bioihbjkbjnl/mcl2 huggingface dataset:
A Trial in Healthy Volunteers, to Evaluate the Tolerability and Cardiac Safety of Prucalopride
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 1

Summary: 
      An escalating dose of prucalopride up to a maximum of 20 mg was given once daily to 32
      healthy volunteers to determine safety at the maximum tolerable dose or at 20 mg.
    

Detailed description: 
      This is a single-centre, double-blind, placebo-controlled, cross-over trial in 32 healthy
      volunteers with two sessions (I and II). Each session consists of a run-in day for baseline
      assessments, 13 treatment days and 5 additional days for assessments. Subjects will be
      randomized to start with either the prucalopride or placebo session.

      Between the 2 sessions, there will be a washout period of 14 to 21 days, to avoid any
      carry-over effect.
    

Intervention name(s): prucalopride; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The dose will be consecutively escalated in 2 mg steps per day, starting from 2 mg up to 20 mg once daily or until severe drug-related adverse events occur (= individual maximum tolerable dose, on decision of the subject and/or investigator).; During the placebo session, the number of placebo tablets will be consecutively escalated in an identical way as described for prucalopride. This means 1 tablet more every day, up to 10 tablets.
Other intervention name(s): Resolor
Intervention MeSH terms: Prucalopride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: constipation; prucalopride; MTD; cardiovascular safety
Association Between Plasma Melatonin and No-reflow
Condition: ST-segment Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      ST-segment elevation myocardial infarction (STEMI) is an acute manifestation of coronary
      heart disease, remaining a frequent cause of death. A better understanding of risk factors
      and pathogenic mechanisms underlying STEMI may help improve the prognosis and life quality of
      these patients. Melatonin is the chief indoleamine produced by the pineal gland, and a
      well-known antioxidant and free radical scavenger. Basic studies have showed that melatonin
      is associated with myocardial infarction and heart failure. However, no study has evaluated
      whether melatonin is associated with adverse clinical outcomes in STEMI patients.
    


Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        PLA general hospital (PLAGH) is a large national tertiary-care center in the Beijing,
        China. The investigators enrolled all patients consecutively hospitalized in PLAGH, with a
        diagnosis of STEMI and needed PCI.
      
Biospecimen description: 
      melatonin, high-sensitivity C-reactive protein (hsCRP), superoxide dismutase levels
    
Keywords: melatonin; STEMI; No-reflow
Home-based Intermittent Pneumatic Compression Therapy for Gynecologic Cancer
Condition: Gynecologic Cancer; Lymphedema of Leg
MeSH terms: Lymphedema
Study type: Interventional

Summary: 
      Investigators conducted a prospective study of cancer patients to investigate the efficacy,
      quality of life, satisfaction, and safety of a home-based intermittent pneumatic compression
      (IPC) device during the maintenance phase of lower extremity lymphedema. This device has a
      unique mode designed to mimic the manual lymphatic drainage (MLD) technique and thereby
      gently facilitate lymphatic draining of proximal extremities.
    


Intervention name(s): home-based intermittent pneumatic compression (IPC) device
Intervention type(s): Device
Intervention description(s): During the intervention, two programmed modes were used. The first mode, which mimics the MLD massage technique, begins with the inflation of the proximal chamber. After reaching the target pressure, the next chamber consecutively inflates while the initially inflated proximal chamber deflates. The inflation time of each chamber is 3 seconds with holding time of 1 second. The deflation and resting time of each chamber is 7 seconds (pressure setting: 40-60 mmHg). After 30 minutes of the first mode, the second mode, which is the conventional mode of sequential inflation from distal to proximal chambers while sustaining the pressure of the previously inflated chambers, was applied for 30 minutes (pressure setting: 80-100 mmHg, inflation time of each chamber: 6 seconds, holding time: 1 second, deflation time of each chamber: 7 seconds). Participants were instructed to use the IPC device with that 1-hour cycle twice a day for four weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
Condition: Hepatitis B; Tetanus; Poliomyelitis; Diphtheria; Haemophilus Influenzae Type b; Acellular Pertussis
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose
      primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity
      in different population of infants residing in Canada.
    

Detailed description: 
      This protocol posting has been updated following Protocol amendment 1 (19-MAY-2010).
    

Intervention name(s): Infanrix™ hexa
Intervention type(s): Biological
Intervention description(s): Intramuscular, three doses
Other intervention name(s): DTPa-HBV-IPV/Hib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Infant; First nation; Aboriginal; Canada
Serum Progesterone on the Day of Thawed Embryo Transfer and Pregnancy Rate After an Artificial Endometrial Preparation
Condition: IVF
Study type: Interventional

Summary: 
      To determine if different serum Progesterone levels on FET day are associated with different
      clinical pregnancy rates (CPR), and if increasing dosage of vaginal Progesterone in cases of
      lower serum Progesterone level on FET day can be either beneficial or detrimental regarding
      the CPR.
    

Detailed description: 
      Over the past decade, the use of frozen-thawed embryo transfer (FET) has risen around the
      globe. There is no consensus which mode of FET is superior, either natural cycle (NC) or
      artificial cycle (AC) with hormonal replacement therapy (HRT). The latter has become more and
      more popular because it allows more flexibility in timing of FET and it requires fewer visits
      for monitoring before the transfer. AC also has the advantage of a more precise control of
      progesterone (P) exposure, which is of utmost importance for controlling the window of
      implantation between the embryo and the endometrium. Although FET in AC give excellent
      results, there is still a need for improvement, as the ideal dose is not individualized to a
      patient's characteristics and serum P required for optimal cycle outcome haven't been
      established.

      Retrospective studies about P levels on the day of FET in AC cycles showed contradictory
      results regarding cycle outcomes. Several studies showed that a lower P levels on FET day, or
      one day prior, are associated with lower clinical pregnancy rate (CPR) or live birth rate
      (LBR), whereas one study showed that women with higher P on FET day were having lower LBRs.
      Recently, a prospective study showed that serum P level < 9.2 ng/ml on the day of FET in
      oocyte reception cycles was associated with a significant lower ongoing pregnancy rate.
      Considering these previous studies, we wanted to determine if different serum P levels on FET
      day are associated with different CPR, and if increasing dosage of vaginal P in cases of
      lower serum P level on FET day can be either beneficial or detrimental.
    

Intervention name(s): Progesterone
Intervention type(s): Drug
Intervention description(s): To determine if different serum P levels on FET day are associated with different clinical pregnancy rates (CPR)
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Absorption, Distribution, Metabolism and Excretion of [14C]- Labeled BIA 5-453 and Metabolites
Condition: Hypertension; Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to:

      To determine the rate and routes of excretion of BIA 5-453 and the mass balance in urine and
      faeces
    

Detailed description: 
      Monocentre, open, non-placebo-controlled, single-group, single-dose study Safety measurements
      (12-lead ECG, vital signs, blood chemistry and haematology) will be conducted before and
      after the study, adverse events will be monitored throughout the study.

      Subjects should be hospitalized the day before the administration until 264 hours thereafter.
    

Intervention name(s): BIA-5-453
Intervention type(s): Drug
Intervention description(s): Each subject will receive a single oral dose of 100 μCi/ 3.7 MBq 14C labeled BIA 5-453 (600 mg).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Korean Red Ginseng on Semen Parameters in Male Infertility Patients: a Randomized, Placebo-controlled, Double-blind Clinical Study
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Interventional
Phase: Phase 4

Summary: 
      Korean Red ginseng (KRG) has long been applied to various diseases as a health-promoting
      herbal medicine in Korea. Many clinical studies of ginseng have been performed to elucidate
      its therapeutic characteristics. KRG has been shown to be effective in many diseases, such as
      cancers, hypertension, Alzheimer's disease, diabetes, acquired immune deficiency syndrome,
      and sexual dysfunction. Several studies have indicated effects of ginseng on improving
      spermatogenesis in animals. The major mechanisms behind these effects were speculated to be
      anti-oxidant and anti-aging effects, as well as modulation of the
      hypothalamus-pituitary-testis axis [7 - 10]. However, there have been no controlled human
      clinical trials to evaluate the effects of KRG on spermatogenesis in patients with male
      infertility.

      Only a small proportion of causes of male infertility are currently curable, including male
      hypogonadal disorders that can be cured by gonadotropic agents, and obstructive azoospermia
      that can be corrected by surgery. In addition, evidence-based medicine has revealed that most
      empirical treatments are ineffective. Similarly, the efficacies of carnitine, anti-estrogens,
      kallikrein, vitamins C and E, and glutathione have not been confirmed.

      Therefore, the investigators investigated the effects of KRG on semen parameters in male
      infertility patients. This is the first placebo-controlled trial to evaluate the therapeutic
      effects of KRG in male patients.
    


Intervention name(s): Korean Red Ginseng (KRG); Varicocelectomy
Intervention type(s): Drug; Procedure
Intervention description(s): The KRG capsules were provided by Korean Ginseng Corporation (Daejeon, Korea). KRG powder was manufactured from roots of a 6-year-old red ginseng, Panax ginseng Meyer, harvested in Republic of Korea. KRG was made by steaming fresh ginseng at 90-100 ◦C for 3 h and then drying at 50-80 ◦C.
KRG powder prepared from grinded red ginseng (KRG capsule : 500mg/capsule). KRG was analyzed by high-performance liquid chromatography. KRG extract contained major ginsenoside-Rb1: 4.26mg/g, -Rb2: 1.62mg/g, -Rc: 1.80mg/g, -Rd: 0.29mg/g, -Re: 1.71mg/g, -Rf: 0.67mg/g, -Rg1: 2.61mg/g, -Rg2: 0.20mg/g, -Rg3: 0.13mg/g, and other minor ginsenosides. During the study period, three capsules were taken daily for 12 weeks.; Surgical microscope-assisted varicocelectomy using the subinguinal approach was conducted by a single surgeon.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Effects of Korean Red Ginseng on semen parameters in male infertility patients: a randomized, placebo-controlled, double-blind clinical study
High Fresh Gas Flow After Intubation
Condition: Atelectasis
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      Atelectasis is common during and after general anesthesia. Atelectasis develops early if
      preoxygenation with 100% oxygen is used and continuously used during induction until
      endotracheal intubation. The investigators hypothesize that a rapid anti-preoxygenation
      maneuver immediately after confirming a successful intubation, reduces the area of
      atelectasis as investigated by computed tomography compared to a standard procedure.
    


Intervention name(s): Control group, conventional ventilatory settings; High fresh gas flow, high minute ventilation
Intervention type(s): Procedure; Procedure
Intervention description(s): Handling of the airway during induction and intubation is performed in a conventional manner.
Initial ventilatory settings are also done in a conventional manner. As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg ideal body weight, PEEP 6 or 8 cm H2O (8 if BMI >25) and a respiratory frequency of 10. The fresh gas flow is set to 1 Liter per minute with an oxygen mixture of 40%, aiming for an inspired FiO2 of 30-35%.
Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.; Handling of the airway during induction and intubation is performed in a conventional manner.
Immediately after confirming a successful intubation, the effect of preoxygenation is eliminated with a fresh gas flow of 10 L/min of air, delivered with volume controlled ventilation consisting of tidal volumes of approximately 15 ml/kg ideal body weight, a positive expiratory pressure of 10 cm H20 and a respiratory frequency of 10. As soon as the end tidal O2 reaches 25%, the ventilator settings are adjusted to normal values (same as in the control group), i.e. tidal volume 7 mL/kg ideal body weight, PEEP 6 or 8 cm H2O (8 if BMI >25). The mixture of oxygen in the fresh gas is increased to 40% and the fresh gas flow is set to 1 Liter per minute, aiming for an inspired FiO2 of 30-35%.
Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Atelectasis; Fresh gas flow; Prevention; Oxygenation; Anaesthesia
Comparison of Respiratory Muscle, Pain, Functional Performance and Cognitive Status in Obstructive Lung Diseases
Condition: Pain, Chronic; Obstructive Pulmonary Disease; Cognitive Impairment; Functional Disturbance
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Chronic Pain
Study type: Observational

Summary: 
      In the literature, there are a limited number of studies evaluating postural awareness,
      cognitive status, respiratory muscle strength and endurance, functional capacity, and pain in
      people with obstructive pulmonary disease, and comparing these parameters with each other and
      with healthy subjects, and most of the studies are on chronic obstructive pulmonary disease
      patients. There we will evaluate these parameters in different obstructive lung diseases and
      compare the findings of healthy individuals.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Obstructive lung diseases in 18-65 years old
Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP)
Condition: Immune Thrombocytopenia (ITP)
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of evaluating the pharmacokinetics and pharmacodynamics of romiplostim in
      patients with immune thrombocytopenia.
    


Intervention name(s): Romiplostim
Intervention type(s): Drug
Other intervention name(s): AMG531
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD)
Condition: Chronic Obstructive Pulmonary Disease; Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to investigate the tolerability and safety of AZD2423 in Patients
      with chronic obstructive pulmonary disease.
    


Intervention name(s): AZD2423; Placebo to AZD2423
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg oral treatment once daily for 28 days; Oral treatment once daily for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Respiratory disease; Chronic Obstructive Pulmonary Disease
Study of the Osteoprotector Effects of a Milk Product Based on Anthocyans and Enriched in Calcium and Vitamin D
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      We hypothesize that anthocyans with calcium and vitamin D have a positive effect on bone
      reshaping in menopausal women.
    


Intervention name(s): Anthocyans, Calcium and Vitamin D; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Vitamin D; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Osteoporosis prevention
Rivaroxaban for Scheduled Work-up of DVT - The Ri-Schedule Study
Condition: Deep Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This prospective outcome study is designed to assess the safety of rivaroxaban in the
      pre-diagnosis phase of DVT.
    

Detailed description: 
      This prospective outcome study is designed to assess the safety of rivaroxaban in the
      pre-diagnosis phase of DVT.

      International guidelines suggest the use of low molecular weight heparin (LMWH) if the
      diagnostic process is expected to be delayed for more than 4 hours.

      Rivaroxaban is a new DOAC that in clinical trials has proven to be non-inferior to LMWH and
      warfarin for the treatment of DVT with the added benefit of causing less major bleeding.

      Because of its rapid onset of action and oral administration, rivaroxaban could be used
      instead of LMWH in the pre-diagnosis phase pending the results of the diagnostic test.
      However, the safety of a such proposed indication has to be proven before it can be adopted
      in clinical practice.

      This study aims to determine the safety and feasibility of pre-diagnostic treatment with
      rivaroxaban. The primary outcome of this study "safety" is a composite endpoint of serious
      bleedings encountered within 48 hours after administration of rivaroxaban.
    

Intervention name(s): Rivaroxaban
Intervention type(s): Drug
Intervention description(s): Rivaroxaban 15 mg every 12 hours until the completion of the diagnostic work-up, which should not exceed 24 hours (maximum 2 tablets)
Other intervention name(s): Xarelto
Intervention MeSH terms: Rivaroxaban
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Deep venous thrombosis; Rivaroxaban
A Study in Asthmatics to Determine the Efficacy and Dose Response of Repeat Doses of GW870086X on Forced Expiratory Volume in 1 Second (FEV1)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomised, double-blind, placebo-controlled, parallel group study to determine the
      efficacy of twenty-seven day- repeat inhaled daily doses of GW870086X on forced expiratory
      volume in 1 second (FEV1). Initially there will be 3 treatment arms; placebo, 2mg GW870086X
      and 4mg GW870086X. After an interim analysis the trial may; continue to completion using the
      original doses, be terminated early, or have a fourth arm added of either 1mg GW870086X once
      daily or 3mg GW870086X once daily.
    

Detailed description: 
      This is a randomised, double-blind, placebo-controlled, parallel group study to determine the
      efficacy of twenty-seven day- repeat inhaled doses of GW870086X on FEV1. GW870086X is a novel
      inhaled corticosteroid with potent glucocorticoid activity currently in development by
      GlaxoSmithKline (GSK) as an inhaled treatment of persistent asthma. Initially, subjects will
      be randomised to receive placebo, 2mg or 4mg GW870086X once daily. An interim analysis will
      be performed on the primary endpoint to potentially adapt the study design after
      approximately 45 subjects have completed dosing. Based on the results of the interim
      analysis, the trial may continue to completion using the original doses or an adaptation to
      the doses could be made. Either the 1mg GW870086X once daily arm or 3mg GW870086X once daily
      arm may be added, or the trial could be terminated early. After screening there will be a 4
      week run in period prior to start of treatment and after will be a follow up period 1-2 weeks
      after last dose. Approximately 120 subjects will complete the study. Key safety assessments
      include; clinical laboratory tests, vital signs and collection of adverse events (AE's).
    

Intervention name(s): GW870086 2mg; GW870086 4mg; GW870086 Placebo; GW870086 1mg; GW870086 3mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral inhalation; oral inhalation; oral inhalation; oral inhalation; oral inhalation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; GW870086; Efficacy; FEV1
Fatigue and Interleukin-1 (IL-1) Blockade in Primary Sjøgrens Syndrome
Condition: Fatigue; Primary Sjogren
MeSH terms: Sjogren's Syndrome; Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      Fatigue is a prevalent phenomenon in Primary Sjøgrens syndrome (PSS). Observations indicate
      that the cytokine IL-1 is of importance for this phenomenon. In this study the investigators
      block IL-1 by giving Anakinra (an IL-1 receptor antagonist) to patients with PSS.
    

Detailed description: 
      A double-blind, placebo-controlled, parallel study of the effect on fatigue of daily
      injections of Anakinra for one month.
    

Intervention name(s): Anakinra; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Anakinra 0.67 ml (100 mg) daily subcutaneously for 4 weeks.; Saline 0.67 ml daily subcutaneously as placebo drug.
Other intervention name(s): Kineret; Saline 0.9%
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment