bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Pulmonary administered anticholinergic agents have shown their importance in the chronic
      obstructive pulmonary disease (COPD) management to reduce morbidity, disability and
      mortality. To date, the recommended treatment of moderate to severe COPD patients consist in
      the combination of ß2 agonist and long acting antimuscarinic compounds. There is still a
      medical need in new product that could exhibit both anti-inflammatory and strong
      bronchodilation potency. V0162 is a compound with a potent anticholinergic activity.

      Secondary PD properties of V0162 could enhance the efficacy of this antimuscarinic compound
      and could bring new option in the treatment of this life-threatening disease.
    

Detailed description: 
      This study has two parts. Part A will be conducted in 72 healthy volunteers. Part B will be
      conducted in 20 patients diagnosed with COPD.

      Part A The primary objective of this part of the study is to assess the local tolerability of
      escalating doses of V0162 in male healthy volunteers.

      Part B The primary objective of this part of the study is to assess the bronchodilator
      properties of V0162 at the maximal tolerated dose (determined in Part A) in COPD patients.

      In addition, pharmacokinetics and vital sign including ECG will be determined.
    

Intervention name(s): Bronchodilatator; Bronchodilatator
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Hyperglycemia
Condition: Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      This study was conducted to investigate the effects of daily supplementation of Angelica
      gigas N. extract on improvement of Hyperglycemia .
    

Detailed description: 
      This study was a 8 weeks, randomized, double-blind, placebo-controlled 2×2 cross-over design
      human trial. Twenty subjects were randomly divided into Angelica gigas N. extract or a
      placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test
      (OGTT) were assessed before and after the intervention.
    

Intervention name(s): Angelica gigas N. extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): capsules(2cap/d, 1,000mg/d) for 8 weeks.; Placebo for 8 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 2×2 cross-over Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Angelica gigas N. extract; Glucose; Clinical Trial
The Treatment of Carpal Tunnel Syndrome Using Thumb Pressure Along the Median Nerve
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to find the efficacy of treating the muscles in the inside
      (biceps,pronator teres) of the arm in order to eliminate the carpal tunnel syndrome .The
      authors hypothesise that eliminating the trigger points located in these muscles would
      diminish the symptoms associated with the carpal tunnel syndrome.
    

Detailed description: 
      The carpal tunnel syndrome is a common condition which should treated by surgery only when
      conservative approaches has been tried.In the present trial the authors intend to find the
      effectiveness of treating the triggers points located in the biceps muscle, the pronator
      teres muscle and the biceps aponeurosis on the symptoms normally associated with the carpal
      tunnel syndrome.

      The technique used in this trial will be ischemic compression(thumb tip pressure)on the
      trigger points located on the previous sites.
    

Intervention name(s): Active Comparator, ischemic compressions
Intervention type(s): Procedure
Intervention description(s): Ischemic Compressions,3 times a week,5 weeks.
Other intervention name(s): Pressure Point Therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Magnesium Oil Application on the Muscle Contractile Properties
Condition: Magnesium; Skeletal Muscle Contraction Properties
Study type: Interventional

Summary: 
      This study will aim to investigate the effects of magnesium oil administration on skeletal
      muscle contractile properties.
    

Detailed description: 
      Aim: This study will aim to investigate the effects of magnesium oil administration on
      skeletal muscle contractile properties (SMcp).

      Design: Randomized controlled study

      Participants: For this purpose, investigators will recruit 40 recreationally active and
      healthy adults of both sexes (18-35 years of age).

      Methods: The experimental leg (EXP) will receive the 10 sprays of magnesium oil (20 mg per
      spray) that will be topically applied to the skin covering the knee extensor muscles, whereas
      the control leg (CON) will receive 10 sprays of natural mineral-free oil. The vastus
      lateralis SMcp will be measured by using a tensiomyography (TMG) device before application
      (PRE) and after 10 (POST10), 20 (POST20), 30 (POST30), 40 (POST40), and 50 (POST50) minutes
      of application onset, respectively.
    

Intervention name(s): Magnesium oil (BetterYou) dermal application; Placebo Control
Intervention type(s): Other; Other
Intervention description(s): 10 sprays (200 mg) of magnesium oil (BetterYou) will be applied to skin covering knee extensor muscles. The magnesium oil will be applied only once; Natural mineral-free oil (10 sprays) will be applied as the control condition. This will be done only once
Other intervention name(s): CONTROL
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Tensiomyography; Skeletal Muscle; Contractile Properties
Treatment With Nivolumab at the Fixed Dose 40 mg (Nivo40) in Patients With Relapsed/Refractory Hodgkins Lymphoma
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A phase I/II trial to evaluate the safety and efficacy of nivolumab at the fixed dose 40 mg
      in patients with relapsed or refractory Hodgkins lymphoma.
    


Intervention name(s): Nivolumab 40 mg in 4 ml Injection
Intervention type(s): Drug
Intervention description(s): 40 mg by intravenous (IV) infusion on day 1 Duration of cycle 14 days
Other intervention name(s): Opdivo
Intervention MeSH terms: Nivolumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nivolumab
Safety Study of BMS-903452 in Healthy Subjects (Panel 1-7) & Relative Bioavailability of the Crystalline and Amorphous Forms of BMS-903452 [Panels 4, 6, 11 & 12(Part A)], and Subjects With Type 2 Diabetes Mellitus (Part B)
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and effect on blood glucose
      control of BMS-903452 compared to placebo in healthy subjects & relative bioavailability of
      the crystalline and amorphous forms of BMS-903452 [Panels 4,6,11 & 12(Part A)] ; and subjects
      with type 2 Diabetes Mellitus (Part B). The study will also determine the amount of
      BMS-903452 in the blood.
    


Intervention name(s): BMS-903452; BMS-903452; BMS-903452; BMS-903452; BMS-903452; BMS-903452; BMS-903452; Placebo; Placebo; BMS-903452; BMS-903452; Placebo; BMS-903452; BMS-903452; BMS-903452
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Solution, Oral, 0.1 mg, once daily, 1 day; Solution, Oral, 0.6 mg, once daily, 1 day; Suspension, Oral, 3.0 mg, once daily, 1 day; Suspension, Oral, 10 mg, once daily, 1 day; Suspension, Oral, 30 mg, once daily, 1 day; Suspension, Oral, 60 mg, once daily, 1 day; Suspension, Oral, 120 mg, once daily, 1 day; Solution, Oral, 0 mg, once daily, 1 day; Suspension, Oral, 0 mg, once daily, 1 day; Suspension using crystalline form, Oral, 10 mg, once daily, 1 day; Suspension using crystalline form, Oral, 60 mg, once daily, 1 day; Suspension using crystalline form, Oral, 0 mg, once daily, 1 day; Solution, Oral, 0.6 mg, once daily, 1 day; Suspension, Oral, 10 mg, once daily, 1 day; Suspension, Oral, 120 mg, once daily, 1 day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Impact of Early Oral Stimulation on Reducing Cardiorespiratory Events and Transition to Oral Feeding in Preterm Infants
Condition: Preterm Infants
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      To assess whether an oral stimulation program, before the introduction of oral feeding,
      enhances the cardiorespiratory manifestations (episodes of oxygen désaturations, and/or
      apnea- bradycardia), and the oral feeding performance, in preterm infants born between 26 to
      29 weeks of gestation age.
    

Detailed description: 
      Preterm infant were randomized into an experimental or an control group. Infants in the
      experimental group receive an oral stimulation program consisting of stimulation of the oral
      structures during 10 consecutive days. Infant in the control group receive no stimulation
      only non nutritive sucking during feeding. Both were administered twice per day, during 20
      minutes, 48 hours after discontinuation of nasal continuous positive air pressure. A long
      term evaluation of oral feeding difficulties and neuromotor development are organized.
    

Intervention name(s): no stimulation of the oral structure; stimulation of the oral structure
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: preterm infants born between 26 to 29 weeks of gestation age.
Safety and Tolerability of Liraglutide in Healthy Japanese Volunteers
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Japan. The aim of this trial is to assess the safety and
      tolerability of liraglutide in healthy Japanese male subjects.
    


Intervention name(s): liraglutide; liraglutide; liraglutide; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 5 mcg/kg for 21 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data; 5 mcg/kg for 7 days followed by 10 mcg/kg for 14 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data; 5 mcg/kg for 7 days followed by 10 mcg/kg for 7 days followed by 15 mcg/kg for 7 days. Injected subcutaneously once daily; Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Modulation Of Airway Reactivity With Chronic Mechanical Strain
Condition: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to see if the use of a machine called CPAP will help children
      with asthma breathe better. CPAP is a machine that produces airflow to help people with
      breathing problems. To use it, you will wear a mask connected by a hose to the CPAP machine.
      We believe that use of CPAP may be a treatment for children with asthma.
    

Detailed description: 
      During the previous funding period of this project, our laboratory demonstrated that chronic
      mechanical strain imposed on the airways in vivo using continuous positive airway pressure
      (CPAP) results in a dramatic reduction in airway reactivity in vivo in mice, ferrets and
      rabbits1-3. Lungs, airways and airway smooth muscle (ASM) tissues isolated from CPAP-treated
      animals studied in vitro exhibited lower responsiveness to bronchoconstrictors1-3. We also
      observed this suppression of airway responsiveness by chronic mechanical strain in a rabbit
      model of allergic asthma5. These animal studies led to a small clinical trial in which adults
      with asthma were treated with nocturnal CPAP for 1 week. CPAP caused a significant reduction
      in airway reactivity in these patients6. This novel approach for treating airway
      hyper-reactivity is currently being evaluated in a NIH multi-center Phase II clinical trial
      of adults with mild to moderate asthma (U01 HL108730).
    

Intervention name(s): Continuous Positive Airway Pressure (CPAP); Continuous Positive Airway Pressure (CPAP) Sham
Intervention type(s): Device; Device
Intervention description(s): Subjects assigned to this group will be asked to use the CPAP machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.; Subjects assigned to this group will be asked to use the CPAP Sham machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Expression of Tuberculosis in the Lung
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Observational

Summary: 
      The purpose of this study is to assess lung immune responses in patients with active
      pulmonary tuberculosis (TB) and in healthy control persons who are exposed to Mycobacterium
      tuberculosis in households of patients with TB or who are unexposed.
    

Detailed description: 
      BACKGROUND:

      M. tuberculosis infects a third of the world's population, and TB is the leading cause of
      morbidity and mortality due to a single infectious agent. However, only 5% to 10% of M.
      tuberculosis-infected subjects without an underlying immunodeficiency develop disease during
      their lifetimes. Therefore protective immunity is induced in the majority of subjects.
      Understanding correlates of protection against M. tuberculosis in humans is needed to better
      direct efforts in the development of antituberculosis vaccines.

      DESIGN NARRATIVE:

      Patients are treated according to good clinical practice; however, no study medications are
      given as part of the research study. This study involves a one-time bronchoalveolar lavage
      and venipuncture to obtain immune cells for laboratory studies of immune responses.
    

Intervention name(s): Bronchoalveolar lavages and venipunctures only
Intervention type(s): Other
Intervention MeSH terms: Dimercaprol
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with tuberculosis and household contacts of patients with tuberculosis.
      
Biospecimen description: 
      Cell culture supernatants and cell lysates from bronchoalveolar cells, as well as peripheral
      blood mononuclear cells.

      Bronchoalveolar lavage fluid
Single and Multiple Dose Study of ORIC-101 in Adult Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, open-label, non-randomised study with up to 2 parts, assessing the
      safety, tolerability, PK and PD of single (Part A) and multiple (Part B; optional) doses of
      oral GR antagonist ORIC-101.
    


Intervention name(s): ORIC-101
Intervention type(s): Drug
Intervention description(s): Capsule or oral suspension
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of Specified Work Site Physical Activity Intervention Among Employees With Physical Heavy Work
Condition: Musculoskeletal Diseases
MeSH terms: Musculoskeletal Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of specified worksite physical-activity
      interventions on musculoskeletal disorders in an industry with physical heavy workload.
    

Detailed description: 
      Studies regarding company adjusted intervention have shown positive effects regarding work
      related neck and shoulder symptoms among workers with monotonous repetitive work. However,
      limited research is available on physical exercise intervention among workers with physically
      heavy work. This study introduces a new intervention concept to treat and prevent
      musculoskeletal disorders including individually and health check based exercise
      intervention.

      The aim of this randomized controlled intervention project is

        1. Through Health check to outline the extent musculoskeletal disability in workers with
           heavy work load in relation to physical and metabolic fitness. Includes is also
           assessment of physical general activity and working conditions.

        2. To evaluate the effect of individual adjusted exercise programs on muscle strength,
           aerobic capacity, musculoskeletal disability, pain, work ability and sick absenteeism
    

Intervention name(s): Physical activity and Health check; Health check only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Strength training, aerobic capacity training.; Health check
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Physical activity
Lower Esophageal Sphincter (LES) Stimulation in Patients With Ineffective Esophageal Motility
Condition: Quality of Life; Dysphagia; Electrical Stimulation of the Lower Esophageal Sphincter; Gastro Esophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      The aim of this study is to evaluate gastroesophageal reflux disease - health related quality
      of life (GERD-HRQL) after electrical stimulation of the lower esophageal sphincter (LES) in
      patients with gastroesophageal reflux disease (GERD) and esophageal dysmotility.
    

Detailed description: 
      Background The growing burden of gastroesophageal reflux disease (GERD) still impacts
      healthcare costs intensively. Although the treatment with proton pump inhibitor (PPI) is
      effective in many cases, surgical treatment remains relevant due to a large amount of PPI
      refractory GERD. Laparoscopic fundoplication (LF) is considered as standard procedure, but
      this type of surgery is linked to side effects as dysphagia, gas bloating and inability to
      belch. Especially patients with ineffective esophageal motility (IEM) are prone to
      postoperative dysphagia after LF. Lower esophageal sphincter electrical stimulation (LES-EST)
      was introduced as an alternative technique to avoid side effects of LF. Rodriquez et al. have
      bee demonstrated that LES-EST significantly raises the LES pressure and improved GERD
      symptoms such as heartburn and regurgitation. The advantage of this procedure is that the
      anatomy of the esophageal-gastric junction is not altered dramatically. Notably, patients
      with severely disordered esophageal peristalsis will benefit from this low-risk profile.

      After successful implementation of this technique at the Medical University of Vienna (EK
      1149/2014), a prospective evaluation of data with the well established gastroesophageal
      reflux disease - health-related quality of life is next. Patients with esophageal motility
      disorder, who undergo LES-EST, will be investigated towards side effects such as
      gas-bloating, inability to belch, flatulence and dysphagia.
    

Intervention name(s): Electrical Stimulation of the Lower Esophageal Sphincter
Intervention type(s): Device
Intervention description(s): Laparoscopic implantation of an electrical stimulation device to perform an electrical sphincter augmentation for the treatment of GERD.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cyclophosphamide in Myalgic Encephalopathy/ Chronic Fatigue Syndrome (ME/CFS)
Condition: Chronic Fatigue Syndrome (CFS); Myalgic Encephalomyelitis (ME)
MeSH terms: Encephalomyelitis; Fatigue Syndrome, Chronic; Myalgia; Brain Diseases; Syndrome; Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      Significant clinical improvements of ME/CFS symptoms were observed in two patients with
      long-standing ME/CFS who received adjuvant chemotherapy including cyclophosphamide for breast
      cancer, also in one ME/CFS patient who received chemotherapy including iphosphamide for
      Hodgkin lymphoma.

      Three pilot ME/CFS patients were thereafter treated with six intravenous infusions four weeks
      apart, in two of these with a significant clinical response.

      The hypothesis is that a subset of ME/CFS patients have an activated immune system, and that
      ME/CFS symptoms may be alleviated by treatment with cyclophosphamide as intravenous pulse
      infusions four weeks apart, six infusions in total.

      The purpose of the present study is to treat ME/CFS patients with cyclophosphamide as
      intravenous pulse infusions four weeks apart, six infusions in total. The effects on ME/CFS
      symptoms and tolerability/side effects during 12 months follow-up will be registered, and
      additional tests will be performed to objectively register changes in physical ability during
      follow-up. Studies to investigate possible large vessel endothelial dysfunction and skin
      microvascular dysfunction will be performed before start of intervention and during
      follow-up.
    


Intervention name(s): Cyclophosphamide
Intervention type(s): Drug
Intervention description(s): Cyclophosphamide intravenous infusions four weeks apart, in total six infusions. First infusion: cyclophosphamide 600mg/m2. Infusions 2 to 6: cyclophosphamide 700 mg/m2 . Follow-up for 12 months.
Intervention MeSH terms: Cyclophosphamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis (ME); Cyclophosphamide; Immunomodulatory treatment; CFS