bioihbjkbjnl/mcl2 huggingface dataset:
Validation BITSS Brussels Infant Stool Scale
Condition: Validation of BITTS
Study type: Observational

Summary: 
      validation of stool scale in toddlers
    

Detailed description: 
      objective : the Bristol stool form scale (BSFS) is inadequate for non-toilet trained
      children.

      The Brussels Infant and Toddler Stool Scale (BITTS) was developed, consisting of 7 photograps
      of diapers containing stools of infants and toddlers. We aimed to evaluate inter-observer
      reliability of stool consistency assessment among parents, nurses and medical doctors using
      the BITTS.

      Method :

      In this multicenter cross-sectional study (2016-2017), Bitts photograps were rated according
      to the BSFS. The reliability of the BITTS was evaluated using the overall proportion of
      perfect agreement and the linearly weighted K statistic.

      What is known :

        -  reliable assessment of stool consistency is important for evaluating children's
           defecation pattern and diagnosing gastrointestinal disorders.

        -  the reliability of the Bristol Stool Form Scale, developed for adults, has been debated
           for young children who are non-toilet trained and wear diapers

      To get validation of the BITTS :

        -  a non-toilet trained child makes stool in diaper

        -  caregiver scores the aspect of the stool according to the BITTS

        -  caregiver takes a picture of the diaper

        -  after 1 monts she rescores the picture according to the BITTS
    

Intervention name(s): validation of Bitts
Intervention type(s): Other
Intervention description(s): No intervention, observation of photographs of stool
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        all children who are non-toilet trained
Deep rTMS and Varenicline for Smoking Cessation
Condition: Tobacco Use Disorder; Smoking Cessation
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of deep repetitive transcranial
      magnetic stimulation (rTMS) using the insula H-coil on smoking outcomes in smokers receiving
      varenicline. It is hypothesized that active deep rTMS will improve abstinence rates,
      attenuate craving and reduce cigarette consumption and dependence severity.
    

Detailed description: 
      This study will be a randomized, double-blind, sham-controlled clinical trial. Nicotine
      dependent participants will be recruited and randomized tor receive either active or sham
      rTMS intervention for 4 weeks (5 sessions/week). All participants will receive an open-label
      treatment of varenicline for 12 weeks and weekly counselling sessions. The aims of the study
      are:

        1. To examine the efficacy of bilateral deep rTMS to the insula on point prevalence smoking
           abstinence in smokers receiving varenicline treatment.

        2. To examine the efficacy of bilateral deep rTMS to the insula on other smoking outcomes
           such as craving, cigarette smoking and dependence severity.

        3. To examine the effect of bilateral deep rTMS to the insula on abstinence at the end of
           rTMS treatment and at 6-month follow up.

      Abstinence will be measured by point prevalence at week 4 and 12 and prolonged continuous
      abstinence at week 26. This will be confirmed using plasma cotinine levels. All other
      measures will be done using various questionnaires such as Fagerstrom Test of Nicotine
      Dependence (FTND), Timeline Follow-Back (TLFB), Minnesota Nicotine Withdrawal Scale (MNWS),
      and Tiffany Questionnaire of Smoking Urges (T-QSU).
    

Intervention name(s): Deep Repetitive Transcranial Magnetic Stimulation (Active); Deep Repetitive Transcranial Magnetic Stimulation (Sham); Varenicline
Intervention type(s): Device; Device; Drug
Intervention description(s): Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula; Sham deep rTMS using the H-coil. The sham coil is built into the same helmet as the active coil. It mimics the active coil with regards to acoustics and scalp sensations.; 12 week course treatment of varenicline (0.5 mg/1 mg) using the standard dosage schedule for smoking cessation (Day 1-3: 0.5 mg daily; day 4-7: 0.5 mg twice a day; day 8-end of treatment: 1 mg twice a day).
Other intervention name(s): Champix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: smoking cessation; varenicline; deep rTMS; insula; addiction; tobacco use disorder
Bioequivalency Study of Zolpidem Tartrate Under Fasting Conditions
Condition: Insomnia
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem
      Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fasting conditions
      using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
    


Intervention name(s): Zolpidem
Intervention type(s): Drug
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Tolerability Study of Two Dosing Regimens of CTP-543 in Adults With Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and tolerability of once-daily versus twice-daily
      dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata.
    


Intervention name(s): CTP-543; CTP-543 Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as 12 mg tablets.; Administered as tablets to aid treatment masking.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effects of an Early Prehospital Administration of Tranexamic Acid on Hyperfibrinolysis in Multiple Trauma
Condition: Hyperfibrinolysis; Haemorrhage; Mortality
MeSH terms: Hemorrhage; Multiple Trauma
Study type: Observational

Summary: 
      Severe external and internal bleedings are common in multiple trauma patients. Uncontrollable
      blood loss is the cause for about one third of all trauma deaths. A number of blood clotting
      mechanisms are known to be triggered by major blood losses. These mechanisms shall secure the
      organisms from loosing even more blood. To avoid an overshooting clotting behavior,
      inhibiting mechanisms occur as well. An important inhibiting (or fibrinolytic) mechanism is
      the fibrinolysis that is based on the conversion of plasminogen to plasmin. In severe
      bleeding situations this mechanism tends to overshoot and therewith contributes to the
      severity of the bleeding. This phenomena is called hyperfibrinolysis and is found in
      approximately one third of all multiple trauma patients. Mortality rates are increased in
      these patients. Tranexamic acid is an antifibrinolytic drug that inhibits the conversion from
      plasminogen to plasmin and therefore is able to limit the effects hyperfibrinolysis. A large
      study showed positive influence of tranexamic acid on mortality rates and blood loss in
      severely injured patients, when it was administered in an early clinical setting. In this
      study we want to answer the question wether a hyperfibrinolysis can be seen in an early
      prehospital (on the scene) setting and how it is influenced by an early prehospital
      administration of tranexamic acid.
    

Detailed description: 
      In patients suffering from multiple trauma the initially responding emergency physician on
      the scene will take a blood sample for thrombelastometry immediately after i.v. access is
      established. According to the initial trauma life support protocols a number of patients will
      receive a dose of tranexamic acid during the initial treatment on the scene or during
      transport to the hospital. A second blood sample will be taken after arrival in the
      resuscitation area of the hospital. Thrombelastometric measurements will be performed with
      both blood samples and the extent of hyperfibrinolysis in both samples will be compared. In a
      second step the outcome of the patients who received tranexamic acid on the scene will be
      compared to those who did not receive the drug before reaching hospital.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited by emergency physicians on the scene by taking a blood sample
        for thrombelastometry.
      
Biospecimen description: 
      blood samples
    
Keywords: Multiple trauma; Polytrauma; Hyperfibrinolysis; Tranexamic acid; Thrombelastometry
Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Study type: Interventional

Summary: 
      This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed
      combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in
      patients with glaucoma or ocular hypertension who do not respond well to topical beta
      blockers.
    


Intervention name(s): brimonidine tartrate/timolol fixed combination ophthalmic solution; brimonidine tartrate ophthalmic solution; timolol ophthalmic solution; fixed combination vehicle
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.; One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.; One drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.; Fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Other intervention name(s): Combigan®; Alphagan®
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence Study of Favipiravir 200 mg Film Tablet (Novelfarma, Turkey) Under Fasting Conditions
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose of Reference product containing 200 mg favipiravir and a single dose of Test
      product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at
      room temperature, in each period under fasting conditions with current pandemic precautions.
    

Detailed description: 
      Favipiravir is a drug with a mechanism of action different from that of the existing
      influenza antiviral drugs and effective against all types and sub-types of human influenza A,
      B and C viruses in vitro, showing anti-viral activity against various influenza virus strains
      including avian and swine viruses. Favipiravir also has shown anti-viral activity even
      against amantadine, oseltamivir and zanamivir-resistant influenza viruses in vitro. The
      mechanism of action of favipiravir is the selective inhibition of RNA polymerase by
      favipiravir ribosyl triphosphate formed by cellular enzymes in the influenza virus leading to
      antiviral activity.
    

Intervention name(s): FAVIRA 200 MG Film Tablet; AVIGAN 200 MG Film Tablets
Intervention type(s): Drug; Drug
Intervention description(s): FAVIRA is containing 200 mg favipiravir manufactured by Novelfarma, Turkey.; AVIGAN is containing 200 mg favipiravir manufactured by Toyama, Japan
Other intervention name(s): FAVIRA 200 MG FT; AVIGAN 200 mg FT
Intervention MeSH terms: Favipiravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: COVID-19 drug treatment; Antiviral Agents; Favipiravir; Novagenix; Farmagen
Calibration and Validation of the STISIM Driving Simulator
Condition: Simulated Driving Performance
Study type: Interventional

Summary: 
      The aim of this study is to calibrate the STISIM driving simulator under influence of three
      different dosages of ethanol (0.05%, 0.08% and 0.11% BAC). The levels of performance
      decrement for the three blood alcohol concentrations will serve as a standard for comparing
      the effects that will be observed with psychoactive drugs in future trials. This will make
      the results of these future studies more easily to interpret and will provide health care
      providers and policy makers who read our scientific work with an easy-to-understand and
      clinically relevant comparison.
    


Intervention name(s): alcohol
Intervention type(s): Other
Intervention description(s): alcohol 0.05%, 0.08% or 0.11% or placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: STISIM; Alcohol
Supportive Care During Childbirth and Well-being
Condition: Psychological Well-being; Childbirth; Care Pattern, Maternal
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effects of continuous supportive care (ICSC) at
      birth on some parameters of maternal psychological well-being.
    

Detailed description: 
      This is a single-blind randomized controlled trial. Data were collected from 80 women who
      gave birth in the obstetrics clinic of a state hospital in the south of Turkey between
      December 2020 and June 2021. Participants who met the inclusion criteria were informed about
      the purpose of the study and the procedures to be performed, informed consent was obtained
      from those who agreed to participate, and women were assigned to the groups in line with a
      computer-based randomization program with an allocation ratio of 1:1. Block randomization
      could not be performed because of the different and long delivery processes. Data were
      collected in both groups at birth (latent phase, active phase, and transitional phase),
      within 24 hours of birth, and 6th-8th postpartum days after hospital admission and at least
      one hour of care. collected by the first author. The CONSORT directive was followed in the
      planning, implementation and writing of the research.
    

Intervention name(s): Continouse supportive care; routine care
Intervention type(s): Other; Other
Intervention description(s): Participants were provided care in different rooms, blinded to the differences in practice used between the two groups. In the same clinic, a room was designed as a positive delivery room by the researchers and a relaxing environment was created. In this room, supportive care parameters recommended by The Royal College of Midwives (2012) were applied to the women in the ICSC group in line with their preferences.
Participants in the control group, on the other hand, received routine care given in the hospital by other midwives in the clinic.; Participants in the control group, on the other hand, received the routine care given in the hospital by other midwives in the clinic, and there was a change of caregiver midwife during shift changes. The care provided in the hospital during delivery is mostly focused on low level of physical comfort and high level of follow-up.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Intrapartum supportive care; birth trauma; fear of childbirth; maternal attachment; perinatal well-being
Effect of White Potatoes on Glycemic Response, Satiety and Food Intake in Children
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of the present study is to explore the influence of cooking methods on
      post-prandial glycaemia and its impact on satiety in children.
    

Detailed description: 
      Each of the 5 study sessions will be at least 7 days apart. Either meal skipping, or one of
      three treatments of white potatoes (a) baked (with skin), (b) mashed, (c) fried French fries,
      or white bread, prepared on the day of testing, will be served to healthy children (9-14
      years). Participants will consume the equivalent to 1 medium sized potato (~280 kcal) or an
      equivalent amount of calories from white bread. Glycemic response, insulin, incretin hormones
      (glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic peptide (GIP)), dipeptidyl
      peptidase 4 (DPP4), and cholecystokinin (CCK) will be measured for 2 h (0, 15, 30, 45, 60, 90
      and 120 min) following meal consumption, as well as mood and subjective appetite. An ad
      libitum test meal will be provided at 120 min to assess food intake suppression.
    

Intervention name(s): White bread; Baked potato with skin; Mashed potato served hot; Fried French fries; Meal skipping
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Toasted, with canola oil added to match for fat content of French fries (13.9 grams), as well as being matched for energy (280 kilocalories) and available carbohydrate content (33 grams) of potato treatments.; Baked russet potato with canola oil added once baked to match for fat content of French fries, and also matched for the salt content of white bread (280 milligrams).; Mashed potatoes prepared from frozen, with canola oil added to match for fat content of French fries, as well as being matched for energy and available carbohydrate content of the baked potato.; Prepared from frozen, matched for energy and available carbohydrate content of baked potato and salt content of white bread.; No food given
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: White potatoes; Children; Satiety; Glycaemia
Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™
Condition: Diphtheria; Tetanus; Pertussis; Hepatitis B; Poliomyelitis; Haemophilus Influenzae Type B Infection
MeSH terms: Influenza, Human; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Haemophilus Infections; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a follow-up of Study A3L11 (NCT00404651).

      Immunogenicity

        -  To describe the antibody persistence following a primary series vaccination of either
           DTaP-IPV-Hep B-PRP~T or Infanrix hexa™.

        -  To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP~T in a subset of
           subjects.

      Safety

      - To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP~T.
    


Intervention name(s): DTaP-IPV-Hep B-PRP~T vaccine (Batch 1); DTaP-IPV-Hep B-PRP~T vaccine (Batch 2); DTaP-IPV-Hep B-PRP~T vaccine (Batch 3); Infanrix Hexa™
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; Hepatitis B; Poliomyelitis; Invasive Haemophilus influenzae type b.; Haemophilus Influenzae Type B Infection
Autologous Fecal Therapy
Condition: Infectious Disease of Digestive Tract
MeSH terms: Communicable Diseases; Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Ten healthy volunteers will be recruited to receive either an autologous stool transplant or
      a saline enema to determine if autologous fecal microbiota therapy will be able to rapidly,
      and safely, restore a patient's fecal microbiome after antimicrobial exposure.
    


Intervention name(s): Autologous fecal microbiota therapy; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Saline enema
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Fecal microbiota therapy
Short Term Effects of Probiotics in the Human Micro-vascular Physiology
Condition: Microcirculation; Endothelial Dysfunction
Study type: Interventional

Summary: 
      While the beneficial properties of kefir consumption have been thoroughly studied for many
      years, very little research has been conducted to explore the potential protective properties
      of kefir consumption to the endothelium in humans. Therefore, the aim of the current study is
      to explore the short-term efficacy of kefir consumption in improving endothelial function in
      older and younger healthy, sedentary adults.
    


Intervention name(s): Kefir consumption
Intervention type(s): Other
Intervention description(s): Following confirmation of eligibility and the provision of informed consent, recruited participants were provided with a 4-week supply of kefir (Live Kefir Company, Pontefract, UK) being instructed to consume 150ml of Kefir per day for the whole 4-week period. No break periods of kefir consumption were offered to any of the participants. In addition, they were instructed to not change their usual dietary habits and exercise routine for the study duration.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention