cyrilzakka/clinical-trials huggingface dataset:
Trial of Omental Roll-up Technique on Pancreato-jejunostomy Anastomosis for Reducing Perioperative Complication in Patients Undergoing Pancreatoduodenectomy

Despite the fact that pancreatoduodenectomy is the standard treatment of malignant tumor at periampullary area, the morbidity and mortality rate with intra-abdominal collection, post pancreatectomy hemorrhage, and delayed gastric emptying, is still high at approximately 50-60%. The causes of these complications usually come from post-operative pancreatic fistula. Nowadays, several methods have been reported to reduce the incidence of pancreatic fistula after undergoing pancreatoduodenectomy, such as pancreatic stenting, the use of intravenous somatostatin, the use of sealant material and wrapping anastomosis by soft tissue.

Wrapping pancreato-jejunal anastomosis with omentum is not a complicate procedure and requires no extra treatment expenses of the patient. It has been reported this technique has been applied in the non-randomized controlled trials and their data have significantly shown that the technique could reduce pancreatic fistula rate. Therefore, the researchers want to conduct an RCT study to compare complication rates between omental roll-up pancreato-jejunal anastomosis and non-omental roll-up groups.

This is a RCT study designed to compare the use of omental roll-up technique with non-omental roll-up technique at pancreato-jejunal anastomosis in patients undergoing pancreatoduodenectomy. The purpose of this study is to prove the hypothesis that omental roll-up technique can reduce the complication rate or pancratic fistula after pancreatoduodenectomy. This study was approved by the committee on human rights to conduct the research involving human subjects, faculty of medicine Ramathibodi hospital, Mahidol university. The patients are operated by experienced surgeons of Hepato-pancreato-biliary unit, department of surgery, Ramathibodi hospital and randomized into two groups by using the closed envelope method after completing pancreato-jejunal anastomosis. Then, patients are followed-up and the data are collected for 30 days after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing pancreatoduodenectomy from these disease, carcinoma at head of pancreas, carcinoma at ampullar of Vater, Distal cholangiocarcinoma, Carcinoma of duodenum

Exclusion Criteria:

* Unresectable pancreatoduodenectomy
* Patients underwent omentectomy from prior surgery
Diagnostic Value of Transbronchial Lung Cryobiopsy

Evaluating the diagnostic value of transbronchial lung cryobiopsy (TBLC) as well as its procedural feasibility and safety in a prospective series of 20 patients with diffuse interstitial lung diseases (DILD) who are referred for invasive histopathological diagnostics

Before one is able to state that TBLC is a technique that is an alternative for VATS biopsy, the diagnostic value of TBLC should be assessed and the value of the histopathological sampling should be compared with what is achieved by surgical lung biopsy. For this purpose direct comparison between VATS biopsy and TBLC is unavoidable. By including TBLC in the work-up of patients with DILD in which histopathological assessment is indicated (as proposed by MDD), we want to assess 3 major points of concern.

Agreement for the histopathological diagnosis between VATS biopsy and TBLC. Value of TBLC in the specific diagnosis in ILD.

Eligibility Criteria:
Inclusion Criteria:

* - Case of DILD presented at the MDD
* Referral for VATS biopsy as advised by MDD.
* Informed consent available
* Age \> 18
* FVC \> 50%pred
* DLCO \> 40%pred
* PaO2 \> 65 mmHg, pCO2 \< 45 mmHg
* No exclusion criteria

Exclusion Criteria:

* - Age \> 75
* PAPS \>40mmHg as measured on transthoracic cardiac ultrasound
* Platelet count \<100000/µl
* INR \> 1.4
* BMI \>30
* Diffuse bullous lung disease
* Active anti-platelet or anticoagulant treatment
* Active heart failure or unstable coronary heart disease
* Patients unfit for VATS under general anaesthesia as assessed by the surgeon and/or anesthesiologist
Promotion of Exercise and Health in Obesity

The primary objectives of this randomized clinical trial are a) to implement and test the impact of a 1-year lifestyle obesity treatment program based on Self-Determination Theory on 3-year change in physical activity and motivation for exercise/physical activity, body weight and fat, and selected eating variables, b) to identify behavioral and psychosocial theory-based moderators or mediators of primary outcomes, especially physical activity and body weight.

Obesity and sedentary lifestyles are worldwide threats to public health but feasible and effective strategies to tackle these problems are scarce. The identification of variables that explain why only a sub-group of overweight persons succeeds at increasing physical activity and achieving long-term weight control is a key research topic in exercise and sports sciences. Subjects are 260 healthy women (BMI, 25 to 40 kg/m2), aged between 25 and 50 years, premenopausal, of whom half receive the treatment intervention, the remaining being randomly assigned to a control group at baseline. This RCT consists of a 1-year intervention plus a 2-year no contact follow-up period. The intervention group attended 30 weekly group sessions, designed to follow SDT basic tenets, covering PA, eating/nutrition, body image, and other cognitive and behavioral contents. Central to the intervention model are autonomy, intrinsic motivation, and self-regulation of behavior change. Autonomy-supportive treatment climate and internal causality orientations are predicted to enhance autonomous regulation, perceived competence, and intrinsic motivation for the targeted behaviors, resulting in lasting behavioral and body weight changes. The intervention was designed to follow SDT, with an emphasis on promoting intrinsic, self-regulated motivation for exercise and weight control. The control group received a general health education curriculum based on several 3- to 6-week long educational topics (e.g. food safety, stress management, self-care, body image, and others). Results are expected to contribute to a better understanding of how individual characteristics, particularly those related to physical activity and exercise influence success, better screening/readiness testing procedures, improved matching of interventions to participants, and lower rates of attrition and unsuccessful weight loss attempts.

Eligibility Criteria:
Inclusion Criteria:

* female (25-50 years old)
* pre-menopausal
* BMI between 25 and 40 kg/m2
* willing to attend weekly meetings (during 1 year)
* willing to not participate in other formal or informal weight loss program during the first year of the study (intervention group only).

Exclusion Criteria:

* major/chronic illness
* taking (or having taken in the previous year) medication known to interfere with body weight regulation, including anti-depressive medication
Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore

Given the high prevalence of COVID19 illness (both SARS-CoV-2 RT-PCR confirmed and highly suspect cases) among healthcare workers (HCW) within the Montefiore Health System (MHS), hydroxychloroquine (HCQ) will be prescribed to healthcare workers who are at the highest risk for severe COVID19 illness.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic with COVID illness (either RT-PCR test confirmed or highly suspect clinical symptoms)
* Call into office within the first 7 days of illness
* Have any of the following high risk conditions:

  * Age \>60
  * HTN, CAD, or chronic heart disease
  * Diabetes
  * Chronic kidney disease
  * Chronic lung disease
  * Active or recent chemotherapy for malignancy
  * Organ transplant
  * Taking Immune-suppressing medications
  * HIV with CD4 \<200 cells/mm3
* Experiencing at least one of the following high risk symptoms:

  * Severe cough
  * Fever 100.0F or greater
  * Diarrhea
  * Shortness of Breath
  * Hypoxia

Exclusion Criteria:

• HCW not meeting high-risk criteria or those with a contraindication to HCQ will not be offered HCQ
A Pilot Study on Whey Protein Supplementation in Non Alcoholic Fatty Liver Disease

An increase in dietary protein intake has been shown to blunt the increase in intrahepatic fat induced by high fat feeding in healthy individuals. The purpose of this study is to determine if a protein supplementation decreases intrahepatic fat in obese patients with non-alcoholic fatty liver disease.

12 obese patients will be be treated with a dietary whey protein supplementation over 4 weeks. Their intrahepatic fat content, glucose tolerance, and body weight will be evaluated before and after 4 weeks of supplementation.

Eligibility Criteria:
Inclusion Criteria:

* BMI higher than 35 kg/m2
* age 18-50 years
* sex male or female
* ASAT/ALAT \> 1.8

Exclusion Criteria:

* treatment with hypolemic or antidiabetic agents
* blood glucose \> 7 mmol/l
* alcohol intake \> 20g/day
* creatinin \> 120 umol/l)
* contra-indications to Magnetic resonnance imaging
Functional ComprEhensive AssessmenT by IVUS Reconstruction in Patients With Suspected IschEmic Heart Disease (FEATURE)

Investigating the diagnostic accuracy of online Ultrasonic Flow Ratio (UFR) assessment to identify hemodynamically significant coronary stenosis in patients with suspected ischemic heart disease using angiography-derived fractional flow reserve (FFR) as a reference standard.

This is a prospective, single-center, observational registry study of patients with suspected ischemic coronary artery disease. The purpose of this registry is to investigate the accuracy of online UFR assessment to identify hemodynamically significant coronary stenosis in patients with suspected ischemic heart disease using angiography-derived FFR as a reference standard.

Study population and sample size calculation are based on the diagnostic performance of previous studies, where an accuracy of 92% was found for UFR. Investigators conservatively estimate the diagnostic accuracy of online UFR assessment as 90% for consecutively enrolled patient population, and with a test target value set as 78% at a two-side significance level of 0.05, statistical power as 90%. Considering incomplete FFR/UFR data of 10% at most, a total of 112 patients need to be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be ≥ 18 years
* Patients suspected with ischemic heart disease
* ≥ 1 diseased vessel with angiographic percent diameter stenosis between 40% and 80% in a vessel ≥ 2.5mm by visual estimation
* Target vessels are limited to major epicardial coronary arteries (left anterior descending artery \[LAD\], left circumflex artery \[LCX\], right coronary artery \[RCA\])

Exclusion Criteria:

* Patients with previous coronary artery bypass grafting (CABG)
* Myocardial infarction within 72h of coronary angiography
* Allergy to the contrast agent or adenosine
* Left main coronary artery stenosis ≥ 50%
* Target vessel with in-stent restenosis
* Target vessel with severe tortuosity or angulation
* 100% occlusion of target vessel
* Target vessel spasm or injury
* Target vessel with severe myocardial bridge
* Target vessel with severe thrombosis
* Intravascular ultrasound (IVUS) pullback fails to cover the complete target lesion
* Presence of false lumen at target vessel based on IVUS
* A serum creatinine level \>150 umol/l, or a glomerular filtration rate \< 45 ml/kg/1.73 m\^2
* Heart failure
* Ineligible for diagnostic intervention (IVUS or FFR examination)
VExUS-guided Fluid Management in Patients With Acute Kidney Injury in the Intensive Care Unit

A quasi experimental study that aims to verify whether the incorporation of VExUS in patients with AKI in the Intensive Care Unit (ICU) may prompt tailored interventions to increases the number of days free from Renal Replacement Therapy (RRT) during the first 28 days.

Fluid overload is associated with organ dysfunction, such as Acute Kidney Injury (AKI), and increased mortality. It remains unclear if fluid overload is merely an epiphenomenon in critically ill patients or if organ congestion is a mediator of complications. Considering AKI related to fluid overload, diuretic therapy would reduce venous congestion and improve renal blood flow. The Venous Excess Ultrasound score (VExUS) identifies clinically significant venous congestion and indicates a high risk of post-operative AKI. This quasi-experimental study aims to verify whether the incorporation of VExUS in patients with AKI in the Intensive Care Unit (ICU) may prompt tailored interventions to increases the number of days free from Renal Replacement Therapy (RRT) during the first 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Non-elective ICU admission
* Severe acute kidney injury (AKI) defined either: A ≥ 2-fold increase in serum creatinine from a known pre-morbid baseline or during the current hospitalization OR Urine output \< 6.0 mL/kg over the preceding 12 hours

Exclusion Criteria:

* Life-threatening indication of RRT (defined as intractable hyperkalaemia, acidosis, uraemic symptoms) at Day 0
* RRT before recruitment
* Use of Extracorporeal membrane oxygenation (ECMO)
* Hepatic cirrhosis or other condition with portal hypertension
* Lack of commitment to provide RRT as part of limitation of ongoing life support
* Known pre-hospitalization advanced chronic kidney disease, defined by an estimated glomerular filtration rate \< 30 mL/min/1.73 m2 or chronic RRT
* Refusal to sign the informed consent form
Gene Therapy for ADA-SCID

This study investigated the safety and efficacy of different gene therapy approaches for Severe Combined Immunodeficiency (SCID) caused by the deficiency of adenosine deaminase (ADA) enzyme. This is a severe condition that can be cured by HLA-matched sibling donor bone marrow transplantation. Patients were enrolled if no HLA-identical sibling donor was available and the patient showed evidence of failure of enzyme replacement therapy or this treatment was not a long-term available option. The aim of the study was to evaluate the safety and efficacy of the procedure and to identify the relative role of peripheral blood lymphocytes and hematopoietic stem cells and progenitor cells in the long-term reconstitution of immune functions after retroviral vector mediated ADA gene transfer.

This is mono-centric, non-randomized, non-controlled, open label, phase I-II trial that evaluated the safety and efficacy of ADA gene transfer into somatic cells for the treatment of ADA-SCID

Eligibility Criteria:
Inclusion Criteria:

* Lack of HLA-identical sibling donor and
* Evidence of failure of the enzyme replacement treatment after \>6 months or
* PEG-ADA is not available as a life long option

Exclusion Criteria:

* HLA identical bone marrow sibling donor
* HIV infection
* Malignancy
Optimal Positioning of Nasopharyngeal Temperature Probes

Core temperature is of greatest interest in terms of temperature monitoring as it is thought to represent the temperature of the vessel-rich groups that are instrumental in thermoregulatory control. The nasopharynx is among the recommended temperature monitoring sites for core body temperature. It is the part of the pharynx that lies above the soft palate. Anteriorly it opens to the nasal cavities through the choanae; inferiorly it communicates with the oropharynx through the pharyngeal isthmus. Nasopharyngeal temperatures are accurate in adults when probes are inserted between 10 and 20 cm.

The optimal depth for insertion of nasopharyngeal probes remains poorly defined in infants and children. While some data suggest that anthropometric measurements are well correlated with endoscopic measurements in infants based on weight, the accuracy of temperature measurements at these and other distances has yet to be quantified. The investigators thus propose to determine the insertion depth (or range of depths) for nasopharyngeal temperature proves that best approximate core temperature as measured in the distal esophagus in infants and children of various sizes. The comparison site will be the distal esophagus since there is broad consensus that the distal third of the esophagus it at core-body temperature.

For the two groups of infants aged up to twelve months, the nasopharyngeal probe will be marked with indelible ink from 2-10 cm in 1-cm increments and inserted 10 cm. For the two groups of children between 1 and 5 years, the nasopharyngeal probe will be marked with indelible ink from 2-15 cm in 1.5-cm increments and inserted 10 cm. For older children, a nasopharyngeal probe will be marked with indelible ink from 2 to 20 cm at 2 cm increments from its tip, and inserted 20 cm.

Both nasopharyngeal and esophageal temperatures will initially be recorded 30 minutes after induction of anesthesia. Nasopharyngeal probes will then be withdrawn at the designated increment for each age group and will be equilibrated for 5 minutes before the temperature is recorded. Thereafter, the nasopharyngeal withdrawal sequence will be repeated. The number of measurement will depend on the initial depth of insertion, with measurements continuing until only 2 centimeters remain in the nostril.


Eligibility Criteria:
Inclusion Criteria:

1. Elective non-cardiac surgery in children to last at least 1.5 hours;
2. Supine position anticipated;
3. General endotracheal anesthesia.

Exclusion Criteria:

1. Nasopharyngeal disease (e.g. sinusitis), upper airway abnormalities, or planned oral or facial surgery;
2. History of genetic or congenital anomalies leading to facial dimorphism;
3. History of recent substantive epistaxis or suspected bleeding disorder;
4. Therapeutic-dose anti-coagulation;
5. Contraindication to esophageal temperature probe insertion (i.e., esophageal varices, congenital anomalies).
Drug Abuse During the COVID-19 Pandemic.

The pandemic we live through has put various sectors of the medical system and its tributaries to the test. The accumulation of external and internal stress has been completely correlated with the predisposition to psycho-emotional problems and, in turn, to drug use as an immature response for ego protection. That is why the economic, social, and psychological evaluation can help understand the current situation about drug abuse and how to help patients afflicted by it. The added stress of personal problems, work alterations, daily life in a pandemic, economic and varied responsibilities, and the understanding of the pandemic have predisposed and amplified the use of drugs to reduce emotional distress perceived by individuals. The hypothesis of this study is that the increment of stress and a lack of preparation for the pandemic are associated with increased drug abuse.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Willing to participate in the study
* Patient currently with a paying job

Exclusion Criteria:

* Patients without a paying job
A Clinical Study to Evaluate the Efficacy and Satisfaction of Ultrasound Therapy Combined With SkinCeuticals A.G.E for Improving Facial Aging

A Prospective, Single-center, Single-blind, Randomized split-face, controlled trial will be conducted. The goal of this clinical trial is to evaluate the efficacy and satisfaction of ultrasound therapy combined with SkinCeuticals A.G.E in improving facial aging, and to explore the medical value of ultrasound therapy combined with SkinCeuticals A.G.E. Participants will be treated with ultrasound combined with SkinCeuticals A.G.E on one randomized side face and ultrasound combined with standard cream on the other side.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese subjects aged 18-65 years inclusive;
2. The subject 's facial skin is rough, flaccid, and lack of elasticity;
3. Subjects with multiple facial fine lines (perioral/periocular/forehead, etc.), decree lines or puppet lines area with static fine lines trend, the lower part showed signs of loosening;
4. Subjects who have consistent facial skin status on both sides and plan to receive ultrasound therapy;
5. Subjects are willing to follow the requirements of the study protocol and complete the corresponding procedures;
6. Subjects understand the nature of the study and sign the informed consent form (ICF).

Exclusion Criteria:

1. Subjects with contraindications to ultrasound treatment (such as malignant tumor, acute systemic infection, severe heart disease, bleeding tendency, etc.) or contraindications to A.G.E use (or allergic to other skin care components);
2. Subjects with facial skin diseases, infection, inflammation or allergic constitution that may affect the judgment of the test results;
3. Subjects with hypertrophic scar or scar constitution;
4. Receiving treatment of tightening medical treatment program (Thermage/Fotona 4D/ultrasound/microneedle, etc.) or planning to receive other tightening medical treatment program and drugs during this treatment in the past 3 months;
5. Patients who have oral or topical cosmetic products that may affect the test results within the past 2 weeks;
6. Subjects who have participated in drug clinical trials or other trials within the past 30 days (or are participating in), or have used drugs affecting the test results within 1 week;
7. Female subjects who are pregnant, lactating or plan to become pregnant;
8. Other subjects who are not suitable for participating in this study as assessed by the investigator.
Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty

This PMCF study is designed to collect safety and efficacy data on hip hemiarthroplasty surgeries with Corin BiPolar-i shell and the Oceane+ or Meije Duo femoral stem up to 10 years.

As part of the current clinical remediation work under the new Medical Device Regulation (MDR), limited data have been identified to support the hemiarthroplasty indication for some of Corin femoral stems. Therefore, this PMCF study has been implemented to collect safety and performance data on hip hemiarthroplasty surgeries with Corin BiPolar-i shell and the Oceane+ or Meije Duo femoral stem up to 10 years.

Eligibility Criteria:
Inclusion Criteria:

1. Both genders.
2. Adult subjects.
3. Subjects clinically suitable for a hip hemiarthroplasty surgery with Corin hip devices based on physical examination, medical history and diagnosis such as: non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement, treatment of non-union, femoral neck and trochanteric fractures of the proximal femur, revision of failed partial hip replacements in which the acetabulum does not require replacement.
4. The subject is willing to comply with the required follow-up visits as per protocol.
5. The subject has signed a Patient Informed Consent Form (PICF), specific to this study, and approved by the local EC.

Exclusion Criteria:

1. Subjects with active infection or sepsis or osteomyelitis.
2. Subjects with unsuitable or insufficient bone support preventing proper fixation of the prosthesis.
3. Subject with marked bone loss or bone absorption.
4. Subject with metabolic disorders which may impair bone formation or bone quality.
5. Subjects under guardianship.
6. Subjects in the opinion of the Investigator/ investigative team who will be unable to comply with study procedures (Examples: recent psychotic or mania disorders, alcohol, drug or substance abusers) and/or those unable for any medical or other reason to comply with study procedures/visits.