bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Adverse Events and How Oral ABBV-552 Capsules Moves Through the Body of Healthy Adult Japanese and Han Chinese Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess how safe ABBV-552 is and how ABBV-552 moves through the body of adult
      healthy Japanese and Han Chinese participants. Adverse Events will be assessed.

      ABBV-552 is an investigational drug being developed for potential treatment of Alzheimer's
      disease (AD). Approximately 18 adult healthy Japanese and Han Chinese volunteers will be
      enrolled in 2 sites in the United States.

      Japanese participants assigned to Arm 1 will receive ascending doses of ABBV-552 oral
      capsules once every week for 3 weeks. Han Chinese participants assigned to Arm 2 will receive
      oral ABBV-552 capsules on Day 1. All participants will be followed for 30 days after their
      last dose.

      Participants will be confined for 22 days or 8 days depending on the Arm they are assigned
      to. Adverse Events and blood tests will be performed.
    


Intervention name(s): ABBV-552
Intervention type(s): Drug
Intervention description(s): Oral Capsule
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ABBV-552; Alzheimer's disease (AD)
Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women
Condition: GBS Disease; Streptococcus Agalactiae
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the safety and immunogenicity of the trivalent group B streptococcus vaccine in
      healthy pregnant women. The study will also evaluate the levels of GBS serotype-specific
      antibodies in infants, placental transfer from the pregnant women to the infant and levels of
      antibodies in the breast milk.
    


Intervention name(s): GBS trivalent vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection - Liquid formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus and conjugated to the Corynebacterium diphtheriae CRM197 carrier protein; Intramuscular injection - Normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Maternal vaccine; IgG; IgA; GBS; pregnant women
Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and High BMI Volunteers
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a, randomized, parallel-group, placebo-controlled, double-blind,
      repeated-dose study to evaluate the safety and efficacy of three oral dose levels of HU6
      compared to placebo over the course of 61 days in subjects with high BMI and evidence of
      elevated liver fat.
    

Detailed description: 
      This is a Phase 2a, randomized, parallel-group, placebo-controlled, double-blind,
      repeated-dose study to evaluate the safety and efficacy of three oral dose levels of HU6
      compared to placebo over the course of 61 days in subjects with high BMI and evidence of
      elevated liver fat.

      Subjects will be screened over a 45 day period to determine their eligibility based on
      specific history, physical, laboratory and imaging evaluations as per the Schedule of
      Assessments. Due to scheduling of the procedures, multiple visits will likely be necessary to
      complete the screening process. However, if all screening assessments and procedures,
      including the MRI, can be completed within 30 days of the first dose, then a single screening
      visit is permissible.
    

Intervention name(s): HU6; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HU6 is designed to reduce the steatosis, inflammation, fibrosis and hepatocyte injury in Noncirrhotic Nonalcoholic Steatohepatitis (NASH); Non-active study drug N = 20
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Duloxetine for Post Laparoscopic Shoulder Pain
Condition: Post Laparoscopic Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Despite recent advances in minimal invasive surgery, postoperative pain control remains a
      challenge for both surgeons and anesthesiologists . Currently, laparoscopy has an obvious
      favor for both diagnostic and therapeutic procedures of pelvic and abdomen; while it is
      minimally invasive, has less pain, and needs less postoperative analgesic use compared with
      open surgeries . Shoulder pain is a frequent problem following laparoscopic procedure
    

Detailed description: 
      Many patients may feel much more discomfort from their shoulder pain than incision pain .
      Post laparoscopic shoulder pain is caused by irritation and/or injury of the diaphragm and
      phrenic nerve by local acidosis and irritative effect of carbon dioxide during
      pneumoperitoneum or distention forces on the diaphragm. Duloxetine is a selective serotonin
      and norepinephrine reuptake inhibitor antidepressant . It is used to treat major depressive
      disorder in adults. Duloxetine is also used to treat general anxiety disorder. It is also
      used in adults to treat fibromyalgia (a chronic pain disorder), or chronic muscle or joint
      pain (such as low back pain and osteoarthritis pain). Duloxetine is also used to treat
      diabetic neuropathy. Previous studies focused on the use of gabapentin and pregabalin (both
      are antineuropathic pain medications) to prevent post laparoscopic shoulder pain after
      laparoscopic ovarian cystectomy and laparoscopic cholecystectomy showed favorable results and
      since duloxetine is an antineuropathic pain medications we assume its use will ameliorate
      diaphragmatic irritation and hencepost laparoscopic shoulder pain.
    

Intervention name(s): Duloxetine 60mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): tablet; Tablet
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
PREPARE: A Randomized Trial of a Pre-pregnancy Weight Loss Intervention
Condition: Overweight; Obese
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The US obesity epidemic is being transmitted to the next generation. Growing evidence
      suggests that both a mothers' weight at pregnancy onset, and excessive weight gain during
      pregnancy, are associated with increased risk of pregnancy-related complications such as
      gestational diabetes and pre-eclampsia, and an increased risk that her child will become
      obese and face obesity-related health issues in later life.

      Currently, over one-third of reproductive-aged women in the U.S. are obese [body mass index
      (BMI) ≥ 30]. Our research team has shown that we can improve birth weight outcomes in babies
      of obese women who start a weight-management intervention program at 14 to 15 weeks of their
      pregnancy (soon after their first prenatal visit). However, organogenesis and metabolic
      programming begin early in the first trimester, well before the first prenatal visit.
      Therefore, waiting to address mothers' weight, physical activity, and diet quality until the
      first prenatal visit is not optimal. Given the need to reach overweight and obese women prior
      to pregnancy, and the Institute of Medicine's (IOM's) recent recommendation, based on
      observational studies, that women should reach a healthy weight before conceiving, this
      randomized clinical trial will evaluate a comprehensive preconception weight loss program.
    

Detailed description: 
      The goals are to help overweight and obese women (BMI ≥ 27) who are considering pregnancy to
      adopt improved dietary and physical activity habits and lose weight prior to becoming
      pregnant, and then help them maintain those habits and prevent excessive weight gain during
      their pregnancy. We model this intervention after successful, frequent-contact interventions
      designed by ourselves and other investigators. We start with face-to-face counseling followed
      by frequent telephone counseling contacts. The expected outcomes for mothers include reduced
      pregnancy-related weight gain (primary) and lower weight at the start of pregnancy
      (secondary) and for babies, decreased risk of exceeding national norms for weight at birth
      (secondary).
    

Intervention name(s): Weight management; Usual Care Control
Intervention type(s): Behavioral; Other
Intervention description(s): Phone counseling for pre-pregnancy weight loss and weight maintenance when BMI </=25, and when pregnant, weight gain within IOM guidelines.; Usual care control participants receive general dietary advice as it relates to planning for a healthy pregnancy (e.g. folate requirements, prenatal vitamins, smoking cessation, alcohol cessation, and prenatal food safety).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pre-pregnancy; Weight management
A Non-Invasive Neuromodulation Device for Treatment of Migraine Headache
Condition: Migraine Headache, Episodic
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      This is a randomized, blinded study designed to assess the efficacy of a portable,
      non-invasive neuromodulation system for the treatment of episodic migraine headaches.
    


Intervention name(s): neuromodulation for episodic migraine headache
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neuromodulation; migraine headache
A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4)
Condition: HIV Infections; Hepatitis C; HCV Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this trial is to compare the efficacy of boceprevir (SCH 503034) 800
      mg three times a day (TID) orally (PO) in combination with peginterferon alfa-2b (PegIFN-2b)
      1.5 µg/kg weekly (QW) subcutaneously (SC) plus weight-based dosing (WBD) of ribavirin (RBV)
      (600 mg/day to 1400 mg/day) PO to therapy with PegIFN-2b + RBV alone in adult participants
      coinfected with human immunodeficiency virus (HIV) and previously untreated chronic hepatitis
      C virus (HCV) genotype 1.

      Boceprevir is a potent, orally administered, novel serine protease inhibitor, specifically
      designed to inhibit the HCV nonstructural protein 3 (NS3) protease and, thereby, inhibit
      viral replication in HCV-infected host cells. The mechanism of inhibition represents a new
      mechanism of action compared to both interferon alfa and ribavirin. Based on previous
      experience with PegIFN-2b and RBV in combination with boceprevir in the HCV-monoinfected
      population, this combination treatment is expected to provide significant benefit to the
      HIV/HCV coinfected population. Given the high unmet medical need of these participants and
      the benefit of the addition of boceprevir to PegIFN-2b/RBV, it is important to demonstrate
      the safety and efficacy of boceprevir in combination with PegIFN-2b/RBV in participants
      coinfected with HIV/HCV.

      This is a randomized, multi-center trial, double-blinded for boceprevir or placebo in
      combination with open-label PegIFN-2b/RBV in participants coinfected with HIV and previously
      untreated chronic HCV (genotype 1), to be conducted in conformance with Good Clinical
      Practice (GCP). This trial consists of two arms, one control arm (Arm 1) and one experimental
      arm (Arm 2). Participants in the control arm (Arm 1) may receive boceprevir/PegIFN-2b/RBV via
      a crossover arm.
    


Intervention name(s): PegIFN-2b; RBV; Placebo to Boceprevir; Boceprevir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PegIFN-2b (1.5 μg/kg/week subcutaneously); Ribavirin (600-1400 mg/day, orally, divided into two daily doses); Placebo to boceprevir (orally, three times per day); Boceprevir (800 mg, orally, three times per day)
Other intervention name(s): SCH 054031; MK-4031; Pegylated interferon alfa-2b; Peginterferon alfa-2b; Ribavirin; SCH 503034; MK-3034; Victrelis
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: coinfection; protease inhibitor; HIV
The Depth of Right Bronchial Blocker Placement in Taiwanese in Video-assisted Thoracoscopic Surgery(VATS)
Condition: Lung Tumor; Pneumothorax
MeSH terms: Pneumothorax
Study type: Observational

Summary: 
      A retrospective study to demonstrate the optimal depth of right side bronchial blocker for
      complete right lung separation. Data were collected from all patients who completed right
      side VATS with right side BB from Jan 2010 through Nov 2010.
    

Detailed description: 
      After general anesthesia, an 8.0 mm internal-diameter single-lumen endotracheal tube was
      inserted orally. An independent Coopdech bronchial blocker, which has a formed-curvature near
      the catheter tip, was directly inserted through the single-lumen endotracheal tube into right
      main bronchus. Chest inspection, auscultation, fiberoptic bronchoscopy confirmation, if
      necessary, by visualizing the blocker cuff located at right main bronchus just below the
      carina was performed firstly. After placing patients in left decubitus position, the position
      of BB was reconfirmed by auscultation firstly; then complete collapse of the right upper lobe
      was adjust, if necessary and reconfirmed on the video of thoracoscopy by both surgeon and
      anesthesiologists. The depth of BB and the need of fiberoptic bronchoscope were recorded. All
      the patients were extubated in operation room after completion of operation with optimal
      analgesia. Data collected included; age, sex, body height and weight and the depth of
      right-sided BB from incisor was then recorded.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients receiving right side VATS( video-assisted thoracoscopic surgery) with right side
        bronchial blocker
      
Keywords: bronchial blocker; VATS
Functional Endoscopic Evaluation of Swallowing
Condition: Cerebral Palsy; Dysphagia
MeSH terms: Deglutition Disorders; Cerebral Palsy
Study type: Observational

Summary: 
      The investigators objective is to describe functional endoscopic evaluation of swallowing
      findings in children with cerebral palsy.
    

Detailed description: 
      Cerebral palsy (CP) is a predominantly motor disorder and dysphagia is a frequent complaint.
      Functional endoscopic evaluation of swallowing (FESS) involves anatomic and functional
      observation of the larynx and pharynx, evaluation of swallowing and maneuvers to improve it,
      also testing the laryngeal sensitivity. We evaluated nine patients with CP of both sexes,
      which age varied from 1 to 10 years old, attended at dysphagia multidisciplinary clinic, at
      NAMI (Integrated Medical Assistance Nucleons).
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children with cerebral palsy
      
Keywords: Cerebral palsy; Dysphagia; Deglutition; Endoscopy
Safety Study of XP12B in Women With Menorrhagia
Condition: Menorrhagia; Heavy Menstrual Bleeding
MeSH terms: Menorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual
      bleeding associated with menorrhagia.
    


Intervention name(s): Tranexamic acid tablets (XP12B)
Intervention type(s): Drug
Intervention description(s): Two 650 mg tranexamic acid tablets (XP12B) taken 3 times daily (3900 mg/Day) for a maximum of 5 days during monthly menstruation
Other intervention name(s): Lysteda; XP12B; tranexamic acid tablets; XP12B-MR
Intervention MeSH terms: Tranexamic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Menorrhagia; Heavy Menstrual Bleeding
Safety and Efficacy Study of IV Artesunate to Treat Malaria
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine how GMP IV Artesunate is metabolized and cleared by
      individuals with uncomplicated malaria infection and to determine how fast it eliminates
      malaria infection from the body.
    

Detailed description: 
      This is an unblinded non-randomized phase II pharmacokinetic study of a new GMP formulation
      of intravenous artesunate. Artesunate has been used throughout Asia and Africa for many
      years. Its overall efficacy associated with the ability to lower parasitemia is well
      established. To date, pharmacokinetic studies have not been done in Africa using GMP (Good
      Manufacturing Practices)-produced drug. The objective of this study is to show that GMP IV
      artesunate rapidly clears parasites in Adult Kenyan populations with malaria and that the
      pharmacokinetic profile of the drug approximates other populations of adults tested (Asians
      and North Americans).
    

Intervention name(s): Artesunate; Malarone
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous Artesunate (2.4 mg/kg) once a day for three days; (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)
Other intervention name(s): quinidine; atovaquone and proguanil hydrochloride
Intervention MeSH terms: Artesunate; Atovaquone; Proguanil; Quinidine; Atovaquone, proguanil drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Uncomplicated Malaria; GMP artesunate
Bisphenol Role in the Pathogenesis of PCOS
Condition: PCOS
Study type: Observational [Patient Registry]

Summary: 
      Polycystic ovary syndrome (PCOS) is the most common and the most heterogeneous endocrine
      disorder in premenopausal women. Its prevalence is estimated from 5 to 10% depending on the
      diagnosis' criteria .

      Apart from signs of hyperandrogenism such as acne, hirsutism and hair loss; women with PCOS
      usually present with menstrual irregularities and fertility problems ..
    

Detailed description: 
      Bisphenol A is formed from acetone and phenol, it is used in production of epoxy resin,
      polyster resins and polyvarbonate resins. Epoxy resins are used in plastics, adhesives, and
      structural composites .

      Humans are at the end of the food chain, thus they are exposed to the highest doses of these
      compounds. EDs have been detected in human adipose tissue and biological fluids such as:
      serum, urine, milk and amniotic fluid .

      Additionally, it has been proven that BPA can also directly stimulate androgen synthesis in
      the ovarian theca-interstitial cells. A correlation between increased serum testosterone
      levels observed in women with PCOS with serum BPA concentrations has also been found .
    

Intervention name(s): Measurement of Bisphenol in urine
Intervention type(s): Diagnostic Test
Intervention description(s): to see level of this material in blood of women
Intervention MeSH terms: Bisphenol A
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        females who were diagnosed to have PCOS
Evaluation of Tiotropium 2.5 and 5 µg Once Daily Delivered Via the Respimat Inhaler Compared to Placebo in Patient With Moderate to Severe Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this trial is to evaluate the safety and efficacy of 2.5 and 5 µg tiotropium over
      a 52-week treatment period as compared to placebo. Tiotropium inhalation solution delivered
      by the Respimat inhaler will be examined on top of maintenance treatment with inhaled
      corticosteroid controller medication in patients with moderate to severe persistent asthma.
      Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma
      exacerbations, effects on asthma control, and number of adverse events.
    


Intervention name(s): Tiotropium Respimat; Placebo Respimat; Tiotropium Respimat
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tiotropium high dose once daily delivered with Respimat inhaler; Tiotropium placebo once daily delivered with Respimat inhaler; Tiotropium low dose once daily delivered with Respimat inhaler
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Concerta and Strattera on the Executive Function in Attention Deficit Hyperactivity Disorder (ADHD) Children
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to compare the effect of Concerta (Osmotic Release Oral System
      Extended Release Methylphenidate HCL, OROS MPH) and Strattera (Atomoxetine) on the laboratory
      and ecological executive function in children with attention deficit hyperactivity disorder.
    

Detailed description: 
      The sample will include 134 ADHD children and adolescence, randomized assigned to Concerta
      and strattera treatment group, with 67 cases in each. It will also include 67 sex and age
      matched normal control. The drug will be titrated to optimal dose. The executive function
      including inhibition, working memory, set shifting and plan will be compared among two
      medication group and the control group, using laboratory executive function test and Behavior
      Rating Inventory of Executive Function (BRIEF).
    

Intervention name(s): OROS MPH; Atomoxetine
Intervention type(s): Drug; Drug
Intervention description(s): The dosage began with 18mg Qd. It can be increased with 18mg every week until an optimal response achieved. The maximum dosage was no more than 54mg/d. The optimal dosage will maintain for 4 to 6 weeks; The dosage begins with 0.5mg/kg.d. It can increased to 0.8mg/kg.d at the second week, 1.2mg/kg.d at the third week, and 1.4mg/kg.d at the 5th week according to the patients response. The optimal dosage will maintain for 4 to 6 weeks.
Other intervention name(s): Concerta; Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: attention deficit hyperactivity disorder; executive function; OROS MPH; atomoxetine