bioihbjkbjnl/mcl2 huggingface dataset:
Positions and Peripheral Oxygen Saturation
Condition: Lung Diseases
MeSH terms: Lung Diseases
Study type: Observational

Summary: 
      The subjects were placed consecutively in random order in the five different positions by
      drawing lots. Oxygen saturation (SaO2) and vital signs (pulse rate, respiratory rate,
      systolic blood pressure, diastolic blood pressure and body temperature) were measured in each
      position at 10, 25 and 40 minutes.
    

Detailed description: 
      The semi-seated position in bed at 45°: SSPB-45° The semi-seated position in bed at 60°
      :SSPB-60° Seated position in bed at 90°: SPB-90° Lying on the right side of the body at 45°:
      LRSB-45° , Lying on the left side of the body at 45°: LLSB-45°

      A questionnaire which consisted of a Subjects' Introduction Form and a Vital Signs-SaO2
      Record Form was used in collecting the data.

      The subjects were placed consecutively in random order in the five different positions,
      SSPB-45°, SSPB-60°, SPB-90°, LRSB-45°, and LLSB-45°, by drawing lots. Oxygen saturation
      (SaO2) and vital signs (pulse rate, respiratory rate, systolic blood pressure, diastolic
      blood pressure and body temperature) were measured in each position at 10, 25 and 40 minutes.
      Oxygen saturation and vital signs were measured with a finger pulse oximeter (Nellcor N-560).
      Nail polish was removed before measurement of oxygen saturation, and if there was any
      physical restraint on subjects it was removed. Body temperature was measured via the ear with
      a tympanic membrane thermometer (Covidiev Genius 2). Systolic and diastolic blood pressure
      were measured with a calibrated sphygmomanometer from the left arm with the same
      sphygmomanometer (Erka aneroid sphygmomanometer®) and stethoscope. Pulse rate and respiratory
      rate were manually monitored for a period of one minute by the researcher using a wristwatch.
      Verbal and written informed consent was obtained from the subjects or from their closest
      relatives.
    

Intervention name(s): position
Intervention type(s): Other
Intervention description(s): Subjects were placed consecutively in random order in five different positions. SaO2 and vital signs were measured at each position after 10, 25, and 40 minutes.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects who were over 18 years of age and who were able to lie in all positions, and who
        had right lung disease (n=20), left lung disease (n=21) or bilateral lung disease (n=68)
        documented by medical diagnosis by a physician were included in this descriptive study.
      
Keywords: patient positioning; lung diseases; oxygenation; hemodynamic parameters; vital signs
West Philadelphia Consortium Randomized Control Trial
Condition: Cancer; Cardiovascular Disease (CVD)
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The investigators will evaluate the effects of an integrated risk counseling program on
      behavioral and psychological outcomes in African American men and women in a randomized trial
      that is implemented and evaluated collaboratively through the West Philadelphia Consortium to
      Address Disparities. The specific aims of this research are as follows:

        1. To evaluate the effects of integrated versus disease specific counseling on risk
           exposure behaviors. The investigators predict that compared to individuals who receive
           disease specific counseling, those who receive integrated counseling will report greater
           intake of fruits and vegetables and increased rates of physical activity.

        2. To evaluate effects of integrated versus disease specific counseling on psychological
           outcomes. The investigators predict that compared to individuals who receive disease
           specific counseling, those who receive integrated counseling will report greater risk
           comprehension related to cancer and cardiovascular disease and will be more motivated to
           make behavioral changes.

        3. To identify the mechanisms through which integrated risk counseling leads to behavioral
           change. The investigators predict that changes in risk exposure behaviors (e.g., diet
           and physical activity) will be mediated by increased risk comprehension and
           self-efficacy for diet and physical activity.
    


Intervention name(s): Integrated vs Non-integrated Risk Education
Intervention type(s): Other
Intervention description(s): Integrated group receives education about risk factors for both cancer and CVD whereas the non-integrated group receives information about CVD only to assess differences in health behavior outcomes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Cancer; CVD; African American; Health Education Intervention; Intervention RCT; Study focus is to examine the influence of health education regarding either CVD or CVD and cancer on health behaviors.
Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma
Condition: Cholangiocarcinoma
MeSH terms: Cholangiocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Cholangiocarcinoma, is a malignant gastrointestinal tumor of low incidence with a poor
      prognosis. Chemotherapy is the most common treatment for advanced disease. On the basis of a
      phase III clinical study, cisplatin plus gemcitabine is considered standard first-line
      treatment in advanced cholangiocarcinoma patients, but there is no established second line
      therapy.

      Since fluorouracil and leucovorin combined with irinotecan and oxaliplatin (FOLFIRINOX)
      appears to be safe and demonstrated efficacy in clinical studies of advanced pancreatic
      cancer, colorectal cancer and a phase I study in cholangiocarcinoma, this combination could
      be an effective second-line treatment for patients with advanced cholangiocarcinoma.
    


Intervention name(s): FOLFIRINOX
Intervention type(s): Drug
Other intervention name(s): Second line treatment
Intervention MeSH terms: Folfirinox
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cholangiocarcinoma; FOLFIRINOX; Phase II study
Preoperative Anxiety Evaluation: a New Visual Smileys Scale
Condition: Anxiety, Preoperative
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      Preoperative anxiety is a complex clinical concept with both physiological and psychological
      consequences.
    

Detailed description: 
      This study looks at the need for a more user friendly, rapid tool for measuring preoperative
      anxiety, specifically by evaluating the visual smileys scale.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        200 patients undergoing surgery at Cedars Sinai Medical Center
      
Keywords: preoperative anxiety assessment; levels of preoperative anxiety using two different scales
Feasibility of Web-based CBT-I Intervention in Individuals With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Forty individuals with multiple sclerosis (MS) will be randomly assigned to a 6-week
      web-based cognitive behavior therapy for insomnia intervention (wCBT-I) or to wCBT-I plus
      biweekly support meetings with research personnel via phone or video. Questionnaires will be
      used to assess sleep quality, fatigue, and satisfaction. Recruitment, retention, attrition,
      adherence, and safety information will also be collected. This study is significant because
      addressing insomnia symptoms through CBT-I could be a low-cost, low-risk, non-pharmacological
      options for improving sleep quality and MS symptoms in individuals with MS. This study is
      innovative because CBT-I has never been delivered via a web-based application to individuals
      with MS which may increase access to services.
    


Intervention name(s): Cognitive behavioral therapy for insomnia; Cognitive behavioral therapy for insomnia + biweekly support
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The web-based CBT-I program is a 6-week interactive, online program that delivers typical CBT-I treatment techniques of stimulus control, sleep restriction, behavioral modifications, and cognitive restructuring.; Individuals randomized into the CBT-I + biweekly support will participate in CBT-I as described as well as a biweekly phone call or video call with research personnel for motivational interviewing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study for Validation of In-vitro Turbidometric Platelet Aggregation Assay Using Human Blood in Healthy Volunteers
Condition: Validation of In-vitro Turbidometric Platelet Aggregation Assay
Study type: Observational

Summary: 
      This study is designed for validation of in-vitro platelet aggregation assay using human
      blood in healthy volunteers. 32ml blood, 2ml for complete blood count test and 30ml for
      platelet aggregation assay, was collected from ten subjects, respectively.

      Preparation of Platelet Rich Plasma (PRP):

        1. Collect human blood using 21g butterfly syringe and dilute 9:1 into 3.8% sodium citrate
           vacutainer vials.

        2. Prepare platelet rich plasma (PRP) by centrifuging blood at 100 x g for 15 minutes at
           room temperature. Using a plastic transfer pipette, carefully transfer and combine PRP
           from multiple vacutainer tubes (if required) into a 15 mL conical tube.

        3. PRP is removed re-centrifuge remaining blood in vacutainer tubes at 2000 x g for 15
           minutes at room temp. to obtain platelet poor plasma (PPP). Transfer PPP to 15 mL
           conical tube.

        4. Measure platelet count in combined PRP using Z1 Coulter Particle Counter or similar
           product. Adjust platelet count to a final concentration of 300,000 +- 10,000 platelets
           in PRP using PPP.

      Aggregation Measurement:

      Aggregation is measured using a model 490-X Chrono-Log Aggregometer or similar product. PPP
      is used as a reference to establish 100% optical transmission.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adult voulteers
Inspiratory Flow and Volumes in Bronchiectatics
Condition: Bronchiectasis
MeSH terms: Respiratory Aspiration; Bronchiectasis
Study type: Observational

Summary: 
      Adequate administration of drugs via dry powder inhalers is dependent on adequate inspiratory
      flow rates and volumes. These vary according to the device being used and its resistance. The
      dry powder inhaler device under investigation is a device approved by the Therapeutic Goods
      Administration (ARTG no. 196255) for use with dry powder mannitol. Dry powder mannitol is
      currently being investigated as a treatment for bronchiectasis. We wish to measure the
      inspiratory flow characteristics of both the low and high resistance devices amongst a group
      of subjects with bronchiectasis.

      We propose that the majority of subjects investigated with varying lung function will achieve
      adequate flow during a controlled inspiration.
    


Sampling method: Non-Probability Sample
Study population: 
        subjects aged 18-80 years, with bronchiectasis and FEV1 greater or equal to 50% predicted
        and greater or equal to 1L
      
Keywords: measure inspiratory spirometry with dry powder inhaler device in series with the spirometer
A Study to Determine the Bioequivalence of Alogliptin and Pioglitazone When Administered as Individual Tablets and as Fixed-Dose Combination (FDC)-SYR-322-4833 BL Tablets to Healthy Russian Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the relative bioavailability and bioequivalence of 2
      strengths of the FDC tablet product SYR-322-4833 BL compared to the individual alogliptin and
      pioglitazone tablets in healthy Russian participants.
    

Detailed description: 
      The drug being tested in this study are called Incresync (SYR-322-4833 BL), alogliptin, and
      pioglitazone. This study will assess the bioequivalence, pharmacokinetics (PK), and safety of
      alogliptin and pioglitazone administered as individual tablets and as the FDC tablet product
      in healthy volunteers.

      The study will enroll approximately 72 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to one of the 4 treatment sequences to receive one of the
      following treatments:

        -  Regimen A: SYR-322-4833 BL (25 mg + 15 mg)

        -  Regimen B: Alogliptin 25 mg + pioglitazone 15 mg

        -  Regimen C: SYR-322-4833 BL (25 mg + 30 mg)

        -  Regimen D: Alogliptin 25 mg + pioglitazone 30 mg

      All participants will be asked to take single dose of study medication on Day 1 of each
      intervention period.

      This single center trial will be conducted in Russia. The overall time to participate in this
      study is 66 days. Participants will make multiple visits to the clinic, and will be contacted
      by telephone 14 days after their last dose of drug for a follow-up assessment.
    

Intervention name(s): Alogliptin; Pioglitazone; SYR-322-4833 BL
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Alogliptin tablets.; Pioglitazone tablets.; SYR-322-4833 BL FDC tablets.
Other intervention name(s): Incresync
Intervention MeSH terms: Pioglitazone; Alogliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug therapy
VEGF Receptor Tyrosine Kinase Inhibitor Axitinib in Children With Recurrent or Refractory Solid Tumors
Condition: Refractory or Recurrent Solid Tumors, Excluding CNS Tumors
MeSH terms: Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will be the first study of axitinib in children and adolescents. The primary
      objective of this Phase 1 trial is to determine a maximum tolerated dose (MTD) or recommended
      Phase 2 dose (RP2D) of axitinib in pediatric patients with refractory solid tumors.
      Additional objectives include measurement of pharmacokinetic and pharmacodynamic parameters,
      description of the toxicity profile of this agent in children and adolescents, and assessment
      of response within the confines of a Phase 1 trial. A standard rolling 6 design will be used
      for dose escalation. Further development of axitinib will focus on development of a joint
      cooperative group (COG/ECOG) Phase 2 study of axitinib in pediatric, adolescent and young
      adult translocation renal cell carcinoma.
    


Intervention name(s): Axitinib
Intervention type(s): Drug
Other intervention name(s): AG-013736, INLYTA®
Intervention MeSH terms: Axitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of 14-day Multiple Dose Titrations of TS-134 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study involving multiple dose titrations of TS-134 in healthy male and
      female subjects. The safety, tolerability and pharmacokinetics of multiple dose titrations of
      TS-134 will be evaluated.
    


Intervention name(s): TS-134; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg to 80 mg oral solution; Matched Placebo oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: TS-134, multiple dose, titration
Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-containing Solutions in Post-Surgical Dental Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to evaluate the therapeutic efficacy and safety of two different
      paracetamol-containing solutions in postoperative dental pain. They will be compared to
      placebo (a dummy treatment which contains no active ingredient).
    


Intervention name(s): Paracetamol (acetaminophen) solution experimental; paracetamol (acetaminophen) solution commercial; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 gm IV; 1 gm IV; equivalent volume IV 0.9% sodium chloride (equivalent volume)
Other intervention name(s): paracetamol; acetaminophen; paracetamol; acetaminophen; sodium chloride; saline
Intervention MeSH terms: Acetaminophen; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain, postoperative; surgery, oral; surgery, dental
Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind placebo-controlled study investigating the acute and persisting
      effects of psilocybin on meditation, spirituality, health, well-being, prosocial attitudes,
      and brain functioning.
    

Detailed description: 
      This study will use questionnaires and functional magnetic resonance imaging (fMRI) to
      examine the acute and persisting effects of psilocybin on brain function, meditation,
      spirituality, and psychology. The majority of the study procedures -- including screening,
      preparatory meetings, placebo and psilocybin sessions, and a large battery of behavioral and
      psychological measures -- will be conducted at the investigator's laboratory at the
      Behavioral Pharmacology Research Unit (BPRU) on the Johns Hopkins Bayview campus. The brain
      imaging procedures will be conducted at F.M. Kirby Research Center at the Kennedy Krieger
      Institute (KKI).
    

Intervention name(s): Moderately-high dose of psilocybin; Moderately-low dose of psilocybin; Very-low dose of psilocybin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral dose of a moderately-high dose of psilocybin.; Oral dose of a moderately-low dose of psilocybin.; Oral dose of a very-low dose of psilocybin.; An oral placebo (lactose pill).
Other intervention name(s): O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine; O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine; O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine; Lactose
Intervention MeSH terms: Psilocybin; N,N-Dimethyltryptamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Psilocybin; Hallucinogens; Pharmacologic Actions; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs
Combined Rg3-enriched Korean Red Ginseng and American Ginseng in the Management of Hypertension in Type 2 Diabetes
Condition: Diabetes Mellitus Type 2; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study is a combined Phase-I like (safety) and Phase-II like (efficacy) double blind
      randomized placebo controlled trial. The objective is to investigate whether the combination
      of AG and Rg3-enriched Korean Red ginseng added to conventional medical treatment are
      effective and safe in the long-term management of high blood pressure while managing type 2
      diabetes. Eighty-five subjects with type 2 diabetes and concomitant high blood pressure (key
      inclusion criteria: HbA1c ≥ 6.5%- ≤ 8.0%) will be recruited for the study.
    


Intervention name(s): Ginseng; Wheat Bran
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2.25g of encapsulated ginseng (1.5g American Ginseng and 0.75g Rg3-enriched Korean Red Ginseng)will be administered in 6 identical capsules, 2 capsules with each meal (total 6 capsules per day).; 2.25g of encapsulated 100% natural wheat bran will be administered in 6 identical capsules, 2 capsules with each meal (total 6 capsules per day).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Early Physiotherapy on Biochemical Parameters in Major Burn Patients: A Burn Center's Experience
Condition: Burns; Physiotherapy; Exercises
MeSH terms: Burns
Study type: Interventional

Summary: 
      Background: This study planned to investigate the effect of early physiotherapy on
      biochemical parameters in major burn patients.

      Methods: Ten women (50%) and 10 men (50%) aged 21-47 years old were included in our study.
      Participants were divided into two groups: one group was the treatment group and the other
      was the control group. In the treatment group, patients were admitted to the physiotherapy
      programme from the first day they have been hospitalised, in addition to their routine
      treatment (medical, surgery, etc.), for 4 days per week. It consisted of parameters such as
      early mobilisation and ambulatory training, chest physiotherapy, and both active and passive
      normal joint movement exercises. The days of treatment were determined as Tuesday, Wednesday,
      Thursday and Friday. Patients could not be treated on a Monday because that was surgery day.
      The control group consisted of patients who could not receive physiotherapy due to various
      reasons. All patients included in the study were evaluated weekly for 6 weeks after admission
      to the hospital. Parameters such as demographic information, characteristics of burn injury,
      C-reactive protein, fibronectin, transferrin and prealbumin were evaluated.
    


Intervention name(s): Burn Physiotherapy Protocol
Intervention type(s): Other
Intervention description(s): It consisted of parameters such as early mobilisation and ambulatory training, chest physiotherapy, and both active and passive normal joint movement exercises.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fibronectin; Prealbumin; Physiotherapy; Major Burns; biochemical parameters