bioihbjkbjnl/mcl2 huggingface dataset:
Dysmenorrhea in Women With Crohn's Disease and Ulcerative Colitis
Condition: Crohn's Disease; Ulcerative Colitis
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer; Dysmenorrhea
Study type: Observational

Summary: 
      This case-control study will screen for dysmenorrhea and assess severity of menstrual
      symptoms in menstruating women with CD and UC compared with healthy age-matched controls. IBD
      activity will be characterized using previously validated clinical disease activity indices.
      General and health-related quality of life will be assessed using validated measures.
    

Detailed description: 
      Given the prior studies in IBD and corollary studies in IBS, we hypothesize that dysmenorrhea
      is more common in menstruating women with CD and UC than in the general population.
      Furthermore, we hypothesize that CD and UC activity as measured by non-invasive disease
      activity scores will be higher, and quality of life lower in women with both CD and UC and
      dysmenorrhea. As deciphering this complex relationship may avoid unnecessary testing or
      changes in therapy, we propose to characterize and compare the prevalence of dysmenorrhea in
      menstruating women with and without CD and UC. Furthermore, we will compare CD and UC
      activity and IBD-related quality of life in women with and without dysmenorrhea in a
      population of menstruating women with IBD. Lastly, we will compare general quality of life in
      women with and without either form of IBD and dysmenorrhea.
    

Intervention name(s): Questionnaire Only
Intervention type(s): Other
Intervention description(s): Subjects will have an interview with a study coordinator to fill out questionnaires for the study
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cases: Women aged 18-48 years with regular menstrual cycles AND with an established
        diagnosis of CD or UC involving the small bowel, colon or both will be eligible for the
        study.

        Controls: Women aged 18-48 years with regular menstrual cycles and without a diagnosis of
        CD will qualify for the study
Paclitaxel in Treating Patients With AIDS-Related Kaposi's Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma, Kaposi; Sarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with
      AIDS-related Kaposi's sarcoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether the body distribution and plasma clearance of paclitaxel is affected
           by protease inhibitors (e.g., indinavir, ritonavir, saquinavir mesylate, or nelfinavir
           mesylate).

      OUTLINE: Patients are stratified according to protease inhibitor treatment (yes vs no), prior
      paclitaxel (yes vs no), and prior doxorubicin or daunorubicin (yes vs no).

      Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 2 weeks for
      at least 1 course in the absence of disease progression or unacceptable toxicity. Patients
      who previously received paclitaxel receive no more than 1 course during this study.

      PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
    

Intervention name(s): indinavir sulfate; nelfinavir mesylate; paclitaxel; ritonavir; saquinavir mesylate
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Ritonavir; Nelfinavir; Indinavir; Saquinavir; Paclitaxel
Primary purpose: Treatment
Keywords: AIDS-related Kaposi sarcoma; recurrent Kaposi sarcoma
Efficacy and Safety of L Arginine to Prevent Preeclampsia
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized double-blind controled clinical trial to assess the efficacy and safety of
      L-arginine to prevent preeclampsia.

      applied to pregnant women with risk factors for preeclampsia. the main result was the
      development of preeclampsia as well as side effects to taking l arginine besides perinatal
      outcomes
    

Detailed description: 
      Two groups were formed. one received L arginine 3 grams orally at day from the 20th week of
      pregnancy. the other group received placebo.

      Each three weeks were evaluated in search of high blood pressure and proteinuria.

      The follow-up was until the end of pregnancy and two weeks after this
    

Intervention name(s): L arginine; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): L arginine is a basic amino-acid precursor of nitric oxide main vasodilator.; calcined magnesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: L arginine; Preeclampsia
Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial
Condition: Breast Feeding; Contraception
Study type: Interventional

Summary: 
      Objectives

      To clarify the relationship between postpartum (2 weeks) use of progestin-only vs. combined
      oral contraceptive pills and the outcomes of breastfeeding continuation, infant growth,
      contraceptive method continuation, and pregnancy rates in breastfeeding women. Specific
      research questions:

        1. To determine whether there is a difference in rates of breastfeeding continuation at 2
           months and 4 months between postpartum breastfeeding women using progestin-only pills
           vs. combined pills.

        2. To determine whether there is a difference in infant growth at 2 weeks and 8 weeks
           between postpartum breastfeeding women using progestin-only pills vs. combined pills.

        3. To determine whether there is a difference in birth control method continuation at 2
           months and 4 months between postpartum breastfeeding women using progestin-only pills
           vs. combined pills.

      Hypothesis

      Combined oral contraceptive pills, when initiated by postpartum breastfeeding women, will
      cause a differential in continuation of breastfeeding: 35% continuation in the combined pill
      group vs. 60% in the progestin-only pill group at 8 weeks.
    


Intervention name(s): Combined estrogen-progestin pill; Progestin-only pill
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo; .35 mg norethindrone once a day orally
Other intervention name(s): OCP; POP
Intervention MeSH terms: Estrogens; Progestins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Breastfeeding rates; Contraceptive continuation; Birth control pills; Lactation
Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain
Condition: Neck Pain; Shoulder Pain; Cervical Pain
MeSH terms: Shoulder Pain; Neck Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the proposed study is to evaluate the efficacy of the InterX 5000 in relieving
      chronic neck and shoulder pain. This study will focus on the efficacy of treating patients
      who have functional limitations in activity because of chronic/recurrent neck or shoulder
      pain.

      H1: InterX therapy will have a moderate effect to reduce pain.

      H2: Functional gains will be greater in patients receiving InterX therapy compared to those
      who received placebo treatment.

      H3: Chronic neck and shoulder pain is more prevalent in patients who exhibit radiographic
      evidence of degenerative spondylosis/arthrosis of the cervical spine.
    

Detailed description: 
      Electrical stimulation modalities of various types have been used as a therapeutic
      intervention for years in a wide variety of applications. Individuals with neck and shoulder
      pain represent a significant segment of the pain population seeking relief. However, there is
      a paucity of data from quality studies published in mainstream peer-reviewed journals
      supporting the effectiveness of this intervention. No well-designed prospective, randomized,
      controlled trials investigating the efficacy or effectiveness of this intervention in
      patients with chronic neck and shoulder pain have been reported. The need for such work is
      becoming increasingly important considering the progressively greater demands for
      evidence-based medicine to justify reimbursement for care.
    

Intervention name(s): Inactive InterX 5000; InterX 5000 Treatment
Intervention type(s): Device; Device
Intervention description(s): Patients will receive will receive InterX placebo treatment 3 times a week for 4 weeks.; Patients will receive will receive InterX treatment 3 times a week for 4 weeks.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neck pain; shoulder pain; cervical pain; chronic; recurrent
Pharmacists' Interventions to Improve Blood Pressure in Chronic Kidney Disease
Condition: Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The aims of the study were to determine whether pharmacists' interventions combining patient
      home-based self-measured BP monitoring improve blood pressure reduction and control compared
      with usual care in chronic kidney disease (CKD) patients
    

Detailed description: 
      This is a prospective randomized two-group pharmacist-led interventional study that was
      conducted in two public nephrology clinics. The study involved the introduction of
      pharmaceutical care to improve blood pressure and adherence to the prescribed medications
      among patients with chronic kidney disease (CKD).

      Recruited patients were randomly divided into two groups; the intervention group and the
      control group, with baseline evaluation of outcomes measured.

      The Control group was provided with usual care. An intervention group was provided in
      addition to the usual care, face-to-face education on CKD, hypertension as a co-morbidity and
      its management, and antihypertensive medication adherence at baseline (group education), 6
      months and 12 months (individualized according to each patient's needs), CKD patient
      educational infographic leaflet at baseline, a calibrated sphygmomanometer digital blood
      pressure monitor (Chidalex®) for home-based self-measured BP monitoring, a BP logbook at
      baseline for the recording of blood pressure values daily and hands-on training on BP
      self-measurement. Also, antihypertensive medication adherence and home-based self-measured BP
      monitoring, reminder cell phone text messages were sent biweekly throughout the trial period,
      while phone-in inquiries from the participants and phone-out reinforcement interventions were
      utilized throughout the trial period.

      Both groups were followed for a period of 12 months.
    

Intervention name(s): Digital BP monitor (Chidalex®)
Intervention type(s): Device
Intervention description(s): Interventions were provided in groups of 4 - 10 participants after data collection at baseline while reinforcing individualized interventions were provided during subsequent visits to the research clinic for follow-up at 6 months and 12 months. Medication reminder text messages were delivered to each participant biweekly.
Other intervention name(s): Chronic Kidney Education; Medication adherence reminder text messages; Other tele-interventions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Blood pressure; Chronic Kidney Disease; Home blood pressure self-monitoring; Nigeria; Pre-dialysis; Pharmacists' interventions
Dermal Blood Flow Response to Escalating Doses of Histamine, Administered by a Skin Prick
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional

Summary: 
      To determine the effective dose and the time course, the dermal blood flow response to
      histamine will be evaluated at different doses (5 µg, 15 µg and 50 µg). Histamine will be
      administered by a skin prick on the volar surface of subjects' forearm, alongside a negative
      control. Changes in dermal blood flow will be measured with laser Doppler imaging at
      different time points following the skin prick.
    


Intervention name(s): 50 µg Histamine; 15 µg Histamine; 5 µg Histamine; Placebo (saline)
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Skin prick through 50 µg/5 µL histamine diHCl; Skin prick through 15 µg/5 µL histamine diHCl; Skin prick through 5 µg/5 µL histamine diHCl; Skin prick through 5 µL saline (0.9% NaCl)
Intervention MeSH terms: Histamine; Histamine phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Occupational Stress and Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Occupational Stress; Bipolar Disorder
Study type: Observational

Summary: 
      Bipolar disorder is a mental disorder characterized by alternance of depressive and manic
      phases, separated by intercritical phases (euthymia). The majority of patients report
      occupation and professional difficulties. Sixty percent of bipolar patients are inactive .
      Indeed, according to the World Health Organisation, bipolar disorder is the second cause of
      days not worked.

      Several factors are related to the lower professional functioning observed in bipolar
      patients: early age of onset, delay of diagnosis and treatment, recurrence of thymic
      episodes, residual symptoms and cognitive disorders during euthymia, side effects of mood
      stabilizers.

      To our knowledge, no study has ever focused on well-being at work in French patients.
      However, suffering from a psychiatric disorder and the lack of support from colleagues and
      the hierarchy are risk factors for burnout, a growing health issue.

      Patients with mental illness are often victims of stigmatization, which may involve the
      professional field. In addition, thymic recurrences may alter professional functioning of
      active patients: multiplication of work disruptions, conflicts with peers. Conversely work
      can be stressful, promoting thyic relapses. It is therefore essential to better understand
      the occupational stresses of active patients suffering from bipolar disorder in order to
      promote functional remission beyond clinical remission.

      The aim of this study is to assess the level of stress and well-being at work in active
      French bipolar patients.
    

Detailed description: 
      Socio-demographic, psychiatric and occupational data of 200 bipolar patients will be
      collected over a period of 6 months.
    

Intervention name(s): Date collection
Intervention type(s): Other
Intervention description(s): Date collection
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with Bipolar disorder
      
Keywords: Bipolar Disorder; occupational stress
A Long Term Post-Marketing Study on the EffIcacy and Safety of Osmotic Release Oral System (OROS) Methylphenidate on the Cognitive Functions of Attention Deficit Hyperactivity Disorder (ADHD) Participants
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this long term post-marketing study is to evaluate the effectiveness and
      safety of osmotic release oral system methylphenidate hydrochloride (OROS-MPH) in
      participants with Attention Deficit Hyperactivity Disorder (ADHD).
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), prospective (study
      following participants forward in time), self-controlled, long-term post-marketing study in
      participants with ADHD. The study consists of 3 periods: screening period, wash-out
      period/run-in period (3 days), and open-label treatment period (12 weeks) which is divided
      into 2 periods that is dosage adjustment period and dose-optimization period. The total
      duration of the study is 12 weeks. During the dosage adjustment period, the dose of
      methylphenidate hydrochloride was adjusted to the optimal dose within 1-3 weeks starting with
      initial dosage of 18 milligram per day (mg/d) which can be increased to 36 mg/d up to a
      maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at
      36 mg or re-adjusted to 18 mg due to intolerance. Participants will receive the optimal dose
      determined during dose adjustment period for 9 weeks during the dose-optimization period. In
      the study, 2 types of participants will be enrolled in 2 groups (according to condition):
      OROS-MPH group (participants with ADHD) and the normal children group (healthy participants).
      The efficacy will be assessed primarily by Digit Span Test and Inattention /Over activity
      With Aggression (IOWA) Conners evaluation scale. Participants' safety will be monitored
      throughout the study.
    

Intervention name(s): Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH); No intervention
Intervention type(s): Drug; Other
Intervention description(s): Osmotic release oral system methylphenidate hydrochloride (OROS-MPH) starting at initial dosage of 18 milligram per day (mg/d) which can be increased to 36mg/d up to a maximum dosage of 54mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18mg due to intolerance.; Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; Methylphenidate Hydrochloride; CONCERTA
A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adolescents
Condition: Covid19 Vaccine
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine
      compared to placebo in participants aged ≥ 12 to < 18 years.
    

Detailed description: 
      This is a Phase II, prospective, placebo-controlled, double-blinded (investigator/site staff
      and participants), multi-center study; the Sponsor will be blinded until the interim
      analysis. Participants aged ≥ 12 to < 18 years will be enrolled. All eligible participants
      will be randomized to receive either MVC-COV1901 or placebo in a 6:1 ratio.
    

Intervention name(s): MVC-COV1901(S protein with adjuvant); MVC-COV1901(Saline)
Intervention type(s): Biological; Biological
Intervention description(s): Approximately 330 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) and Visit 4 (Day 29) via intramuscular (IM) injection in the deltoid region; Approximately 55 participants will receive 2 doses of MVC-COV1901(Saline) at Visit 2 (Day 1) and Visit 4 (Day 29) via IM injection in the deltoid region
Intervention MeSH terms: Somatomedin B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Covid19 Vaccine