bioihbjkbjnl/mcl2 huggingface dataset:
A Rehabilitation Tool to Determine Patient's Stay in Hospital After Joint Replacement
Condition: Total Joint Replacement Surgery
Study type: Interventional

Summary: 
      SPARTA force plate is used as rehabilitation tool in this study. The device is Force Plate
      coupled with SPARTA scan software that enables quick assessment of individual movement and
      balance within minutes. The magnitude as well as efficiency of force production is analyzed
      to determine an patient recovery graph.
    

Detailed description: 
      The investigator hope to learn co-relation between the rehab tool and clinical findings and
      analyse association if any. In this study, force plate is rehab tool, which will optimize
      care according to the patient's specific needs and provided insights to patients length of
      stay in the hospital. these data driven insights will be used to observe correlation between
      machine and clinic data
    

Intervention name(s): SPARTA force plate
Intervention type(s): Device
Intervention description(s): The Sparta Platform includes force plate hardware coupled with Sparta Scan software that enables quick assessment of an individual's movement and balance within minutes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis
Condition: Familial Adenomatous Polyposis; Duodenal Neoplasms; Duodenal Polyps
MeSH terms: Neoplasms; Adenoma; Colorectal Neoplasms; Nasopharyngeal Neoplasms; Adenomatous Polyposis Coli; Duodenal Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous
      Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is
      to determine wether celecoxib combined with ursodeoxycholic acid is an effective
      chemoprevention strategy to influence the progression of duodenal adenomas to carcinomas in
      patients with FAP.
    


Intervention name(s): Celecoxib; Ursodeoxycholic acid; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Celecoxib: 400mg twice daily, orally, 6 months; Ursodeoxycholic acid: orally, 6 months, dosage based on body weight:
below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses; Placebo: orally, 6 months, dosage based on body weight:
below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses
Intervention MeSH terms: Celecoxib; Ursodeoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Familial adenomatous polyposis; Adenomatous Polyposis Coli; Digestive System Neoplasms; Gastrointestinal Disease; Intestinal disease; Intestinal neoplasms; Gastrointestinal neoplasms; Polyps; Adenoma; Adenomatous Polyps; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Genetic Diseases, Inborn; Chemoprevention; Celecoxib; Ursodeoxycholic acid; Anti-Inflammatory agents, Non-Steroidal; Cyclooxygenase Inhibitors
A Study to Evaluate Dose Responses of Efficacy and Safety of ASP0456 in Patient With Chronic Constipation
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to investigate dose-responses of efficacy and safety of
      ASP0456 in patients with chronic constipation (diagnosed by Rome III criteria of functional
      constipation (FC), not including constipation due to organic diseases) compared to placebo
      and to find the appropriate dose for P3 study.
    

Detailed description: 
      To determine optimum dose of ASP0456 for the patients with chronic constipation (not
      including constipation due to organic diseases) in Japan based on its efficacy and safety,
      multicentered, placebo-controlled, double-blind, parallel group comparative study will be
      conducted.

      After two-week observation period, the patient who meets the primary registration criteria
      will be randomized to the one from five groups and will start treatment period. The patients
      will take once daily orally before the breakfast for two weeks.
    

Intervention name(s): ASP0456; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Linaclotide
Intervention MeSH terms: Linaclotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: linaclotide; ASP0456; chronic constipation
EUS-guided Intratumoral Gemcitabine in Locally Advanced Unresectable Pancreatic Cancer
Condition: Pancreatic Adenocarcinoma
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Pancreatic cancer is the 11th most common type of cancer but it is the fourth leading cause
      of cancer death. The only effective treatment for pancreatic cancer includes surgery.
      However, only 20% of the patients have surgically treatable disease. Also, the 5-year
      survival for the surgically treated patients is only 15%.

      About 40% of the patients present with advanced disease with distant metastasis, and the
      remaining 40% present with locally advanced unresectable cancer with the tumor invaded into
      surrounding major vessels. For those with locally advanced disease, systemic chemotherapy
      with or without radiotherapy provides palliation of the symptoms but cannot cure the
      disorder. Systemic chemotherapy is given through peripheral vessels.

      The investigators hypothesized that direct injection of the chemotherapeutic drug into the
      tumor may help to boost the effect of systemic chemotherapy and radiotherapy in those with
      locally advanced pancreatic cancer.
    

Detailed description: 
      In this study, gemcitabine will be injected directly into the tumor by means of endoscopic
      ultrasound (EUS) in the eligible patients.
    

Intervention name(s): Gemcitabine
Intervention type(s): Drug
Intervention description(s): Two intratumoral injections of gemcitabine under endoscopic ultrasound (EUS)-guidance at month 0 and month 3.
The patients will receive systemic chemotherapy with or without radiotherapy at the discretion of oncologist
Other intervention name(s): Gemzar
Intervention MeSH terms: Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic cancer; Pancreatic adenocarcinoma; Endoscopic ultrasound
Obstructive Sleep Apnea Syndrome (OSA) and Getemed
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      It is often clinically impossible to differentiate children with an isolated snoring from
      those with OSA. The diagnosis of OSA is currently based on nocturnal, laboratory-based
      polysomnography. This expensive examination is poorly accessible due to appointments delays
      at hospital.

      Our study is designed to compare the characteristics of a home polysomnography versus
      standard polysomnography for the diagnosis of pediatric OSA.
    


Intervention name(s): home polysomnography (GETEMED); standard polysomnography (BRAINNET II)
Intervention type(s): Device; Device
Other intervention name(s): GETEMED; BRAINNET II
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Obstructive Sleep Apnea syndrome; polysomnography; Home monitoring
Day of Embryo Transfer for Patients Undergoing In Vitro Fertilization
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      We are examining whether pregnancy rates differ based on day of embryo transfer in patients
      who replace all available embryos after an In vitro Fertilization (IVF) cycle. Patients must
      be undergoing IVF treatment at Stanford University and patients will not receive compensation
      for their participation (no medical costs covered or patient payment for participation).
    

Detailed description: 
      The decision on the number of embryos to transfer after an IVF cycle is based on the number
      of available embryos, the quality of the embryos, the patient's age, and the goal of limiting
      multiple gestations. Stanford Fertility Center and most IVF centers examine the embryos on
      the third day after oocyte (egg) retrieval to select for the best quality embryos to
      transfer, and depending on quality, the remaining embryos are frozen to be used in the
      future. Patients with a limited number of embryos, those that plan to replace all available
      embryos after an IVF cycle, do not need to wait until the third day after oocyte retrieval to
      select embryos, and may replace the embryos on the second day after the oocyte retrieval. We
      are examining whether pregnancy rates differ among these patients based on the day of embryo
      transfer (Day 2 vs. Day3). Patients must be undergoing IVF treatment at Stanford University
      and patients will not receive compensation for their participation (no medical costs covered
      or patient payment for participation).
    

Intervention name(s): Day 3 embryo transfer; Day 2 embryo transfer
Intervention type(s): Procedure; Procedure
Intervention description(s): Standard of care; Embryos are transferred 1 day prior to standard of care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Compare the Pharmacokinetics of Budesonide Delivered by BDA MDI to Budesonide Delivered by Pulmicort Respules in Children With Asthma Aged 4 to 8 Years.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the pharmacokinetics of budesonide delivered by BDA MDI to budesonide delivered by
      Pulmicort Respules in children with Asthma aged 4 to 8 years.
    


Intervention name(s): BDA MDI (PT027) 160/180 μg; Pulmicort Respules 0.5 MG/ML Inhalation Suspension
Intervention type(s): Drug; Drug
Intervention description(s): Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/90 μg per puff. Two puffs to administer 160/180 μg dose.; Budesonide 0.5 mg/ml. Each 2 ml Respule contains 1 mg budesonide.
Other intervention name(s): PT027
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Salty Gut: Effects of High Dietary Salt Intake on the Gut Microbiota
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      Gut microbiota has a role in cardiovascular disease and recent findings in rodents show
      dietary salt can negatively alter gut microbiota composition. High salt intake is a risk
      factor for cardiovascular disease. Americans consume dietary salt in excess of Dietary
      Guidelines and American Heart Association recommendations. The objective of this project is
      to investigate the influence of high dietary salt consumption on the gut microbiota
      composition in men and women.
    

Detailed description: 
      Gut microbiota composition and function has an important role in host physiology. In general,
      gut microbial diversity is positively correlated with health status. Recent evidence confirms
      the role of gut dysbiosis in cardiovascular disease. Americans consume 50% more salt than the
      amount recommended by the Dietary Guidelines and 130% more than recommended by the American
      Heart Association. Excess salt intake is considered a modifiable risk factor for
      cardiovascular disease. Changes in the gut microbiota composition followed by immune system
      activation is reported with high salt intake in animals. In particular, abundance of
      proinflammatory T helper 17 (Th17) cells increases with excess salt consumption. In contrast,
      T regulatory (Treg) cells oppose Th17 cell action and may aid in reducing inflammation
      associated with high salt intake, a hypothesis that has not yet been tested in humans. Only
      one preliminary study assessed changes in gut bacterial composition with high salt intake in
      humans, when only men were recruited. The study also found an increase in Th17 cell
      abundance. Thus, the objective of this study is to investigate the influence of high salt
      intake on the gut microbiota diversity and Th17 and Treg cell abundance in men and women.
    

Intervention name(s): High Salt; Recommended Salt
Intervention type(s): Other; Other
Intervention description(s): Consumption of pills containing table salt for 10 days.; Consumption of pills containing dextrose for 10 days.
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants will complete each arm.
Masking: Single (Participant)
Primary purpose: Other
Keywords: Dietary sodium; Gut microbiota
Effect of Yoghurts Enriched With XXS (Mixture of Natural Polyphenolic Compounds and Plant Extracts) on the Evolution of Weight in Overweight Subjects
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Overweight and obesity are public health problems worldwide. Even though heredity may be one
      of the causes the diseases, the vast majority of cases is rather linked to a sedentary
      lifestyle associated or not with a low-variety, high-calorie diet. Many diets and slimming
      methods propose low-calorie meals or physical exercise, and the consequences of these are
      sometimes negative with advancing age (muscle wasting). Certain studies have shown the
      efficacy of foods with antioxidant properties on the reduction of blood pressure, Low Density
      Lipoprotein (LDL)-cholesterol and weight or on the distribution of fat mass-lean mass. The
      investigators put forward the hypothesis that the daily consumption of two yoghurts
      containing XXS, a mixture of natural polyphenolic compounds -rich in quercetin- from plant
      extracts, could lead to weight loss, a better fat mass-lean mass distribution and an
      improvement in markers of oxidative stress in overweight persons aged 50 to 65 years.
    


Intervention name(s): yoghurts enriched with XXS; yoghurts non enriched with XXS
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
A Mind-Body Medicine Curriculum for Peer Counselors
Condition: Anxiety
Study type: Observational

Summary: 
      This study will evaluate a Mind-Body Medicine curriculum for high school peer counselors in
      order to answer the following research questions:

        1. Will peer counselor participation in the Mind-Body Medicine curriculum increase their
           sense of self-regulation, responsibility, social competence, and empathy; decrease
           anxiety; and increase hope?

        2. What are the experiences of peer support counselors participating in the Mind-Body
           Medicine curriculum?
    

Detailed description: 
      The study will be done at the Marjory Stoneman Douglas High School. The research will use a
      mixed-methods design by collecting both quantitative and qualitative data. The quantitative
      data will be in the form of standardized research instruments and the qualitative data will
      be gathered through focus group interviews with the peer-counselors.
    

Intervention name(s): Mind-Body Medicine Curriculum
Intervention type(s): Behavioral
Intervention description(s): The Mind-Body Medicine curriculum consists of presentations on different mind-body techniques as well as the research supporting the use of these techniques.The mind-body technique is then practiced in a supportive small group setting. Mind-body techniques will include guided imagery, relaxation techniques, several forms of meditation, autogenic training and biofeedback.
Other intervention name(s): Mind-Body Skills Groups
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        High school students who are participating in the Peer Counseling Program at Marjory
        Stoneman Douglas High School
      
Keywords: Empathy; Hope
Effects of Pregnane X Receptor (PXR) Activation on Human Glucose, Lipid and Hormone Homeostasis
Condition: Glucose Metabolism
Study type: Interventional
Phase: Phase 4

Summary: 
      This clinical trial is designed to study the effects of pregnane X receptor activator
      rifampicin on the glucose, lipid and hormone homeostasis in healthy volunteers. The main
      hypothesis is that rifampicin raises postprandial glucose studied with oral glucose tolerance
      test. The study is a non-randomized, one-phase, open-label trial. Twelve subjects will be
      given 600 mg of rifampicin a day for a week. The main outcome measures are the changes in the
      glucose and insulin levels during oral glucose tolerance test.
    


Intervention name(s): Rifampicin
Intervention type(s): Drug
Intervention description(s): Rifampicin 600 mg daily for a week
Other intervention name(s): Rimapen, ATC J04AB02
Intervention MeSH terms: Rifampin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PXR, glucose, cholesterol
Reparixin in Pancreatic Islet Transplantation
Condition: Pancreatic Islet Transplantation in Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Inhibition of CXCL8 activity might represent a relevant therapeutic target to prevent injury
      occurring after pancreatic islet transplantation. Reparixin is a novel and specific inhibitor
      of CXCL8. This study is designed to explore the efficacy of reparixin in preventing graft
      dysfunction after islet transplantation in type 1 diabetes patients (T1D).
    

Detailed description: 
      Pancreatic islet transplantation has become a feasible option in the treatment of T1D which
      offers advantages over whole pancreas transplantation. However to date insulin independence
      can be obtained in most cases only after the patient has received repeated infusions from
      several donors. A non-specific immune response, mediated predominantly by innate inflammatory
      processes, coupled with specific cellular immune responses, possibly promoted by early
      inflammation, play a major role in the loss of transplanted islets from the liver. PMNs have
      been found to be the predominant cell types infiltrating in vitro the islets. In this regard,
      CXCL8 has been shown to be expressed by human islets and could play a crucial role in
      triggering the inflammatory reaction. Thus, CXCL8 might represent a relevant therapeutic
      target to prevent early graft failure. The efficacy of reparixin in improving graft outcome
      in mice models of intrahepatic islet transplantation, as well as the safety shown in human
      phase 1 and 2 studies, provide a rationale for a clinical study aimed at evaluating the
      effect of reparixin in preventing graft dysfunction after islet transplantation in T1D
      patients.
    

Intervention name(s): Reparixin
Intervention type(s): Drug
Intervention description(s): Reparixin + immunosuppression
Other intervention name(s): REP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Islet transplantation; Type 1 diabetes mellitus
High-Dose Statin Combined With Telmisartan vs Amlodipine on Glucose Metabolism in ASCVD Patients With IFG and Hypertension
Condition: ASCVD; Impaired Fasting Glucose; Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effect of high-dose rosuvastatin combined with telmisartan or
      amlodipine on glucose metabolism in ASCVD patients with impaired fasting glucose and
      hypertension.
    


Intervention name(s): Duowell®; Monorova® + Amlopin®
Intervention type(s): Drug; Drug
Intervention description(s): Telmisartan/Rosuvastatin 40/20mg (increased to Telmisartan 80mg if SBP > 140mmHg or DBP > 90mmHg at week 12); Rosuvastatin 20mg + Amlodipine 5mg (increased to Amlodipine 10mg if SBP > 140mmHg or DBP > 90mmHg at week 12)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the trial is to determine the maximum tolerated doses (MTD) of BI
      860585 alone and in combination with exemestane or paclitaxel. To determine the MTDs,
      patients are entered sequentially into escalating dose cohorts. Secondary objectives are
      objective response and disease control according to RECIST criteria version 1.1
    


Intervention name(s): BI 860585; exemestane; BI 860585; BI 860585; paclitaxel
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): BI 860585 multiple dose escalation, once daily; exemestane once daily; BI 860585 multiple dose escalation, once daily; BI 860585 multiple dose escalation, once daily; paclitaxel once weekly
Intervention MeSH terms: Paclitaxel; Exemestane
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment