bioihbjkbjnl/mcl2 huggingface dataset:
Sexual Function Changes in High-Risk Pregnancies
Condition: Sexual Dysfunctions, Psychological; High Risk Pregnancy; Sexual Behavior
MeSH terms: Sexual Dysfunctions, Psychological
Study type: Observational [Patient Registry]

Summary: 
      Sexual Function Changes in High-Risk Pregnancies
    

Detailed description: 
      Background and Aim: Sexual functions generally decrease during pregnancy, and high-risk
      pregnancies are more severe clinical conditions that cause couples to reduce or abstain
      entirely from their intimacy. However, the evidence on the sexual functions in high-risk
      pregnancies is scarce. Therefore, this study aimed to evaluate the sexual function changes in
      high-risk pregnancies compared to normal pregnancies.

      Methods: A total of 200 pregnant women (100 women in high-risk pregnancy and normal pregnancy
      groups each) were included. Demographic and obstetric data were collected, and participants
      completed The Female Sexual Function Index (FSFI).
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The women who followed up for HrP were invited to participate and women with HrP in the
        second trimester (14th to 28th gestational weeks), between 20 to 40 years old, and followed
        up at our perinatology department with a diagnosis of IUGR, cholestasis, diabetes,
        preeclampsia, or hypertension were included.
      
Keywords: sexual dysfunction, high-risk pregnancy, FSFI, quality of life
An Exploration of the Impact of Emicizumab on the Lives of People With Haemophilia and Inhibitors and Their Families
Condition: Hemophilia A With Inhibitor
MeSH terms: Hemophilia A
Study type: Observational

Summary: 
      This study aims to examine the real-life experience and impact of using emicizumab in a
      cohort of patients with haemophilia and inhibitors, who were prescribed emicizumab as part of
      the early access to medicine schema (EAMS),those who have been in clinical trials and those
      now receiving emicizumab as part of routine haemophilia care.

      The Investigators also intend to capture the impact of emicizumab use on the lives of close
      family members (parents/carers/children/partners/siblings). Each participant and his family
      members will be deemed a study 'dyad'.

      This is a prospective, observational cohort qualitative research study to be conducted among
      patients using emicizumab in routine clinical practice.

      The study is designed to allow English-speaking patients and their families to tell their own
      life stories through narrative accounts. The narratives represent a true sharing of
      experiences and therefore offers insight into how these patients and families cope with
      haemophilia.
    


Intervention name(s): Qualitative Interview
Intervention type(s): Other
Intervention description(s): A single one hour semi structured qualitative interview
Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male participants with Hameophilia A and inhibitors currently on emicizumab prophylaxis and
        a member of their family
      
Keywords: Haemophilia, Quality of Life
Cannabidiol and CES1 Interactions in Healthy Subjects
Condition: Drug Interaction
Study type: Interventional
Phase: Phase 4

Summary: 
      The proposed study will assess the drug interaction potential between oral cannabidiol
      (Epidiolex®) and the carboxylesterase 1 (CES1) substrate methylphenidate (Ritalin®) in 12
      healthy research subjects
    


Intervention name(s): di-Methylphenidate plus Cannabidiol; di-Methylphenidate plus Cannabidiol Placebo solution
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be administered one (1) 10 mg tablet of dl-methylphenidate (Ritalin®) plus CBD 750 mg (administered as 7.5 ml of Epidiolex® solution [100 mg/ml] of CBD); Subjects will be administered one (1) 10 mg tablet of dl-methylphenidate (Ritalin®) 7.5 ml of Epidiolex® placebo solution containing no CBD.
Other intervention name(s): Ritalin®; Epidiolex®; Ritalin®; Epidiolex®
Intervention MeSH terms: Cannabidiol; Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: An open-label, randomized crossover design is proposed wherein healthy volunteer subjects (n=12) would receive a single dose of immediate-release dl-methylphenidate (Ritalin®) concomitantly with orally administered CBD (Epidiolex®) solution or an equal volume of Epidiolex® placebo solution (i.e vehicle with no CBD) which have been dosed to plasma steady-state conditions.
Masking: None (Open Label)
Primary purpose: Other
The Effect of Vitamin D and Exercise on Balance in Postmenopausal Women
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      In recent years, skeletal and nonskeletal effects of vitamin D has been studied. One of the
      effects of it was balance and fall prevention. However, these studies were performed on older
      patients who had not vitamin D deficiency. This study aimed to evaluate the effect of vitamin
      D replacement therapy and exercise on balance in 50-70 years-old postmenopausal women.
    


Intervention name(s): Vitamin D; Exercise
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Vitamin D3 50.000 IU/per week, for 8 weeks; Core stability, balance exercises
Other intervention name(s): exercise
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: balance; vitamin D; exercise; fall risk
Artemether-Lumefantrine Clinical Effectiveness Study
Condition: Parasitologically Confirmed; Malarial
Study type: Interventional
Phase: Phase 4

Summary: 
      In 2009, Papua New Guinea officially adopted artemether-lumefantrine (AL) as new national
      first-line drug for uncomplicated malaria. The principal purpose of this study is to measure
      the absolute effectiveness of AL when used under real-life clinical conditions, as compared
      to optimized in-vivo trial conditions. This question was raised by the National Department of
      Health in preparation for the country-wide roll-out of AL.

      The study is designed as a randomized controlled trial comparing two study arms. Patients in
      the "effectiveness arm" receive the first dose of AL under full supervision in the clinic;
      the following doses will be taken at home, as in real-life clinical practice and according to
      the new national treatment guidelines. Patients in the "efficacy arm" will receive all doses
      of AL as directly observed treatment in the clinic in order to establish the efficacy of the
      drug when used under ideal conditions.

      The study will enroll outpatients aged 6 months to 10 years with a history of fever and a
      positive rapid test for malaria. Patients meeting all enrollment criteria and providing full
      written informed consent by a parent/caretaker will be randomized into either of the two
      study arms. Patients in both arms will be followed up actively for 42 days. Patients in the
      efficacy arm will be scheduled for visits on days 0, 1, 2, 3, 7, 14, 28 and 42; patients in
      the effectiveness arm on days 0, 3, 7, 14, 28 and 42.
    


Intervention name(s): Artemether-lumefantrine combination
Intervention type(s): Drug
Intervention description(s): fixed-dose tablet, six doses over three days, according to weight group
Other intervention name(s): Coartem, Novartis
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malaria; Plasmodium; Papua New Guinea; artemether/lumefantrine
United Kingdom User Evaluation, MiniMed Paradigm® X54 System
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The user evaluation is to assess user acceptance and the quality of training materials for
      the MiniMed Paradigm® X54 System (X54 System) in preparation for commercial distribution of
      the new system.
    


Intervention name(s): X54 insulin pump with low suspend feature
Intervention type(s): Device
Intervention description(s): Change from current insulin pump to new X54 pump
Other intervention name(s): Veo
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Ciclesonide on Exercise Induced Bronchoconstriction
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to study the effects of once daily inhaled ciclesonide at
      varying doses on exercise provoked asthma symptoms, fall in lung function after exercise and
      sputum characteristics.
    

Detailed description: 
      To study the effects of 4 doses of ciclesonide on exercise-induced bronchoconstriction,
      bronchial responsiveness to mannitol, sputum parameters and other parameters of asthma
      control in asthmatic patients. The primary aim was to evaluate exercise-induced
      bronchoconstriction as a method of determining the dose and time responses of inhaled
      corticosteroid therapy. The secondary aims were to evaluate the dose and time responses of
      sputum parameters and responsiveness to mannitol to inhaled corticosteroid therapy.
      Furthermore to explore the relationship(s) between exercise induced bronchoconstriction,
      sputum parameters and mannitol responsiveness.
    

Intervention name(s): ciclesonide; ciclesonide
Intervention type(s): Drug; Drug
Intervention description(s): low dose- 50ug and 200ug; high dose- 100ug and 400ug
Other intervention name(s): ciclesonide (Alvesco); ciclesonide (Alvesco)
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma; exercise induced bronchoconstriction; sputum eosinophils
A Study of Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Been Treated With Anti-HIV Drugs
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil
      once a day for 4 weeks to HIV-infected patients who never have been treated with anti-HIV
      medicine. This study also examines how the body processes adefovir dipivoxil.
    

Detailed description: 
      This a double-blind, placebo-controlled, randomized Phase I/II study of the safety,
      tolerance, pharmacokinetics, and anti-HIV activity of adefovir dipivoxil in HIV-infected
      patients naive to antiretroviral therapy. Patients are randomized to receive a single daily
      dose of adefovir dipivoxil or matching placebo tablet for 4 weeks.
    

Intervention name(s): Adefovir dipivoxil
Intervention type(s): Drug
Intervention MeSH terms: Adefovir; Adefovir dipivoxil
Masking: Double
Primary purpose: Treatment
Keywords: HIV-1; Adenine; Anti-HIV Agents
Knee Osteoarthritis, Kinesiophobia and Physical Activity
Condition: Fear of Pain; Knee Osteoarthritis; Physical Activity
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Kinesiophobia
Study type: Observational

Summary: 
      Although the importance of regular physical activity in patients with knee osteoarthritis is
      known, and fear of movement is considered as one of the causes of physical inactivity and is
      widely researched in terms of its role in the pathogenesis of pain, there remains to be
      limited number of studies on kinesiophobia in these patients. In this study, we aimed to
      evaluate the levels of kinesiophobia and physical activity in patients with knee
      osteoarthritis and to investigate whether they were associated with demographic
      characteristics, body mass index, pain intensity, depression, disability, radiological grade,
      and quality of life.
    

Detailed description: 
      A total of 96 female and male patients aged 50 to 75 years with knee osteoarthritis (OA) and
      knee pain lasting for more than three months (knee pain intensity over 20 mm on Visual Analog
      Scale-VAS) were included in the study. The severity of pain at night, pain at rest and
      activity-related pain was evaluated by Visual Analog Scale (VAS), kinesiophobia by Tampa
      Scale of Kinesiophobia (TSK) and Brief Fear of Movement Scale (BFOM), depression by the Beck
      Depression Inventory (BDI), disability by the Western Ontario and McMaster Universities
      Arthritis Index (WOMAC), physical activity level by the International Physical Activity
      Questionnaire (IPAQ) short form and quality of life by the Short Form 12 Health Survey
      Questionnaire (SF-12). Age, gender, marital status, educational status, additional disease,
      drug history, and sociodemographic data such as BMI were obtained from the patients and
      recorded in the evaluation form.
    

Intervention name(s): kinesiophobia
Intervention type(s): Behavioral
Intervention description(s): patients who have a high-level or low-level kinesiophobia have been evaluated.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All the patients presenting to Aksaray Training and Research Hospital Physical Medicine and
        Rehabilitation Outpatient Clinic between April 2018 and October 2018, who volunteered to
        participate in the study and fulfilled the inclusion criteria, completed the questionnaire
        forms.
      
Keywords: kinesiophobia; osteoarthritis; fear of movement; tampa; physical inactivity
Alcohol and Gender Effects on Stress Circuit Function
Condition: Alcoholism; Stress; Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      The purpose of this study is to look at the stress hormone response to medication-induced
      stress and a placebo (an inactive compound) in non-drinking, recovering male and female
      alcoholics, with a specific emphasis on the differences between men and women in the two
      recovering alcoholic groups.
    

Detailed description: 
      Women and men differ in the ways stress affects the development and maintenance of
      alcoholism. However, no published studies in alcohol dependent patients have examined sex
      differences in stress responsiveness that most likely mediate these effects and influence the
      clinical course and treatment of the disorder.

      The long-range goal of this research program is to define aspects of the neural, genetic and
      environmental mechanisms differentially regulating the stress response in alcohol dependent
      women and men. The proposed study extends prior work revealing sex-dependent alterations in
      basal and serotonin-induced stress hormone concentrations in abstinent alcoholics. Our
      central hypothesis is that sex differences in serotonin function or HPA sensitivity conspire
      with genetically influenced alterations in serotonin signaling to produce maladaptive stress
      responses in some alcoholic women. These altered stress responses may serve as the target of
      novel, sex-specific pharmacotherapies.
    

Intervention name(s): Citalopram; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.; Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.
Other intervention name(s): Celexa; Sugar Pill
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Alcoholism; Stress; Gender Differences; Addiction; Alcohol Dependence
BCI (Brain Computer Interface) Intervention in Autism
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This study aims to demonstrate that improvements in identification of social clues (and
      improvement of overall social behaviour) in subjects with ASD can be achieved using social
      games together with a BCI setup.

      The primary goal is to ensure increased rate of responses to joint attention cues.

      Intervention Type is a Device (brain computer interface using EEG). Structure: (1) initial
      eligibility screening (within 1 week after admission), (2) pre-intervention (first week of
      study, baseline outcome measures and additional evaluations), (3) intervention process (16
      weeks), (4) post-intervention (outcome measures and additional evaluations), and (5)
      follow-up (outcome measures at 6 months).
    

Detailed description: 
      Clinical research has demonstrated that ASD children have deficits in the interpretation of
      others intentions from gaze-direction or other social attention cues (Baron-Cohen, Baldwin, &
      Crowson, 1997).

      The purpose of the study is to investigate whether a brain computer interface (BCI) using
      electroencephalographic (EEG) signals can be used to train social cognition skills (in
      particular interpretation of gaze direction pointing to objects of interest) in ASD patients
      and whether this improves clinical symptoms.

      The intervention comprehends seven BCI sessions spread over four months. The first four
      sessions are planned to occur weekly, and the rest monthly. In each session, the subject is
      asked to identify objects of interest based on the gaze direction of an avatar. The subject
      response is interpreted from the EEG signal (using the P300 component, as established in our
      previous work).
    

Intervention name(s): BCI to train joint attention in ASD
Intervention type(s): Device
Intervention description(s): The intervention comprehends seven BCI sessions spread over four months. The first four sessions are planned to occur weekly, and the rest monthly. In each session, the subject is asked to identify objects of interest based on the gaze direction of an avatar. The subject response is interpreted from the EEG signal (using the P300 component, as established in our previous work).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children
Condition: Cystic Fibrosis; Pneumonia; Pseudomonas Aeruginosa Infection
MeSH terms: Pseudomonas Infections; Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will determine the concentrations of the antibiotic meropenem when administered as
      a 3 hour prolonged infusion in children with cystic fibrosis who are hospitalized with an
      acute pulmonary exacerbation. Safety and practicality of administering meropenem as a 3 hour
      infusion will be measured.
    

Detailed description: 
      This study will be conducted at 7 pediatric hospitals in the United States (Columbia
      University Medical Center, New York, New York; University of North Carolina, Chapel Hill,
      North Carolina; St. Christopher's Hospital for Children, Philadelphia, Pennsylvania,
      Connecticut Children's Medical Center, Hartford, Connecticut, Riley Hospital for Children,
      Indianapolis, Indiana, Nationwide Hospital for Children, Columbus, Ohio, and Children's
      Medical Center, Dallas, Texas). Cystic Fibrosis children (age 6-17 years) admitted to one of
      these enrolling sites with an acute exacerbation of his or her pulmonary infection who
      require antibiotic therapy with meropenem will be eligible. Meropenem will be administered as
      a 3 hour prolonged infusion and blood concentrations will be measured to determine the
      population pharmacokinetics in 30 patients, the safety of prolonged infusion meropenem, and
      the practicality as measured be treatment burden using a questionaire. The population
      pharmacokinetic model developed will be utilized to determine the optimal dose of meropenem
      to administer to children with Cystic Fibrosis, and define an exposure response relationship
      for the drug in this population.
    

Intervention name(s): meropenem
Intervention type(s): Drug
Intervention description(s): meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion.
Other intervention name(s): Merrem
Intervention MeSH terms: Meropenem
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; Acute Pulmonary Exacerbations; Pseudomonas aeruginosa
Effect of Yoga@Work Program
Condition: Musculoskeletal Pain; Neck Pain; Shoulder Pain
MeSH terms: Shoulder Pain; Musculoskeletal Pain; Neck Pain
Study type: Interventional

Summary: 
      Employees working in IT industry are prone to develop musculoskeletal pain,specifically back,
      neck and shoulder pain. This study evaluates the effectiveness of work-site yoga
      intervention, Yoga@work on neck and shoulder pain in IT employees.
    


Intervention name(s): Yoga@work
Intervention type(s): Other
Intervention description(s): Each session included warm-up practices(for the large joints, spine, and extremities), Physical postures (Asana), breathing exercises (pranayama) and supine meditation/relaxation (savasana).
Other intervention name(s): Yoga
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment