bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Medical Hypnosis in Virtual Reality on Insomnia Disorders
Condition: Insomnia Chronic
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The prevalence of chronic insomnia is 13.3% in France in 2019 (8.9 million). The consequences
      for these people are multiple: drowsiness, memory problems, difficulty concentrating,
      anxiety.

      Cognitive and Behavioral Therapy (CBT) is today the reference treatment recommended by the
      "Haute Autorité de Santé" and the American College of Physicians for chronic insomnia. Today,
      however, few patients use CBT treatment due to the lack of trained practitioners, the cost of
      non-reimbursed sessions and the time and involvement that these sessions require.

      Several clinical trials have shown beneficial effects of hypnotherapy on sleep disorders. The
      hypothesis of this work is that the use of hypnosis in virtual reality improves sleep time in
      patients suffering from insomnia disorders.
    


Intervention name(s): Cognitive-behavioural therapy; HypnoVR® device
Intervention type(s): Behavioral; Device
Intervention description(s): Cognitive-behavioural therapy sessions during 6 weeks of treatment; HypnoVR® sessions during 6 weeks of treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Virtual reality; Hypnosis; Sleep
Trial of Mentalization-Based Therapy for Substance Using Mothers of Infants and Toddlers
Condition: Parenting Capacities of Substance Abusing Mothers
Study type: Interventional

Summary: 
      A formal randomized efficacy trial testing the Mothers and Toddlers' program, an
      attachment-based parenting intervention for mothers enrolled in addiction treatment and
      caring for young children.
    

Detailed description: 
      Five years ago the investigators were funded to develop the Mothers and Toddlers Program
      (MTP; R01 DA17294 / Project Period: 8/20/04 - 12/31/09). MTP is the first parenting
      intervention developed for substance abusing mothers based on the attachment theory. It is
      also the only parenting intervention for substance abusing mothers that has led to
      improvement in maternal caregiving sensitivity and responsiveness to infant and toddler
      distress in observed lab-based interactions. The investigators now have all the research
      materials to conduct a Stage II randomized clinical trial including a treatment manual,
      treatment fidelity scales therapist training program and outcome measures. In this Stage II
      formal efficacy trial, the investigators (1) Introduce new measures of dyadic adjustment and
      child attachment, (2) Add an 18 week follow up period to test for sustained treatment
      effects, (3) Measure major constructs (reflective functioning, representations, dyadic
      adjustment, and child attachment) when they are expected to change, (4) Examine temporal
      mechanisms of change proposed in the MTP treatment model (5) Determine whether improvements
      in dyadic adjustment reduces incidence of relapse, (6) Broaden the MTP therapist pool by
      training four new therapists and (7) Broaden the coding pool by training 3 additional coders
      per measure. One hundred and fifty mothers caring for children ages 12 to 60 months of age
      will be recruited from outpatient substance abuse treatment services at the APT Foundation
      into the intention-to-treat sample and will be randomized to 12 weeks of MTP vs. PEP and
      followed for 33 weeks.
    

Intervention name(s): Mothers and Toddlers Program; Parent Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This intervention is a short-term attachment-based parenting therapy for substance using mothers of young children that emphasizes the development of the capacity for mentalizing.; PE was developed to represent parent education and support that is typically available to mothers with substance use problems who are at high risk for neglecting their young children. Mothers enrolled in PEP will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs and a choice of pamphlets on age-related parenting topics.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: parenting intervention; mother-child relations; substance abuse; attachment; child development
Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Naprosyn E
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the uptake in the body of naproxen; one of the two
      active substances in PN400. We also want to show that the body's uptake of naproxen given as
      PN400 is comparable to that of currently marketed naproxen tablets.
    


Intervention name(s): PN400; Naproxen
Intervention type(s): Drug; Drug
Intervention description(s): oral tablet; oral tablet
Other intervention name(s): VIMOVO™; Naprosyn E
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Phase 1; Healthy Volunteer; Healthy Volunteer Study
Myocardial Injury in Remifentanil-based Versus Sevoflurane-sufentanil Balanced Regimens in OPCAB Surgery
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Interventional

Summary: 
      In patients undergoing off-pump coronary artery bypass (OPCAB) surgery with different
      anesthesia regimens: remifentanil (0.75 mcg/kg/min) and propofol (TCI effect-site
      concentration 0.8-1.5 mcg/ml) (Group -RP); remifentanil (0.75 mcg/kg/min) and sevoflurane
      (end-tidal 0.8 vol%) (Group-RS), or sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI
      effect site concentration 0.35-0.75 ng/ml) (Group-SS), intergroup difference in the level of
      Troponin I (c-TnI) and creatinine kinase subtype-MB is determined before surgery (control),
      during vascular graft harvesting (harvesting), after completing graft construction
      (postgrafting), and one day after surgery (postoperative).
    

Detailed description: 
      To determine the difference of myocardial injury upon using different anesthesia regimens:
      remifentanil-based regimen versus sevoflurane-sufentanil balanced regimen.

      Patients undergoing off-pump coronary artery bypass (OPCAB) surgery are randomly allocated to
      get remifentanil (0.75 mcg/kg/min) and propofol (TCI effect-site concentration 0.8-1.5
      mcg/ml) (Group -RP), remifentanil (0.75 mcg/kg/min) and sevoflurane (end-tidal 0.8 vol%)
      (Group-RS), or sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site
      concentration0.35-0.75 ng/ml) (Group-SS).

      Intergroup difference in the level of Troponin I (c-TnI) and creatine kinase-MB is determined
      before surgery (control), during vascular graft harvesting (harvesting), after completing
      graft construction (postgrafting), 1 day after surgery (postoperative).
    

Intervention name(s): Remifentanil; sevoflurane 1; sevoflurane 2; propofol; sufentanil
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): administering remifentanil for anesthesia maintenance; administering sevoflurane 1 for anesthesia maintenance; administering sevoflurane 2 for anesthesia maintenance; administering propofol for anesthesia maintenance; administering sufentanil for anesthesia maintenance
Intervention MeSH terms: Sufentanil; Remifentanil; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer
Condition: HER2 Positive Early or Locally Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the
      Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB3 (proposed trastuzumab
      biosimilar) and Herceptin® in Women with Newly Diagnosed HER2 Positive Early or Locally
      Advanced Breast Cancer in Neoadjuvant Setting
    


Intervention name(s): Herceptin (trastuzuamb); SB3 (proposed trastuzumab biosimilar)
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous administration; Intravenous administration
Other intervention name(s): Herceptin
Intervention MeSH terms: Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HER2 Positive Breast Cancer; Trastuzumab; Biosimilar
Bioavailability of BI 10773 and Pioglitazone in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study was to investigate whether there is a drug-drug interaction
      between BI 10773 and pioglitazone when co-administered as multiple oral doses. Therefore, the
      relative bioavailabilities of BI 10773 and pioglitazone were determined when both drugs were
      given in combination compared with BI 10773 and pioglitazone given alone.
    


Intervention name(s): BI 10773; Pioglitazone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pioglitazone; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Investigate the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Idarucizumab in Chinese Healthy Male and Female Volunteers Who Had Taken Dabigatran Etexilate and Whose Plasma Concentrations of Dabigatran Were at or Close to Steady State
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the trial is to investigate the pharmacokinetics and
      pharmacodynamics of idarucizumab in Chinese healthy male and female subjects following
      intravenous administration of idarucizumab followed by idarucizumab with 15 minutes interval
      when administered at or close to the steady state of dabigatran.

      Another objective of this trial is to explore the effect idarucizumab on the PK
      (pharmacokinetic(s)) and PD (pharmacodynamic) parameters of dabigatran.
    


Intervention name(s): Dabigatran etexilate; Idarucizumab
Intervention type(s): Drug; Drug
Intervention description(s): Days 1-4 and Day 8-11; Day 11
Other intervention name(s): PRADAXA, PRAZAXA; PRAXBIND, Praxbind, Prizbind
Intervention MeSH terms: Dabigatran
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-136)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial will compare the effectiveness of one dose of ciclesonide against one dose of
      budesonide in patients with asthma.

      The aim of the present trial is to compare the efficacy of ciclesonide versus budesonide on
      pulmonary function, symptoms and use of rescue medication in patients with asthma. The onset
      of action and the safety and tolerability of ciclesonide in comparison to budesonide will
      also be investigated.
    


Intervention name(s): Ciclesonide
Intervention type(s): Drug
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Ciclesonide; Budesonide
Dopaminergic Enhancement of Learning and Memory in Aphasia
Condition: Cerebrovascular Accident; Aphasia
MeSH terms: Aphasia; Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether levodopa, in combination with a high
      frequency language training, is effective in boosting naming performance in patients with
      aphasia.
    

Detailed description: 
      Our prior work shows that d-amphetamine and the dopamine precursor levodopa markedly improve
      word learning success in healthy subjects. In this randomized, placebo-controlled,
      double-blind clinical trial, we probe whether daily administration of levodopa, coupled with
      several hours of language training every day, will significantly improve naming abilities in
      patients with aphasia as compared to placebo administration. We furthermore examine with
      magnetic resonance imaging which brain regions need to be functionally intact for a
      dopaminergic improvement of language therapy.
    

Intervention name(s): levodopa
Intervention type(s): Drug
Intervention description(s): 100mg levodopa per day over 10 days/ treatment phase
Intervention MeSH terms: Levodopa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: language acquisition; plasticity; stroke recovery; aphasia treatment; naming; levodopa; stroke
Oscillations of Dietary Fat/Carbohydrate Intake Over Interval of 3 to 4 Days
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to understand the mechanisms for oscillations of dietary
      fat/carbohydrate intake and how fat intake affect insulin resistance and liver fat over
      interval of 3 to 4 days.
    

Detailed description: 
      You will be expected to keep diet records for 17 consecutive days. You will start with a
      fasting screening visit (only water allowed). A physical exam and Medical history it taken at
      screening visit. Your body composition will be gathered by CT and Dexa Scan. Blood and urine
      will be collected for a chemical profile and other determinations. Questionnaires will be
      administered along with an accelerometer to be worn for the remainder of the study. The final
      day you will return the dietary records, accelerometer, and a few procedures will be
      performed as weight.
    

Intervention name(s): Dietary fat/intake of carbohydrate; Spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake.
Intervention type(s): Other; Behavioral
Intervention description(s): Spontaneous intake of fat, carbohydrate, protein and alcohol each day for 17 days.; Dietitians and senior level or graduate level dietetics students who are not restrained eaters to participate in food intake over 17 days. During this same time interval, integrated energy expenditure will be recorded using doubly-labeled water and day to day energy expenditure by accelerometer. Periodic blood sampling for leptin will be done completed at site intervals.
Other intervention name(s): Dietitian II
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leptin; Changes in leptin may precede the; phasing of oscillations of dietary fat intake
Pevonedistat With VXLD Chemotherapy for Adolescent/Young Adults With Relapsed/Refractory ALL or Lymphoblastic NHL
Condition: Refractory Acute Lymphoblastic Leukemia; Relapsed Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators postulate that Pevonedistat will be effective in patients with
      relapsed/refractory acute lymphoblastic leukemia (ALL) when combined with a standard backbone
      ALL chemotherapy regimen.
    

Detailed description: 
      This is a phase I study of the addition of pevonedistat to induction chemotherapy for AYA
      patients (16-39 years of age) with relapsed/refractory ALL utilizing a traditional 3+3 design
      with dose expansion cohort of 6 patients. Starting dose level for pevonedistat is 15 mg/m2.
      If the number of dose-limiting toxicities (DLTs) is greater than 1 out of 3 patients in the
      starting dose level, next dose level is 10 mg/m2 (dose level -1). Chemotherapy will consist
      of pevonedistat in combination with a standard VXLD regimen. The duration of each cycle will
      be 29 days.
    

Intervention name(s): Pevonedistat; Vincristine; Dexamethasone; PEG-asparaginase; Doxorubicin; Cytarabine; Methotrexate; Hydrocortisone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered each cycle on days 1, 3 and 5.; Administered each cycle on days 2, 9, 16 and 23.; Taken orally each cycle on days 2 through 15.; Administered via intramuscular injection (IM) each cycle on days 9 and 23.; Administered via IV each cycle on day 2.; Administered to all subjects via IT injection on day 1; and on days 9, 16, and 23 to CNS positive subjects.; Administered via IT injection to CNS negative subjects on day 16; and to CNS positive subjects on days 9, 16 and 23.; Administered via IT injection to CNS positive subjects on days 9, 16, and 23.
Other intervention name(s): TAK-924; MLN4924; Oncovin; VCR; LCR; Decadron; Hexadrol; Dexone; Dexameth; Oncaspar; Pegaspargase; Polyethylene Glycol Conjugated L-asparaginase-H; Adriamycin; ARA-C; MTX; Amethopterin; Cortisol
Intervention MeSH terms: Cytarabine; Dexamethasone; Hydrocortisone; Doxorubicin; Methotrexate; Vincristine; Asparaginase; Pegaspargase; Pevonedistat
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Naturalistic Study of Ketamine for Treatment Resistant Mood Disorders
Condition: Treatment Resistant Depression; Bipolar Depression; Ketamine; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Mood Disorders; Bipolar Disorder
Study type: Observational [Patient Registry]

Summary: 
      This study aims to openly test the long-term safety, tolerability and effectiveness of
      repeated administration of IV, nasal spray and oral ketamine for treatment-resistant mood
      disorders.
    

Detailed description: 
      Current pharmacological treatments for depression prove unsatisfactory efficacy with a
      proportion of subjects demonstrating treatment-resistant depression (TRD). The observation
      applies both to major depressive disorder (MDD) as well as bipolar I depression. There is
      growing evidence that the glutamatergic system plays a role in the pathophysiology and
      treatment of depression. Discovery of rapid, although transient antidepressant effect of
      ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist used in a single sub-anaesthetic
      intravenous dose in unipolar, bipolar and treatment-resistant patients provides evidence for
      a glutamatergic antidepressant. Subsequent studies confirmed this effect in repeated doses.
      Further research demonstrated that repeated ketamine infusions result in sustainable
      antidepressant effect with both, twice-weekly and thrice-weekly administration schedules.
      However, the worsening of depression may occur after infusions are completed. Given the risk
      of relapses, there is a definite need for the development of new strategies to maintain the
      beneficial effects of ketamine treatment. In the present study, the investigators aim to
      openly assess the safety, tolerability, and effectiveness of repeated, individually tailored
      IV, nasal spray and oral ketamine for treatment-resistant mood disorders. The investigators
      intend to explore questions regarding optimal dose, treatment frequency and duration.
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): Ketamine will be infused (slow IV infusions of ketamine (0.5 mg/kg) over 40 minutes) twice weekly over a period of 4 weeks) Ketamine will be given in intranasal spray twice weekly over a period of 4 weeks Ketamine will be given orally (solution 2.0mg/kg, 2.5mg/kg) twice weekly over a period of 4 weeks.
Intervention MeSH terms: Ketamine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Inpatients with TRD referred to the tertiary-reference unit for mood disorders
      
Keywords: treatment resistant depression; bipolar depression; ketamine; multiple series; major depressive disorder
Validity and Reliability of the Turkish Version of the Sydney Swallow Questionnaire
Condition: Dysphagia, Oropharyngeal; Swallowing Disorder; Validation
MeSH terms: Deglutition Disorders
Study type: Observational

Summary: 
      Purpose of the study is the validity and reliability of the Turkish version of the Sydney
      Swallow Questionnaire (SSQ-T), so that it would be used as an assessment tool for Turkish
      dysphagia patients. Despite being translated and validated in many languages, there is no
      validated Turkish version of SSQ to measure the severity of oropharyngeal dysphagia.
    

Detailed description: 
      The swallow function is a multidirectional process that depends on complex neuro-muscular
      network. The function can be evaluated using instrumental, such as fibreoptic endoscopic
      evaluation of swallowing (FEES), videofluoroscopy, or well structured questionnaires. There
      are many questionnaire and scales for assessment of swallow but very few have been validated.
      The study will assess the construct validity and reliability of the Turkish version of
      Self-report Symptom Inventory as known as Sydney Swallow Questionnaire. The investigators
      developed the Turkish version of this questionnaire (SSQ-T), according to the cross-cultural
      adaptation guidelines. Two translators translated the SSQ into Turkish and a native English
      language speaker reverse-translated it into English. The back translation was sent to the
      original author for proofreading. The SSQ questionnaire consisted of 17 basic questions
      related with dysphagia symptoms.
    

Intervention name(s): Turkish Version of Sydney Swallow Questionnaire
Intervention type(s): Other
Intervention description(s): The Turkish Version of Sydney Swallow Questionnaire consists of 17 questions related with dysphagia.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adults with oropharyngeal dysphagia and healthy adults
Clinical Trial to Evaluate the Efficacy of Treatment With Hyperimmune Plasma Obtained From Convalescent Antibodies of COVID-19 Infection
Condition: SARS-CoV 2
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase I / II multicentre, randomized and controlled clinical trial to evaluate the efficacy
      of treatment with hyperimmune plasma obtained from convalescent antibodies of COVID-19
      infection.
    


Intervention name(s): Hyperimmune plasma; Standard of care for SARS-CoV-2 infection
Intervention type(s): Biological; Drug
Intervention description(s): PLASMA OF CONVALESCENT COVID-19; Standard of care for SARS-CoV-2 infection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment