bioihbjkbjnl/mcl2 huggingface dataset:
An Evaluation of the Safety and Efficacy of the dTMS Treatment for OCD
Condition: Obsessive Compulsive Disorder
MeSH terms: Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of the Deep TMS (DTMS)
      treatment in subjects with OCD. The device technology is based on the application of deep
      brain TMS by means of repetitive pulse trains at a predetermined frequency. The Brainsway
      DTMS study is a randomized, 10 week, double blind, multi-center trial comparing active DTMS
      treatment to sham treatment.
    

Detailed description: 
      The OCD study will compare one group of OCD subjects receiving DTMS treatment (HAC-coil) to a
      second group of OCD subjects receiving sham treatment (sham coil). The treatment group will
      receive 5 weeks of daily DTMS treatments followed by 4 treatments in week 6, for a total of
      29 treatment sessions. The control group will receive the same treatments with a sham coil.
      Subjects may continue to take SSRI medications (if prescribed) and any other antidepressant
      medications will be tapered down prior to the first treatment. SSRI medications approved for
      OCD include Fluoxetine (Prozac, Sarafem, Symbyax), Fluvoxamine (Luvox, Luvox CR), Paroxetine
      (Paxil, Paxil CR, Pexeva) and Sertraline (Zoloft). Efficacy will be assessed using the
      Yale-Brown Obsessive Compulsive Scale score (YBOCS), as well as other efficacy scales. Safety
      will be assessed by monitoring of adverse events, vital signs, physical and neurological
      examination and using certain safety questionnaires.
    

Intervention name(s): Active DTMS Treatment; Sham Treatment
Intervention type(s): Device; Device
Intervention description(s): H-coil Deep TMS 29 TMS treatments over 6 weeks.; 29 treatments over 6 weeks.
Other intervention name(s): Deep TMS Sham treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: OCD
Ketamine Infusion for Treatment-resistant Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Suicidal Ideation
Study type: Interventional

Summary: 
      Ketamine infusion has been shown to have rapid antidepressant properties, however the
      possible use of ketamine in treatment-resistant depression as augmentation has not been
      investigated. The overall aim of this study is to assess the feasibility, safety and
      tolerability, efficacy and duration of the effect of intravenous N-methyl-D-aspartate
      antagonist ketamine as augmentation of antidepressants for chronic suicidal ideation in
      subjects with severe treatment-resistant depression (TRD).

      This is an open-label study (pilot).
    

Detailed description: 
      Patients will undergo two weeks of prospective observation, they will then receive ketamine
      IV 0.5mg/kg over 45 minutes as augmentation of their ongoing antidepressant regimen; after
      three infusions this dose will be increased increase to 0.75 mg/kg in non-responders. The
      schedule of administration will be twice a week for 3 weeks. After this phase, the patient
      will be followed with assessments every two weeks for three months.

      Total duration of the study is 5 months.
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment resistant; suicidal ideation; major depressive disorder
Effects of Milnacipran on Widespread Mechanical and Thermal Hyperalgesia of Fibromyalgia Patients
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Hyperalgesia
Study type: Interventional
Phase: Phase 1

Summary: 
      Fibromyalgia syndrome (FM) shares many symptoms common to chronic neuropathic pain, including
      the characteristic hyperalgesia of the skin (thermal, mechanical) and muscles (mechanical)
      found in almost all FM patients. Milnacipran, a balance norepinephrine-serotonin re-uptake
      inhibitor, has been found to reduce pain and improve physical function of FM patients.
      However, little is known about the pain mechanisms that are affected by this medication.
      Therefore, the investigator wants to determine the efficacy of milnacipran in reducing pain
      as well as mechanical and thermal hyperalgesia of FM patients during a randomized,
      double-blind, placebo controlled trial. Because the investigator expects anti-hyperalgesic
      effects to coincide or precede with effects on clinical FM pain the proposed duration for
      this trial is 6 weeks.
    


Intervention name(s): Milnacipran
Intervention type(s): Drug
Intervention description(s): 50 mg BID Oral x 6 Weeks
Other intervention name(s): Savella
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Fibromyalgia; Hyperalgesia; Pain; Central Sensitization
Safety and Pharmacokinetics of GH002 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are to investigate the safety and serum pharmacokinetics
      of 5-MeO-DMT in healthy volunteers in a double-blind, placebo-controlled, randomized study
      design with single, injected doses of GH002 and in an open-label, non-randomized study design
      with intra-subject dose-escalation of GH002. As secondary objectives, the PK/ pharmacodynamic
      relationship, PD profile of GH002 as evaluated by its psychoactive effects and impact on
      cognitive performance, and the serum PK of the metabolite bufotenine are also assessed.
    


Intervention name(s): 5 Methoxy N,N Dimethyltryptamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GH002 administered via i.v. bolus injection(s); GH002 placebo administered via i.v. bolus injection
Other intervention name(s): GH002; 5-MeO-DMT; GH002 placebo
Intervention MeSH terms: N,N-Dimethyltryptamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will include separate single and multiple-dose parts.
Single-dose Part:
A double-blind, placebo-controlled, randomized, dose escalation design with single doses of GH002 delivered by i.v. bolus injection in 7 consecutive cohorts with 8 subjects per cohort (randomized as 6 active and 2 placebo):
Cohort A: Dose A
Cohort B: Dose B
Cohort C: Dose C
Cohort D: Dose D
Cohort E: Dose E
Cohort F: Dose F
Cohort G: Dose G
Up to 2 additional cohorts may be added before the IDR part is initiated. These will be named cohorts H and I, if needed.
Multiple-Dose Part:
An open-label, non-randomized design with up to 3 doses of GH002 administered to subjects by i.v. bolus injection(s) on a single day in one cohort of 8 subjects:
Cohort J: Individualized Dosing Regimen with GH002.
The exact doses of study drug to be administered will be determined after an unblinded review of the safety, PK and PD data from all of the cohorts in the single dose part of the trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: 5-MeO-DMT; 5-methoxy-N,N-dimethyltryptamine; Healthy Volunteers; Pharmacokinetics; Mebufotenin
Pharmacokinetic and Pharmacodynamic Profiles of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to compare the pharmacokinetic (PK) profiles of
      Albuterol Spiromax® and ProAir HFA after administration of a single inhaled dose of 180 mcg
      albuterol base from each product.
    

Detailed description: 
      This is a single center, open-label, 2-period crossover study. The study consists of a
      screening visit followed by a treatment period comprising 2 treatment visits. The treatment
      period visits will be separated by a 4 to 14-day washout period. Eligible patients will be
      kept overnight prior to each treatment period.
    

Intervention name(s): Albuterol Spiromax®; ProAir® HFA
Intervention type(s): Drug; Drug
Intervention description(s): Albuterol Spiromax® 180 mcg (administered as 2 actuations of 90 mcg of albuterol base/actuation ex-mouthpiece) orally inhaled, single dose; ProAir® HFA 180 mcg (administered as 2 actuations of 90 mcg of albuterol base/actuation ex-mouthpiece) orally inhaled, single dose
Other intervention name(s): Spiromax®; ProAir®
Intervention MeSH terms: Albuterol; Procaterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: persistent asthma; Albuterol Spiromax®; ProAir® HFA; Pediatric Patients; Phase 1
Impact of Pyloric Injection of Magnesium Sulfate and Lidocaine Mixture on Outcome After Sleeve Gastrectomy
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Postoperative nausea and vomiting is a common adverse effect after sleeve gastrectomy, mostly
      due to increased intragastric pressure. The present trial aimed to assess the effect of
      pyloric injection of mixture of magnesium sulfate and lidocaine on postoperative gastric
      intraluminal pressure and incidence of nausea and vomiting.
    


Intervention name(s): Pyloric injection of magnesium sulfate and lidocaine mixture; Pyloric injection of saline
Intervention type(s): Procedure; Procedure
Intervention description(s): 100 mg / 2 ml of magnesium sulphate (Magnesium Sulfate®) is mixed with 5 ml of 2% lidocaine and injected in the pylorus; 5 ml of normal saline is injected in the pylorus
Intervention MeSH terms: Lidocaine; Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Use of suPAR Algorithm for the ED Decision Making
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Observational [Patient Registry]

Summary: 
      Will the use of a clinical decision algorithm in the ED improve discharge or admission
      decisions.
    

Detailed description: 
      Background Crowding and readmissions are common challenges in Emergency departments across
      Europe. The decision whether to admit or discharge the patient is challenging and is often
      based on clinical signs and symptoms e.g. blood pressure, pulse, respiratory rate, oxygen
      saturation and temperature. But some patients are unnecessarily admitted and may have been
      better off if sent home. Other patients may be discharged without - and one out of five
      patients are readmitted within a month raising the question whether the patient should have
      been admitted at first presentation in the ED. suPAR is a strong prognostic biomarker
      measured routinely in acute medical patients in some emergency department (ED) settings.suPAR
      is a broadly applicable biomarker of risk, and it has been developed an algorithm for simple
      interpretation of suPAR in clinical decisions for the study.

      Objective To evaluate the use of a clinical decision algorithm in the ED with the aim of
      improving discharge or admission decisions.
    

Intervention name(s): suPAR algoritm
Intervention type(s): Diagnostic Test
Intervention description(s): All medical patients attending to the ED and who will have blood drawn for routine examination will be part of the study. In patients with low suPAR (green group, suPAR below 3 ng/ml) and in patients with high suPAR (red group, suPAR > 6 ng/mL) the Intervention will be carried out
Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        All patients during the study period who signed the consent
      
Keywords: ED; Critical illness; Decision making; POC test; suPAR
Feasibility of Technology Mediated Lifestyle Intervention for Overweight and Obese Young Adults
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Rashakaty (Fitness for Me) study aimed to design a new technologies-based intervention using
      a website and smart phone applications and to test the feasibility of implementing a
      lifestyle intervention using these technologies for overweight and obese university students.
      The intervention was implemented in two universities in the United Arab Emirates
    

Detailed description: 
      Poor eating habits and sedentary lifestyle are common among young adults and increase risk
      for chronic diseases in subsequent years of life. Rashakaty (Fitness for Me) study aimed to
      design a new technologies-based intervention using a website and smart phone applications and
      to test the feasibility of implementing a lifestyle intervention using these technologies for
      overweight and obese university students. The study intervention was guided by Social
      Cognitive Theory. The study involved the development of a website, integrating educational
      material and mobile applications for monitoring diet and physical activity and a16-week
      feasibility trial to promote weight loss, improve food choices and increase physical activity
      levels. The trial consisted of two arms: Rashakaty Basic (R-Basic) and Rashakaty Enhanced
      (R-Enhanced).
    

Intervention name(s): R-Basic; R-Enhanced
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in the R-Basic arm received access to a static website that contained educational materials on healthier eating and physical activity and the study questionnaires. The R-Basic intervention was implemented in the University of Sharjah.; The R-Enhanced intervention was guided by the Social Cognitive Theory and employed a variety of behavior modification strategies, including self-monitoring, goal setting, self-efficacy, and social support to facilitate changes in diet and physical activity. In addition, participants in the R-Enhanced intervention had online access to a nutritionist. The R-Enhanced intervention was implemented in the United Arab Emirates University.
Other intervention name(s): Rashakaty Basic intervention; Rashakaty Enhanced intervention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two arms, non-randomized
Masking: None (Open Label)
Primary purpose: Treatment
IMPACT (Improving Plasma Collection) Clinical Trial
Condition: Apheresis Related Hypotension
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      Prospective, multi-center, randomized, controlled clinical trial to study the safety and
      effectiveness of a novel plasma collection system software.
    

Detailed description: 
      Prospective, multi-center, randomized, controlled clinical trial that will be conducted at
      three source plasma collection centers throughout the United States. The objective of the
      trial is to study the safety and effectiveness of a novel plasma collection nomogram run on
      the bi-directionally integrated Haemonetics NexSys PCS® and Haemonetics NexLynk DMS® plasma
      collection system. Subjects will be randomized into an intervention and control arm. The
      control arm will donate plasma using the current software. The intervention arm will donate
      plasma using a novel software that supports a more individualized collection approach.
    

Intervention name(s): Updated Plasma Collection Feature; Current Plasma Collection Approach
Intervention type(s): Device; Device
Intervention description(s): Plasma collection using a novel, patented system that supports a more individualized collection approach.; Plasma collection using the current collection approach.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-arm, randomized, controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Plasmapheresis (Source plasma collection)
Bioavailability of Warfarin After Coadministration With Multiple Doses of BI 1356 Compared to the Bioavailability of Warfarin Alone in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate whether and to what extent BI 1356 affects pharmacokinetic and pharmacodynamic
      parameters of warfarin
    


Intervention name(s): Warfarin; BI 1356
Intervention type(s): Drug; Drug
Intervention MeSH terms: Linagliptin; Warfarin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Effect of Arterial Carbon Dioxide Tension on the Recovery of Spontaneous Respiration
Condition: Surgery; Anesthesia
Study type: Interventional

Summary: 
      The investigators data reveal an important new observation regarding the recovery of
      breathing during emergence from general anesthesia: respiration resumes as a prolonged
      abdominal expiration event.

      The present study aims to further clarify the physiology of recovery of breathing with the
      addition of a cutaneous monitor for arterial carbon dioxide measurement and a comparison of
      two different recovery paradigms.
    

Detailed description: 
      The present study will use non-invasive respiratory inductance plethysmography(RIP) and
      transcutaneous carbon dioxide measurement to compare recovery of respiration under constant
      Transcutaneous carbon dioxide measurement( ptcCO2) with continuous high frequency jet
      ventilation HFJV (study method) with recovery of respiration during rising and apnea (current
      standard).

      The investigators hypothesize that the prolonged abdominal expiration that we observed during
      recovery of breathing in prior studies will be unaffected by arterial carbon dioxide (CO2)
      levels.
    

Intervention name(s): Continuation of High Frequency Jet Ventilation (HFJV)
Intervention type(s): Other
Intervention description(s): In Group B, after cessation of anesthetic infusions, High Frequency Jet Ventilation (HFJV) will continue through the endotracheal tube. Patient will be extubated when awake. Respiratory Inductance Plethysmography (RIP) and Transcutaneous carbon dioxide (PtcCO2) measurements will continue for the duration of emergence.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: High frequency jet ventilation
Primary and Booster Vaccination Study With a Pneumococcal Vaccine in HIV Infected, HIV Exposed Uninfected and HIV Uninfected Children 6 to 10 Weeks of Age.
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purposes of this study:

        -  To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine
           GSK1024850A in HIV infected infants, HIV exposed uninfected infants and HIV unexposed
           uninfected infants following a 3-dose primary vaccination at 6, 10 and 14 weeks of age
           and following booster vaccination at 9-10 months of age.

        -  To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine
           GSK1024850A in HIV unexposed uninfected infants receiving either a 3-dose primary
           vaccination according to the EPI vaccination schedule at 6, 10 and 14 weeks of age with
           or without booster vaccination at 9-10 months of age or a 2-dose primary vaccination at
           6 and 14 weeks of age followed by booster vaccination at 9-10 months of age.

        -  This study also aims to assess the impact of the pneumococcal vaccine GSK1024850A on
           nasopharyngeal carriage of S. pneumoniae and H. influenzae up to 24 months of age in all
           study participants.
    

Detailed description: 
      This protocol posting has been updated according to Protocol amendment 1, December 08
    

Intervention name(s): Pneumococcal vaccine GSK1024850A; Tritanrix-HepB/Hib; measles; Rotarix; Local OPV
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular injection, administered as 3 or 4 doses; Intramuscular injection, 4 doses; Intramuscular injection, 2 doses; Oral, 2 doses; Oral 4 doses. Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
Other intervention name(s): DTPw-HBV/Hib; HRV; Human rotavirus; oral poliovirus vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Human Immunodeficiency Virus; Booster vaccination; Safety; Primary vaccination; Pneumococcal vaccine; Immunogenicity; Pneumococcal disease
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery
Condition: Meniscus Tear, Tibial; Pain, Postoperative; Postoperative Complications; Ketorolac Adverse Reaction; Opioid Use
MeSH terms: Pain, Postoperative; Postoperative Complications; Tibial Meniscus Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      The utilization of arthroscopic surgery to treat meniscus injuries has continued to increase
      in recent years, partly due to a younger, more active population, and improved technology and
      technique. However, pain management in the post-operative period is critical to the ability
      to perform this procedure as an outpatient surgery. Traditionally, oral narcotic agents have
      been the preferred analgesic postoperatively in orthopaedic surgery. However, these agents
      are associated with several side effects, including nausea/vomiting, constipation, and
      somnolence. In addition, opioid agents have a significant potential for abuse in comparison
      to non-narcotic analgesics. In light of the rising opioid epidemic and nationwide initiatives
      to limit narcotic usage, surgeons must explore alternate pain modalities in the acute
      postoperative period. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) with
      analgesic and anti-inflammatory properties.1 Multiple prior studies have examined the
      beneficial effect of oral and intravenous (IV) ketorolac as an analgesic in the postoperative
      period,1-3 including arthroscopic meniscus surgery. However, the beneficial effects of this
      agent following arthroscopic meniscus surgery have not been extensively described.
    


Intervention name(s): Ketorolac; Oxycodone-Acetaminophen
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac.; Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery.
Intervention MeSH terms: Acetaminophen; Ketorolac; Acetaminophen, hydrocodone drug combination; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ketorolac; meniscus tear; analgesics; pain