bioihbjkbjnl/mcl2 huggingface dataset:
Adolescent Mite Allergy Safety Evaluation
Condition: Allergic Rhinitis; Allergic Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 28-day clinical trial studying the safety of the house dust mite tablet in
      adolescents with allergic rhinitis/rhinoconjunctivitis.

      The purpose of this trial is to collect additional safety information about a tablet used to
      treat house dust mite allergies, when used to treat adolescents who have these allergies.

      The trial medication used is already approved to treat allergic rhinitis caused by house dust
      mite in adults and adolescents (12-17 years old) in several countries.
    

Detailed description: 
      This trial is a 28-day, single-arm open-label phase III trial to evaluate safety of the house
      dust mite SLIT-tablet in adolescents (12-17 years of age) with HDM allergic
      rhinitis/rhinoconjunctivitis with or without asthma. Approximately 250 adolescents will be
      enrolled in the trial and will receive the house dust mite SLIT tablet. The trial is
      conducted in several European countries.
    

Intervention name(s): HDM SLIT-tablet
Intervention type(s): Biological
Intervention description(s): Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
Other intervention name(s): ACARIZAX, ODACTRA
Intervention model: Single Group Assignment
Intervention model description: single-armed
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allergic rhinitis; House dust mite; Adolescent; Pediatric
Family-Centered Songwriting in Pediatric Palliative Care
Condition: Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study evaluates the feasibility and efficacy of a family-centered songwriting
      intervention for cognitively-impaired children referred to a palliative care service.
    

Detailed description: 
      Music-based interventions have previously been shown to reduce psychological distress in
      children with life-threatening conditions. However, children with cognitive impairment are
      frequently excluded from these studies. Our study will evaluate the efficacy a
      family-centered songwriting intervention for the following outcomes: child psychological and
      physical symptoms, parent psychological distress, and family environment.

      Following recruitment, parent-child dyads will undergo 4 sessions with a licensed music
      therapist (anticipated to last 1 hour each). During these sessions, families and their
      children will select a song and engage in a songwriting process which includes various
      physiologic sounds from the child (i.e. heart rate, breathing). At the conclusion of these
      four sessions, a music DVD will be produced and delivered to the family.
    

Intervention name(s): Songwriting with licensed music therapist
Intervention type(s): Behavioral
Intervention description(s): Song selected by parent-child dyad with recordings of physiologic components (i.e. heartbeat, breathing)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: palliative care; pediatrics; music therapy
Changes of Body Temperature During Shoulder Arthroscopy
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effect of electrically heated humidifier on the
      body temperature during shoulder arthroscopy.
    

Detailed description: 
      On the control group, use only routine anesthetic respiratory circuit for mechanical
      ventilation On the comparative group, use electrically heated humidifier for mechanical
      ventilation And compared the changes of body temperature durgin shoulder artheroscopy.
    

Intervention name(s): heated circuit; control
Intervention type(s): Procedure; Procedure
Intervention description(s): use electrically heated respiratory circuit (set at 37oC)during mechanical ventilation of anesthetic machine during shoulder arthroscopy; use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy
Other intervention name(s): heat circuit
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: heated circuit; body temperature
A Study to Evaluate the Safety, Tolerability and Plasma Concentration Profiles of MK0633 in Asthmatic Children Aged 12 to Less Than 16 Years (0633-019)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability and pharmacokinetics (PK) of MK0633 in adolescent
      mild-to-moderate asthma patients to permit further clinical investigation.
    


Intervention name(s): Comparator: MK0633
Intervention type(s): Drug
Intervention description(s): patients will receive single 50mg oral dose with follow-up observation for 5 weeks.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor
Condition: Hereditary Angioedema Types I and II
MeSH terms: Angioedema; Angioedemas, Hereditary; Hereditary Angioedema Types I and II
Study type: Interventional
Phase: Phase 1

Summary: 
      A new formulation of Berinert (CSL830) is being investigated for the management of hereditary
      angioedema (HAE). The main aim of the study is to assess the safety of a single 1500 IU dose
      of the new formulation of Berinert. This study will also look at the pharmacokinetics of
      CSL830 relative to Berinert currently on the market.
    


Intervention name(s): Berinert; CSL830
Intervention type(s): Biological; Biological
Intervention description(s): Berinert is a plasma-derived C1 esterase inhibitor (human), supplied as a freeze-dried powder for reconstitution.; CSL830 is a formulation of Berinert.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase 1 Study for Safety of ACHN-490
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human phase 1 study to assess if ACHN-490 Injection is safe in people.
      Groups of people will receive either the study medication (ACHN-490) or a placebo (normal
      saline) as a single infusion. If the single dose is well tolerated then this group will
      receive 1 dose per day for up to 10 consecutive days. A new group of people will receive the
      study medication at a higher dose than the previous dose level as long as the previous dose
      was safe.
    


Intervention name(s): ACHN-490 Injection vs placebo
Intervention type(s): Drug
Intervention description(s): Escalating doses beginning with test dose given once, followed by 4 mg/kg with a single dose then multiple dose. Dose escalation to continue up to 15 mg/kg as long as the treatment is deemed safe.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: healthy; volunteers; subjects
A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)
Condition: Hypertension, Pulmonary
MeSH terms: Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this study is to evaluate the safety and efficacy of tadalafil in
      pediatric participants with pulmonary arterial hypertension. Participants will receive study
      treatment for 6 months in the double-blind period (Period 1), and then will be eligible to
      enroll into an open-label 2 year extension period (Period 2) during which participants will
      receive tadalafil.
    


Intervention name(s): Tadalafil; Placebo; ERA as specific PAH treatment
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally by tablet form for heavy and middle weight participants. Administered orally by suspension for light weight participants.; Administered orally by tablet for heavy and middle weight participants. Administered orally by suspension for light weight participants.; All participants were taking endothelin receptor antagonist (ERA) (such as bosentan, ambrisentan and macitentan).
Other intervention name(s): LY450190; Cialis; Adcirca; IC351
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure.
Condition: Adult; Acute Respiratory Failure Admitted in ICU; Immuno Compromized
MeSH terms: Respiratory Insufficiency; Respiratory Distress Syndrome
Study type: Interventional

Summary: 
      Assess the superiority of early non invasive ventilation in comparison to Oxygen therapy
      only, for immuno-compromized patients with acute respiratory failure
    


Intervention name(s): Early non invasive ventilation; Oxygen therapy only
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Flushing in Social Anxiety Disorder on Seroquel
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 3

Summary: 
      To add to our understanding of the relationship between blushing, symptom severity and
      potential mechanisms that underlie blushing in patients with Social Phobia (SP), the
      investigators propose comparing SP patients' vascular responses to topical m-N pre and post
      treatment with Seroquel or placebo.

      Atypical antipsychotics such as seroquel have been used successfully as adjunctive treatments
      in other anxiety disorders, including PTSD (Labatte, 2001; Krashin & Oates, 1999; McDougle et
      al., 2000; Pfanner et al., 2000; Bogetto et al., 2000) and Generalized Anxiety Disorder
      (Katzman et al., 2005). Responses to the blushing exposure will be assessed prior to and
      following treatment with seroquel or placebo and at one month following intervention. Levels
      of prostaglandin will be compared between groups and will also be correlated with symptom
      severity in the clinical groups.

      The objective of this randomized, double blind flexible -dose study will be to evaluate the
      efficacy , safety and tolerability of seroquel SR 50mg to 800mg and placebo in outpatient
      subjects diagnosed with SP. The study will begin with a single week of Seroquel 50mg or
      placebo. Subsequently, tablets will be administered by the investigator in a flexible dose
      fashion during the visits. Patients will be followed up weekly (biweekly after week 6) and at
      the clinician's discretion. After the fist week the patients' dosage will be increased up to
      a maximum of 800 mg daily with expected average dose of 300mg dail. This dose will remain
      fixed after 8 weeks of treatment until week 16.
    


Intervention name(s): Seroquel; Sugar Pill
Intervention type(s): Drug; Drug
Intervention description(s): seroquel XR- oral extended release tablets, 50mg - 300mg, 16 weeks; Sugar pill to match seroquel
Other intervention name(s): Quetiapine
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Niapsan as Add -on Therapy to Antipsychotic Treatment in First Episode Psychosis
Condition: Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to help understand if by adding Niaspan FCT (study drug) to
      antipsychotic medications will it help maintain or improve cognitve functioning.
    


Intervention name(s): Niaspan
Intervention type(s): Drug
Intervention MeSH terms: Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of AOC 1001 in Adult Myotonic Dystrophy Type 1 (DM1) Patients
Condition: DM1; Myotonic Dystrophy 1; Myotonic Dystrophy; Myotonic Dystrophy Type 1 (DM1); Dystrophy Myotonic; Myotonic Disorders; Steinert Disease; Myotonic Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Myotonic Dystrophy; Myotonic Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      AOC 1001-CS1 is a randomized, double-blind, placebo-controlled, Phase 1/2 study to evaluate
      the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple-doses
      of AOC 1001 Administered Intravenously to Adult Myotonic Dystrophy Type 1 (DM1) patients
      (MARINA).

      Part A is a single dose design with 1 cohort (dose level). In Part A, the patient duration is
      6 months as the treatment period is 1 day followed by a 6 month follow-up period.

      Part B is a multiple-ascending dose design with 2 cohorts (dose levels). In Part B, the
      patient duration is 6 months as the treatment period is 3 months followed by a 3 month
      follow-up period.
    


Intervention name(s): AOC 1001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AOC 1001 will be administered by intravenous (IV) infusion.; Placebo will be administered by intravenous (IV) infusion.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: DM1; Myotonic Dystrophy 1; Myotonic Dystrophy Type 1 (DM1); Myotonic Dystrophy; DM; Dystrophy Myotonic; Myotonic Disorders; Steinert Disease; MARINA; Avidity Biosciences; Avidity; AOC 1001; Myotonic Muscular Dystrophy
Early Diagnosis of Leukemic Children Patients Based on Clinical, Age Estimation and Radiographical Evaluation of Oral Affection
Condition: Leukemia
Study type: Observational [Patient Registry]

Summary: 
      Early diagnosis of leukemia which is malignant tumor affecting bone especially in children is
      import to allow early intervention improving prognosis. It is known that leukemic patients
      suffer from clinical signs as anemia, thrombocytopenia, and pronounced hepatosplenomegaly or
      lymphadenopathy. However, sometimes these clinical signs may be not clearly manifested and
      may look like anemia. The early diagnosis could be achieved through dentist by accessing
      clinical and radiographical signs such as oral masses, gingival bleeding /or enlargement and
      oral ulceration with radiographical features including focal or generalized osteolysis of
      bone with presence of moth eating appearance and even with abnormal teeth chronology
      regarding teeth morphology, germ formation of permanent teeth and their sequence of eruption.
      Therefore, accessing of these special clinical and radiographical features by the dentist
      could help in early diagnosis of leukemic children patients
    

Detailed description: 
      Ten children patients suffer from leukemia selected after initial diagnosis from hematology
      unit of faculty of medicine, Tanta university based on their clinical signs such as; bone
      pain, fatigability, lymph node enlargement…etc., with abnormal CBC revealing anemia or
      abnormal WBCs. These patients accessed clinically for oral signs and accessed
      radiographically using panoramic radiographs and cone beam computed tomography (CBCT) to
      evaluate chronology and bone density.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        ten Children leukemic patients selected from hematology Unit of faculty of medicine, Tanta
        university revealing anemia or abnormal WBCs confirmed by bone marrow aspiration biopsy,
        these Children patients examined orally for any oral pathology as gingival masses, oral
        ulceration, bone resorption, teeth mobility, and assessed radiographically by panoramic and
        CBCT for age estimation , bone density to help in their early diagnose if they came to the
        dentist
Investigating the Effect of Telmisartan (Micardis®) on the Average 24h Blood Pressure of Therapy-naive and Therapy-experienced Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Practical experience report (PER) investigating the effect of Micardis® on the average 24h
      blood pressure of therapy-naive and therapy-experienced patients
    


Intervention name(s): Micardis
Intervention type(s): Drug
Intervention MeSH terms: Telmisartan
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        hypertensive patients
CARDS Is Designed To Show If Lowering Cholesterol With Atorvastatin In Type 2 Diabetics Without CV Disease Reduces The Risk Of CV Events
Condition: Major Coronary Event; Cerebrovascular Accident; Coronary Artery Bypass Graft; Angina, Unstable; Revascularization
MeSH terms: Stroke; Angina, Unstable
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to assess the efficacy of once daily atorvastatin 10 mg versus placebo on
      cardiovascular endpoints in patients with non-insulin-dependent diabetes mellitus (NIDDM) who
      have a history of either hypertension, retinopathy, microalbuminuria, macroalbuminuria, or
      who currently smoke, but who do not have established corornary heart disease or other
      macrovascular disease.
    


Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Cross-linked Emulsion Study
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This comparative pilot study is designed to compare the rates of gastric emptying and by
      inference rates of digestion of two food emulsions. Two types of milk protein stabilised food
      emulsion will be compared, one standard emulsion preparation and one emulsion preparation
      cross-linked with microbial transglutaminase. The information from this study will then be
      compared to data on satiety and endocrine hormones from a parallel study undertaken in
      Finland using the same two meal formulations. The drinks will be labeled with a stable
      isotope of carbon and samples of breath collected every 20 minutes after consumption of the
      drink. This will allow gastric residence time to be calculated. The pilot will also fulfill
      two secondary objectives. At the same time as the breath samples are collected MRI scans of
      the upper abdomen will be made so that gastric volumes can be measured in order to compare
      the two methods of measuring gastric emptying rates. Additionally, samples of saliva will
      also be collected after every MRI scan for subsequent mass spectrometry analysis. These are
      to assess the efficacy of mass spectrometry analysis for detection of the presence of
      specific digestion related hormones such as ghrelin.
    


Intervention name(s): cross-linking of an emulsion drink
Intervention type(s): Other
Intervention description(s): This study will assess whether a subtle change in food structure (cross-linking of interfacial protein) can alter gastric emptying rate.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: emulsion; protein; cross-linking; gastric emptying
Host Response to Infection and Treatment in Lymphatic Filarial Disease in India
Condition: Lymphatic Filarial Disease
MeSH terms: Infections
Study type: Observational

Summary: 
      Patients admitted on this protocol will have, or be suspected of having, one of the lymphatic
      filarial infections affecting humans. After routine clinical evaluation they will be studied
      in depth immunologically, and their blood cells and/or serum will be collected to provide
      reagents (eg., specific antibodies, T cell clones, etc.) that will be used in the laboratory
      to address the broader questions of immunodiagnosis, immunoregulation, immunopathology and
      immunoprophylaxis. Careful observations of the patients' clinical and immunologic responses
      to therapy will be made, as well as long-term follow-up of these changes. It is anticipated
      both that the patients will receive optimal clinical care for their infections and that the
      specimens collected from them will prove to be valuable reagents for the laboratory studies
      of the immunologic responses unique to filarial or other helminthic infections.
    

Detailed description: 
      This study is designed to determine the presence of and the immune response to filarial and
      stronglyloides infections in an area endemic for both infections in South India. This study
      will aim to examine the presence of filarial and Strongyloides stercoralis infection at a
      community level as well as in hospital settings. After routine clinical evaluation and
      screening, individuals enrolled in this protocol will be studied in depth immunologically,
      and their blood cells and/or serum will be collected to address the broader questions of
      immunodiagnosis, immunoregulation and immunopathology. Careful observations of the individual
      s clinical and immunologic responses to therapy will be made, as well as long-term follow-up
      of these changes. In addition to infected individuals, this protocol will also be used to
      study individuals with filarial pathology and endemic normal individuals. This will enable us
      to characterize the immunological profiles of infected, uninfected and diseased individuals
      in an endemic area and provide greater insight into the pathogenesis of lymphatic filarial
      disease as well as the immunology of strongyloides infection.
    

Observational model: Cohort
Time perspective: Prospective
Keywords: Filarial Parasites; Wuchereria Bancrofti; Brugia Malayi; Diethylcarbamazine (DEC); Ivermectin
Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Secondary Progressive
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is 1) to study the safety and tolerability of escalating doses of
      myelin peptide reactive T cells in MS patients and 2) to study the clinical effectiveness of
      T Cell Vaccine ion the clinical course of MS.
    

Detailed description: 
      The principle of TCV is similar to that of traditional microbial vaccination where attenuated
      infectious agents are used to stimulate protective immune responses. Because pathogentic
      autoreactive T cells are viewed as pathogens in T cell-mediated autoimmune diseases, they can
      be used, as a vaccine to prevent and treat the diseases in which they are able to induce.
    

Intervention name(s): Tovaxin Autologous T Cell Vaccine
Intervention type(s): Biological
Intervention description(s): Primary Series (x1): 4 subcutaneous injections (wks 0, 4, 12 and 20 with 52 week evaluable period.
Retreatment Series (x3): 3 subcutaneous injections (wks 0, 4, and 8) with 26-week evaluable periods.
Retreatment Series (x3): 5 subcutaneous injections (wks 0, 8, 26, 24 and 32) with 52-week evaluable periods.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tovaxin; TCV; Autologous