bioihbjkbjnl/mcl2 huggingface dataset:
mHealth Usage Among Nigeria Women Diagnosed With Breast Cancer Receiving Chemotherapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The research is studying the effect of a mHealth psychoeducational intervention on
      self-efficacy, coping and psychological distress of Nigerian women diagnosed with breast
      cancer receiving chemotherapy

      The study is a two-arm assessor-blinded randomised controlled trial which will be conducted
      in two University Teaching Hospitals in Nigeria.
    

Detailed description: 
      Aim The study aims to develop and implement a culturally adapted mHealth psychoeducational
      intervention (mPEI) for Nigerian women diagnosed with breast cancer receiving chemotherapy.

      Objectives

        1. To evaluate the effectiveness of the programme on self-efficacy (primary outcome),
           coping, symptom distress, anxiety, depression, and quality of life (secondary outcomes)
           among women with breast cancer receiving chemotherapy

        2. To explore the participants' experiences and feelings towards the intervention.

      Hypothesis

      It is hypothesised that participants who receive the mPEI program, when compared with the
      control group at baseline and immediately after the intervention, will demonstrate:

        1. a significantly higher level of self-efficacy,

        2. a significantly higher level of coping,

        3. a significantly higher level of quality of life,

        4. a significantly lower level of symptom distress,

        5. a significantly lower level of anxiety and depression.
    

Intervention name(s): mHealth psychoeducational intervention
Intervention type(s): Other
Intervention description(s): The mPEI program will be delivered through a mobile application (app). The app has five components which include: Breast cancer education, coping skills training, discussion forum, nurse-led consultation, and psychological support. Breast cancer education and coping skills training will be conducted by the principal investigator for 30 minutes per week for six weeks and will be delivered via text, audio and video on the mobile app. Group discussion will be moderated by the principal investigator in a text format for 30 minutes per week. Nurse-led consultation and psychological support will be provided by the oncology nurse on the research team through a 15-20-minute call in the first week, third week and fifth week.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Chemotherapy; Women; Psychoeducation; mHealth; Nursing; Psychological issues; Nigeria
Comparison of Two Formulations of Proellex for Oral Administration
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a double-blind crossover study in female healthy volunteers to compare the
      pharmacokinetics and safety of a single dose each of two different formulations of Proellex
      for oral administration. Each formulation will be designated as either Treatment A or
      Treatment B. A total of 12 subjects who meet the eligibility criteria will be randomized to
      receive either Treatment A or Treatment B as their first assigned treatment. After a 7-day
      washout period subjects will receive the alternative treatment. On the day of each treatment
      subjects will remain in the clinic overnight and undergo 72-hour pharmacokinetic assessment
      at the following time points: 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 and 72 hours after
      administration of study drug.
    


Intervention name(s): Telapristone Acetate, Proellex 12 mg Formulation A; Telapristone Acetate, Proellex 12 mg Formulation B
Intervention type(s): Drug; Drug
Other intervention name(s): Proellex; Proellex
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Clinical Test for Armed-used Blood Pressure Monitor With Preformed Cuff(Monitor When Being Inflated)
Condition: Blood Pressure
Study type: Observational

Summary: 
      The purpose of this study is to monitor the blood pressure level of the patient using a blood
      pressure monitor which test the blood pressure level in inflating state . The cuff range in
      the study is 22cm-48cm
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        hospital population, including patient and accompanies.
      
Keywords: BP
Evaluation of the Effectiveness and Safety of Physician Versus Patient-led of Insulin Glargine Initiation and Titration in Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To compare patient-led titration (intervention group) versus physician-led titration (usual
      standard of care) in optimizing the clinical use of insulin glargine in an Asian population
      of patients with Type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetic drugs
      (OADs).

      Secondary Objectives:

      To determine the difference in glycemic control, safety, quality of life and treatment
      satisfaction between patient-led titration and usual care.
    


Intervention name(s): Insulin Glargine
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: solution for injection
Route of administration: subcutaneous
Dose regimen: initial: once a day in the evening at bedtime. Titration will occur each time the middle FPG (Fasting Plasma Glucose) value is above target
Other intervention name(s): Solostar
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Randomized Controlled Trial Comparing ECV Success Rates With and Without Full Urinary Bladder
Condition: Breech Presentation; Before Labor
MeSH terms: Breech Presentation
Study type: Interventional

Summary: 
      A comparison of external cephalic (ECV) success rates when ECV performed with full urinary
      bladder or not. The study is prospective and randomised. Both nulliparous and multiparous
      women will be enrolled in the study, however each group will be randomized separately either
      to full urinary bladder or not. Written informed consent will be obtained prior to inclusion
      in the study.
    

Detailed description: 
      A comparison of external cephalic (ECV) success rates when ECV performed with full urinary
      bladder or not. The study is prospective and randomised. Both nulliparous and multiparous
      women will be enrolled in the study, however each group will be randomized separately either
      to full urinary bladder or not. Written informed consent will be obtained prior to inclusion
      in the study.
    

Intervention name(s): external cephalic version
Intervention type(s): Procedure
Intervention description(s): external cephalic version
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breech; ECV; version
Wound Infiltration With Sodium Diclofenac vs Bupivacaine for Postoperative Pain Following Appendectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The infiltration of the surgical wound is an effective strategy for postoperative analgesia.
      Nonsteroidal antiinflammatories are useful in this way.

      Objective: To compare the analgesic effectiveness of diclofenac sodium, bupivacaine or
      bupivacaine plus diclofenac sodium infiltrating wound appendectomies.

      Method: Comparative, double blind, American Society Anesthesiologist classification
      I-II,18-65años. Group 1 (Bupivacaine n = 14), Group 2 (Diclofenac Sodium n = 14), Group 3
      (Bupivacaine + Diclofenac Sodium n = 15). Pain at rest and dynamic, rescue analgesic
      consumption in Post Anesthesia Care Unit (PACU) and 24 hours after surgery were evaluated.
    


Intervention name(s): Bupivacaine; Sodium diclofenac
Intervention type(s): Drug; Drug
Intervention MeSH terms: Diclofenac; Bupivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study of LY900014 in Participants With Type 1 Diabetes on Insulin Injection Therapy
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be conducted in participants with type1 diabetes on insulin injection therapy
      to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar
      levels. Side effects and tolerability will be documented. The study will be conducted in two
      parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in
      both parts.
    


Intervention name(s): LY900014; Insulin Lispro
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (SC); Administered SC
Other intervention name(s): Ultra-Rapid Lispro; LY275585
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Bedside Ultrasound for Fluid Estimation
Condition: Catheterization
Study type: Observational

Summary: 
      The study aims to standardize patient positioning during bedside ultrasound assessment of
      internal jugular vein (IJV) and correlate the results with invasive hemodynamics obtained
      immediately after. The study hypothesizes that the respiratory variation in the size of IJV,
      as estimated through ultrasound at bedside, is an accurate estimation of the patient's actual
      right atrial pressure estimated through right heart catheterization.
    


Intervention name(s): Ultrasound imaging
Intervention type(s): Device
Intervention description(s): Patients scheduled to undergo right heart catheterization (RHC) as their standard of care will be included in the study.
The patient will be positioned supine at 0 degrees with normal restful breathing and patient looking straight up. After the right sternocleidomastoid muscle is identified, internal jugular vein (IJV) will be imaged at the apex of the triangle formed by the sternal and clavicular heads of the muscle. Similarly, the inferior vena cava (IVC) will be imaged at the caudal end of the sternum. The diameters of both the veins will be noted during normal respiration. The patients will then be asked to sniff and collapsibility of the veins will be noted. No pressure will be applied on the neck. The anticipated duration for image acquisition is between 5 to 10 minutes.
The patients will undergo the scheduled RHC within 1 hour as scheduled.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive adult patients scheduled to undergo right heart catheterization.
      
Keywords: Internal jugular vein; Inferior vena cava; Right heart catheterization
A Study of Supaglutide in Chinese Type 2 Diabetes Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      A study on the safety, efficacy, pharmacokinetics and pharmacodynamics of Supaglutide dosing
      weekly and bi-weekly in patients with type 2 diabetes mellitus.
    


Intervention name(s): Supaglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): Diabegone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Methadone/Buprenorphine Cross-Over Study - 4
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore ways to cross patients over from methadone to
      buprenorphine.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity Study of MenC-TT Vaccine (NeisVac-C) in Toddlers Previously Immunized With PCV7 (Prevenar®)
Condition: Neisseria Meningitidis (Bacterial Meningitis); Invasive Pneumococcal Disease (IPD)
MeSH terms: Pneumococcal Infections; Meningitis, Bacterial; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study in healthy toddlers who have not previously been immunized against
      MenC infection and who completed their primary immunization series with PCV-7 (3
      vaccinations) during infancy is to demonstrate that the concomitant administration of a
      single dose of MenC-TT vaccine and a PCV7 booster does not influence the immune response to
      the seven pneumococcal strains contained in PCV7 as compared to administration of PCV7 alone,
      and does not influence the immune response to the MenC-TT vaccine as compared to
      administration of MenC-TT vaccine alone.
    


Intervention name(s): Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7); 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7); Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): MenC-TT vaccine (0.5 ml) to be administered in the left thigh muscle, PCV7 (0.5 ml) to be administered in the right thigh muscle; PCV7 (0.5 ml) to be administered in the right thigh muscle; MenC-TT vaccine (0.5 ml) to be administered in the left thigh muscle
Other intervention name(s): NeisVac-C and Prevenar®; Prevenar®; NeisVac-C
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study of Hormonal Sideeffects in Patients Taking Levetiracetam, Carbamazepine or Lamotrigine for Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      Some antiepileptic drugs are found to have hormonal side effects. We want to study possible
      hormonal side effects of the relatively new antiepileptic drug; levetiracetam and compare it
      to the older drugs; lamotrigine and carbamazepine. The participants are going to fill in a
      questionnaire and we will collect blood samples from them, to analyse hormones.
    

Detailed description: 
      We have previously performed long-term studies of rats treated with levetiracetam and
      compared them with a control group. Here we have found that levetiracetam has a probable
      effect on the ovaries, since the treated animals had larger ovaries, fewer cysts, more
      corpora lutea and more secondary follicles than the untreated animals (Taubøll et al 2004).
      Blood tests on the animals showed that those treated with levetiracetam had higher
      testosterone levels and lower levels of estrogen and FSH, whilst LH and progesterone levels
      were unaffected by the treatment (Svalheim et al, 2005a, b). Studies on cell cultures from
      pig ovaries, as carried out by our group in collaboration with Jagiellonian University,
      Krakow, Poland, appeared to support these findings (Taubøll et al. 2006, submitted).

      Our wish therefore now is to study fertile men and women in order to look for any changes in
      the balance of sex hormones during use of levetiracetam in order to establish whether the
      findings in animal trials are clinically relevant to humans.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients from the outpatients clinic
Efficacy Study of TEPSO® Socks in Improving Palmoplantar Psoriasis
Condition: Palmoplantar Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of a special sock, manufactured using
      TEPSO®, compared to a normal cotton sock in the prognosis of symmetrical palmoplantar
      psoriasis present for at least one year.
    

Detailed description: 
      The clinical manifestations of palmoplantar psoriasis have an important impact on well being
      and quality of life. The manifestation of the disease is often exacerbated by factors such as
      significant physical and mechanical stress resulting from repeated and prolonged pressure
      over the affected areas and by everyday clothing. These problems have led the textile
      industry Lenzi Egisto S.p.A. to conduct some preliminary analyses to find a fabric that meets
      the specific needs of psoriatic patients in relation to everyday clothing. This preliminary
      study led to the creation of a particular fabric, TEPSO®, with features specific to the
      identified needs. This material consists essentially of PTFE (commercially known as Teflon®)
      and thus presents interesting characteristics that make it suitable for creating garments for
      patients with psoriasis:

        -  Excellent flow properties and low surface friction

        -  non-stick

        -  Complete biocompatibility and chemical inertness

      We can therefore speculate that in palmoplantar psoriasis high smoothness of the fabric and
      low coefficient of friction may translate into less discomfort felt by patients during normal
      physical activities, and into improved clinical course of the disease. In the end, it is
      expected that reduced mechanical compression and friction, would result into partial or
      complete clinical remission within a few weeks of use.

      Therefore we propose to conduct a randomized controlled, double-blind, left-right clinical
      trial to assess the hypothesis that in palmoplantar psoriasis the use of TEPSO® could induce
      an improvement of disease and overall quality of life. To better assess the effects of
      treatment, the use of clothing in the study will be limited to symmetrical psoriatic lesions
      of feets in order to include areas that are comparable and relevant from a functional point
      of view.
    

Intervention name(s): TEPSO cloth; Standard cloth
Intervention type(s): Device; Device
Intervention description(s): TEPSO stocks should be worn continuously for 4 weeks of the study and will be changed every 3 days without wearing again those already used (even after washing).; Standard cotton stocks should be worn continuously for 4 weeks of the study and will be changed every 3 days without wearing again those already used (even after washing).
Other intervention name(s): Teflon; cotton
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: psoriasis; soles; teflon
Treatment of Binge Eating Disorder
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional

Summary: 
      This is a study examining the use of different degrees of therapist involvement in the
      treatment of Binge Eating Disorder. The study will examine both which approaches work best
      for decreasing symptoms and which are most cost-effective.
    


Intervention name(s): Group Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Phase 1, QT/QTC Interval Study in Healthy Subjects
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the effect of multiple doses of lumacaftor in combination
      with ivacaftor on cardiac repolarization, as detected by QT/QTc interval corrected for heart
      rate in healthy subjects.
    


Intervention name(s): Lumacaftor; Lumacaftor Placebo; Ivacaftor; Ivacaftor Placebo; moxifloxacin hydrochloride
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Other intervention name(s): VX-809; VX-770
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ivacaftor
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Concurrent Treatment of Squamous Cell Carcinoma or Adenocarcinoma of the Cervix With CIGB-300 for Local Application
Condition: Squamous Cell Carcinoma of the Cervix; Adenocarcinoma of the Cervix
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Adenocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      They include patients who are candidates to complete concurrent treatment with endocavitary
      brachytherapy External radiation therapy + more QT based weekly cisplatin.
    


Intervention name(s): CIGB300
Intervention type(s): Drug
Intervention description(s): CIGB300: 15 mg, 35 mg and 70 mg All groups will receive CIGB-300 for local application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Riluzole in the Treatment of Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional

Summary: 
      Bipolar disorder is a common and often chronic and debilitating mental illness. The
      depressive phase of bipolar disorder contributes the largest portion of the disorder, and
      treatment resistant bipolar depression represents a significant public health problem. Recent
      research has suggested that bipolar depression is associated with elevated brain glutamate
      activity. We hypothesize that riluzole, a drug approved for ALS which inhibits glutamate
      activity, will lead to clinical improvement in patients with bipolar depression.
    

Detailed description: 
      We hypothesize that riluzole will lead to significant reduction in depressive symptoms as
      measured by the Hamilton Depression Rating Scale (HAM-D). Additionally, improvement in
      depressive symptoms will be associated with reduced glutamate levels in the anterior
      cingulate cortex, but not parieto-occipital cortex, both at day two and day 42.
    

Intervention name(s): Riluzole
Intervention type(s): Drug
Intervention description(s): 50 mg twice daily for 2 weeks 50 mg in the morning and 100 mg in the evening for 1 week 100 mg twice daily for 3 weeks
Other intervention name(s): Rilutek
Intervention MeSH terms: Riluzole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar; depression