf cramps is a common complaint in patients with lumbar spinal stenosis. The purpose of this study is to evaluate the effect of botulinum toxin A injection into the gastrocnemius muscle in lumbar spinal stenosis patients receiving conservative therapy. We will compare pain score, insomnia severity, functional ability, patient satisfaction, and neurophysiological variables change using electrical stimulator between control (conservative management for spinal stenosis) and botox group (conservative management for spinal stenosis plus botox injection into the gastrocnemius muscle).


Eligibility Criteria:
Inclusion Criteria:

1. diagnosed lumbar spinal stenosis with MRI finding
2. nocturnal calf cramps symptoms at least once per week

Exclusion Criteria:

1. electrolyte disorder
2. congenital muscle disease
3. muscle cramps related medication (statins, diuretics, calcium channel blockers, anticonvulsants etc.)
4. cognitive impairments
Preliminary Research Using Artificial Intelligence Technology to Identify Differences in Facial Expressions Between Healthy People, Patients With Cognitive Decline, and Patients With Dementia

Through artificial intelligence technology, we have conducted a preliminary study aimed at identifying differences in facial expressions among healthy individuals, patients with cognitive decline, and dementia patients. This research offers a novel method and tool for dementia screening, contributing to effective strategies for dementia prevention in our country. By utilizing this approach, we can effectively delay the onset of disability, promote healthy aging among our elderly population, reduce the caregiving burden on individuals, families, and society, and lower medical expenses.


Eligibility Criteria:
Inclusion Criteria:

Age between 50 and 75 years.

* Experimental group:
* MCI group: CDR score of 0.5 or MMSE score between 20-25 (mild/early stage).
* Dementia group: CDR score greater than 1 or MMSE score between 10-19 (moderate/middle stage).
* Control group:
* Health group: MMSE score of 26 or above.
* Participants must be conscious and able to follow instructions.
Trend Analysis of the Service of Pediatric Palliative Care

Palliative care has received considerable attention in Taiwan in recent years. The relevant research has been widely conducted for palliative care in adult population. However, the research in children population is relatively insufficient. In the limited studies, most of them are the experiences generated from individual institutions. This study is going to retrieve the data from 2008-2017 National Health Insurance Research Database, Cancer Registry Database, Death Registry Database and other relevant materials in order to analyze the trends of using pediatric palliative care service, the types of services, the timing of initiating palliative care, and the preference of using palliative care service among different life span in the past decade. In addition, the study will examine the differences of the timing of initiating of pediatric palliative care service and the types of diseases among different characteristics of children and healthcare providers. And the study will discuss how pediatric palliative care services affect medical costs.


Eligibility Criteria:
Inclusion Criteria:

Individuals died from cancer between 2008 and 2017.

Exclusion Criteria:

-
Evaluation of an Innovative Tuberculosis Diagnostic Test

Diagnosis of tuberculosis (TB)in young children is a challenge due to atypical non-specific symptoms, difficulty to expectorate mucus, paucibacillary nature of pulmonary TB and low sensitivity of available diagnostic tools.

This project aims at evaluating two innovative immunological methods for diagnosing of active TB among HIV-infected and uninfected children.

The study is designed as a prospective study for the evaluation of diagnostic tests.

Children admitted with probable TB based on clinical and radiological symptoms are recruited. Gastric lavage or sputum on two to three consecutive days will be collected as per routine practise. Active TB will be defined as a positive GeneXpert diagnostic test or MTB culture.

In addition, children with no sign of TB will be recruited to estimate the specificity of the diagnostic tests. These children will be recruited from the surgical ward of the hospital, and matched for age group and HIV status.

In all children, blood samples will be drawn and stored to perform quantiferon (R) and the new tests under evaluation.

The analysis will evaluate the sensitivity and specificity of the tests against the current gold standard (detection of Mycobacterium tuberculosis (MTB) in any specimen obtained from the patient). Identification of diagnosis algorithms, including these tests if they prove to be informative, will be elaborated and evaluated.

Eligibility Criteria:
Inclusion Criteria for tuberculosis cases:

* one of 4 clinical signs

  * persistent and unexplained cough
  * unexplained weight loss or failure to thrive
  * persistent and unexplained fever
  * persistent and unexplained lethargy or reduced playfulness
* chest X-Ray consistent with a tuberculosis infection
* an adenitis compatible with non-pulmonary tuberculosis Among these children only those with confirmed TB will be analysed for the primary outcome

Inclusion Criteria for controls:

* children without any of the signs and symptoms quoted above
Albumin Administration in Cirrhotic Patients With Bacterial Infection and a Systemic Inflammatory Response Syndrome Unrelated to Spontaneous Bacterial Peritonitis

Patients with cirrhosis present an increased susceptibility to bacterial infections. Spontaneous bacterial peritonitis (SBP) is the most frequent infection and induces severe circulatory dysfunction associated with renal failure in about 30% of cases. Renal failure is a reliable surrogate marker of in-hospital mortality in patients with SBP or with non-SBP infections. Albumin, as an adjuvant to antibiotherapy reduces significantly the rate of renal failure, in-hospital mortality, and overall mortality (Sort P, et al. NEJM 1999). However, little is known regarding the effect of albumin administration in patients with non-SBP infections. Two recent prospective studies demonstrated that non-SBP infections are associated with impairment of the effective circulating volume and precipitate renal failure whatever the presence of ascites.

The aim of this randomized clinical trial is to evaluate the effects of albumin, associated with appropriate antibiotic therapy, on occurrence or deterioration of renal failure and survival in septic (SIRS criteria required) cirrhotic patients with non-SBP infections and presenting with a Child-Pugh score \> 8.

* Cirrhosis defined by clinical, laboratory or ultrasonographic findings
* Child-Pugh \> 8
* Sepsis defined by the presence of proved or suspected infection with two of the four SIRS (systemic inflammatory response syndrome) criteria (Wong F, et al. Sepsis in cirrhosis: report on the 7th meeting of the international ascites club. Gut 2005)
* Creatinine \< 160 µmol/L

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis defined by clinical, laboratory or ultrasonographic findings
* Child-Pugh \> 8
* Sepsis defined by the presence of proved or suspected infection with two of the four SIRS (systemic inflammatory response syndrome) criteria (Wong F, et al. Sepsis in cirrhosis: report on the 7th meeting of the international ascites club. Gut 2005)
* Creatinine \< 160 µmol/L
* Written informed consent
* Absence of the exclusion criteria

Exclusion Criteria:

* Spontaneous bacterial peritonitis
* Difficult to treat infections such as : endocarditis, septic arthritis, osteomyelitis
* Heart insufficiency (YHA III-IV)
* Digestive bleeding during the week preceding the study
* Septic shock
* Hepatocellular carcinoma : stage D
* Use of antibiotics during the week preceding the study, except noroxin used for long-term antibioprophylaxy
* Diseases which can influence the short term survival
VItamin D in PregnanCy for PrevenTion of EaRlY Childhood Asthma

The overall aim of the study is to develop a nutritional preventive vitamin D supplementation strategy in pregnancy for early childhood asthma/persistent wheeze during the first three years of life as we hypothesize that supplementation in higher doses than recommended could reduce the risk of disease development.

Randomization of 2000 pregnant women to vitamin D of high-dose (3200 IU/day) vitamin D vs placebo on top of the recommended 400 IU/day. Supplementation begins in gestational week 24 (22-26) until 1 week after delivery. Allocation to the trial will be determined based on the pre-interventional maternal blood levels of EPA+DHA with a dried blood screening test. Women with high levels (above 4.7% of total fatty acids) will be assigned to the vitamin D RCT. Maternal blood will be used for genetic, metabolomic and proteomic profiling. A 3-year follow-up of the children with longitudinal registration of parent reported symptoms, diagnoses, medication use, and hospitalizations will be performed. The primary outcome is persistent wheeze or asthma until age 3 years, with predefined analyses of effect modification by maternal genotypes. Secondary outcomes are lower respiratory tract infections, gastrointestinal infections, croup, troublesome lung symptoms, eczema, allergy, bone fractures, developmental milestones, mental health, cognition, and growth until age 3 years. A follow-up on both primary and secondary outcomes is planned after unblinding, from age 3 to 6 years.

Eligibility Criteria:
* Pregnant Danish women before week 26 with blood levels of EPA+DHA above 4.7% of total fatty acids
* No current vitamin D intake above the recommended 400 IU/day
* No endocrine-, heart-, kidney- or auto-immune disorders
Inhospital Resuscitation: Incidence, Causes and Outcome

Define the frequency and survival pattern of cardiac arrests in relation to the hospital day of event and etiology of arrest.

Define the frequency and survival pattern of cardiac arrests in relation to the hospital day of event and etiology of arrest.

The study aims to evaluate the outcome of in-hospital cardiac arrests, focusing on the relationship between etiology and outcome and, in particular, in relation to the length of hospitalization prior to the cardiac arrest. The aimed to sought to test the hypothesis that cardiac arrests occurring after longer hospitalizations were associated with lower survival rates and worse neurological outcomes compared to shorter hospitalizations.

Eligibility Criteria:
Inclusion Criteria:

* Cases where the emergency help team is called

Exclusion Criteria:

* Absence of informed consent
* Lack of data records of patients