bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of the Training Program Provided to Primipara Pregnant Women Through the Motivational Interview Method on Their Fear of Childbirth, Childbirth Self-Efficacy and Delivery Mode
Condition: Fear of Childbirth; Childbirth Self-efficacy; Mode of Delivery; Motivational Interview
Study type: Interventional

Summary: 
      This two-group, parallel randomized controlled study was conducted to evaluate the effect of
      the training program provided to primipara pregnant women through the motivational interview
      method on their fear of childbirth, childbirth self-efficacy and delivery mode. The primipara
      pregnant women included in the study sample were assigned to the intervention (n=37) and
      control (n=36) groups using the block randomization method. The women in the intervention
      group were individually provided with "Training Program on Fear of Childbirth Based on
      Motivational Interview Method" once a week, four sessions in total, while no interventions
      were made for those in the control group other than routine hospital practices. Study data
      were collected using a descriptive information form, the Wijma Delivery Expectancy/Experience
      Questionnaire (W-DEQ) versions A-B, the Childbirth Self-Efficacy Inventory-Short Form
      (CBSEI-SF) and the Delivery Evaluation Form. The value of p<0.05 was accepted statistically
      significant in the data analyses.
    


Intervention name(s): Antenatal education
Intervention type(s): Behavioral
Intervention description(s): Training Program on Fear of Childbirth Based on Motivational Interview Method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
The Effect of Variety on Physical Activity
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Increasing physical activity continues to be a challenge among many individuals, particularly
      those who are overweight. Recent data from the National Health and Nutrition Examination
      Survey (NHANES) showed that individuals who reported engaging in a variety of activities were
      more likely to meet national physical activity recommendations compared to those who reported
      no variety. Incorporating a variety of activities into a physical activity program may be a
      way to increase physical increase physical activity levels.

      One method to increase variety in physical activities is to use active videogames. Videogames
      that use motion sensors allow a gamer to physically perform a variety of activities. Thus,
      the purpose ot this laboratory-based investigation is to conduct a study to examine the
      effect of engaging in a greater variety of active videogames on energy expenditure in 30
      non-obese, regularly active adults.
    

Detailed description: 
      Thirty men and women, aged 18- to 35- years, recruited from the local area, with a normal
      body mass index (BMI) between 18.5 and 29.9 kg/m, will participate in two experimental
      sessions, VARIETY and NON-VARIETY, with order of experimental sessions counterbalanced across
      participants. Participants will be assessed on liking of the active videogames, energy,
      tiredness, motivation, to succeed, interest in the games, and energy expenditure during the
      experimental sessions.
    

Intervention name(s): Variety of Active Videogames
Intervention type(s): Behavioral
Intervention description(s): Thirty men and women, aged 18- to 35- years, recruited from the local area, with a normal body mass index (BMI) between 18.5 and 29.9 kg/m, will participate in two experimental sessions, VARIETY (playing the same active video game over 4 sessions) and NON-VARIETY (playing 4 different active video games over 4 sessions), with order of experimental sessions counterbalanced across participants.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: active video games; Energy expenditure
A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-Risk Populations in Kenya, Africa
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the safety and acceptability of an intermittent and daily PrEP
      regimen using Tenofovir Disoproxil Fumarate plus Emtricitabine (FTC/TDF) in men and women at
      risk for HIV, and it will directly compare adherence and intracellular drug levels in daily
      and intermittent PrEP recipients. It will also evaluate the relationship between drug
      adherence, sexual behavior and intracellular drug levels with an intermittent PrEP regimen.
      In addition it will evaluate the relationship between adherence to an intermittent PrEP
      regimen and timing of sexual activity in relation to PrEP dosing. The study will use
      objective medication event monitoring medication event monitors (MEMS) adherence measurement
      and evaluate the feasibility of newer adherence measurements such as hair sampling and plasma
      drug levels. The study will also evaluate the feasibility of using SMS (text messages) to
      collect sexual activity data in an African setting. It will allow study teams and communities
      to prepare for potential subsequent larger trials of intermittent PrEP. This study is not
      sized to evaluate efficacy. If the intermittent PrEP regimen is shown to be safe, feasible in
      terms of adherence, and achieves intracellular drug levels similar to daily PrEP, these data
      could be used to design a larger phase 2 study with one or more intermittent PrEP regimens.
      The goal of such a trial would be to provide bridging data if daily PrEP regimens are found
      to be effective or to prepare for efficacy or non-inferiority trials of intermittent versus
      daily PrEP.

      Investigation of immune responses associated with FTC/TDF will also be evaluated in the pilot
      study. The proportion of volunteers on FTC/TDF with HIV-specific immune responses, due to
      exposures that did not lead to established HIV infection, will be assessed at 2-3 time points
      and compared to responses in volunteers assigned to placebo. Immune responses may be
      correlated with risk behavior and host factors, such as human leukocyte antigen (HLA) type.
      As noted above, very few HIV infections are expected to occur during the study, so
      correlation of HIV-specific immune responses and protection from infection or attenuation of
      disease progression will not be possible until a larger study is conducted.
    


Intervention name(s): FTC/TDF; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): emtricitabine/tenofovir disoproxil fumarate; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV; Human Immunodeficiency Virus
Airway Response to Repeat Allergen Challenge and the Effect of Ibuprofen in Mild Atopic Asthma
Condition: Atopic Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The study will assess airway responses in mild atopic asthmatics undergoing repeat allergen
      challenge testing and will investigate whether ibuprofen changes the response.
    


Intervention name(s): ibuprofen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2x 200mg ibuprofen, single dose, blinded in 00 capsules; lactose filled 00 capsules to match appearance of ibuprofen intervention
Other intervention name(s): Advil
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia
Condition: Leukemia
MeSH terms: Leukemia
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop
      cancer cells from dividing so they stop growing or die.

      PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide in
      treating young patients with refractory or recurrent leukemia.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose and recommended phase II dose of temozolomide in
           pediatric patients with refractory or recurrent leukemia.

        -  Determine the toxic effects of this drug in these patients.

        -  Determine the pharmacokinetics of this drug in these patients.

      Secondary

        -  Determine the antitumor activity of this drug in these patients.

        -  Determine the biologic activity and mechanism(s) of resistance to this drug in these
           patients.

      OUTLINE: This is an open-label, dose-escalation, multicenter study.

      Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days
      for up to 12 courses in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
      patients experience dose-limiting toxicity.

      PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 18-24
      months.
    

Intervention name(s): temozolomide
Intervention type(s): Drug
Other intervention name(s): Temodar; NSC # 362856
Intervention MeSH terms: Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent childhood acute lymphoblastic leukemia; recurrent childhood acute myeloid leukemia; relapsing chronic myelogenous leukemia; childhood acute promyelocytic leukemia (M3); blastic phase chronic myelogenous leukemia
Development and Validation of an Noninvasive Model for Predicting High Risk Esophageal Varices in Cirrhosis
Condition: Esophageal and Gastric Varices
MeSH terms: Esophageal and Gastric Varices; Varicose Veins
Study type: Observational

Summary: 
      The aim of the study is to develop and validate a new noninvasive method based on routine
      examination during clinical practice for predicting high risk esophageal varices in
      cirrhosis.
    

Detailed description: 
      Portal hypertension is the main consequence of cirrhosis. Variceal bleeding is the principal
      and life-threatening complication of portal hypertension. Endoscopic screening is the golden
      standard to detect esophageal varices. However, endoscopy is limited by its invasiveness,
      cost and the discomfort it imposes on patients. With the goal of circumventing these
      disadvantages, we intend to develop an noninvasive method for predicting high risk esophageal
      varices.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        We queried the cirrhotic patients treated in Qilu Hospital Affiliated to Shandong
        University and Jinan Central Hospital Affiliated to Shandong University.
      
Keywords: noninvasive; portal hypertension; radiomics
Abdominal and Lower Extremity Compression During Tilt Table Testing in Adolescent POTS Patients
Condition: Postural Orthostatic Tachycardia Syndrome (POTS); Syncope
MeSH terms: Syncope; Postural Orthostatic Tachycardia Syndrome; Tachycardia
Study type: Interventional

Summary: 
      Postural orthostatic tachycardia syndrome (POTS) is a common cause of orthostatic intolerance
      in adolescents and adults. Compression stockings are commonly recommended as a treatment
      modality for POTS, but the effects of abdominal and lower extremity compression during tilt
      table testing have not been measured in adolescent patients. The aims of our study are to
      compare heart-rate changes and symptom onset during tilt table testing (a) with and without
      abdomen/lower extremity compression and (b) with abdominal compression only versus lower
      extremity compression only. During phase 1, 20 adolescents with POTS will undergo up to 10
      minutes of tilt without compression (trial #1), a repeat study of up to 10 minutes with full
      compression (trial #2), and a third study without compression up to 10 minutes (trial #3).
      Compression will be performed using the non-inflatable Zoex anti-shock garment. During study
      phase 2, an additional 20 adolescent POTS patients will undergo up to 10 minutes of tilt
      without compression (trial #1), a repeat study of up to 10 minutes with abdominal compression
      only [n=10] or lower extremity compression only [n=10] (trial #2), and a third study repeated
      without compression up to 10 minutes (trial #3). To limit compression to the abdomen only, we
      will use the Zoex garment strap numbers 4 and 5 (thigh and abdomen) without straps 1-3 (lower
      extremities). For lower extremity-only compression, we will use Zoex garment straps 1-4
      (lower extremity and thigh) without strap 5. Data collected will include mean and peak heart
      rates and timing of symptoms with each trial. A paired-samples t-test will be used to compare
      mean heart rates between trials for each study phase. Hazard analyses will be used to assess
      time-based endpoints.
    


Intervention name(s): Zoex compression garment
Intervention type(s): Device
Intervention description(s): 5-strap compression of abdomen, thighs and legs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: POTS; Orthostatic; Adolescent
Efficacy and Safety of C2L-OCT-01 PR in Acromegalic Patients
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the biological safety and efficacy of using the drug,
      C2L-OCT-01 PR, 30 mg to treat acromegalic patients.
    


Intervention name(s): C2L-OCT-01 PR, 30 mg; Octreotide acetate prolonged release, 30 mg
Intervention type(s): Drug; Drug
Intervention description(s): Administered by deep IM injection (gluteus) on days 1 and 42; Administered by deep IM (gluteus) on Days 1, 28 and 56
Other intervention name(s): Sandostatin LAR, 30 mg
Intervention MeSH terms: Octreotide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acromegaly
Fetal Front-abdominal Wall Thickness and Perinatal Outcome
Condition: Fetal Macrosomia; Abdominal Wall Mass; Perinatal Problems
MeSH terms: Fetal Macrosomia
Study type: Observational [Patient Registry]

Summary: 
      Abnormal fetal development such as macrosomia can cause some complications on both fetus and
      mother.The measurement of fetal anterior abdominal wall thickness (FAWT) is an easy
      examination that it can be obtained during an examination of a pregnant woman by ultrasound.
      Macrosomia for fetus can lead to some morbidities. It can affect perinatal outcome and
      increase childbirth complications and operative birth. There are some studies scrutinizing
      the relationship between FAWT and diabetes in the literature. However there are few studies
      which scrutinize effect of FAWT on both abnormal fetal development and adverse perinatal
      outcomes in non-diabetic pregnancies and non high risk pregnancies. Hence the investigators
      wonder if FAWT can anticipate birth-weight or macrosomic infant or perinatal outcome
      regarding with macrosomia in the second trimester.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 96 women with low risk pregnancy coming to our clinic for a routine antenatal
        examination in 26-28th gestational weeks were included to this study
      
Keywords: fetal macrosomia; fetal abdominal wall thickness; subcutaneous adipose tissue
A Study to Evaluate the Performance of VibraTip® by Different Clinical Users
Condition: Diabetes
Study type: Observational

Summary: 
      VibraTip® is a pocket-sized, wipe-clean, disposable device that provides a consistent source
      of gentle vibration. It has been specifically designed to overcome the limitations of tuning
      forks for testing the integrity of vibration sense in clinic and by the bedside. The product
      is a hand held device that is used to examine the feet of Diabetic patients who are
      susceptible to peripheral neuropathy that can in turn lead to ulcers. Treatment is expensive
      and can be over a period of time, often not being completely resolved, and can lead to
      amputation. The product will increase awareness of foot care and achieve a reduction in
      incidence of foot ulcers.

      The study aims to evaluate the accuracy of the VibraTip device compared to the Gold Standard,
      the 10g Semmes Weinstein Monofilament (MF) Test, and the accuracy and usability of the
      VibraTip® device, as measured by different community medical practitioners.
    

Detailed description: 
      Primary Objective The accuracy of the VibraTip® device, as measured by a comparison with the
      Gold Standard, the 10g Semmes Weinstein Monofilament (MF) Test by a Diabetologist.

      Secondary Objectives The accuracy and usability of the VibraTip® device, as measured by
      different community medical practitioners compared to expert validation by a Diabetologist.

      Prospective, single centre diagnostic evaluation. A single centre in the UK (Tameside
      Hospital NHS Foundation Trust). Patients will be recruited while attending Tameside Hospital
      NHS Foundation Trust Diabetes Clinic for a routine 12 month diabetes check up. Subjects will
      receive a Patient Letter to invite them to take part in the VibraTip study and a Patient
      Information Leaflet about the study enclosed within their Diabetes Clinic appointment. The
      study will aim to invite 180 patients to take part in the study and aims to recruit 100
      subjects into the study within 3 months. Subjects aged 18 to 75 (inclusive) of either sex
      with pre-existing diabetes (Type 1 and Type 2). The study aims to recruit approximately 50
      (50%) of patients with diabetic peripheral neuropathy (both painful and painless) and 50
      (50%) without diabetic peripheral neuropathy. (we will go for even split if possible)
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited while attending Tameside Hospital NHS Foundation Trust Diabetes
        Clinic for a routine 12 month diabetes check up
Coached or Non-Coached Weight Loss Intervention
Condition: Obesity; Behavior, Health; Behavior, Eating; Weight Loss; Overweight and Obesity; Self Efficacy
MeSH terms: Obesity; Overweight; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      To evaluate the effect of one-on-one coaching in the Noom Healthy Weight Program, a digital
      behavior change, weight loss intervention, compared to the same program with no coaching, as
      well as influential factors.
    


Intervention name(s): Noom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching; Noom Healthy Weight; mobile behavior change program for weight loss
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention consists of a curriculum, provided through daily articles that users are encouraged to read; logging features for weight, meals, and physical activity; in-app groups; and a virtual coach, who will communicate with participants via in-app messaging. During the first week of the study, participants will be introduced to the program, the Noom app, and their coach.
Coaches will use a secure dashboard to monitor patient progress, which is used to increase engagement and motivation. Participants are encouraged to log their weight and physical activity on a weekly basis, and meals daily.; The intervention consists of a curriculum, provided through daily articles that users are encouraged to read; logging features for weight, meals, and physical activity. During the first week of the study, participants will be introduced to the program, and the Noom app.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Active Video Game on Metabolic, Cardiovascular, and Psychological Metrics in Older Adults
Condition: Aging
Study type: Interventional

Summary: 
      The Xbox Kinect seems to be a good alternative for the older adults to perform physical
      activities at times that are typically associated with sedentary behaviors. The Xbox Kinect
      active video game has been used in various parts of the world as entertainment. The study of
      metabolic, cardiovascular and psychological responses during these activities may bring
      relevant information regarding the intensity of the exercises and, consequently, about the
      possibility of using these games to maintain and / or improve the cardiorespiratory fitness
      of the older adults. In addition, the present study may clarify the responses of activities
      on Xbox Kinect in elderly people with anxiety and depression symptoms. Will be selected 100
      older adults. All volunteers will initially perform assessments of resting metabolic rate,
      cardiorespiratory fitness, functional tests, as well as subjective assessments of physical
      activity level, anxiety and mood. Subsequently, they will perform activities with body
      movements on the Xbox Kinect, which will be compared with sedentary behavior activity (TV /
      Movie). All activities will be monitored by means of a gas analyzer, which will record
      information about the behavior of energy expenditure, resting heart rate and activity. In
      addition, assessments of perception of effort and fun during activities will be made through
      subjective scales. The effects of Xbox Kinect activity on anxiety symptoms and mood will also
      be assessed.
    


Intervention name(s): Active Video Game Exercise; Treadmill walking exercise; Sedentary Behavior
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Play during 30 minutes in the easy level; 30 minutes (65 - 75% heart rate maximal); Quiet Rest: 30 minutes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: physical activity; active video game; older adults