bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Cabergoline for the Treatment of Cocaine Dependence - 1
Condition: Cocaine-Related Disorders; Substance-Related Disorders
MeSH terms: Cocaine-Related Disorders; Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess cabergoline for the Treatment of Cocaine Dependence
    

Detailed description: 
      To assess the efficacy and safety of cabergoline in reducing cocaine use in subjects with
      cocaine dependence. This is a DB, placebo-controlled, parallel group design study where
      subjects will receive either .5mg cabergoline or placebo for 12 weeks with a 4 week
      follow-up.
    

Intervention name(s): Cabergoline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): sugar pill manufactured to mimic cabergoline 05mg tablet
Other intervention name(s): Dostinex
Intervention MeSH terms: Cabergoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A MRI Study of Visual and Motor Pathways in Premature Infants
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Approximately 30,000 babies annually are born with extremely low birth weight (ELBW) in the
      US. These babies often have motor and/or visual problems when they grow up. It is very
      important to identify high risk ELBW infants as early as possible, so that the investigators
      can treat them earlier to prevent poor development. Neurological examination at early age is
      not good enough to identify high risk ELBW infants. One the other hand, some magnetic
      resonance imaging (MRI) methods such as diffusion tensor imaging (DTI) and resting state
      functional MRI (rfMRI) have shown great sensitivity to brain injury which may cause motor and
      visual problems. Therefore, the investigators propose to use DTI and rfMRI on ELBW infants at
      a very early age to predict long-term outcome and to identify infants who are at high risk of
      having motor and/or visual problems when they grow up.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ELBW infants with birth weight 401-1000 g (gestational age <30 weeks)
A Study to Evaluate the Safety and Immunogenicity of Heterologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and
      Ad26.ZEBOV administered as heterologous prime-boost vaccine regimens in healthy adult
      participants.
    

Detailed description: 
      This is a randomized placebo-controlled, double-blind study evaluating the safety,
      tolerability and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered in different
      sequences and schedules to healthy adult participants. The study consists of a screening
      period of up to 28 days, a vaccination period in which participants will be vaccinated at
      Baseline [Day 1] followed by a boost on Day 29 or 57 and a post-boost follow-up, until all
      participants have had their 21-day post-boost visit (Day 50 or Day 78). The participants who
      received active vaccine will enter a long-term follow-up. The total duration of the study
      will be about 1 year for participants who received vaccine and about 3 months for
      participants who received placebo. Immunogenicity and safety will be monitored during the
      study.
    

Intervention name(s): MVA-BN-Filo; Ad26.ZEBOV; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]) on Day 1, 29, 57.; One 0.5 mL IM injection of 5*10^10 viral particles (vp) on Day 1, 29, 57.; One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 or on Day 1 and 57.
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Healthy; Ebola viruses; Ebola Viral Disease (EVD); Filoviruses; Monovalent vaccine; Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV); Modified Vaccinia Virus Ankara - Bavarian Nordic (MVA-BN) Filo-vector; Safety; Immunogenicity
Observation of Atelectasis Using Lung Ultrasonography in Children Undergoing General Anesthesia: the Cohort Study for Evaluation of the Relationship Between the Incidence and Severity of Upper Respiratory Tract Infection and the Magnitude of Anesthesia-induced Atelectasis
Condition: Surgery
MeSH terms: Respiratory Tract Infections; Pulmonary Atelectasis
Study type: Observational

Summary: 
      Pediatric patients between 6months and 6years old will be included. They are scheduled for
      elective general or urologic surgery at a single tertiary medical center. Before the
      operation, the researcher interviews the parents of the pediatric patients to check whether
      they have the upper respiratory tract infection and asks them to fill out a questionnaire
      about the severity of their symptoms. The researcher will get the symptom score of the upper
      respiratory tract infection in the questionnaire. The degree of anesthesia induced
      atelectasis is measured using lung ultrasound. Pulmonary ultrasound is performed after
      endotracheal intubation and at the end of the operation dividing the patient's thorax into 12
      regions. The investigator grades the degree of atelectasis at each region form 0 to 3 points.
      After the end of the operation, check whether the respiratory adverse effects occurred during
      emergence and recovery at the post anesthesia care unit.
    


Intervention name(s): questionnaire about the severity of their symptoms of upper respiratory tract infection
Intervention type(s): Other
Intervention description(s): Before the operation, the researcher interviews the parents of the pediatric patients to check whether they have the upper respiratory tract infection and asks them to fill out a questionnaire about the severity of their symptoms. The questionnaire consists of 8 types of symptom about upper respiratory infections and each symptom was checked from 0 to 3 according to severity by their patients.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients between 6months and 6years old scheduled for elective general or
        urologic surgery at a single thetiary medical center.
Evaluation of the Antiviral Pharmacodynamic Effect, Safety, and Pharmacokinetics of Escalating Doses of BILB 1941 ZW to Patients With Chronic Hepatitis C Genotype 1 Virus Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To assess the antiviral effect, safety and pharmacokinetics of rising doses of 10 mg, 20 mg,
      40 mg, 60 mg, 80 mg, 100 mg, 150 mg, 200 mg, 300 mg, 450 mg, 650 mg, 900 mg oral BILB 1941 ZW
      administered Q8H in a polyethyleneglycol 400 (PEG 400): distilled water: Tromethamine (TRIS)
      drinking solution for five days to patients with chronic HCV genotype 1 infection
    


Intervention name(s): BILB 1941 ZW; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
At-Home Olfactory Training
Condition: Olfactory Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine the impact of a twice daily at-home olfactory
      training program with a twenty scent, essential oil-based smell test in patients with
      olfactory dysfunction.
    

Detailed description: 
      This study randomizes participants to receive either a four scent or fourteen scent olfactory
      retraining protocol. Baseline olfaction will be tested with a currently commercially
      available smell test as well as an essential oil based smell test. The protocol involves
      twice daily retraining where the participant inhales the scent and makes a mental note of
      what they should be smelling. The training period is six months total with a visit at 3
      months to re-assess smell function as well as at six months.
    

Intervention name(s): Smell Test
Intervention type(s): Other
Intervention description(s): Oils are used for each of the different scents. Each scent will be put on an aromatherapy inhaling stick.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sense of smell; smell test; at-home smell test; essential oil; olfactory loss
The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis
Condition: Acute Appendicitis
MeSH terms: Appendicitis; Acute Disease
Study type: Observational

Summary: 
      This study will consist of a brief interaction with the subject or parent or guardian to
      obtain consent, collect a blood sample, medical history, and physical examination of those
      who meet the inclusion criteria. The blood sample will be tested for the WBC value, as well
      as processed into plasma in order to compute the APPY1 Test result, which is based on a
      combination of the WBC value and the plasma MRP 8/14 and CRP concentrations received from the
      APPY1 Test cassette. There will be a 2-week (14 days +/- 3) follow-up telephone call for
      those subjects that were discharged from the ED without an appendectomy or diagnosis of acute
      appendicitis. Use of the APPY1 Test to help identify low risk patients could significantly
      reduce the use of CT scans in diagnosis of AA, thereby reducing the exposure to ionizing
      radiation in children, adolescents, and young adults.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children, adolescents and young adults 2 to 20 years old.
      
Biospecimen description: 
      Surplus plasma samples will be retrieved by the Sponsor for future development of protein
      biomarkers.
Repurposing Dexmedetomidine as an Orally Administered Sleep Therapeutic
Condition: Sleep; Insomnia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The broad objective of this investigation is to assess the safety and efficacy of oral
      therapy with dexmedetomidine for the induction and maintenance of restful sleep.
    

Detailed description: 
      Sleep is a basic human function that occupies approximately one-third of our lives. Much of
      what is known about the benefits of sleep in humans has been obtained from studies of
      patients with insomnia, the most common sleep disorder with a reported prevalence of 10 to
      15%. Unfortunately, insomnia is an independent risk factor for acute myocardial infarction,
      coronary heart disease, heart failure, hypertension, diabetes, and death. More so, sleep
      disturbances lead to neurocognitive deficits such as delirium and psychosis. However, the
      principal medications (i.e. benzodiazepines, zolpidem) currently used to treat insomnia are
      associated with side effects such as daytime sedation, delirium, anterograde memory
      disturbance, and complex sleep-related behaviors. We recently found that a nighttime
      intravenous bolus administration of dexmedetomidine was associated with normal sleep
      architecture comprising of rapid eye movement (REM) and non-REM (N1, N2, N3) sleep, with
      improved next-day psychomotor vigilance performance compared to zolpidem. Presently,
      dexmedetomidine is only available in an intravenous formulation. The goal of this project is
      to develop dexmedetomidine, an alpha-2 receptor agonist, into an oral sleep therapeutic with
      a neurocognitive sparing profile.
    

Intervention name(s): Dexmedetomidine; Saline Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral form; Saline Placebo
Other intervention name(s): Precedex; Saline
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients will receive both the oral dexmedetomidine intervention and placebo comparator in a randomized order.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
PET Scans in Diagnosing Primary or Recurrent Cervical Cancer in Patients Who Are Undergoing Surgery
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: New imaging procedures such as fludeoxyglucose F 18 PET scan may improve the
      ability to detect cancer or recurrence of cancer.

      PURPOSE: Clinical trial to study the effectiveness of fludeoxyglucose F 18 PET scan in
      diagnosing primary or recurrent cervical cancer in patients who are undergoing surgery.
    

Detailed description: 
      OBJECTIVES:

        -  Assess the feasibility of using fludeoxyglucose F 18 (FDG) positron emission tomography
           (PET) imaging in patients with primary or recurrent cervical cancer.

        -  Investigate the ability of FDG-PET scan imaging to detect lymph node metastases in these
           patients.

        -  Investigate the ability of FDG-PET imaging to identify locally advanced disease in early
           stage cervical cancers.

        -  Compare FDG-PET to CT scan imaging with respect to distinguishing between postradiation
           pelvic fibrosis and recurrent cervical cancer.

        -  Investigate the ability of FDG-PET to identify recurrent cervical cancer.

      OUTLINE: This is a diagnostic study.

      Patients with primary cervical cancer receive fludeoxyglucose F 18 (FDG) intravenously
      followed 45 minutes later with positron emission tomography (PET) imaging over 60 minutes, as
      well as computed tomography (CT) scan. Both diagnostic imaging techniques are to assess the
      abdomen and pelvis, and must be done within 2 weeks prior to surgery. Patients eligible for
      surgery undergo radical hysterectomy and lymphadenectomy and all specimens are evaluated for
      correlation with the preoperative diagnostic tests findings.

      Patients with recurrent cervical cancer obtain FDG-PET scan and CT scan of the thorax,
      abdomen, and pelvis prior to surgical exploration for pelvic exenteration. All biopsy
      specimens are evaluated for correlation with diagnostic tests findings.

      PROJECTED ACCRUAL: A total of 30 patients (20 patients with primary cervical cancer and 10
      patients with recurrent cervical cancer) will be accrued for this study.
    

Intervention name(s): biopsy; computed tomography; positron emission tomography; fludeoxyglucose F 18
Intervention type(s): Procedure; Procedure; Procedure; Radiation
Intervention MeSH terms: Fluorodeoxyglucose F18
Primary purpose: Diagnostic
Keywords: stage I cervical cancer; stage II cervical cancer; recurrent cervical cancer
Immune-modulation Effects of an Arginine Rich Nutritional Supplement in Surgical Patients
Condition: Immunity
Study type: Interventional

Summary: 
      The primary objective of this study is to characterize the immune-modulatory effects of
      arginine-rich nutritional supplements in patients undergoing surgery. Numerical and
      functional changes of all circulating immune cells will be assessed with mass cytometry.
    


Intervention name(s): An arginine rich nutritional supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Impact is a nutritional supplement formulated with 18 grams of protein per serving and 24 essential nutrients including arginine.
Other intervention name(s): 'Impact' made by Nestle Corporation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Treatment of Cutaneous Leishmaniasis With Meglumine Antimoniate Versus Meglumine Antimoniate and Allopurinol
Condition: Leishmaniasis, Cutaneous
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional

Summary: 
      Background: Cutaneous Leishmaniasis is a worldwide disease, endemic in over 88 countries,
      that has shown an increasing incidence over the last many decades. For the last 60 years
      antimony compounds are considered the treatment of choice. Though their use is expensive,
      cumbersome, has many adverse effects and not effective in all patients, the search for a
      better alternative is still going on. Low dose antimony compounds in combination with several
      agents have shown promise of reducing adverse effects of antimony compounds without
      compromising efficacy. Allopurinol is one such agent which though promising lacks randomized,
      controlled trials to prove efficacy. The main objective of this study is to evaluate low dose
      sodium stibogluconate in combination with allopurinol and to compare it with high dose sodium
      stibogluconate in terms of efficacy and adverse effects.

      Methods and design: A multi-center randomized, controlled trial including 620 patients from
      endemic areas for Leishmaniasis in Pakistan will be undertaken to assess the research
      question. Parasitologically confirmed cutaneous leishmaniasis will be included in the study.
      After evaluating the inclusion/exclusion criteria patients will be randomized to receive
      either meglumine antimoniate (20 mg/kg/day/intramuscular, till clinical resolution or a
      maximum of 28 days) or combination of meglumine antimoniate (10 mg/kg/day intramuscular) and
      allopurinol (20 mg/kg/day/oral) till clinical resolution or a maximum of 28 days. During
      treatment patients will be admitted to hospital and monitored daily for the presence of
      adverse effects. Follow up period will last six months during which patients will visits the
      research centers for assessment of healing process at monthly intervals.
    


Intervention name(s): meglumine antimoniate, allopurinol; meglumine antimoniate; meglumine antimoniate, allopurinol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): first drug in injectable, second is in tablet form.; injectable 20 mg/kg/day/intramuscular for 21 days.; injectable meglumine antimoniate 10 mg/kg/day/intramuscular for 21 days plus tablet allopurinol 300mg/4times a day for 21 days.
Intervention MeSH terms: Meglumine Antimoniate; Allopurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cutaneous leishmaniasis of the old world
A Study to Learn How [14C]ASP0367 is Processed by the Body in Healthy Men
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      ASP0367 is a potential new treatment for people with Duchenne Muscular Dystrophy and
      Mitochondrial Myopathies. Before ASP0367 is available as a treatment, the researchers need to
      understand how it is processed by and acts upon the body. This study is in healthy men.

      The main aim of this study is to learn how ASP0367 is processed by and acts upon the bodies
      of healthy men. To do this, [14C] which is a certain chemical (called a tracer, or
      radionuclide) has been added to ASP0367. [14C] gives off radiation, but the dose is very low
      (about the same as the dose from an x-ray) and will leave the body within a few days. [14C]
      will be picked up by a scanner and will be used to follow ASP0367 through the body.
      [14C]ASP0367 will be a liquid.

      During the study, the men who take part will stay in the clinic for 6 days and 5 nights. Some
      men may need to stay up to an extra 7 days in the clinic. This will happen if there is a
      medical reason or if they still have traces of radiation in their blood, urine or feces. On
      the day before they drink [14C]ASP0367, the men will be asked about their medical history,
      have a medical examination, and have their vital signs checked (blood pressure and pulse).
      They will also have an ECG to check their heart rhythm. They will give urine, stool and blood
      samples for laboratory tests. They will also be asked if they have had any medical problems.

      The men will fast for 10 hours or more before drinking [14C]ASP0367 and for 4 hours
      afterwards. They will only have one drink of [14C]ASP0367. They will need to lie still for 4
      hours after drinking [14C]ASP0367. They will have their vital signs checked and give urine,
      stool and blood samples for laboratory tests. Then, they will give urine, stool and blood
      samples every day until they leave the clinic. They will also be asked every day if they have
      had any medical problems.

      The day after they drink [14C]ASP0367, the men will also have an ECG. On the last clinic day,
      the men will also have a physical exam, have their vital signs checked and have an ECG. The
      men can leave the clinic once [14C]ASP0367 has left the body and they have no medical
      problems.

      About 10 days later, the clinic will call the men to check if there were any further medical
      problems.

      No other visits are planned during this study.
    


Intervention name(s): 14C-labeled ASP0367
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): MA-0211; bocidelpar
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Healthy Volunteers; ASP0367; MA-0211
Turkish Validity and Reliability of Gait Outcomes Assessment List (GOAL)
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Observational

Summary: 
      The aim of this study is to investigate the reliability and validity of the Turkish Gait
      Outcomes Assessment List (GOAL) Questionnaire, in children with cerebral palsy (CP) with
      GMFCS level1, 2, and 3.
    

Detailed description: 
      Most children with cerebral palsy (CP) can walk. Musculoskeletal disorders of these children
      cause deterioration in gait functions. Disruptions in gait limit children's participation. To
      minimize these impairments, various interventions are usually applied to children with CP who
      can walk. The ultimate goal of these interventions is to help these children achieve the best
      possible participation in activities of daily living. In addition, goal determination by
      children and families in treatment planning is important in terms of treatment success. The
      Gait Outcomes Assessment List (GOAL) is a scale developed to contribute to the determination
      of these goals. This questionnaire includes the priorities, expectations, and goals of
      children with CP who can walk and reveals their walking characteristics. The questionnaire is
      used in two languages, English and German, and there is no Turkish version of the
      questionnaire. Therefore, the aim of this study is to create the Turkish version of the 'Gait
      Outcomes Assessment List (GOAL)' family and child questionnaires and to examine its validity
      and reliability.
    

Intervention name(s): Gait Outcomes Assessment List (GOAL)
Intervention type(s): Other
Intervention description(s): Gait Outcomes Assessment List (GOAL) is a scale developed to contribute to the determination of treatment goals. This questionnaire includes the priorities, expectations, and goals of children with CP who can walk and reveals their walking characteristics.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children with Cerebral Palsy with GMFCS level 1,2, and 3