bioihbjkbjnl/mcl2 huggingface dataset:
Nutritional Status and Its Modifications After Hip Replacement
Condition: Hip Arthropathy; Malnutrition; Anemia; Frail Elderly Syndrome
MeSH terms: Malnutrition
Study type: Observational

Summary: 
      Data literature lacks of evidence concerning the variation of the nutritional status in
      patients undergoing hip surgery, thus preventing an effective application a nutritional
      support program. It is therefore necessary to start identifying the clinical steps
      (pre-operative and post-operative) that may be defined as critical control points for
      malnutrition. The observation should foresee the identification of nutritional status
      indicators, such as weight, hemoglobin, albumin, food intake, and others that might affect a
      proper recovery. This study aims to investigate the prognostic nutritional factors that might
      influence clinical outcomes, and their variation in relation to hospitalization and
      rehabilitation periods.
    

Detailed description: 
      Data literature lacks of evidence concerning the variation of the nutritional status in
      patients undergoing hip surgery, thus preventing an effective application a nutritional
      support program. It is therefore necessary to start identifying the clinical steps
      (pre-operative and post-operative) that may be defined as critical control points for
      malnutrition. Patients undergoing hip surgery would be enrolled before the surgical operation
      and would be evaluated three times: preoperative, postoperative, and after discharge. The
      observation should foresee the identification of nutritional status indicators, such as
      weight, hemoglobin, albumin, food intake, and others that might affect a proper recovery.
      This study aims to investigate the prognostic nutritional factors that might influence
      clinical outcomes, and their variation in relation to hospitalization and rehabilitation
      periods.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care clinic
A Dose-escalating Clinical Trial With KH176
Condition: MELAS; LHON; Leigh Syndrome; Mitochondrial Disease; Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation
MeSH terms: Leigh Disease; Mitochondrial Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Mitochondrial Diseases are rare progressive, multi-system, often early fatal disorders
      affecting both children and adults. KH176 is a novel chemical entity currently under
      development for the treatment of inherited mitochondrial diseases, including MELAS
      (Mitochondrial Encephalomyopathy, Lactic acidosis, and Stroke-like episodes), Leigh's Disease
      and Leber's Hereditary Optic Neuropathy (LHON). KH176 is a potent intracellular redox
      modulating agent targeting the reactive oxygen species which are important in the
      pathogenesis of disorders of mitochondrial oxidative phosphorylation. After demonstrating a
      favourable safety profile in the pre-clinical testing, the safety, tolerability and
      pharmacokinetic and pharmacodynamic characteristics of the compound will now be evaluated in
      healthy male subjects in this trial
    


Intervention name(s): KH176; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: 6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Tocilizumab (TCZ) in New-onset Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus; New-onset Type 1 Diabetes Mellitus; T1DM; T1D
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study
      doctors think that giving medicines to affect the immune system soon after diabetes is
      diagnosed may stop, delay or decrease the destruction of beta cells, resulting in better
      glucose control.

      Researchers believe that tocilizumab could have some effect on the cells in the immune system
      that are thought to be involved in the development of type 1 diabetes. This study will test
      whether tocilizumab can help preserve or delay destruction of remaining beta cells in people
      recently diagnosed type 1 diabetes.
    

Detailed description: 
      Staggered enrollment is planned for this trial.

      Prior to initiating the study in the pediatric age group (6-17 years old), 30-99 eligible
      adults (ages 18-45 years) will be randomized 2:1 to tocilizumab or placebo, respectively.
      Once the first thirty adult participants have completed 12 weeks of treatment, the FDA and
      Data and Safety Monitoring Board (DSMB) will review available data (e.g., interim analysis)
      to weigh potential risks and benefits before opening the trial to pediatric participants.

      As of ≥ May 15, 2017: Study enrollment limited to participants ages 6 to 17 years inclusive.
    

Intervention name(s): Tocilizumab (TCZ); Placebo; Standard of Care
Intervention type(s): Drug; Drug; Other
Intervention description(s): Subjects assigned to this group will receive tocilizumab intravenous (IV) infusions of either 8.0 mg/kg (body weight ≥ 30kg) or 10.0 mg/kg (body weight <30kg) every 4 weeks for 24 weeks.; Subjects assigned to this group will receive placebo intravenous (IV) infusions of either 8.0 mg/kg (body weight ≥ 30kg) or 10.0 mg/kg (body weight <30kg) every 4 weeks for 24 weeks.; Participants will also receive standard intensive diabetes management (in accordance with the American Diabetes Association guidelines [Standard of Care, SOC])
Other intervention name(s): Actemra®; Placebo for Tocilizumab; SOC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: interleukin-6 (IL-6) receptor inhibitor
Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis
Condition: Meningococcal Infections; Septic Shock; Severe Sepsis
MeSH terms: Sepsis; Toxemia; Shock, Septic; Meningococcal Infections
Study type: Interventional

Summary: 
      Use of brain natriuretic peptide to evaluate the cardiac function in the course of
      meningococcal septic shock or severe sepsis.
    

Detailed description: 
      OBJECTIVES: determining sensibility and specificity of BNP blood level to detect myocardial
      dysfunction in septic shock or severe sepsis due to Neisseria meningitidis in children.

      METHODS: Prospective multicentric clinical trial including 7 French pediatric intensive care
      units. Serial cardiac ultra sounds and blood sampling will be done for patients hospitalized
      for purpura fulminans beginning at the time of admission in pediatric intensive care. Any
      child from 6 months to 18 years without preexisting cardiac disease and presenting with
      purpura fulminans will be enrolled after obtaining consent of both parents. From adult's
      studies on septic shock and BNP, a total number of 30 patients was calculated to be necessary
      to prove the interest of BNP in this indication.
    

Intervention name(s): BNP
Intervention type(s): Biological
Intervention description(s): Repeated brain natriuretic peptide dosages and cardiac echographies up to day 5
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: brain natriuretic peptide; cardiac function; meningococcal infections; septic shock; severe sepsis
Core Stability Program in Colorectal Cancer Survivors
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of physical training program to improve
      deep stabilizer muscle in colorectal cancer survivors
    

Detailed description: 
      Background: Colorectal cancer is the third most common cancer when considering both genders.
      Musculoskeletal alterations have been described related to techniques used during surgery,
      that it produces an inhibition of deep abdominal muscles. These muscles are in charge of
      lumbopelvic stabilization muscle linked to reduced ability to maintain independence in daily
      activity life that could have affected their quality of life

      Objective: The aim objective will be evaluated short and long-term effects of physical
      activity program for muscle stabilization.

      Methods: 20 colorectal cancer survivors will be recruited from the Department of Oncology of
      Clínico San Cecilio Hospital. Patients will be randomized in physical activity program group
      and usual care group. Physical activity groups will receive an eight week program form
      improve the muscle stabilization.

      Discussion: Researchers attempts to increase the fitness level and reduce musculoskeletal
      disorders in colorectal cancer survivors through a physical activity interventions focusing
      in muscle stabilization.
    

Intervention name(s): core stability
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: colorectal-neoplasms,deep-muscles of the back,rehabilitation
A Study of JNJ-67835989 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of JNJ-67835989
      versus placebo after single (or divided) oral dose administration (ascending dose levels) in
      healthy participants, pharmacokinetics (PK) of JNJ-67835989 in plasma and urine after single
      (or divided) oral dose administration in healthy participants, effects of JNJ-67835989
      following single (or divided) oral dose administration in healthy participants on
      cardiovascular parameters, effects of JNJ-67835989 following single (or divided) oral dose
      administration on dissociative symptoms in healthy participants, and sedative effects of
      JNJ-67835989 following single (or divided) oral dose administration in healthy participants.
    


Intervention name(s): JNJ-67835989; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-67835989 will be administered orally.; Matching placebo will be administered orally.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
VX-950-TiDP24-C132: A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Telaprevir.
Condition: Hepatitis C; Kidney Diseases
MeSH terms: Hepatitis C; Kidney Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of severe renal impairment or failure
      on the single-dose pharmacokinetics of telaprevir (TVR). Pharmacokinetics means how the drug
      is absorbed into the bloodstream, distributed in the body and eliminated from the body. In
      addition, the effect of severe renal impairment on the total and unbound plasma
      concentrations of the sum of TVR and its R-diastereomer VRT-127394 will be assessed.
      (Diastereomers are substances whose chemical structures are mirror images of each other).
      Finally, the short-term safety and tolerability of TVR in participants with severe kidney
      disease will be determined. The results of this study will guide dose recommendations for TVR
      in subjects with kidney disease.
    

Detailed description: 
      This is a Phase I, open-label trial to investigate the single-dose pharmacokinetics of
      telaprevir (TVR) in 12 participants with severe renal impairment (defined as creatinine
      clearance (CrCl) < 30 mL/min) as compared to 12 participants with normal renal function,
      matched for sex, race, age (± 10 years) and BMI (± 20%). Open-label means that the study
      doctor and the participants know what treatment will be assigned to them. All participants
      will receive a single 750-mg dose of TVR. Pharmacokinetic profiles of total TVR up to 24
      hours postdose will be determined. A 24 hour urine collection test will be performed to
      estimate the CrCl. In addition, the effect of severe renal impairment on the total and
      unbound plasma concentrations of the sum of TVR and VRT-127394 will be assessed. Tolerability
      and safety of TVR will be assessed throughout the trial period. Illnesses and side effects
      will be checked at every visit. Blood and urine samples will be taken at screening, on Day 1,
      2 and at the 2 follow-up visits. ECG and vital signs will be taken at screening, twice on day
      1, on day 2 and at the first follow-up visit. At the second follow-up visit vital signs alone
      will be determined. A physical examination will be done at screening, on the day before TVR
      intake, on day 2 and at both follow-up visits. All participants will receive a single 750-mg
      dose of telaprevir (TVR) given by mouth as 2 tablets of 375 mg.
    

Intervention name(s): telaprevir
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: VX-950-TiDP24-C132; VX-950-C132; VX-950; HCV
Clinical Trial to Assess Efficacy of cYclosporine Plus Standard of Care in Hospitalized Patients With COVID19
Condition: COVID19 Infection
MeSH terms: Infections; COVID-19
Study type: Interventional
Phase: Phase 4

Summary: 
      The study hypothesis is that cyclosporine, added to standard treatment of hospitalized
      patients with COVID19 infection may improve their prognosis.
    


Intervention name(s): Cyclosporine; Standard treatment
Intervention type(s): Drug; Drug
Intervention description(s): In the experimental group, cyclosporine will be started according to patient weight, and then increased depending on patient tolerance (monitoring renal function and blood pressure); Standard of care according to hospital protocol
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Comparing AIN457 to Placebo in Subjects With a Diagnosis of Moderate to Severe Stable Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a two-arm, parallel group, double-blind, placebo-controlled proof-of-concept study
      comparing 3 mg/kg of AIN457 to placebo. Subjects with a diagnosis of moderate to severe
      stable plaque psoriasis will be randomized to receive either AIN457 or placebo. AIN457 or
      placebo will be administered by single infusion at baseline and subjects will be observed for
      up to 26 weeks following the infusion.
    


Intervention name(s): AIN457; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): single infusion of 3 mg/kg; single infusion of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: Plaque psoriasis
Phase II Study of Immunization With a Hepatitis C Virus (HCV) Antigen Peptide Vaccine
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives are

        1. to determine the immunological profile (CD4+, CD8+ cells, DTH) induced by immunization
           with HCV antigen peptide vaccine with polyarginine.

        2. to document virological (HCV-RNA) and biochemical (ALT) responses following immunization
           with HCV antigen peptide vaccine with polyarginine.

        3. to assess the safety of immunization with HCV antigen peptide vaccine with polyarginine.
    

Detailed description: 
      This is a double blind, randomized, parallel group, controlled, multicenter phase II study.

      60 patients will be enrolled and assigned to one of the 5 dose or control groups. Each study
      group will include 8 patients.

      Each patient will receive a total of 6 injections according to the dose of the assigned study
      group. The injections will be administered subcutaneously in the upper arm once every four
      weeks for 5 months, i.e. at days 1, 29, 57, 85, 113 and 141.

      The volume of each injection will be 0.5 ml in all groups.
    

Intervention name(s): IC41
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (5mg/1000mg) Extended Release in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose
      combination (FDC) tablet containing linagliptin and metformin extended release compared to
      the free combination of linagliptin and metformin extended release, both under fed and fasted
      conditions.
    


Intervention name(s): Linagliptin/Metformin ER FDC; Linagliptin; Metformin ER
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1x Linagliptin/Metformin FDC tablet; 1x Linagliptin tablet; 2x Metformin ER tablets
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients
Condition: Muscular Atrophy, Spinal
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      A two-period, two-treatment, crossover study to evaluate the safety, tolerability and
      efficacy of amifampridine phosphate in ambulatory patients diagnosed with spinal muscular
      atrophy (SMA) Type 3.
    

Detailed description: 
      This randomized (1:1), double-blind, placebo-controlled, 2-period, 2-treatment, crossover,
      outpatient study is designed to evaluate the safety, tolerability and efficacy of
      amifampridine phosphate in ambulatory patients diagnosed with SMA Type 3. The study is
      planned to include approximately 12 male and female SMA Type 3 patients. The planned duration
      of participation for each patient is approximately 2 months, based upon length of dose
      titration and excluding the screening period, which can last up to 14 days. Patients should
      only be taking the assigned investigational product (amifampridine phosphate 10 mg tablets or
      matching placebo tablets), no new therapies are permitted during the study.
    

Intervention name(s): Amifampridine Phosphate; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Amifampridine phosphate tablets 10 mg will be provided in round, white-scored tablets, and containing amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.; Placebo Oral Tablet
Other intervention name(s): 3,4 diaminopyridine phosphate
Intervention MeSH terms: Amifampridine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 3
Simvastatin in Colorectal Surgery
Condition: Intestinal Neoplasm; Perioperative Care
MeSH terms: Intestinal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Statins (HMG-CoA reductase inhibitors) are a widely used class of cholesterol-lowering drugs
      that have an established role in the medical management of cardiovascular disease. Their
      benefits have also been shown in the surgical setting with decreased cardiovascular
      complications and lower perioperative mortality following cardiac and vascular surgery. There
      is now considerable evidence showing statins have useful pleiotropic properties that extend
      beyond cholesterol lowering, including anti-inflammatory, anti-oxidant, immunomodulatory and
      fibrinolytic effects. Growing evidence suggests these effects may be useful in attenuating
      the proinflammatory and metabolic stress response to surgery and the benefit of statins may
      extend to other surgical settings such as abdominal surgery.

      Laboratory studies demonstrate the surgically-relevant benefits of statins and show they
      decrease peritoneal inflammation, reduce the severity of intestinal ischaemia-reperfusion
      injury, improve survival in models of abdominal sepsis, decrease the formation of
      postoperative intraperitoneal adhesions and improve the healing of colonic anastomoses.
      Retrospective clinical studies show statins improve outcomes in sepsis, reduce the
      postoperative systemic inflammatory response syndrome (SIRS) and are associated with
      decreased rates of surgical wound infections and postoperative respiratory complications
      following various non-cardiac general surgical procedures. However, no prospective studies
      have specifically evaluated the perioperative use of statins in abdominal surgery. Using
      colorectal surgery as a model for major abdominal surgery, the investigators will conduct a
      randomised controlled trial evaluating the effect of perioperative statin use on
      postoperative morbidity, local and systemic inflammatory response, and functional recovery
      after surgery.
    


Intervention name(s): Simvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40mg orally, given 3-7 days pre-op and continued till 14 days post-op; Placebo (Inert calcium lactate) tablets 3-7 days pre-op to 14 days post-op (as per experimental arm)
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Statin; Colon; Colorectal; Intestinal Neoplasms; ERAS; Perioperative Care