bioihbjkbjnl/mcl2 huggingface dataset:
Calanus Oil Supplementation and Maximal Oxygen Uptake
Condition: Healthy
Study type: Interventional

Summary: 
      Copepod oil is extracted from the marine copepod Calanus finmarchicus, the dominant plankton
      species in the marine food web in the Norwegian Sea. Copepods constitute the largest
      renewable and harvestable resource in the Norwegian Sea and adjacent waters, and it is now
      developed knowledge and technology for sustainable harvesting of this "new" resource. The
      purpose of this study is to investigate whether Calanus copepod oil supplementation has an
      equivalent effect on maximal oxygen uptake in humans to that seen in experimental studies in
      mice.
    


Intervention name(s): Calanus oil; placebo dietary oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Biological Products/therapeutic use; Copepoda; Dietary Supplements; Fish Oils; Fatty Acids, Omega-3; Oxygen Consumption; Calanus; Maximal oxygen uptake; Zooplankton
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Felodipine Extended-Release Tablets Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      Primary objective of the present study was to compare the single dose bioavailability of
      Torrent's Felodipine Extended-Release Tablets USP 10 mg and Innovator's (Mylan
      Pharmaceuticals Inc., USA) Felodipine Extended-Release Tablets USP 10 mg. Dosing periods were
      separated by a washout period of 21 days during fasting study.

      Study Design:

      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence
      Study
    


Intervention name(s): Torrent's Felodipine Extended-Release Tablets
Intervention type(s): Drug
Intervention MeSH terms: Felodipine
Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis (0476-297)
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to look at the preliminary safety profile of an investigational
      drug in children 1 to < 3 months of age with bronchiolitis.
    


Intervention name(s): MK0476, Montelukast Sodium /Duration of Treatment : 14 Days
Intervention type(s): Drug
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Smartphone Push Notifications on Brain Power Score
Condition: Healthy
Study type: Interventional

Summary: 
      This study will examine how Brain Power Score, an objective measure of brain function, is
      affected by the presence of smartphone push notifications.
    

Detailed description: 
      Smartphones are a common device integrated into the lives of many individuals around the
      world. Researchers have previously found a relationship between mobile phone use and changes
      in brain activity, reaction times and sleep patterns.

      Brain Power is a consumer-grade application using a proprietary combination of neurological
      (EEG) and behavioral (reaction time and accuracy) data to create a comprehensive score out of
      1000 which allows users to have an objective evaluation of their brain performance.

      This study will examine how Brain Power Score is affected by the presence of smartphone push
      notifications.
    

Intervention name(s): Smartphone push notifications
Intervention type(s): Behavioral
Intervention description(s): The purpose of this study is to assess how smartphone push notifications can impact the overall score, accuracy and reaction time of participants using the Brain Power Score application (app). Push notification quantity will be varied and counter-balanced.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Dermacyd in Odor Reducing.
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      - To prove the efficacy superiority in reducing the genital odor and increase hydration in
      mucosa genital comparing the use of Dermacyd (different fragrances) and Glycerine Vegetal
      Soap Granado Traditional

      Secondary Objective:

      - To evaluate the safety in normal conditions of use, verifying clinical signs and lab exams.
    


Intervention name(s): LACTIC ACID (Dermacid); Glycerine Vegetal Soap Granado Traditional
Intervention type(s): Drug; Drug
Intervention description(s): Route of administration: local; Route of administration: local
Intervention MeSH terms: Glycerol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Duowell® vs. Telmisartan Monotherapy in Mild Dyslipidemia Patients With Hypertension
Condition: Hypertension; Dyslipidemia
MeSH terms: Hypertension; Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to evaluate effect and safety on central blood pressure with Duowell compared
      to telmisartan monotherapy in mild dyslipidemia patients with hypertension during 16 weeks.
    


Intervention name(s): Duowell®; Telmisartan
Intervention type(s): Drug; Drug
Intervention description(s): telmisartan 80mg/rosuvastatin 10mg for ASCVD risk=5%~7.5% or telmisartan 80mg/rosuvastatin 20mg for ASCVD risk≥7.5%; telmisartan 80mg
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the
      efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler
      once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol
      (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.
    


Intervention name(s): tiotropium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral inhalation once daily of 18mcg tiotropium via handihaler; Oral inhalation once daily of placebo matching tiotropium via handihaler
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study to Evaluate Safety, PK, Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy
Condition: Hallux Valgus
MeSH terms: Hallux Valgus; Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, randomized, double-blind, 2-part comparator- and placebo-controlled study
      to evaluate the safety, PK, and efficacy of TLC590 via a single infiltrative local
      administration in adult subjects following bunionectomy.
    

Detailed description: 
      This is a Phase 2, randomized, double-blind, 2-part comparator- and placebo-controlled study
      to evaluate the safety, PK, and efficacy of TLC590 via a single infiltrative local
      administration in adult subjects following bunionectomy.

      The primary objective of this study is to evaluate the analgesic efficacy of TLC590 for
      post-surgical pain management in subjects following bunionectomy.

      The secondary objectives of this study are:

        -  To evaluate the pharmacokinetic (PK) profile and dose-exposure relationship of TLC590,
           as well as the bioavailability as compared with Naropin®.

        -  To evaluate the safety and tolerability of TLC590 for post-surgical pain management in
           subjects following bunionectomy.

        -  To evaluate the exposure-response relationship between PK parameters and pain intensity.

      The study will be divided into two parts:

      Part 1: Blinded Pharmacokinetics of TLC590 and Naropin®. Approximately 48 subjects will be
      randomized to treatments.

      Part 2: Efficacy and Safety of TLC590 versus bupivacaine and Placebo. Part 2 of the study
      will randomize approximately 150 evaluable subjects who meet all entry criteria.
    

Intervention name(s): TLC590; Naropin®; Normal Saline; Bupivacaine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): TLC590, a sustained-release formulation of the local anesthetics with lipid-based excipients; Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. 50 mg (0.5%, 10 mL); Normal Saline (0.9% sodium chloride, 10ml); Bupivacaine 50 mg (0.5%, 10 mL)
Other intervention name(s): TLC590 (Ropivacaine Liposome Injectable Suspension); Naropin, 0.5% Injectable Solution; Saline
Intervention MeSH terms: Bupivacaine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Evaluate Efficacy of FB825 in Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open labeled exploratory study to evaluate efficacy of FB825 in adults with atopic
      dermatitis (AD). The study will be conduct at one medical center in Taiwan. Approximately 20
      subjects with atopic dermatitis (AD), who meet the criteria for study entry, will be enrolled
      to the study. All eligible subjects will receive FB825, 5mg/kg, by 1 hour IV infusion on Day
      1. Subjects will return to the study site on Days 15, 29 and 57 for the safety and efficacy
      evaluation. Subjects who premature withdraw from the study will have an end of study (EOS)
      visit within 7 days.
    


Intervention name(s): FB825
Intervention type(s): Biological
Intervention description(s): FB825, 5mg/kg, by 1 hour IV infusion on Day 1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Marijuana's Impact on Alcohol Motivation and Consumption
Condition: Alcohol Drinking; Marijuana
MeSH terms: Marijuana Abuse; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      This laboratory study will employ a repeated measures experimental design to examine the
      effect of high (7.2% THC) and moderate (3% THC) dose of marijuana, relative to placebo, on
      alcohol craving and on behavioral economic measure of alcohol demand after exposure to
      alcohol cues, and on subsequent drinking in an alcohol choice task in which participants
      choose either to drink or receive monetary reinforcement for drinks not consume. The study
      will recruit 173 non-treatment seeking heavy episodic alcohol drinkers who smoke marijuana at
      least twice weekly.
    

Detailed description: 
      This laboratory study will employ a repeated measures experimental design to examine the
      effect of high (7.2% THC) and moderate (3.0% THC) dose of marijuana, relative to placebo, on
      alcohol craving and on behavioral economic measure of alcohol demand after exposure to
      alcohol cues, and on subsequent drinking in an alcohol choice task in which participants
      choose either to drink or receive monetary reinforcement for drinks not consumed. Moderators
      of the marijuana's effects on alcohol-related dependent variables will be tested: DSM5
      alcohol use disorder severity, affective vulnerability, trait impulsivity, and working memory
      functioning. Several empirically-determined mechanisms that may explain why marijuana may
      increase risk of alcohol relapse and help maintain heavy drinking will be tested as mediators
      of marijuana's effects on alcohol. The study will recruit 173 non-treatment seeking heavy
      episodic alcohol drinkers who smoke marijuana at least twice weekly to obtain the final
      sample of 150 with complete data (15% of attrition). Participants will be tested at a
      baseline session and during three experimental sessions. Investigators will collect blood
      samples for analysis of cannabinoid plasma levels and to examine marijuana-induced changes in
      hormones and other biomarkers potentially related to appetite, inflammation and stress.
      Collection of these biomarkers would allow for a greater understanding about the mechanisms
      whereby marijuana may acutely increase alcohol motivation and use. The findings will inform
      researchers and clinicians about how marijuana acutely increases alcohol craving and
      consumption. The strategy of this proposal is to use the most comprehensive controlled test
      characterizing marijuana's putative effects on alcohol.
    

Intervention name(s): THC 7.2%; THC 3.0%; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 smoked marijuana cigarette with 7.2% THC; 1 smoked marijuana cigarette with 3.0% THC; 1 smoked placebo marijuana cigarette
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Cemented K-wire Fixation vs Plating for Finger Fractures
Condition: Closed Fracture of Finger; Finger Fracture Open
MeSH terms: Fractures, Bone; Fractures, Closed
Study type: Interventional

Summary: 
      To introduce a novel external-fixation technique using the combination of K-wires and cement.
      For comparison, we also included another group of patients who were treated using a mini
      plate and screw system. Bone healing, range of motion of the fingers, costs of treatments,
      and patient satisfaction were assessed.
    

Detailed description: 
      Shaft fractures of the proximal phalanx are common injuries that may significantly affect
      hand function. Good fracture stability to allow early mobilization of joints and thus early
      return of function. The objective of this report is to introduce a novel external-fixation
      technique using the combination of K-wires and cement. For comparison, we also included
      another group of patients who were treated using a mini plate and screw system. A total of
      104 patients (131 fingers) were randomly allocated into group A (56 patients) and B (51
      patients). Patients in group A were treated with cemented K-wire fixation; and patients in
      group B were treated with conventional mini-plate. Bone healing, range of motion of the
      fingers, costs of treatments, and patient satisfaction were assessed.
    

Intervention name(s): Cemented K-wire Fixation; Plating
Intervention type(s): Device; Device
Intervention description(s): Fractures were reduced and then fixed with cemented K-wires.; Fractures were reduced and then fixed with Plate.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with proximal phalangeal fractures of fingers.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Reduction, Fracture
Safety and Efficacy Study of a Triplet Combination of MLN9708, Lenalidomide and Dexamethasone in the Initial Management of Multiple Myeloma (IFM2013-06)
Condition: Newly Diagnosed Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, multicenter, open-label study to evaluate the safety and efficacy of
      MLN9708 in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed
      multiple myeloma. The patient population will consist of adult men and women younger than 66
      years, who have a confirmed diagnosis of MM who meet eligibility criteria.

      Following the screening period, patients will be enrolled and treated then, they will receive
      induction therapy (3 cycles), a systematic Peripheral Blood Stem Cell harvest. After
      Peripheral Blood Stem Cell Transplantation, patient will enter in the consolidation phase
      (early and late one) 2 months after transplantation. Finally, patients follow a Maintenance
      therapy (start 1 month after the last cycle of consolidation) during 12 months.
    


Intervention name(s): MLN9708; Lenalidomide; Dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Induction therapy Patients will receive 3 cycles of induction therapy with MLN9708 (4 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 through 21 and Dexamethasone (40 mg) on Days 1, 8, 15 and 22 of a 28-day cycle.
Consolidation therapy
Early consolidation (consolidation part 1) will comprise 2 cycles of MRD identical to induction therapy.
Late consolidation (consolidation part 2) will consist in 6 additional cycles of MLN9708 (4 mg on Days 1, 8 and 15) plus lenalidomide (25 mg on Days 1 through 21) of a 28-day cycle.
Maintenance therapy MLN9708 monotherapy (4 mg/day), will be given on days 1, 8 and 15 of a 28 day cycle, during 12 months.
Intervention MeSH terms: Dexamethasone; Lenalidomide; Ixazomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple myeloma
Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder
Condition: Chronic Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The primary aim of this pilot study is to test the efficacy of the selective serotonin
      re-uptake inhibitor, Escitalopram, in the treatment of posttraumatic stress disorder (PTSD)
      in an open clinical trial.

      A secondary aim is to determine whether treatment with escitalopram increases plasma
      allopregnanolone levels in patients with PTSD and if increases in allopregnanolone levels are
      correlated with treatment efficacy.
    


Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): Subjects were started on 5mg escitalopram. Medication was increased as tolerated in weekly 2.5, 5 or 10 mg increments, until a maximally tolerated dosage or a clinical response was achieved. The final dosage ranged from 5 to 20 mg/day.
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Posttraumatic Stress Disorder; Escitalopram; Efficacy
City of Rochester Teen Outreach Program (TOP™) Evaluation
Condition: Adolescent Problems; Sex Behavior; Academic Underachievement Disorder of Childhood or Adolescence
Study type: Interventional

Summary: 
      As part of a 5-year national effort to reduce teen pregnancy, the University of Rochester is
      partnering with the City of Rochester Department of Recreation and Youth Services to evaluate
      the City's replication of the Teen Outreach Program (TOP™) for 11-14 year old youth
      registered at 11 selected Recreation Centers (RCs). A youth development program with
      demonstrated efficacy to reduce teen pregnancy, school failure and drop-out rates, TOP™ has
      never been studied in RCs. Advancing from efficacy to effectiveness, the investigators will
      also measure program fidelity obtained in RCs.
    


Intervention name(s): TOP; Control intervention
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate the Safety, Tolerability, PK and PD of DA-1241 in Healthy Male Subjects and Subjects With T2DM
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, placebo-controlled, multiple ascending dose study to evaluate the
      safety, tolerability, PK and PD of DA-1241 in healthy male subjects and subjects with T2DM
    


Intervention name(s): DA-1241; Placebo; Sitagliptin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): [Part1] Administration once daily for 28 days; Dose strength for each cohort (Cohort 1, 2 and 3) is planned as 50mg, 100mg and 200mg, respectively.
[Part2] Administration once daily for 56 days; Dose strength for each cohort (Cohort 4, 5 and 6) is planned as 25mg, 50mg and 100mg, respectively.
(Dose escalation and dose level decisions for subsequent cohorts will be made via interim dose escalation review meetings.); [Part1] Administration once daily for 28 days. [Part2] Administration once daily for 56 days.; [Part2] Administration of Sitagliptin 100mg once daily for 56 days.
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Bevacizumab may stop the growth of tumor cells by stopping blood flow to
      the tumor. Giving gemcitabine and capecitabine together with bevacizumab may kill more tumor
      cells.

      PURPOSE: This phase II trial is studying how well giving gemcitabine and capecitabine
      together with bevacizumab works in treating patients with metastatic or unresectable
      pancreatic cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine progression-free survival of patients with metastatic or unresectable
           adenocarcinoma of the pancreas treated with gemcitabine, capecitabine, and bevacizumab.

      Secondary

        -  Determine clinical response in patients treated with this regimen.

        -  Determine toxicity of this regimen in these patients.

        -  Determine quality of life of patients treated with this regimen.

      OUTLINE: This is an open-label, multicenter study.

      Patients receive bevacizumab IV over 30-90 minutes on day 1, oral capecitabine twice daily on
      days 1-14, and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 21 days
      for up to 12 months in the absence of disease progression or unacceptable toxicity.

      Quality of life is assessed at baseline then weekly for 3 weeks.

      Patients are followed every 2-4 months for 1 year and then every 6 months for at least 5
      years.

      PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within 8.8-17.5
      months.
    

Intervention name(s): bevacizumab; capecitabine; gemcitabine hydrochloride
Intervention type(s): Biological; Drug; Drug
Intervention description(s): 30-90 minutes on day 1, every 21 days up to 12 months.; twice daily on days 1-14. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.; IV over 30 minutes on days 1 and 8. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Intervention MeSH terms: Bevacizumab; Gemcitabine; Capecitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the pancreas; recurrent pancreatic cancer; stage IV pancreatic cancer