bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Patients With Anxiety Disorder (0777-022)
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to examine the safety and efficacy of MK0777 during treatment for
      Generalized Anxiety Disorder.
    


Intervention name(s): MK0777; Comparator: placebo (unspecified)
Intervention type(s): Drug; Drug
Intervention description(s): Duration of Treatment: 4 weeks; Duration of Treatment: 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Monitoring Obese Patients : Impact on the Frequency of Monitoring Weight
Condition: Obesity; Morbid Obesity; Quality of Life
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      The literature data show that long-term monitoring has an effect on weight loss, comorbidity
      and on improving the quality of life. However, there are still no studies on monitoring obese
      patients after taking initial multidisciplinary approach. The recommendations of the HAS 2011
      advocated "continuous monitoring needed to prevent weight regain, monitor the consequences of
      overweight and treat comorbidities. This requires a long-term support. "The frequency of
      follow-up consultations is not specified and "must be adapted to achieve a weight loss target
      and maintain." Having no specific recommendations on the frequency of monitoring, the
      investigators chose to experiment closer monitoring than our current monitoring to assess
      what is the best frequency monitoring, in terms of: weight loss, quality of life, feeding
      behavior, changes in physical abilities, evolution of comorbidities associated with obesity.
      The recommendations of the HAS 2011 advocate support of a multidisciplinary obesity for
      weight loss of 5% to 10 %, which, if maintained, can reduce comorbidities associated with
      obesity (type 2 diabetes, hypertension, pain associated with osteoarthritis).
    

Detailed description: 
      2 groups of randomized patients will be followed:

        -  The control group will follow the current center: every four months for a year, combined
           with monitoring by email or regular mail during the year.

        -  The experimental group will be a follow-up every two months for one year HDJ more of the
           same followed by email or postal mail.

      Follow by email or mail is identical to the control group, as well as HDJ 12 months.
    

Intervention name(s): closer monitoring
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Obesity; Morbid Obesity; Therapeutic education
Sunlight Exposure and Vitamin D Status of Children of South Asian Ethnicity Living in the UK
Condition: Healthy Volunteers
Study type: Observational

Summary: 
      The purpose of this study is to examine the amount of sunlight exposure and vitamin D status
      of adolescent schoolchildren of South Asian ethnicity in each season throughout the year.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Schoolchildren of South Asian ethnicity in Greater Manchester
Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Antipsychotic alone is limit to improve the overall outcome of schizophrenia and has a high
      discontinue rate.To solve these problems, we provide practical and available psychosocial
      intervention. We hypothesize that there will be significant difference in the overall
      effectiveness between antipsychotic and antipsychotic combination with psychosocial
      intervention.
    

Detailed description: 
      The study is designed as a national, multicenter, randomized, naturalistic trial, with
      research assessors intended to be blind to the intervention status.

      We plan to recruit 1400 patients at 10 china sites and randomly assign them to two group. the
      control group only receive antipsychotic and the study group receive antipsychotic
      combination with psychosocial intervention. The course is 12 months. Patients use one of the
      seven study drugs (chlorpromazine, sulpiride, clozapine, olanzapine, risperidone, quetiapine,
      and aripitrazole)to the maintain treatment. The psychosocial intervention include
      psychoeducation, family intervention, skills training, and cognitive-behavioral therapy. The
      primary aim is to delineate differences in the overall effectiveness of the two treatment
      model.The assessments include the outcome of symptomatology，neurobiology，social
      psychology，medical economics.
    

Intervention name(s): Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole; psychosocial intervention
Intervention type(s): Drug; Behavioral
Intervention description(s): patient will receive one of the seven study drugs (Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole) as the maintain treatment. the dose is flexible, is based on the study doctor's judgment.; the psychosocial interventions include psychoeducaiton, family intervention, skill training, and cognitive-behavioral therapy.
Intervention MeSH terms: Olanzapine; Chlorpromazine; Risperidone; Quetiapine Fumarate; Clozapine; Sulpiride
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; antipsychotic; outcome; psychosocial intervention
Dermacyd Femina (Lactic Acid) Pocket BR - Compatibility
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate the absence of irritation potential (primary dermic irritability and cumulated
      dermic irritability) and allergy (sensibilization) of the product Dermacyd Femina (Lactic
      Acid) Pocket BR.
    


Intervention name(s): Lactic Acid
Intervention type(s): Drug
Intervention description(s): Lactic Acid (Dermacyd Femina)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Closed-Loop Glucagon Pump for Treatment of Post-Bariatric Hypoglycemia
Condition: Post-bariatric Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To assess the efficacy of a closed loop glucagon system to prevent and treat hypoglycemia
      occurring in patients with Post-Bariatric Hypoglycemia (PBH) in response to meals and
      exercise.
    

Detailed description: 
      A control system for sensor-guided delivery was previously developed and tested in a
      Proof-of-Concept (POC) study in a clinical research setting during 9 mixed meal tolerance
      tests in 8 unique patients with severe hypoglycemia following bariatric surgery. This
      optimized algorithm will now be implemented to deliver stable glucagon in a closed-loop
      system.

      A randomized, placebo-controlled, masked trial will be conducted to assess the efficacy of
      the closed loop system to prevent and treat hypoglycemia occurring in patients with PBH in
      response to meals (part 1). Part 2 will test whether the closed loop system can also prevent
      and treat hypoglycemia in patients with PBH in response to exercise. A manufacturing program
      from our collaborating team at Xeris Pharmaceuticals will continue to produce supplies of
      glucagon for the clinical trial in a current good manufacturing practice (cGMP) facility,
      with continued shelf-life stability testing.
    

Intervention name(s): glucagon; Closed loop glucagon pump
Intervention type(s): Drug; Device
Intervention description(s): novel, stable non-aqueous glucagon formulation provided by Xeris Pharmaceuticals; a novel closed-loop glucagon system (CLG) incorporating a novel, stable non-aqueous glucagon formulation together with an infusion pump system (Omnipod) guided by real-time continuous glucose monitoring (Dexcom) that is triggered by a hypoglycemia alert algorithm.
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomization scheme will be devised to assign half the subjects to receive glucagon during their first challenge visit and the other half to receive vehicle during their first challenge visit. At their second challenge subjects will be assigned to the product not received during their first challenge. The label will include a subject randomization number and information as to which vial should be administered during the first challenge and which should be administered during the second challenge.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Fatty Acid Supplementation in Children With ASD
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine how fatty acid supplementation alters biological
      signatures in children with ASD
    

Detailed description: 
      Children with Autism Spectrum Disorder (ASD) suffer from both mental and physical symptoms
      that affect their quality of life and severely disrupt family well-being. Fatty acid
      supplements are natural products with anti-inflammatory properties often used for treatment
      of ASD symptoms, but their efficacy remains unproven. The objective of the proposed protocol
      is to quantify the impact of Omega 3-6 on pre-specified biological signatures. The hypotheses
      were formulated based on data from the investigators previous studies and other published
      data which suggest that the inflammatory markers, IL-1β, IL-2, and IFNγ are consistently
      elevated in children with ASD and decreases in these markers correlate with ASD symptom
      improvement. The investigators long-term goal is to identify effective treatments for ASD.
    

Intervention name(s): LCPUFA Oil Supplement; Canola Oil Placebo
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): 25 mg/kg, 50 mg/kg, or 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days; Equal volume (25 mg/kg, 50 mg/kg, or 75 mg/kg) of placebo (canola) oil to be administered twice per day by mouth for 90 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Intervention for Sleep and Pain in Youth
Condition: Headache Disorders; Migraine Disorders; Insomnia
MeSH terms: Migraine Disorders; Headache Disorders; Headache
Study type: Interventional

Summary: 
      This study tests the feasibility, acceptability, and preliminary efficacy of a seven-session
      cognitive-behavioral therapy intervention to treat sleep and pain problems in youth ages
      11-17 with co-morbid headache and insomnia.
    

Detailed description: 
      Cognitive-behavioral interventions have been developed to treat childhood insomnia and
      childhood headache. In this study, we have combined strategies from these interventions into
      a single, seven-session protocol to treat sleep and pain problems in youth with co-morbid
      headache and insomnia. In this single-arm pilot study, we will test the feasibility,
      acceptability, and preliminary efficacy of this intervention.
    

Intervention name(s): Intervention for Sleep and Pain in Youth
Intervention type(s): Behavioral
Intervention description(s): See arm description.
Other intervention name(s): Hybrid cognitive behavioral therapy for insomnia and headache
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric; children; adolescent; sleep; pain; cognitive-behavioral therapy
Central Corneal Swelling With Silicone Hydrogel Materials
Condition: Corneal Swelling
Study type: Interventional

Summary: 
      This is a prospective, single site, unmasked, cross-over study with three silicone hydrogel
      contact lenses comparing central corneal swelling.
    


Intervention name(s): etafilcon A; lotrafilcon B; comfilcon A
Intervention type(s): Device; Device; Device
Intervention description(s): spherical hydrophilic soft contact lens worn in a daily wear modality
Other intervention name(s): Investigational Soft Contact Lens -
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Compare Two Anti-Scorpion Venom Serum In Children
Condition: Scorpion Sting
MeSH terms: Scorpion Stings
Study type: Interventional
Phase: Phase 3

Summary: 
      The morbidity associated with scorpion sting intoxication presents an endemic pattern in the
      country, where there are highly venomous species of scorpions so the scorpion sting
      intoxication (IPPA) is considered a medical emergency.

      On the other hand, there is scarce scientific literature from different controlled studies
      evaluating anti-scorpion serum, considering clinical severity scales, lab results and their
      safety. The aim of this study is to compare the efficacy and safety of scorpion sting
      treatment, using two sera, one produced by Birmex versus Alacramyn ® (Bioclon).
    

Detailed description: 
      We consider relevant conduct this study because the poisoning scorpion bite represents a
      public health problem.

      This is a randomized clinical trial, which included 120 subjects of both sexes aged 0 and 15
      years old and residents of the state of Guanajuato, divided into 2 groups: 60 patients
      received antiscorpion serum of Birmex and 60 patients receive other commercial serum
      (Alacramyn).
    

Intervention name(s): Anti-scorpion venom serum Birmex; Anti-scorpion venom serum Alacramyn
Intervention type(s): Biological; Biological
Intervention description(s): the dose may be required for the patient according to clinical manifestations and evolution; The dose may be required fot the patient according to clinical manifestations and evolution
Other intervention name(s): anti-scorpion venom serum; antiscorpion venom serum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Anti-Scorpion venom serum; venom; efficacy; safety; children
Long Term Effects of Diabetes of Very Young Children
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      To investigate neurocognitive and behavioral measures in 25 children aged 6-10 years
      diagnosed with diabetes for > 5 years who have received long-term insulin pump therapy (> 3
      years) compared to a group of children matched for age, sex, glycemic control, and diabetes
      duration treated with insulin injections. Outcome measures will assess: clinical variables,
      cognitive status (intelligence, neuropsychological functioning), academic achievement,
      behavior, parenting stress, and quality of life.

      It is hypothesized that long term insulin pump therapy initiated during early childhood can
      delay the progression of neurocognitive complications of diabetes, decrease parental stress,
      and improve school performance and quality of life, as compared to insulin injections.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children between ages 6 and 10. Diagnosed with type 1 diabetes prior to the age of 5 years.
      
Keywords: type 1 diabetes; neurocognitive measures; behavioral measures
Study of Calcium Metabolism in Teenage Girls With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The proposed pilot study will enroll 33 adolescent females with type 1 diabetes for the
      assessment of whole body calcium metabolism using dual stable calcium isotopes. This is the
      state of the art technique for assessing calcium metabolism in the body and has been used in
      both healthy and diseased pediatric populations.
    


Intervention name(s): calcium isotope analysis
Intervention type(s): Diagnostic Test
Intervention description(s): A dual stable calcium isotope method will be used to determine fractional calcium absorption. Two stable calcium isotopes will be administered to participants in order to determine fractional calcium absorption. 7 mg of 44Ca will be administered orally in 60 mL of liquid at the start of the study. 2 mg of 42Ca will then be administered intravenously. 24 hour urine collection will begin immediately following oral tracer administration for the assessment of urinary calcium excretion. The enrichment of 44Ca and 42Ca in urine will be determined by magnetic sector thermal ionization mass spectrometry. The isotopic ratios of 44Ca and 42Ca to 48Ca (another naturally occurring calcium isotope present in the human body) will be calculated (42Ca/48Ca and 44Ca/48Ca). The relative fraction of the oral to intravenously administered isotope in the 24 hour urine sample [(42Ca/48Ca) / (44Ca/48Ca)] is the fractional calcium absorption.
Intervention MeSH terms: Calcium
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Teenage girls with type 1 diabetes.
Study to Investigate the Causes of Fever in Children Living in Urban Dar es Salaam and Rural Ifakara
Condition: Fever; Children; Infectious Diseases
MeSH terms: Communicable Diseases; Infections; Fever; Hyperthermia
Study type: Observational

Summary: 
      The goal is to improve the evidence-based management of fever cases seen in outpatient
      clinics in malaria endemic countries, through a better understanding of the value of accurate
      malaria diagnosis, and through an improved understanding of the other causes of fever in
      children. The objective is to describe systematically (as much as possible) the etiologies of
      fever in children in an urban and in a rural environment of sub-Saharan Africa.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive patients aged 2 months to 10 years presenting at the outpatient clinic of Amana
        district hospital in Dar es Salaam, and at the outpatient clinic of St-Francis
        designated-district hospital in Ifakara, Kilombero District.
      
Keywords: Fever; Children; Non-malaria fevers; Diagnosis
FX-322 in Sensorineural Hearing Loss
Condition: Sensorineural Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase 1/2 study of FX-322 at two dose levels compared to placebo in male and female
      adults otherwise healthy with stable sensorineural hearing loss.
    

Detailed description: 
      Sensorineural hearing loss (SNHL) accounts for about 90% of all cases of hearing loss. The
      study will assess the safety of FX-322 (laduviglusib and sodium valproate) given as a single
      intratympanic injection in subjects with a medical history of sensorineural hearing loss that
      is associated with noise exposure or sudden hearing loss. Safety will be evaluated both
      systemically (lab and clinical monitoring) and locally (otoscopy and audiometry) in 24
      subjects, and a blood PK profile of FX-322 will also be determined.
    

Intervention name(s): FX-322; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intratympanic injection of FX-322 consists of laduviglusib and sodium valproate; Intratympanic injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intratympanic Administration; Hearing Restoration
BRCA1-associated DNA Repair Dysfunction in Patients With Early Triple Negative Breast Cancer Treated With Neoadjuvant Platinum-based Chemotherapy
Condition: Early Triple Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess efficacy of platinum-based neoadjuvant chemotherapy in
      correlation with BRCA1-associated DNA repair dysfunction in patients with early triple
      negative breast cancer.
    

Detailed description: 
      Recent gene expression profiling of breast cancer has identified specific subtypes with
      clinical, biologic, and therapeutic implications. The basal-like group of tumors is
      associated with aggressive behavior and poor prognosis, and typically do not express hormone
      receptors or HER-2 ("triple-negative" phenotype). Therefore, patients with basal-like cancers
      do not benefit from currently available targeted systemic therapy.

      There is a lot of evidence about a link between basal-like breast cancer and BRCA1
      deficiency. Many clinical characteristics and molecular features are shared by basal-like
      breast cancers and tumors that arise in carriers of BRCA1 germline mutations.

      Some studies have indicated that BRCA1 mRNA expression was lower in basal-like sporadic
      cancers than in controls matched for age and grade. BRCA1 is rarely mutated in sporadic
      breast cancers and, therefore, it is believed that this may be a result of epigenetic
      mechanisms such as acquired methylation of the BRCA1 gene promoter or a dysfunction in the
      pathways that regulate BRCA1 expression, such as overexpression of ID4. The profound
      similarities between hereditary BRCA1-related breast tumors and basal-like tumors strongly
      implicate a fundamental defect in the BRCA1 or associated DNA-repair pathways (p53, PTEN) in
      sporadic basal-like tumors.

      There is increasing evidence that the BRCA1-related DNA-repair defects, especially defective
      homologous recombination, determines sensitivity to certain agents, such as platinum
      salts-based chemotherapy. The complexity in downregulation of BRCA1 expression suggests that
      these approaches may only be effective in the treatment of a subset of sporadic basal-like
      cancers. Identification of specific markers for these cancers will be essential to translate
      an understanding of defective DNA repair into targeted treatments for this poor prognosis
      subtype.
    

Intervention name(s): Doxorubicin, Paclitaxel, Cisplatin
Intervention type(s): Drug
Intervention description(s): Doxorubicin 25 mg/m2, IV weekly. Number of Cycles: 8 Paclitaxel 100 mg/m2, IV weekly. Number of Cycles: 8. Cisplatin 30 mg/m2, IV weekly. Number of Cycles: 8.
Intervention MeSH terms: Paclitaxel; Doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment