bioihbjkbjnl/mcl2 huggingface dataset:
Study to Examine Safety, Tolerability and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight Subjects
Condition: Obesity; Overweight
MeSH terms: Overweight; Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to examine
      the safety, tolerability, and effect on body weight of subcutaneous AC2307 in obese or
      overweight subjects.
    


Intervention name(s): AC2307; placebo; AC2307; placebo; AC2307; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): subcutaneous, twice daily, low dose; subcutaneous, twice daily, low dose; subcutaneous, twice daily, middle dose; subcutaneous, twice daily, middle dose; subcutaneous, twice daily, high dose; subcutaneous, twice daily, high dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: obesity; overweight; weight loss; Amylin; AC2307
Ascending Single Doses of Erenumab (AMG 334) in Healthy Adults and Migraine Patients
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine whether erenumab is safe and well tolerated
      in healthy adults and migraine patients. As part of the secondary objectives, this study will
      be conducted to characterize the pharmacokinetic (PK) profile of erenumab after single
      subcutaneous (SC) or intravenous (IV) doses in healthy participants and migraine patients as
      well as to characterize the effect of erenumab on the capsaicin-induced increase in dermal
      blood flow after single SC or IV doses in healthy participants and migraine patients.
    

Detailed description: 
      This study was a single-dose, double-blind, placebo-controlled, sequential dose escalation
      study in which participants were to be enrolled into 8 cohorts.

      In Part 1 healthy participants were randomized in a 3:1 ratio (erenumab:placebo) into 6
      cohorts: 5 cohorts received the investigational product (IP) as an SC administration and 1
      cohort received it as an IV administration. In Part 2 a total of 12 migraine patients were
      randomized in a 1:1 ratio (erenumab:placebo) in cohort 7. An additional 8 migraine patients
      could have been enrolled and randomized in a 3:1 ratio in the optional cohort 8, however this
      cohort was not enrolled.
    

Intervention name(s): Erenumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous injection or intravenous injection; Administered by subcutaneous injection or intravenous injection
Other intervention name(s): AMG 334; Aimovig™
Intervention MeSH terms: Erenumab
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Migraine
Guanfacine for the Treatment of Post Traumatic Stress Disorder (PTSD)
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, placebo-controlled, randomized study lasting 8 weeks. Purpose of the
      study is two-fold: first, to use a pharmacological agent to treat symptoms of PTSD, and
      second, to explore neurobiological mechanisms of action of guanfacine.
    

Detailed description: 
      Subject population is comprised of 100 persons with PTSD. 50 patients will receive guanfacine
      and 50 patients will receive a placebo. Guanfacine is prescribed at 1 mg/day and may be
      increased to 2 mg/day. Samples of plasma MHPG will be collected weekly. Clinical ratings of
      PTSD anxiety and depression, as well as vital signs, will be assessed weekly. Repeated
      measures analysis of variance will assess significance of main effect of drug, time, and drug
      by time.
    

Intervention name(s): guanfacine
Intervention type(s): Drug
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: PTSD
Acceleration of Orthodontic Tooth Movement
Condition: Mild to Moderate Anterior Mandibular Segment Crowdind
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      EVALUATION OF EFFICACY OF LOCALLY INJECTED Vitamin D3 (calcitriol or 1.25
      dihidroxicolecalciferol) IN ACCELERATING ORTHODONTIC MOVEMENT Design: A randomized,
      controlled, crossover, double-blind clinical study including Eighteen adult , aged 15-25
      years old.
    

Detailed description: 
      The rate of orthodontic tooth movement depends on two general factors: the forces used in
      order to cause orthodontic tooth movement and respectively the individual (biological)
      response of the body to these forces.

      There are many methods for accelerating orthodontic tooth movement. but, every method has its
      disadvantages, such as pain and root absorption. Locally injected of vitamin d3 was proposed
      to accelerates tooth movement with minimal disadvantages, but there aren't enough clinical
      studies to prove this claim.
    

Intervention name(s): Dihydroxycholecalciferols; dimethyl sulfoxide; serum
Intervention type(s): Drug; Other; Other
Intervention description(s): Injection of Dihydroxycholecalciferols solution in the periodontal ligament for lower anterior segment teeth.; Injection of dimethyl sulfoxide in the periodontal ligament for lower anterior segment teeth.; Injection of serum in the periodontal ligament for lower anterior segment teeth.
Intervention MeSH terms: Dihydroxycholecalciferols; Dimethyl Sulfoxide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment, A randomized, controlled, parallel, double-blind clinical study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Orthodontic, Calcitriol, Local injection, OTM Randomized controlled trial, Vitamin D,.
Using the Canary Breathing System for Panic Disorder Patients
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to test the effectiveness of the Canary Breathing System (CBS)
      in treating the symptoms of panic disorder.
    

Detailed description: 
      Panic disorder (PD) is associated with hyperventilation. The efficacy of a brief respiratory
      feedback program for PD has been previously established. The aim of the present study was to
      expand these results by testing a similar program with more clinically representative
      patients and settings. The intervention is delivered via home use following initial training
      by a clinician and provides remote monitoring of client adherence and progress by the
      clinician. Outcomes were assessed post-treatment and at 2- and 12-month follow-up.
    

Intervention name(s): Canary Breathing System
Intervention type(s): Device
Intervention description(s): The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: carbon dioxide monitoring; panic disorder; biofeedback; breathing training; Primary diagnosis; panic attacks
Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches
Condition: Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a double-blind, placebo-controlled study. Subjects who meet the entry criteria will
      be randomized o receive one of three blinded treatments [C213 1.9 mg patch and placebo patch;
      C213 3.8 mg (1.9 mg x 2 patches), two placebo patches] on Day 1 and will have up to 48 weeks
      to confirm and treat a cluster headache. Subjects will self-administer the patches and
      respond to questions in the electronic diary (eDiary) until 1-hour post treatment
      administration.
    

Detailed description: 
      This is a randomized, double-blinded, placebo-controlled study. Approximately 120 subjects
      who meet the entry criteria will be randomized 1:1:1 to receive one of three blinded
      treatments [C213 1.9 mg patch and placebo patch; C213 3.8 mg (1.9 mg x 2 patches), two
      placebo patches].

      Qualified subjects will randomize to the double-blind treatment period at Day 1 and will have
      up to 48 weeks to confirm and treat a cluster headache. Using the eDiary to confirm they are
      experiencing a cluster headache, subjects will self-administer the patches and continue to
      respond to questions in the eDiary until 1-hour post treatment administration.
    

Intervention name(s): C213 Microneedle System; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm^2 array) is attached to a 5 cm^2 adhesive patch.; The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.
Other intervention name(s): Zolmitriptan Microneedle System; ZP Placebo
Intervention MeSH terms: Zolmitriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Qualified subjects are assigned to received a single administration of one of three blinded treatment assignments (one of two dose levels or placebo)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Episodic cluster headache; Chronic cluster headache
The ShortCut™ Study Protocol
Condition: Risk of Coronary Obstruction Following TAVR Procedure
Study type: Interventional

Summary: 
      A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to
      Demonstrate the Safety and Effectiveness of the ShortCut™ device for splitting bioprosthetic
      aortic valve leaflets in patients who are presented for a valve-in-valve transcatheter aortic
      valve replacement (TAVR) procedure for an approved ViV indication, and who are at risk for
      TAVR-induced coronary artery ostium obstruction.
    


Intervention name(s): ShortCut™
Intervention type(s): Device
Intervention description(s): Splitting bioprosthetic aortic valve leaflets
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Assessment of Blood Glucose Monitoring Devices With New Insight Features
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      To investigate whether novel insight features in new BGMs can improve glycemic control.
    


Intervention name(s): OneTouch Verio®; OneTouch Verio® Flex; Subject's Own Blood Glucose Meter
Intervention type(s): Device; Device; Device
Intervention description(s): Colour Enhanced Blood Glucose Meter.; Colour Enhanced Blood Glucose Meter.; Subject's Own Blood Glucose Meter
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Other
Susceptibility to High Altitude Pulmonary Edema in Subjects With Increased Hypoxic Pulmonary Vasoconstriction
Condition: High Altitude Pulmonary Edema
MeSH terms: Altitude Sickness; Pulmonary Edema; Hypertension, Pulmonary; Edema
Study type: Interventional

Summary: 
      It has been shown, that subjects susceptible to high altitude pulmonary edema (HAPE)are
      characterized by an abnormal increase of pulmonary artery pressure at rest in hypoxia and
      during exercise in normoxia. This abnormal rise of pulmonary artery pressure has also been
      observed in about 10 % of otherwise healthy subjects without prior altitude exposure. The aim
      of the study is to investigate the susceptibility to HAPE in unacclimatized subjects with
      abnormal increase of pulmonary artery pressure at rest in hypoxia and during exercise in
      normoxia after rapid ascent to high altitude (4559 m).
    


Intervention name(s): Altitude Exposure:
Intervention type(s): Other
Intervention description(s): rapid ascent to Margherita Hut (4559 m) within 24 h
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: high altitude pulmonary edema; hypoxic pulmonary vasoconstriction; right ventricular function; hypoxia
Cardiovascular Vulnerability to Particulate Exposure
Condition: Heart Disease; Lung Disease
MeSH terms: Lung Diseases; Heart Diseases
Study type: Observational

Summary: 
      This project is part of a program project directed toward assessing cardiac effects of
      particulate and other ambient air pollutants. In this project active elderly adults living in
      the communities of Boston and Steubenville have attended 12 weekly sessions including
      approximately 40 minutes of Holter monitoring, blood pressure, and oximetry evaluation
      before, during, and after outdoor exercise. To investigate the relation of air pollution to
      cardiac and pulmonary rehabilitation, a second portion of this study involves abstraction of
      blood pressure and symptom data and downloading of available repeated measures telemetry data
      in two populations. These populations include: 1) 200 outpatients attending 8 to 36 repeated
      weekly exercise training sessions in a major hospital cardiac rehabilitation unit.
    

Detailed description: 
      Approximately 60 subjects have participated fully in Boston and Steubenville in the repeated
      40 minute measurement of continuous EKG (Holter), blood pressure, and oximetry. In
      Steubenville we have also measured exhaled nitrogen oxide, an index of pulmonary
      inflammation. The exposure monitoring has included outdoor particle mass of PM2.5, outdoor
      gaseous pollutants, and indoor home and personal monitoring to evaluate the indoor
      contribution of pollution to health effects.
    

Observational model: Defined Population
Time perspective: Prospective
Keywords: Holter monitoring; ECG; Cardiac; particulate exposure
Quantitative Studies of Urinary Bladder Sensation
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Study type: Observational

Summary: 
      The purpose of this study is to determine whether more than one subpopulation exists of
      patients with the diagnosis of Interstitial Cystitis (IC) based on sensory testing and to
      determine if subjects with IC have normal counterirritation-related modulatory systems.
    

Detailed description: 
      To determine whether more than one subpopulation exists of patients with the diagnosis of
      Interstitial Cystitis (IC) based on sensory testing and to determine if subjects with IC have
      normal counterirritation-related modulatory systems. Previous studies by the PI suggest that
      two populations of subjects are present in the IC population but a larger number of subjects
      with IC would need to be tested in order to determine if this were indeed true. Other studies
      have demonstrated that counterirritation-related effects are absent in several chronic pain
      populations including fibromyalgia and chronic headaches. Identification of a subset of IC
      patients or the identification of a failure of counterirritation-related effects may predict
      responses to therapeutic interventions.
    

Intervention name(s): Quantitative Sensory Testing and Stimulus
Intervention type(s): Other
Intervention description(s): No therapeutic intervention will be given. Quantitative Sensory Testing, thermal/mechanical/ischemic stimulus will be performed.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Non-healthy subjects will be recruited from Kirklin Clinic Urology Clinic and Pain
        Treatment Center. Healthy subjects will be recruited via advertisements.
      
Keywords: Cystitis; Urinary; Bladder
Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
Condition: Hepatic Impairment; Hepatic Insufficiency; Healthy Subjects
MeSH terms: Liver Diseases; Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is investigate the influence of severe hepatic impairment on the pharmacokinetics
      of acalabrutinib and its metabolite.
    


Intervention name(s): acalabrutinib
Intervention type(s): Drug
Intervention description(s): A 50-mg single oral dose of acalabrutinib will be administered.
Intervention MeSH terms: Acalabrutinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic; Acalabrutinib
Small Bowel Obstruction and Surgery
Condition: Acute Small Intestine Obstruction
MeSH terms: Intestinal Obstruction
Study type: Observational

Summary: 
      Postoperative management after small bowel obstruction (SBO) surgery is not consensual and
      better knowledge of risk factors for postoperative morbidity could help to add evidence of
      the feasibility of enhanced recovery programs (ERPs).

      In elective surgery, ERPs have shown a significant benefit for the patient but this is not
      performed routinely in emergency surgery due to the difficulty to avoid postoperative
      nasogastric tube.

      The aim was to identify risk factors for postoperative morbidity and for nasogastric tube
      (NGT) replacement after SBO surgery.
    


Intervention name(s): Nasogastric tube removal
Intervention type(s): Procedure
Intervention description(s): Nasogastric tube was removed immediately after surgery
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All patients undergoing surgery for adhesive small bowel obstruction in the CHU of Angers
        between January 1, 2014 and December 31, 2017
Effects of Azithromycin on Airway Oxidative Stress Markers in Patients With Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Interventional

Summary: 
      The mechanism by which macrolide antibiotics have immune modifying effects independent from
      its antibacterial activity has not been well established. In the present work, the
      investigators will analyze the effect of long-term treatment with azithromycin (250 mg three
      times per week during three months) on airway oxidative stress markers in exhaled breath
      condensate of adult patients with stable non-CF bronchiectasis.
    

Detailed description: 
      The mechanism by which macrolide antibiotics have immune modifying effects independent from
      its antibacterial activity has not been well established. In the present work, we will
      analyze the effect of long-term treatment with azithromycin (AZ) on airway oxidative stress
      markers in exhaled breath condensate of adult patients with stable non-CF bronchiectasis.
      Patients will be randomized in an open label model to receive AZ 250 mg three times per week
      during three months or nothing.Dyspnea (Borg scale), exacerbations (Nº) in the last three
      months, sputum volume (cc), sputum colour (15-point scale), and health related quality of
      life (Questionnaire St.George) will be measured in both groups before and after treatment.
      Lung function, sputum culture, CT scan (Bhalla score) and inflammatory markers in blood (ESR,
      PCR),exhaled air (Nitric Oxide,) and exhaled condensed air (pH, nitrites, isoprostane) will
      be assessed before and after treatment. Relationships between clinical and inflammatory
      markers will be studied
    

Intervention name(s): Azithromycin
Intervention type(s): Drug
Intervention description(s): 250 mg three times a week during three months
Other intervention name(s): Before treatment or after treatment
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bronchiectasis; Oxidative stress markers; Airway inflammation
Clinical Outcomes of Surgery After Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Observational

Summary: 
      The purpose of this study was to investigate the clinical outcomes of patients with locally
      advanced pancreatic cancer (LA-PC) who underwent surgery after neoadjuvant chemotherapy
      (NACT) at Asan Medical Center's Department of Hepato-Biliary-Pancreatic Surgery from 2017 to
      2020.
    

Detailed description: 
      Pancreatic cancer (PC) has a very low survival rate. Most PC patients have non-specific
      symptoms that are advanced enough to be contraindications for surgical treatment; therefore,
      surgery is often impossible by the time PC is diagnosed. According to the NCCN guidelines,
      PCs with no metastases can be divided into resectable, borderline resectable , and locally
      advanced cases. Patients with borderline resectable PC (BR-PC) and locally advanced PC
      (LA-PC) currently receive multimodal therapy before surgery. The goal of these neoadjuvant
      treatments, including chemotherapy and radiation therapy, is to ultimately reduce local
      recurrence after surgery in patients with BR-PC and further improve their survival time.
      Additionally, several recent studies have reported results on the prognosis when surgery is
      performed after neoadjuvant chemotherapy (NACT) in patients with LA-PC. In the patients with
      LA-PC, surgery technically difficult because of major vascular invasion before NACT.
      Therefore, this study investigated the clinical outcomes of patients with LA-PC who underwent
      surgery after NACT. Additionally, the investigators evaluated factors affecting the prognosis
      related to survival after surgery in patients with LA-PC.
    

Intervention name(s): surgery after neoadjuvant chemotherapy
Intervention type(s): Procedure
Intervention description(s): surgery after neoadjuvant chemotherapy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        We retrospectively reviewed records of patients who were diagnosed with resectable,
        borderline resectable, or locally advanced pancreatic adenocarcinoma between January 2017
        and December 2020, at the Department of Surgery, Asan Medical Center, Seoul, South Korea. A
        total of 1,358 patients were diagnosed with pancreatic ductal adenocarcinoma and treated.
Efficacy and Safety of XC8, Film-coated Tablets, 40 mg in Patients With Dry Non-productive Cough Against Acute Respiratory Viral Infection
Condition: Common Cold; Acute Respiratory Infection; Influenza, Human
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Virus Diseases; Common Cold; Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to assess the efficacy and safety of XC8, film-coated tablets, 10 mg in comparison with
      placebo in patients with dry non-productive cough against acute respiratory infection.
    


Intervention name(s): XC8, film-coated tablets, 10 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 80 mg/day: 4 tablets (40 mg) twice a day; 4 tablets twice a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment