bioihbjkbjnl/mcl2 huggingface dataset:
Tidal Model's Effect on Coping and Self-Esteem
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      The aim of the study was to determine the effect of the psychiatric nursing approach based on
      the Tidal Model on coping and self-esteem in people with alcohol dependency.
    


Intervention name(s): The Psychiatric Nursing Approach Based On The Tidal Model
Intervention type(s): Behavioral
Intervention description(s): To provide individualized care for patients in the experimental group, the One-to-One Sessions were initiated and interventions were performed in line with the goals of the persons and the aims of the research. The interventions were selected from interventions regarding with coping and self-esteem from the Nursing Interventions Classification(NIC) system.The One-to-One sessions help the person recognize change and focus the person on achievement and goals.Taking into account the basic process of the Tidal Model, care stages, the following interview plan was drawn up, containing the details of the interviews to be carried out with people with alcohol dependency, and the One-to-One Sessions were held in line with this plan two times per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Alcoholics [M01.066]
Ex-vivo Expanded γδ T-lymphocytes (OmnImmune®) in Patients With Acute Myeloid Leukaemia (AML)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates the potential curative properties of gamma delta T-cells obtained
      from a blood-related donor of an AML patient.
    

Detailed description: 
      This is an open-label, safety and efficacy, escalating dose, single arm study on 9 adult
      subjects (3 cohorts) and 3+3 design will be used. HLA typed patients and potential
      blood-related donors will be screened for comorbidities. Suitably matched or haploidentical
      family donors will be selected according to protocol specified criteria and institutional
      guidelines of participating site.
    

Intervention name(s): OmnImmune®
Intervention type(s): Biological
Intervention description(s): infusion of OmnImmune® (expanded gamma delta T lymphocytes)
Other intervention name(s): fludarabine; cyclophosphamide
Intervention MeSH terms: Cyclophosphamide; Fludarabine
Intervention model: Sequential Assignment
Intervention model description: Dose escalation, 3 cohorts, x10 dose increments between cohorts (10^6, 10^7, 10^8 of cells per kg of body weight).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gamma Delta T Lymphocytes
Phase 4 Study to Evaluate Efficacy of Paliperidone Extended-Release(ER) in Schizophrenic Participants
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the efficacy of flexibly dosed paliperidone
      extended-release (mechanism to dissolve a drug over time in order to be released slower and
      steadier into the blood stream) in improving or maintaining the subjective symptoms of the
      participants in three participants' groups (that is, by the reason to switch: lack of
      efficacy group, lack of tolerability group, and lack of compliance group) who switched from
      other previous antipsychotic drugs to paliperidone extended-release tablets at flexible
      doses.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), prospective (study
      following participants forward in time), single arm, and non-comparative study of
      paliperidone Extended-release (ER) in participants switching from the previous oral
      antipsychotic to flexibly dosed paliperidone ER. The total study duration will be
      approximately of 24 weeks per participant. The study consists of 2 parts: Screening (that is,
      14 days before study commences on Day 1); Treatment (24 weeks). Efficacy will primarily be
      evaluated by change from baseline in symptom checklist 90-R (SCL90-R) at Week 24.
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): Paliperidone
Intervention type(s): Drug
Intervention description(s): Paliperidone oral tablet will be administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
Other intervention name(s): R076477; Invega Extended-release tablet
Intervention MeSH terms: Paliperidone Palmitate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Paliperidone; Paliperidone extended-release; Antipsychotics Agents
The Impact of a Prebiotics and Lactoferrin Containing Infant Formula on Stool Characteristics in Healthy Term Infants
Condition: Infant Formula Intolerance
Study type: Interventional

Summary: 
      Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of
      beneficial nutrients such as prebiotics and lactoferrin. Previous studies have shown that
      both prebiotics and lactoferrin play important roles in generating a bifidobacteria-dominated
      colonic microflora.The purpose of this study is to investigate the stool
      characteristics,acceptability, and gastrointestinal tolerance in term infants fed a starting
      infant formula supplemented with prebiotics and lactoferrin.
    

Detailed description: 
      Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of
      beneficial nutrients such as prebiotics and lactoferrin. Previous studies have shown that
      both prebiotics and lactoferrin play important roles in generating a bifidobacteria-dominated
      colonic microflora as well as the intestinal immune systems. The purpose of this study is to
      investigate the stool characteristics（including intestinal microbiota） acceptability, and
      gastrointestinal tolerance in infants fed a starting infant formula supplemented with
      prebiotics and lactoferrin, and compared these data with infants on exclusively breast
      feeding.
    

Intervention name(s): formula
Intervention type(s): Other
Intervention description(s): An infant formula contains prebiotics and lactoferrin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Bronchodilator Effect of CHF1535 pMDI Versus Free Combination of Beclometasone Plus Formoterol pMDI in Asthmatic Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical study is to compare the improvement in breathing of single
      administration of CHF 1535 50/6 pMDI (fixed combination of a corticosteroid drug
      beclomethasone 50 µg + formoterol 6 µg/puff, 2 inhalations, total dose 100/12 µg) given with
      spacer versus free combination of beclomethasone 50 µg/puff pMDI (2 inhalations, total dose
      100 µg) given with spacer plus formoterol 6 µg/puff pMDI (2 inhalations, total dose 12 µg)
      given with spacer in terms of FEV1 from 0 to 12 hours in asthmatic children.

      Additionally the study aims to evaluate the effects of doses of CHF 1535 pMDI compared to
      placebo and the effect on other lung function parameters, to assess the safety and
      tolerability of CHF 1535 dosages in children.
    

Detailed description: 
      FEV1 from 0 to 12 hours standardised by time will be statistically analysed taking into
      account treatment, period and subject and pre-dose FEV1.
    

Intervention name(s): beclomethasone+formoterol 50/6 (1 inhalation); CHF 1535 50/6 (2 inhalations); CHF 1535 50/6 (4 inhalations); Formoterol + Beclomethasone dipropionate; Placebo (6 inhalations)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): CHF 1535 50/6 (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose) administered via a pMDI with spacer; CHF 1535 50/6 (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose) administered via a pMDI with spacer; CHF 1535 50/6 (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose) administered via a pMDI with spacer; Formoterol HFA pMDI 6 µg / actuation
Extrafine BDP HFA pMDI 50 µg/actuation; Matched placebo via pMDI
Other intervention name(s): CHF1535, Atimos®, Ventolair®, Ventolin®; CHF1535, Atimos®, Ventolair®, Ventolin®; CHF1535, Atimos®, Ventolair®, Ventolin®; CHF1535, Atimos®, Ventolair®, Ventolin®; CHF1535, Atimos®, Ventolair®, Ventolin®
Intervention MeSH terms: Beclomethasone; Albuterol; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phenylephrine and Hypotension During Spinal Anesthesia for Cesarean Section
Condition: Anesthesia, Obstetrical; Anesthesia, Spinal
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 2

Summary: 
      Pregnant women with a positive preoperative Supine stress test were found to be a subgroup at
      increased risk of symptomatic hypotension after spinal anesthesia
    

Detailed description: 
      Patients will be placed in dorsal decubitus dislocating the uterus to the left for a few
      minutes, with blood pressure and heart rate recorded three times, with a three-minute
      interval between measurements to obtain mean baseline levels and this will be repeated in an
      upright position to record the same measurement.Orthostatic hypotension (Orthostatic
      hypotension "OH" is defined specifically as a 20mmHg drop in systolic, and/or a 10mmHg drop
      in diastolic blood pressure within 3 minutes of standing.
    

Intervention name(s): Phenylephrine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): it will be given as a prophylaxis for prevention of hypotension after spinal anesthesia in pregnant patients undergoing cesarean section; 5 ml normal saline will be given before spinal anesthesia
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Orthostatic; Cesarean section; Pregnant; Phenyephrine; Hypotension
Safety Study of Transdermal Testosterone for Low Libido in Pre and Postmenopausal Women
Condition: Sex Behavior
Study type: Interventional
Phase: Phase 2

Summary: 
      Female sexual dysfunction (FSD) is an established side effect of Selective serotonin reuptake
      inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitors (SNRIs), causing symptoms
      such as loss of libido, arousal difficulties, or delayed orgasm or anorgasmia.

      Efficacy of testosterone therapy for the treatment of hypoactive sexual desire disorder
      (HSDD) in women has been demonstrated in studies including naturally and surgically
      menopausal women, either alone or in combination with estrogen, with or without progestin
      therapy.
    

Detailed description: 
      Recent studies have reported an increase in the number of satisfactory sexual events recorded
      in a 4-week daily diary, as a primary outcome, and reduction in associated personal distress.

      There is also evidence that testosterone therapy results in a similar improvement in sexual
      function in premenopausal women with loss of libido.

      Testosterone therapy has been associated with significantly improved well-being in studies in
      which the participants had low well-being at enrollment.

      Trials of testosterone for HSDD in women have excluded those with clinical depression, as
      well as those taking antidepressants.

      Whether testosterone will benefit women with HSDD who are taking an antidepressant is not
      known.

      The primary aim of this study was to examine the effects of transdermal testosterone therapy
      with a nanoemulsion BIOLIPID B2 on sexual function in women at midlife, who were experiencing
      treatment-emergent low libido. The primary study outcome was the change in the total score of
      the Sabbatsberg Sexual Self-rating Scale (SSS).

      In line with previous studies of women without depression, efficacy was measured by the
      change in the frequency of SSEs over 4 weeks, as well as the domains of the SSS, general
      well-being, depression, and mood status.

      In this present study these factors will be analized in 12 weeks interval
    

Intervention name(s): Biolipid B2 (blanked/placebo); Testosterone, Transdermal, Behavior
Intervention type(s): Drug; Drug
Intervention description(s): the intervention will be the comparison effects of both emulsions; Transdermal 0.5% testosterone Biolipid/B2
Other intervention name(s): Biolipid B2 0.5% testosterone, Evidence, Fortaleza, Brazil; Biolipid B2 0.5% testosterone, Pharmacom, São Paulo, Brazil; Transdermal testosterone Biolipid/B2
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Libido; Sexual Dysfunction; testosterone
Using Preoperative Anxiety Score to Determine the Precise Dose of Butorphanol for Sedation
Condition: Preoperative Anxiety; Precise Dose of Butorphanol
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Pre-operative anxiety usually lead to increased anesthetics during the surgery. The precise
      sedative requirement which can keep adequate sedative state and avoid adverse effects caused
      by excessive drugs still needs further study. Therefore, our purpose was to confirm the
      sedative effect of butorphanol and to explore the relationship between pre-operative anxiety
      and intra-operative butorphanol requirement to evaluate the precise sedative requirement
      which can keep adequate sedation for patients by pre-operative anxiety score.
    

Detailed description: 
      A total of 142 patients (aged 18-75 years) who were scheduled for elective low limb
      orthopedic procedures under spinal anesthesia were included in this study. Patients were
      divided into two groups based on pre-operative anxiety score evaluated by the Amsterdam
      pre-operative anxiety and information scale before the surgery. And intramuscular midazolam
      0.05mg/kg as a premedication in preoperative room was given to patients before shifting into
      operation room. Patients in each group were randomly divided into butorphanol group and 0.9%
      saline group. The sedation score, the duration of reaching adequate sedation state and
      postoperative recovery were recorded.
    

Intervention name(s): Butorphanol; Physiological saline
Intervention type(s): Drug; Other
Intervention description(s): intravenous loading dose of 15ug/kg butorphanol 5 mins before starting the surgery, then followed by infusion of 7.5ug/kg/h butorphanol and stopped infusion when the Ramsay sedation score (RSS) reached 4; intravenous infusion of the same volume of 0.9% saline
Intervention MeSH terms: Butorphanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: butorphanol; preoperative anxiety; sedation; recommend dose
Neurocognitive Features of Patients With Treatment-Resistant Depression
Condition: Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Observational

Summary: 
      There is an urgent need for novel and effective interventions for treatment-resistant
      depression (TRD). In previous studies, ketamine has been shown to rapidly reduce depressive
      symptoms; however, the exact mechanisms of action of ketamine remain unknown. There are some
      preliminary findings to suggest that ketamine may exert its antidepressant effects through
      promotion of neurogenesis in the dentate gyrus. The aim of this study is to help delineate
      the neurocognitive effects of ketamine exposure using a behavioral task (specifically, a
      pattern separation task) and a battery of other well-established cognitive measures.

      This is an assessment-only study, as we will be recruiting subjects to complete an assessment
      battery at two time points, before and after receiving ongoing ketamine administrations for
      at least four weeks.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligibility for participants includes those ages 18-80 years old who meet criteria for a
        moderate/severe (as indicated by a score of > 14 on the QIDS-SR) depressive episode
        (unipolar or bipolar mood disorder), have a history of at least three failed antidepressant
        trails, and are seeking non-research ketamine treatment through the ketamine clinic at
        Massachusetts General Hospital (and are deemed appropriate for treatment at the clinic.
        Participants must also be able to read, understand, and provide written informed consent in
        English.
Bioequivalence Study of Sumatriptan Succinate Tablets 100 mg in Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the relative bioavailability of Sumatriptan
      Succinate Tablets 100 mg with Imitrex Tablets 100 mg under fed conditions in healthy adult
      human subjects.
    

Detailed description: 
      Open Label, Randomized, Two way crossover, comparative evaluation of relative bioavailability
      of two formulations of Sumatriptan Succinate Tablets 100 mg (Dr. Reddy's Laboratories
      Limited, India) With the Reference Formulation Imitrex® 100 mg Tablet (Glaxosmithkline,
      USA)Under Fed Conditions in Healthy Human Adult Subjects. 50 healthy, adult, human male
      subjects were enrolled in the study and 43 subjects are completed the study.
    

Intervention name(s): Sumatriptan
Intervention type(s): Drug
Intervention description(s): Sumatriptan Succinate Tablets 100 mg
Other intervention name(s): Imitrex
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; two way crossover
Substudy of Protocol TB-018 (NCT01755598): Collection and Storage of Biological Samples for Evaluation of Correlates of TB (C-041-972)
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Observational

Summary: 
      This is an independent optional sub-study parallel to TB-018 (NCT01755598) in which
      biological samples will be collected for future investigations on biological correlates,
      markers or prognostic factors for TB disease. Subjects who consent to enroll in TB-018, "A
      phase IIb, double-blind, randomised, placebo-controlled study to evaluate the efficacy,
      safety and immunogenicity of GSK Biologicals' candidate tuberculosis (TB) vaccine GSK 692342
      (M72/AS01E) against TB disease, in healthy adults aged 18-50 years, living in a TB endemic
      region", (see NCT 01755598) will be asked to participate in this sub-study. Subjects enrolled
      in TB-018 who also consent to C-041-972 will be followed according to the TB-018 protocol but
      will have additional blood samples collected for the sub-study.
    

Detailed description: 
      Additional information in the protocol
    

Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Subjects who have consented to participate in TB-018 will be approached for participation
        in this sub-study. Subjects who have consented to participate in TB-018 are not required to
        participate in this sub-study.
      
Biospecimen description: 
      Specimens for this sub-study are collected from an interventional Phase 2 study (TB-018 see
      NCT 01755598) and later analyzed for correlates of risk to tuberculosis.

      PBMC/Plasma; Whole Blood cell count; Intracellular RNA
    
Keywords: Correlates of risk; TB; Tuberculosis; Sub-study; TB-018
Study to Evaluate the Effect of ALS-008176 on Cardiac Repolarization Interval in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the effect of supratherapeutic exposures
      of ALS-008176 on the QT/ corrected QT interval (QTc) interval in healthy participants (Panel
      2).
    

Detailed description: 
      This is a two-part Phase 1 study consisting of a dose escalation part (Part 1) and a TQT part
      (Part 2), performed in two separate panels (Panels 1 and 2). Panel 1 will be a double blind
      (neither the researchers nor the participants know what treatment the participant is
      receiving), randomized (study medication assigned to participants by chance), placebo
      controlled dose escalation study in healthy participants to determine the safety,
      tolerability and pharmacokinetics of ALS-008176 after administration of single doses of 1500
      milligrams (mg), 2500 mg and 3000 mg under fasted conditions. The final dose to be used in
      the Panel 2 will be determined based on the results of this dose escalation part. An interim
      analysis will be conducted on Panel 1 to select the dose for Panel 2. Panel 2 will be a
      double blind, double dummy, randomized, 3 period crossover (the same medications provided to
      all participants but in different sequence), placebo and positive controlled study to
      evaluate the effect of ALS-008176 on the QT/QTc interval in healthy participants.
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): ALS-008176; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive a single dose of ALS-008176 orally.; Matching Placebo will be administered.; Participants will receive a single dose of moxifloxacin 400 mg.
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetics of PN-232 in Healthy Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of
      PN-232 in healthy volunteers. It is a first-in-human (FIH) study for PN-232 that will be
      conducted in three parts. Part 1 is a single ascending dose study, Part 2 is multiple
      ascending dose study, and Part 3 is crossover solid dose comparison and effect of food study.
    

Detailed description: 
      Part 1: Approximately 32 subjects will be enrolled into 4 cohorts to receive PN-232 or
      placebo as single doses.

      Part 2: Up to 40 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo once
      daily for 10 days.

      Part 3: Twelve subjects will receive single doses of PN-232 in a 3-way, randomized, crossover
      fashion.

      In total, approximately 84 subjects will participate.
    

Intervention name(s): PN-232; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active Drug; Matching Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment