bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Running Shoe Sole Hardness on Vibration and Neuromuscular Fatigue During a Half-marathon Run on a Treadmill
Condition: Healthy Volunteers
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      During running, each contact between the foot and the ground causes an impact. Ground
      reaction forces (GRF) are considered as an input into the musculoskeletal system. It involves
      a sudden deceleration in the lower limb packages (including muscles) which generates
      Soft-Tissue Vibrations (STV). The body is able to attenuate Soft-Tissue Vibrations (STV) but
      this capability decreases with fatigue. STV could be minimize by improving shoe midsole
      hardness.
    

Detailed description: 
      Only 4 studies have studied Soft-Tissue Vibrations (STV) with a distance not exceeding 10 km
      and without evaluating the potential influence of the shoe. Thus, the effects of shoe midsole
      hardness on Soft-Tissue Vibrations (STV) and neuromuscular fatigue at the end of an intense
      and/or long run remains unknown.

      The purpose is to compare two shoes whose only midsole hardness differs during a
      half-marathon on Soft-Tissue Vibrations (STV), neuromuscular fatigue and running kinetics.

      Maybe the shoe ensuring a better STV damping of the medial gastrocnemius muscle would reduce
      neuromuscular fatigue and improve comfort.
    

Intervention name(s): "hard shoes" runners evaluation; "Soft shoes" runners evaluation
Intervention type(s): Other; Other
Intervention description(s): The "hard shoes" runners get on the treadmill for 21 km at a speed corresponding to 70 percent (%) of their the maximum aerobic speed (MAV) and are evaluated.; The "soft shoes" runners get on the treadmill for 21 km at a speed corresponding to 70 percent (%) of their the maximum aerobic speed (MAV) and are evaluated.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Soft-tissue vibrations; Footwear; Endurance athletes; Running; Muscle Weakness
Candesartan Versus Propranolol for Migraine Prevention
Condition: Migraine Without Aura; Migraine With Aura; Chronic Migraine
MeSH terms: Migraine Disorders; Migraine without Aura; Migraine with Aura
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The main aim of the present study is to compare candesartan with propranolol for migraine
      prophylaxis.
    

Detailed description: 
      Candesartan was shown to be effective for migraine prophylaxis in a randomized double blind
      cross-over study published in 2003. The drug is now widely used for this purpose in many
      countries, although no confirmatory study has been published. The aims of the present study
      are: 1) to see if the results in the first candesartan study can be replicated in a new
      patient population, including patients with chronic migraine, and, 2) to perform a
      head-to-head comparison of candesartan 16 mg/day with standard treatment with propranolol 160
      mg slow release. We also intend to study whether responsiveness to these drugs may be related
      to heart rate variability and baroreceptor sensitivity.
    

Intervention name(s): Candesartan; propranolol; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Candesartan cilexitil tablets, 16 mg once daily; Propranolol hydrochloride capsules 160 mg once daily, slow release formulation; placebo tablets and capsules
Intervention MeSH terms: Propranolol; Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Retrospective, Uncontrolled Cohort Study on the Therapy of Chronic Megalon
Condition: Megacolon
MeSH terms: Megacolon
Study type: Observational

Summary: 
      The aim of this retrospective cohort study is to analyze all available data of patients with
      chronic megacolon in three clinical centers with respect of conservative and surgical
      therapies.
    

Detailed description: 
      Megacolon may be defined as dilatation of the abdominal colon with a minimum of 9 cm in
      diameter and the absence of mechanical obstruction. Chronic megacolon in adults is an
      acquired uncommon condition that generally is associated with constipation. It has to be
      distinguished from other forms of megacolon such as acute toxic megacolon, acute non-toxic
      megacolon (Ogilvie´s-syndrome) and congenital megacolon (Hirschsprung disease). Regardless of
      concomitant diseases and causes, most patients with chronic megacolon were treated by
      laxative measures. Less is known about the optimal conservative therapy . If conservative
      measures fail, there are several surgical options, depending upon anorectal function.
      However, less in known about the optimal surgical therapy of patients with chronic megacolon.
      The aim of this retrospective cohort study is to analyze all available data of patients with
      chronic megacolon in three clinical centers with respect of conservative and surgical
      therapies.
    

Intervention name(s): colon surgery; Laxatives
Intervention type(s): Procedure; Drug
Intervention description(s): There are no guidelines to direct surgical therapy in patients with chronic megacolon. Historically, it is the surgeons individual choice to use one of the above mentioned surgical treatments. Therefore, the aim of this study is to analyze the success and downsides of the different surgical approaches.; There are no guidelines to direct laxative measures in patients with chronic megacolon. Historically, it is the gastroenterologists individual choice to use one of the above mentioned laxative measures. Therefore, the aim of this study is to analyze the success and downsides of the different Laxative measures.
Other intervention name(s): Subtotal colectomy with ileorectal anastomosis; Diverting loop ileostomy; Colectomy with ileoanal anastomosis; Decompressive cecostomy with periodic antegrade enemas; Segmental colon resection; High-colonic water enema; Water-soluble contrast enema; PEG electrolyte solution; Colon decompression probe; Prucaloprid; Bisacodyl
Intervention MeSH terms: Bisacodyl; Laxatives
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The databases of three clinical centers were systematically screened for patients with
        chronic megacolon (exclusion/inclusion criteria) in the time frame from 1.5.2005 to
        1.5.2020.
      
Keywords: Megacolon
DBPR108 Tablets in Type 2 Diabetes Mellitus Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluate DRBP108 in the treatment of type 2 diabetes mellitus. The patients were
      randomly allocated to four groups: 50 mg, 100 mg, 200 mg and placebo group.
    

Detailed description: 
      This study was to evaluate DRBP108 in the treatment of type 2 diabetes mellitus. A total of
      268 subjects were randomly allocated to four treatment arms: 50 mg, 100 mg, 200 mg or placebo
      group, in a 1:1:1:1 ratio.
    

Intervention name(s): DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg); DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg); DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg); Placebo matching DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One DBPR108 tablet(50mg) administered orally once a day + Two Placebos matching DBPR108 tablet(100mg) administered orally once a day for 12 weeks; One DBPR108 tablet(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(50mg) administered orally once a day for 12 weeks; Two DBPR108 tablets(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(50mg) administered orally once a day for 12 weeks; Two Placebos matching DBPR108 tablet(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(50mg) administered orally once a day for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: DBPR108; type 2 diabetes mellitus; DPP4 inhibitor
Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Condition: Systemic Sclerosis; Scleroderma
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This Phase I/II placebo controlled trial will evaluate tofacitinib in subjects with diffuse
      cutaneous systemic scleroderma (dcSSc). This trial is intended to provide safety, and
      tolerability data in participants with dcSSc when dosed to target exposures similar to that
      used in adult participants with rheumatoid arthritis.
    

Detailed description: 
      The purpose of this clinical research study is to evaluate the safety, tolerability and
      efficacy of treatment with tofacitinib (study drug) versus placebo (a substance with no
      active ingredients and therefore may have no treatment benefit) in people with diffuse
      cutaneous systemic scleroderma. Subjects will be randomized to tofacitinib vs. placebo in a
      2:1 ratio at 5 mg twice a day for 24 weeks. Subjects will then be offered to participate in
      an open label phase during which they will receive tofacitinib 5 mg twice a day for 24 weeks.
    

Intervention name(s): Tofacitinib; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Oral medication tofacitinib 5 mg twice a day for 24 weeks.; Oral Placebo 5 mg twice a day for 24 weeks
Other intervention name(s): Xeljanz
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible subjects will be randomized to tofacitinib or placebo in a 2:1 manner.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diffuse; scleroderma; systemic sclerosis
Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer
Condition: Ovarian Neoplasms
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to compare the efficacy and safety of 2 doses of drug AZD2281
      against liposomal doxorubicin to see which is effective and well tolerated in treating
      patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and who have failed
      previous platinum therapy.
    


Intervention name(s): AZD2281; Liposomal Doxorubicin; AZD2281
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 400mg Oral twice daily; 50mg/m2 Monthly Intravenous; 200mg oral twice daily
Other intervention name(s): Olaparib; Doxil®
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Olaparib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced ovarian cancer; BRCA1 protein; BRCA2 protein; Poly(ADP ribose) polymerases
A Comparison of Controlled Ventilation With the V60 Non-Invasive Ventilator vs. Traditional Mask Ventilation
Condition: Respiratory Complications Due to Anesthesia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether an experienced anesthesia provider can
      adequately and/or easily mask ventilate an anesthetized patient with a commercial
      non-invasive ventilator device.
    

Detailed description: 
      The purpose of this study is to determine whether an experienced anesthesia provider can
      adequately and/or easily mask ventilate an anesthetized patient with a commercial
      non-invasive ventilator device. The ventilator subject of this study is commonly used in the
      ICU and investigators aim to evaluate its usefulness in the OR. Investigators believe that
      the ventilator will ventilate with consistent breath rates, adequate tidal volumes and
      minimal airway pressures. The providers subjective scoring of ease or difficulty of
      ventilation with each device will also be recorded.
    

Intervention name(s): Noninvasive Ventilator, V60 (Philips); Manual Bag
Intervention type(s): Device; Device
Intervention description(s): The noninvasive ventilator will be set to deliver 10 breaths per minute with a pressure setting of 8 cm H2O during exhalation and 20 cm H2O during inspiration. The inspired oxygen fraction given by the ventilator will be set at the maximum level (100% oxygen).; Oxygen will flow through the standard breathing circuit with the fresh gas flow rate set at 10 L/min and the patient will be ventilated. The anesthesia provider will manually bag mask ventilate the patient until the anesthesiologist feels comfortable that the patient can be ventilated appropriately.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Multiple Instrumentation for ACL Reconstruction Regarding Bacterial Contamination
Condition: Anterior Cruciate Ligament Injuries
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Observational [Patient Registry]

Summary: 
      To determine the Effect of multiple instrumentation regarding bacterial contamination in
      transportal and transtibial techniques in ACL reconstruction .A Randomized controlled study
    

Detailed description: 
      Infection is a catastrophic and one of the most dreaded complications in orthopaedic surgery.
      Several measures have been undertaken to reduce the risk of infection, one of which is the
      use of systemic prophylactic antibiotics.

      The purpose of this study is to determine the effect of multiple instrumentation regarding
      bacterial contamination in transportal and transtibial techniques in ACL reconstruction .
      About Eighty consecutive patients having surgical indication for ACL-R will be included, the
      cases will be divided into two groups, 35 cases will undergo for the transtibial technique
      and the other 45 cases will undergo for the transportal technique. After preparation, swabs
      will be obtained from subcutaneous tissue at antromedial portal track in transportal
      technique (femoral tunnel drilling) and in transtibial technique before and after the
      instrumentation and femoral screw insertion, a control sample will be taken at antrolateral
      track in both techniques, then samples will be sended to the lab to be studied.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Total coverage of all eligible cases will be admitted to Arthoscopic Unit within 6 months
      
Biospecimen description: 
      After preparation, swabs will be obtained from subcutaneous tissue at antromedial portal
      track in transportal technique (femoral tunnel drilling) and in transtibial technique before
      and after the instrumentation and femoral screw insertion, a control sample will be taken at
      antrolateral track in both techniques, then samples will be sended to the lab to be studied.
Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
Condition: Hypoglycemia; Complications of Bariatric Procedures
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to test an optimized control system for sensor-guided
      (physician administered) delivery of glucagon, and test Proof-of-Concept (POC) in a clinical
      setting in patients with severe hypoglycemia following bariatric surgery.
    

Detailed description: 
      This is a Phase 2a, single-center, open-label, proof-of-concept study designed to test the
      ability of the control algorithm to detect and direct timing of G-Pump™ glucagon infused from
      an OmniPod® pump to prevent hypoglycemia in patients with post-bariatric hypoglycemia
      syndrome. While the algorithm will provide an alert as to when glucagon should be dosed to
      prevent hypoglycemia, there will be no automation in this clinical trial and it will
      ultimately be up to the physician to initiate dosing via the OmniPod® controller.

      Participant on continuous glucose monitoring will arrive at the clinic and IV line will be
      inserted for venous access. Subject will then be asked to drink a liquid mixed meal
      containing 60 g of carbohydrates, e.g. Boost® Nutritional Drink, over 10 minutes. Blood
      samples will be collected for glucose and hormone measurement.

      The open-loop system will be set to recognize low sensor glucose values, triggering an alert
      to the physician, who will deliver a bolus of 150 or 300 µg of glucagon via the pump, with
      the goal of preventing further decline in glucose values. Depending on response, a second
      bolus dose of 150 or 300 µg of glucagon may be administered. Plasma glucose will be measured
      after glucagon administration to ensure successful treatment and glucose stability, and
      glucagon levels will be analyzed concurrently to determine magnitude of increase above
      baseline. Sensors will be downloaded for subsequent analysis of appropriateness of alert
      timing and trigger for glucagon bolus delivery.
    

Intervention name(s): G-Pump™ (glucagon infusion)
Intervention type(s): Drug
Intervention description(s): 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump
Other intervention name(s): glucagon
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypoglycemia; glucagon; glucose metabolism disorders; hormones; gastrointestinal agents; bariatric surgery; incretins
Study of MEDI 507 in the Treatment of Pediatric Patients
Condition: Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety of escalating dose levels of MEDI-507 in pediatric stem cell and bone
      marrow allograft recipients who have at least Grade II GvHD.
    

Detailed description: 
      This is a Phase I, open-label dose escalation trial of MEDI-507 in pediatric SCT and BMT
      recipients with at least Grade II acute GvHD. All patients will receive steroid therapy and
      MEDI-507 for treatment of GvHD
    

Intervention name(s): MEDI-507; MEDI-507; MEDI-507
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.012 mg/kg given intravenously on Study Days 0, 3, 6 and 9; 0.04 mg/kg given intravenously on Study Days 0, 3, 6 and 9; 0.12 mg/kg given intravenously on Study Days 0, 3, 6 and 9
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute GvHD of at least Grade II severity
Behavioral Pharmacology of THC and D-limonene
Condition: D-limonene and THC Pharmacodynamics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized d-limonene
      and THC administered via inhalation.
    

Detailed description: 
      The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research
      Unit (BPRU). Participants will complete 9 acute drug administration periods in which they
      will administer THC alone, limonene alone, THC and limonene together, or placebo. Subjective
      drug effects and vital signs will be assessed following drug administration. Each participant
      will receive all 9 dose conditions in a randomized order using a placebo controlled
      within-subject crossover design. The study will help us understand the individual and
      interactive effects of THC and d-limonene, two common constituents found in cannabis.
    

Intervention name(s): Placebo; Vaporized THC, limonene, or THC and limonene
Intervention type(s): Drug; Drug
Intervention description(s): Placebo vapor (distilled water); Acute drug exposure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Resveratrol and First-degree Relatives of Type 2 Diabetic Patients
Condition: Pre-diabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The main objective of the study is to investigate if resveratrol supplementation can improve
      overall and muscle-specific insulin sensitivity in first-degree relatives of type 2 diabetic
      patients.

      As a secondary objective the investigators want to investigate whether the improved insulin
      sensitivity can be attributed to improved muscle mitochondrial oxidative capacity and a
      reduced intrahepatic and cardiac lipid content. Furthermore, in a subset of the participants
      the investigators want to investigate the effect of resveratrol on glucose uptake in brown
      adipose tissue.
    


Intervention name(s): placebo; resveratrol
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A placebo will given for 30 days or 34 days (if included in brown adipose tissue measurement), twice daily. One pill will be provided with lunch, and the other pill will be provided with dinner.; resveratrol will be given for 30 days or 34 days (if included in brown adipose tissue measurement), twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill, also containing 75 mg will be given with dinner. So in total a dose of 150 mg/day will be given.
Other intervention name(s): resVida (99% pure trans-resveratrol)
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Resveratrol; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Hematologic Agents; Antimutagenic Agents; Anticarcinogenic Agents; Central Nervous System Agents; Brown Adipose Tissue
A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to study the clinical safety, tolerability, and efficacy of
      zoledronic acid compared to an oral bisphosphonate in postmenopausal women with osteoporosis.
    


Intervention name(s): zoledronic acid
Intervention type(s): Drug
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Osteoporosis, osteopenia, post-menopausal, zoledronic acid