bioihbjkbjnl/mcl2 huggingface dataset:
Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein
Condition: Chemotherapy-induced Neutropenia
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the dosages of recombinant human serum
      albumin/granulocyte colony-stimulating factor fusion protein by injection for preventing
      neutrophilic granulocytopenia among chemotherapy patients.

      Conduct Pharmacokinetics (PK) study on recombinant human serum albumin/granulocyte
      colony-stimulating factor fusion protein with recombinant human granulocyte
      colony-stimulating factor injection as a control.
    

Detailed description: 
      -  Brief Protocol: Treat the patients taking Taxotere+Epirubicin+Cyclophosphamide (TEC)
           treatment or Taxotere+Epirubicin (TE) treatment chemotherapy with the study medicine or
           positive control during the period between two chemotherapy treatments.

        -  Positive control：recombinant human granulocyte colony-stimulating factor injection.

        -  Targeted patients: breast cancer

        -  Grouping: Group 1: 1.2 mg recombinant human serum albumin/granulocyte colony-stimulating
           factor fusion protein with TEC or TE treatment; Group 2: 1.5 mg recombinant human serum
           albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment;
           Group 3: positive control with TEC or TE treatment.

        -  Number of patients: 216

        -  Concomitant medicines will be conducted.
    

Intervention name(s): HSA-GCSF 1.2 mg; HSA-GCSF 1.5 mg; GCSF
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Human Serum Albumin GCSF 1.2mg at day 3 and Day 7; Human Serum Albumin GCSF 1.5 mg at day 3 and Day 7; GCSF 5 mcg/kg/day
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Predicting the Outcomes of Labor Induction
Condition: Induction of Labor Affected Fetus / Newborn
Study type: Observational

Summary: 
      Pre induction assessment using bishop scoring system and Manipal cervical scoring system
      performed on 105 pregnant females
    

Detailed description: 
      preinduction cervical assessment using The Burnett modification of Bishop score with

        1. Cervical dilatation in centimeters will be given a score of zero if dilatation less than
           1cm, a score of 1 if 1-2 cm dilated, a score of 2 if more than 2 cm dilataion.

        2. Length of the cervix will be given a score of zero if more than 2 cm, a score of 1 if
           1-2 cm, a score of 2 if less than 1 cm.

        3. Station of fetal head will be given a score of zero if -2 or higher , a score of 1 if
           -1, a score of 2 if zero or lower.

        4. Consistency of the cervix will be given a score of zero if firm, a score of 1 if soft
           and a score of 2 if soft and stretchable.

        5. Position of the cervix will be given a score of zero if posterior, a score of 1 if mid
           position and a score of 2 if anterior. So, a total score (sum of all scores) of zero at
           a minimum to 10 at a maximum can be estimated.

      and also preinduction cervical assessment using transvaginal ultrasound and Manipal system
      where:

        1. Length of the cervix will be given a score of zero if more than 3 cm, a score of 1 if
           2-3 cm, a score of 2 if less than 2 cm.

        2. Length of the funnel will be given a score of zero if absent, a score of 1 if ≤ 0.5 cm,
           a score of 2 if more than 0.5 cm.

        3. width of the funnel will be given a score of zero if absent, a score of 1 if ≤ 0.5 cm, a
           score of 2 if more than 0.5 cm.

        4. cervical position and shape will be given a score of zero if curved, a score of 2 if
           straight

        5. Distance of presenting part to external os will be given a score of zero if more than 3
           cm, a score of 1 if 2-3 cm, a score of 2 if less than 2 cm
    

Intervention name(s): Manipal cervical scoring system
Intervention type(s): Diagnostic Test
Other intervention name(s): The Burnett modification of Bishop score
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        105 females with singleton term pregnancy undergoing induction of labor
Perfusion Index as an Objective Measure for Supraclavicular Brachial Plexus Block in Pediatric Patients
Condition: Supraclavicular Brachial Plexus Block
Study type: Observational

Summary: 
      The aim of the present study is to evaluate the effects of supraclavicular brachial plexus
      block using perfusion index in pediatric patients undergoing Upper limb surgery.
    

Detailed description: 
      The role of perfusion index in the prediction of peripheral block success was previously
      reported for infraclavicular brachial plexus block, axillary brachial plexus block,
      interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients.
      The aim of the present study is to assess the effects of perfusion index on success of
      supraclavicular brachial plexus block in pediatric patients.
    

Intervention name(s): perfusion index
Intervention type(s): Device
Intervention description(s): perfusion index in the prediction of peripheral block success was previously reported for infraclavicular brachial plexus block, axillary brachial plexus block, interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ASA physical status I-II,Age 1 month-12 year,Children undergoing Upper limb surgery.
      
Keywords: perfusion index; supraclavicular brachial plexus block; children
Clinical Assessment Of Association Pharmacokinetics Atorvastatin + Losartana + Hydrochlorothiazide
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this clinical study, randomized, crossover is to evaluate the
      pharmacokinetic profile of the polypill (atorvastatin + lorsatana + hydrochlorothiazide)
      Laboratory Hypermarcas S / A, in relation to drugs Citalor ® (atovastatina - Pfizer) and
      Hyzaar ® (losartan + hydrochlorothiazide - Merck Sharp & Dohme) by comparing the serum
      concentration of analytes unchanged (AT, LS and HCTZ) in healthy subjects.
    

Detailed description: 
      The pharmacokinetic profile of the drug will also be assessed by comparing the serum
      concentration of active metabolites following:

        -  O-hydroxy atorvastatin (2-Hydroxy atorvastatin, O-HAT): metabolite of AT

        -  carboxylic acid (E-3174, LS-CA): active metabolite of LS
    

Intervention name(s): Atorvastatin; Hydrochlorothiazide + Losartan; Hydrochlorothiazide + Losartan + Atorvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg; 12.5 mg + 50 mg; 12.5 mg + 50 mg + 10 mg
Other intervention name(s): Citalor; Hyzaar; Polipílula
Intervention MeSH terms: Losartan; Hydrochlorothiazide; Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study in Healthy Male Volunteers to Investigate Different Doses of a New Drug for the Treatment of Metabolic Diseases
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of the study is to see how safe SRT3025 (study drug) is when given at
      different doses. The study will also investigate how the study drug is taken up, metabolised
      (chemically broken down), distributed through the body and excreted. A further aim is to look
      at how taking the study drug after eating might change this process.
    

Detailed description: 
      SRT3025 is being developed for the treatment of metabolic diseases. This study is the first
      administration of SRT3025 in humans and seeks to establish the initial safety, tolerability,
      and pharmacokinetic (PK) profile of SRT3025 (and any metabolites, if analyzed) before
      proceeding to future Phase 1 studies or Phase 2 patient studies.

      This protocol details a Phase 1, randomized, placebo-controlled, single-blind, dose
      escalation study to determine the safety, tolerability, and PK profile of SRT3025 in healthy
      male subjects. The study will be conducted in two parts. In Part 1A, 6 Cohorts of subjects
      will receive single escalating doses of SRT3025. In Part 1B, an additional one to two cohorts
      may be enrolled to investigate the effect of a moderate fat/calorie meal on single dose PK
      endpoints. In Part 2A, up to three cohorts may be enrolled to receive 14-day repeat doses of
      SRT3025 chosen from the Part 1A safety, tolerability, and PK data. In Part 2B, one to two
      additional cohorts may receive 14-day repeat doses of SRT3025 in combination with a moderate
      fat/calorie meal.
    

Intervention name(s): SRT3025; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SRT3025 will be supplied as hard gelatin capsules containing either 27.4 mg (25 mg SRT3025 free base equivalent) or 274 mg (250 mg SRT3025 free base equivalent) of SRT3025 HCl monohydrate drug substance.; For placebo product, the SRT3025 drug substance will be replaced by Microcrystalline Cellulose (Avicel® PH 105) to match the SRT3025 investigational product.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Expanded Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      PainQx is conducting a study to collect electroencephalography (EEG) data from 250 people
      with chronic pain and 50 healthy controls in order to develop algorithms that will
      objectively assess the level of pain a person is experiencing.
    


Intervention name(s): ALGOS System
Intervention type(s): Diagnostic Test
Intervention description(s): A Quantitative Electroencephalography (QEEG) based pain biomarker assessment that scales with patient reported Numeric Rating Scale (NRS)
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Two hundred fifty (250) male and female pain patients with symptoms in excess of 3 months
        duration (per the IASP definition of Chronic Pain) between the ages of 18-85 years will be
        enrolled in this phase of the study. Fifty (50) healthy normal subjects between the ages of
        18-85 years will also be enrolled. The normal subjects are added to assure that the study
        spans the entire pain scale including those with an NRS of 0.
Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function
Condition: Cognitive Impairment; Estrogen Deficiency; Menopause; Endothelial Dysfunction; Vascular Stiffness
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Complaints about memory and thinking are common in women as they go through menopause. The
      female hormone estrogen is important for both the health of both the brain and the blood
      vessels. In Alzheimer's disease there is damage to the blood vessels in the brain. This study
      will look at how the loss of the female hormone estrogen affects brain function and the
      health of blood vessels.
    


Intervention name(s): GnRHant + E2; GnRHant + Placebo
Intervention type(s): Other; Other
Intervention description(s): GnRH antagonist with estradiol add-back; GnRH antagonist with placebo add-back
Other intervention name(s): Degarelix acetate, Firmagon + Estradiol, Climara transdermal system; Degarelix acetate, Firmagon
Intervention MeSH terms: Estradiol; LHRH, N-acetyl-(4-chlorophenylalanyl)(1)-(4-chlorophenylalanyl)(2)-tryptophyl(3)-arginyl(6)-alanine(10)-
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: cognitive impairment; menopause; estrogen; functional MRI; executive function; endothelial function; arterial stiffness
Study of KD026 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare the safety, tolerability and efficacy of the combination of KD026 and
      metformin compared to placebo and metformin on improving glycemic control in patients with
      type 2 diabetes mellitus.
    


Intervention name(s): KD026; Placebo; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dosed in combination; Dosed in combination; Drug prescribed by each subject's prescribing physician
Other intervention name(s): SLx-4090
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants
Condition: Iron Deficiency Anemia; Infectious Diseases; Undernutrition
MeSH terms: Communicable Diseases; Infections; Anemia, Iron-Deficiency; Iron Deficiencies; Malnutrition
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the program is to examine the efficacy of 6 month home micronutrient
      supplementation in Bedouin and Jewish children on improvements in nutritional status
      including measures of iron, ferritin, zinc and folic acid, and measures of growth and health
      parameters i.e.reported and recorded morbidity.
    

Detailed description: 
      The high level of anemia persists in Negev children despite the existence of a policy of the
      Ministry of Health that calls for Iron, Vitamin A and Vitamin D supplementation up to 12
      months of age. In addition, other micronutrient deficiencies in this population have been
      described in several studies. These may be related to; low adherence with existing
      recommendations; need for additional micronutrients other than Iron, Vitamin A and Vitamin D;
      the need for a different delivery system more acceptable to mothers and infants.

      We will compare in Bedouin and Jewish children separately the efficacy of daily use of
      Sprinkles(home Micronutrient fortification) from age 6 to 12 months in infants recruited in
      Maternal and Child Health clinics.

      The comparison will be children recruited in clinics of comparable socioeconomic status,
      where current Ministry of Health recommendations (drops of iron and vitamins A plus D) are
      the treatment regimen.
    

Intervention name(s): Sprinkles; Ferripel-3, Vitamins A&D drops
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily dosage of fat coated iron (desote fumarate) 12.5 mg, zinc 5mg, vitamin A 300 micrograms, folic acid 150 micrograms, ascorbic acid 50 mg.; Daily dosage of Iron tonic 15mg, vitamins A 300 micrograms, vitamin D 10 micrograms once a day from age 6 months up to age 12 months
Other intervention name(s): oral drops
Intervention MeSH terms: Vitamin D; Vitamin A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Clinical trial, controlled; Micronutrients; Dietary Supplementation; Infants
Study to Assess the Acceptability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Pediatric Participants, Using Matching Placebo Tablets
Condition: HIV-1
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the ability to swallow the scored film-coated
      darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination
      (FDC) tablet, irrespective of the mode of intake (whole and split tablet).
    

Detailed description: 
      This study will be performed in 24 human immunodeficiency virus type 1 (HIV-1) infected
      pediatric participants. This study is being conducted to obtain data needed to assist in
      further pediatric development of D/C/F/TAF by assessing the acceptability of the scored
      film-coated D/C/F/TAF FDC tablet administered as a matching placebo tablet in a pediatric
      population. At Day 1, each participant will sequentially take 2 placebo tablets and the
      sequence of placebo tablet, swallowed whole or as split tablet, is assigned by computer
      generated randomization. After each intake period (within 15 minutes and before the next
      intake period, as applicable), participants will be asked to fill out an acceptability
      questionnaires. Every attempt should be made for the participant to complete the
      questionnaire (marking the correct box to correspond with their impact of taking the placebo
      tablet). Caregivers may explain the wording/text in the questionnaire to aid in completion.
      If a participant and his or her caregiver have difficulties in completing the questionnaire,
      then the study-site personnel may assist. Primarily ability to swallow the scored film-coated
      D/C/F/TAF FDC tablet, irrespective of the mode of intake will be assessed. Participants
      safety will be evaluated throughout the study from signing of the Informed Consent Form
      (ICF)/Assent Form onwards until the last study-related visit.
    

Intervention name(s): D/C/F/TAF FDC placebo
Intervention type(s): Drug
Intervention description(s): Participants will receive matching placebo tablet (whole and split) of D/C/F/TAF 675/150/200/10 mg FDC on Day 1 as intake period 1 and intake period 2.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Sex Differences in Attentional Bias in Marijuana-dependent Individuals
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      The purpose of this study is to explore sex differences in cognitive functioning and
      responses to marijuana-related items, and to determine whether stress impacts these measures.

      Hypothesis 1: Attentional bias will be greater for marijuana cues in male marijuana-dependent
      subjects relative to female marijuana-dependent or non-dependent male controls.

      Hypothesis 2: Marijuana-dependent females will exhibit greater stress-induced changes in
      attentional bias and cognitive functioning than marijuana-dependent males.
    

Detailed description: 
      Ample evidence implicates both environmental cues and negative affective states in
      maintaining drug use or triggering relapse. However, although 'craving' is believed to drive
      continued drug use, it is not well understood how cognitive processes influence craving and
      relapse, nor how they may differ between the sexes. Therefore, the goal of this study
      protocol is to provide insight into sex differences in the cognitive aspects of drug craving
      and to assess the impact of stress on attentional bias for drug-related cues as well as on
      the availability of cognitive resources.
    

Intervention name(s): Cognitive stressor
Intervention type(s): Other
Intervention description(s): The Paced Auditory Serial Addition Task (PASAT-C), has been modified for use as a computerized laboratory-based stressor. Single digits are presented, and the patient must add each new digit to the one immediately prior to it and click on the appropriate answer. Failure to do so in the allotted time results in a noxious error sound.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: marijuana; dependence; cognition; stress
Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Safety.
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to prove the safety in normal conditions of useof the product
      Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).
    


Intervention name(s): Lactic Acid
Intervention type(s): Drug
Intervention description(s): Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
The Effect of Eye Movement Desensitization and Reprocessing Intervention in Hypertension Patient.
Condition: Eye Movement Desensitization and Reprocessing Intervention; Blood Pressure; Heart Rate Variability; Anxiety
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Eye Movement Desensitization and Reprocessing intervention may improve anxiety, depression,
      systolic blood pressure and heart rate variability in patients with hypertension.
    


Intervention name(s): Eye Movement Desensitization and Reprocessing
Intervention type(s): Behavioral
Intervention description(s): Effects of Eye Movement Desensitization and Reprocessing on Anxiety, Depression, Quality of Life, Blood Pressure and Heart Rate Variability in Patients with Hypertension.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Preoperative Nutritional Status and Postoperative Acute Kidney Injury
Condition: Postoperative Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Observational

Summary: 
      There is a high prevalence of postoperative acute kidney injury (AKI) in patients who undergo
      intra-abdominal surgery, and it is particularly common in the elderly. Identifying high-risk
      patients for postoperative AKI early can facilitate the development of preventive and
      therapeutic management strategies.

      The goal of this retrospective study is to investigate the predictive value of preoperative
      nutritional status, as measured by three scoring systems - the geriatric nutritional risk
      index (GNRI), prognostic nutritional index (PNI), and controlling nutritional status (CONUT)
      score - on postoperative AKI in elderly patients undergoing major abdominal surgery.
    


Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Elderly patients (aged ≥ 65 years) who underwent a major abdominal surgery under general
        anesthesia at Tongji Hospital between July 2018 and December 2021 were included in our
        study.