bioihbjkbjnl/mcl2 huggingface dataset:
Validation of a Diagnostic Tool for Postprandial Hypoglycaemia in Patients After Roux en Y Gastric Bypass Surgery
Condition: Post Prandial Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Observational

Summary: 
      Roux-en-Y gastric bypass (RYGB) leads to weight reduction but has also some unwanted side
      effects. A part of this population will develop postprandial reactive hypoglycemia (PPRH). At
      this moment no validated diagnostic tool exists for PPRH. The aim of this study is to prove
      an association between the Sigstad´s Score and the lowest postprandial glucose level in
      patients after RYGB surgery. This is investigated using a liquid mixed meal tolerance test
      (LMMTT). As a secondary hypothesis, associations between Edinburgh Hypoglycemia Scale (EHS)
      and postprandial glucose levels are investigated. Furthermore, changes of insulin and GLP-1
      levels during the test are analysed. Patient characteristics including co-morbidities are
      studied as possible influencing parameters. Moreover, a healthy control group is included to
      validate the results. Finally, a flowchart/diagnostic method will be proposed for diagnosing
      patients who had a RYBG surgery with symptoms suggestive of PPRH. Besides the LMMTT,
      participants at the Ghent University Hospital will undergo additional tests such as a solid
      mixed meal tolerance test (SMMTT) and continuous glucose monitoring (CGM). Associations
      between Sigstad Score, EHS and the lowest glucose measured during CGM and SMMTT will be
      investigated and compared to the results of the LMMTT.
    


Intervention name(s): Post Prandial Hypoglycemia test
Intervention type(s): Diagnostic Test
Intervention description(s): three test assessing hypoglycemia will be used: liquid mixed meal tolerance test, solid mixed meal tolerances test, continuous glucose monitoring
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        In total 100 GBS patients which will be recruited over multiple sites in Germany, Great
        Britain, Belgium and Denmark.

        Belgium will be the only site performing the solid mixed meal tolerance test and the
        continuous glucose monitoring additional to the liquid mixed meal tolerance test. All other
        sites will only do the liquid mixed meal tolerance test.

        In total 20 control patients (10 with a BMI 18-25 kg/m² and 10 with a BMI > 30 kg/m²) will
        be recruited. These will be recruited in Belgium (Ghent University Hospital) and the
        patients will undergo a liquid mixed meal tolerance test, a solid mixed meal tolerance test
        and a continuous glucose monitoring
      
Keywords: Roux en Y Gastric Bypass Surgery, Hypoglycemia, Postprandial
Early Bactericidal Activity of TBA-7371 in Pulmonary Tuberculosis
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, early bactericidal activity (EBA) and
      pharmacokinetics of TBA-7371 in adult participants with rifampicin-sensitive tuberculosis and
      select dose regimen(s) for future studies.
    


Intervention name(s): TBA-7371; TBA-7371; TBA-7371; TBA-7371; TBA-7371; HRZE
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive TBA-7371 oral suspension 100 milligram (mg) once daily (QD) for 14 days.; Participants will receive TBA-7371 oral suspension 100 mg twice daily (BID) for 14 days.; Participants will receive TBA-7371 oral suspension 200 mg QD for 14 days.; Participants will receive TBA-7371 oral suspension 100 mg three times daily (TID) for 14 days.; Participants will receive TBA-7371 oral suspension 400 mg QD for 14 days.; Participants will receive Isoniazid [H] / rifampicin [R] / pyrazinamide [Z] / ethambutol [E] (HRZE), a fixed dose combination (H: 75 mg / R: 150 mg / Z: 400 mg / E: 275 mg) tablet QD for 14 days.
Other intervention name(s): Rifafour® e-275
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rifampicin-sensitive pulmonary tuberculosis; TBA-7371; Pulmonary tuberculosis
Comparison Between Auto CPAP and Fixed CPAP in Chinese Patients With OSA
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      AutoCPAP would lead to better compliance than FixCPAP
    

Detailed description: 
      A prospective, randomized crossover cohort. Study subjects consisted of patients newly
      diagnosed with obstructive sleep apnea (OSA) confirmed with sleep study. All are CPAP naïve.

      Randomization:

      Arm 1: auto CPAP sleep study then auto CPAP for 2 months Arm 2: fixed CPAP titration then
      fixed CPAP for 2 months

      Then switch over to the other arm

      Trial end after 4 months, compliance and other parameters would be compared between two arms
      as described in the endpoint session.
    

Intervention name(s): AutoCPAP; FixCPAP
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
The Influence of Methotrexate on the Metabolism and Vascular Effects of Adenosine in Humans
Condition: Methotrexate; Vasodilation
Study type: Interventional

Summary: 
      In this study we aim to determine whether methotrexate influences the metabolism and vascular
      effects of adenosine in humans in vivo. Adenosine is an endogenous purine-nucleoside with
      potent anti-inflammatory effects. Also, adenosine receptor stimulation induces vasodilation,
      ischaemic preconditioning and many other cardiovacular effects. Previous animal studies have
      provided limited evidence that the anti-inflammatory effects of methotrexate are mediated by
      adenosine receptor stimulation. In this study, we aim to determine whether also in humans in
      vivo, methotretate influences endogenous adenosine. Therefore, 10 patients with inflammatory
      arthritis are treated with methotretxae (15 mg/week orally) for 12 weeks. Before and after
      treatment, vasodilation to the infusion of adenosine and dipyridamole into the brachial
      artery is assessed as biomarker for the endogenous adenosine concentration.

      Also, blood is drawn for the determination of CRP, ESR, Adenosine deaminase activity adn
      homocysteine.
    


Intervention name(s): Methotrexate 15 mg/week for 12 weeks
Intervention type(s): Drug
Intervention MeSH terms: Methotrexate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Rebound Therapy in Parkinson's Patients
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Today, physiotherapy approaches in Parkinson's Disease (PD) form the basis of optimal
      treatment together with medical and surgical treatment. It is stated that various
      rehabilitation interventions may be effective in the field of physiotherapy. The frequently
      preferred among these rehabilitation interventions is the conventional treatment approach. In
      the conventional treatment, various exercises are preferred to improve balance and walking,
      as well as stretching and strengthening. On the other hand, rebound therapy require strong
      integration of the neuromuscular system and provide more active use of lower extremity muscle
      strength. Rebound therapy have been shown to be effective in improving balance in many
      neurological disease groups, but there is very little study on rebound therapy in PD. It was
      shown that rebound therapy improve proprioceptive sense, joint range of motion and quality of
      life. On the other hand, no study has been found showing its effect on balance and walking.
      Therefore, there is a need to investigate the effectiveness of rebound therapy on balance and
      walking.
    

Detailed description: 
      This study is a randomized controlled study. The patients will be randomly divided into two
      groups as rebound and control. The rebound group will perform exercises on a trampoline,
      consisting of 15 minutes of trunk and extremity stretching, 10 minutes of walking, and
      approximately 30 minutes of task-oriented exercises, twice a week for six weeks. While the
      control group will follow the same program as the rebound group, they will only perform
      task-oriented exercises on a stable surface, unlike the rebound group. As the outcome
      measures, disease severity and disability, balance, and gait performance will be evaluated.
    

Intervention name(s): Rebound therapy; Exercises on a stable surface
Intervention type(s): Other; Other
Intervention description(s): Participants will receive exercise-based training on a trampoline; Participants will receive exercise-based training on a stable surface
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups as rebound group and control group
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; rebound therapy; task oriented training; balance and walking performance
Effectiveness of Myofascial Release Versus Manual Lymphatic Drainage After Breast Cancer Surgery
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Objective. To compare the effectiveness of myofascial therapy against manual lymphatic
      drainage in the reduction of sequelae secondary to conservative surgery and radiotherapy in
      women who survived breast cancer.

      Design. Randomized clinical trial. Site. Faculty of Physiotherapy of the University of
      Valencia. Participants. Twenty-four patients were included in the study. Interventions. 13
      patients were randomly assigned to treatment with myofascial therapy and 11 to receive manual
      lymphatic drainage.

      Main measurements. Pain measured using the Visual Analogue Scale, shoulder joint range,
      shoulder functionality using the DASH questionnaire, quality of life assessed using the
      FACT-B questionnaire, and the depressed status of the patients using the PHQ-9 . All of this
      was assessed before and after treatment, and one month later as follow-up.
    


Intervention name(s): Lymphatic Drainage; Myofascial Release
Intervention type(s): Other; Other
Intervention description(s): It was applied with the patient in a supine position with 30º elevation of the arm and very superficial and smooth maneuvers were performed in the axillary lymph nodes, the chest region and the arm.; For the use of the treatment the bases of Pilat, A. 2016 were followed. The global and specific techniques for the periganglionar and upper thoracic region were chosen. The application of each smooth maneuver three-dimensional fascial movement has been carried out has an approximate duration of about 10 minutes and a total of 50 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myofascial-reléase; Fibromyalgia; Lymphatic drainage; Breast cancer
The TREFOIL Concept 5 Year Clinical Investigation
Condition: Edentulous or Failing Dentition Mandible
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      Prospective, single cohort, multi-center study evaluating the TREFOIL concept for the
      treatment of edentulous or patients with failing mandibular dentition over 5 years. 90
      patients (15 per centre) will be included. The subject population is at least 18 years old,
      in need of an implant restored full prosthesis providing sufficient bone in the
      interforaminal where a fixed restoration on three implants is regarded as an appropriate
      treatment solution. The components are TREFOIL treatment concept (implants and framework).
    


Intervention name(s): TREFOIL concept
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glucocorticoid in Treatment of Adult Idiopathic Nephrotic Syndrome：a Prospective Observational Study
Condition: Nephrotic Syndrome，Idiopathic
MeSH terms: Nephrotic Syndrome; Nephrosis; Syndrome
Study type: Interventional

Summary: 
      This study is to assess the efficacy and safety of 8-weeks full-dose induction protocol
      (prednisone 1mg/kg, maximum 60mg/day) and protracted tapering protocol in the treatment of
      adult idiopathic nephrotic syndrome.
    

Detailed description: 
      In full-dose induction period, patients scheme to visit at the 4th and 8th week, and in
      protracted tapering period at 10th , 22nd, 42nd and 66th week. If the patients reach complete
      remission within 4 weeks, prednisone may be decreased at the 6th week, otherwise keep on the
      course to the 8th week. All patients reach complete remission will shift to protracted
      tapering period and follow up until prednisone withdrawal, except the cases that relapse and
      drop out the study. If proteinuria reappears in someone, angiotensin-converting enzyme
      inhibitor（ACEI） or angiotensin receptor blocker（ARB） will be considered combination, on the
      premise of the blood pressure is affordable.
    

Intervention name(s): prednisone
Intervention type(s): Drug
Intervention description(s): Full-dose induction period: Prednisone 1mg/kg.day, maximum 60mg/day, orally, divided into 3 times; Protracted tapering period: orally, no ask for fract. dos.
Intervention MeSH terms: Prednisone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prednisone; idiopathic nephrotic syndrome; prospective
A Safety and Tolerability Study of BDB-001 in Mild, Moderate COVID-19 Patients
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This open, multi-center, multiple ascending dose study was designed to evaluate the safety,
      tolerability, preliminary efficacy and PK/PD of BDB-001 injection in patients with mild, or
      general COVID-19.
    


Intervention name(s): BDB-001 injection; BDB-001 injection; BDB-001 injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV infusions of Injection diluted in sodium chloride; IV infusions of Injection diluted in sodium chloride; IV infusions of Injection diluted in sodium chloride
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Remote Ischaemic Preconditioning in Children Undergoing Cardiac Surgery
Condition: Ischaemic Reperfusion Injury
MeSH terms: Reperfusion Injury; Ischemia
Study type: Interventional

Summary: 
      Surgical correction of congenital heart defects in children requires the utilization of
      cardiopulmonary bypass, a technique that temporarily substitutes heart and lung functions
      during surgery. During this process the patient´s circulation is controlled by a bypass
      machine which provides several functions:

        1. Controls the patient's blood flow by pumping of blood in the patient's body.

        2. Controls the correct oxygen levels in the patient's blood.

        3. Regulates the temperature and fluid level of the blood. This process triggers negative
           responses in the heart and throughout the whole body, potentially resulting in injury to
           the heart and other organs such as brain, kidneys and lungs.

      Remote ischaemic preconditioning (RIPC) describes a procedure that could potentially reduce
      the injury to heart muscle during cardiac surgery. The procedure consists of the inflation of
      a blood pressure cuff on the child's leg for three 5 minute cycles. This process acts by
      briefly reducing blood flow to the leg muscle, which will then activate the body´s own
      protective mechanisms and thereby reduce heart injury.

      Several animal studies have been used to help the understanding of the mechanisms behind this
      process, and trials in human adults have showed optimistic results; however evidence
      regarding the paediatric population is limited and necessary since children present different
      basal profiles, risks and requirements.

      The investigators propose a randomized clinical trial assessing the efficacy of RIPC to
      provide protection against injury to the heart and other organs in children going through
      cardiac surgery using CPB at the Royal Hospital for Sick Children. The research project will
      have a translational approach, integrating basic molecular mechanisms to clinical outcome.
      The investigators hope it will allow the understanding and utilisation of the patient´s own
      protective mechanisms, reducing CPB-related injury and ultimately improving patient outcome.
    


Intervention name(s): Remote ischaemic preconditioning (RIPC); Placebo
Intervention type(s): Procedure; Procedure
Intervention description(s): RIPC will be performed by 3 cycles of 5 minute leg ischaemia induced by inflation of a blood pressure cuff to 40 mmHg above the patient's systolic pressure. This protocol will be performed at two phases: 24 hours before surgery and during anaesthesia immediately prior to surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Drainage Seton With Flap Versus EAS Preserving Seton in Treatment of Transsphincteric Anal Fistula
Condition: Anal Cancer
MeSH terms: Anus Neoplasms; Rectal Fistula; Fistula
Study type: Interventional

Summary: 
      Patients with high trans-sphincteric anal fistula will be randomized to one of two equal
      group: group 1 will have drainage seton with mucosal advancement flap and group 2 will
      undergo external anal sphincter sparing seton
    


Intervention name(s): Drainage seton with flap; EAS sparing seton
Intervention type(s): Procedure; Procedure
Intervention description(s): Seton is placed around the external sphincter then mucosal advancement flap will be constructed; Rerouting of the seton around the internal sphincter only sparing the external sphincter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Safety With Ziprasidone in First-episode Psychosis
Condition: First Episode Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to investigate the efficacy and safety of ziprasidone in patients
      with first episode psychosis.
    


Intervention name(s): Ziprasidone
Intervention type(s): Drug
Intervention description(s): 8 week prospective study
Intervention MeSH terms: Ziprasidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase I Study to Determine the Effect of Mifepristone on the Pharmacokinetics of Fluvastatin in Healthy Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to determine the effect of single and multiple oral doses of mifepristone on
      the pharmacokinetics of a single oral dose of fluvastatin administered to healthy volunteers.
    

Detailed description: 
      This is a fixed-sequence, drug-drug interaction study in healthy volunteers lasting up to a
      total of 9 weeks: up to 4 weeks screening, approximately 2 weeks for dosing (including a
      1-week washout between periods), and approximately 3 weeks of a drug-free interval until
      termination. The purpose of this study is to determine the effect of single and multiple oral
      doses of CORLUX on the pharmacokinetics of a single oral dose of fluvastatin administered to
      healthy volunteers.
    

Intervention name(s): mifepristone + fluvastatin
Intervention type(s): Drug
Intervention description(s): Subjects will receive a single oral dose of 40 mg PO of fluvastatin on three occasions: alone (Day 1), at the same time as a single dose of CORLUX 1200 mg (Day 8) and during concomitant administration of CORLUX 1200 mg/day (CORLUX on Days 8-14, fluvastatin on Day 14).
Other intervention name(s): CORLUX + Lescol
Intervention MeSH terms: Mifepristone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: mifepristone; CORLUX; fluvastatin; Lescol; drug-drug interaction; DDI; pharmacokinetics
Safety and Effectiveness of Lopinavir/Ritonavir in HIV Infected Infants
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to find out if the drug lopinavir/ritonavir (LPV/RTV) is safe
      and well tolerated in HIV infected infants. This study will also determine the most effective
      dose of LPV/RTV for infants.
    

Detailed description: 
      LPV/RTV has shown significant antiviral activity and tolerability in clinical trials in
      adults and children over 6 months of age. LPV/RTV has been approved by the FDA to treat older
      children and adults with HIV. Data for children under 6 months, however, have not been
      available. LPV/RTV has not been approved for infants less than 6 months old, and the
      appropriate dose for young infants is not known. Dosing guidelines are needed for young
      infants, most of whom are in the early stages of primary infection. This study will help
      identify an appropriate dose range of LPV/RTV and evaluate response to therapy in infants
      less than 6 months of age. The study will also evaluate whether early therapy allows normal
      development of the immune system.

      Infants between 14 days and 6 months of age will receive LPV/RTV in combination with 2
      nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their physicians. Twelve-hour
      pharmacokinetic sampling is performed on Day 14 of drug treatment and when the patient
      reaches 12 months of age. Patients will undergo a physical exam, medical history assessment,
      and blood collection at selected study visits. Study visits will occur every 2 weeks for the
      first 8 weeks, then every 4 weeks until the end of the first year of the study. Study visits
      during the second year will be every 12 weeks until the end of the study. The parent or
      guardian will be contacted by phone every 6 weeks to monitor adverse drug effects.
      Participants between the ages of 6 weeks but less than 6 months old will be followed for 96
      weeks after the enrollment of the last participant. Participants between the ages of 14 weeks
      but less than 6 weeks will be followed for 48 weeks after the enrollment of the last
      participant.
    

Intervention name(s): Lopinavir/Ritonavir
Intervention type(s): Drug
Intervention MeSH terms: Ritonavir; Lopinavir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lopinavir; HIV-1; Drug Therapy, Combination; HIV Protease Inhibitors; Ritonavir; Reverse Transcriptase Inhibitors