bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Avastin (Bevacizumab) and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This 2 arm study will compare the effect of Avastin + irinotecan versus temozolomide, in
      combination with conventional involved field radiotherapy, in patients with newly diagnosed
      glioblastoma and a non-methylated MGMT promoter. Patients will be randomized 3:1 to receive
      Avastin 10mg/kg iv every 2 weeks + irinotecan 125mg/m2 iv every 2 weeks, or temozolomide
      75mg/m2 po daily during radiotherapy followed by 6 cycles of temozolomide 150-200mg/m2 po
      daily on days 1-5 of each 4 week cycle. The anticipated time on study treatment is until
      disease progression, and the target sample size is 100-500 individuals.
    


Intervention name(s): bevacizumab [Avastin]; irinotecan; temozolomide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10mg/kg iv every 2 weeks; 125mg/m2 iv every 2 weeks; 75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy
Intervention MeSH terms: Bevacizumab; Irinotecan; Temozolomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-384)
Condition: Hypercholesterolemia; Heterozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the safety and tolerability of Ezetimibe (EZ) 10 mg/Atorvastatin
      (Atora) 10 mg and EZ 10mg/Atora 20 mg fixed-dose combination (FDC) in Japanese participants
      with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Atorvastatin up
      to 20 mg. There is no formal hypothesis for the study.
    


Intervention name(s): EZ 10 mg/Atorva 20 mg FDC; EZ 10 mg/Atorva 10 mg FDC
Intervention type(s): Drug; Drug
Other intervention name(s): MK-0653C; MK-0653C
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intravitreal Dexamethasone Implant for Refractory Diabetic Macular Edema:
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Observational

Summary: 
      We have been using DEX for refractory DME for a long time (since 2016). Thus, we are sharing
      our results , evaluating both anatomical and functional outcomes of DEX therapy for
      refractory DME.
    

Detailed description: 
      Our study aims at evaluating both anatomical and functional outcomes of DEX therapy for cases
      of refractory DME, with both a single injection, and /or with retreatments.
    

Intervention name(s): Intravitreal Dexamethasone Implant for refractory Diabetic macular edema:
Intervention type(s): Drug
Intervention description(s): Intravitreal Dexamethasone implants (DEX) (0.7 mg) (Ozurdex, Allergan, Inc, Irvine, CA, USA) had been used with greater efficacy and safety in DME.
Other intervention name(s): Ozurdex
Intervention MeSH terms: Dexamethasone
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Retrospective Review of records of patients with Non-tractional diffuse diabetic macular
        edema (NTDME), for whom Ozurdex had been used , in the period between 2016 and 2022.
Efficacy of Genicular Nerve Alcohol Neurolysis in Knee Osteoarthritis Pain
Condition: Knee Pain Chronic
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      This study aimed to evaluate the efficacy of genicular nerve alcohol neurolysis in the
      treatment of pain caused by chronic knee osteoarthritis. The investigators will evaluate the
      efficacy of genicular nerve alcohol neurolysis using the numeric rating scale (NRS) and the
      Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). NRS and WOMAC scores
      will be evaluated before, 1, and 3 months after the procedure.
    

Detailed description: 
      Alcohol neurolysis of the genicular nerve is a procedure that involves injecting alcohol
      around the nerve branches that supply sensation to the knee joint. The alcohol destroys the
      nerve fibers and blocks the transmission of pain signals from the knee to the brain. This
      technique can be used to treat chronic knee pain caused by osteoarthritis (OA).

      Several studies have reported that alcohol neurolysis of the genicular nerve can provide
      significant pain relief and functional improvement in patients with knee OA or postoperative
      pain. For example, Dass et al. (1) reported two cases of alcohol neurolysis of the genicular
      nerve using fluoroscopy and ultrasonography in patients with knee OA or persistent
      postsurgical pain of the knee. Both patients had more than 50% reduction in their numerical
      rating scale (NRS) scores and improved range of motion and quality of life at 3 months
      follow-up.

      Ultrasonography-guided genicular nerve alcohol neurolysis is prominent with its easy
      applicability and low cost. There are no studies in the literature evaluating the efficacy of
      genicular nerve alcohol neurolysis for chronic knee OA. In this prospective study, the
      investigators will evaluate the NRS and WOMAC scores of patients who underwent genicular
      nerve alcohol neurolysis for chronic knee OA before, 1, and 3 months after the procedure. In
      addition, the incidence of procedure-related adverse events (such as paresthesia) recorded in
      patient records will be analyzed.

      1. Dass RM et al. Alcohol neurolysis of genicular nerve for chronic knee pain. Korean J Pain
      2019; 32 (3): 223-227. https://www.epain.org/journal/view.html?doi=10.3344/kjp.2019.32.3.223
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female patients who underwent genicular nerve alcohol neurolysis for knee
        osteoarthritis pain
      
Keywords: Osteoarthritis; Pain; Ultrasonography; Paresthesia
The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Influenza (Acute Upper Respiratory Infection)
Condition: Acute Upper Respiratory Infection
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, double blind, double dummy, positive drug parallel comparison, multi-centre
      clinical trial to assess the efficacy and safety of Fuganlin Oral Liquid in children with
      influenza (acute upper respiratory infection).
    

Detailed description: 
      Treatment group: Fuganlin Oral Liquid 10mL. Control group: Xiaoer Jiebiao oral liquid 100mL.
      Treatment for one week. Patients who were recovered within one week can withdrawal at any
      time.
    

Intervention name(s): Fuganlin Oral Liquid; Xiaoer Jiebiao Oral Liquid
Intervention type(s): Drug; Drug
Intervention description(s): less than 1 years old: 5mL each time and three times a day
1~3 years old: 10mL each time and three times a day
4~6 years old: 10mL each time and four times a day
7~12 years old: 10mL each time and five times a day; 1~2 years old: 5mL each time and twice a day
3~5 years old: 5mL each time and three times a day
6~14 years old: 10mL each time and twice a day
Other intervention name(s): No other names; No other names
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: acute upper respiratory infection
Study of Adriamycin Plus Cyclophosphamide Followed by Abraxane as Adjuvant Therapy for Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      In this trial, the safety of combination treatment of Adriamycin plus cyclophosphamide
      followed by Abraxane as adjuvant therapy will be evaluated in patients with limited stage
      breast cancer.
    

Detailed description: 
      This is an open-label, pilot study to evaluate the safety of Adriamycin and cyclophosphamide
      (AC) administered every 2 weeks for 4 cycles followed by Abraxane administered every 2 weeks
      for 4 cycles as adjuvant therapy for patients with limited stage breast cancer.
    

Intervention name(s): Abraxane
Intervention type(s): Drug
Intervention MeSH terms: Albumin-Bound Paclitaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; Adriamycin; Cyclophosphamide; Abraxane
Effect of ADC4022 Co-Administered With Budesonide on Pulmonary Inflammation in Subjects With Moderate to Severe COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Pneumonia; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the tolerability and efficacy of inhaled theophylline
      (ADC4022) on markers of pulmonary inflammation (white blood cells) in induced sputum and in
      bronchial biopsy samples in subjects with moderate to severe Chronic Obstructive Pulmonary
      Disease (COPD) when co-administered with budesonide and compared to placebo.
    


Intervention name(s): Theophylline - ADC4022; Placebo; Budesonide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Inhaled theophylline (ADC4022) administered twice daily for 28 days; Inhaled matching placebo administered twice daily for 28 days; Inhaled budesonide twice daily for 28 days
Other intervention name(s): ADC4022; Pulmicort
Intervention MeSH terms: Budesonide; Theophylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
Effects of Massage Therapy and Kinesthetic Stimulation on Pre-Term Infants
Condition: Prematurity
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The purpose of this study was to determine whether massage with or without physical exercise
      impacted weight gain or length of hospital stay for premature infants.
    

Detailed description: 
      Premature infants are often cared for in a fashion that minimizes physical activity in order
      to reduce stress and stress-related complications. Previous studies have indicated that
      massage therapy may increase weight gain and enabled earlier discharge of premature infants.

      In this study, premature infants were randomly assigned to one of three groups:

      A: Control Group

      B: Massage Group, 15 minutes twice a day;

      C: Massage and physical exercise group 15 minutes each, twice a day.
    

Intervention name(s): Massage therapy without exercise; Massage therapy with exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Infants will receive massage twice a day; 15 minutes each.; Infants will receive massage with exercise twice a day; 15 minutes each.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: preterm infants; massage; physical activity; weight gain; length of hospital stay; NICU
Optimal Dose of Propofol for Induction of Deep Sedation for Brain MRI Scanning in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The children with CP has been shown different drug responses from the normal population of
      children and it may related with a various oral medications such as baclofen, tizanidine,
      diazepam, dantrolene, or anticonvulsant drugs.

      The aim of this study is to establish the optimal induction dose of propofol for deep
      sedation to start MRI for < 30 min in children with CP.
    


Intervention name(s): propofol
Intervention type(s): Drug
Intervention description(s): optimization of propofol dose from 1.5 mg/kg to 2.5 mg/kg using Dixon's up and down method during MRI scanning
Intervention MeSH terms: Propofol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab')2 Fragment (INM004) in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is Prospective Randomized Placebo controlled Single Blind Phase I study to evaluate the
      safety, tolerance and pharmacokinetics of the anti-Shiga toxin hyperimmune equine
      immunoglobulin F(ab')2 fragment (INM004) in healthy volunteers.
    

Detailed description: 
      This is a study that will be conducted at a single site in Argentina to characterize the
      Pharmacokinetics (PK) profile, safety and tolerability of anti-Shiga toxin hyperimmune equine
      immunoglobulin F(ab')2 fragment (INM004) in 14 healthy subjects. This is a dose escalation
      study. Subjects will receive a single dose of an infusion of the biological product or
      placebo in Stage I where 2 cohorts will be assessed with 2 different doses of INM004.
      Subjects will receive a repeated dose (3 doses total, every 24 hs) of an infusion of the
      biological product or placebo in Stage II. The total duration of study participation is 4
      weeks for each subject. Subjects will complete a follow-up visit at Day 30 after the dosing.
      Study duration is expected to last 6 months. The investigational product intent to use is for
      the prevention of the development of Hemolytic Uremic Syndrome (HUS) associated to Shigatoxin
      producing Escherichia coli (STEC).
    

Intervention name(s): Drug: INM004 Dose 1; Drug: INM004 Dose 2; Drug: INM004- Repeated dose; Placebo
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): Stage I- Cohort I: (2mg/kg) administered at a single dose. The ratio is 3:1 (investigational product:placebo) -; Stage I- Cohort II: Dose 2 (4mg/kg) administered at a single dose. The ratio is 3:1 (investigational product:placebo); Stage II: Either 3 doses of 2 mg/kg or 4 mg/kg will be administered every 24 hs. The ratio is 5:1 (investigational product : placebo).; A placebo infusion will be administered at the same infusion rate as the Drug arm
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Other
Does a Clinical Support System for Parenteral Nutrition (PN) Facilitate the Judgement on Choosing the Most Effective Commercial Solution Per Patient (and Modify it, if Necessary)?
Condition: Clinical Decision Support System
Study type: Interventional

Summary: 
      Standard formulas of PN have been developed and provided to patients. Only few randomized
      controlled studies compared standardized vs individualized PN. Individually tailored PN, only
      if standard PN solutions do not meet patient's nutritional needs. ASPEN society recommends
      the use computerized prescribing. Technology has enabled the incorporation of medical
      guidelines in CDSSs. New approach: Comparison of patient's calculated nutritional needs with
      commercial available solutions.
    


Intervention name(s): CDSS Canceling
Intervention type(s): Other
Intervention description(s): The use of Clinical Decision Support System in Parenteral Nutrition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Controlled Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      Multicenter, open-label, controlled, randomized clinical study to evaluate the efficacy and
      safety of Racecadotril in infants, children and adolescents with acute diarrhea
    


Intervention name(s): Racecadotril plus ORS; ORS
Intervention type(s): Drug; Drug
Intervention description(s): Racecadotril plus ORS; ORS
Intervention MeSH terms: Racecadotril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study of 12-week Trehalose Intake in Patients With Fatty Liver Disease
Condition: Non-alcoholic Fatty Liver
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      This clinical study will be conducted to evaluate the efficacy and safety of trehalose in
      patients with fatty liver disease. After 12-week intake, subjects will be checked up fat
      content in liver using CT scan.
    


Intervention name(s): Trehalose; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 80 mL pouch/day for 12 weeks, containing trehalose 5 g, water 74.92 g and scent additive 0.08 g; 80 mL pouch/day for 12 weeks, containing water 79.92 g and scent additive 0.08 g
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Vietnamese Women's Health Project III
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      The purpose of this protocol is to understand the extent of symptom perception and preventive
      care-seeking among Vietnamese American women and their impact on cervical cancer screening
      from the perspectives and experiences of key informants including primary health care
      providers and Vietnamese American women (VAW, foreign-born and United States-born). With this
      information, the investigators can better understand how to promote cervical cancer screening
      in the Vietnamese community.
    

Detailed description: 
      No further extensive description.
    

Intervention name(s): Demographic Form and Semi-Structured Interview Guide
Intervention type(s): Other
Intervention description(s): The demographic form will include the following items: age, age at immigration, years lived in the United States, Vietnamese speaking ability, and marital status. In addition for participants who are primary health care providers, the following items will be included: annual income before taxes, gender, race and ethnicity, specialty area of practice, and number of years practicing as a primary health care provider, practice setting, and country received Pap test training.
A semi-structured interview guide will also be used and will include possible probing questions. A semi-structured interview guide was developed with the research team.
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Potential participants will be recruited from the Portland, Oregon Metropolitan area
        through referrals and snowball method. Primary health care providers are eligible to
        participate in the study if they meet the following criteria: self-identify as currently
        practicing as a primary licensed independent practitioner including as a medical physician
        or nurse practitioner, whose service populations include Vietnamese American women, and are
        able to understand and speak English or Vietnamese. Vietnamese American women are eligible
        to participate in the study if they meet the following criteria: self-identify as a
        Vietnamese American woman, between ages 21 to 65 years old, have not had a hysterectomy,
        and are able to understand and speak English or Vietnamese.
      
Keywords: screening
Neural and Mobile Assessment OF Behavior Change Among Problem Drinkers
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      This study will examine the neural mechanisms underlying both spontaneous behavior change and
      behavior change in response to a brief intervention among problem drinkers.
    

Detailed description: 
      Although problem drinkers (PD) are a less severe, highly prevalent sub-type of alcohol use
      disorder (AUD) who are more likely to undergo reductions in alcohol use, compared to more
      severe AUD, the underlying mechanisms that maintain PD, as well as the mechanisms that
      underlie both spontaneous and treatment- related behavior change in this population, are not
      well understood. This proposal takes a lab to life approach by combining functional
      neuroimaging (fMRI), ecological momentary assessment (EMA), and brief interventions (BI) in
      non-treatment seeking PD to test whether heightened incentive salience (reactivity) to
      alcohol cues and impaired ability to regulate cue-induce craving are the mechanisms that
      characterize PD, and play a role in behavior change vs. persistence of behavior. Identifying
      these mechanisms is critical for testing and understanding treatments and uncovering who is
      most likely to respond to interventions.
    

Intervention name(s): Brief intervention
Intervention type(s): Behavioral
Intervention description(s): A brief motivational intervention with feedback about drinking levels compared to norms
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Other
Keywords: brief intervention; fMRI