bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Simvastatin in the Treatment of Portal Hypertension
Condition: Cirrhosis; Portal Hypertension
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Hypertension; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of continuous simvastatin administration
      on the hepatic venous pressure gradient (HVPG), as a surrogate marker of prognosis, and its
      safety in patients with cirrhosis and portal hypertension.
    

Detailed description: 
      Statins exert beneficial vascular effects independently of cholesterol reduction by improving
      endothelial dysfunction. In cirrhosis sinusoidal endothelial dysfunction further increases
      intrahepatic resistance and portal pressure. Previous studies have shown that statins improve
      hepatic endothelial dysfunction in cirrhosis, suggesting that statins could be an effective
      therapy for portal hypertension (PHT). This randomized controlled trial evaluated the effects
      of continuous simvastatin administration on the hepatic venous pressure gradient (HVPG), as a
      surrogate marker of prognosis, and its safety in patients with cirrhosis and PHT.
    

Intervention name(s): Simvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg/day p.o., increased to 40 mg/day at day 15 if no safety end-point was met; Placebo with the same characteristics of the drug and at the same dose
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Statins; HMG-CoA reductase inhibitors; Cirrhosis; Portal hypertension; Variceal bleeding
A Study to Evaluate the Effect of ALKS 5461 on QT Intervals in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effects of ALKS 5461 on QT intervals in healthy volunteers as
      well as evaluate the safety and tolerability of ALKS 5461.
    


Intervention name(s): Moxifloxacin; ALKS 5461; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single administration; Daily administration for a total of 12 dosing days; Placebo will be matched to Moxifloxacin or ALKS 5461
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alkermes; Samidorphan; ALKS 5461; QT/QTc; Buprenorphine; Pharmacodynamics
Effect of Robot-assisted Gait Training on Brain Reorganization in Hemiplegic Patients
Condition: Stroke
Study type: Interventional

Summary: 
      Purpose: To evaluate the effect of robotic gait therapy for brain reorganization in
      hemiplegia patients.
    

Detailed description: 
      This study designed an interventional pre-post compared clinical study. The subjects received
      conventional physical therapy with Walkbot training (3 sessions per week for 7 weeks, 20
      session). Before and after intervention all subjects evaluated using diffusion tensor imaging
      and clinical outcome measurements.
    

Intervention name(s): Walkbot
Intervention type(s): Device
Intervention description(s): Robot assisted gait training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation (MycaCOORD)
Condition: Invasive Fungal Infection
MeSH terms: Mycoses; Invasive Fungal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Infections due to post transplant immune deficiency are a major problem following allogeneic
      stem cell transplantation (Allo-SCT), particularly in patients receiving cord blood
      transplant (CB). Duration of neutropenia is one of the most important risk factor for
      invasive fungal infection (IFI). In this setting, Micafungin has been approved for antifungal
      prophylaxis for patients undergoing Allo-SCT. In a randomized, double-blind, comparative,
      phase III trial, the overall efficacy of micafungin was superior to that of fluconazole as
      antifungal prophylaxis during the neutropenic phase after Allo-SCT. However, very few
      patients in this study received a CB transplant.

      This is phase IIb, prospective, open-label, non-comparative study to assess the safety of
      micafungin when use in prevention of IFI in neutropenic patients receiving allo-SCT using CB
      as source of stem cells.
    


Intervention name(s): Micafungin
Intervention type(s): Drug
Intervention description(s): All patients meeting selection criteria will receive micafungin IV. Prophylaxis will start within 48 hours of the beginning of the transplant-related conditioning regimen until 5 days after recovery from neutropenia (ANC ≥ 500/µl), or occurrence of an IFI, or up to 42 days, or withdrawal for any reason (e.g. patient's or investigator's decision, development of intolerance, death), whichever come first
Intervention MeSH terms: Micafungin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adult; allo-Stem Cell Transplantation; Cord Blood
A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a randomized, placebo-controlled, multicenter, blinded Phase I/II, investigator and
      subject-blinded study of the safety of escalating doses of ocrelizumab in combination with
      MTX in subjects with moderate to severe RA
    


Intervention name(s): ocrelizumab
Intervention type(s): Drug
Intervention MeSH terms: Ocrelizumab
Primary purpose: Treatment
Keywords: Moderate to severe rheumatoid arthritis
Football Fitness After Breast Cancer
Condition: Breast Neoplasm Female
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Late effects of breast cancer treatment are widely reported including deteriorating fitness,
      fatigue, loss of muscle and bone mass, and increased body fat percentage. Exercise
      interventions may ameliorate a number of these effects including fatigue, fitness and improve
      quality of life. However only limited knowledge exists on the potential of novel
      interventions and settings, such as sports outside the hospital setting, to improve late
      effects of breast cancer treatment. The 'Football Fitness After Breast Cancer' (FF ABC) study
      is a randomized trial comparing the effects of a football training intervention with standard
      treatment approaches on fitness, bone mineralization, body composition, muscle strength,
      blood pressure, and patient-reported outcomes in women treated for breast cancer.
    


Intervention name(s): Football fitness
Intervention type(s): Behavioral
Intervention description(s): The training will consist of 30 min of warm-up exercises (running, dribbling, passing, shooting, balance and muscle strength exercises), followed by 2 x 15 minutes of 4-7 a-side games.
Training will take place on a natural grass pitch. In adverse weather conditions (i.e., < 5°C or heavy rain) training will be performed indoors
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1/3 of participants will be randomly allocated to the control group and 2/3 of participants will be randomly allocated to the Football fitness intervention group.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Breast cancer; Football; Late effects; Physical exercise; Soccer training; Rehabilitation; Bone mineralization; Body composition; Fitness; Aerobic capacity
Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the effect of cimetidine on the pharmacokinetics (PK) of
      dexpramipexole in healthy volunteer and evaluate the safety and tolerability of
      dexpramipexole when given with or without cimetidine. Additionally, this study will explore
      the influence of genetic variation on the PK of dexpramipexole when given with or without
      cimetidine.
    

Detailed description: 
      This is a single-center, open-label, randomized, two-period, crossover study in approximately
      14 healthy subjects. The goals of this study are as follows:

      To assess the effect of cimetidine on the pharmacokinetics (PK) of dexpramipexole in healthy
      volunteers.

      To evaluate the safety and tolerability of dexpramipexole when given with or without
      cimetidine.

      To explore the influence of genetic variation on the PK of dexpramipexole when given with or
      without cimetidine.
    

Intervention name(s): Dexpramipexole; Cimetidine plus Dexpramipexole
Intervention type(s): Drug; Drug
Intervention description(s): Single Oral Dose; Multiple Oral Doses
Intervention MeSH terms: Pramipexole; Cimetidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Prone Position in Patients Under Spontaneous Breathing on Intubation or Non-invasive Ventilation or Death Incidence During COVID-19 Acute Respiratory Distress
Condition: COVID19; Oxygen Therapy; Prone Position; Spontaneous Ventilation; Respiratory Distress Syndrome
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

Summary: 
      The SARS-Cov2 viral pandemic is responsible for a new infectious disease called COVID-19
      (CoronaVIrus Disease), is a major health problem. Respiratory complications occur in 15 to
      40%, the most serious is acute respiratory distress syndrome (ARDS).

      The management of COVID-19 is essentially symptomatic with respiratory oxygen supplementation
      in mild forms to invasive mechanical ventilation in the most severe forms.

      Prone position (PP) reduced mortality in patients with ARDS in intensive care. Ding et al
      showed that PP and high flow oxygenation reduced the intubation in patients with moderate to
      severe ARDS.

      The investigators hypothesize that the use of PP in spontaneously ventilation patients under
      oxygen standard could decrease incidence of intubation or non-invasive ventilation or death
      compared to conventional positioning management in medical departments.
    

Detailed description: 
      This is a multicenter randomized controlled study. 400 patients with COVID-19 documentation
      and undergoing oxygen therapy will be randomly assigned, with a 1:1 ratio, to conventional
      positioning or repeated prone sessions.

      The control group will have conventional positioning: semi-seated in bed or seated in a
      chair. The prone position is not allowed during the day (it is allowed at night if it is the
      natural sleeping position).

      The intervention group will have:

        -  Two sessions minimum of prone position over the day. With a total objective of at least
           2h30 of cumulated duration over the day. The objective is to spend as much time as
           possible in prone position if the patient tolerates it well.

        -  The maximum of prone position at night. Patients must be able to take position by
           themselves or with minimal assistance. The rails will be positioned in order to prevent
           falling out of bed. The patient will be free to choose his preferred prone position as
           long as the back is not compressed
    

Intervention name(s): prone position
Intervention type(s): Other
Intervention description(s): Two sessions minimum of prone position over the day. With a total objective of at least 2h30 of cumulated duration over the day. The objective is to spend as much time as possible in prone position if the patient tolerates it well.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled multicenter trial Ratio 1:1
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: COVID19; Oxygen therapy; Prone position; Spontaneous ventilation; Acute respiratory failure
The Calmer Project
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      The purpose of this study is to see if the Calmer is more effective at managing acute pain in
      preterm infants in the neonatal intensive care than the current standard of care in the unit.

      Hypothesis: While receiving treatment with Calmer, infants will show lower behavioral pain
      scores and lower heart rates, and more stable autonomic regulation as measured by heart rate
      variability indices, than infants given a soother plus facilitated tucking (standard of care)
      during routine blood collection.
    

Detailed description: 
      60 infants will be randomized to either receive the standard of care or the Calmer during a
      routine blood collection.
    

Intervention name(s): The Calmer; Standard of Care
Intervention type(s): Device; Other
Intervention description(s): This platform, called the Calmer, interacts with the infant to help reduce stress to help promote better outcomes. Infants can be placed on it for care to mimic Kangaroo Care, maternal skin to skin.; Infant would receive the standard of care for bloodwork, provided a soother and facilitated tucking.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Managing infant pain; 27 - 36+6 weeks gestation; Preterm infants
A Study of JNJ-38518168 in Symptomatic Adult Participants With Uncontrolled, Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics
      (PK), and pharmacodynamics (PD) of JNJ-38518168 compared with placebo in participants with
      persistent asthma that is inadequately controlled despite current treatment.
    

Detailed description: 
      This study will be randomized (treatment group assigned by chance, like flipping a coin),
      double-blind (study investigators and participants will not know what treatment is being
      administered), and placebo-controlled (a placebo is identical to the study agent, but
      contains no active ingredients). A total of 160 participants will receive either placebo or
      JNJ-38518168 once daily. The study duration will be approximately 32 weeks and will include a
      screening phase of approximately 4 weeks, a 24-week placebo-controlled treatment phase, and a
      4-week follow-up phase. Participant safety will be monitored throughout the entire study
      period..
    

Intervention name(s): Placebo; JNJ-38518168
Intervention type(s): Drug; Drug
Intervention description(s): Placebo tablet, taken once daily; JNJ-38518168, 30 mg tablet, taken once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Uncontrolled, persistent asthma
Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      B2611002 is designed to study how safe and effective an investigational medication
      (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 5
      treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug,
      and another treatment will be placebo, which does not contain active ingredient.
    


Intervention name(s): Placebo; 150 mg PF-04991532; 450 mg PF-04991532; 750 mg PF-04991532; Sitagliptin 100 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets (n=6), 0 mg, once daily for 84 days; Tablets (n=1), 150 mg + tablets (n=5), 0 mg, all once daily for 84 days; Tablets (n=3), 150 mg + tablets (n=3), 0 mg, all once daily for 84 days; Tablets (n=5), 150 mg + tablets (n=1), 0 mg, all once daily for 84 days; Tablets (n=1), 100 mg strength + tablets (n=5), 0 mg, all once daily for 84 days
Intervention MeSH terms: Nicotinic Acids; Sitagliptin Phosphate; 6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Phase 2; safety and efficacy study with PF-04991532; Type 2 diabetes
Evaluation of Pharmacokinetic/Pharmacodynamic Properties and Safety of Leucostim® Compared to Neupogen® in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, Open-label, Two-way Crossover, Open-label Clinical Trial to Compare
      Pharmacokinetic/Pharmacodynamic Properties and Safety after Subcutaneous Administration of
      Leucostim® and Neupogen® in Healthy Adult Volunteers
    


Intervention name(s): Leucostim®; Neupogen®
Intervention type(s): Drug; Drug
Other intervention name(s): DA-3030
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exercise Capacity and Physical Activity Levels in Newly Diagnosed Hematologic Malignant Patients
Condition: Hematologic Malignancies
MeSH terms: Hematologic Neoplasms
Study type: Observational

Summary: 
      Hematologic malignancies are neoplasms that affect the blood, bone marrow, and lymph nodes.
      Hematological malignancies are the most common forms of leukemia, lymphoma, and myeloma, with
      numerous subtypes. The general symptoms of leukemia are fatigue, increased susceptibility to
      infection, bleeding, and the formation of bruises easily. Typical lymphoma symptoms are night
      sweats and involuntary weight loss, recurrent fever, fatigue, and itching. Myeloma patients
      often have bone pain, fatigue, anemia, hypercalcemia or infection symptoms.

      Adverse effects of hematologic malignancies and treatments cause abnormality in physical
      function and quality of life. Treatments such as chemotherapy, radiotherapy and hematopoietic
      stem cell transplantation, which may have side effects on the body systems are used in early
      or late period. The most common side effect due to chemotherapy is fatigue. Vomiting, weight
      loss, anemia, depression, decreased aerobic capacity, loss of muscle strength, decreased
      physical functioning and deterioration in the quality of life are indirect side effects seen
      in patients.

      In the literature, side effects of hematological malignancies have been investigated after
      treatment in patients. However, no study investigated exercise capacity, quality of life,
      physical activity level and pulmonary functions on newly diagnosed hematologic malignant
      patients. Therefore, the investigators aimed to compare aforementioned outcomes in newly
      diagnosed hematologic malignant patients and healthy controls.
    

Detailed description: 
      According to sample size calculation 30 newly diagnosed hematologic malignant patients and 30
      healthy individuals will be included. Before treatment submaximal exercise capacity, physical
      activity, quality of life, pulmonary functions, respiratory and peripheral muscle strength,
      respiratory muscle endurance, dyspnea and fatigue perception, anxiety and depression will be
      evaluated. Primary outcome measurements are exercise capacity, physical activity, quality of
      life, secondary outcomes are respiratory and peripheral muscle strength, respiratory muscle
      endurance, pulmonary functions, dyspnea and fatigue perception, anxiety and depression.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Hospitalized patients and healthy volunteers
      
Keywords: Exercise capacity; Physical activity; Quality of life; Pulmonary functions; Muscle strength; Respiratory muscle strength; Respiratory muscle endurance; Dyspnea; Anxiety; Fatigue
Laparoscopic Nissen Versus Anterior Partial Fundoplication
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      The most widely used operative technique for gastroesophageal reflux is total fundoplication
      where the gastric fundus is sutured around the distal esophagus like a wrap. This operation
      effectively prevents gastroesophageal reflux but gives rise to postoperative symptoms related
      to over-competence of the gastroesophageal junction. 40% of the operated patients experience
      increased flatulence and 20% dysphagia. Anterior fundoplication is an alternative technique
      where the distal esophagus is anchored to the crura of the hiatus esophagi and only a part of
      the front wall of the esophagus is covered with fundus. An anterior fundoplication is un
      attempt to create a more physiologic reflux control and less functional problems
      postoperatively. The aim with this study is to compare the results postoperatively, both
      short time and long time results.
    

Detailed description: 
      Aim: To establish if there is a difference in the incidence of postoperative flatulence after
      the two different operative techniques. The secondary aims are to establish differences in
      relapse of reflux, incidence of postoperative dysphagia, dyspepsia, quality of life, hospital
      stay, sick-leave and complications.

      Method: All patients operated on for reflux disease in Lund, Malmö,Trollättan and Kalmar are
      randomised between the two operations. Postoperatively, telephone interview is performed
      weekly the first two months. One year and ten years postoperatively. The patients are
      investigated with endoscopy, esophageal manometry, 24 hour pH-monitoring and symptom
      evaluation.
    

Intervention name(s): Nissen fundoplication; Laparoscopic antireflux surgery ad modum Watson
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic Nissen fundoplication; Laparoscopic anterior fundoplication
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux; Fundoplication; Surgical Procedures