bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      The study was 8 weeks, randomized, double-blind, placebo-controlled trial to assess the
      effect of zinc sulphate on symptoms of mild and moderate acne vulgaris in 122 patients.
      Participants was assessed at baseline, and 8 weeks. Subjects was randomized to receive either
      20 mg elemental zinc daily or 20 mg placebo tablet daily for 8 weeks. The primary outcome was
      the measure of the GAGS score and the secondary measure includes serum zinc level and
      evaluate adverse effects.
    

Detailed description: 
      Acne vulgaris (AV) is the eighth most prevalent disease worldwide. Acne is a self-limiting
      condition, it may cause significant psychological and social problems, depression,
      disfigurement, and scarring that can persist for a lifetime. Multiple factors contribute to
      acne pathogenesis including increased sebum production, aberrant keratinization of the
      pilosebaceous duct, bacteria such as Propionibacterium acnes, hormonal influences, the skin
      microbiome, and chronic inflammation. Relapse rates in patients with acne after treatment
      with standard of care vary between 10% and 60%. Recent trials attempted to assess the effect
      of zinc in reducing the severity of symptoms of acne vulgaris patients. This study evaluates
      whether there is any role of zinc in reducing acne symptoms between those who did and did not
      receive zinc in an 8 weeks period. This includes 122 acne vulgaris patients who were
      recruited from Dermatology and Venereology OPD of BSMMU. Participants took either 20 mg
      elemental zinc daily in the form of zinc sulphate tablet or 20 mg placebo tablet daily for 8
      weeks. Initially, baseline serum zinc level was measured and repeated again after 8 weeks of
      intervention. A baseline acne symptoms survey was done by GAGS score and also repeated at 8
      weeks.
    

Intervention name(s): Zinc sulphate tablet 20 mg; Placebo tablet 20 mg
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Zinc sulphate tablet 20 mg daily orally for 8 weeks along with topical retinoids.; Placebo tablet 20 mg daily orally for 8 weeks along with topical retinoids
Intervention MeSH terms: Zinc Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Newly diagnosed Acne vulgaris patients
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: AV Zinc GAGS Serum zinc level
Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus MOVIPREP® Using 2-Day Split-Dosing and 1-Day Morning Split-Dosing Regimen in Adults.
Condition: Colorectal Cancer; Colorectal Carcinoma; Colon Cleansing
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the efficacy, safety and tolerability of NER1006 versus MOVIPREP in
      adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel,
      using a 2-Day evening/morning Split-Dosing and 1-Day morning only Split-Dosing regimens.
      Approximately 810 patients will be randomised with the aim of achieving a minimum of 245
      patients in each of the 3 groups.
    


Intervention name(s): NER1006, 2-Day Split-Dosing; NER1006,1-Day Morning Split-Dosing; MOVIPREP, 2-Day Split-Dosing
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy.; The subject will self-administer the first dose of the investigational product on the morning of the colonoscopy and take mandatory additional clear fluid.
After a 1-2 hour break the subject will self-administer the second dose plus additional clear mandatory fluid.; The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take recommended additional clear fluid. Subject will take the second dose together with recommended additional clear fluids on the morning of the colonoscopy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Screening
Dentoskeletal Changes In The Transverse Dimension Using Tooth Bone-Borne Vs. Bone-Borne Expansion Appliances
Condition: Transverse Maxillary Deficiency
Study type: Interventional

Summary: 
      This study aimed to investigate the skeletal, dentoalveolar, and periodontal changes of
      tooth-bone-borne (TBB) and bone-borne (BB) appliances with identical miniscrew placement
      using cone-beam computed tomography (CBCT) in the post-pubertal growth spurt stage.
    

Detailed description: 
      Eighteen patients were divided into 2 groups: TBB group (n = 9, 16.11 ± 0.59 years of age)
      and BB group (n = 9, 15.33 ± 1.22 years of age). CBCT scans were obtained before treatment
      and after 3 months of expansion. Transverse skeletal and dental expansion, alveolar and tooth
      inclination, and buccal alveolar bone thickness were evaluated in maxillary first premolars
      and molars. Paired t tests and independent-sample t tests were used to compare the expansion
      appliances.
    

Intervention name(s): skeletal anchorage and rapid palatal expansion
Intervention type(s): Device
Intervention description(s): Eighteen patients were randomly divided into 2 groups through a free randomization program (Random Allocation Software 2.0). Baseline demographic characteristics were matched in both groups. All appliances were fabricated by the same technician in the orthodontic lab. All individuals were treated by a single practitioner.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eighteen patients were divided into 2 groups: TBB group (n = 9, 16.11 ± 0.59 years of age) and BB group (n = 9, 15.33 ± 1.22 years of age). CBCT scans were obtained before treatment and after 3 months of expansion. Transverse skeletal and dental expansion, alveolar and tooth inclination, and buccal alveolar bone thickness were evaluated in maxillary first premolars and molars. Paired t tests and independent-sample t tests were used to compare the expansion appliances.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Maxillary expansion; CBCT; tooth-bone-borne; bone-borne
Telehealth Cognitive Behavioral Stress Management for Adults With Cystic Fibrosis
Condition: Anxiety; Depression; Stress; Coping Skills; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study to to assess the feasibility, acceptability, and satisfaction of a
      telehealth cognitive behavioral stress management (CBSM) intervention among adults with
      cystic fibrosis (CF) who exhibit elevated anxiety and/or depression symptoms.
    


Intervention name(s): Cognitive Behavioral Stress Management
Intervention type(s): Behavioral
Intervention description(s): Cognitive behavioral stress management is a well-established, practical intervention that combines elements of cognitive behavioral therapy with techniques designed to improve coping skills, social support, communication, and relaxation/mindfulness.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Bio-availability Comparison of Three Formulations of Certolizumab Pegol in Healthy Volunteers
Condition: Bioavailability Study on Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the bioavailability of a single dose of certolizumab pegol solutions given
      subcutaneously either by one of the three formulations and to investigate safety and
      tolerability.
    


Intervention name(s): Certolizumab pegol; Certolizumab pegol; Certolizumab pegol
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Lyophilized certolizumab pegol vial of 200mg for reconstitution of a solution with 1 mL water for injection, single dose of 400 mg given as two subcutaneous injections of 200mg; Certolizumab pegol liquid formulation 200 mg/mL in 1 mL vial single dose of 400 mg given as two subcutaneous injections of 200mg; 200 mg/1 mL liquid certolizumab pegol solution in a pre-filled syringe, single dose of 400 mg given as two subcutaneous injections of 200mg
Other intervention name(s): Cimzia; CDP870; Cimzia; CDP870; Cimzia; CDP870
Intervention MeSH terms: Certolizumab Pegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cimzia; certolizumab pegol; Bioavailability; Healthy volunteers
Effect of the Electronic Cigarette on Withdrawal Symptoms
Condition: Mental and Behavioral Disorders; Withdrawal State
MeSH terms: Substance Withdrawal Syndrome
Study type: Interventional

Summary: 
      Study rationale: Sensory/behavioural elements of smoking play a role in smoking behaviour and
      may have a potential to assist smoking cessation. Among current treatments for smokers, only
      the nicotine inhalator is attempting to address such factors. The inhalator's efficacy does
      not exceed that of the other nicotine replacement therapy (NRT) products, but it mimics the
      relevant sensory input to only a limited extent, and its nicotine delivery is dependent on
      intensive puffing. Recently a new product, the Electronic Cigarette (E-C) has become
      available, which provides a more realistic behaviour and sensory replacement for smoking and
      can provide good nicotine levels with less effort.

      Primary objective: To compare E-C and nicotine inhalator in their effects on tobacco
      withdrawal symptoms over 24hr abstinence.

      Hypotheses: E-C will be more effective than the inhalator in reducing withdrawal symptoms and
      craving and elicit more favorable user ratings. It will also provide higher nicotine levels.

      Study design: In a cross-over study, participants will be randomized to the sequence of
      conditions and provide baseline measures and samples for salivary cotinine analysis. They
      will be asked to abstain from smoking their usual cigarettes and use the allocated product
      over 24 hours. They will return to the study centre the following day, and complete measures
      of craving and withdrawal, ratings of subjective and sensory effects of the products, product
      satisfaction, and adverse effects. They will also provide saliva samples for cotinine
      analysis. Abstinence from smoking will be verified with CO readings.
    

Detailed description: 
      There is considerable interest in E-Cs at the moment and the study would provide information
      on whether the E-C surpasses the tried and tested nicotine inhalator. If so, it would open a
      possibility of its utilization in smoking cessation, and provide encouragement for further
      examination of the role of sensorimotor replacements in the treatment of tobacco dependence.
    

Intervention name(s): Nicotine
Intervention type(s): Drug
Intervention description(s): Inhalation of nicotine.
Other intervention name(s): Nicorette inhalator
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: nicotine; inhalator; electronic cigarette; tobacco
Pharmacokinetic Drug Interaction Study Between Gemigliptin and Irbesartan After Oral Administration in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to investigate the drug interaction between Gemigliptin and
      Irbesartan by comparing pharmacokinetics of Gemigliptin and Irbesartan administered
      concomitantly and each alone in healthy male subjects.
    


Intervention name(s): Gemigliptin; Irbesartan
Intervention type(s): Drug; Drug
Intervention MeSH terms: Irbesartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of a Single Oral Repeated Dose of 500 mg Nicotinic Acid as Tablets in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be a double-blind, randomized, placebo-controlled, single-center, 2
      treatment,3-way crossover to investigate the pharmacodynamics, i.e. the flush-symptom of a
      single oral repeated dose of 500 mg nicotinic acid in healthy subjects. Subjects will be
      randomly allocated to a treatment sequence - AAB, ABA or BAA. The two treatments will be:

        -  Treatment A: 500 mg nicotinic acid

        -  Treatment B: Placebo
    


Intervention name(s): Nicotinic Acids
Intervention type(s): Drug
Intervention MeSH terms: Nicotinic Acids; Niacin; Niacinamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Basic Science
Time-differentiated Therapeutic Hypothermia
Condition: Out of Hospital Cardiac Arrest
MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest; Hypothermia
Study type: Interventional

Summary: 
      The purpose of this study is to determine if 48 hours of mild therapeutic hypothermia
      following out of hospital cardiac arrest gives a better cerebral outcome compared to 24 hours
      therapeutic hypothermia.
    

Detailed description: 
      Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death. However,
      in 2002 it was in two clinical trials demonstrated that mild therapeutic hypothermia in
      comatose OOH-CA victims yields a better cerebral outcome measured by Cerebral Performance
      Category Score (CPC) after 6 month. The optimal mild hypothermia treatment time is however
      not known. The two trials from 2002 apply the treatment for 12 and 24 hours respectively. In
      newborns with cerebral hypoxic damage the standard treatment time is 72 hours. It is
      therefore relevant to investigate the influence of the treatment time on the cerebral outcome
      in OOH-CA victims. In the present study cerebral outcome after mild therapeutic hypothermia
      (target temperature 33 degrees centigrade) in OOH-CA patients for 24 is compared to outcome
      after 48 hours of mild hypothermia. The main outcome parameter is mortality and CPC score
      measured 6 month after the treatment.
    

Intervention name(s): Therapeutic hypothermia
Intervention type(s): Other
Intervention description(s): Mild therapeutic hypothermia with a target temperature of 33 degrees Centigrade for 24 or 48 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Temporal Discounting Delayed Outcomes on Opioid-Dependent Outpatients - 20
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the degree in which opioid-dependent outpatients
      discount the value of an additional maintenance dose of buprenorphine under differing states
      of opioid deprivation.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Primary purpose: Treatment
The Comparison of Supraperiosteal Nerve Block With Opiate Analgesia in Alleviating the Pain of Toothache
Condition: Toothache
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare the degree of pain control provided by two techniques for persons
      with toothache in an emergency department. The two techniques include;

        -  standard oral narcotic pain medication

        -  numbing the tooth with local anesthetic by needle injection
    

Detailed description: 
      Background: Toothache is a common complaint among patients presenting to the emergency
      department. There are two commonly employed methods of alleviating this severe form of pain.
      Oral opioid analgesia is the most commonly utilized strategy for treating this pain. However,
      many emergency physicians and dentists employ a local anesthetic technique known as
      supraperiosteal nerve block. This study will compare the relative efficacy of these
      techniques.

      Patients meeting enrollment criteria will be randomized to either receive a supraperiosteal
      nerve block or oral hydrocodone 10 mg/acetaminophen 650 mg. They will otherwise be managed
      identically. Reduction of pain scores between entry and 30 minutes post intervention will be
      compared as well as numeric pain scores obtained by phone contact 24 hours later. Secondary
      outcomes will include the proportion of individuals from each group filling prescriptions for
      pain medication and the number of pain pills taken.
    

Intervention name(s): hydrocodone/acetaminophen; bupivacaine (supraperiosteal nerve block)
Intervention type(s): Drug; Drug
Intervention description(s): oral hydrocodone 10 mg/acetaminophen 650 mg; Administration of Bupivacaine 0.5% 2 ml adjacent to tooth root
Other intervention name(s): Lortab; Vicodin; Marcaine
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: toothache; regional anesthesia; emergency department
A Study to Evaluate Efficacy and Safety of LCI699 in Participants With Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was a proof-of-efficacy, dose finding study of LCI699 in participants with
      mild-to-moderate uncomplicated essential hypertension in order to assess the blood pressure
      (BP) lowering effect, safety and tolerability of LCI699 as compared to placebo and
      eplerenone.
    


Intervention name(s): LCI699; Eplerenone; LCI699-matching Placebo; Eplerenone-matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): LCI699 oral capsules; Eplerenone oral capsules; LCI699-matching placebo oral capsules; Eplerenone-matching placebo oral capsules
Intervention MeSH terms: Eplerenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Essential hypertension; Phase 2 study; Antihypertensive agent
Program on Lung Cancer Screening and Tobacco Cessation
Condition: Smoking
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      In this sequential, multiple assignment, randomized trial (SMART) current smokers who are
      eligible for lung cancer screening will be identified using the electronic medical record at
      the University of Minnesota and Minneapolis VA (N=1000). All participants will receive 8
      weeks of evidence-based first-line smoking cessation treatment. Participants will be eligible
      for three potential randomizations during one year of smoking intervention: 1) to timing of
      identifying early response to treatment at 4 vs. 8 weeks (all participants), 2) to
      telephone-based tobacco longitudinal care (TLC) vs. TLC plus pharmacist-administered
      Medication Therapy Management (incomplete responders to first-line treatment, Primary Aim),
      and 3) to monthly TLC contact vs. quarterly TLC contact (complete responders to first-line
      treatment, Secondary Aim). The primary outcome will be 6 months of prolonged abstinence
      measured 18 months after the beginning of treatment.
    

Detailed description: 
      In this sequential, multiple assignment, randomized trial (SMART) current smokers who are
      eligible for lung cancer screening will be identified using the electronic medical record at
      the University of Minnesota and Minneapolis VA (N=1000). All participants will receive 8
      weeks of evidence-based first-line smoking cessation treatment. Participants will be eligible
      for three potential randomizations during one year of smoking intervention: 1) to timing of
      identifying early response to treatment at 4 vs. 8 weeks (all participants), 2) to
      telephone-based tobacco longitudinal care (TLC) vs. TLC plus pharmacist-administered
      Medication Therapy Management (incomplete responders to first-line treatment, Primary Aim),
      and 3) to monthly TLC contact vs. quarterly TLC contact (complete responders to first-line
      treatment, Secondary Aim). The primary outcome will be 6 months of prolonged abstinence
      measured 18 months after the beginning of treatment (self-reported smoking abstinence using
      imputation for missing data).
    

Intervention name(s): TLC monthly; TLC quarterly; MTM; 4 week assessment; 8 week assessment
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Tobacco longitudinal care monthly; Tobacco longitudinal care quarterly; Medication management therapy; 4 week assessment; 8 week assessment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking,; Smoking cessation; Sequential, multiple assignment, randomized trials (SMART); Lung cancer screening
Comparison of Interscalene Block and Suprascapular With Axillary Block
Condition: Shoulder Arthroplasty; Ultrasound Guided
Study type: Interventional

Summary: 
      In this study, the investigators are going to compare the analgesia effectiveness of
      interscalane block and suprascapular with axillary block in shoulder arthroplasties
    

Detailed description: 
      In the preoperative period, the participants will be taken to the block room. The
      participants will be monitored, standard sedation will be applied.

      The first group will be get interscalene block. The second group will be get suprascapular
      and axillary block. The third group patient will be get no block. Afterwards, the
      participants will be operated under general anesthesia. A patient-controlled analgesia device
      will be attached to each group of participants and their postoperative follow-up will be
      made.
    

Intervention name(s): interscalene block; suprascapular block + axillary block
Intervention type(s): Procedure; Procedure
Intervention description(s): peripheral nerve block; peripheral nerve block
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study group - Study group- Control group
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: axillary block; suprascapular block