bioihbjkbjnl/mcl2 huggingface dataset:
Infiltration in the Region of the Palatine Ganglion Spheno by Ropivacaine on Postoperative Pain
Condition: Pain
MeSH terms: Ganglion Cysts; Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      Endoscopic sinus surgery (ESS) is a prevalent surgical procedure. It is required in many
      chronic rhinosinusitis for whom the medical treatment failed. In order to improve the
      postoperative management of patients treated with ESS, we aim to assess the analgesic action
      of local injection of ropivacaine in the nasal fossa.
    

Detailed description: 
      A prospective randomized double blind placebo controlled study was designed. Local injection
      of ropivacaine or placebo was conducted at the end of the surgical procedure in both nasal
      fossa through endoscopic view in the sphenopalatine region.

      Pain was measured in the postoperative course with visual analogic scale in the recovery room
      and the rhinologic department.
    

Intervention name(s): ropivacaine; saline solution 0.9%
Intervention type(s): Drug; Drug
Intervention description(s): injection of 4mL of ropivacaine in the sphenopalatine area through an endoscopic approach; injection of 4 mL of saline solution in the sphenopalatine area through an endoscopic approach
Other intervention name(s): NAROPEINE; NaCL 0.9% injectable
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sinus surgery; sphenopalatin ganglion; ropivacaine; local anesthesia
A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure
Condition: Heart Failure, Congestive
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is a single center, open-label, dose-finding study of recombinant human relaxin
      (rhRlx) given intravenously (IV) to patients with stable, compensated CHF.
    

Detailed description: 
      Serial cohorts of patients with stable CHF will be enrolled upon meeting eligibility
      criteria. Dose escalation will be guided by hemodynamic response, safety and tolerability.
      The effects of rhRlx on hemodynamics will be assessed.
    

Intervention name(s): Relaxin
Intervention type(s): Drug
Intervention MeSH terms: Methocarbamol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Congestive heart failure; Relaxin; Cardiac hemodynamics
Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a multi-center, randomized, open-label and positive controlled Phase II
      Clinical trial to assess the efficacy and safety of Ypeginterferon alfa-2b (with Ribavirin),
      once a week, in 3 dose-groups respectively, for treatment of Chronic Hepatitis C patients,
      with Pegasys 180mcg/week & Ribavirin as positive control. It is aimed to establish a dose
      response and safety relationship sufficient to allow the subsequent design and conduct of
      Phase III trials, and generate the PK data in hepatitis C patients to satisfy regulatory
      requirements.
    


Intervention name(s): Ypeginterferon alfa-2b; Peginterferon alfa-2a
Intervention type(s): Drug; Drug
Intervention description(s): sc, qw, for 48 weeks.; sc, qw, for 48 weeks.
Other intervention name(s): Peginterferon alfa-2b; Pegasys
Intervention MeSH terms: Peginterferon alfa-2a; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCV; CHC; Hepatitis C, Chronic; Liver Diseases; Hepatitis, Chronic; Hepatitis, Viral, Human; Hepadnaviridae Infections; Antiviral Agents; Virus Diseases; Peginterferon alfa
Maladaptive Psychosocial Beliefs and Adolescents With Patellofemoral Pain
Condition: Patellofemoral Pain Syndrome; Knee Pain Chronic; Patellofemoral Syndrome; Anterior Knee Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      This is a randomized prospective study assessing the impact of psychosocial factors on pain
      and physical performance among adolescents with patellofemoral pain. A set of psychosocial
      surveys assessing fear avoidance beliefs, kinesiophobia, and pain catastrophizing will be
      completed by the participant/parents. Participants will then complete an activity
      questionnaire, numeric pain rating scale, and a self-report questionnaire of functional
      ability. Participants will then be randomized into one of two groups (psychologically
      informed education group and a control group). Participants will view a series of educational
      videos (based upon group assignment) and complete physical therapy exercises for lower
      extremity strengthening, flexibility, and neuromuscular control. Participants with
      patellofemoral pain will then complete follow-up surveys of their psychosocial beliefs, pain
      and self-reported functional ability through REDcap at immediately post-intervention, 1 week,
      3 weeks, 6 weeks, and 3 months.
    


Intervention name(s): Psychologically Informed Education; Biomedical Education (Control)
Intervention type(s): Other; Other
Intervention description(s): This arm will provide an education intervention which will attempt to address maladaptive psychological behaviors in adolescents with knee pain; This arm will provide education of basic knee anatomy, lower extremity mechanics, and simple exercises and will not address maladaptive psychological behaviors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee; Adolescent; Psychologically-informed; Anterior Knee Pain
Lung Ultrasound and Alveolar Recruitment in Mechanically Ventilated Infants
Condition: Pulmonary Atelectasis
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      Investigators hypothesized that lung ultrasound-assisted recruitment maneuver would be
      beneficial in mechanically ventilated infants compared to those who did not receive lung
      ultrasound and alveolar recruitment maneuver.
    


Intervention name(s): Lung ultrasound
Intervention type(s): Device
Intervention description(s): Lung ultrasound on both hemithorax in supine position
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: ultrasonography; infant; perioperative period; general anesthesia
Preoperative Ultrasound as a Predictor for Difficulty in Bariatric Surgery
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      the left lobe of the liver in obese patient usually fatty and enlarged and may cause
      difficulty during bariatric surgery. the aim of this study is to test the impact of routine
      preoperative ultrasound to evaluate the size of left lobe of the liver as a preoperative
      predictor for difficulty
    

Detailed description: 
      the left lobe of the liver in obese patient usually fatty and enlarged and may cause
      difficulty during bariatric surgery. the aim of this study is to test the impact of routine
      preoperative ultrasound to evaluate the size of left lobe of the liver as a preoperative
      predictor for difficulty. two equal groups of patients are operated by laparoscopic sleeve
      gastrectomy with loop bipartition, in one group routine abdominal ultrasound is done, in the
      other group ultrasound not routinely done.
    

Intervention name(s): Routine measurement of left lobe; control group
Intervention type(s): Other; Other
Intervention description(s): Routine preoperative measurement of left lobe; no routine preoperative measurement of left lobe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir
      given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) versus
      treatment with peg-IFN and RBV alone in Japanese treatment-naïve participants with chronic
      hepatitis C (CHC) genotype (GT)1. The primary efficacy hypothesis is that the percentage of
      participants achieving sustained virologic response 24 weeks after completion of all study
      therapy (SVR24) in at least one of the vaniprevir arms is superior to the percentage of
      participants achieving SVR24 in the control arm.
    


Intervention name(s): vaniprevir; Placebo to vaniprevir; Peg-IFN; ribavirin
Intervention type(s): Drug; Drug; Biological; Drug
Intervention description(s): Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks; Placebo to vaniprevir, capsules, orally, twice daily for 12 weeks or 24 weeks; Peg-IFN 1.5 μg/kg once per week, subcutaneously (SC) for 24 or 48 weeks; Capsules containing 200 mg RBV orally, 3 to 5 capsules, dosage based on the participant's weight (600 mg/day to 1000 mg/day), for 24 or 48 weeks
Other intervention name(s): MK-7009; PegIntron; REBETOL®
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety/Effectiveness of Adding Monthly Dexamethasone to Weekly Avonex for MS
Condition: Relapsing-remitting Multiple Sclerosis; Clinically Isolated Syndrome
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      The purpose of the study is to determine whether giving intravenous dexamethasone every 4
      weeks during the first 12 months of weekly Avonex dosing will reduce the progression of
      functional impairment, brain atrophy, relapse rate and frequency, and new and enlarging brain
      lesions over the first 24 months of Avonex therapy in patients with relapsing-remitting or
      mono-symptomatic multiple sclerosis.
    

Detailed description: 
      Beta Interferon-1a (Avonex)was approved by the FDA in 1996 to treat relapsing-remitting
      multiple sclerosis. Clinical trials have shown evidence in the reduction of relapses and
      progression of neurological and cognitive disability with the use of Avonex, as well as
      reduction in brain atrophy and new MS lesions on MRI were observed. Despite this, Avonex does
      not abolish disease activity, therefore, there is frequent need for adjunctive therapy, such
      as short courses of corticosteroids.

      This study will research the value of adding monthly pulsed corticosteroids as adjunctive
      therapy during the first year of Avonex use to determine: a)safety and tolerability b)if this
      therapy will reduce the progression of functional impairment, and c)if this therapy will
      reduce the progression of whole brain atrophy over a 13 month observation period.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Treatment-naive MS patients with either RRMS or CIS, of either gender, between 18 to 55
        years of age inclusive, with baseline EDSS of 0 to 3.5, fulfilling McDonald criteria for MS
        or CHAMPS criteria for CIS, were randomly assigned to one of two treatment groups.
      
Keywords: Multiple Sclerosis; Interferon Beta 1-a; Pulsed steroids
A Study to Evaluate the Effects of ER Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites (0524A-079)(COMPLETED)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER
      niacin, laropiprant, and placebo over the course of seven days on urinary levels of a
      specific metabolite (which is a marker of in vivo platelet reactivity).
    

Detailed description: 
      Subjects will receive 1 of 4 treatments per period and will eventually receive all 4
      treatments:

      Treatment A: ER niacin 2g/laropiprant 40 mg daily + Placebo to laropiprant for 7 days

      Treatment B: ER niacin 2 g daily + Placebo to laropiprant for 7

      days

      Treatment C: laropiprant 40 mg daily + Placebo to ER niacin/laropiprant for 7 days

      Treatment D: placebo daily for 7 days. There will be at least a 7-day interval between dosing
      on Day 7 of a period and dosing on Day 1 of the subsequent period
    

Intervention name(s): Comparator: ER niacin (+) laropiprant; Comparator: ER niacin; Comparator: laropiprant; Comparator: placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ER niacin 2 g/ laropiprant 40 mg daily for 7 days.; ER niacin 2 g daily for 7 days.; laropiprant 40 mg daily for 7 days.; matching placebo tablets for each of the interventions once daily for 7 days
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness
Condition: Dizziness Chronic
MeSH terms: Vertigo; Dizziness
Study type: Interventional

Summary: 
      Researchers are gathering information on the safety and effectiveness of a new device called
      the BalanceBelt.
    

Detailed description: 
      Ten consecutive subjects, ages 25-70 years, diagnosed with Chronic Subjective Dizziness (CDS)
      and ten healthy age and gender matched subjects will be asked to perform tests involving
      walking and balance while wearing the BalanceBelt. The BalanceBelt is a lightweight belt that
      will be worn under the clothes around the subjects waist and uses sensitive motion detectors
      and vibrates against the skin at four locations to provide information about posture and
      motion.
    

Intervention name(s): Balance Belt
Intervention type(s): Device
Intervention description(s): Vestibular habituation therapy worn under the clothes around the waist that uses sensitive motion detectors and vibrates against the skin at four locations to provide information about posture and gait
Other intervention name(s): Stabalon Belt; Vibrating Belt
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pilot study; Assessment of sway phase; Therapy trial phase
A Study of Octave System for Improving Lines and Wrinkles of the Décolleté
Condition: Décolleté Wrinkles
Study type: Interventional

Summary: 
      To demonstrate the safety and effectiveness of the Octave System for improving lines and
      wrinkles of the décolleté.
    


Intervention name(s): Octave-Ultherapy treatment
Intervention type(s): Device
Intervention description(s): Micro-focused ultrasound delivered below the surface of the skin.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combination Therapy in Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to determine the safety and the efficacy of Tretinoin and
      Pioglitazone HCL in patients with ALS who are currently on Riluzole.
    

Detailed description: 
      Physicians at Phoenix Neurological Associates (PNA) are looking for individuals diagnosed
      with ALS to participate in a double-blind, placebo controlled study of Tretinoin and
      Pioglitazone HCL, used in combination with Riluzole, for treating ALS. This investigator
      initiated trial conducted by Dr. Todd Levine and Dr. David Saperstein will help determine
      whether Tretinoin and Pioglitazone HCL, in combination, can slow the progression of ALS.

      At present, there is little to no effective therapy for ALS, nor is there a known cause.
      Therefore there is a tremendous unmet need for more effective therapy for this disease and
      that is why the physicians at PNA have been very interested in the role of developing a more
      active anti-excitotoxic cocktail for patients with ALS. Since recent data have suggested that
      inflammatory mechanisms may interact with and promote neurodegeneration (where cells in the
      spinal cord and brain are lost), there have been a number of anti-inflammatory treatment
      strategies that have been evaluated in animal models. Some studies have shown that mice that
      were given Pioglitazone HCL demonstrated improved muscle strength and body weight, exhibited
      a delayed disease onset as well as had a longer survival rate compared to non treated mice.

      In addition to these studies, retinoic acids have been studied extensively in various models
      of the injured nervous system. These studies have shown that retinoic acids, such as
      Tretinoin may be neuroprotective and support axonal growth, which could in turn slow disease
      progression.

      The purpose of this study is to determine if such a drug "cocktail" could offer the best
      chance of attaining a significant reduction in disease progression by utilizing currently
      available FDA-approved agents
    

Intervention name(s): Pioglitazone and Tretinoin; Tretinoin and Pioglitazone HCL; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tretinoin: 1 pill twice a day (10 mg/bid) Pioglitazone HCL: 1 pill once a day (30 mg/qd); Tretinoin 10 mg 1 pill po twice a day Pioglitazone HCL 30 mg 1 pill po once a day; Placebo
Intervention MeSH terms: Pioglitazone; Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ALS Treatment; Tretinoin; Pioglitazone HCL; Actos; Tau levels; ALS
The Effect of Lifestyle Intervention Versus Gastric Bypass on Various Comorbidities in Morbidly Obese Subjects
Condition: Obstructive Sleep Apnea; Diabetes Mellitus; Hypertension
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      This follow up study (>1 year) aims to compare the effects of lifestyle intervention and
      gastric by pass surgery on various comorbidities associated with morbid obesity.
    

Detailed description: 
      Not addressed
    

Intervention name(s): Bariatric surgery; Intensive lifestyle intervention
Intervention type(s): Procedure; Behavioral
Intervention description(s): Bariatric surgery as a part of public health service offered treatment seeking morbidly obese patients.; Intensive lifestyle intervention as a part of public health service offered treatment seeking morbidly obese patients.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the efficacy of acute treatment with 10 mg/day vortioxetine versus placebo on
      cognitive performance (focusing on the aspect concerning speed of processing, executive
      functioning, attention) in working patients with major depressive disorder (MDD).
    


Intervention name(s): Vortioxetine 10 mg; Paroxetine 20 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Brintellix®; Lu AA21004
Intervention MeSH terms: Vortioxetine; Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of GFH312 in Healthy Subjects
Condition: Toxicity; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      GFH312 is a small molecule inhibitor of receptor-interacting serine/threonine protein-1(RIP1)
      kinase, a key regulator of the TNF-α downstream. RIPK1 can regulate the NF- κB signaling and
      necroptosis, a type of cell death which can trigger immune response and enhance inflammation.
      As such, GFH312 represents a novel, selective mechanism for the treatment of inflammatory
      conditions.

      This study is the first administration of GFH312 to humans. The purpose of the study is to
      evaluate the safety/tolerability and pharmacokinetics in healthy subjects. The intention of
      this study is to provide confidence in the safety of the molecule to inform progression to
      further proof-of-concept studies. The dose range proposed in this study is based on a low
      starting dose escalating to supra-therapeutic doses.
    


Intervention name(s): GFH312; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses; Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study drug: GFH312 and placebo In part Ia, subjects will be randomized and dosed in different cohorts in single dose. In part Ib, one of the cohorts will selected as food effect cohort with washout period of part Ia.
In part II, subjects will be randomized and dosed in different cohorts in multiple doses.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Safety; Tolerability; Pharmacokinetics
Pain Management for Cystoscopy: A Prospective Randomized Study Focused on Understanding the Role of the "Bag Squeeze" to Manage Pain for Patients Undergoing Cystoscopy
Condition: Pain, Procedural
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether utilization of the "bag squeeze" technique
      during flexible cystoscopy changes pain scores using a study questionnaire designed by the
      team which comprises a validated Lingard pain rating scale.
    


Intervention name(s): Bag Squeeze; No Bag Squeeze
Intervention type(s): Procedure; Procedure
Intervention description(s): Participants will receive a "bag squeeze" of irrigation fluid (500 ml/~2 cups of % 0.9 saline solution) during the insertion of the cystocopy tube during their cystocopy.; Participants will receive a standard cystocopy procedure as per standard of care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other