bioihbjkbjnl/mcl2 huggingface dataset:
Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
Condition: Endocrine Dysfunction; Trauma; Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to address 3 short term objectives; (1) Determine the effects
      of physiologic testosterone (T) therapy on neurological function and functional independence
      following traumatic brain injury (TBI) in hypogonadal men during inpatient rehabilitation;
      (2) Document the natural history of neuroendocrine dysfunction and recovery in men during
      inpatient rehabilitation after TBI; (3) Obtain data to validate the NIH toolbox, a novel
      assessment of neurological function for use in the TBI population; and 2 long-term
      objectives: (1) Utilize study findings to design a multicenter trial to further assess the
      impact of T therapy in hypogonadal men following TBI and (2) Impact TBI practice management
      with new information about neuroendocrine dysfunction after TBI and hormone treatments to
      improve outcomes.
    

Detailed description: 
      This randomized, double blind, placebo-controlled pilot study assessed the hormonal status of
      men on admission to an inpatient TBI rehabilitation program. 498 consecutively admitted men
      for TBI rehabilitation were screened for participation in the study. 22 participants with low
      T who met all criteria were randomized into placebo (n=10), or physiologic T therapy (n=12).
      Of those with normal T who met all criteria, 24 were randomized into a follow up group. All
      participants were evaluated every two weeks for up to 12 weeks: hormone levels, FIM ratings
      and NIH Toolbox testing as able. There was participant drop out over time as participants
      were discharged from the hospital. The final analysis examined differences between the normal
      T, low T Treatment and low T placebo groups on hormone levels, FIM ratings and NIH Toolbox
      results at baseline and weeks 2, 4 and 6.
    

Intervention name(s): Androgel (Testosterone Gel); Placebo gel
Intervention type(s): Drug; Other
Intervention description(s): 2.5 gram stickpacks administered with starting dosage of 5g increasing to a max of 10g.; 2.5 gram stickpacks with starting dose of 5g increasing to max of 10g.
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Testosterone; Traumatic Brain Injury; Hypogonadism; Endocrine Dysfunction; Low Testosterone in men with new Traumatic Brain Injury
Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with
      severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to
      omalizumab over time will be assessed by physicians and patients evaluating the overall
      improvement in control of their asthma.

      THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.
    


Intervention name(s): Omalizumab; Optimized asthma therapy
Intervention type(s): Drug; Other
Intervention description(s): Omalizumab administered by subcutaneous injection. The dosage received was individualized based on body weight and serum IgE level.; Optimized asthma therapy (OAT) according to Global Initiative for Asthma (GINA) 2004 guidelines during the first 4 weeks of the run-in period of the study.
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; omalizumab; Severe persistent allergic asthma
Post Implantation/Post Market Evaluation of the Swedish Adjustable Gastric Band
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the long term safety of the Swedish Adjustable
      Gastric Band (SAGB) in subjects with an SAGB in place. Specifically it is designed to
      determine the re-operation rate (band revision, band replacement and explants resulting from
      serious adverse device-related event {SADE}) of gastric banding at 4 and 5 year post implant.
    

Detailed description: 
      NCT00543140 (CI-06-0001) is the 2 year Safety and QOL subject follow-up study to NCT00166205
      (CI-02-0006), completed on November 10, 2008. As a condition of approval, the FDA required
      additional subjects with long-term safety data. These subjects enrolled under protocol
      CI-07-0006 (NCT00813462)-5 Year Post-Approval Study With the REALIZE (TM) Adjustable Gastric
      Band. Protocol CI-06-0001 was amended to combine these study subjects with study subjects
      from CI-07-0006. NCT00543140 (CI-06-0001) will not be completed (analysis of results) until
      the additional subjects in NCT00813462 (CI-07-0006) complete this study since the original
      intent was to pool the data together from the above two studies to obtain the appropriate
      sample size for estimation of the re-operation rate at 4 and 5 years post implantation.
    

Intervention name(s): REALIZE™ Swedish Adjustable Gastric Band
Intervention type(s): Device
Intervention description(s): Laparoscopic placement of the Swedish Adjustable Gastric Band
Other intervention name(s): REALIZE Band
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Morbid Obesity
Effect of Amino Acid on Muscle Damage
Condition: Healthy
Study type: Interventional

Summary: 
      The primary objective is to determine the impact of essential amino acids on integrated
      muscle protein synthesis over 4 days after resistance exercise.

      In addition, the secondary objective is to determine the effect of essential amino acids on
      satellite cell regulation and inflammatory responses during this prolonged recovery period.
    


Intervention name(s): Active; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 4g of essential amino acids; 4g of maltdextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: exercise; recovery; muscle; protein
CALERIE (Tufts) - Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy
Condition: Aging
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is one of three CALERIE trials that test the hypothesis that a reduced calorie,
      nutritionally sound diet increases the length of life and prevents some age-related chronic
      diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are
      participating in the CALERIE trial represent a diversity of subject populations and
      interventional strategies.
    

Detailed description: 
      Researchers at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts
      University are enrolling overweight men and women aged 20-42 in a 1-year study to develop an
      effective calorie restricted regimen that minimizes hunger and prevents weight regain. The
      study also examines the effects of weight loss on body composition, metabolism and aging. Two
      different diets containing usual foods and a healthy balance of nutrients will be tested at 2
      levels of caloric restriction, 10% and 30% (in other words, 90% or 70% of what one would
      normally eat). Weight loss is expected for most volunteers participating in this study, but
      cannot be guaranteed.
    

Intervention name(s): Caloric Restriction (CR)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Longevity; Calorie restriction; Physical activity; Weight loss
Effect of High-calcium Intake on Substrate Metabolism During Exercise
Condition: Lipid Metabolism
Study type: Interventional

Summary: 
      A high-calcium intake can accelerate fat loss under energy-restricted diets. Part of this may
      be due to a shift in substrate metabolism where there is an increase in the rate of fat
      oxidation. However, whether high-calcium intake can influence substrate metabolism during
      exercise is not known. Accordingly, we aim to investigate the effect of 2 weeks of
      high-calcium intake on substrate metabolism during exercise.
    


Intervention name(s): Calcium; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Milk-extracted calcium supplement will be used to modulate the calcium content of the milkshakes used.
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Electrophysiological Study of the Effects of Limb Cooling on Essential Tremor
Condition: Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional

Summary: 
      To determine the effects of upper limb forearm cooling on Essential Tremor upper limb tremor
      using a more practical method of limb cooling through a forearm cold pack.
    


Intervention name(s): 15 - 30; 30 - 15
Intervention type(s): Other; Other
Intervention description(s): The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.; The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Essential Tremor; Cooling; Temperature; Patients with Essential Tremor involving the upper limbs with at least moderate tremor.
Medium-chain Triglyceride Oil Massage on Growth in Preterm
Condition: Preterm Infants; MCT Oil Massage; Growth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Aim: To explore the effect of medium-chain triglyceride (MCT) oil massage on growth in
      preterm infants.

      Methods: This randomized controlled trial was conducted in the newborn center of a regional
      hospital in Taiwan. Preterm infants weighing between 1500 and 2000 g were recruited and
      randomly assigned to three groups: the MCT oil massage, massage alone and no massage groups.
      The massages were given three times per day for 7 consecutive days. Weight, length and head
      circumference were measured in the three groups at birth and on study days 1 to 7.
    


Intervention name(s): massage with MCT oil (group 1)
Intervention type(s): Other
Intervention description(s): Two trained nurse took turns performing standardized massage techniques in group 1 and group 2. The difference was that in group 1, the neonates received massage with MCT oil, and in group 2, the neonates received massage without using the oil. The 10-min massage intervention consisted of two 5-min phases: tactile and kinesthetic stimulation (13), which were given three times a day for 7 consecutive days. The massage force was approximately 300 grams, and the massager practiced applying the pressure by using a food scale. The massage was given in the prone and supine positions, and the actions included gentle touching of the head, back and limbs for five 1-min periods, followed by six passive flexion/extension movements lasting 10 s apiece for each arm, then each leg, and finally both legs together for a total of five 1-min periods. Premature infants in the oil massage group received massage with 10 mL/kg/day of MCT oil divided equally into three applications.
Other intervention name(s): massage without MCT oil (group 2)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Staccato Loxapine in Agitation (Proof of Concept)
Condition: Schizophrenia
MeSH terms: Psychomotor Agitation; Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess efficacy and safety of Staccato Loxapine in the
      treatment of acute agitation in schizophrenic patients. The study will be conducted in 120
      agitated schizophrenic patients - either newly admitted to a hospital setting or a research
      unit for acute agitation or already in hospital for chronic underlying conditions. Patients
      meeting entry criteria will be randomized to one of two doses of Staccato Loxapine or to
      Staccato Placebo. Following administration of study drug, assessment of agitation state will
      be conducted at serial time points using standard agitation scales over a 24 hour period.
    


Intervention name(s): Inhaled Placebo; Inhaled Loxapine 5 mg; Inhaled Loxapine 10 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Inhaled Placebo, single dose; Inhaled Staccato Loxapine 5 mg, single dose; Inhaled Staccato Loxapine 10 mg, single dose
Other intervention name(s): Staccato Loxapine Placebo; Inhaled Staccato Loxapine 5 mg; ADASUVE 5 mg; Inhaled Staccato Loxapine 10 mg; ADASUVE 10 mg
Intervention MeSH terms: Loxapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Agitation; Schizophrenia
DSM265 Phase IIa Investigation Treating Plasmodium Falciparum or Vivax
Condition: Plasmodium Falciparum Malaria; Plasmodium Vivax Malaria
MeSH terms: Malaria; Malaria, Falciparum; Malaria, Vivax
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a Proof-of-concept / Phase IIa, open label study to examine the efficacy of
      DSM265 in uncomplicated Plasmodium vivax and Plasmodium falciparum blood-stage malaria in
      adult patients. A minimum of two cohorts (20 patients) and a maximum of 6 cohorts (60
      patients, 3 dose levels) will be tested. The starting dose of DSM265 for the first P. vivax
      and P. falciparum cohorts will be 400 mg. This dose is expected to show complete clearance of
      parasites by microscopy by Day 7 and a decrease in recrudescence rate assessed at Day 14
      (success criteria for dose de-escalation and continuation of the study).
    


Intervention name(s): DSM265 400mg; DSM265 xmg; DSM265 ymg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dose of DSM265 to be determined based on the results of the first cohort; Dose of DSM265 to be determined based on the results of the second cohort
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Plasmodium; falciparum; malaria; vivax; DSM265; pharmacokinetics; adult
A Study of SYNT001 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is being done to compare the safety, tolerability, pharmacokinetics (PK),
      pharmacodynamics (PD), and immunogenicity of an intravenous (IV) formulation of SYNT001. This
      is the first-in-human (FIH) study of SYNT001.
    


Intervention name(s): SYNT001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single IV infusion; single IV infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Reducing Pain of Lidocaine Injection
Condition: Pain of Anesthesia at Breast Biopsy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the benefit, if any, of buffering lidocaine (adding
      sodium bicarbonate) when used for local anesthesia prior to percutaneous breast needle core
      biopsies. The medicine doctors use to reduce the pain of breast biopsies, lidocaine, can
      cause pain for approximately 15 seconds until the numbing effect begins. It is possible that
      this pain is caused because lidocaine is acidic. Some physicians believe that reducing the
      acidity of lidocaine by mixing it with sodium bicarbonate will reduce the initial pain of
      injecting the lidocaine. Both approaches - injecting 1% lidocaine alone and injecting 1%
      lidocaine mixed with sodium bicarbonate - are used as routine standard of care by
      radiologists today. The purpose of this study is to determine if either approach is more
      comfortable for patients having breast procedures.
    


Intervention name(s): 1% Lidocaine; 1% Lidocaine plus sodium bicarbonate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls
Condition: Cervical Intraepithelial Neoplasia; Cervical Cancer; Vaginal Intraepithelial Neoplasia; Vulvar Intraepithelial Neoplasia; Persistent Infection
MeSH terms: Persistent Infection; Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Study type: Observational

Summary: 
      The primary objective of this study is to evaluate the immuno-persistence (type specific IgG
      antibody) of the tested vaccine administered in girls aged 9-17 years ,comparing to young
      healthy adults of 18-26 years who received the standard 3-dose schedule (0,1,6 months).
    

Detailed description: 
      This is a follow-up study which is based on the bridging study of a recombinant human
      papillomavirus 16/18 bivalent vaccine in preadolescent girls(Unique Protocol
      ID:HPV-PRO-006,Identifiers: NCT02562508) .We will recruit people who have participated in
      bridging study before and collect their serum samples to test the seroprevalence and
      geometric mean concentrations of anti-HPV16 and anti-HPV18 antibody on 18 and 30 months after
      dose 1.
    

Intervention name(s): 3 doses of HPV 16/18 bivalent vaccine; 2 doses of HPV 16/18 bivalent vaccine
Intervention type(s): Procedure; Procedure
Intervention description(s): Participants have received 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months); Participants have received 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)
Intervention MeSH terms: Vaccines
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants who participated in the bridging study (Unique Protocol ID:HPV-PRO-006-2,
        Identifiers: NCT02562508) and received at least one dose will be recruited.
      
Keywords: Human Papilloma Virus 16; Human Papilloma Virus 18; adolescent girl; non-inferiority; immuno-persistence
Eye Tracking Technology in the Diagnosis of Neurological Patients
Condition: Postcomatose Unawareness State; Minimally Conscious State; Vegetative State; Disorder of Consciousness; Post-Traumatic Coma; Neurological Injury; Traumatic Brain Injury; Diagnosis; Cognitive Dysfunction; Neurological Disease
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Consciousness Disorders; Nervous System Diseases; Persistent Vegetative State; Trauma, Nervous System; Coma, Post-Head Injury; Disease; Wounds and Injuries; Cognitive Dysfunction
Study type: Observational

Summary: 
      Demonstrating that diagnostics of the state of consciousness and cognitive functions of
      patients with consciousness disorders performed using C-Eye X (based on eye-tracking
      technology) allows a more objective assessment of state of patients who were wrongly
      diagnosed based on popular methods using in a clinical practice (like behavioural scales on
      paper forms).
    

Detailed description: 
      The aim of this Study is to perform a clinical evaluation of the authors' original battery of
      diagnostic tests in the C-Eye X system (based on eye-tracking technology), addressed to
      patients who have suffered damage to the central nervous system (CNS) with communication
      barriers. Validation is being conducting for 2 original diagnostic tests: MCSD (Minimally
      Conscious State Detection): to differentiate patients' state of consciousness (for patients
      diagnosed as being in unresponsive wakefulness syndrome (UWS) or minimally consciousness
      state (MCS) and CFA (Cognitive Functions Assessment) to assess the level of preserved
      cognitive functions in patients (for patients diagnosed as being in at least minimally
      consciousness state minus (MCS-). The intention of the project's authors is to introduce a
      novel diagnostic solution that will help reduce misdiagnoses made for neurological patients
      with reduced consciousness, due to the inadequacy of current behavioural tools to work with
      patients after severe brain damage.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Neurological patients after brain injury with communication barriers, diagnosed as
        unresponsive wakefulness syndrome (UWS) or minimal consciousness state (MCS) patients.
      
Keywords: Coma; Hypoxia; Cognitive Functions Assessment (CFA); trauma; cognitive assessment; diagnostic test; reduced consciousness; eye tracking; Unresponsive Wakefulness Syndrome (UWS); Minimally Conscious State Detection (MCSD); brain injury; coma recovery
A Study to Learn About the Study Medicine Called Zavegepant in Healthy Chinese Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to learn about:

        -  how Zavegepant is changed and removed from the body after taken.

        -  safety of Zavegepant.

        -  the extent to which side effects can be tolerated after taking Zavegepant for the
           possible short-term treatment of migraine.

      This study is seeking participants who:

        -  are healthy Chinese adults and includes participants who are between 18 to 55 years old.

        -  have body mass index (BMI) of 18 to 30 kg/m^2.

        -  have a total body weight of:

        -  equal to or more than 50 kilograms (110 pounds) for males.

        -  equal to or more than 45 kilograms (99 pounds) for females.

        -  are non-smoker (no use of tobacco or nicotine products).

      All participants in this study will receive Zavegepant by nose, once at the study clinic.

      The experiences of the participants receiving the study medicine will be looked at. This will
      help see if the study medicine is safe.

      Participants will take part in this study for around 9 weeks. During this time, participants
      will have 2 study visits at the study clinic and 1 contact over the phone.
    


Intervention name(s): Zavegepant
Intervention type(s): Drug
Intervention description(s): Participants receiving single dose of Zavegepant 10 mg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Zavegepant; Healthy volunteer