bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of a Family-Based Treatment for Preventing Anxiety Disorders in At-Risk Children
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study will test the effectiveness of a family-based, cognitive behavioral therapy
      (CBT)-based program for preventing anxiety disorders in at-risk children.
    

Detailed description: 
      Anxiety disorders are among the most common mental disorders in children and adolescents, and
      they are associated with short- and long-term impairment in social, academic, familial, and
      psychological functioning. The children of parents with anxiety disorders are more likely to
      develop anxiety disorders themselves, because of genetic factors and the atmosphere in which
      they are raised. Previous research indicates that the risk of anxiety disorders among
      children can be reduced through preventive therapeutic interventions. In children with
      anxiety disorders whose parents also have anxiety disorders, therapy that includes their
      family is more successful than therapy focused only on the child. This study will test the
      effectiveness of a preventive, family-based therapy for children whose parents have anxiety
      disorders.

      Participation in this study will last 1 year. First, interested participants will be asked to
      perform a screening assessment. This will include providing information about the symptoms,
      behaviors, and functioning of parent and child participants; filling out questionnaires; and
      videotaping the child and parent participants interacting. If, after the screening,
      participants are selected to continue with the study, they will be randomly assigned to
      receive either information monitoring or family-based cognitive behavioral therapy. Child and
      parent participants assigned to information monitoring will receive a booklet with
      information on coping with anxiety. Child and parent participants assigned to family-based
      cognitive behavioral therapy will meet with a study clinician for eight, weekly, 1-hour
      intervention visits, during which participants will learn skills to reduce anxiety. After
      completing the weekly visits, participants in this group will also receive three monthly
      booster sessions, in which coping skills will be reviewed. In addition to the screening
      visit, all participants will undergo identical assessments at three more time periods: 9
      weeks, 6 months, and 12 months after entering the study. All participants will also receive
      monthly phone calls throughout the study to monitor the children's anxiety symptoms.
    

Intervention name(s): Family-based CBT; Information Monitoring
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Eight, 1-hour weekly sessions with a trained clinician.; Packet providing information on strategies for coping with anxiety
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Anxiety
Effects of Dexmedetomidine on Breast Cancer Cell Function in Vitro
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Dexmedetomidine is widely used as an anaesthetic for general anesthesia during surgery.
      Previous studies in cells and animals show that dexmedetomidine may promote cancer growth.
      Using serum from breast cancer surgery patients randomized to receive dexmedetomidine or
      saline during surgery, we investigated the effects of dexmedetomidine on proliferation,
      migration and metastasis in MCF-7 breast cancer cells in vitro.
    

Detailed description: 
      Women diagnosed with breast cancer undergoing elective surgery under general anesthesia will
      be randomly allocated to dexmedetomidine group or control group. Patients from both groups
      will receive midazolam, propofol, fentanyl, remifentanil and CIS atracurium for total
      intravenous anesthesia. BIS value will be controlled between 40-60 during surgery. Patients
      of dexmedetomidine group will receive a loading does of 1ug/kg dexmedetomidine since 15 mins
      before induction, and receive another 1ug/kg of dexmedetomidine at a rate of 0.5ug/kg/h for 2
      continuous hours during surgery. Patients of control group will receive same amount of normal
      saline. Serum will be collected from patients of both groups at before induction and 1h
      post-surgery. The MCF-7 breast cancer cell line will be treated with patient serum from both
      groups. The effects of dexmedetomidine on cellular proliferation, migration and metastasis
      will be measured.
    

Intervention name(s): Dexmedetomidine; saline
Intervention type(s): Drug; Drug
Intervention description(s): Patients in the experimental group will receive Dexmedetomidine during surgery.; Patients in the control group will receive saline but not Dexmedetomidine during surgery.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Human Mass Balance Study to Determine the Total Recovery of Radioactivity in Urine and Faeces Following a Single Oral Dose of 14C Radiolabelled ONO-4053
Condition: Healthy Adult Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single dose mass balance study in healthy adult male volunteers to investigate the
      metabolism and excretion of [14C]-ONO-4053.
    

Detailed description: 
      This is a single centre, open-label, non-randomised study in healthy adult male subjects. Six
      subjects will receive a single dose of 14C ONO-4053 administered orally as a suspension.
      Safety measurements (ECG, vital signs, biochemistry and haematology) and adverse events will
      be monitored throughout the study. After administration of 14C ONO-4053 subjects will remain
      in the clinical facility for collection of blood, urine and faecessamples. Samples will be
      analysed for recovery of radioactivity and characterisation of metabolites of ONO-4053.
    

Intervention name(s): [14C]ONO-4053
Intervention type(s): Drug
Intervention description(s): Single dose [14C]ONO-4053
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: ONO-4053; Healthy adult male subjects; pharmacokinetics; metabolism; excretion; mass balance
Adolescent Mothers, Grandmothers, Breastfeeding and Complementary Feeding
Condition: Breastfeeding; Weaning
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether counseling sessions on breastfeeding for
      adolescent mothers and their grandmothers in the maternity ward and at home are effective in
      to improve the exclusive and total breastfeeding rates during the first six month, as well as
      the convenient timing of supplementary feeding introduction.
    

Detailed description: 
      Despite the recognized value of exclusive breastfeeding during the first months of a child's
      life and efforts for promoting this practice, rates for this pattern of breastfeeding in
      Brazil are below those recommended by the World Health Organization(WHO), which advocates
      exclusive breastfeeding during the first 6 months. The last national survey about the
      prevalence of breastfeeding revealed a median duration of 10 months. However , the length of
      exclusive breastfeeding was only 23 days.

      A lot of studies identified maternal age as predictor of breastfeeding. In African, Asian,
      Latin American and the Pacific societies, older women, or grandmothers,traditionally have
      considerable influence on decisions related to maternal and child health at the household
      level.

      Considering all that, interventions intended to increase frequency of breastfeeding,
      particularly exclusive breastfeeding. However, there are few studies on this subject.
    

Intervention name(s): counseling sessions
Intervention type(s): Behavioral
Intervention description(s): The intervention groups received counseling sessions about breastfeeding and complementary feeding at maternity ward and at home with 7,15,30,60 and 120 days.
Other intervention name(s): Group one- no grandmother and no intervention; Group two- no gradmother and with intervention; Group three - with grandmother and no intervention; Group four- with grandmother and with intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: breastfeeding; exclusive breastfeeding; lactation counseling; teenagers; complementary food; adolescent; caregivers
Activation of Alternative Cellular Energy (ACE) Pathway in the Therapy of Herpes Virus Infections
Condition: Herpes Simplex; Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Study type: Observational

Summary: 
      The research question to be addressed is whether indirect phototherapy based activation of
      the body's alternative cellular energy (ACE) pathway will lead to expedited healing of active
      herpes simplex virus (HSV) and herpes zoster virus (HZV)skin lesions, and also possibly
      inhibit both latent HSV infections and residual HZV infections.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HSV and HZV infected patients
      
Keywords: herpes; HSV; zoster; HZV; shingles
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Condition: Chronic Hepatitis C Virus (HCV) Infection Genotype 1
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated
      with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without
      ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.
    

Detailed description: 
      This study (TOPAZ-I; M14-423), was a Phase 3b, open-label, multicenter study conducted
      outside of the United States which, together with its companion study TOPAZ-II (M14-222; NCT
      02167945) conducted in the United States, was designed with the primary objective of
      assessing the effect of treatment response on long-term clinical outcomes in adults with
      chronic HCV GT1 infection with or without compensated cirrhosis, who were either
      treatment-naïve or interferon/ribavirin (IFN/RBV) treatment- experienced. In both studies,
      participants were treated with the 3-DAA regimen with or without RBV. This study consisted of
      a screening period of up to 42 days, a treatment period of either 12 weeks for HCV
      GT1a-infected subjects without cirrhosis and for HCV GT1b-infected subjects without cirrhosis
      or with compensated cirrhosis or 24 weeks for GT1a-infected participants with compensated
      cirrhosis, and a 260-week post-treatment period.
    

Intervention name(s): ABT-450/r/ABT-267; ABT-333; Ribavirin (RBV)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet for oral use; Tablet for oral use; Ribavirin was provided as 200 mg tablets, and dosed based on weight,1000 to 1200 mg divided twice daily per local label. For example, for participants weighing < 75 kg, RBV may have been taken orally as 2 tablets in the morning and 3 tablets in the evening which corresponds to a 1000 mg total daily dose. For participants weighing ≥ 75 kg, RBV may have been taken orally as 3 tablets in the morning and 3 tablets in the evening which corresponds to a 1200 mg total daily dose.
Other intervention name(s): ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir; Paritaprevir/ritonavir/ombitasvir also known as Viekirax; ABT-333 also known as dasabuvir; ABT-333 also known as Exviera
Intervention MeSH terms: Ritonavir; Ribavirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C Genotype 1; Compensated Cirrhosis; Cirrhosis; Naive; Hepatitis C; Hepatitis C Virus; Treatment-Experienced; Relapser; Null responder; Non responder
Visual Restoration for Hemianopia
Condition: Stroke Induced Vision Loss; Hemianopia; Quadrantanopia
MeSH terms: Hemianopsia
Study type: Interventional

Summary: 
      The purpose of this research is to assess the efficacy of a visual training task on reducing
      the size of a visual field deficit caused by brain damage in adults, and its ability to
      improve visual functions in this patient population.
    


Intervention name(s): Training in the blind field; Training in the intact field
Intervention type(s): Device; Device
Intervention description(s): A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks.; A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the intact field of vision. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 706321 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the pharmacokinetics of a single oral dose of BI 706321 when given alone or in
      combination with itraconazole.
    


Intervention name(s): BI 706321; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): BI 706321; Itraconazole
Intervention MeSH terms: Itraconazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: In the first treatment period all subjects are planned to undergo the reference treatment (R), and in the second treatment period all subjects are planned to undergo the test treatment (T).
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Fluid Management Guided by Pulse Pressure Variation Vs Central Venous Pressure on Lung Water Assessed by Lung Ultrasound During Liver Transplantation
Condition: Lung; Congestive; Liver Transplantation
Study type: Interventional

Summary: 
      the aim in this study to assess the effect of fluid management in patient undergoing
      orthotopic liver transplantation either by using pulse pressure variation or by central
      venous pressure. we will assess the impact of fluid management by either methods on
      oxygenation and extra vascular lung water visualized by lung ultrasound.
    

Detailed description: 
      After induction of anesthesia lung ultrasound will be performed and arterial blood gases
      (ABG) will be taken.

      All patients in both groups will receive maintenance fluid in the form of crystalloids
      (ringer acetate) 4 ml/kg/H. Then fluid boluses will be given according to each group:

      Group c (cvp): will receive 250 ml albumin 5% boluses to maintain CVP around 5 cmH2o Group P
      (ppv): will receive 250 ml albumin 5% boluses to maintain PPV below 13% as detected from
      invasive blood pressure monitor.

      For all patients in both groups: blood transfusion will be indicated with decreased HB% level
      below 7 mg/dl in arterial blood gases. Other blood product (FFP, platelets and
      cryoprecipitate) transfusion will be guided by lab results and clinical status of patient.
      Plasma will be transfused if INR > 1.5 and platelets will be transfused if count < 50, 000

      Lung ultrasound will be performed to diagnose EVLW. A Philips C5 ultrasound system (frequency
      5Hz; Philips Medical Systems, Suresnes, France) with an ordinary echo probe will be used.
      Chest ultrasound will be performed using the 12 regions method. Intercostals spaces on each
      side will be examined anteriorly (midclavicular line), laterally (anterior axillary line) and
      posteriorly (posterior axillary line) Four ultrasound aeration patterns a. Normal aeration
      (N): 0 score ; line sliding sign associated with respiratory movement or less than 3 B lines
      ; b. Moderate loss of lung aeration: score 1 ; a clear number of multiple visible B-lines
      with horizontal spacing between adjacent B lines ≤ 7 mm (B7 lines) c. Severe loss of lung
      aeration: score 2; multiple B lines fused together that were difficult to count with
      horizontal spacing between adjacent B lines ≤ 3 mm (B3 lines); and d. Pulmonary
      consolidation: score 3; hyperechoic lung tissue, accompanied by dynamic air bronchogram.

      The final LUS of the patient was the sum of each regional ultrasound score (ranging from 0 to
      36).
    

Intervention name(s): fluid therapy
Intervention type(s): Other
Intervention description(s): fluid resuscitation guided by CVP or PPV
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups one recieve fluid guided by CVP and othe by PPV
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Efficacy of Rostafuroxin in the Treatment of Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to verify the efficacy of Rostafuroxin in the treatment of
      essential hypertension and to determine the best effective dose to be administered in the
      general hypertensive population and in a subset of this population in which genetic patterns
      could be involved in the etiology of essential hypertension.
    

Detailed description: 
      Elevated arterial pressure is probably the most important public health problem. about 30% of
      the world adult population are affected by hypertension in industrialised countries.
      Development of a pharmacogenomic approach to the therapy of primary hypertension give new
      opportunities for the treatment of hypertension. This approach consists in the identification
      of the genetic-molecular mechanisms responsible for hypertension in a given subset of
      patients, and in the development of drugs able to interfere with such mechanisms, thus
      leading to very selective therapeutic interventions with enhanced efficacy and reduced side
      effects.
    

Intervention name(s): Rostafuroxin; Rostafuroxin; Rostafuroxin; Rostafuroxin; Rostafuroxin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1 capusle of 50 micrograms of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin; 1 capusle of 150 micrograms of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin; 1 capusle of 500 micrograms of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin; 1 capusle of 1.5 milligrams of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin; 1 capusle of 5 milligrams of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hypertension; pharmacogenomic; adducin; ouabain; rostafuroxin
Predictors of Postoperative Delirium in Elder Patients After Spine Surgery: Regional Cerebral Oxygen Saturation
Condition: Postoperative Delirium in Elder Patients After Spine Surgery
MeSH terms: Delirium; Emergence Delirium
Study type: Observational

Summary: 
      Postoperative delirium is an important problem in patients undergoing major surgery. The
      incidence of delirium was 12.5% in the patients over 70 years old undergoing spine surgery. A
      study shows that a low preoperative regional cerebral oxygen saturation (rSO2) is associated
      with postoperative delirium after on-pump cardiac surgery. This same perturbation likely also
      increases the risk for postoperative delirium after spine surgery, although there are little
      data that have evaluated this hypothesis. Therefore, this observational study was designed to
      explore the relationship between perioperative rSO2 and the delirium in elderly patients
      undergoing spine surgery.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients undergoing spine surgery
      
Keywords: spine surgery; cerebral oximetry; postoperative delirium
Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Imipramine Pamoate 75 mg
      Capsules under fasting conditions
    


Intervention name(s): Imipramine Pamoate
Intervention type(s): Drug
Intervention description(s): 75 mg capsule
Other intervention name(s): TOFRANIL-PM
Intervention MeSH terms: Imipramine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment