bioihbjkbjnl/mcl2 huggingface dataset:
Aclidinium/Formoterol Fixed Combination Dose Finding Study
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The study seeks to determine the optimal dose of the Aclidinium/Formoterol combination for
      investigation in Phase III clinical trials
    

Detailed description: 
      Dose-finding clinical trial, to assess the efficacy, safety and pharmacokinetics of three
      different doses of formoterol combined with the inhaled anticholinergic aclidinium bromide,
      aclidinium bromide monotherapy and formoterol monotherapy
    

Intervention name(s): Aclidinium bromide and formoterol; Aclidinium bromide and formoterol placebo
Intervention type(s): Drug; Drug
Intervention description(s): once daily; once daily
Intervention MeSH terms: Bromides; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bronchitis; Chronic; Emphysema; Smokers or ex-Smokers
Anti-Helicobacter Pylori Antibodies (IgG) in Serum of Women With Unexplained Infertility
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      Prevalence of anti-H.pylori IgG in serum of women with unexplained infertility and comparing
      that with it's prevalence in fertile women.
    

Detailed description: 
      Unexplained infertility was diagnosed according to standard World Health Organization (WHO)
      criteria. All women in the study had hormonal assessment to evaluate their ovulatory cycles,
      thyroid function, circulating prolactin and androgen levels. The ovarian reserve was checked
      by measurement of serum FSH and an antral follicle count on the third day of the menstrual
      cycle. Screening for infertility also included transvaginal ultrasound and
      hysterosalpingography, to exclude possible uterine malformations or pathologies, and to
      assess the patency of the fallopian tubes. Male factor infertility was excluded in all
      couples, according to standard WHO semen analysis.

      Following admission, all patients underwent complete clinical examination and detailed
      medical history was obtained.

      A venous sample was collected to test serum for HP IgG seropositivity by enzyme linked
      immunoassay for HELICOBACTOR PYLORI IgG (ENZYME IMMUNOASSAY TEST KIT).
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        female healthy participants who attend the outpatient clinic
A Study of the Feasibility of Prehospital Remote Ischemic Conditioning
Condition: Chest Pain
MeSH terms: Chest Pain
Study type: Interventional

Summary: 
      Prospective, single center, single arm pilot study evaluating the feasibility of delivering
      remote ischemic conditioning (RIC) by emergency medical services (EMS) in the prehospital
      setting. Eligible patients will have chest pain or anginal equivalent symptoms and require
      ground ambulance transport to the hospital. All subjects will undergo the standard RIC
      procedure (i.e., up to four cycles of alternating 5-min inflation and 5-min deflation) with
      the autoRIC® device (CellAegis Devices, Inc., Toronto, Ontario). The primary objective is to
      evaluate the number of cycles of RIC completed in patients having the procedure initiated by
      EMS in the prehospital setting.
    

Detailed description: 
      This single-arm, open-label pilot study will evaluate the feasibility of delivering remote
      ischemic conditioning (RIC) by emergency medical services (EMS) in the prehospital setting.
      Eligible patients will be at least 18 years of age, and require ground ambulance transport to
      the hospital. Patients suspected of ST-elevation myocardial infarction (STEMI) based on the
      prehospital electrocardiogram and thus requiring urgent intervention in the cardiac
      catheterization lab will be excluded.

      All subjects will undergo the standard RIC procedure (i.e., up to four cycles of alternating
      5-min inflation and 5-min deflation) with the autoRIC® device (CellAegis Devices, Inc.). The
      automated procedure will be initiated by paramedics during ambulance transport, and the RIC
      cycles will continue through emergency department (ED) arrival and stay for a total of 40
      minutes.

      The primary objective of this pilot study is to examine the duration of RIC administered in
      patients having the procedure initiated in the prehospital setting. The investigators
      hypothesize four cycles of RIC will be completed in at least 80% of patients having the
      procedure initiated. Secondary objectives are to assess enrollment rates and protocol
      implementation; paramedic acceptability of protocol; and patient tolerability of RIC.
    

Intervention name(s): autoRIC® device
Intervention type(s): Device
Intervention description(s): The autoRIC® automatically delivers four RIC cycles of five minutes of pressure at 200 mm Hg followed by five minutes of no pressure for a total 40-min treatment period
Intervention model: Single Group Assignment
Intervention model description: Prospective, single center, single arm pilot study evaluating the feasibility of delivering remote ischemic conditioning by emergency medical services during ground ambulance transport of patients experiencing chest pain or anginal equivalent symptom
Masking: None (Open Label)
Primary purpose: Other
Keywords: Emergency Medical Services
Diflucan Bioequivalence Study For Transferring The Manufacture
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the bioequivalence between fluconazole 50mg capsules from two
      different manufacturers. This is a open-label, randomized, single dose, 2-treatment, 2-period
      crossover study in healthy Korean male and female subjects aged 19-55, to assess the
      bioequivalence after taking study drugs.
    

Detailed description: 
      Twenty-eight (28) healthy subjects will be enrolled into the study. Screening evaluation will
      occur within 28 days prior to the first dose of study medication.

      Subjects will be randomized to the following treatments:

        -  Treatment A: Fluconazole capsule, 1 x 50 mg, Diflucan, West Ryde (REFERENCE)

        -  Treatment B: Fluconazole capsule, 1 x 50 mg, Diflucan, Amboise (TEST)
    

Intervention name(s): Test drug; Reference drug
Intervention type(s): Drug; Drug
Intervention description(s): Fluconazole capsule 50 mg Manufacturer: West Ryde; Fluconazole capsule 50 mg Manufacturer: Amboise
Other intervention name(s): Fluconazole capsule 50mg; Fluconazole capsule 50mg
Intervention MeSH terms: Fluconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: open-label, randomized, single dose, 2-treatment, 2-period crossover study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Fluconazole
Chronic Kidney Disease (CKD) Platelet Study
Condition: Chronic Kidney Diseases; Heart Attack; Stroke, Ischemic
MeSH terms: Ischemic Stroke; Kidney Diseases; Renal Insufficiency, Chronic; Myocardial Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates how aspirin, clopidogrel and ticagrelor work in people with chronic
      kidney disease (CKD) compared to people with normal kidneys. In the first part of the study,
      half of CKD participants will be randomly assigned to ticagrelor and aspirin, while the other
      half will be assigned to clopidogrel and aspirin in a blinded fashion. The treatment duration
      will be two weeks. After recruiting CKD participants the investigator will recruit controls
      with normal kidney function that will receive only ticagrelor and aspirin for two weeks.
    

Detailed description: 
      It is known that people with chronic kidney disease (CKD) are at higher risk to have heart
      and blood vessel problems like heart attack and stroke compared to people that do not have
      kidney problems. Aspirin, clopidogrel and ticagrelor prevent blood clots building up in the
      vessels. If a blood clot is present in one vessel, it could stop oxygen carrying blood to get
      to a specific organ, and that could cause problems like heart attack or stroke. There is very
      little knowledge about the way this group of medicines works in people with chronic kidney
      disease as well as it works in individuals with normal kidney function.
    

Intervention name(s): Ticagrelor 90mg; Clopidogrel 75mg; Aspirin 81 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ticagrelor Pill; Clopidogrel Pill and a matching placebo to conceal frequency; Aspirin Pill
Other intervention name(s): Brilinta; Plavix; baby aspirin
Intervention MeSH terms: Aspirin; Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: CKD participants will be double-blind randomized in these two arms:
Arm 1 - Ticagrelor, 90 mg twice daily (one pill in the morning and one pill in the evening) + Aspirin 81 mg/day. Ticagrelor is the test treatment.
Arm 2 - Clopidogrel, 75 mg/day in the morning and a matching placebo in the evening + Aspirin 81 mg/day. Clopidogrel is the reference treatment.
Arm 3: Control with normal kidney function will be recruited after matching for age and diabetes status to the Arm 1 participants. Participants will be asked to take Ticagrelor, 90 mg twice daily (one pill in the morning and one pill in the evening) and aspirin 81 mg/day. Open label treatment.
All participants are required to take the oral treatment for a total of two weeks.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: P2Y12 inhibitors; Platelet aggregation; ticagrelor; clopidogrel; chronic kidney disease
Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea
Condition: Type 2 Diabetes Mellitus; Inadequate Glycaemic Control
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin as
      an addition to metformin is effective and safe in treating patients with type 2 diabetes when
      compared to glimepiride (sulphonylurea) as an addition to metformin treatment.
    


Intervention name(s): Dapagliflozin; Saxagliptin; Glimepiride; Placebo for dapagliflozin; Placebo for saxagliptin; Placebo for glimepiride
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 10 mg, orally Green, plain, diamond-shaped, film-coated tablet; 5 mg, orally Plain, yellow, biconvex, round, film-coated tablet; 1, 2, or 4 mg, orally Opaque gray capsule; Does not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet; Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet; Does not contain active ingredient, orally. Opaque gray capsule
Other intervention name(s): Forxiga; Onglyza™; Amaryl
Intervention MeSH terms: Dapagliflozin; Glimepiride; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus Type 2,; metformin,; saxagliptin,; dapagliflozin,; glimepiride,; inadequate glycaemic control
A Phase III Clinical Study of KW-2246
Condition: Pain, Cancer
MeSH terms: Cancer Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to assess the safety and efficacy of long-term KW-2246 treatment as
      rescue medication for breakthrough pain.
    


Intervention name(s): KW-2246 (fentanyl citrate)
Intervention type(s): Drug
Intervention description(s): KW-2246 (fentanyl citrate)
Intervention MeSH terms: Fentanyl
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain, Cancer
Study of the AL3810 in the Treatment of Advanced Solid Tumor
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a monocentric, open label, non-randomised, non-comparative, dose-finding phase I
      study
    

Detailed description: 
      Methodology:

      This was a monocentric, open label, non-randomised, non-comparative, dose-finding phase I
      study with a traditional 3+3 design, conducted in Chinese patients with advanced solid
      tumours without an established therapeutic alternative.This study was performed in strict
      accordance with Good Clinical Practice including the archiving of essential documents.
    

Intervention name(s): Lucitanib
Intervention type(s): Drug
Other intervention name(s): AL3810
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tolerability Pharmacokinetics
Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery
Condition: Postoperative Pain; Hysterectomy
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will be investigating the efficacy and safety administration of multiple doses of
      intravenous (IV) acetaminophen (IVAPAP) in the 48 hour period following Gynecologic Surgery.
    

Detailed description: 
      The research hypothesis is that IV Acetaminophen will provide greater reduction in pain
      intensity and greater pain relief for moderate and severe pain as compared to placebo in the
      48 hours following surgery.
    

Intervention name(s): IV Acetaminophen; IV Placebo 100 mL solution
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous acetaminophen 1 g/100 mL; IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)
Other intervention name(s): IV Acetaminophen (IV APAP); IV Placebo (non-active product)
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Gynecologic; IV Acetaminophen; Postoperative; Analgesic
Exercise Dosing for Pain in Healthy Participants
Condition: Pain
Study type: Interventional

Summary: 
      In this study investigators will examine the effect of dose related to exercise therapy for
      pain in healthy adult humans. An acute pain model will be employed to study the effect of
      exercise dose on pain. Acute pain models are currently used to study pain (both acute and
      chronic) in human samples as there is currently no chronic pain model.
    

Detailed description: 
      This study is designed as a randomized controlled trial with repeated measures. The effect of
      exercise dose on pain: subjects will be randomly assigned to one of four exercise groups: 1.)
      no exercise (control); 2.) low dose exercise (3x/week); 3.) moderate dose exercise (5x/week).
      4.) high dose exercise (10x/week).
    

Intervention name(s): Walking Exercise; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.; The Control group will perform 30 minutes of quiet rest.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pseudo-randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Dose; Analgesia
Safety, Feasibility and Effect of an Individualized Physical Activity Intervention for Gastric Cancer Patient Undergoing Minimally Invasive Gastrectomy: a Pilot Study
Condition: Gastric Cancer Patient
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      Gastric cancer is a major health issue and one of the most common malignance in Korea. With
      the popularization of cancer screenings and increasing the average lifespan, the number of
      gastric cancer patients is increased. In the past, most of the research were concerned with
      survival and recovery after cancer surgery. However, as the medical technology had been
      developed and recovery rate and survival rate of cancer patients had risen, the patients
      wanted to return to a daily life and desire for participation for leisure. In other words,
      the patients who underwent surgery wants to maintain a high quality of life(QOL) level as
      like prior to cancer surgery.

      There are many reports on the effect of the exercise program after cancer surgery. In
      addition, exercise program was associated with improving the QOL and functional recovery,
      decreasing a mood of depression, maintaining a muscle mass and improving the survival rate.

      However, the subject patients of previous studies were Western people. Therefore, The results
      were not disclosed whether the exercise program suited to the body characteristics of Korean
      people. Furthermore there was no exercise program studies for the gastric cancer patients.

      Medical service for cancer patients care should include not only diagnosis, treatment as like
      surgery but efforts on enhancing the quality of life. In other words, post-management
      education and management program as like exercise program are necessary for the cancer
      patients after surgery. So, the research about how to practice the exercise program and how
      to evaluate the effect on the recovery is needed.
    


Intervention name(s): physical activity intervention
Intervention type(s): Behavioral
Intervention description(s): Exercise program is scheduled to be conducted in three phases. Phase I is in-hospital exercise program. This program will be conducted in hospital during 1 week after surgery. Phase II is home-exercise program that will be performed at home during 1 week after discharge. Phase III is main-exercise program that will be conducted the fitness center nearby hospital during 8 weeks after phase II program. Main-exercise program is focused on the functional recovery.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Gastric cancer, minimally invasive gastrectomy, Physical activity intervention
Evaluation of the Deep TMS H-Coil in the Treatment of Major Depression- Augmentation of Antidepressant Medication
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Evaluation of the novel deep TMS H-Coil design as an augmentation measure in the treatment of
      medication resistant major depression. Stimulation is administered with and without
      cognitive-emotional provocation.
    


Intervention name(s): Transcranial Magnetic Stimulation (TMS)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TMS; drug resistant depression
Top-Down Executive Control in Traumatic Brain Injury (TBI), PTSD and Combined
Condition: PTSD; TBI (Traumatic Brain Injury)
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      This research investigates processes involved with one being able to focus on relevant
      information and ignore non-relevant information in veterans with PTSD and those with a
      history of traumatic brain injury. In addition, this study evaluates whether there is an
      additive effect of having both PTSD and history of TBI on ability to focus attention and
      inhibit distracting information.
    

Detailed description: 
      Traumatic brain injury (TBI) and PTSD both are characterized by deficits in attention, yet it
      is unclear as to whether this is related to an inability to focus on relevant information or
      ignore non-relevant information. History of TBI and PTSD are common to returning soldiers
      from OEF/OIF and thus is highly relevant to veteran health care. It is unclear how TBI and
      PTSD separately, and together, affect one's ability to focus attention versus inhibit
      distracting stimuli. This research investigates this issue by use of a working memory
      paradigm with functional magnetic resonance imaging (fMRI) that entails the subject being
      instructed to ignore some stimuli and remember other stimuli resulting in discrete biomarkers
      of (1) task-related enhancement of neural processes as well as (2) suppression of
      task-irrelevant neural processes. In this way, the specific aspect of attention in TBI and
      PTSD will be elucidated in addition to exploring whether PTSD and TBI have an additive, or
      even synergist, effect when combined.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        OEF/OIF Veterans enrolled in the Northern California Health Care System
      
Keywords: TBI (Traumatic Brain Injury); PTSD; fMRI; attention
Eyelid Movement Sensor Device- Blinking Characterizing
Condition: Eyelid Movement Disorders
MeSH terms: Movement Disorders
Study type: Interventional

Summary: 
      The investigators have developed a simple to use device that facilitates the monitoring of
      the upper eyelids motion, acquires the eyelid vertical movement and enables analysis and
      graphic presentation of the results. the device system consists 3 components : glasses for
      the patient including magneto sensitive probes, hardware and dedicated software.

      Our purpose is to characterize eyelid motion in normal population. The methods include
      measuring each patient 10 minutes during watching a short movie.
    

Detailed description: 
      Essentially, for Hall-probes monitor the magnetic field generated by a tiny magnets attached
      to the upper eyelid.
    

Intervention name(s): eyelid motion sensor device (Hall-probe)
Intervention type(s): Device
Intervention description(s): all volunteers will wear the eyelid motion sensor device (Hall-probe) (including the tiny magnets on the upper eyelid). a 10 minutes movie will be screened on 40 inch television screen in a 3 meters distance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science