bioihbjkbjnl/mcl2 huggingface dataset:
An Investigator Initiated, Within-Subject, Proof of Concept Study to Assess the Efficacy and Safety of Voltaren Gel in Subjects With DOMS
Condition: Pain; Delayed Onset Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate analgesic efficacy of Topical Voltaren Gel
      (diclofenac sodium gel) 1% applied QID compared to Placebo in Subjects Experiencing Delayed
      Onset Muscle Soreness.
    

Detailed description: 
      The purpose of this randomized, double-blind, placebo controlled, within-subject study is to
      evaluate the efficacy of topical diclofenac sodium gel (DSG) 1% in reducing pain associated
      with delayed onset muscle soreness (DOMS). Following exercise, subjects reporting significant
      DOMS received topical DSG 1% applied to 1 leg and placebo applied to the other every 6 hours
      for 48 hours.
    

Intervention name(s): 1% diclofenac sodium gel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours; Placebo gel 4gm applied topically Q6 hour for 48 hours
Other intervention name(s): Voltaren; Matching placebo
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: DOMS
Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma in Healthy and Sick Children
Condition: Colloid Osmotic Pressure
Study type: Observational

Summary: 
      The purpose of this study is to measure colloid osmotic pressure in interstitial fluid and
      plasma in healthy children under two years, in asphyxiated babies and in children undergoing
      heart surgery.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Asphyxiated babyes Children with heart defects who need surgery Newborn who need blood
        transfusion
      
Biospecimen description: 
      Plasma and interstitial fluid
    
Keywords: Colloid Osmotic pressure in interstitial fluid; Colloid Osmotic pressure in plasma; Protein fractions in interstitial fluid
A Study Designed to Compare 2 Dose Strengths of TI Inhalation Powder in Adults With Type 1 Diabetes Mellitus and to Compare One of Those Formulations (30Units) With an Injection of Insulin Lispro
Condition: Diabetes Mellitus: Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      28 subjects to be enrolled for a screening period, 3 dosing visits & a follow-up visit.
      Visits 2 and 3 dosing of TI Inhalation Powder, cross over between two 15 U cartridges and one
      30 U cartridge. Visit 4 dosing will be a sc injection of 10 IU of RAA (rapid-acting insulin
      analogue).
    

Detailed description: 
      28 eligible subjects were planned to be enrolled to determine bioequivalence and safety
      parameters of two 15 U TI Inhalation Powder cartridges versus one 30 U TI Inhalation Powder
      cartridge, according to a randomized, 2-way crossover design. Additionally, bioavailability
      of one 30 U TI Inhalation Powder cartridge to a single subcutaneous injection of 10 IU of RAA
      will be compared.
    

Intervention name(s): Technosphere® Insulin Inhalation Powder; Technosphere Insulin® Inhalation Powder; RAA Population
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TI Inhalation Powder, two 15 U cartridges; TI Inhalation Powder, one 30 U cartridge; RAA Population: All subjects received a single 10 IU sc injection of insulin lispro.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetic adult male, diabetic adult female
Evaluation of Cutera Excel V™ Laser With Green Genesis and Micro-Lens Array (MLA)Attachment
Condition: Wrinkle; Rosacea; Scarring
MeSH terms: Rosacea
Study type: Interventional

Summary: 
      Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array (MLA) Attachment
    

Detailed description: 
      This is an open-label, prospective, single-center, split-face Feasibility study to Evaluate
      1) the safety and efficacy of the Cutera excel V™ laser and the Micro-Lens Array attachment
      to the Genesis V hand piece, and 2) the safety and efficacy of the Cutera excel V™ laser
      Green Genesis V hand piece to the CoolView hand piece.
    

Intervention name(s): Excel V™ Laser With Green Genesis
Intervention type(s): Device
Intervention description(s): Subject(s) will receive treatments with a Cutera Excel V™ Laser
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Pulse Width on Scar Treatment Using a 595-nm Pulsed Dye Laser
Condition: Keloids; Hypertrophic Scars
MeSH terms: Keloid; Hypertrophy; Cicatrix, Hypertrophic
Study type: Interventional

Summary: 
      To investigate the effect of pulse width on the treatment response of keloidal and
      hypertrophic sternotomy scars to a 595-nm pulsed dye laser
    

Detailed description: 
      The pulse width of the previous model of pulsed dye laser was fixed at 0.45 millisecond,
      whereas the pulse widths of the latest model of PDL are tunable ranging between 0.45-40
      milliseconds. The long-pulsed PDL has been proven to be safe and more effective in treating
      certain vascular abnormalities including adult port-wine-stain and small leg vein.9-12 In the
      present study, we would like to investigate the effect of pulse widths on the treatment
      response of keloidal and hypertrophic sternotomy scars to the 595-nm PDL.
    

Intervention name(s): Pulsed dye laser
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Pulsed dye laser; Keloids; Hypertrophic scars; Pulse width; Pulse duration
Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Renal Function
Condition: Long QT Syndrome
MeSH terms: Renal Insufficiency; Long QT Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral
      dose of eleclazine and its metabolite, GS-623134, in participants with normal and impaired
      renal function. Participants in the healthy control group will be matched to participants
      with impaired renal function by age (± 5 years), gender, and body mass index (± 10%).
    


Intervention name(s): Eleclazine
Intervention type(s): Drug
Intervention description(s): Eleclazine tablets administered orally in morning with food
Other intervention name(s): GS-6615
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal Impairment
A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of AL-335
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of
      AL-335 in participants with various degrees of impaired renal function (mild, moderate, and
      severe) compared to participants with normal renal function.
    


Intervention name(s): AL-335
Intervention type(s): Drug
Intervention description(s): Participants with various degrees of impaired renal function (mild [Cohort 1], moderate [Cohort 2], severe [Cohort 3]) and normal renal function (Cohort 4) will receive a single oral dose of AL-335 800 mg (given as 2*400-mg tablets).
Intervention MeSH terms: Adafosbuvir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Atrial Fibrillation in Cryptogenic Stroke and TIA
Condition: Atrial Fibrillation; Ischemic Stroke; TIA
MeSH terms: Stroke; Ischemic Stroke; Atrial Fibrillation
Study type: Observational

Summary: 
      Background:

      Different studies with real-life data and randomized controlled trials have shown a detection
      rate of paroxysmal atrial fibrillation (AF) of 10-20% in patients with cryptogenic stroke
      using insertable continuous cardiac monitoring for 6 months. More studies are needed,
      however, to identify factors which can be used to select the patients where the possibility
      of detecting AF with prolonged rhythm monitoring is highest, to evaluate the best duration of
      rhythm monitoring, to determine the optimal deﬁnition of short-term AF that warrants
      intervention and to evaluate whether intervention results in improved clinical outcomes.

      Methods: The NOR-FIB study is a multi-centre prospective observational trial, designed to
      evaluate detection of AF in cryptogenic stroke and transient ischemic attack (TIA). Patients
      admitted with cryptogenic stroke or TIA in stroke units in the Nordic countries, aged 18-80
      years are included and have the Reveal LINQ® Insertable cardiac monitor system implanted for
      12 months for the purpose of AF detection. Biomarkers that may identify patients, who could
      derive the most clinical benefit from the detection of AF by prolonged monitoring, are being
      studied.

      Conclusion: This NOR-FIB study will increase our knowledge regarding the occurrence of AF in
      patients with cryptogenic stroke and TIA that potentially can improve secondary prevention.
      The study will provide information on biomarkers that may be used to select cryptogenic TIA
      and stroke patients for long-term monitoring as well as information on the significance of
      short-term AF and optimal duration of cardiac rhythm monitoring.
    


Intervention name(s): Medtronic Reveal LINQ
Intervention type(s): Device
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to stroke units with cryptogenic ischemic stroke or TIA
      
Biospecimen description: 
      blood samples
    
Keywords: etiology
Electroconvulsive Therapy in Clozapine Refractory Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Schizophrenia, Treatment-Resistant
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate electroconvulsive therapy (ECT) in patients who have not responded
      adequately to clozapine.
    

Detailed description: 
      ECT augmentation of clozapine will be compared to clozapine monotherapy in schizophrenic
      patients who continue to have psychotic symptoms despite optimal treatment with clozapine.
    

Intervention name(s): Electroconvulsive Therapy (ECT); Clozapine
Intervention type(s): Procedure; Drug
Intervention description(s): ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.; Patients with psychotic symptoms will receive clozapine
Other intervention name(s): Clozaril
Intervention MeSH terms: Clozapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Electroconvulsive Therapy
Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] NKTR-118
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to Assess the Absorption, Metabolism and Excretion of [14C] NKTR-118 after a
      Single-Dose Oral Administration.
    


Intervention name(s): [14C] NKTR-118
Intervention type(s): Drug
Intervention description(s): Single 25 mg oral dose administered on Day 1
Intervention MeSH terms: Naloxegol
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Radioactive carbon; Absorption; Distribution; Metabolism; Excretion; Healthy Volunteers
Reducing the Harmful Effects of Cannabis Use: Finding the Optimal CBD:THC Ratio
Condition: Cannabis Use
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      This study will recruit healthy volunteers who use cannabis infrequently. Each participant
      will attend the laboratory on five occasions: an initial visit to check that they are safe to
      join the study and four days of testing.

      Participants will be administered, in a randomized order, vaporized cannabis containing one
      of four different ratios of CBD:THC (0:1, 1:1, 2:1, 3:1). The cannabis administration will
      follow a standardised inhalation procedure using a medical-grade vaporizer device.

      Participants will complete a series of tasks measuring cognition, psychosis, anxiety and
      other subjective experiences.

      The study will be carried out at the NIHR-Wellcome Trust Clinical Research Facility at King's
      College Hospital.
    


Intervention name(s): THC; Cannabidiol; Cannabidiol; Cannabidiol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Inhaled cannabis containing 10mg THC; Inhaled cannabis containing 10mg CBD; Inhaled cannabis containing 20mg CBD; Inhaled cannabis containing 30mg CBD
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Myomectomy Operation and Fundus Incision, Energy Modalities and Methods of Extraction
Condition: Myoma;Uterus; Surgery
MeSH terms: Leiomyoma; Myofibroma; Surgical Wound
Study type: Observational

Summary: 
      Myomectomy operation due to myoma uteri is an operation that can cause serious blood loss.
      For some anatomical reasons, fundal myomas were removed, while a group of investigators
      recommended the initiation of a longitudinal incision and some surgeons preferred a
      transverse incision. the authors aim to show some surgical differences, intraoperative blood
      loss, and difficulties and ease of removal of myoma in patients with these approaches without
      consensus. It is also noted that the incision made with the same energy modality is recorded;
      The effect of energy modality on blood loss and surgical comfort will be examined. Different
      approaches are used for laparoscopic surgical operations in order to remove myoma from the
      abdomen. It can be removed from the vagina by colpotomy and can also be minimized in the
      abdomen by a morselator. In particular, patients with vaginal myoma removed, such as
      complaints of postoperative dyspareunia will be followed. In this way, the investigators aim
      to evaluate the methods which have not yet gained clarity in the literature or have not
      proven superiority to each other.
    


Intervention name(s): Myomectomy Operation
Intervention type(s): Procedure
Intervention description(s): Patients undergoing myomectomy for myoma uteri
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients operated with the diagnosis of myoma uteri
      
Keywords: Myomectomy; Fundus Incision; Energy Modalities; Methods of Extraction
OPAL Study: A Study of Avastin (Bevacizumab) in Combination With FOLFOXIRI in Patients With Previously Untreated Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This single arm study will assess progression-free survival, feasibility of use and safety of
      Avastin in combination with 5-FU/FA, oxaliplatin and irinotecan (FOLFOXIRI) as first line
      treatment in patients with metastatic colorectal cancer. Patients will receive up to 12
      bi-weekly cycles of Avastin (5mg/kg iv) in combination with this standard neoadjuvant
      chemotherapy regimen followed by up to 40 bi-weekly cycles with Avastin plus 5-FU/FA. The
      anticipated time on study treatment is until disease progression, and the target sample size
      is <100 individuals.
    


Intervention name(s): 5-FU; bevacizumab [Avastin]; irinotecan; leucovorin; oxaliplatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 3200mg/m2 continuous iv infusions, day 1 every 2 weeks; 5mg/kg iv infusion, day 1 every 2 weeks; 165mg/m2 iv infusion, day 1 every 2 weeks; 200mg/m2 iv infusion, day 1 every 2 weeks; 85mg/m2 iv infusion, day 1 every 2 weeks
Intervention MeSH terms: Leucovorin; Bevacizumab; Oxaliplatin; Irinotecan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Defunctioning Stoma and Postoperative Morbidity
Condition: Loopileostomy; Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
Study type: Observational

Summary: 
      In an attempt to reduce the risk for anastomotic leakage after low anterior resection it is
      common to create a diverting stoma at the same procedure. Several studies have shown that
      ERAS (Enhanced Recovery After Surgery)application reduces the risk of surgical stress and
      postoperative complications after major colorectal surgery. The aim of this study is to
      evaluate wether a diverting stoma, after low anterior resection for rectal cancer, affects
      postoperative morbidity in patients treated within an ERAS program.
    

Detailed description: 
      See above.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Rectal cancer
Open-Label, Placebo-Controlled, Parallel Group Study in Healthy Volunteers to Evaluate the Effects of Two Single MT 400 or Naproxen Sodium Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, parallel group, single-center study. The study design consists of a
      screening and a treatment period. A total of 42 (approximately 21 of each sex) non-smoking
      healthy volunteers aged 18 - 35.
    

Detailed description: 
      This is an open-label, parallel group, single-center study. The study design consists of a
      screening and a treatment period. A total of 42 (approximately 21 of each sex) non-smoking
      healthy volunteers aged 18 - 35, will be selected for treatment. Potential subjects will be
      assessed for exposure to ionizing radiation or working with cytotoxic chemicals, or who have
      cell cycle times that fall outside the range of 13 ± 1.5 hours or subjects with stable
      chromosomal rearrangements and/or abnormally high background chromosomal aberration
      frequencies. Approximately 30 subjects (10 per arm) are estimated to be needed for analysis.
    

Intervention name(s): MT400
Intervention type(s): Drug
Intervention description(s): MT 400, naproxen sodium 550mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: non-smoking healthy volunteers aged 18 - 35
Precision Public Health: Enhancing Connections to Develop Just-in-Time Adaptive Intervention Strategies
Condition: Overweight and Obesity; Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      The purpose of this pilot study is to examine the effects of different types of just-in-time
      intervention messages on daily meeting dietary, activity, and weighing goals in a sample of
      young adults participating in a mobile-based weight loss program.
    

Detailed description: 
      Public health interventions typically rely on a set schedule of intervention delivery.
      Advances in technology and computer tailoring allow us to go from a "one size fits all"
      approach to one that uses digital health data to deliver "just-in-time adaptive
      interventions," or JITAIs, that can vary the timing, dose, and content of intervention
      messages to individuals. This pilot study is a micro-randomized trial that evaluates the
      effects of various intervention message options delivered in JIT moments on meeting dietary,
      activity, and weighing goals among young adults in a mobile-based weight loss program.

      The Nudge study is a 12-week mobile health weight loss program delivered via a native
      smartphone application. Individuals are asked to track their red foods (high-calorie,
      high-fat foods) in the app daily and meet their personalized red foods goal, wear a Fitbit
      daily and meet their daily active minutes goal, and weigh daily on their WiFi-enabled scale.
      Up to 4 times each day, participants are randomized to receive or not receive intervention
      messages in order to examine the effects of these intervention message types on meeting daily
      weighing goals, red food goals, and activity goals. This is a within-subjects design in which
      each participant serves as their own control, and data is analyzed at the person-day level.
    

Intervention name(s): Nudge
Intervention type(s): Behavioral
Intervention description(s): Nudge is a smartphone-app-based micro-randomized trial that tests the effect of 7 intervention message types based on behavior change techniques on daily goal attainment. Participants have three daily goals: weigh daily, red foods goal, and active minutes goal.
Intervention model: Single Group Assignment
Intervention model description: Each participant-time point is randomized between intervention message or no intervention message
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mobile health; Physical activity; Nutrition; Self-monitoring; Smartphone app; Digital health tools
Dual Injection ESPB Versus Single Injection ESPB for Laparotomies
Condition: Post Operative Pain; Regional Block
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      To evaluate and compare the efficacy of single level injection erector spinae plane block
      versus double level injection Erector spinae plane block in laparotomies
    


Intervention name(s): single level; dual level
Intervention type(s): Procedure; Procedure
Intervention description(s): injection of 40 ml bupivacaine 0.25 at T8 (20 ml on each side); injection of 40 ml of bupivacaine 0.25 at two level T7 and T9 (10 ml on each level of both side)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ESPB; pain; regional block
Trigeminal Endonasal Perception: A Predictor for Septoplasty Outcome
Condition: Empty Nose Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      This study investigates wether patients with increased trigeminal perception threshold and
      low expression of TRP channels have more often nasal blockage despite functionally successful
      nasal surgery (TRP channel = transient receptor potential channel).
    

Detailed description: 
      The aim of this study is to find out wether patients with high trigeminal perception
      threshold (=decreased intranasal sensibility) and low expression of TRP channels of the
      mucosa suffer more often from impaired nasal breathing after surgery. This could lead to the
      identification of prognostic factors and therefore prevention of nasal surgery with bad
      outcome.

      Further, differences between patients with empty nose syndrome and asymptomatic patients
      after extended intranasal surgery, concerning trigeminal perception and TRP channel
      expression will be investigated.
    

Intervention name(s): Nasal surgery
Intervention type(s): Procedure
Other intervention name(s): Septoplasty; Turbinoplasty; Removal of turbinates and septum parts
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Functional nasal surgery; Empty Nose Syndrome (ENS)