bioihbjkbjnl/mcl2 huggingface dataset:
Functional Exercises With Water Intake in Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      Dysmenorrhea and its associated symptoms are very common in women. In Pakistan, almost 78% of
      women report Primary Dysmenorrhea. This will be a randomized controlled trial with two
      parallel groups. one group will be receiving functional exercises along with water intake and
      the other will be receiving no interventions.
    

Detailed description: 
      Mostly in the reproductive years of age women suffers from the Pain of Menstruation which is
      known as Dysmenorrhea. In Pakistan every other girl is silently suffers from this disease
      leading to the inefficiency and one of the main cause of school and work absenteeism. This
      novel study is designed to target the menstrual symptoms of women with functional exercises
      combine with optimal intake of water. The objective of this study is to determine the effects
      of functional exercises with water intake on menstrual symptoms and pain in Primary
      Dysmenorrhea.

      This is a Randomized controlled study. Before the study, all the participants will go through
      baseline evaluation, and then allocated to the groups. The exercise protocol consisting of
      the combination of exercises with regular intake of water (in bouts) will be informed to
      them. Females fulfilling the criteria and willing to participate in exercise trial will be
      recruited in the study. Outcome will be assessed at baseline and post treatment after 8th
      week.
    

Intervention name(s): Exercise and Water Intake
Intervention type(s): Other
Intervention description(s): The exercise protocol for this group will be abdominals, pelvic stretching and kegels exercises (PFM) for three days/week lasting about 30 minutes with approximately 1600-1800ml (8-10 glasses) intake of water for 8 weeks (two consecutive menstrual cycles)
Exercises include:
Piriformis stretching (5 repetitions×20 seconds) Adductor stretching (5 repetitions×20 seconds) Sit-ups (10 repetitions×3 sets) Bridging (10 repetitions×3 sets) Kegels exercises (10 repetions×3 sets) Pelvic elevation (10 repetitions×3 sets) Pelvic rotation (10 repetitions×3 sets) Cobra pose (5 repetitions×20 seconds)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There will be two parallel groups in the study.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Functional exercises, water intake, Menstrual Pain, Sleep
A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess the Efficacy, Safety and Tolerability profile of CSL's Influenza
      Vaccine administered intramuscularly against laboratory-confirmed influenza illness in a
      population defined as being not at risk of severe complications following influenza
      infection.
    


Intervention name(s): CSL Limited Influenza Vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): A single 0.5 mL, intramuscular Injection in the deltoid region of the arm on day 0.; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Seroquel Long-Term NIS for Schizophrenia Patients
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Observational

Summary: 
      To assess the efficacy of 24-week treatment with quetiapine in patients with schizophrenia or
      schizoaffective disorder
    


Time perspective: Prospective
Keywords: Schizophrenia; Schizoaffective; quetiapine; long-term efficacy; Naturalistic; Observational
A Study to Evaluate the Immunogenicity, Safety and Tolerability of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the humoral immune response induced by 3 different
      batches of Ad26.ZEBOV as measured by enzyme - linked immunosorbent assay (ELISA) against the
      Ebola virus (EBOV) GP (Glycoprotein) at 56 days post prime.
    

Detailed description: 
      This is a randomized, double - blind, placebo - controlled, parallel - group, multicenter,
      Phase 3 study to evaluate the immunogenic equivalence of a heterologous prime - boost regimen
      using 3 different batches of Ad26.ZEBOV in healthy adult participants. The study consists of
      a screening period of up to 6 weeks, a vaccination period in which participants will be
      vaccinated at baseline (Day 1), followed by a boost vaccination on Day 57, and a
      post-vaccination phase until 6 months post-boost visit (Day 237). The participants will be
      randomized at baseline (on Day 1) in a 2:2:2:1 ratio to Groups 1, 2, 3 and 4. Safety will be
      monitored throughout the study.
    

Intervention name(s): Ad26.ZEBOV-Batch #1; Ad26.ZEBOV-Batch #2; Ad26.ZEBOV-Batch #3; MVA-BN-Filo; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Ad26.ZEBOV - Batch #1, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles on Day 1; Ad26.ZEBOV - Batch #2, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles on Day 1; Ad26.ZEBOV - Batch #3, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles on Day 1; MVA-BN-Filo- live replication incompetent vaccine, 0.5 mL IM injection of 1*10^8 Infectious Unit [Inf. U.] once on Day 57.; One 0.5 ml IM injection of 0.9% saline once on Day 1 and Day 57.
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Ebola viruses; Ebola virus disease (EVD); Filoviruses; Monovalent vaccine; Safety; Immunogenicity; Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV); Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector (MVA-BN Filo); Healthy participants
Effects of Different Forms of Fatigue on Double-Task Performance in the Elderly
Condition: Elderly
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The dual task (walking and cognitive task at the same time) is increasingly used in
      geriatrics in protocols for detecting people who are falling and/or for highlighting
      cognitive disorders. However, frail elderly people tend to get tired quickly and a lack of
      awareness of the effects of fatigue on dual-task performance could alter the diagnosis.

      There are two types of fatigue: mental fatigue and peripheral muscle fatigue. Each
      participant will do both types of fatigue over 2 appointments spaced by 7 days so that the
      subject can recover from induced fatigue. The sequence of fatigue tasks will be randomized.

      At the first appointment (day 0):

        1. Pre-fatigue assessment :

             -  The subject must walk on 10m with round trip for 1min.

             -  the subject must do the arithmetic count of 3 in 3

             -  Then comes the evaluation in double task (walking and counting at once for 1min).
                The subject must walk on 10m with round trip for 1min by doing the arithmetic count
                of 3 in 3 at the same time.

        2. mental fatigue task or muscle fatigue task (randomized)

        3. post-fatigue assessment (the same as pre-fatigue assessment)

      7 resting days

      Second appointment (day 7)

        1. Pre-fatigue assessment :

             -  The subject must walk on 10m with round trip for 1min.

             -  the subject must do the arithmetic count of 3 in 3

             -  Then comes the evaluation in double task (walking and counting at once for 1min).
                The subject must walk on 10m with round trip for 1min by doing the arithmetic count
                of 3 in 3 at the same time.

        2. mental fatigue task or muscle fatigue task (randomized)

        3. post-fatigue assessment (the same as pre-fatigue assessment)
    


Intervention name(s): Fatigability assessment
Intervention type(s): Other
Intervention description(s): Each participant will do both types of fatigue over 2 appointments spaced by 7 days so that the subject can recover from induced fatigue. The sequence of fatigue tasks will be randomized.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy of the Brushless Scrub
Condition: Focus of Study: Handwashing
Study type: Interventional

Summary: 
      The aim of this research is to examine if the brushless scrub is effective in reducing
      bioburden on the hands of the operating room (OR) personnel both with a prewash of one minute
      prior to scrub and without a prewash prior to scrub, and to compare the bioburden reduction
      between both methods.

      Hypothesis I: A soap and water prewash used prior to brushless scrub further decreases
      bioburden than brushless scrub alone.

      Hypothesis II: Brushless scrub is effective in reducing the bioburden measured just after the
      application of the brushless scrub within 20 seconds of application for both groups.

      Exploratory Hypothesis: We will also compare the bioburden measured before and at 1.5 minutes
      after application of the brushless scrub for both groups.
    

Detailed description: 
      Hand washing by operating room personnel prior to surgical procedures is essential in the
      prevention of intraoperative infection. The use of the brushless surgical hand hygiene has
      been used since the CDC stated in 2002 that using a brush and sponge is no longer necessary.
      Empirical literature supports the reduction of the incidence of bacteria or OR personnel
      hands with the use of alcohol-based products.

      An annotated integrative search of the literature was conducted and conflicting information
      regarding the use of a prewash prior to the brushless scrub was found. This study can help us
      utilize the brushless scrub to the fullest capacity and prevent surgical site infections.

      The time point at which the outcome measure will be assessed at an individual level will be
      immediately pre-intervention and also 1.5 minutes after the intervention. For example, within
      15 seconds prior to brushless scrub, or prewash, a sample swab will be collected and then
      another sample swab will be obtained 1.5 minutes later for postintervention measure. The
      study should take approximately 4 months to complete to get an adequate sample size of
      individuals for statistical power. The data will be aggregated and presented at a staff
      in-service within 3 months after data collection and analysis is completed.
    

Intervention name(s): Prewash
Intervention type(s): Other
Intervention description(s): The intervention will be the addition of the prewash utilizing non-antimicrobial soap and water.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Varying Testosterone Levels on Insulin Sensitivity in Normal and IHH Men
Condition: Hypogonadism
MeSH terms: Insulin Resistance; Hypogonadism
Study type: Interventional

Summary: 
      Type 2 diabetes is one of the most common metabolic disorders in the U.S, estimated to affect
      16 million Americans. Established risk factors for this disease include obesity, increased
      waist/hip ratio, high insulin levels in the blood, and insulin resistance. Testosterone may
      play a role in developing or preventing diabetes, but we do not yet know for sure. The
      purpose of this research study is to determine if changing testosterone levels in men will
      result in changes in insulin sensitivity. Information learned form this research study may
      have important public health implications and may point to new strategies for treating or
      preventing diabetes.
    

Detailed description: 
      The overall aim of this study is to examine the effect of testosterone on insulin sensitivity
      using the models of acute and chronic hypogonadism. All subjects will be in good general
      health and 2 groups of men will be studied in this protocol:

        1. Thirty healthy normal men aged 18-75 years with normal blood pressure, normal
           testosterone levels, and not taking any medications known to influence glucose
           homeostasis or testosterone

        2. Ten adult men (over the age of 18) with idiopathic hypogonadotropic hypogonadism
           (IHH)and normal thyroid, adrenal, and growth hormone axes as well as normal prolactin
           levels and no abnormalities on imaging of the hypothalamic-pituitary region. These men
           will be on no medications known to influence glucose homeostasis and will have been off
           hormone therapy for a suitable washout period depending on the type of prior androgen
           replacement.
    

Intervention name(s): GnRH antagonist (Acyline)
Intervention type(s): Drug
Intervention description(s): 3 Subcutaneous injections (300 mcg/kg) over 36 days
Other intervention name(s): IND # 62,621
Intervention MeSH terms: Acyline
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: IHH; Kallmann syndrome; hypogonadism
Transcutaneous Electrical Nerve Stimulation and Interferential Currents in Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study was to compare the effects of the TENS and IFC in patients with non
      specific chronic low back pain.
    

Detailed description: 
      Setting Outpatient physiotherapy department in university (Cesumar)

      Participants A hundred and fifty patients with non specific chronic low back pain with or
      without radicular pain.

      Interventions The patients were randomly divided into three groups: 1) TENS; 2) IFC; e 3)
      Control. Ten sessions of electrotherapy for groups 1 and 2, while the patients of the Control
      group stayed without any treatment in the same period

      Main Outcome Measures Intensity of the pain through the Visual Analogue Scale and McGill Pain
      Questionnaire; specific functional disability by Roland Morris Disability Questionnaire;
      Analgesic period (hours); and the medication consumption

      Statistic Analysis All data were analyzed using Statistica version 7 and SAS version 9.1.
      Baseline characteristics were compared using the Shapiro-Wilks test for continuous variables
      and then analysis of variance for measuring independent data. The characteristics of the
      patients who finished the treatment were compared with those of the lost patients, using
      one-way ANOVA and the Kruskal-Wallis test.
    

Intervention name(s): TENS; Interferential currents
Intervention type(s): Other; Other
Intervention description(s): The TENS equipment was calibrated on 20 hertz frequency, and a pulse width of 330 ms (standing in control number seven) with two channels.; The IFC was adjusted to a base frequency of 4000 Hz, with a modulation frequency range of 20 Hz, ∆F of 10 Hz and slope of 1/1, in quadripolar mode.
Other intervention name(s): Transcutaneous electrical nervous stimulation; IFC: intereferential currents; electrotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: rehabilitation; electrotherapy; back pain
Serum Antimullerian Hormone Levels in Patients Who Underwent Uterine Artery Ligation
Condition: Uterine Artery Ligation; Ovarian Reserve
Study type: Observational

Summary: 
      Investigators would like to see the amh values after uterine artery ligation
    

Detailed description: 
      Group/cohort:

      Uterine artery ligation (UAL) Investigators would like to invite the patients to the hospital
      at least 6 months after surgery who underwent only uterine artery ligation performed due to
      uterine atony during C-section.

      Participants would be evaluated for their ovarian reserve via hormones and antral follicle
      count (AFC)

      Control Group:

      Investigators would like to invite the patients to the hospital at least 6 months after
      C-section who delivered baby without any complication.

      Participants would be also evaluated for their ovarian reserve via hormones and antral
      follicle count (AFC)
    

Intervention name(s): Uterine artery ligation (UAL)
Intervention type(s): Diagnostic Test
Intervention description(s): Uterine artery ligation (UAL) We will invite the patients to the hospital at least 6 months after surgery who underwent only uterine artery ligation performed due to uterine atony during C-section.
They will evaluated for their ovarian reserve via hormones and antral follicle count (AFC)
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who had uterine artery ligation during C-section. Control group is age-matched
        postpartum patients.
      
Keywords: Uterine atony; amh
Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in
      Japanese patients with T2DM at first treatment period. The second treatment period is
      required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese
      patients with T2DM according to the ICH E1 guideline.
    


Intervention name(s): Placebo (low dose); Placebo (low dose); Placebo (mid dose); Placebo (high dose); BI 10773; Placebo (mid dose); Placebo (high dose); Placebo (high dose); BI 10773; BI 10773; Placebo (mid dose); Placebo (high dose); Placebo (low dose); Placebo (low dose); BI 10773; Placebo (mid dose)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo tablets once a day; Placebo tablets once a day; Placebo tablets once a day; Placebo tablets once a day; BI 10773 tablets low dose once a day; Placebo tablets once a day; Placebo tablets once a day; Placebo tablets once a day; BI 10773 tablets mid-high dose once a day; BI 10773 tablets high dose once a day; Placebo tablets once a day; Placebo tablets once a day; Placebo tablets once a day; Placebo tablets once a day; BI 10773 tablets mid-low dose once a day; Placebo tablets once a day
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Investigation of the Relationship Between Foot Posture Index Score and Foot Function and Balance Performance
Condition: Foot Posture Index Score
Study type: Observational

Summary: 
      The foot is a terminal joint that opposes external resistance in the lower kinetic chain. It
      plays a primary role in weight transfer and ground response between the body and the ground.
      It plays a role in maintaining an upright posture, lowering the gravitational line against a
      narrow support surface during walking, providing stability and absorbing the shocks that
      occur during daily life activities.

      Foot problems are common worldwide. These problems affect people negatively by giving
      symptoms during activities of daily living.
    

Detailed description: 
      There is not much data on whether these changes are related to age or not. Deformities,
      kinetic chain disorders, and other problems that affect balance are likely to increase with
      age. For this reason, in our study, the relationship between foot posture and
      functional-balance was examined on the basis of age groups.

      Body balance may be impaired by deficiencies in the strength and mechanical stability of any
      joint or structure along the lower extremity kinetic chain, or by decreased afferent
      feedback. It is necessary to know the foot posture and biomechanics about the causes of
      injury and susceptibility to injury during activities of daily living and sports.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Individuals who will participate in the study will be reached via social media, whatsapp
        and message.
      
Keywords: balance
Study to Evaluate The Analgesic Efficacy and Safety of Intravenous Paracetamol in Subjects With Postoperative Pain After Total Hip Arthroplasty
Condition: Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose is to evaluate the analgesic efficacy of 1g of intravenous (Iv) paracetamol
      versus i.v. placebo, administered every 6h, as measured by the reduction of the 24-hour
      cumulative dose of the opioid tramadol in the treatment of postoperative pain following total
      hip arthroplasty.
    


Intervention name(s): Paracetamol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IV Solution, Intravenous, 100 mL (10 mg/mL), 4 times at 6-hour intervals, 24 hours; IV Solution, Intravenous, 100 mL (0 mg/mL), 4 times at 6-hour intervals, 24 hours
Other intervention name(s): Perfalgan
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Subjects with postoperative pain after Total Hip Arthroplasty