bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of KADIAN 100 mg When Dosed With Alcohol Under Fasting and Fed Conditions Compared to Water
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the single-dose relative bioavailability of
      Alpharma Branded Products Division Inc. (KADIAN) 100 mg morphine sulfate extended-release
      capsules when dosed with alcohol under fasting and fed conditions compared to water.
    

Detailed description: 
      This study was to evaluate the effect of consumming alcohol on the pharmacokie and
      bioavailability of Alpharma Branded Products Division Inc. (KADIAN) 100 mg morphine sulfate
      extended-release capsules under fasting and fed conditions.

      In addition, the pharmacokinetics of an immediate release solution following a 20 mg dose was
      assessed for informational purposes and for possible modeling.
    

Intervention name(s): KADIAN Capsule + alcohol (under fasting conditions); KADIAN Capsule + water (under fasting conditions); morphine sulfate IR oral solution + water; KADIAN Capsule + alcohol (under fed conditions)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL; Capsules 100mg + 240 mL in 4 shots of 60 mL; Morphine sulfate IR oral solution + water (under fasting conditions); Capsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL
Other intervention name(s): Kadian; Kadian; Morphine sulfate; Kadian
Intervention MeSH terms: Ethanol; Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: KADIAN; morphine; alcohol; water; solution; fed; fasting
A Study of RC48-ADC in Subjects With HER2-Positive Advanced Malignant Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I Study to Evaluate the Safety,Tolerability and Pharmacokinetics of RC48-ADC for
      Injection in Subjects With Advanced Malignant Solid Tumors With HER2-positive
    


Intervention name(s): RC48-ADC
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Role of Vit-D Supplementation on BioNTech, Pfizer Vaccine Side Effect and Immunoglobulin G Response
Condition: COVID-19 Respiratory Infection
MeSH terms: COVID-19; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this clinical trial study is to investigate the role of anthropometric indices
      and Vit-D supplementation on BioNTech, Pfizer vaccine side effect and immunoglobulin G
      response against SARS-CoV-2 in individuals infected with COVID-19.

      The main question[s] it aims to answer are:

        1. BMI has role in reduce BioNTech, Pfizer vaccine side effect

        2. BMI has role in improve IgG titer

        3. Vit-D supplementation has role in reduce BioNTech, Pfizer vaccine side effect

        4. Vit-D supplementation has role in improve IgG titer
    

Detailed description: 
      The intervention group received 600IU of vitamin D supplements every day, one hour after
      breakfast, for 14-16 weeks. The control group took a placebo prepared with the same shape and
      size of supplements. The supplement was given to the patients by someone other than the
      researcher, to ensure that the researchers did not know which group receiving the
      supplement/placebo (given the double-blindness of the study). Also, in this study, the person
      who did the data analysis did not aware of randomization. at first, a 3-day recall food
      questionnaire was taken from two groups. From the day, the subjects tested positive, they
      were asked to start supplementation for 4 weeks and return after that to take the first dose
      of the vaccine. Subjects were asked to continue to use supplements after the first
      vaccination. After 6 to 8 weeks, patients came back for another vaccination dose and were
      again asked to use the supplement for 4 weeks again, after that subjects were asked to come
      for a blood test.
    

Intervention name(s): Vitamin-D
Intervention type(s): Combination Product
Intervention description(s): The intervention group received 600IU of vitamin D supplements every day, one hour after breakfast for 14-16 weeks.
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Vitamin D, Immunoglobulin G, COVID-19 vaccine, Side effects
Early Intervention for Children at Risk for Anxiety
Condition: Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The aim of this study was to develop and pilot a cognitive-behavioral therapy (CBT)
      parent-child intervention for 4-7-year-old children at risk for anxiety disorders. The
      20-session intervention was first piloted openly in 9 children (between 3/10/98 and
      1/1/2001). The intervention was then tested in 65 children in a randomized controlled trial
      versus a monitoring-only wait-list control condition. Children had to either have an anxiety
      disorder, behavioral inhibition, or be the offspring of a parent with an anxiety disorder who
      had elevated symptoms of anxiety. In practice all children but one had at least one anxiety
      disorder at baseline. Children were blocked on presence or absence of parental anxiety
      disorder and randomized to the intervention or to a no-intervention wait-list control group.
      The intervention consisted of 6 parent-only sessions, 8-13 child-parent sessions, and a final
      parent session. Post-trial assessments were conducted at six months, and at one-year
      follow-up. The hypotheses were that the children assigned to the intervention group would
      show significantly better improvement (measured via Clinician Global Impression-Anxiety
      Improvement scale and absence of anxiety disorders) than children assigned to the wait-list
      condition.
    


Intervention name(s): "Being Brave: A Program for Coping with Anxiety for Young Children and Their Parents."
Intervention type(s): Behavioral
Intervention description(s): This is a cognitive-behavioral intervention modeled loosely after Kendall's "Coping Cat," which includes 7 parent-only sessions and 8-13 child-only sessions. It focuses on helping parents learn strategies for coaching their child in coping with anxiety, and on teaching the child coping skills and carrying out exposure exercises in session and in parent-child homework assignments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive behavioral therapy; Anxiety; Preschoolers; Young Children; Parents; At-risk; Behavioral Inhibition
Bioequivalence Study of Divalproex Sodium DR Tablets 500 mg of Dr. Reddy's Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioavailability of Divalproex Sodium DR Tablets
      500 mg versus Depakote DR 500 mg tablets with a washout period of 10 days in healthy
      subjects.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, bioequivalence study of Divalproex sodium DR 500 mg tablets of Dr.Reddy's
      Laboratories Limited, Generics, India comparing with that of Depakote® DR (containing
      Divalproex sodium) 500 mg tablets of Abbott Laboratories PR Ltd., Barceloneta, PR, in
      healthy, adult, human subjects under fed conditions.
    

Intervention name(s): Divalproex Sodium
Intervention type(s): Drug
Intervention description(s): Divalproex Sodium DR Tablets 500 mg
Other intervention name(s): Depakote DR 500 mg Tablets
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Divalproex Sodium
A Study to Evaluate the Effectiveness and Safety of CNTO6785 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Chronic Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the effect of CNTO6785 compared with placebo in
      participants with moderate to severe Chronic Obstructive Pulmonary Disease.
    

Detailed description: 
      This is a multi-center, randomized (study medication is assigned by chance),
      placebo-controlled (effect of the study medication will be compared with the effect of
      placebo [inactive substance]), double-blind (neither physician nor participant knows the
      treatment that the participant receives), parallel-group study (each group of participants
      will be treated at the same time). This study consists of 3 phases: a screening phase (within
      3 weeks prior to the start of study medication), a treatment phase (12 weeks), and a
      follow-up phase (12 weeks after the last administration of study medication). Approximately
      170 participants will be enrolled in this study to receive CNTO6785 or placebo in 1:1 ratio.
      Safety will be evaluated by the assessment of adverse events, vital signs, 12-lead
      electrocardiogram, physical examination, early detection of active tuberculosis, and clinical
      laboratory tests which will be monitored throughout the study. The total duration of study
      participation for a participant will be 30 weeks.
    

Intervention name(s): CNTO 6785; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CNTO 6785 (6 mg/kg) will be administered by intravenous (into a vein) infusion on Weeks 0, 2, 4, 8 and 12. Participants who weigh more than 100 kg will receive a dose of 600 mg of CNTO 6785.; Sterile, 5 percent dextrose will be used as the placebo in this study. Placebo will be administered by intravenous infusion on Weeks 0, 2, 4, 8 and 12.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulmonary Disease, Chronic Obstructive; Moderate to Severe Chronic Obstructive Pulmonary Disease; CNTO 6785; Placebo
Utility of Postoperative Bracing
Condition: Postoperative Bracing for Spinal Deformity
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      The study is being done to assess if the use of bracing helps improve quality of life of
      patients that are undergoing a spinal fusion for deformity.

      If the participant agrees to be in this trial they will be randomly assigned (like the flip
      of a coin) to receive either brace treatment or non-brace treatment.

      Regardless of what treatment group the participants are in, they will undergo surgery as
      planned. After surgery, patients in both groups will be treated per standard of care.
    


Intervention name(s): Thoracolumbosacral (TLSO) brace; No Bracing
Intervention type(s): Other; Other
Intervention description(s): Patients will be required to wear the TLSO brace when out of bed, beginning on postoperative day 2 through 6 week follow-up period.; Participants will not wear a brace in the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Thoracolumbosacral (TLSO) brace; Lumbosacral orthotic (LSO) brace; Adult spinal deformity; Postoperative Brace
Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine
Condition: Pneumococcal Vaccines
Study type: Interventional
Phase: Phase 1

Summary: 
      A first-in-human, Phase 1 trial to evaluate safety, tolerability, and immunogenicity of
      Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25)
    

Detailed description: 
      A first-in-human, multicenter, randomized, active-controlled, observer-blind Phase 1 study of
      IVT PCV-25 designed to evaluate the safety, tolerability, and immunogenicity of the vaccine.
      Adult subjects will be randomized 1:1 to receive either IVT PCV-25 or Prevnar 20™.
    

Intervention name(s): IVT PCV-25; PCV 20
Intervention type(s): Biological; Biological
Intervention description(s): 25 valent pneumococcal conjugate vaccine; 20 valent pneumococcal conjugate vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single center, randomized, active-controlled, observer-blind Phase 1study in which adults were randomized in a 1:1 ratio to evaluate safety and tolerability of IVT PCV 25 to comparator.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTab™ in Patients Undergoing an Elective Abdominal Liposuction Procedure
Condition: Sedation; Anxiety; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of a study medication
      that contains a combination of a pain medication, sufentanil, and a sedative, triazolam. This
      drug is being designed to provide mild sedation as well as reduce anxiety and pain before and
      during a procedure (in this case elective abdominal liposuction).
    


Intervention name(s): Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03); Placebo NanoTab™
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™; Single dose of sublingual placebo NanoTab™
Intervention MeSH terms: Sufentanil; Triazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: procedural sedation
Effects of a Dietary Supplement Containing Salacia Extract, Citrus Bioflavonoids, and Trivalent Chromium on Markers of Glucose Control
Condition: Glucose Intolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      This study was a double-blind, randomized, placebo-controlled, clinical trial with two
      parallel groups. Participants reported to a single investigational center in Ohio (i.e., The
      Center for Applied Health Sciences) during the 12 week trial.
    

Detailed description: 
      This study was a double-blind, randomized, two-arm, placebo-controlled trial of apparently
      healthy men and women recruited at a single investigational center in Northeast Ohio (i.e.
      The Center for Applied Health Sciences).

      Subjects will attend four study visits. During Visit 1, subjects will be screened for
      participation (i.e., medical history, physical exam, routine blood work [also HgA1c,
      insulin], background baseline diet). Over the next 12 weeks, subjects will attend Visits 2-4,
      wherein assessments of serum glucose, insulin, HOMA-IR, 2-hour glucose tolerance test (GTT),
      NMR profile, HgA1c, C-reactive protein, adiponectin, ferritin, waist circumference, quality
      of life questionnaire, and various visual analog scales for appetite, satiety, and cravings
      will be made (see Study Schematic for details).

      Comprehensive side effect profile/ adverse event monitoring will take place throughout the
      study duration. The study will be conducted following ICH-GCP guidelines to ensure subject
      safety and scientific integrity of the data.
    

Intervention name(s): Active; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Blend of chromium, amla fruit extract, and citrus bioflavonoids; Maltodextrin tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants were randomly assigned to receive either the active product or a placebo. Subjects were instructed to consume their respective supplement daily for 12 weeks, approximately 15-30 minutes prior to their evening meal.
Masking: Single (Investigator)
Primary purpose: Basic Science
Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00029
Condition: Healthy
Study type: Interventional

Summary: 
      ORi is a unitless index that could help clinicians with their assessments of normoxic and
      hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi
      of 0.00 corresponds to PaO2 values of 100mmHg and below, and an ORi of 1.00 corresponds to
      PaO2 values of 200mmHg and above. In this study, the PaO2 is varied by controlling the
      concentration of oxygen the study volunteer breathes. Changes in ORi values are analyzed by
      comparing it to corresponding changes in PaO2 measurements from blood samples.
    


Intervention name(s): INVSENSOR00029
Intervention type(s): Device
Intervention description(s): Noninvasive pulse oximeter sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of Efficacy, Safety of Fulranumab Monotherapy for OA of Hip or Knee, PAI3002
Condition: Osteoarthritis; Pain
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the efficacy, safety, and tolerability of
      fulranumab as Monotherapy compared with placebo in participants with signs and symptoms of
      osteoarthritis of the hip or knee that are not adequately controlled by current pain therapy.
    

Detailed description: 
      This is a randomized (the study drug is assigned by chance), double-blind (neither physician
      nor participant knows the name of the assigned drug), placebo-controlled (an inactive
      substance is given to one group of participants while active drug is given to another group
      of participants to see if there is a difference in response), parallel-group (study drugs
      given to participants in all treatment groups during the same time period) to evaluate the
      efficacy (capacity of the investigational drug to produce an effect), safety, and
      tolerability of fulranumab administered as monotherapy (alone; not in combination with other
      drug therapy) to participants with chronic moderate to severe pain and functional impairment
      from knee or hip osteoarthritis (OA) that is not adequately controlled by current pain
      therapy. The duration of participation in the study for an individual participant will be up
      to 67 weeks (includes a screening period of 3 weeks, a double-blind treatment period of 16
      weeks, and a post-treatment follow-up period of up to 48 weeks).). All participants will be
      randomly assigned in a 1:1:1 ratio to 1 of 3 treatments (placebo, fulranumab 1mg, fulranumab
      3mg) and given a single injection subcutaneously (under the skin) once every 4 weeks for up
      to 16 weeks. Blood samples will be collected from each participant at time points during the
      study. Safety evaluations will include assessment of adverse events, physical examinations,
      laboratory tests and vital signs which will be monitored throughout the study.
    

Intervention name(s): Placebo; Fulranumab 1 mg; Fulranumab 3 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo will be administered once every 4 weeks for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen.; Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.; Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; Pain; Fulranumab; JNJ-42160443; Monotherapy; Hip; Knee; Joint replacement surgery
Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness
Condition: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder; Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      Obesity is increasing at an alarming rate in patients with schizophrenia, possibly in
      association with the increased use of atypical antipsychotics. In order to address the weight
      and metabolic syndrome issues, Manhattan Psychiatric Center (MPC) has implemented the
      Solutions for Wellness and Team Solutions Program. This program is designed to create a
      supportive, educational and monitoring environment to stabilize both the psychiatric and
      medical conditions and to prepare patients for independent management of their psychiatric
      and physical health condition in the community.
    

Detailed description: 
      The present program is divided into five detailed segments with three progressive levels,
      that provide a manualized lesson-by-lesson curriculum for implementation on the treatment
      mall.

        -  Medication Education

        -  Symptom recognition and management

        -  Living Healthy

        -  Interpersonal Skills

        -  Discharge Preparation

      The program comprised of detailed instructor and patient manuals, specific curriculums and
      pre- and post-tests to determine acquisition of the learned materials. All modules are
      imbedded in weekly small group sessions.

        -  Each of the 5 modules are discussed in groups in weekly morning or afternoon session,
           Monday through Friday.

        -  Each module is divided into three 12-week periods for a total of 36 sessions.

        -  Upon completing 12 weeks at Level 1, each patient moves to Level 2 and then Level 3 for
           12 weeks each.

        -  Each group has two trained instructors.

        -  Number of patients per group: ≤ 15.

        -  Sessions are interspersed within the patient's regular treatment mall classes
    

Intervention name(s): Wellness Program
Intervention type(s): Other
Intervention description(s): 36 weeks of educational and supportive interventions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Phase 2 Study Of PF-00232798 In HIV Positive Patients
Condition: HIV
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the viral load response, safety, tolerability and pharmacokinetics of multiple oral
      doses of PF 00232798 in HIV-positive patient volunteers.
    


Intervention name(s): PF-00232798; PF-00232798; PF-00232798; PF-00232798; PF-00232798; PF-00232798
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Solution, 20 mg. once daily, 10 days; Solution, 150 mg. once daily, 10 days; Solution, 5 mg. once daily, 10 days; Solution, 40 mg. once daily, 10 days; Solution, 300 mg. once daily, 10 days; Solution, 400 mg. once daily, 10 days
Intervention MeSH terms: PF 232798
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Treatment Experienced; Treatment Naive