bioihbjkbjnl/mcl2 huggingface dataset:
Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.
Condition: Bipolar Affective Disorder
MeSH terms: Genetic Diseases, X-Linked; Mood Disorders; Bipolar Disorder
Study type: Interventional

Summary: 
      Based in an embodied approach of cognition, several studies have highlighted a direct link
      between perception of an object or an emotion and the associated motor responses. This study
      investigated in patients suffering from bipolar affective disorders whether the perception of
      emotional words involves an automatic sensorimotor simulation of approach and avoidance
      behaviors, and whether the perception of an object involves an automatic sensorimotor
      simulation of object prehension (affordance). We hypothesize that, in this pathology, low
      level (sensorimotor) cognitive processes are preserved whereas high-level (attentional) are
      altered. 20 patients suffering from bipolar affective disorders and 20 healthy controls will
      be recruited. The main objective is the emergence of sensorimotor compatibility effects in
      approach-avoidance task with emotional stimuli (gain between compatible vs incompatible
      conditions).
    


Intervention name(s): cognitive tasks + IQ + MINI; cognitive tasks
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients will perform different tasks:
cognitive tasks : reaction time (Alert TEA, Zimmermann and Fimm, 2005) + Edinburgh laterality questionnaire (Oldfield,1971) + hamilton and young's scale (Tohen et al., 2009) + Montreal Cognitive Assessment (MoCA) (Nasreddine et al., 2005) + experimental task (approach/ avoidance and affordance task).
Intelligence Quotient (IQ) test (PM38, Raven, 1960)
Mini International Neuropsychiatric Interview (MINI, Van Vliet et al., 2006); Healthy volunteers will perform only the cognitive tasks = reaction time alert TEA, Zimmermann and Fimm, 2005 + Edinburgh laterality questionnaire (Oldfield, 1971) + experimental task (approach/ avoidance and affordance task).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bipolar affective disorders; Cognition; Emotion; Embodiment; Sensorimotor; Simulation
The Effect of Cold Vapor Application on Postoperative Sore Throat
Condition: Sore Throat
MeSH terms: Pharyngitis
Study type: Interventional

Summary: 
      To determine the effect of cold vapor given in the post-extubation period on sore throat.
    

Detailed description: 
      General anesthesia increases the comfort of the patient by ensuring that the patient does not
      feel the surgical interventions and pain during the operation. The necessity of intubation is
      known in patients who have undergone surgery under general anesthesia. Intubation provides
      benefits such as keeping the airway open, controlling the airway and breathing, reducing
      respiratory effort and dead space volume, preventing aspiration, and facilitating
      resuscitation in case of any problem.

      Although surgical interventions are an important treatment option for health problems,
      postoperative complications such as sore throat, dry throat, hoarseness and dysphagia due to
      laryngeal and pharyngeal traumas caused by intubation are frequently observed especially in
      patients receiving general anesthesia.

      Although it is seen in the literature that pharmacological, non-pharmacological and herbal
      methods are applied to reduce postoperative sore throat, there are not enough studies
      examining the effect of cold steam application on sore throat. With this research, it is
      expected that the cold steam given in the postoperative period will contribute to the relief
      of sore throat.
    

Intervention name(s): Cold vapor
Intervention type(s): Procedure
Intervention description(s): The Ramsey Sedation Scale was used to assess wakefulness after patients were extubated and arrived at the recovery unit at the 0th hour postoperatively. Sore throat, localization of pain, hoarseness, dry throat, and swallowing difficulty were evaluated in patients with a score of 2 according to this scale. Sore throat of the patients was evaluated with Numerical Rating Scale. Then, cold vapor was applied for 15 minutes with a vapor machine used as a standard in the hospital by the researcher. After the cold vapor application was finished, the patients' sore throat, localization of pain, hoarseness, swallowing difficulty and dry throat were re-evaluated with the same forms.
Sore throat were evaluated before the application of cold vapor at the 2nd and 6th hours. Then cold vapor was applied for 15 minutes. After the cold vapor application was finished, sore throat were re-evaluated.
At the 24th hour, cold vapor was not applied to the patients. Only sore throat were evaluated.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were divided into intervention and control groups using a simple randomized control method.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Extubation; Sore throat; Cold vapor; Nursing
Language and Deglutition in Children
Condition: Child; Development
Study type: Observational

Summary: 
      The first years of life are considered essential to child development, as there is greater
      brain growth and formation of more neural connections. Therefore, the stimulation of children
      in various fields of development becomes relevant to the acquisition of knowledge and skills.
    

Detailed description: 
      Child development, food and language, particularly in young children in different
      socioeconomic and cultural, as this is the basis for the growth conditions, socialization and
      learning.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        89 children, 41 children in public kindergarten and 48 children in daycare facilities.
      
Keywords: Child Development; Child; Daycare centers; Language
E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - EU/Russia Study
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding
      pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol
      (E4)/3 mg drospirenone (DRSP) combination in healthy women aged 18 to 50 years.
    


Intervention name(s): 15 mg E4/3 mg DRSP
Intervention type(s): Drug
Intervention description(s): 15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
Other intervention name(s): 15 mg estetrol and 3 mg drospirenone
Intervention MeSH terms: Drospirenone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Estetrol
Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of GSK 257049 Vaccine
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      The RTS,S/AS02A vaccine (or GSK 257049 vaccine), GSK Biologicals' candidate Plasmodium
      falciparum (P. falciparum) malaria vaccine is being developed for the routine immunization of
      infants and children living in malaria endemic areas. The vaccine would offer protection
      against malaria disease due to the parasite P. falciparum. The vaccine would also provide
      protection against infection with hepatitis B virus (HBV).

      This phase IIb trial is being carried out following the demonstration of efficacy of the
      candidate malaria vaccine in children in Mozambique: there, the vaccine demonstrated
      approximately 30% efficacy against clinical episodes of malaria and approximately 58%
      efficacy against severe malaria disease.

      In this study, the children from Mozambique (NCT= NCT00197041) are followed-up to assess the
      safety, immunogenicity and efficacy of the candidate malaria vaccine for a two year period
      commencing 21 months after Dose 1.

      This protocol posting deals with objectives & outcome measures of the extension phase at year
      2. During this extension study, no new subjects will be recruited and no vaccine will be
      administered.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    


Intervention name(s): GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049; Engerix™-B; Hiberix®; Prevnar™; sulfadoxine-pyrimethamine; amodiaquine
Intervention type(s): Biological; Biological; Biological; Biological; Drug; Drug
Intervention description(s): IM injection in the deltoid muscle; IM injection in the deltoid muscle; IM injection in the deltoid muscle; IM injection in the deltoid muscle; 1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance; 1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance
Other intervention name(s): RTS; S/AS02A vaccine
Intervention MeSH terms: Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Amodiaquine; Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
IL-39 & IL-35 Gingival Crevicular Fluid Levels in Diabetic Patients With Generalized Periodontitis
Condition: Generalized Periodontal Disease, AVDC Stage 3
MeSH terms: Periodontitis; Periodontal Diseases
Study type: Interventional

Summary: 
      The sudy was aiming to assess and compare GCF levels of IL-39 & IL-35 in gingival crevicular
      fluid and to correlate the relationship between different patient groups before and after
      non-surgical therapy.
    

Detailed description: 
      Methodology:

      Group I (Periodontitis Group): 19 patients suffering from generalized periodontitis with T2DM
      age range, 35-50 years.

      Group II (Periodontitis Group): 19 patients suffering from generalized periodontitis &
      systemically healthy, age range: 35-50 years.

      Group III (Control group): 19 Periodontally and systemically healthy volunteers who served as
      control subjects age range: 30-45 years.

      Periodontitis participants will be collected from the outpatient clinic of oral medicine and
      periodontology departments in Fayoum, Beni-Swief and Ahram-Candian universities. The
      periodontitis included subjects will be diagnosed according to the 2017 World Workshop on the
      Classification of Periodontal and Peri-Implant Diseases and Conditions (Tonetti, MS,
      Greenwell, H, Kornman, KS. Staging and grading of periodontitis: framework and proposal of a
      new classification and case definition. J Periodontol.; 89( Suppl 1): S159- S172, 2018.)

      Diabetic patients will be enrolled in this study according to the criteria of American
      Diabetes Association. (American Diabetes Association. (2) Classification and diagnosis of
      diabetes. Diabetes Care 38: S8-S16, 2015.)

      The control group will be selected from healthy subjects who attended the restorative dental
      clinic and has apparently clinically healthy gingiva.

      Micropipettes will be used for collection of GCF samples for control group and periodontitis
      patients before & after periodontal treatment.

      A complete mouth non-surgical periodontal therapy will be carried out for both periodontitis
      groups

      The levels of IL-35 in the GCF samples were assessed using an ELISA kit following the
      guidelines by the manufacturer.
    

Intervention name(s): Scaling & root planning
Intervention type(s): Procedure
Intervention description(s): Non Surgical periodontal therapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Chronic periodontitis group chronic periodontitis with diabetes control group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Periodontitis & Diabetes mellitus
A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects
Condition: Renal Impairment; Healthy
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of renal impairment on rivipansel.
    


Intervention name(s): Rivipansel
Intervention type(s): Drug
Intervention description(s): A single 840mg dose of Rivipansel over 20 minutes
Other intervention name(s): GMI-1070
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Renal Insufficiency
A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection.
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This 7 arm study will determine the optimal treatment combination, based on efficacy and
      safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7
      treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV
      polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus PEGASYS (90 or
      180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24
      weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus
      1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus
      PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks,
      those achieving a rapid virological response (RVR) will stop all medication, and non-RVR
      patients will remain on triple combination for an additional 24 weeks. Group 7 will receive
      standard of care (SOC) for 48 weeks. There will be a 24 week period of treatment-free
      follow-up for all treatment groups. The anticipated time on study treatment is 3-12 months,
      and the target sample size is 100-500 individuals.
    


Intervention name(s): Copegus; Pegasys; Pegasys; RO4588161; RO4588161; RO4588161
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1000/1200mg po daily for 24 weeks; 180 micrograms sc weekly for 24 weeks; 90 micrograms sc weekly for 24 weeks; 1000mg po bid for 24 weeks; 500mg po bid for 24 weeks; 1500mg po bid for 24 weeks
Intervention MeSH terms: Peginterferon alfa-2a; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
Condition: Pneumonia, Pneumocystis Carinii; HIV Infections
MeSH terms: Pneumonia; Pneumonia, Pneumocystis
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary: To compare the pharmacokinetics of biweekly and monthly dose regimens of intravenous
      pentamidine in HIV-infected infants and children who require PCP prophylaxis and who are
      intolerant to oral trimethoprim - sulfamethoxazole. To determine the safety and tolerance of
      these regimens in this patient population.

      Secondary: To obtain information on the rate of PCP breakthrough in infants and children
      receiving parenteral pentamidine prophylaxis.

      Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected
      children considered to be at high risk. In children younger than 5 years of age with
      intolerance to trimethoprim - sulfamethoxazole, parenteral pentamidine may be a successful
      alternative.
    

Detailed description: 
      Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected
      children considered to be at high risk. In children younger than 5 years of age with
      intolerance to trimethoprim - sulfamethoxazole, parenteral pentamidine may be a successful
      alternative.

      Thirty-two children are randomized to one of two treatment arms. Patients receive pentamidine
      on either a biweekly or a monthly treatment schedule. Treatment continues until the last
      child enrolled has received at least 6 months of pentamidine. Patients are stratified
      according to age < 24 months or age >= 24 months. Steady-state pharmacokinetics will be
      examined in a subsample of 20 patients.
    

Intervention name(s): Pentamidine isethionate
Intervention type(s): Drug
Intervention MeSH terms: Pentamidine
Primary purpose: Treatment
Keywords: Pneumonia, Pneumocystis carinii; Pentamidine; Acquired Immunodeficiency Syndrome; AIDS-Related Complex
Effects of a Zinc Oxide Underarm Formula on Normal and Injured Skin in Healthy Volunteers
Condition: Microbiome of the Axillae
Study type: Interventional

Summary: 
      Bothersome odor from the axilla is in most cases caused by Corynebacterium spp.
      Anti-microbial effects of zinc oxide (ZnO) are well documented.

      The overall objective of this study is to verify that repeated applications of a ZnO
      containing formulation can be directly linked to reduced growth of Corynebacterium spp. in
      the axillae.
    

Detailed description: 
      In the trial the effects of the ZnO formulation on the skin of the forearms and axillae are
      investigated simultaneously. In both locations the skin is treated daily with the ZnO/placebo
      formulations.

      At day -8 skin areas of the forearms and the axillae are sampled by adhesive tape that is
      extracted in phosphate-buffered saline (PBS) and PBS extract analyzed on total proteins (BCA)
      and IL-1α. In the axillae swabs are taken for Corynebacterium spp. semi quantification and pH
      is measured in the axillae and on the forearm.

      At day 0 treated skin areas of the forearms and the axillae are sampled by adhesive tape that
      is extracted in PBS and PBS extract analyzed on total proteins (BCA) and IL-1α, and compared
      to adjacent non-treated skin. In the axillae and on the forearms, swabs are first taken for
      Corynebacterium spp. semi quantification followed by wounding using ablative fractional (10%)
      carbon dioxide laser at 20 millijoule/microbeam and pediatric lancet. pH is measured in the
      axillae and on the forearm.

      Progress of wound healing is assessed by dermatoscopy at days 3, 4 and 5. At day 5 swabs are
      taken in the axillae for Corynebacterium spp. semi quantification and pH is measured.
      Furthermore, skin areas of the axillae are sampled by adhesive tape that is extracted in PBS
      and PBS extract analyzed on total proteins (BCA) and IL-1α.
    

Intervention name(s): Formula with ZnO; Formula without ZnO
Intervention type(s): Other; Other
Intervention description(s): Forearms and axillae are treated by the volunteers once daily with a standardized amount of the roll-on with ZnO; Forearms and axillae are treated by the volunteers once daily with a standardized amount of the roll-on without ZnO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Multiple Dose Dental Pain Study Of Ibuprofen Extended Release
Condition: Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 3

Summary: 
      The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide
      analgesic efficacy superior to placebo over 12-hour dosing intervals.
    


Intervention name(s): Ibuprofen 600 mg ER; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One 600 mg caplet dosed at 0, 12, 24 and 36 hours; One placebo caplet dosed at times 0, 12, 24 and 36 hours
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dental pain; multiple dose; ibuprofen; third molar extraction
Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis
Condition: Primary Biliary Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety, tolerability, and activity of extended
      treatment with NGM282 in patients with Primary Biliary Cirrhosis.
    


Intervention name(s): NGM282
Intervention type(s): Biological
Intervention description(s): NGM282
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Stressor-evoked Brain and Cardiovascular Responses to Acute Psychological Stress
Condition: Acute Psychological Stress
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The present study will examine the relationship between metabolically excessive
      cardiovascular and neural responses to acute psychological stress using a cross-sectional
      approach.
    

Detailed description: 
      All participants in this study will undergo an acute psychological stress paradigm, there
      will be no randomization or assignment since all participants will complete the same tasks.
      Sample size was calculated based off of recent papers examining multivariate pattern brain
      responses predicting cardiovascular responses to stress.
    

Intervention name(s): Acute psychological stress
Intervention type(s): Other
Intervention description(s): Participants will undergo an acute psychological stress task that has been shown to elicit neural, cardiovascular, and psychological (feelings of stressfulness) responses.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science