cyrilzakka/clinical-trials huggingface dataset:
Nutrition and Exercise Study to Understand Metabolic Syndrome

The purpose of this study is to measure the metabolic and behavioral effects of a 12-week yoga program coupled to health education (HED) compared to HED alone.

The purpose of this study is to measure the metabolic and behavioral effects of a 12-week yoga program coupled to health education (HED) compared to HED alone. In a randomized clinical trial of 90 patients (45 patients per arm), investigators will measure the effects of the two interventions on IR, HTN, dysplidemia, and body composition (See Figure 1. Study Diagram). Subjects will be scheduled for outcome assessment at baseline, 12 weeks, and 24 weeks. In addition, investigators will collect data at baseline and 12 weeks on self-efficacy, stress, mindfulness, and mood. As a sub-study to the randomized controlled trial, investigators will measure the aerobic intensity of the yoga to estimate the dose of physical exercise provided by the yoga (n=10).

Subjects willing and eligible to participate in the RCT will receive written consent. Consented subjects will be randomized to either 12 weeks of yoga with HED versus HED alone. Subjects randomized to yoga will receive 30 to 45 minutes of weekly yoga instruction, followed by 30 to 45 minutes of HED. Subjects will receive written instructions for home yoga practice and lifestyle changes based on HED. Subjects randomized to HED alone will receive a weekly standardized HED curriculum which will be attention and time matched to the yoga with HED arm.

Eligibility Criteria:
Inclusion Criteria:

* Elevated waist circumference (Men greater than 102cm; women greater than 88cm)
* Impaired fasting glucose (100-125 mg/dl)
* Elevated blood pressure (systolic ≥130 and/or diastolic ≥ 85)
* Dyslipidemia (triglycerides ≥150 and/or HDL≤ 40 for men; 50 for women)
* Age ≥ 18
* English speaking

Exclusion Criteria:

* Currently taking blood pressure medications, oral diabetic medication or insulin, or lipid medication
* Systolic blood pressure ≥160 and/or diastolic ≥100
* Unstable cardiac disease e.g. angina, life threatening arrhythmia
* Lung disease requiring oxygen supplementation at rest or with ambulation
* History of dementia or cognitive impairment
* Uncontrolled psychiatric disorders, such as major depression or psychosis
* Current participation in a mind-body practice/program
The Effect of Manual Lymphatic Drainage on Acute and Post-acute Ankle Sprain in Athletes

Manual lymphatic drainage techniques (MLDTs) are special techniques in manual therapy used in rehabilitation for treatment of physical dysfunctions and pathologies. Such practices could be done by medical team or clinicians. Theories on MLDTs address functions like stimulating the lymphatic system by increasing lymph circulation, facilitating the removal of waste products from body tissues, reducing edema, and decreasing the responses of sympathetic nervous system while increasing the parasympathetic nervous tone leading to a relaxed body state.

This study will examine the effect of manual lymphatic drainage on pain intensity, ankle swelling, range of motion, static and dynamic functional stability in acute and post-acute ankle sprain in athletes.

Edema treatment includes a variety of techniques; elevation, compression, electrical stimulation, ultrasound, and massage are a few of them. Profound clinical check is required to determine the kind of edema management. However, the effect of these techniques on the lymphatic system and the edema itself is questionable. Manual Lymphatic Drainage mechanism, although still under investigation, is also a valid treatment management that does not cause inflammation, reduces the absorption of waste products and excess fluid and still urges the lymphatic system to work better.

Eligibility Criteria:
Inclusion Criteria:

1. . Basketball Athletes patients diagnosed as acute and post-acute ankle sprain. 2. Patients within 18 and 30 years old. 3. Patients with grade I, II ankle inversion sprain. 4. All participants complains of pain and moderate swelling in the ankle.

Exclusion Criteria:

1. Previous ankle surgery.
2. Serious pathology.
3. History of fractures in the ankle joint.
4. Vascular disorders.
5. Grade III ankle sprain.
Observing Infant Feeding Interactions

The objective of the proposed research is to conduct a within-subject experimental study that will assess the effect of environmental distractions on a mothers' ability to recognize and feed in response to infants' feeding cues. Investigators hypothesize that mothers will spend significantly more time looking at their technology compared to looking at their infant, which will be negatively associated with the mothers' responsiveness to her infant. This will have a positive association with infant intake during the feeding. Investigators also hypothesize that mothers will show less sensitivity when distracted when compared to when they are not distracted.


Eligibility Criteria:
Inclusion Criteria:

* Mothers must be 18 years or older
* Infants must be between 0-6 months of age

Exclusion Criteria:

* Preterm birth
* Medical conditions that interfere with feeding
Atrial Fibrillation and the Risk for Neurological Complications

B8: Atrial fibrillation and the risk of neurological complications

Twenty-five thousand acute strokes are caused by atrial fibrillation every year. But even more frequent than symptomatic strokes are silent infarctions of the brain. Silent strokes remain undetected in most cases, but cumulate over time and progressively impair cognition. The impact of atrial fibrillation on subacute brain infarctions is not yet known. Moreover, it has not been elucidated so far how effective different therapeutic strategies in the treatment of atrial fibrillation prevent cognitive impairment. Thus, this study aims at evaluating the influence of different types of atrial fibrillation on silent strokes and the related impairment in cognitive functions. Other risk factors and cardiovascular diseases that are known to provoke the development of strokes will be assessed as well. So, it will be possible to isolate the contribution of atrial fibrillation to silent strokes and related cognitive impairment in segregation to other relevant factors. AF patients and controls will be examined twice in two years in order to evaluate the role of atrial fibrillation and differential therapeutic interventions with regard to the progression of silent strokes and cognitive impairment in a within subject-design.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of permanent, paroxysmal or episodic atrial fibrillation in the past or at present

Exclusion Criteria:

* Pacemaker
* Metal implants
* History of acute stroke
* Diagnosis of vascular or degenerative dementia
* History of brain tumors
* History of severe brain injury
* History of psychiatric disorders
* Pregnancy
The Effect of the COVID-19 on Patient Preferences and Decision Making for Obstructive Urinary Stone Interventions

In this study, the investigators aim to evaluate the intervention preferences of patients with obstructive urinary stones who are suitable for operation during the COVID-19 pandemic. The secondary aim is to compare and evaluate the preferences compared to the pre-pandemic period and to gain a perspective on how the decision-making process has changed from the patient's point of view. Thus, by trying to understand how the COVID-19 epidemic affects the treatment choice decisions of patients, the investigators aim to determine how the state of anxiety changes these preferences.

The transformative impact of the COVID-19 pandemic on healthcare use remains an open question. At the onset of the pandemic, policies to limit transmission were adopted, including stay-at-home decisions, social distancing, and postponing elective surgery. Such policies have contributed to reduced emergency room admissions, increased concern about COVID-19, and hospital systems have had to prioritize emergency intervention.

Obstructive urolithiasis is a clinical condition that usually causes severe flank pain and causes emergency admission. It is still unclear how the epidemic impairs the treatment pathways of the obstructive urolithiasis that contributes to the emergency room visit. Treatment options range from observation and medical expulsive therapy to operative interventions such as extracorporeal shock wave lithotripsy, ureteroscopy and percutaneous nephrolithotomy. Patient preference, stone characteristics and comorbidities are of great importance in decision making. However, since obstructive ureteral stones that cannot be resolved spontaneously can cause irreversible renal parenchymal damage and obstructive pyelonephritis in a short time, the option of operation is always prioritized.

Patient perspectives on how COVID-19 is changing healthcare use and decision-making still remain unclear. In our study, the investigators plan to record patient treatment preferences by explaining in detail how and where treatment options will be applied, success and complication rates for patients diagnosed with obstructive urolithiasis and suitable for intervention in the outpatient clinic. In addition, when evaluating patient preferences, the investigators foresee to determine how the COVID-19 pandemic process has changed compared to before. It is planned that our study will have a patient-centered approach with detailed oral and written information in outpatient clinic conditions.

Eligibility Criteria:
Inclusion Criteria:

* Obstructive Urinary Stone

Exclusion Criteria:

* Previous operation for urinary stone
* Presence of bladder stone
* Presence of stent in the ureter
* Previous radiotherapy to the pelvic and abdominal region
* Pregnancy
* Neurological disease
Optimization of HIV-1 DNA Genotyping by High Throughput Sequencing to Document Antiretroviral Resistant Mutations

The analysis of HIV resistance to antiretrovirals (Sanger sequencing on RNA) is difficult when the viral load is undetectable or during therapeutic breaks. In these situations, the ultra-deep sequencing (UDS) can be done on proviral DNA in order to improve characterization of archived resistant variants with may reflect past virological failures.

This study is a cross-sectional study which will require only one additional tube which can be taken during a routine check-up as part of the usual follow-up of the individuals included.


Eligibility Criteria:
Inclusion Criteria:

* Patient who has given consent
* Adult patient
* Patient living with HIV-1
* Controlled viral load (\<50 RNA copies/ml) for at least 1 year.
* At least two previous virologic failures, either :

  * Initial failure : defined as the persistence of a viral load greater than 50 copies/ml beyond 1 year, after the initiation of triple antiretroviral therapy, and without virological control (VL \> 50 copies/ml) since the initiation of the very first antiretroviral treatment.
  * A rebound in HIV viral load to more than 50 copies/ml after a period of virological success, confirmed on two consecutive samples at least one month apart.
* At least 2 Sanger RNA genotypes have been done or could be done from the existing library.

Exclusion Criteria:

* Patient not affiliated to a medical insurance scheme
* Protected adult
* Pregnant, parturient or breastfeeding woman
* Discontinuation of clinical and immuno-virological follow-up for more than 2 years
Colorectal Cancer Screening Navigator Program for Low Income and Non-English Speaking Populations

The goal of this study is to implement and in a controlled randomised trial test a program to identify and overcome barriers to CRC screening and thus improve CRC screening rates at MGH Chelsea HC.

Our hypothesis is that a bilingual navigator program, enhanced by using trained interpreting staff will improve CRC screening rates at MGH Chelsea HC overall, and decrease disparities between patients with limited English proficiency and English speakers

We developed a training program for five health center interpreters fluent in eight different languages. Patients randomly assigned to the study intervention receive an introductory letter in their native language. During the initial contact the navigator educates patients about CRC screening and explores patients' barriers to CRC screening. Based on results from a qualitative study conducted at in 2006, we developed interventions to overcome individual barriers to CRC screening tailored to each individual patient. Specific interventions include elucidation of culturally-specific health beliefs; teaching about cancer risk, colonoscopy, and colon prep administration; and help with appointment-making and transport.

Eligibility Criteria:
Inclusion Criteria:

* Between 52-79 years of age
* Have not had a colonoscopy within the last 10 years
* Have not had a sigmoidoscopy/barium enema within the past 5 years
* Have not had a home fecal occult blood testing within the past year.

Exclusion Criteria:

* Acutely ill
* Dementia
* Metastatic cancer
* Schizophrenia
* Any end stage disease
GS Regimen as the First-line Chemotherapy in Chinese Advanced PC Patients

Gemcitabine plus S-1 (GS) prolonged progression-free survival (PFS) and greatly improved objective response rate (ORR) as well as disease control rate (DCR) of Asian patients with locally advanced and metastatic pancreatic cancer (PC). However, limited data of GS regimen exist on the efficacy and safety in the treatment of Chinese patients with advanced PC. To assess the efficacy and safety of gemcitabine plus S-1 (GS regimen) as the first-line chemotherapy in Chinese patients with advanced PC, we designed this prospective study.


Eligibility Criteria:
Inclusion Criteria:

* 1.Histologically confirmed pancreatic adenocarcinoma 2.Locally advanced or metastatic PC 3.Chemotherapy-naïve 4.ECOG performance status of 0 or 1 5. An adequate bone marrow, liver function and kidney function

Exclusion Criteria:

* 1.Age ≥80 years 2.Brain metastasis 3.With other malignancies 4.Chronic diarrhea, cardiac disease, pregnancy or breast feeding
Minimal Invasive Autopsies to Investigate Changes in Deceased COVID-19 Patients

Rationale In a very short time corona virus disease 2019 (COVID-19) has become a pandemic with high morbidity and mortality. The main cause of death is respiratory failure including acute respiratory distress syndrome, however the exact mechanisms and other underlying pathology is currently not yet known. In the current setting of the COVID-19 pandemic complete autopsies seem too risky due to the risk of SARS CoV-2 transmission. Yet, as so little is known, additional histopathological, microbiological and virologic study of tissue of deceased COVID-19 patients will provide important clinical and pathophysiological information. Minimal invasive autopsy combined with postmortem imaging seems therefore an optimal method combining safety on the one hand yet proving significant information on the other.

This study aims to determine the cause of death and attributable conditions in deceased COVID-19 patients. This will be performed using post-mortem CT-scanning plus CT-guided MIA to obtain tissue for further histological, microbiological and pathological diagnostics. In addition, the pathophysiology of COVID-19 will be examined by further tissue analysis.


Eligibility Criteria:
Inclusion Criteria:

* All patients with COVID-19 that die during hospitalization in Jessa hospital. COVID-19 is defined as either a positive SARS CoV-2 PCR result OR a high clinical suspicion combined with typical radiologic findings in the absence of an alternative explanation for the clinical picture.

Exclusion Criteria:

* None
Progrip Ventral Study for Sublay Repair

A novel concept of self-gripping mesh has been developed to achieve secure and long-term posterior wall reinforcement. ProGrip™ mesh is a lightweight (40g/m2) monofilament polypropylene or polyester mesh with resorbable polylactic acid (PLA) micro-grips, which provide self-gripping properties during the first few months after implantation. The self-fixation of the mesh to the underlying tissues is instantly achieved at application, limiting or avoiding the requirement of sutures (which can penetrate underlying tissues and damage cutaneous nerves), and providing a near tension-¬free repair.

Case series confirmed that Parietex ProGrip™ placed in onlay position allows a safe and painless treatment of incisional hernias and provides secure and efficient fixation mesh. On this basis, larger sizes Parietex ProGrip™ meshes have been developed for larger incisional hernia defect treatment. In order to assess the clinical outcomes following the use of ProGrip™ larger sizes in incisional hernia repair, this mono-center observational study has been initiated.


Eligibility Criteria:
Inclusion Criteria:

* All patients at participating hospital undergoing incisional hernia repair by using retromuscular placement by open approach.
* Defect size: 5cm ≤ width\*, 10 cm ≤ length ≤ 20 cm
SCP® Observational Study of the Knee

Post Market clinical outcomes study to collect data on the short - and long-term outcomes for subjects who are undergoing or who have undergone the Subchondroplasty (SCP) Procedure in the knee in a standard clinical setting. Outcomes to be assessed include pain medication usage, pain, function, activity levels and patient satisfaction.

This is a post-market, multi-center, patient outcomes centered study to evaluate the on-label use of AccuFill during the Subchondroplasty procedure. Enrolled subjects will sign an informed consent form, satisfy the inclusion/exclusion criteria and have at least one Bone Marrow Lesion (BML) in the knee. Demographics, medical history and medications will recorded at the time of enrollment. Surgical details including the SCP procedure, concomitant surgical procedures and intraoperative safety events will be recorded. Subjects will complete patient reported outcomes measures pre-operatively including the Visual Analog Scale (VAS) for knee pain, International Knee Documentation Committee Subject Knee (IKDC) Form and the Veterans Rand 12 (VR-12) Item Health Survey. These measures will also be administered post-operatively at 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. Screening for adverse events and revision surgeries will occur throughout the study.

Target enrollment is 1000 subjects at up to 30 clinical sites. Subjects will complete the study at 5 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.

Eligibility Criteria:
Inclusion Criteria:

1. Surgeon considers patient appropriate for SCP procedure.
2. Patient has agreed to undergo the SCP procedure or has already undergone the procedure.
3. Subject is willing and able to sign a written consent form.
4. The subject has the mental capacity and the willingness to contribute follow-up outcome data.
5. Patient is willing and able to complete outcome forms in person or by phone, email or regular mail.

Exclusion Criteria:

1. Patient is not comfortable with speaking, reading, and understanding questions and providing responses in an available language for the PROs in the protocol.
A Registry Study on Tanreqing（a Chinese Medicine Injection）Used in Hospitals in China

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in December 2012.

The purpose of this study is to make a event monitoring to see whether Tanreqing injection is safe and the characteristic and mechanism of anaphylactic reaction used Tanreqing injection in hospitals in China.

It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.

In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for Tanreqing injection safety surveillance with 3000 patients will be conducted from Jan.2013 to Mar.2013.At the same time,Patients who have anaphylactic reaction are selected as the allergic group and not have anaphylactic reaction are selected as the control group.The proportion of allergic group and control group is 1:4.All the patients who are selected should draw blood.

Eligibility criteria Patients who will use Tanreqing injection in selected hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Patients using Tanreqing injection from January to March 2013

Exclusion Criteria:

-
A Health Economic Evaluation of Using N-Terminal Pro Brain Natriuretic Peptide (NT-Pro BNP) in Acute Heart Failure

Cardiac biomarkers have dramatically impacted the way HF patients are evaluated and managed. In fact, the role of biomarkers has developed to better differentiate HF against other diseases and, to timely initiate and influence more accurate diagnosis (rule out) and treatments, to predict the onset of future HF, to risk-stratify affected patients, and to serve as a tool to guide intensity of therapy. NT-proBNP has become validated biomarkers with highest guideline recommendation (class I) and independent predictors for re-hospitalization and mortality in HF patients. However, many Indonesian cardiologists do not use of those biomarkers, mostly due to limited available cardiac biomarkers for the cost effective heart failure management. We evaluate 2 alternative treatments which one that more cost-effective between biomarker's guided therapy and without biomarker.

With growing demands on limited health care budgets, optimal resource allocation in HF patients is essential. Although NT pro BNP is proposed to be effective for the evaluation and management patients with heart failure, no data exist about cost-effectiveness analysis that are based on practice patterns endorsed by universal coverage systems in Indonesia (Jaminan Kesehatan Nasional). Because NT-proBNP therapy guidance in HF is believed to create additional costs, it is not yet broadly applicable. Its why we need to elaborate this issue.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-75 years
* The primary diagnosis at the Emergency Department (ED) is acute decompensated heart failure (ADHF)
* Using the national health insurance
* Willing to be followed for 3 months
* Willing to sign informed consent.

Exclusion Criteria:

* Severe life-threatening comorbidities with a life expectancy of \<2 years
* Acute heart failure other than ADHF such as acute pulmonary edema, acute heart failure in the setting of acute coronary syndrome, cardiogenic shock, right heart failure, and hypertensive heart failure
* ADHF accompanied by sepsis, liver disease, lung disease with severe radiological findings, mechanical complications of acute myocardial infarction, aortic dissection, congenital heart disease, idiopathic pulmonary hypertension, lung emboli, severe respiratory failure, and severe burns
* Patients admitted to ICVCU (Intensive Cardiovascular Care Unit)
* Patients did not take medication regularly and controls routinely.
Who Contributes to the Ordering of CT Scans in Emergency Department Patients?

The primary objectives are:

1. To investigate which healthcare workers and other individuals contribute to the decision to order computed tomography (CT) scans for emergency department (ED) patients.
2. To investigate the specific reasons healthcare workers and other individuals order or request CT scans for ED patients.
3. To determine the frequency of clinically important actions following CT scan results.

Once the drivers of ED CT utilization are identified, interventions including education, incentives for compliance with evidence-based best practices, and interventions for noncompliance could be targeted appropriately.


Eligibility Criteria:
Inclusion Criteria:

- Patients from age 0 to \<17 years, and patients age 18 years and older with traumatic and non-traumatic presentations, who visit Adult and Pediatric EDs and receive a CT scan during their ED visit

Exclusion Criteria:

* Patients older than 17, yet younger then 18.
* Patients who are unable to consent and who do not have a legally authorized representative.