bioihbjkbjnl/mcl2 huggingface dataset:
Warming Mattress Versus Polyethylene Wrapping to Prevent Hypothermia in Preterm Newborns.
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      Mean axillary temperatures, taken during NICU resuscitation upon admission to the NICU, will
      not differ between VLBW babies who are occlusively wrapped and very low birth weight (VLBW)
      babies who are placed on thermal warming blankets.
    


Intervention name(s): NeoWrap; InfaTherm
Intervention type(s): Device; Device
Intervention description(s): This is a polyethylene wrap that will be placed around the ELGAN from the neck down to prevent heat loss.; A gel blanket containing a sodium acetate-based medium that, when activated, becomes exothermic and provides heat.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hypothermia; Prevention; ELGANs(Extremely low gestational age neonates); Polyethylene Wrap; Sodium Acetate Transport Mattress
A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus
Condition: Hypoglycemia; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial's objective is to evaluate the immunogenicity of repeated single doses of
      dasiglucagon* and GlucaGen following subcutaneous (SC) administration in patients with type 1
      diabetes mellitus (T1DM) and further to evaluate the safety and tolerability of dasiglucagon
      and GlucaGen.

      *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207
    

Detailed description: 
      Patients with T1DM were randomly assigned in a 1:1 ratio to receive 3 SC injections of either
      dasiglucagon (0.6 mg) or GlucaGen (1 mg), with 1 week between doses. Patients were followed
      for 15 weeks from the day of the first dose to assess the immune response. Patients with
      previous exogenic glucagon exposure were not excluded from the trial, but the information on
      previous glucagon administration was recorded to enable subgroup analyses. It was expected
      that 112 patients in total would be randomly assigned to treatment groups and treated. A
      total of 90 patients were expected to complete the trial (45 in each treatment arm). To
      qualify as completed, the patient had to be dosed according to the procedure described in the
      protocol and to have blood drawn for the antidrug antibody analyses as scheduled.
    

Intervention name(s): dasiglucagon; GlucaGen
Intervention type(s): Drug; Drug
Intervention description(s): Glucagon Analog; Native Glucagon
Other intervention name(s): ZP4207; GlucaGen HypoKit
Intervention MeSH terms: Glucagon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucagon; Dasiglucagon
Community-based Individualized Homeopathic Rehabilitation in Post COVID-19 Patients
Condition: Post-COVID Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      A growing number of studies identify a spectrum of persistent symptoms experienced by
      COVID-19 patients for months after recovery. Symptoms include cough, fatigue, dyspnea, pain,
      and brain fog (cognitive impairment, including confusion and memory loss), which have a
      negative impact on daily activities. Homoeopathic practitioners from around the world have
      documented a number of successful cases of Post COVID treatment. Even though evidence from
      practice-based research is limited, the purpose of the current study was to evaluate the
      effect of individualized homoeopathy treatment on post-COVID syndrome.
    


Intervention name(s): Homeopathy
Intervention type(s): Other
Intervention description(s): Individualized homoeopathic medicines on impregnated lactose pellets was prescribed based on totality of physical, emotional, and mental symptoms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rehabilitation; Homeopathy; Post-COVID Syndrome
Advanced MRI Sequences for Radiation Therapy Treatment Planning
Condition: Cancer
Study type: Observational

Summary: 
      The purpose of this study is to determine if it would be helpful to use advanced MRI imaging
      techniques to take additional views of the tumor target for radiation treatment planning or
      treatment follow-up MRI.
    

Detailed description: 
      The results of this research project will be used to establish a standard MRI protocol
      specific to each tumor or disease site. An MRI protocol is a list of MR image types that are
      acquired for each disease site. These images are used to generate the patient's treatment
      plan.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects who are planning to have radiation therapy for their cancer.
      
Keywords: Anal canal; Brain; Breast; Cervix; Esophagus; Gynecology; Head and Neck; Lung; Pancreas; Primary liver or liver metastases; Prostate cancer; Sarcoma
NitiNotes' EndoZip System for the Treatment of Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This is first-in-man safety and performance feasibility study, aimed to provide initial
      clinical assessment of safety and effectiveness of the EndoZip in the treatment of obesity.
    


Intervention name(s): EndoZip System
Intervention type(s): Device
Intervention description(s): The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within.
Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight.
Intervention model: Single Group Assignment
Intervention model description: Open label, single arm, open label study
Masking: None (Open Label)
Primary purpose: Device Feasibility
Relative Bioavailability of BI 671800 HEA in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the relative bioavailability of single doses of 200 mg BI 671800 HEA (choline)
      administered as a delayed release (enteric coated) tablet; or via the EnterionTM capsule as
      solution to the jejunum, ascending or descending colon, or as particulate to the ascending
      colon
    


Intervention name(s): BI 671800 HEA delayed release (enteric coated) tablet; BI 671800 HEA solution; BI 671800 HEA particulate
Intervention type(s): Drug; Drug; Drug
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Repeated Insult Patch Test of Personal Lubricants
Condition: Erythema; Edema
MeSH terms: Erythema
Study type: Interventional

Summary: 
      Determine the ability of the study material (personal lubricant) to cause sensitization by
      repeated topical application to the skin of humans under controlled patch test conditions.
    


Intervention name(s): Experimental: Novel lubricant Miami Fragrance; Experimental: Novel lubricant Miami no Fragrance; KY Liquid lubricant; Astroglide Gel lubricant
Intervention type(s): Device; Device; Device; Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Evaluation of NaproxenSodium and CodeinePhosphate Combination in Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Osteoarthritis (OA) pain treatment has limitations in terms of serious adverse effects and
      low efficacy. The investigators aimed to evaluate efficacy and safety of naproxen
      sodium/codeine phosphate combination in these patients.
    

Detailed description: 
      In this prospective, randomized, double blind, placebo controlled clinical trial, 135
      patients with osteoarthritis, who were 40-65 years; applied to institution's orthopaedics
      outpatient clinic; had grade 1, 2, or 3 primary osteoarthritis diagnosed in last 1 year; and
      had Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score≥40, and
      Visual Analogue Scale score≥40,were enrolled. Subjects were randomized (1:1) to placebo (n=
      67) or combination (n= 68) arms, in which 550 mg naproxen sodium/30mg codeine phosphate was
      given orally twice a day for 7 days. Rescue medicine was 500 mg paracetamol (max= 6
      tablets/day). Demographic characteristics, medical history, adverse events, VAS and WOMAC
      scores were collected in study visits performed within 10days.The study was approved by local
      institutional ethics committee and written informed consents were obtained from all
      participants.
    

Intervention name(s): Naproxen Sodium Codeine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One tablet twice a day; One tablet twice a day
Other intervention name(s): Apranax Plus
Intervention MeSH terms: Naproxen; Codeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis; NAPROXEN SODIUM
Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)
Condition: Cervical Cancer; Vulvar Cancer; Vaginal Cancer; Genital Warts; Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections; Condylomata Acuminata; Vulvar Neoplasms; Vaginal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison
      to GARDASIL (TM)
    


Intervention name(s): Comparator: V505 formulation 1; Comparator: V505 formulation 2; Comparator: V505 formulation 2; Comparator: V505 formulation 3; Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant; Comparator: Placebo (unspecified)
Intervention type(s): Biological; Drug; Drug; Biological; Biological; Biological
Intervention description(s): 0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.; 0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.; 0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6.; 0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6.; 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen at Day 1, Month 2 and Month 6.; 0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
I-Gel Versus Disposable Laryngeal Mask (LMA) for General Anesthesia (GA) With Controlled Ventilation
Condition: Healthy
Study type: Interventional

Summary: 
      Randomized controlled trial comparing performance of the I-gel and disposable Laryngeal Mask
      Airways under controlled ventilation. 200 patients, 100 in each arm. Measurement of peak
      airway and sealing pressures. Postoperative questionnaires at 1 and 24hrs.

      Hypothesis

      There is no difference between the performance* of the I-gel and disposable laryngeal mask
      airways for controlled ventilation under general anesthesia.

      *as defined by peak airway pressure and sealing pressures.
    


Intervention name(s): Insertion of laryngeal mask airway (AuraOnce mask); Insertion of I-gel airway; Measurement of airway pressures
Intervention type(s): Device; Device; Other
Intervention description(s): Insertion of laryngeal mask airway under anaesthesia: Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg; AuraOnce disposable laryngeal mask; Insertion of I-gel airway under anaesthesia; Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg; Measurement of peak airway pressure under steady state; measurement of device seal pressure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Supraglottic airway; I-gel; Laryngeal mask; Controlled ventilation; Peak airway pressure; Seal pressure; Anaesthesia; Surgery
Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy
Condition: Hemostatic Techniques; Nephrectomy
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, randomized, single blind, standard care- controlled study, which will
      include a total of 30 patients divided into two treatment arms: First are: patents who will
      be treated in accordance with standard of care. Second arm: patients for which the Fibrin
      Fleece will be applied directly on the active bleeding site.
    


Intervention name(s): Fleece
Intervention type(s): Biological
Intervention description(s): Fibrin Patch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Patients undergoing elective open partial nephrectomy surgery; Excision of a kidney
Clitoral Location in Relation to Sexual Function Using Pelvic Imaging
Condition: Female Sexual Dysfunction; Anorgasmia
Study type: Observational

Summary: 
      Women who are unable to achieve orgasm compared to women who have normal orgasmic function
      may have different clitoral anatomy and different hormone levels. The investigators
      hypothesis is that women who have difficulty with orgasm may have a clitoris that is closer
      to the vagina and may have higher testosterone levels. Pelvic MRI will be used to observe
      whether clitoral measurements differ between women with normal orgasmic function vs. those
      with anorgasmia.
    

Detailed description: 
      Women unable with anorgasmia and those with normal orgasmic function will undergo pelvic MRI
      so that clitoral measurements can be taken and then compared for differences.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Sexually active premenopausal females aged 18-55 years old presenting to private gynecology
        practice
      
Biospecimen description: 
      Blood hormone levels
    
Keywords: female sexual dysfunction; anorgasmia; clitoral complex; pelvic MRI; testosterone
An Open-label, Bioequivalence Study to Evaluate LEV Administered as a 45-min Intravenous Infusion and Same Dosage LEV Oral Tablet in Chinese
Condition: Human Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The part A of N01362 is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg
      intravenous (iv) infusion when compared to tablet oral administration in Chinese healthy
      volunteers.
    

Detailed description: 
      The study includes 2 parts, part A is to evaluate the bioequivalence of Levetiracetam (LEV)
      1500 mg intravenous (iv) infusion when compared to oral tablet, part B is to assess
      pharmacokinetic profile of LEV infusion during repeated dosing in Chinese healthy volunteers.
    

Intervention name(s): Levetiracetam; Levetiracetam
Intervention type(s): Drug; Drug
Intervention description(s): Levetiracetam 1.500 mg (500 mg/ 5 mL vials) administered as a 45 minutes intravenous infusion diluted in 100 mL 0.9 % saline solution in the morning of Day 1.; Levetiracetam single oral administration of 3 tablets of 500 mg immediate release tablet.
Other intervention name(s): Keppra; Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Keppra Levetiracetam intravenous; Oral tablets; Bioequivalence; Pharmacokinetics; Safety; Chinese healthy volunteers
Effectiveness of Sana Treatment in Post-Traumatic Stress Disorder (PTSD)
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effectiveness of the Sana Device when added to
      Treatment as Usual in participants with a diagnosis of post-traumatic stress disorder (PTSD)
    

Detailed description: 
      This is a study designed to assess the effectiveness of the Sana Device when added to
      Treatment as Usual in participants with a diagnosis of post-traumatic stress disorder (PTSD)
      on severity of symptoms as measured by CAPS-5. We will use a 2-arm repeated measures
      randomized controlled design in which participants will be randomly assigned to either Sana
      plus Treatment as Usual (Sana+TAU) or Treatment as Usual (TAU).
    

Intervention name(s): Sana Device
Intervention type(s): Device
Intervention description(s): Externally worn mask that physically contacts the skin of the face. The Sana Device delivers Audio Visual Stimulation (AVS) in the form of coordinated pulses of light (through closed eyelids) and sound at various frequencies.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel 2-arm study in which participants will be randomly assigned to either Sana plus Treatment as Usual (Sana+TAU) or Treatment as Usual (TAU)
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Spinal Manipulative Therapy: Dual-Task Performance
Condition: Balance
Study type: Interventional

Summary: 
      The purposes of this study is to determined the effects of instrument applied spinal
      manipulative therapy upon dual-task performance involving complex postural and cognitive
      task.
    

Detailed description: 
      This study sought to determine whether a 2-week regimen of spinal manipulative therapy could
      improve postural control under 2 conditions. Condition one was a complex postural task which
      consisted of a shoulder width stance on a compliant surface with eyes closed to remove visual
      input. Condition 2 was as above with the addition of visio-spatial cognitive task (serial 7s
      subtraction). These tasks were performed on a force-place designed to capture center of
      pressure data. Data was captured prior to the onset of therapy and then again after 6
      treatment sessions (2-week period). Data was also collected 1 week post treatment to note any
      lasting effects following therapy. This pilot study utilized a repeated measures designed
      with no control group.
    

Intervention name(s): Pro-adjuster mechanical spinal manipulative device
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dual-task; postural control; cognitive
Measurements of Anemia and Physiologic Tissue Response to Blood Transfusions in VLBW Infants Using Quantitative NIRS
Condition: Infant Development
MeSH terms: Anemia
Study type: Observational

Summary: 
      The study quantified functional measures of red blood cell mass and oxygen in neonatal
      tissues using a non-invasive optical technique: near infrared optical spectroscopy . The
      study will determine the absolute concentrations of deoxygenated and oxygenated hemoglobin
      and calculate the tissue hemoglobin saturation and total hemoglobin concentration in viv.
      Near infrared optical spectroscopy technique use to assessing and defining tissue status in
      the anemic state and the tissue's response to transfusions, as well as in monitoring
      hemoglobin and hematocrit without pain or loss of blood.
    

Detailed description: 
      Near infrared optical spectroscopy measurements will be conducted on the muscle, on the upper
      leg,arm or on the back, abdomen and the head. The actual location will depend upon the
      neonate position and size. A small soft plastic optical fibers probe will be placed to the
      select study areas and thhe time of the measurement will not exceed 1 hour.

      NIRS measurements of hemoglobin and hemoglobin saturation in tissues before and after
      red-cell transfusions in VLBW infants will determine the true effect of the transfusions, and
      develop more substantial guidelines regarding indications for transfusion. The accuracy of
      conventional (invasive) measurements of Hb and Hct could be comparison with results from the
      NIRS technique and clinical usefulness of the NIRS technique could be evaluated by comparison
      with trends in conventionally measured values taking fluid status into account.

      Near-infrared light does not ionize biological tissue and poses no significant health risk.
      Since water absorption is low within this spectral range, local heating of the tissue is also
      minimal. Burns and heat damage to the neonate are highly unlikely.
    

Intervention name(s): Optical measurement
Intervention type(s): Device
Intervention description(s): Optical measurement neonatal tissues
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic
Effect of Inhalatory Sedation in Subarachnoid Hemorrhage
Condition: Subarachnoid Hemorrhage; Aneurysmal Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the effect of inhalational sedation on cerebral
      perfusion in patients with SAH.

      It will evaluate whether the administration of isofluorane, by inducing direct vasodilation
      in the cerebral parenchyma, can improve the cerebral perfusion rates.

      Perfusional CT will be used to study the variation of cerebral blood flow to rule out the
      vasodilatory effect on territories with different cerebrovascular reactivity aggravating the
      phenomena of distrectual hypoperfusion (theft theory).
    


Intervention name(s): Isoflurane Inhal Soln
Intervention type(s): Drug
Intervention description(s): Administration of isofluorane in patients with severe SAH
Intervention MeSH terms: Isoflurane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: perfusion; isofluorane; inhalatory; sedation
Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn
Condition: Persistent Pulmonary Hypertension of the Newborn
MeSH terms: Hypertension, Pulmonary; Persistent Fetal Circulation Syndrome; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This pilot study aims to assess the safety and treatment effect of acute dosing with IV
      Remodulin in neonates with persistent pulmonary hypertension of the newborn (PPHN).
    

Detailed description: 
      This study will enroll subjects with PPHN who do not show an adequate response to inhaled
      nitric oxide with the hypothesis that the addition of intravenous (IV) Remodulin will reduce
      the rate of clinical worsening as compared to standard of care. Additionally, this study aims
      to evaluate the treatment effect of Remodulin and better understand the dosing and
      pharmacokinetics in the neonatal population.
    

Intervention name(s): IV Remodulin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Treprostinil is a chemically stable tricyclic analogue of prostacyclin.; matching placebo
Other intervention name(s): treprostinil
Intervention MeSH terms: Treprostinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PPHN