bioihbjkbjnl/mcl2 huggingface dataset:
Metoclopramide Versus Ketorolac for Tension-type Headache
Condition: Headache
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      Occasionally, episodic tension-type headache may be severe enough to require an emergency
      department (ED) visit. The purpose of this study is to compare two commonly used medications
      to see which is better for tension type headache. Patients who present to the ED with an
      acute tension-type headache requiring treatment with injectable medication will be randomized
      to metoclopramide or ketorolac.
    


Intervention name(s): Metoclopramide; Ketorolac
Intervention type(s): Drug; Drug
Intervention description(s): metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS; ketorolac 30mg IVSS
Other intervention name(s): Reglan; Toradol
Intervention MeSH terms: Ketorolac; Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: headache; tension-type headache
Study of Enfuvirtide in HIV-Positive Subjects
Condition: HIV Infections; AIDS
MeSH terms: HIV Infections; HIV Seropositivity
Study type: Interventional
Phase: Phase 1

Summary: 
      A total of 26 patients will be admitted to the clinic where they will be dosed with each
      injection device. There will be a 7-day washout between doses and a 7-10 day follow-up
      period.
    


Intervention name(s): Fuzeon
Intervention type(s): Drug
Intervention MeSH terms: Enfuvirtide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MRI on Persons With Mutations in POMT2 Gene (LGMD2N)
Condition: Limb-girdle Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophies, Limb-Girdle
Study type: Observational

Summary: 
      POMT2 mutation is known to cause Walker Warburg Syndrome and Muscle-Brain-Eye syndrome.
      Recently it has been connected to limb girdle muscular dystrophy (LGMD), a disorder
      characterized by muscle weakness and atrophy of the proximal muscles of the shoulder and
      pelvic girdles. LGMD is classified based on its inheritance pattern and genetic cause into
      more than 31 different types. LGMD with POMT2 mutations is a new phenotype - type 2N. Very
      few patients with the LGMD2N phenotype has been reported. In this study, the investigators
      examine five new cases with the LGMD phenotype. The primary aim is to examine the muscle
      involvement using MRI.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Persons diagnosed with LGMD2N in Denmark and France are invited to the study.
      
Keywords: MRI; LGMD; POMT2
A Clinical Study to Evaluate the Sensitizing Potential of LEO 43204 Gel
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, single-center, controlled, within-subject comparison study assessing
      the sensitization potential of the investigational product, LEO 43204 gel under open
      conditions in healthy volunteers.

      LEO 43204 Gel and Vehicle Gel will be applied to adjacent sites on the infrascapular area of
      the back. Evaluation of dermal reactions at the application sites will be assessed clinically
      using a visual scale that rates the degree of erythema, edema and other signs of cutaneous
      irritation.

      Following induction, subjects will have a 10 to 14-day Rest Phase, after which they will
      enter the Challenge Phase, which consists of one 48-hour application to a naive site on the
      opposite side of the back. Observations at the naive site during Challenge and the patterns
      of reactivity during the Induction Phase will provide a basis for an interpretation of
      contact sensitization.

      A total of 10 applications will be made over a period of approximately 6-8 weeks.
    


Intervention name(s): LEO 43204; LEO 43204 Vehicle
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
A Trial of SHR - 1906 in Healthy Subjects
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a phase 1 single dose escalation study of SHR-1906 in healthy subjects. The
      purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of SHR-1906
      in healthy subjects.
    


Intervention name(s): SHR-1906；Placebo
Intervention type(s): Drug
Intervention description(s): Drug: SHR-1906 IV, single dose
Drug: Placebo IV, single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: SHR-1906 compared with placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Changes in Nasal Patency With Changes in Posture, Temperature, Humidity and Nasal Patency Seen by Acoustic Rhinometry
Condition: Mucosal Congestion
Study type: Interventional
Phase: Phase 4

Summary: 
      To study nasal physiologic responses to changes in posture, temperatures, humidity and nasal
      patency with acoustic rhinometry.
    

Detailed description: 
      The purpose of this study was to utilize acoustic rhinometry to assess changes in nasal
      patency after alterations in posture, unilateral mechanical obstruction, temperature, and
      humidity.

      Eight healthy adult volunteer subjects underwent acoustic rhinometry under the following
      conditions: 1) upright, sitting position (control), 2) supine position, 3) left lateral
      recumbent position, 4) one nostril mechanically blocked, 5) icepack on neck, 6) drinking cold
      water, 7) drinking hot water, 8) nasal nebulizer, 9)oxymetazoline decongestant.

      Changes in nasal cavity volumes were detected by acoustic rhinometry after alterations in
      posture, unilateral mechanical obstruction, temperature, and humidity. Nebulizer treatment
      and hot water ingestion caused a significant decrease in nasal volume. The nose was able to
      adapt to environmental and physiological changes in order to maintain a consistent total
      nasal volume.
    

Intervention name(s): Acoustic rhinometry (procedure)
Intervention type(s): Procedure
Intervention description(s): Acoustic rhinometry is a procedure that uses sound waves to measure the cross-sectional area and volume of the nasal cavity.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Mucosal congestion; Acoustic rhinometry; Physiology
Nd:YAG Laser Hyaloidotomy for Premacular Hemorrhage in Diabetic Eyes
Condition: Proliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Hemorrhage
Study type: Interventional

Summary: 
      Premacular Subhyaloid hemorrhage is a sudden profound loss of vision in eyes with
      proliferative diabetic retinopathy (PDR). Pars plana vitrectomy is the treatment of choice
      for premacular hemorrhage in eyes with proliferative changes. Nd:YAG laser hyaloidotomy has
      been used to evacuate the premacular hemorrhage
    


Intervention name(s): Nd:YAG laser Hyaloidotomy
Intervention type(s): Procedure
Intervention description(s): Using the YAG laser for opening the posterior hyaloid in eyes with premacular hemorrhage, and evacuating the entrapped hemorrhage
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Prospective, Open Label Study of CERtican in KIdney Transplantation
Condition: Kidney Transplant
Study type: Interventional
Phase: Phase 4

Summary: 
      A prospective, open label study of CERtican in KIdney transplantation
    


Intervention name(s): Everolimus
Intervention type(s): Drug
Intervention description(s): A prospective, open-label study to assess safety of Certican in kidney transplant patients
Intervention MeSH terms: Everolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: kidney transplant; Certican
Optimizing Navigation to Successful Colorectal Cancer Screening
Condition: Colorectal Cancer Screening
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Colorectal cancer is the second leading cause of death from cancer in the United States. Two
      major barriers to successful colorectal cancer screening are appointment keeping and proper
      bowel preparation. The purpose of this study is to test the efficacy of a patient navigation
      program to increase colorectal cancer screening at Rush University Medical Center. The
      investigators hypothesize that colorectal cancer screening will be improved for subjects who
      utilize a patient navigator.
    


Intervention name(s): Navigation
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Colonoscopy; Colon cancer; screening; navigation
Precision Orthodontics: A Comparison of Custom vs Traditional Bracket Treatment Efficiency
Condition: Dental Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      This investigational testing aims to target multiple investigations sites to examine
      treatment efficiency metrics using a completely digital and patient-specific bracket
      treatment system for the correction of malocclusions.
    


Intervention name(s): LightForce Orthodontic System
Intervention type(s): Device
Intervention description(s): The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Combination Cholesterol Treatments in Patients With High Cholesterol.
Condition: Hyperlipidemia; Dyslipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see if combination therapy with a "statin" medication and two
      additional agents that work differently than "statin" medications can further lower the
      so-called "bad cholesterol." One therapy is a prescription drug approved by the Food and Drug
      Administration to treat high cholesterol (Welchol). The other therapy is Minute Maid Heart
      Wise orange juice. This study juice is available in supermarkets and contains plant sterols
      that have been shown to lower cholesterol.
    

Detailed description: 
      Coronary heart disease (CHD) is the primary cause of morbidity and mortality in the United
      States. Lowering LDL cholesterol in both patients with and without CHD reduces coronary
      events and death. Statin medications are the primary mechanism of lowering LDL cholesterol,
      but some patients do not reach their goal LDL with maximum tolerated statin doses and must
      utilize combination therapy to further lower cholesterol. Additionally, some patients prefer
      to utilize "natural" mechanisms to lower cholesterol. This prospective, double-blinded,
      randomized study will compare plant sterol (natural cholesterol treatment) with placebo in
      patients treated with combination statin and colesevelam therapy.
    

Intervention name(s): Minute Maid Heart Wise orange juice; Welchol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Antilipemic agents; hyperlipidemia
Dose Extension Study of BIIX 1 XX in Healthy Young Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers.
    


Intervention name(s): BIIX 1 XX inhalation solution; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single doses of 800, 1000, 1200, 1400, 1600, 1800, or 2000 mcg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Phase III Trial Evaluating Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients （FRESCO)
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Fruquintinib administered at 5mg once daily(QD) in 4 weeks treatment cycle (three weeks on
      and one week off) was well tolerated and demonstrated encouraging preliminary clinical
      antitumor activity in patients with metastatic colorectal cancer (CRC) in phase Ib and phase
      2 study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in the
      treatment of patients with metastatic CRC who have progressed after second line or above
      standard chemotherapy
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial
      to compare the efficacy and safety of Fruquintinib plus BSC versus placebo plus BSC in
      patients with metastatic colorectal cancer who have progressed after second-line or above
      standard chemotherapy. After checking eligibility criteria, subjects will be randomized into
      Fruquintinib plus BSC group (treatment group) or placebo plus BSC group (control group) in a
      ration of 2:1. Primary Efficacy Endpoint: Overall Survival (OS). Secondary Efficacy
      Endpoints: Progression free survival (PFS) (According to RECIST Version 1.1), Objective
      Response Rate (ORR), Disease Control Rate (DCR), . Safety and tolerance will be evaluated by
      incidence, severity and outcomes of AEs and categorized by severity in accordance with the
      NCI CTC AE Version 4.0.
    

Intervention name(s): fruquintinib; placebo
Intervention type(s): Drug; Drug
Intervention description(s): fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off; fruquintinib placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
Other intervention name(s): HMPL-013; HMPL-013 placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: colorectal cancer
Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer
Condition: Colorectal Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells. It is not
      yet known if combination chemotherapy is more effective with or without irinotecan in
      treating colon cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy
      with or without irinotecan in treating patients who have stage III colon cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the effect of leucovorin calcium and fluorouracil with or without irinotecan on
           the 3 year survival rate and overall survival of patients with resected node positive
           colon cancer at high risk of recurrence.

        -  Compare toxicities of these regimens in these patients.

        -  Compare quality of life of these patients.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      center, disease type (occlusion vs perforation vs N2 only), delay between surgery and
      chemotherapy (28 days or less vs over 28 days), and age (under 65 vs 65 and over). Patients
      are randomized to one of two treatment arms.

        -  Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 22
           hours on days 1 and 2.

        -  Arm II: Patients receive irinotecan IV over 90 minutes on day 1 followed by leucovorin
           calcium and fluorouracil as in arm I.

      Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or
      unacceptable toxicity.

      Quality of life is assessed before treatment, after 6 and 12 courses, and then at 1 year.

      Patients are followed every 3 months for 2 years, then every 6 months for 3 years.

      PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study
      within 3 years.
    

Intervention name(s): FOLFIRI regimen; fluorouracil; irinotecan hydrochloride; leucovorin calcium
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Fluorouracil; Irinotecan; Calcium; Levoleucovorin
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage III colon cancer; adenocarcinoma of the colon
Safety, Tolerability, Pharmacokinetic, and Efficacy Study of SPD489 in Preschool Children With Attention-deficit/Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to gain initial safety, tolerability, pharmacokinetic, and
      efficacy information on SPD489 in preschool children 4-5 years old who are diagnosed with
      ADHD. Generating such data will provide data on the use of SPD489 in the preschool ADHD
      population.
    


Intervention name(s): SPD489
Intervention type(s): Drug
Intervention description(s): All subjects will begin with 5mg of SPD489 daily and will be titrated until optimal dose is reached (5, 10, 15, 20, and 30mg)
Other intervention name(s): Lisdexmfetamine dimesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reassessment of the Nutritional Status in Thai Orphans Living With HIV in a Family Style Community
Condition: HIV Infection; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Observational

Summary: 
      To reassess nutritional status of HIV-infected Thai children living in the family style
      community after receiving nutrition support program for 6 months.
    

Detailed description: 
      The first assessment indicated that improving dietary intake, either energy or micronutrient
      intakes, to meet the recommended for HIV-infected children (CLHIV) would be able to improve
      growth of these children. We implemented the nutrition support program through the two
      strategies aiming to increase dietary intake for all children to meet the current World
      Health Organization (WHO) recommendations which the recommended energy requirements are
      increased by10% for asymptomatic CLHIV and increased by 20 to 50% for children who require
      catch up growth or experiencing opportunistic infections. The nutrition support program
      composed two strategies. Firstly is providing nutrition education to caregivers and also
      children. Secondly, revision food menus by caregivers with assisting from the nutritionists
      of the project. After this program have been implemented for 6 months, reassessment is needed
      to evaluate the changes of nutritional status and health outcomes in this children aiming to
      further providing support and applying to other settings.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Thai HIV-infected children living in a family style community located in rural central
        region of Thailand
      
Keywords: Nutritional status; Thai HIV-infected children
Safety, Tolerability, Pharmacokinetics, and Biological Activity of ATYR1940 in Adult Participants With Muscular Dystrophy
Condition: Facioscapulohumeral Muscular Dystrophy (FSHD)
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Facioscapulohumeral
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety and tolerability profile of ATYR1940 in the
      treatment of adult participants with molecularly defined genetic muscular dystrophies
    

Detailed description: 
      Study ATYR1940-C-002 is a multi-national, multi-center, double-blind, randomized,
      placebo-controlled, ascending dose study designed to evaluate the safety, tolerability, PK,
      immunogenicity, and pharmacodynamic effects of ATYR1940 in participants with FSHD. Up to 44
      participants are planned to be enrolled at multiple study centers in the United States and
      Europe; the actual number of participants enrolled will depend on the number of cohorts
      initiated.

      Participants will be screened for study eligibility during the Screening period within 3
      weeks before Baseline (that is, Day 1, the first day of Study Drug administration). Eligible
      participants, based on Screening assessments, will be randomly assigned to treatment with
      ATYR1940 or placebo. Participants who are randomized will be considered enrolled in the
      study.
    

Intervention name(s): Placebo; ATYR1940
Intervention type(s): Biological; Biological
Intervention description(s): Concentrate for solution for infusion; Concentrate for solution for infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: FSHD
Genomic Opioid Optimization of Dosing and Selections (GOODS) Study
Condition: Perioperative/Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      The researchers are conducting this study to see if pharmacogenomic testing before surgery
      helps the doctor to choose which medications will work best for the patient.
    

Detailed description: 
      Participants, undergoing total knee replacements, will be randomized into two groups. Both
      groups will receive pharmacogenomics (PGx) testing preoperatively. The PGx guided group will
      have their results reviewed by the clinicians during their treatment and the results may
      guide clinical decisions. The control group results will be sealed until completion of
      treatment and clinicians will not have access to this information. These participants will
      undergo standard treatment dosing and medication selection.
    

Intervention name(s): Pharmacogenomic (PGx); Review results
Intervention type(s): Other; Other
Intervention description(s): Administer a pharmacogenomics test (buccal swab) during the pre-operative setting; Pharmacogenomic (PGx) results reviewed by the clinicians during their treatment and the results may guide clinical decisions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All subjects meeting inclusion/exclusion criteria will undergo pharmacogenomic testing. A pharmacist will review the pharmacogemic report and make recommendations for patients in the interventional group. The anesthesiologist and orthopedic surgeon will use that information for preoperative clinical decisions related to anesthesia and analgesia.
Masking: Single (Participant)
Primary purpose: Screening
Keywords: pharmacogenomics; preoperative evaluation; perioperative opioid use