bioihbjkbjnl/mcl2 huggingface dataset:
Neoadyuvant High-dose of Ifosfamide and Concurrent Radiotherapy in Soft Tissue Sarcoma
Condition: Soft Tissue Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      To study the activity and toxicity of a neoadjuvant regimen including high-dose ifosfamide in
      combination with radiotherapy, and subsequent surgery, in high-risk soft tissue sarcomas.
    

Detailed description: 
      This is a phase II multicenter study designed in two phases. A total of 32 patients will be
      included in 10 hospitals belonging to the Spanish Group for Research in Sarcomas (GEIS).
      Selection criteria are: patients with localized soft tissue sarcoma from the extremities or
      trunk with high-risk features (>5 cm and grade 2-3), or recurrences after prior inadequate
      surgery. The treatment schedule will be: initial biopsy, 3 cycles of high-dose Ifosfamide, 12
      gr/m2 in 5 days, concurrent with Radiotherapy 50 Gy, and subsequent wide surgery. To assess
      the predictive factors of response to the combination therapy, DNA and RNA extraction will be
      performed on the pretreatment biopsies. DNA will be used to hybridize Affymetrix GeneChip®
      Human Mapping 500K Array, which allows for the study of 500000 SNPs throughout the genome.
      The expression of 39000 RNA transcripts will be evaluated employing the Affymetrix Genechip
      Human Genome HG-U133 Plus 2.0, and validated by real-time RT-PCR.
    

Intervention name(s): Ifosfamide
Intervention type(s): Drug
Intervention description(s): 3 cycles of Ifosfamide (12g/m2) associated to Mesna (6g/m2), in i.v infusion 6 days, every 3 weeks
Intervention MeSH terms: Ifosfamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sarcoma; ifosfamide
Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder
Condition: Premenstrual Syndrome; Menstruation Disturbances
MeSH terms: Premenstrual Syndrome; Menstruation Disturbances
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Levonorgestrel/Ethinyl Estradiol (LNG/EE)
      is effective in treating the symptoms of severe Premenstrual Dysphoric Disorder.
    


Intervention name(s): Levonorgestrel/Ethinyl Estradiol
Intervention type(s): Drug
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Premenstrual Syndrome (PMS); Hormone Therapy
Bariatric Surgery During Lockdown, Impact of COVID-19 on Physical and Mental Health
Condition: Obese; Morbid Obesity
MeSH terms: COVID-19; Obesity, Morbid
Study type: Observational [Patient Registry]

Summary: 
      From the beginning of March 2020, lockdown regimens prevented patients with obesity from
      receiving bariatric surgery. Surgical emergencies and oncological procedures were the only
      operations allowed in public hospitals. Consequently, patients with morbid obesity were put
      in a stand-by situation. With the aim at exploring physical and psychological conditions of
      the investigators future bariatric surgery patients, the investigators built a Questionnaire
      concerning obesity and COVID-19.
    

Detailed description: 
      Introduction: the investigators present an investigation about the impact of COVID-19 on
      individuals suffering from severe obesity that were in the waiting list for bariatric
      surgery. Worldwide and in Italy bariatric procedures are considered as elective surgery and
      therefore were interrupted during the lockdown. The patients are well-known victim of stigma,
      social discrimination and the majority of them is affected by maladaptive eating behaviors
      that are supposed to worsen due to the isolation, absence of healthcare check-up and alarming
      pandemic scenario.the investigators performed telephonic interview providing an ad hoc
      questionnaire with the aim to explore their emotional and physical status.

      Method: A total of 116 bariatric surgery candidates were approached using a telephonic
      interview during the Italian lockdown.
    

Intervention name(s): Telephonic interview during the Italian lockdown.
Intervention type(s): Behavioral
Intervention description(s): The interview was composed of socio-demographic items lockdown, and dichotomous questions about physical and mental health in relation to the COVID-19 emergency
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        From March 9th to May 4th 2020, 116 bariatric surgery candidates were approached using a
        telephonic interview during the Italian lockdown. The interview was composed of
        socio-demographic items and dichotomous about physical and mental health in relation to the
        COVID-19 emergency.
      
Keywords: Bariatric surgery; Covid-19; Obesity; Mental health; Eating disorder
Pharmacodynamics of NPC-01/IKH-01; Effect of NPC-01/IKH-01 on Sexual Hormone Concentrations in Healthy Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the serum levels of estradiol, progesterone, FSH and
      LH in NPC-01 or IKH-01 one treatment cycle with those in before and after administration
      cycle.
    


Intervention name(s): NPC-01; IKH-01
Intervention type(s): Drug; Drug
Intervention description(s): NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol; IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol
Other intervention name(s): norethisterone and ethinyl estradiol; norethisterone and ethinyl estradiol
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Norinyl; Mestranol; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: NPC-01; IKH-01; Pharmacodynamics; Norethisterone; Ethinyl Estradiol; Estradiol; Progesterone; FSH; LH
Effect of Celecoxib Versus Placebo Before and After Knee Surgery on Overall Use of Analgesics After Surgery
Condition: Arthroscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare total analgesic use at 24 hours after arthroscopic knee surgery in
      celecoxib-treated versus placebo-treated patients
    


Intervention name(s): Placebo; Celecoxib
Intervention type(s): Other; Drug
Intervention description(s): Matched oral capsule administered 1 hour prior to surgery and matched oral capsule administered post surgery as needed; 400 mg oral capsule as single dose administered 1 hour prior to surgery and 200 mg oral capsule as single dose administered post surgery as needed
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Knee Surgery Arthroscopic Surgery
Interpersonal Psychotherapy for Adolescent Girls
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study will evaluate the efficacy of Interpersonal Psychotherapy for Adolescents (IPT-A)
      for the treatment of depression and prevention of depression in maltreated and nonmaltreated
      girls between the ages of 13-15 years old.
    

Detailed description: 
      Child maltreatment poses a serious public health problem and heightens the risk of
      psychopathology across the life course. Adolescence also represents a peak time for the
      emergence of depressive disorders particularly in girls. Effective interventions to prevent
      and treat depression in low income adolescent girls with or without histories of maltreatment
      are needed.

      Three groups will be recruited: Maltreated Depressive Symptoms (MDS), Nonmaltreated
      Depressive Symptoms (NDS), and a Nonmaltreated Nonsymptomatic Comparison (NNC), comparable in
      SES, race/ethnicity, and household composition. The MDS and NDS groups will be randomized
      into IPT-A or Enhanced Care (EC). Adolescent girls in these groups will receive 13 sessions
      of therapy. Girls in the NNC group will only complete research visits.

      Research assessments will be conducted at T1 (baseline/prior to intervention), T2 (6-weeks
      mid-intervention), T3 (end of intervention), T4 (1-year post) and T5 (18 months post). Girls
      and their mothers will participate in these research sessions. A multi-level-of-analysis
      approach, integrating genotyping, hormone assays, cognitive testing, adolescent- and
      maternal-report, mother-teen observation, and DHS and school records will be utilized to
      assess the effectiveness of the interventions.
    

Intervention name(s): Interpersonal Psychotherapy for Adolescents; Enhanced Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Adolescents will receive IPT-A a manualized intervention for depression and prevention of depression that emphasizes current interpersonal relationships, focusing on their immediate social context.; Adolescents will receive enhanced care which is consistent with care typically provided in community settings to treat and prevent depression.
Other intervention name(s): IPT-A; EC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Depression; Adolescents
Diagnosis of Cancer Using Breath Samples
Condition: Cancer
Study type: Observational

Summary: 
      The purpose of this study is to collect breath samples from healthy and cancer sick patients.
      The breath, collected to special bags, will be transferred to laboratories in the Technion
      and analyzed using an electronic nose system developed in Hossam Haick's labs (Chemical
      Engineering, Technion). The hypothesis is that based on the analysis of the chemical
      bio-markers present in the exhaled breath, cancer states can be distinguished from healthy
      subjects or before and after treatment, allowing a technique for diagnosis of cancer and/or
      cancer treatment.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        People that undergo screening for breast, colon or lung cancers people diagnosed with
        breast, colon or lung cancers
      
Keywords: Cancer; Breast Cancer; Colon cancer; Lung Cancer
Psychosocial Situation of Children With Rare (Congenital) Pediatric Surgical Diseases and Their Families
Condition: Rare Diseases
MeSH terms: Rare Diseases
Study type: Observational [Patient Registry]

Summary: 
      Families of children with rare diseases (i.e., not more than 5 out of 10.000 people are
      affected) are often highly burdened with fears, insecurities and concerns regarding the
      affected child and his/her siblings. The aim of the present research project is to examine
      the psychosocial burden of the children with rare (congenital) pediatric surgical diseases
      and their family in order to draw attention to a possible psychosocial care gap in this
      population.
    

Detailed description: 
      The central objective of the cross-sectional study is to show the psychosocial supply gap for
      families with children and adolescents affected by rare diseases in the field of pediatric
      surgery. Among the rare diseases that are included are diaphragmatic hernia, anorectal
      malformations, esophageal atresia, Hirschsprung's disease and biliary atresia. In order to
      have a comparative sample, additional data of a matched control group are collected. Central
      standardized psychosocial outcomes will be assessed from the perspectives of the parents, the
      affected child and the siblings.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Clinical study participants for the diagnostic study are patients who have sought treatment
        at the University Medical Center Hamburg-Eppendorf due to a rare pediatric surgical
        disease. Participants in the healthy control sample are matched to the clinical sample in
        terms of age and gender. Included are families of children aged 0-21 years, who have
        undergone a surgical procedure at the University Medical Center Hamburg-Eppendorfin the
        first 3 years of life that does not cause chronic complaints; such as hernia surgery or
        testicular relocation.
      
Keywords: rare diseases; pediatric surgery; children and adolescent; quality of life; psychological distress
A Study to Investigate the Antidepressant Mechanism-of-action of JNJ-42847922 in Participants With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to explore if the magnitude of treatment effect (JNJ-42847922;
      placebo) on symptoms of depression (as measured by Hamilton rating scale for depression-17
      [HDRS17], Sleep item-adjusted HDRS17, Anxiety/somatization factor score and the 6-item
      subscale from HDRS17 [HAM-D6]) differs across different levels of hyper-arousal status
      (characterized by Sleep parameters, ruminative response scale [RRS], Sleep and Worry visual
      analogue scale [VAS], quantitative electro-encephalography [qEEG], heart rate variability
      [HRV] and others).
    


Intervention name(s): JNJ-42847922 20mg; JNJ-42847922 40mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will swallow 20 mg (2*10 mg) JNJ-42847922 capsule orally for 5 weeks during treatment period.; Participants will swallow 40 mg (2*20 mg) JNJ-42847922 capsule orally for 5 weeks during treatment period.; All participants will receive matching placebo capsule during lead in period, treatment period and withdrawal period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Open Trial to Assess the Tolerability of AVANZ Mite Mix Immunotherapy
Condition: Allergic Rhinitis Due to Dust Mite
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the trial is to assess the tolerability of the up-dosing phase of AVANZ Mite
      mix.
    

Detailed description: 
      The frequency of patients with adverse reactions will be the primary endpoint.
    

Intervention name(s): AVANZ MITE
Intervention type(s): Biological
Intervention description(s): Immunotherapy Dermatophagoides mix
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: House dust mites sensitisation
Study to Explore the Effective Doses and to Assess the Safety and Efficacy of Hypidone Hydrochloride Tablets
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the safety and efficacy of Hypidone Hydrochloride
      tablets in treatment of patients with major depressive disorder (MDD) by evaluating the
      change of MADRS total scores from baseline to week 6.
    

Detailed description: 
      A total of 240 major depressive disorder (MDD) subjects between the ages of 18-65 who have
      current major depressive disorder diagnosed by DSM-5 will be recruited, Eligible patients
      will be randomized with a 1:1:1:1 ratio into the 4 treatment arms to receive either Hypidone
      Hydrochloride tablets or placebo, and will be accepted into the protocol after review and
      providing voluntary written informed consent forms and completion of a comprehensive medical
      and psychiatric history, physical examination, mental status examination, and routine
      laboratory assessment.

      The subjects will accept the drug treatment twice daily orally for 6 weeks. During the
      treatment follow up will occur at 8±1 days after treatment, 15±1 days after treatment, 29±2
      days after treatment , 43±2 days after treatment to evaluate the safety and efficacy of the
      drug.
    

Intervention name(s): Hypidone Hydrochloride tablets; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Hypidone Hydrochloride tablets will be given orally, twice daily, for 6 weeks; Placebo tablets will be given orally, twice daily, for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
CogEcig: Cognitive Functioning and Electronic Cigarette
Condition: Tobacco Abuse Smoke
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The aim of the present study is to compare cognitive scores (attention, executive function
      and working memory) of different e-Cigarette strength with usual cigarettes.
    

Detailed description: 
      The study is randomised cross-over trial designed to compare: 1) Cognitive performances
      levels for four different e-Cigarette strength. Participants will be requested to abstain
      from smoking and alcohol from 20:00 on the night before each study day and from food and
      caffeine for at least 1 h before the session. On arrival at the study centre, carbon monoxide
      (CO) will be measured in participants' expired breath. If CO will be >15 parts per million
      (ppm), the assigned study treatment will be allocated; however, if CO was >15 ppm or they
      will report smoking in the previous 12 h, participants will be rescheduled wherever possible
      to a subsequent session.

      On the first study day, participants will be randomised to use one of five ordered
      conditions: Electronic Nicotine Delivery Device (ENDD) (fourth generation) containing
      nicotine 2,4%; Electronic Nicotine Delivery Device (ENDD (second generation) containing
      nicotine 7,4 mg; Electronic Nicotine Delivery Device (ENDD containing nicotine 9 mg;
      Electronic Nicotine Delivery Device (ENDD nicotine free; their usual cigarette. Additionally
      participants will be trained to use an electronic cigarette. The following tests will be
      completed at the each visits: Continuous Performance Test - AX version (CPT-AX), Wisconsin
      card sorting test( WCST), Working memory test (N-BACK).
    

Intervention name(s): Own Brand cigarette; one high 2,4% nicotine; original 7,4 mg nicotine; nicotine free; Ego 9mg
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Smoke, 15 puff of, Own Brand cigarettes;; Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine; Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine; smoke, 15 puff, of electronic cigarette nicotine free; smoke, 15 puff, of electronic cigarette Ego 9 mg
Other intervention name(s): Categoria electronic cigarette one high 2,4% nicotine; Categoria electronic cigarette 7,4 mg nicotine; categoria electronic cigarette nicotine free "mint".; electronic cigarette Ego 9 mg nicotine
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Mucus Dehydration and Evolution of Chronic Obstructive Pulmonary Disease (COPD) Lung Disease
Condition: Chronic Obstructive Pulmonary Disease; Chronic Bronchitis
MeSH terms: Bronchitis; Bronchitis, Chronic; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The purpose of this research is to understand the properties of mucus in persons with COPD,
      specifically Chronic Bronchitis. We hypothesize that those with Chronic Bronchitis have
      dehydrated mucus, and thus have a harder time coughing it out of their lungs. This leads to a
      greater vulnerability for lung infection, inflammation and airflow obstruction. Ultimately,
      our goal is to understand how mucus dehydration contributes to the progression of
      COPD/Chronic Bronchitis so that better therapies and interventions can be developed for
      future generations.
    

Detailed description: 
      Specific Aim I directly tests the hypothesis that mucus clearance is impaired due to mucus
      dehydration. It measures 1) COPD Mucociliary and Cough Clearance 2) mucus hydration 3) the
      concentrations of the dominant regulators of airway hydration and 4) the consequences of
      mucus dehydration on mucus biophysical properties and bacterial infection.

      Specific Aim II tests the hypothesis that COPD acute exacerbations are associated with
      failures of mucus clearance. Measurements will be similar to that of Specific Aim I, but
      conducted during periods of baseline health, acute exacerbation and recovery.

      Specific Aim III tests whether airway surface hydration with 7% Hypertonic Saline will
      restore clearance in the basal state and during a COPD acute exacerbation. COPD subjects will
      be exposed to inhaled Hypertonic Saline during periods of baseline health and acute
      exacerbation. Acute efficacy via measures of mucus clearance and spirometry will studied.
    

Intervention name(s): 7% hypertonic saline
Intervention type(s): Other
Intervention description(s): Administered via jet nebulizer to subjects in specific aim 3
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community members with a history of cigarette smoking and COPD/chronic bronchitis.
      
Biospecimen description: 
      Blood
    
Keywords: Mucus; COPD; Chronic Bronchitis
Observational Study on Changing the Quality of Life in Daily Life Activities After Clinical Approach Positioning the Wheelchair
Condition: Mobility Limitation; Wheelchairs
MeSH terms: Mobility Limitation
Study type: Observational

Summary: 
      Stemming from the common practice of attribution of the technical helps in the posture in
      Canada, the multidisciplinary approach of positioning develops in France for more than 10
      years old.

      To date, no observatory study was led to estimate the impact of such consultation in daily
      activities, an essential objective conditioning the observance and the acceptance of
      assistive devices. This study wants to estimate the impact through modification of WHOM
      scale.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Personns which are in wheelchair since more than 6 months
Non-invasive Hemodynamic Monitoring During Blood Donation for Developing Models of Early Blood Loss
Condition: Hemorrhage
MeSH terms: Hemorrhage
Study type: Observational

Summary: 
      This study is part of a Phase II STTR project to develop an algorithm called CipherSensor to
      apply feature extraction and machine learning techniques to non-invasive hemodynamic data to
      identify early signs of acute blood loss. The availability of this information may help to
      establish required interventions for treating trauma patients and battlefield casualties.

      Study hypothesis: Hemodynamic changes measured non-invasively during the blood donation
      process can be modeled to provide early estimations of blood loss.
    


Intervention name(s): No treatment
Intervention type(s): Other
Intervention description(s): No treatment, only collecting observational data.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults
      
Keywords: Hemorrhage