bioihbjkbjnl/mcl2 huggingface dataset:
Effect of tDCS Timing on Safety Memory in PTSD
Condition: PTSD
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The primary purpose of this study is to investigate the effects of tDCS timing on safety
      memory in PTSD. A total of 90 participants will be randomized equally across one of three
      groups:

        1. One group receiving active stimulation during extinction and sham during consolidation

        2. One group receiving sham stimulation during extinction and active during consolidation

        3. One group receiving sham stimulation both during extinction and consolidation

      This study will also include an online sub-study focused on contextual processing along the
      PTSD spectrum. A maximum of 500 participants will be recruited using an online, panel-based
      platform.
    

Detailed description: 
      This is a three-arm study composed of four to five visits over an approximate period of three
      weeks. Ninety participants will be exposed to a fear conditioning, extinction and recall
      paradigm at three separate study visits; one of these study visits will include active or
      sham transcranial direct current stimulation (tDCS) for a period of 15-20 minutes. Additional
      study procedures will include a screening period and two optional MRI scans, one done on
      study day 2 and one done on study day 5.

      SUB-STUDY: The objective of this sub-study is to test performance differences between
      configural and elemental contextual processing in individuals across the PTSD spectrum using
      an online, panel-based platform. Following a within-subjects study design, up to 500 adult
      participants, 18-89 years, will be asked to complete experimental tasks that assess
      configural and elemental contextual learning and memory. They will also provide demographic
      information and complete questionnaires.
    

Intervention name(s): transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Active tDCS will consist of 15 minutes of 2 mA intensity once, either applied during or after extinction learning.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Individuals deemed eligible for the study will be randomized to 1) receiving active tDCS during extinction learning; sham during extinction consolidation, 2) receiving sham during extinction learning; active tDCS during extinction consolidation, 3) receiving sham during extinction learning; sham during extinction consolidation. (Anticipated enrollment: 90 participants)
SUB-STUDY: Individuals deemed eligible will all complete the same experimental tasks and questionnaires. (Anticipated enrollment: 500 participants)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: safety memory; PTSD; tDCS; ventromedial prefrontal cortex; fear conditioning; context processing
PF-06291874 Multiple Ascending Dose Study In Type 2 Diabetes Mellitus Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of multiple ascending doses of PF-06291874 in Type 2 Diabetes patients.
    


Intervention name(s): PF-06291874; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The dosing schedule is 5, 15, 50, 100 and 150 mg QD for 14 days for the first 5 cohorts in Part A. The dosing schedule for the first cohort in Part B is 15 mg QD for 14 days and 30 mg QD for 28 days; Placebo tablets will be administered QD in each of the cohorts for 14 days (Part A cohorts 1- 5 and Part B cohort 1) or 28 days (Part B cohort 2).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Serum Anti-mullerian Hormone and Polycystic Ovarian Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      In 1935 the polycystic ovary syndrome was a clinical diagnosis made on the morphological
      appearance of the ovaries in association with amenorrhoea, hirsutism and frequently obesity.
      At that time wedge resection of the ovaries was introduced on an empirical basis and proved a
      successful treatment for the associated anovulation and infertility. In the ensuing fifty
      years the limitations of a purely surgical approach to therapy have become recognized and the
      importance of the biochemical abnormalities appreciated. Prevalence of polycystic Ovary
      Syndrome: The prevalence of polycystic ovary syndrome in any specified population is
      dependent upon the diagnostic criteria used, but does have some regional and ethnic
      variation. While most reports on the prevalence of polycystic ovary syndrome range between 2
      and 20%, the chosen diagnostic criteria are recognized to influence the determined
      prevalence. Anti-mullerian hormone which is a predictor of ovarian reserve is known to
      decrease after laparoscopic ovarian drilling. On the best of our knowledge no study had been
      done to use the level of anti-mullerian hormone as a factor for planning the number of
      ovarian drills in each ovary.
    


Intervention name(s): Laparoscopic ovarian drilling; Antimullerian hormone
Intervention type(s): Procedure; Biological
Intervention description(s): The electric current used was set at 40 Watts. The power was activated just before touching the ovary, and then the needle electrode was held against the antimesenteric surface of the ovary for 4 seconds until penetration of the ovarian capsule. Four or eight puncture points were made through the ovarian capsule of each ovary according to the study protocol. The ovaries were cooled in the pool of the Ringer's lactate after each cauterization both to minimize adhesion formation and to prevent heat trauma to the adjacent viscera. Complete hemostasis was ensured. At the end of the procedure, the ovaries were copiously rinsed with Ringer's lactate (Aqua-purator, Storz, Germany). An amount about 200 ml of heparinized Ringers lactate (5000 IU/1000 ml) was left in the pelvis to avoid postoperative adhesions.; In patients with Antimullerian hormone between 4-8 ng/ml 4 punctures in each ovary were performed.
In patients with Antimullerian hormone above 8 ng/ml 8 punctures in each ovary were performed.
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Follow-up of the Natural Course of the Small EUS-suspected Gastric Gastointestinal Stromal Tumors
Condition: Tumor
Study type: Observational

Summary: 
      Gastric gastrointestinal stromal tumors (GISTs) less than 2 cm are usually followed up
      conservatively. However, little is known about the natural course of small GISTs. The goal of
      this study was to evaluate the clinical course of the small EUS-suspected gastric GISTs and
      to determine the size predicting subsequent progression with increased malignant potential.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This was a retrospective study. We reviewed 256 consecutive patients with the diagnosis of
        suspected gastric GISTs by EUS, from January 1997 to December 2008 at the National Taiwan
        University Hospital, Yuan's General Hospital and En Chu Kong Hospital.
      
Keywords: Gastrointestinal stromal tumor,endoscopic ultrasound,submucosal tumor
The Effect of Folic Acid Supplementation and Pregnancy on the Folate Forms in Red Blood Cells
Condition: Pregnancy
Study type: Observational

Summary: 
      The purpose of this cross-sectional study was to examine whether or not physical changes or
      adaptations occur in response pregnancy or to the higher intakes of folic acid from
      supplementation typically consumed during the reproductive period.
    

Detailed description: 
      Higher folate requirements during pregnancy to support growth and development are well
      established but it is unknown what metabolic changes occur in 1-carbon metabolism to provide
      sufficient nucleotides for DNA/RNA synthesis. Periconceptual folic acid (FA) supplementation
      and fortification of the food supply have been shown to reduce the risk of pregnancies with
      neural tube defects but conversely expose women to high FA intakes for extended periods of
      time. The purpose of this cross-sectional study is to establish if physiological adaptations
      occur in folate metabolism in response to pregnancy or higher intakes of FA typically
      consumed among women during the reproductive period. A convenience sample of thirty-two women
      (n=8/group) were recruited to compare the total concentrations and forms of folate
      (tetrahydrofolate [THF], 5-methylTHF, 5-formylTHF and 5, 10-methenylTHF) in red blood cells
      in four groups: a) pregnant women (PW, 30-36 weeks gestation) taking 1.0 mg of FA b)
      non-pregnant women (NPW) taking 0 mg of FA c) NPW taking 1.0 mg FA and d) NPW taking 5.0 mg
      FA. Blood samples were taken at a single time point and compared across groups. Total red
      blood cell concentrations were measured using both microbiological assay and liquid
      chromatography/tandem mass spectrometry (LC/MS/MS) analysis. LC/MS/MS analysis was used to
      determine folate form concentrations.
    

Intervention name(s): folic acid
Intervention type(s): Dietary Supplement
Intervention description(s): subjects take multivitamin supplement containing folic acid. Women were enrolled based on whether or not they were taking supplements.
Intervention MeSH terms: Folic Acid
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        women of reproductive age
      
Keywords: pregnancy; folic acid supplementation; reproduction; folate
Impact of Physical Activity for Chronic Pelvic Pain
Condition: Pelvic Pain
MeSH terms: Pelvic Pain
Study type: Interventional

Summary: 
      The purpose of this pilot study is to evaluate the impact of an intervention to increase
      physical activity on pain, function and quality of life in women with chronic pelvic pain.
    

Detailed description: 
      The primary aim of this pilot study is to evaluate the impact of moderate-intensity physical
      activity on pelvic pain in women with chronic pelvic pain. We will develop a
      moderate-intensity physical activity program for patients with chronic pelvic pain in
      conjunction with exercise physiologists and physical medicine and rehabilitation (PM&R)
      physicians. Based on prior research in fibromyalgia and other centralized pain disorders, we
      hypothesize that eight weeks of moderate-intensity physical activity will reduce pain
      intensity and pain interference in women with chronic pelvic pain. We will also evaluate the
      impact of moderate-intensity physical activity on physical function, fatigue, sexual
      function, sleep, anxiety, depression, catastrophization and patient global impression of
      change in women with chronic pelvic pain. We hypothesize that eight weeks of
      moderate-intensity physical activity will result in improvements in these measures of
      function and quality of life.
    

Intervention name(s): Physical Activity
Intervention type(s): Behavioral
Intervention description(s): 8 week exercise program specifically designed for patients with chronic pain at Transitions Training Studio, a rehab-focused, medically-based fitness center based at the University of Michigan.
The program is designed to gradually increase intensity and duration. If causes pain exacerbation, patients will go back to earlier level of intensity. It favors short, frequent activity episodes as this is often better tolerated than longer, infrequent episodes. The program begins with 30 minutes sessions 3 times per week with goal of increasing duration over course of the program.
The program incorporates elements of flexibility, strength and cardio. Program design includes common elements but allows for a personalized program based on a subject's baseline fitness, interest and tolerance to activity. The program design emphasizes activities that patients can incorporate into their daily routine.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic pelvic pain; central pain amplification; exercise; physical activity
Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered
      for up to 12 months.
    


Intervention name(s): ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
Intervention type(s): Drug
Intervention description(s): capsules, available dosage strengths 20, 30, 40, 50, 60, 80, and 100 mg morphine sulfate with 4% by weight naltrexone hydrochloride given once or twice daily
Other intervention name(s): Embeda
Intervention MeSH terms: Naltrexone; Morphine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic pain; joint pain; back pain; diabetic peripheral neuropathy; post herpetic neuralgia; ALO-01; Embeda; Chronic Non-Malignant Pain
Premenstrual Symptoms Treatment Comparing Between Oral Contraceptives Containing Desogestrel and Drospirenone
Condition: Premenstrual Syndrome
MeSH terms: Premenstrual Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether low-dose combine oral contraceptives (COC)
      containing desogestrel 150 mg and drospirenone 3 mg are effective in the treatment of
      Premenstrual symptoms.
    

Detailed description: 
      Premenstrual syndrome is commonly reported 20-90 percent in reproductive-aged women. Only a
      small percentage of women (2 to 5%) have significant premenstrual symptoms defined as
      Premenstrual dysphoric disorder (PMDD). The exact symptoms and their intensity vary from
      woman to woman and even from cycle to cycle.While exact causes of PMS are not fully
      understood,current thinking suspects that fluctuation of endogenous sex hormones are
      relevant. The standard 21/7 design may induce menstrual-related symptoms including headache,
      mood swings, abdominal cramping, bloating, and breast tenderness that increase during the
      last week of active pills extending along the 7-day hormone free interval(HFI). The decline
      in endogenous estradiol levels during HFI may be responsible for the estrogen-withdrawal
      symptoms. While a new COC with drospirenone introduced in 24/4 design has been shown in
      clinical trials to significantly improve the symptoms of PMS, there has been questioned about
      efficacy of the other kind of COC which has optimal properties, for example, good-control
      cycles extend to the similar 24/4 regimen.
    

Intervention name(s): EE 20 microgram with desogestrel 150 mg; EE 20 microgram with drospirenone 3 mg
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of 2 different low-dose oral contraceptive pill which one consists of 20 microgram ethinyl estradiol and 150 mg desogestrel and the other consists of 20 microgram ethinyl estradiol and 3 mg drospirenone. Both were taken orally by participants every day beginning Day1 to Day 3 of the first menstrual cycle until complete 24 days and continued with free-hormone pills for 4 days. The next cycle has to continue in the same way until complete 6 cycles.; Comparison of 2 different low-dose oral contraceptive pill which one consists of 20 microgram ethinyl estradiol and 150 mg desogestrel and the other consists of 20 microgram ethinyl estradiol and 3 mg drospirenone. Both were taken orally by participants every day beginning Day1 to Day 3 of the first menstrual cycle until complete 24 days and continued with free-hormone pills for 4 days. The next cycle has to continue in the same way until complete 6 cycles.
Other intervention name(s): Mercilon; Yaz
Intervention MeSH terms: Drospirenone; Desogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PMS; Low-dose combine contraceptives pills; COC
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 11634 Solution in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      First evaluation of safety, tolerability, pharmacokinetics and the pharmacodynamic effect of
      BI 11634 on coagulation parameters
    


Intervention name(s): BI 11634 drinking solution; BI 11634 tablet; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Rabeprazole in Subjects With Gastroesophageal Reflux Disease (GERD)
Condition: Esophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the production of mucin in GERD/RE subjects before
      and after 8 weeks of treatment with rabeprazole.
    

Detailed description: 
      Enrolled patients will undergo collection of salivary and esophageal secretions.
      Subsequently, all patients will receive rabeprazole (20mg QD) for 8 weeks and will be
      re-endoscoped to confirm complete healing of reflux esophagitis. In patients with completely
      healed reflux esophagitis the second collection of salivary and esophageal secretion will be
      implemented. In both secretions, adequately coded for the laboratory Research Fellow (blinded
      in terms of which sample is collected before and which after treatment with rabeprazole) the
      content of mucin will be measured using commercially available assay and its secretion
      expressed in units per minute of collection time.
    

Intervention name(s): Rabeprazole
Intervention type(s): Drug
Intervention MeSH terms: Rabeprazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessing the Acceptability of the Use of a Mobile Health App Among Young Adult Female Survivors of Childhood Cancer
Condition: Childhood Cancer Survivor
Study type: Interventional

Summary: 
      The purpose of this research study is to understand if a mobile app is useful to assist young
      adult female survivors of childhood cancer in the self-management of survivorship-related
      needs.
    

Detailed description: 
      Survivorship related needs include managing lingering symptoms from treatment, how to keep a
      healthy lifestyle, social and medical issues, as well as other needs. The mobile health app
      that will be used in this study is the Health Storylines TM app developed by Self Care
      Catalysts Inc. The app can be used for an unlimited amount of time over nine months, which is
      how long the study will be conducted. The use of the Health Storylines TM app in this study
      is investigational.

      Participation in this study starts with setting up a study specific profile on the app and
      entering information including email address, age, ethnicity/race, cancer diagnosis, as well
      as other optional information for the profile (example health goals or current health
      conditions). Participants will then be prompted by the app to complete three questionnaires
      about their ability to self-manage their survivorship-related needs, their perception of
      their survivorship-related illness symptoms and perceived health related quality of life.
      They will be prompted on the app to complete these questionnaires again at the 3, 6 and 9
      month intervals of using the app. It will take about 20 minutes to complete the
      questionnaires at each measurement time. The only additional information that will be
      reported from the app for the study is the amount of time and features of programs accessed
      during the study period.
    

Intervention name(s): Mobile Health App
Intervention type(s): Other
Intervention description(s): Mobile Health is a multi-featured app designed to enable participants to self-record and track their health and wellness. Participations will set up a profile and complete questionnaires. The app also records the amount of time and features of programs accessed.
Intervention model: Single Group Assignment
Intervention model description: This project is a longitudinal one-group pilot study evaluating the use of a Mobile Health (mHealth) app intervention. This study will examine: 1) the amount/type of usage, 2 ) compliance with study evaluations and 3) the association of this mHealth app use with perceived self-efficacy in managing survivorship related needs, perceived health illness and health related quality of life. The study period will be nine months, with four measurement points to assess the study's outcomes: baseline, three, six, and nine months post initiation of the mHealth app.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: survivors of childhood cancer; young adult female; mobile app; questionnaire; health tracking
Study on the Effects of an AMP Challenge on Asthmatic Patients Following Treatment With Fluticasone Propionate
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Inhaling AMP causes an inflammatory response in the lung. This study will investigate whether
      5-days of treatment with fluticasone propionate protects the lung from responding to the AMP
      in this way.
    

Detailed description: 
      A randomised, double-blind, placebo-controlled, incomplete block, 4-period crossover study to
      investigate the effects of 5-day repeat inhaled doses of fluticasone propionate (BID, 50-2000
      mcg) on airway responsiveness to adenosine-5'-monophosphate (AMP) challenge when delivered
      after the last dose in mild asthmatic subjects
    

Intervention name(s): Fluticasone propionate
Intervention type(s): Drug
Intervention description(s): Study drug
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma; AMP challenge