bioihbjkbjnl/mcl2 huggingface dataset:
Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome
Condition: Myelodysplastic Syndrome
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, open-label, Phase 1 study to assess the safety and antitumor activity
      of MEDI4736 as Monotherapy or in Combination with Tremelimumab with or without Azacitidine in
      Subjects with myelodysplastic syndrome after treatment with hypomethylating agents
    

Detailed description: 
      A dose-escalation and dose-expansion study of MEDI4736 (a monoclonal antibody that targets
      programmed cell death-1 ligand 1 [PD-L1]) to evaluate the safety, tolerability, PK, IM, and
      antitumor activity of MEDI4736 as monotherapy or in combination with Tremelimumab with or
      without Azacitidine in adult patients with myelodysplastic syndrome.
    

Intervention name(s): MEDI4736 Evaluate MEDI4736 in MDS; VIDAZA; tremelimumab
Intervention type(s): Biological; Drug; Biological
Intervention description(s): MEDI4736 will be administered by IV infusion; VIDAZA will be administered subcutaneously as described on the package insert VIDAZA will be administered in combination with MEDI4736 upon progression from MEDI4736 monotherapy; tremelimumab will be administered by IV infusion
Other intervention name(s): durvalumab; azacitidine
Intervention MeSH terms: Azacitidine; Durvalumab; Tremelimumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myelodysplastic syndrome; MDS
Clinical Trial to Evaluate ANT-1403 in the Treatment of Primary Axillary Hyperhidrosis
Condition: Primary Axillary Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to confirm the effect of ANT-1403 in the treatment of primary
      axillary hyperhidrosis.
    


Intervention name(s): ANT-1403; placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A First Time in Man Study to Asses the Safety and Tolerability of AZD7624 in Healthy Subjects
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a First in Human study to assess the safety and tolerability of AZD7624, following
      inhaled administration of single ascending doses in healthy male volunteers and female
      volunteers of non-child bearing potential. Pharmacokinetics (what the body does to the drug)
      and pharmacodynamic (what the drug does to the body) parameters will be also assessed as
      secondary objectives.
    

Detailed description: 
      A Double-blind Placebo-controlled, Randomised, Single centre, First Time in Man Study to
      evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending
      Inhaled Doses of AZD7624 in Healthy Subjects
    

Intervention name(s): AZD7624; Placebo to match
Intervention type(s): Drug; Drug
Intervention description(s): Single dose inhaled IMP via a nebulizer; Single dose inhaled Placebo via a nebulizer
Intervention MeSH terms: AZD7624
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; Healthy Volunteers; Single Ascending Dose (SAD); First Time in Man; Pharmacokinetics; Pharmacodynamics
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy
      and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with
      relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab
      600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the
      first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks,
      with placebo injections matching interferon beta-1a SC three times per week; or interferon
      beta-1a 44 mcg SC injections three times per week (with placebo infusions matching
      ocrelizumab infusions every 24 weeks). Planned duration of double-blind treatment is 96
      weeks. Participants who complete the 96-week double-blind treatment will have an option to
      enter a single-group, active-treatment, open-label extension period, providing they fulfill
      the eligibility criteria.
    


Intervention name(s): Interferon beta-1a; Ocrelizumab-matching placebo; Ocrelizumab; Interferon beta-1a-matching placebo
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Rebif; RO4964913
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Ocrelizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
n-CPAP Versus n-BiPAP and NIPPV for Postextubation in RDS in Preterms
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

Summary: 
      non-invasive ventilation in preterms complaining from RDS a randomized, controlled trial to
      compare between capap, n-bipap and NIPPV
    

Detailed description: 
      The primary aim of this study is to compare the impact of early extubation to nasal
      continuous positive airway pressure (n-CPAP) versus nasal Bilevel positive airway pressure
      (n-BiPAP) and non invasive positive pressure ventilation(NIPPV) on the need for mechanical
      ventilation via endotracheal tube (MVET) to 7 days of age or less in preterm infants less
      than or equal to 34 weeks' gestation requiring intubation and surfactant if indicated for
      respiratory distress syndrome within 120 min of delivery . Second aim is to compare different
      outcomes of post-extubation n-CPAP , n-BiPAPand NIPPV.
    

Intervention name(s): N-CPAP; n-BiPAP; NIPPV
Intervention type(s): Device; Device; Device
Intervention description(s): The n-CPAP group will receive at extubation a single level continuous positive airway pressure of 7 cm water for at least 48 hours before weaning is commenced. If the infant is stable for the preceding 48 hours defined by having fewer than three minor apneas and no increase in oxygen requirement, weaning will be permitted.
CPAP will be decreased from 6 cm water by 1 cm water every 24 hours if tolerated based on the above criteria. This will be done until a pressure of 4 cm water is reached.
If a pressure of 4 cm water is successfully tolerated for 48 hours then time off n-CPAP will be allowed. Thereafter, no fixed weaning regime based on number of hours in a day the infant will be allowed to come off CPAP will be prescribed.; The n-BiPAP group will receive at extubation a mean airway pressure of 7 cm water (positive end expiratory pressure of 5 cm water and peak inspiratory pressure of 9 cm of water). Inspiratory time of one second and respiratory rate of 30/min will always be maintained.
The infant will then receive a mean airway pressure of 5 cm water (positive end expiratory pressure of 4 cm water and peak inspiratory pressure of 6 cm of water).; The NIPPV group will receive at extubation a positive end expiratory pressure of 5 cm water , a peak inspiratory pressure of 9 cm of water, RR of 35 and ti of 0.32
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Timing of Surgical Intervention After Percutaneous Catheter Drainage in STEP UP Approach for Severe Acute Pancreatitis
Condition: Acute Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional

Summary: 
      1. To determine the appropriate timing of surgical intervention after Percutaneous Catheter
           Drainage (PCD) in infected pancreatic necrosis (IPN).

        2. To see the change in morbidity and mortality after changing the interval of surgery
           after PCD
    

Detailed description: 
      In present study we plan to determine the appropriate timing of surgical intervention after
      PCD in step up approach of Infected pancreatic necrosis (IPN).

      The investigators also intend to evaluate the role of PCD in obviating the surgical
      intervention in the management of IPN and evaluate the risks & benefits of extended treatment
      policy of PCD in step up approach of IPN in comparison to early surgery after PCD.
    

Intervention name(s): surgical intervention after percutaneous catheter drainage
Intervention type(s): Procedure
Intervention description(s): Patients who are not improving by day 10 after PCD insertion will be included in the present study and are randomized to group A (early surgery i.e. between 10-15days after PCD insertion ) or group B (Extended treatment with PCD with saline irrigation for more than 15days after PCD insertion)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation of Sacroiliac Fusion Treatment (INSITE)
Condition: Degenerative Sacroiliitis; Sacroiliac Joint Disruption
MeSH terms: Sacroiliitis
Study type: Interventional

Summary: 
      The purpose of this study is to compare outcomes when patients with degenerative sacroiliitis
      (arthritis of the SI joint) and or sacroiliac disruption (abnormal separation or tearing of
      the sacroiliac joint)undergo either SI joint fusion with the iFuse Implant System or undergo
      specific, targeted non-surgical treatment of the SI joint.
    

Detailed description: 
      The intended analysis was to examine differences in responses at 6 months. It was
      acknowledged that subjects with chronic pain in the NSM arm group might not experience any
      benefit as there was little evidence at the time that NSM was helpful. The protocol included
      optional crossover to other treatments, including surgical treatment. The protocol
      anticipated a high crossover rate and therefore did not include any comparative analyses
      after month 6.
    

Intervention name(s): iFuse Implant System; Non-surgical management
Intervention type(s): Device; Other
Intervention description(s): Placement of iFuse implant system via surgery; Medications for pain, physical therapy, SI joint injection and RF ablation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel group randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: si joint; si joint pain; si joint injury; si joint treatment; si joint injections; si joint inflammation; si joint problems; si joint symptoms; hypermobile si joint; si joint arthritis; si joint pain treatment; inflamed si joint; si joint sclerosis; locked si joint; si joint injuries; si joint disease; si joint infection; sacroiliac joint pelvic pain; sacroiliac joint arthritis treatment
Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation
Condition: Atrial Fibrillation; Hypertension
MeSH terms: Hypertension; Atrial Fibrillation
Study type: Interventional

Summary: 
      The purpose of this clinical study is to evaluate the feasibility of performing both renal
      nerve denervation and pulmonary vein isolation on the same patient with the intent of
      characterizing both safety and effectiveness in a paroxysmal and persistent atrial
      fibrillation population with hypertension. To assess safety, the study will measure the
      occurrence of a composite safety endpoint and, to assess effectiveness, the study will
      measure freedom of chronic treatment failure through a minimum of six months of follow-up.
    


Intervention name(s): Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter; Arctic Front Advance™ Cardiac Cryoablation System
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cranial Electrotherapy Stimulation in Burned Patients
Condition: Post Traumatic Stress Disorders; Burns
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      To find out if Cranial Electrotherapy Stimulation is a useful treatment for people who have
      been burned and have Post Traumatic Stress Disorder. CES may be helpful in giving relief to
      some or all of those symptoms.
    

Detailed description: 
      The purpose of this research study is to systematically determine if CES therapy is effective
      in managing post traumatic stress disorder (PTSD) in the burn patient. Cranial Electrotherapy
      Stimulation (CES) is the delivery of low-level electrical stimulation across the head,
      delivered with ear lobe electrode clips or self-adhesive electrode pads. CES in the current
      form has been used for the past 30 years to successfully treat anxiety, depression, insomnia
      and pain in a variety of patient populations. This FDA approved medical device is
      non-invasive and has no reported significant side effects. It will be used on patients
      undergoing outpatient rehabilitation in our burn center.
    

Intervention name(s): Alpha Stim 100 (Cranial Electrotherapy Stimulation)
Intervention type(s): Device
Intervention description(s): cranial electrical stimulation 100 microamps
Other intervention name(s): Alpha Stim 100- Electromedical Products International, Inc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: anxiety; insomnia; pain; Alpha Stim; Cranial electrotherapy stimulation
Extended ECG Monitoring in HCM Patients
Condition: Hypertrophic Cardiomyopathy; Nonsustained Ventricular Tachycardia; Ventricular Tachycardia; Atrial Fibrillation; Arrhythmia
MeSH terms: Atrial Fibrillation; Cardiomyopathies; Tachycardia; Tachycardia, Ventricular; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Observational

Summary: 
      The purpose of this study is to determine, among a large cohort of 300 consecutive patients
      with hypertrophic cardiomyopathy, if extended ambulatory monitoring using the iRhythm
      Technologies, Inc. Zio XT device results in identifying a greater burden of nonsustained
      ventricular tachyarrhythmia (nsVT) compared to current ACCF/AHA guideline recommended 48-hour
      monitoring.
    

Detailed description: 
      Optimal duration to monitor patients for identifying nsVT remains unclear. The investigators
      aim to determine the prevalence and burden of nsVT with longer term monitoring with the
      iRhythm Zio XT device over a 2-week period vs. 48 hours; and whether, this greater burden of
      nsVT compared to conventional shorter monitoring potentially identifies a subset of HCM
      patients who may be at higher risk of sudden cardiac death.
    

Intervention name(s): Zio XT
Intervention type(s): Device
Intervention description(s): ambulatory cardiac monitoring device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients from the hypertrophic cardiomyopathy population will be recruited.
      
Keywords: electrocardiography; electrocardiogram; mobile cardiac monitoring; ambulatory monitoring; ECG; EKG
Activating and Connecting Teens (ACT) Study
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      National data indicate over 650,000 children and adolescents are exposed to physical, sexual,
      or emotional abuse or physical or emotional neglect each year. Moreover, youth with a history
      of childhood maltreatment (CM) are at least twice as likely to develop depression and are at
      substantial risk for nonresponse to current best practice depression interventions (i.e.,
      cognitive behavioral therapy and antidepressants) compared to non-maltreated peers. Research
      suggests that CM increases risk for depression through disruptions in the positive valence
      system, such as reward processing, and Behavioral Activation (BA) may be an alternative
      depression intervention that targets these deficits. This study takes an innovative approach
      integrating neural, behavioral, and novel mobile technologies to measure longitudinal change
      in reward processing as a mechanism of BA intervention response among depressed adolescents
      with a history of CM. Specifically, depressed adolescents with a history of CM will complete
      pre- and post- BA intervention fMRI and behavioral measures of reward processing along with
      daily passive mobile monitoring of physical (steps) and social (amount of texts, calls,
      social media usage) activity to determine 1) how BA targets neural and behavioral reward
      processing and real-world behavioral engagement (Specific Aim 1), and 2) whether change in
      neural and behavioral reward processing predicts intervention response and maintenance
      (Specific Aim 2).
    


Intervention name(s): Behavioral Activation
Intervention type(s): Behavioral
Intervention description(s): The Adolescent Behavioral Activation Program (ABAP) will be used as the BA protocol. ABAP was developed and validated by McCauley, Dimidjian et al. to adapt BA to adolescents. ABAP is a 12-week protocol that utilizes an idiographic approach to foster rewarding experiences, effective problem solving, and goal attainment, and decrease avoidance, barriers to activation, and depressive rumination that may be contributing to depression severity and maintenance.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Childhood adversity; Behavioral Activation; Reward Processing; fMRI
Cold Application in Lateral Epicondylitis
Condition: Lateral Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      Purpose: The purpose of this study was to investigate which cold application is more
      effective to regulate skin temperature in patients with lateral epicondylitis. Materials and
      Methods: Fifty-four patients with lateral epicondylitis were randomly divided into 2 groups
      as cooling gel (n=27) group and cold pack (n=27) group. Cooling gel and cold pack
      applications were applied on painful lateral epicondyle region for 15 minutes. Patients were
      assessed before and after the application. Assessments included the severity of pain during
      wrist extension, evaluated by Visual Analog Scale (VAS) and thermal imaging of lateral
      epicondyle region evaluated by Infrared Thermography (FLIR5 Thermal Camera).
    


Intervention name(s): Cooling Gel; Cold Pack
Intervention type(s): Other; Other
Intervention description(s): Cooling gel (Nelsons Arnicare Arnica Cooling Gel) was applied to the lateral epicondyle region with sponge head 3 times a day. The cooling gel was applied to the painful area around the lateral epicondyle; Cold pack was applied to the painful area for 15 minutes on a moist towel placed on the painful area around the lateral epicondyle.
Intervention MeSH terms: Methyl salicylate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Fifty-four volunteers diagnosed with lateral epicondylitis were included in our study and were randomly divided into two groups.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kinesio Tape; Thermal Analysis; Cold
A Study of Omalizumab (Xolair) in Subjects With Moderate to Severe Persistent Asthma (EXTRA)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy,
      safety, and tolerability of subcutaneously administered Xolair as add-on therapy for the
      treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are
      inadequately controlled with high-dose inhaled corticosteroids (ICS)+ long-acting
      beta-agonists (LABA) with or without additional controller therapy.
    


Intervention name(s): omalizumab (Xolair); placebo; corticosteroids; long-acting beta-agonists
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Omalizumab (Xolair) was administered by subcutaneous (SC) injection every 2 or 4 weeks. Xolair was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that were reconstituted with Sterile Water for Injection (SWFI), USP.; Placebo was administered by subcutaneous (SC) injection every 2 or 4 weeks. Placebo contained the same ingredients as the lyophilized formulation of Xolair,excluding omalizumab.; Minimum dose of 500 µg of fluticasone dry-powder inhaler or its equivalent ex-valve dose twice a day.; 50 µg salmeterol twice daily or 12 µg formoterol twice daily.
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Persistent Asthma; EXTRA; Xolair; Difficult Breathing
Effect of Prophylactic Prosthesis Placement With Versus Without Omega-3 at the Umbilical Trocar Level on Surgical Site Infection and Herniation After Laparoscopic Cholecystectomy in Patients With Risk Factors.
Condition: Surgical Site Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection
Study type: Observational

Summary: 
      TITLE:

      Effect of prophylactic prosthesis placement with versus without omega-3 at the umbilical
      trocar level on surgical site infection and herniation after laparoscopic cholecystectomy in
      patients with risk factors.

      OBJECTIVE: To evaluate whether the placement of a synthetic prosthesis with omega-3 in its
      composition at the level of the umbilical trocar after laparoscopic cholecystectomy versus
      the placement of a synthetic umbilical prosthesis without omega-3 in its composition
      decreases the rate of surgical site infection (SSI) and trocar site hernia (TSH) in patients
      with risk factors for infection and herniation.
    

Detailed description: 
      METHODS: A prospective study was conducted with 2 consecutive series of patients operated on
      for cholelithiasis who also had some of the following risk factors that increase the
      occurrence of SSI or TSH: BMI > 30 kg/m2, diabetes mellitus, age > 65 years and chronic
      obstructive pulmonary disease. A circular prosthesis with an omega-3 coating was placed in
      patients in group A, and a prosthesis without omega-3 in its composition was placed in
      patients in group B. The main variables evaluated were the occurrence of SSI and TSH.
    

Intervention name(s): MESH WHIT OMEGA-3; MESH WITHOUT OMEGA-3
Intervention type(s): Procedure; Procedure
Intervention description(s): Mesh placement with Omega-3 at the umbilical trocar level after laparoscopic cholecystectomy in patients with risk factors for SSI and eventration.; Mesh placement without Omega-3 at the umbilical trocar level after laparoscopic cholecystectomy in patients with risk factors for SSI and eventration.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients were between the ages of 18 and 90 years, underwent elective laparoscopic
        cholecystectomy for symptomatic cholelithiasis and had one of the following risk factors
        that increase the occurrence of SSI or TSIH, included in general surgery consultations.