bioihbjkbjnl/mcl2 huggingface dataset:
Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program
Condition: Colon Cancer; Inflammatory Bowel Diseases; Diverticulitis
MeSH terms: Inflammatory Bowel Diseases; Diverticulitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a blinded randomized controlled trial in patients undergoing laparoscopic colon
      surgery. The aim of this study is to assess whether spinal analgesia with a mixture of
      bupivacaine and morphine provides better pain relief than systemic morphine in a group of
      patients undergoing colonic resection and using the Enhanced Recovery After Surgery (ERAS)
      program.

      Twenty patients will receive spinal analgesia and twenty patients will receive only Patient
      Control Analgesia (PCA).
    

Detailed description: 
      This is a blinded randomized controlled trial in patients undergoing laparoscopic colon
      surgery. The aim of this study is to assess whether spinal analgesia with a mixture of
      bupivacaine and morphine provides better pain relief than systemic morphine in a group of
      patients undergoing colonic resection and using the ERAS program.
    

Intervention name(s): Spinal analgesia; Patient Control Analgesia (PCA) Morphine
Intervention type(s): Drug; Drug
Intervention description(s): isobaric bupivacaine 0.5% 10 mg together with preservative-free morphine was injected. The dose of morphine was based on patient's age, with 200 μg in patients aged ≤ 75 years and 150 μg in patients aged > 75 years.; PCA Morphine is set to the patient for 48 hours postoperative. 2 mg. of morphine is given to a patient as much as patient requires, maximum at every 7 minutes.
Other intervention name(s): Spinal block, intrathecal block; Patient Control Analgesia Morphine.
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Immune Response to the ASP7373 and Its Safety in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is to investigate the clinically recommended dosage for ASP7373 based on the
      comparison of the immunogenicity and safety among the three doses of ASP7373 in healthy
      adults.
    


Intervention name(s): ASP7373; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Intermuscular administration; Intramuscular administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Recombinant Influenza HA vaccine; Immunogenicity of ASP7373
Diaphragmatic Activity During Weaning With NAVA, a Pilot Study (NAVA: Neurally Adjusted Ventilatory Assist)
Condition: Postoperative Patients
Study type: Interventional

Summary: 
      The purpose of this study is to describe the diaphragm electromyographic activity (Edi) in
      healthy lung patients due to obtain a reference to guide the weaning in those patients
    

Detailed description: 
      We obtained the Edi recording data at each NAVA level during the weaning in NAVA group, and
      we compared the respiratory parameters between the PSV and NAVA groups
    

Intervention name(s): weaning protocol
Intervention type(s): Procedure
Intervention description(s): The patients were allocated in the NAVA weaning protocol group o in the PSV weaning protocol group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: NAVA: neurally adjusted ventilatory assist; Diaphragm electromyographic activity; Weaning
Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effects of sequential multiple dose regimens of cariprazine on
      cardiac repolarization in patients with schizophrenia.
    


Intervention name(s): Cariprazine; Risperidone/Moxifloxacin; Risperidone/Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients meeting all study eligibility criteria will be randomized to receive cariprazine (Group 1) 1.5 to 18 mg once daily, administered orally.; Patients randomized to Group 2A will receive double blind placebo for Days 1-5, Moxifloxacin (400mg) on Day 6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-35.; Patients randomized to Group 2B will receive double blind placebo for Days 1-6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-34, Moxifloxacin (400mg) on Day 35.
Intervention MeSH terms: Moxifloxacin; Risperidone; Cariprazine; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; QTc; cardiac repolarization
Treatment of Postpartum Urinary Retention
Condition: Retention, Urinary
MeSH terms: Urinary Retention
Study type: Interventional

Summary: 
      The aim of the study is to evaluate what is the most effective catheterization duration to
      resolve covert and overt postpartum urinary retention following vaginal delivery and
      caesarean delivery, with the highest patients' satisfaction.
    

Detailed description: 
      1. Women who are unable to micturate for more than 6-8 hours following vaginal delivery or
           within six to eight hours following removal of an indwelling catheter after cesarean
           delivery (overt postpartum urinary retention), or women with postvoid residual bladder
           volume of at least 150 mL (covert postpartum urinary retention) will be randomized into
           2 groups: one group will include women who are catheterized intermittently every 6-8
           hours up to a total time of 48 hours. If at any time, post voiding residual volume is
           less than 150cc (assessed by ultrasound or by catheterization), no additional
           catheterization is needed. The second group will include women which will have an
           indwelling catheter inserted for 24 hours. The catheter will be removed 24 hours
           following its insertion and post voiding residual volume will be assessed 6 hours
           following the catheter removal (by ultrasound or by catheterization). In cases of post
           voiding residual volume more than 150 cc or women are unable to micturate spontaneously,
           an indwelling catheter will be inserted for additional 24 hours.

        2. After 48 hours from postpartum urinary retention diagnosis, an indwelling catheter will
           be inserted for additional time that will be set at every center by its common protocol.
    

Intervention name(s): Foley Catheter
Intervention type(s): Device
Intervention description(s): Foley catheter used for treatment of urinary retention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria
Condition: Proteinuria
MeSH terms: Proteinuria; Albuminuria
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this study is to examine if paricalcitol may reduce progression of
      graft fibrosis and proteinuria in kidney transplant patients. Cyclosporine and tacrolimus
      have a detrimental long-term effect by inducing graft fibrosis. About 50% of graft losses are
      related to interstitial fibrosis. Paricalcitol is a vitamin D receptor activator indicated
      for treatment of secondary hyperparathyroidism. Paricalcitol is known to exert an
      anti-inflammatory and antifibrotic and attenuate cyclosporine-induced fibrosis. Paricalcitol
      is also shown to be renoprotective by reducing proteinuria. No randomized controlled trials
      with paricalcitol are performed in renal transplant patients examining the effect on
      proteinuria and graft fibrosis.
    

Detailed description: 
      77 randomized, 37 paricalcitol, 40 no treatment
    

Intervention name(s): Paricalcitol
Intervention type(s): Drug
Intervention description(s): Zemplar (paricalcitol) 2ug daily, oral intake
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: kidney transplant patients; Albuminuria
Bioindicators Associated With Sarcopenia Before and After Intensive Lifestyle Intervention
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this clinical trial is to explore whether the bioindicators of body composition,
      nutrition-related indicators (lymphocytes, albumin), lipids, and thyroid hormones are
      associated with sarcopenia and the changes in these indicators after an intensive lifestyle
      intervention. The main questions it aims to answer are:

        -  whether the bioindicators such as lymphocytes, albumin, lipids, thyroid hormones, fat
           mass, fat-free mass, and basal metabolic mass are associated with the development of
           sarcopenia.

        -  the changes of these bioindicators that occur in older adults after going through an
           intensive intervention.

      Participants will receive a 3-month intensive intervention consisting of an intensive
      nutritional intervention and an individually designed exercise intervention. Nutritional and
      exercise prescriptions are co-designed through a nutritionist and rehabilitation physician.

      Researchers will compare bioindicators in the sarcopenia group before and after intensive
      lifestyle intervention to determine the association with sarcopenia.
    


Intervention name(s): 3-month intensive intervention
Intervention type(s): Combination Product
Intervention description(s): Intensive nutritional interventions were as follows: i）Estimation of ideal body weight according to height, calculation of calories by giving 30-40kcal/kg/day according to BMI stratification, and calculation of daily protein requirement at 1.5g/kg/day, which was finally converted into daily dietary recommendations according to the results of the calculations. ii）Distribution of additional protein supplementation by whey protein, each sachet containing 15g of whey protein.
The resistance training program included 5 min of warm-up, 20 min of muscle strength training, and 5 min of slow walking and was performed three times a week. Resistance training involved a dumbbell and sandbags as weights for the major muscles of the upper and lower limbs. In the study, aerobic training is brisk walking or jogging for 30 minutes/day, five times a week.
Other intervention name(s): Sarcopenia group
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Sarcopenia; Bioindicators; Intensive lifestyle intervention; Exercise intervention; Nutritional intervention
Comparison of Remimazolam and Propofol Effect on Oxygenation Reservoir During Diagnostic Gastric Endoscopy
Condition: Diagnostic Gastric Endoscopy
Study type: Interventional

Summary: 
      Propofol is one of the most commonly used sedative in endoscopic procedures, while its
      potency to induce respiratory depression may threaten patient safety. Remimazolam is known to
      less likely induce hemodynamic instability when compared to propofol, yet its favorable
      effects are not clearly evaluated in endoscopic procedures. Hence, this study aimed to
      compare hemodynamic effects of remimazolam and propofol, by evaluating oxygen reserve index
      (ORI) in patients scheduled for diagnostic gastric endoscopy.
    


Intervention name(s): Remimazolam besylate; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Patients in this group receives 0.1mg/kg of remimazolam to induce sedation prior to endoscope insertion.; Patients in this group receives 0.5mg/kg of propofol to induce sedation prior to endoscope insertion.
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Efficacy of Lodotra®(Prednisone) in Reduction of Morning Stiffness Duration(K-IMPROvE)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is multicenter, Ph IV, single arm, interventional study to assess relative
      reduction of morning stiffness of Lodotra® in Rheumatoid Arthritis patients.Study medication
      will start after study visit at baseline (week 0, visit 1) and follow-up visit will be after
      2, 6 and 12 weeks after treatment (visit 2,3,4).
    

Detailed description: 
      Test Treatment, Dose, and Mode of Administration:

      Starting dose is 10mg, and depending on the clinical symptoms and the patient's response, the
      initial dose can quickly be reduced to a lower maintenance dose. When changing over from the
      standard regimen (glucocorticoid administration in the morning) to Lodotra® administered at
      bedtime (at about 10 pm), the same dose (in mg prednisone equivalent) should be maintained,
      if the subject has taken stable dose within 30 days. Lodotra® dose cannot exceed more than
      10mg.

      Lodotra® should be taken at bedtime (at about 10 pm), with or after the evening meal and be
      swallowed whole with sufficient liquid. If more than 2 - 3 hours have passed since the
      evening meal, it is recommended to take Lodotra® with a light meal or snack.

      Modified-release tablets are not to be broken, divided or chewed.

      Treatment procedure:At Visit 1(week 0), subjects who qualify for entry into the study will
      medicated to Lodotra® starting dose of 10 mg daily. (Written informed consent has to be
      obtained, and subjects will undergo complete evaluation for study eligibility) No dose
      increase will be allowed for more than 10mg
    

Intervention name(s): Lodotra®
Intervention type(s): Drug
Intervention description(s): Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response
Other intervention name(s): Modified Release Prednisone
Intervention MeSH terms: Prednisone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RA, MS, Safety, Efficacy, MR prednisone
Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CS0159
Condition: Primary Sclerosing Cholangitis (PSC)
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Study type: Interventional
Phase: Phase 1

Summary: 
      The whole study includes 2 parts. Both the SAD study and MAD study are randomized,
      double-blinded, and placebo-controlled studies, conducted in healthy subjects, to assess the
      safety, tolerability, pharmacokinetics, and pharmacodynamics profiles of CS0159. The SAD part
      also involves a pilot food effect (FE) study, designed to assess the food effect on
      single-dose PK profile in healthy subjects.
    

Detailed description: 
      A total of 48 healthy subjects will be allocated to 1 of 6 cohorts (cohort A1~A6) in the SAD
      study, each cohort including 8 subjects (6 subjects will receive investigational new drug
      (IND) product and 2 receive placebo). Each subject in fasted state will be randomly assigned
      to receive a single oral dose of CS0159 or placebo.To ensure the safety for all SAD cohorts
      (including A3 in both treatment periods).

      The MAD study will enroll 32 healthy subjects, allocated to 1 of 4 cohorts (cohort B1~B4) and
      each cohort including 8 participants (6 subjects will receive IND products and 2 receive
      placebo). Subjects will be randomly assigned to orally receive the IND product or placebo.
    

Intervention name(s): CS0159
Intervention type(s): Drug
Intervention description(s): Tablets administered orally
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06882961 in Japanese Adults With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double blind (sponsor open), parallel, placebo controlled,
      twice daily oral dosing study of PF 06882961 in adult Japanese participants with T2DM
      inadequately controlled on diet and exercise alone.
    


Intervention name(s): Placebo; PF-06882961
Intervention type(s): Drug; Drug
Intervention description(s): 3 matching placebo tablets taken twice a day (BID); Participants will be randomized to one of 3 active doses (40, 80, or 120 mg), taking 3 tablets twice daily for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Gastric Electrical Stimulation (GES) for the Treatment of Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this feasibility study is to provide safety data on the implantable Exilis
      gastric electrical stimulation (GES) system, to individually adjust stimulation parameters to
      levels that are comfortable for implanted subjects during chronic daily treatment, and to
      collect data on acute gastrointestinal function and food intake responses to GES during
      in-clinic testing.
    


Intervention name(s): Exilis Implantable Gastric Electrical Stimulation (GES)
Intervention type(s): Device
Other intervention name(s): Exilis Implantable Gastric Electrical Stimulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Return of Actionable Variants Empirical Study
Condition: Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Observational

Summary: 
      This is a genomic implementation project with ancillary studies to understand the impact on
      patients' health and well-being of returning genomic results to them and depositing those
      results in the medical record.
    

Detailed description: 
      Study participant DNA samples will be sequenced for 109 genes of interest along with
      genotyping of select polymorphisms. Genetic tests will be performed in a Clinical Laboratory
      Improvement Amendments (CLIA) certified lab (Baylor Human Genome Sequencing Laboratory).
      Selected results (pathogenic/likely pathogenic) will be returned to participants by a genetic
      counselor and deposited into the Electronic Health Record (EHR).
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We recruited 3030 participants from Mayo Clinic biobanks in Rochester, MN, who had
        hypercholesterolemia, colon polyps or both, thereby enriching for FH.
      
Biospecimen description: 
      DNA obtained from blood samples in the primary cohort and from saliva in family members.
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content and GI Consumed Alone.
Condition: Metabolism and Nutrition Disorders
MeSH terms: Nutrition Disorders
Study type: Interventional

Summary: 
      This is a laboratory-based research study conducted in two parts. Open cross-over design. 2
      test sessions per subject included in the study. It aims at determining the postprandial
      blood glucose and insulin responses to the ingestion of cereal product differing by their SDS
      content and GI in 20 healthy non-smoking voluntary subjects, aged from 18 to 45 years.
    

Detailed description: 
      This is a laboratory-based research study conducted in two parts. Open cross-over design. 2
      test sessions per subject included in the study. It aims at determining the postprandial
      blood glucose and insulin responses to the ingestion of cereal product differing by their SDS
      content and GI in 20 healthy non-smoking voluntary subjects, aged from 18 to 45 years.
    

Intervention name(s): High-SDS biscuit; Low-SDS extruded cereals
Intervention type(s): Other; Other
Intervention description(s): Consumption of the high-SDS product (50g) alone with a glass of water; Consumption of the low-SDS product (42g) alone with a glass of water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Nutrition, glycemic response, cereal products
A Study To Investigate The Clearance Of PF-04776548 From The Body Following A Very Low (Micro) Dose Of The Compound Using A Low Level Of Radiotracer To Help Quantify Expected Low Concentrations Of PF-04776548 In The Body
Condition: Human Immunodeficiency Virus (HIV)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the pharmacokinetics of PF-04776548 following administration of a micro-dose
      of PF-04776548 via both intravenous and oral routes.
    


Intervention name(s): PF-04776548
Intervention type(s): Drug
Intervention description(s): single intravenous or oral administration of 0.1mg PF-04776548.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: micro-dose; pharmacokinetics; open label; PF-04776548
Recreational Diving Practice for Stress Management
Condition: Psychological Stresses
MeSH terms: Stress, Psychological
Study type: Observational

Summary: 
      Within the components of Scuba diving there are similarities with meditation and mindfulness
      techniques. Perceived stress is known to be diminished during meditation practice. This study
      evaluates the benefits of scuba diving on perceived stress and mindful functioning.
    

Detailed description: 
      Background: within the components of Scuba diving there are similarities with meditation and
      mindfulness techniques. Perceived stress is known to be diminished during meditation
      practice. This study evaluates the benefits of scuba diving on perceived stress and mindful
      functioning.

      Method: A recreational diving group, composed of 37 subjects, was compared with a multisport
      control group, composed of 30 subjetcs, on perceived stress, mood, well-being and mindfulness
      by answering auto-questionnaires before and after a one-week long course. For the diving
      group, stability of the effects was evaluated one month later using similar
      auto-questionnaires.
    

Intervention name(s): sport
Intervention type(s): Behavioral
Intervention description(s): recreaational sport : diving or multisport
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        middle-class populations registered at a leisure sports club were included: one population
        sample registered for a one-week recreational scuba diving course (37 subjects, diving
        group) and one population sample registered for a one-week multisport course (30 subjects,
        control group).