bioihbjkbjnl/mcl2 huggingface dataset:
Citalopram for Children With Autism and Repetitive Behavior (STAART Study 1)
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine the efficacy and safety of citalopram compared to placebo in the
      treatment of children with autism.
    

Detailed description: 
      For children with autism spectrum disorders (ASD, also known as Pervasive Developmental
      Disorders - PDDs), repetitive behaviors are common and frequently interfere with functioning
      in the home as well as in social and educational settings. These behaviors may involve
      repetitive movements, rigid routines, repetitive play, and even repetitive speech. These
      behaviors may be associated with high levels of anxiety, severe tantrums. Self-injury can
      occur when these behaviors and routines are interrupted.

      Participants will be randomly assigned to receive citalopram or placebo (administered as
      liquid), and carefully followed every two weeks. At the end of 12 weeks, children who have
      responded to treatment will be given the opportunity to continue in the study, with monthly
      visits, for an additional 24 weeks. Children who received placebo and did not respond to
      treatment at 12 weeks will be given the opportunity to receive a carefully monitored 12 week
      course of citalopram.
    

Intervention name(s): citalopram hydrobromide; placebo
Intervention type(s): Drug; Other
Intervention description(s): 10mg/5ml solution; up to equivalent of 20 mg of active comparator daily
Other intervention name(s): celexa
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Asperger Syndrome; Pervasive Developmental Disorder; PDD; Rituals; Compulsions; Stereotypy; Routines; Repetitive behavior; SSRI; Serotonin
Measurement of Natriuretic Hormone Peptides in Exacerbation of Asthma
Condition: ASTHMA
MeSH terms: Asthma
Study type: Observational

Summary: 
      The investigators hypothesize that there is a statistically significant decrease of
      Natriuretic Hormone Peptides (NHPs) in subjects with asthma exacerbation compared to levels
      following treatment of an exacerbation of asthma.
    

Detailed description: 
      Overall Study Design

        1. Measurement of Natriuretic Hormone Peptides in individuals suffering from exacerbation
           of asthma.

        2. Measurement of Natriuretic Hormone Peptides 5-7 days after initiation of treatment of
           exacerbation of asthma.

        3. Measurement of Natriuretic Hormone Peptides 10-14 days after initiation of treatment of
           exacerbation of asthma.

      3 comparisons of Natriuretic Hormone Peptides levels will be made:

        1. Exacerbation compared to 5-7 days after initiation of treatment

        2. Exacerbation compared to 10-14 days after initiation of treatment

        3. 5-7 days after initiation of treatment compared to 10-14 days after initiation of
           treatment.

      Samples of blood will be secured in the Division of Allergy/Immunology at the University of
      South Florida, Joy McCann Culverhouse Airways Disease Center. All samples will be
      appropriately coded to maintain confidentiality. Blood specimens will be held at minus 20
      degrees Celsius.
    

Sampling method: Probability Sample
Study population: 
        The Asthma Control Test score of less than 18.

        Asthma control test consists of five questions, scored 1-5 each.
      
Biospecimen description: 
      Samples of blood will be secured in the Division of Allergy/Immunology at the University of
      South Florida, Joy McCann Culverhouse Airways Disease Center. All samples will be
      appropriately coded to maintain confidentiality. Blood specimens will be held at minus 20
      degrees Celsius. GENETICS SAMPLES ARE OPTIONAL
    
Keywords: ASTHMA; ACUTE EXACERBATION OF ASTHMA
Risk Stratification-directed Therapy for AML With t(8;21) /AML1-ETO+
Condition: Acute Myeloid Leukemia; Risk Stratification
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional

Summary: 
      Acute myeloid leukemia with t(8;21) /AML1-ETO-positive (AE AML) is a heterogeneous disease
      entailing different prognoses. There were significant differences in the therapeutic effect
      between different subgroups of AE AML. Therefore, risk stratification-directed therapy is
      very necessary for AE AML.
    

Detailed description: 
      Acute myeloid leukemia with t(8;21) /AML1-ETO-positive (AE AML) is a heterogeneous disease
      entailing different prognoses.There were significant differences in the therapeutic effect
      between different subgroups of AE AML. For example, patients with c-kit mutation had higher
      relapse rate and lower overall survival, compared with those without c-kit mutation.
      Therefore, risk stratification-directed therapy is very necessary for AE AML. The purpose of
      this study is to establish risk stratification-directed therapy for AE AML.
    

Intervention name(s): Consolidation with chemotherapy (CT) or autologous hematopoietic stem cell transplantation (auto-HSCT); Consolidation with auto-HSCT or HLA-matched HSCT; allogeneic HSCT
Intervention type(s): Other; Other; Other
Intervention description(s): For CT, patients were treated with high dose cytarabine (HDAC), cytarabine at a dosage of 1-3 g/m2 q12 h ×6 doses, for 4-6 cycles.
For auto-HSCT, patients were treated with 3 cycles of HDAC and then bridged to auto-HSCT.; For auto-HSCT, patients were treated with 3 cycles of HDAC and then bridged to auto-HSCT.
For HLA-matched HSCT, patients were treated with 1-2 cycles of HDAC and then bridged to HLA-matched HSCT. HLA-matched donors were available in these patients.; For allogeneic HSCT, patients were treated with 1-2 cycles of HDAC and then bridged to allogeneic HSCT, including HLA-matched and haploidentical transplantation.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with newly diagnosed AML1/ETO-positive AML took risk-directed stratification therapy based on c-KIT and ASXL1 mutations and measurable residual disease (MRD). low risk (LR) group (KIT-ASXL1- with main molecular response (MMR)) was recommended to chemotherapy (CT) or autologous hematopoietic stem cell transplantation (auto-HSCT). Intermediate risk (IR) group (KIT+/ASXL1+ with MMR) was suggested for auto-HSCT or HLA-matched HSCT. High risk (HR) group (KIT+ASXL1+ or without MMR) was treated with allogeneic (allo-) HSCT.
Masking: None (Open Label)
Primary purpose: Treatment
Steno Diabetes Dialogue Cards Teaching on Group Education on Blood Sugar Control in Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes; HbA1c; Self-management
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The Type 1 diabetes is the autoimmunity system produces the antibody which starts to attack
      the B lymphocytes while the autoimmunity is also been attacked. When the autoimmunity system
      has been destoyed, the insulin couldn't be secreted normally. thus, the hyperglycaemia is
      caused. Then, the patients need to rely on the insulin injection throughout the lifetime. The
      main symptoms are the three mores （eat more, drink more and urinate more）, weight loss, urine
      sugar, lethargy, ketone bodies and ect. The most serious complications of the diabetes type 1
      is the Diabetic ketoacidosis, DKA. It is caused by the severe infection or poor Glycemic
      Control. If the DKA happened, the patients need to be rescued in the ICU. is because it
      sometimes endager life. The diabetes type 1 patients rely on the insulin injection throughout
      the lifetime and a good habbit of diet, boold sugar controlling and exercise. The DKA happens
      when the boold sugar is not well controlled.
    


Intervention name(s): Education
Intervention type(s): Other
Intervention description(s): Common Education
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: type 1 diabetes mellitus; Steno Balance Card; group health education; blood sugar control; self-management
Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture
Condition: Atrophy
MeSH terms: Atrophy; Tibial Plateau Fractures
Study type: Observational

Summary: 
      This study will quantify and examine the extent to which the quadriceps femoris muscle group
      atrophies following tibial plateau fractures and the length of time that atrophy affects
      function. The study will also look at the effects of tibial plateau fractures on the
      quadriceps muscle and the effect this atrophy has on functional outcome. Quadriceps atrophy
      will be measured both clinically and by using MRI scans taken pre-operatively, 3 months post
      operatively, and 1 year post-operatively. The injured leg and the non-injured leg will be
      scanned in order for the non-injured leg to serve as the control. In this way muscle volume
      can be estimated from the muscle thickness at specific locations in the thigh. The muscle
      strength of the quadriceps will also be assessed at the 3 month and 1 year visit by measuring
      isokinetic knee-extension torque, and functional assessment questionnaires will be completed
      at each study visit.
    


Intervention name(s): MRI
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who opt for surgical treatment or non-operative treatment of their fracture.
      
Keywords: Quadriceps; Tibial Plateau; Fracture
An Open-Label Study to Determine Safety , Tolerability, and Efficacy of Oral Lacosamide in Children With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      SP848 is an open-label study to evaluate long-term safety, tolerability, and efficacy in
      children with epilepsy treated with Lacosamide (LCM) oral solution (syrup) or LCM tablets as
      adjunctive therapy.
    

Detailed description: 
      SP848 is an open-label study to evaluate long-term safety, tolerability, and efficacy in
      children with epilepsy treated with Lacosamide (LCM) oral solution (syrup) or LCM tablets as
      adjunctive therapy. In addition, the study is designed to provide continued availability of
      LCM to subjects who have completed the SP847 (NCT00938431) study and to subjects who have
      discontinued from SP847 (NCT00938431) and who, in the investigator's opinion, would benefit
      from long-term administration of LCM.

      SP848 will be open to subjects who have participated in other LCM pediatric clinical studies
      in epilepsy and will also be open to up to 100 subjects enrolling directly into SP848.
      Permissible LCM doses in SP848 are between 2-12 mg/kg/day (oral solution [syrup]) or the
      corresponding tablet dose up to a maximum dose of 600 mg/day.

      Subjects enrolled in SP848 have the option of remaining on the oral solution formulation of
      LCM or switching to the commercial tablet formulation, if feasible.
    

Intervention name(s): Lacosamide; Lacosamide
Intervention type(s): Drug; Drug
Intervention description(s): Lacosamide oral solution (syrup): Total daily dose between 2 mg/kg/day (1 mg/kg bid) to 12 mg/kg/day (6 mg/kg bid); Lacosamide tablets: Total daily dose between 100 mg (50mg bid) - 600mg (300 mg bid).
The maximum permissible dose of LCM will be 12 mg/kg/day or 600 mg/day.
Other intervention name(s): Vimpat®; Vimpat®
Intervention MeSH terms: Lacosamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lacosamide (VIMPAT)
Swallowing Sound in Preterm Infant Evaluation of Feeding Maturation
Condition: Other Preterm Infants
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Our objective was to evaluate maturation of sucking and swallowing in preterm infants using a
      non-invasive method: assessment of swallowing sounds. Findings in healthy term infants were
      used as reference values.
    

Detailed description: 
      Successful transition to full oral feeding in preterm infants is important for safe discharge
      from hospital and for facilitating the mother-infant bond. Preterm infants were evaluated
      weekly for sucking and swallowing performance (i.e., feeding performance) from the time they
      began oral feeding (frequency 1-2 oral feedings/day) until they reached independent oral
      feeding (frequency 8 oral feedings/day) at postmenstrual 38-40 weeks. For the term infants,
      we evaluated a single oral feeding during the first week of life.

      The exclusion criteria were major congenital abnormalities, craniofacial malformation,
      intracranial hemorrhage, bronchopulmonary dysplasia, culture-positive sepsis, and necrotizing
      enterocolitis. Each swallowing-sound recording was 2 minutes long and was captured in a quiet
      environment by the same investigator. The feeding parameters generated from the recordings
      were as follows: total number of swallows (S), total number of rhythmic swallows (RS), total
      number of resting intervals (RI), average time between resting intervals (ATRI), average time
      between swallows (ATS), average time between rhythmic swallows (ATRS), maximum number of
      rythymic swallows (MRS), and volume of milk ingested (VM) during the 2-minute evaluation.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Preterm infants (< 37 gestational weeks) and term infants (>=37 gestational weeks)
      
Keywords: Maturation; preterm infants; sucking and swallowing
A Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers
Condition: Essential Hypertension
MeSH terms: Essential Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetic drug interaction after oral concurrent administration of
      fimasartan and amlodipine in healthy male volunteers
    


Intervention name(s): Fimasartan; Amlodipine
Intervention type(s): Drug; Drug
Intervention description(s): Fimasartan (1d~7d) Amlodipine (12d~14d) Fimasartan + Amlodipine(15d~21d); Amlodipine (1d~10d) Amlodipine (25d~27d) Fimasartan + Amlodipine(28d~34d)
Intervention MeSH terms: Amlodipine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Fimasartan; Drug interaction
COVID-19 in Pain Perspective
Condition: Infection; COVID; Pain
MeSH terms: Infections
Study type: Observational

Summary: 
      In our hospital's Infectious Diseases and Clinical Microbiology service, patients who have
      been hospitalized due to Covid -19 infection have a musculoskeletal pain and headache during
      this process, and 466 patients will be recruited to compare them with the pre-disease state
      of the patients and to evaluate the pain status of the patients after treatment.
    

Detailed description: 
      This retrospectively designed study was carried out by analyzing SARS-CoV-2 infected and
      hospitalized patients in our hospital for 2 month. The patients, whose contact information
      can be accessed from the hospital records, will be called by phone and pain inquiries were
      made during the SARS-CoV-2 infection process. In addition, patients' demographic data, living
      conditions (number and characteristics of the person in the household), comorbidities,
      symptom inquiry related to infection, duration of symptoms, length of hospitalstay,
      pre-infection pain conditions and current pain, anxiety, depression levels and quality of
      life will be questioned.

      The pain questioning include the painful body region/s, severity (Numeric Rating Scale), type
      of analgesic drugs used, and duration of use that occurred during infection. Anxiety and
      depression levels will be evaluated, hospital anxiety and depression scale (HADS), and
      quality of life will be evaluated with SF-12 health assessment questionnaire.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        In our hospital, patients who were treated with the diagnosis of COVID-19 were selected.
        During the selection, patients between the ages of 18-95 were selected, considering the
        inclusion and exclusion criteria.
      
Keywords: infections; pain; Coronavirus
PK of Depo SubQ Injected in the Upper Arm
Condition: Contraception
Study type: Interventional

Summary: 
      A single-arm trial to demonstrate that Depo-SubQ Provera injected in the upper arm is
      adequate for effective contraception
    

Detailed description: 
      A single-arm trial to demonstrate that the blood levels of medroxyprogesterone acetate are
      adequate for effective contraception when Depo-SubQ Provera 104 is injected in the upper arm
    

Intervention name(s): Medroxyprogesterone acetate
Intervention type(s): Drug
Intervention description(s): Injectable hormonal contraceptive
Other intervention name(s): Depo-SubQ Provera 104
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: AE adverse event; DCF data collection forms; DMC Data Monitoring Committee; FDA U.S.) Food and Drug Administration; GCP Good Clinical Practice guidelines; ICH International Conference of Harmonisation; IND Investigational New Drug Application; IRB Institutional Review Board; IU International units; mg milligram(s); SAE serious adverse event; µg microgram; ULN upper limit of the normal range
Scapular Mobilization on Inspiratory Capacity of Post-CABG Patients
Condition: CABG
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      To determine the effects of scapular mobilization on pulmonary functions of post-CABG
      patients.
    


Intervention name(s): Conventional Treatment; Scapular Mobilization
Intervention type(s): Other; Other
Intervention description(s): Thrice a day for complete length of stay. This is Conventional treatment The total duration of session will be of 15-20 mins.; Thrice a day for complete length of stay including two sets of repetitions with a rest interval of 30 seconds between sets. Grade 1-3 As reported in a study Scapular mobilization (SM) i.e., Scapular superior, inferior glides, upward and downward rotations and scapular distraction, along with Conventional treatment according to American Heart Association Guidelines i.e., Incentive spirometer, chest clearance, expectoration of the sputum (suctioning if needed), mobilizing the patient out of bed, AAROM and AROM exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 1 mg
Condition: Anxiety
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Alprazolam tablets, 1 mg.
    


Intervention name(s): Alprazolam Tablets, 1 mg (Geneva Pharmaceuticals); Alprazolam Tablets, 1 mg (The Upjohn Company)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Efficacy and Safety of Controlled Release Arbaclofen Placarbil (XP19986) in Patients With Gastroesophageal Reflux Disease
Condition: GERD
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of arbaclofen placarbil
      (XP19986) compared to placebo in patients with gastroesophageal reflux disease.
    


Intervention name(s): XP19986 CR; Placebo for XP19986 CR
Intervention type(s): Drug; Drug
Other intervention name(s): Eudragit RL 100; Sugar Pill
Intervention MeSH terms: Arbaclofen placarbil; Baclofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Carbon Monoxide Monitor for the Measurement of End-Tidal Carbon Monoxide Levels in Children With or Without Hemolysis
Condition: Sickle Cell Anemia
MeSH terms: Anemia, Sickle Cell; Hemolysis
Study type: Interventional

Summary: 
      People who have Sickle Cell Anemia (HbSS) produce red blood cells with shorter lifespans.
      These red blood cells breakdown faster, and this is called hemolysis. When red blood cells
      breakdown, a tiny amount of Carbon Monoxide (CO) is released into the blood and is eliminated
      in exhaled breath. This research study will use a device called CoSense™, which will measure
      Carbon Monoxide (CO) levels in breath. The purpose of the study is to see how well the device
      measures the CO levels that an individual breathes out.
    

Detailed description: 
      Subjects diagnosed with homozygous sickle cell anemia (Hb SS) have red blood cells with a
      decreased lifespan, which leads to an increase in the rate of heme turnover. Carbon monoxide
      (CO) is a by-product of heme oxidation and is excreted in exhaled breath. The concentration
      of CO in end-tidal breath can be measured and used to indicate the rate of heme oxidation,
      bilirubin production and the presence of hemolysis. The objective of this study is to
      characterize the performance of CoSense™ in children with or without sickle cell anemia. This
      is a single-center, open-label, non-randomized, proof of concept study to characterize the
      ability of CoSense™ to assess ETCO levels in subjects with a diagnosis of sickle cell anemia
      (Hb SS). Up to 40 children (5-14 years old), of which 20 participants will have a diagnosis
      of Hb SS, will be enrolled. Each participant will have two breath samples collected
      non-invasively, one immediately after the other. It takes approximately 120 seconds to
      collect the each breath sample. This study and investigational device are a non-significant
      risk to the patient. The nasal cannula is made of a biocompatibility-tested polyvinyl
      chloride (PVC) material with a soft open-end, and will be gently placed adjacent to one of
      the nostrils and partially inserted by approximately 5 mm. The objective of this study will
      be assessed through reproducibility of ETCO measurements and comparison of ETCO levels
      between children diagnosed with Hb SS and healthy children. The study would help in the
      development of a portable CO measurement device which has potential health applications in
      monitoring diseases with altered bilirubin metabolism.
    

Intervention name(s): Measurement of carbon monoxide level in exhaled breath
Intervention type(s): Other
Intervention description(s): Measurement of end-tidal carbon monoxide concentration
Other intervention name(s): CoSense Carbon Monoxide Monitor
Intervention MeSH terms: Carbon Monoxide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic