bioihbjkbjnl/mcl2 huggingface dataset:
Ocytocine and Cerebral Activation in Relation With Attachement
Condition: Attachement Style
Study type: Interventional
Phase: Phase 2

Summary: 
      The study aims to characterize the cerebral activation modifications related to nasal
      oxytocin administration during vizualisation of distress images in population of healthy
      people with different attachement styles.
    

Detailed description: 
      Healthy adult male will be recruited. Their attachement style will be assessed through the
      Attachement scale interview (ASI).

      They will have 2 fMRI sessions, during which emotional images will be presented.

      One session will be preceded by a nasal administration of oxytocin and the other session will
      be preceded by a placebo nasal administration. The order of both administrations will be
      randomized.
    

Intervention name(s): nasal oxytocin or placebo; fMRI; Attachement scale interview (ASI); psychometric scales
Intervention type(s): Drug; Device; Behavioral; Behavioral
Intervention description(s): nasal administration of oxytocin or palcebo 45 min befor fMRI session; FMRI during emotional image visualization; this scale is used to determine the attachement style of each participant; self adminstrated questionnaires which asses the level of anxiety (Spielberger State-trait anxiety interview-STAI), depression (Beck depression inventory-BDI) and alexithymia (Toronta Alexuthymia scale-TAS 20)
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attachement; Oxytocin; fMRI
A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subjects
Condition: Overweight Subjects; Obese Subjects
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in China. The aim of the trial is to investigate the influence of
      IBI362 on pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics
      (the effect of the investigated drug on the body) of warfarin, metformin, warfarin,
      atorvastatin, digoxin in overweight or obese subjects.
    


Intervention name(s): metformin; digoxin; IBI362; warfarin; atorvastatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): For oral administration, given as a single dose. The first dose is given before IBI362 treatment and the second dose is given at the end of IBI362 treatment.; For oral administration, given as a single dose. The first dose is given before IBI362 treatment and the second dose is given at the end of IBI362 treatment.; Subjects will initiate treatment with 2 mg for the first four weeks followed by 4mg for four weeks and up to a dose of 6 mg for six weeks.; For oral administration, given as a single dose. The first dose is given before IBI362 treatment and the second dose is given at the end of IBI362 treatment.; For oral administration, given as a single dose. The first dose is given before IBI362 treatment and the second dose is given at the end of IBI362 treatment.
Intervention MeSH terms: Metformin; Digoxin; Warfarin; Atorvastatin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy Study on Symptomatic Control of Patient With Knee Osteoarthritis Between 0.0125% of Capsaicin to Placebo
Condition: Osteoarthritis, Knee Joint; Capsicum
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether capsaicin gel is effective in treating mild
      to moderate degrees of osteoarthritis of the knee in the elderly patient compared with
      placebo gel.
    

Detailed description: 
      Osteoarthritis (OA) is the most common form of arthritis in the population. It is
      characterized pathologically by both focal loss of articular cartilage and marginal and
      central new bone formation. OA of knee, the principal large joint to be affected, results in
      disabling knee symptoms in an estimated 10% of people older than 55 years, a quarter of whom
      are severely disabled. The risk of disability attributable to knee OA alone is as great as
      that due to cardiac disease and greater than that due to any other medical disorder in the
      elderly. A recent World Health Organization report on the global burden of disease indicates
      that knee OA is likely to become the fourth most important global cause of disability in
      women and the eighth most important in men. Knee OA is associated with symptoms of pain and
      functional disability. Physical disability arising from pain and loss of functional capacity
      reduces quality of life and increases the risk of further morbidity and mortality. Current
      treatments aim at alleviating these symptoms of mild to moderate OA by several different
      methods: non-pharmacological treatment (for example education, exercise, lifestyle changes)
      or pharmacological treatments(for example paracetamol, NSAIDs and Capsaicin gel topical
      treatments). Current evidence to support the various treatments in current use, however, is
      very variable. Capsaicin, the active principle of hot chili pepper, is thought to selectively
      stimulate unmyelinated C fibre afferent neurons and cause the release of substance P.
      Prolonged application of capsaicin reversibly depletes stores of substance P, and possibly
      other neurotransmitters, from sensory nerve endings. This reduces or abolishes the
      transmission of painful stimuli from the peripheral nerve fibres to the higher centres.There
      were many study on Capsaicin gel to confirm the effectiveness of capsaicin gel in many
      dosages. However, there has been no efficacy study on the capsaicin 0.0125% of the Thai
      produce "Capsika gel " before, therefore, this study is proposed.
    

Intervention name(s): 0.0125% Capsaicin gel "CAPSIKA gel"; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteoarthritis; knee; capsaicin gel; capsicum
Stress and Sleep Study
Condition: Stress, Psychological; Sleep; Transcutaneous Electric Nerve Stimulation; Vagus Nerve Stimulation; Mindfulness
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      This between-subject, longitudinal pilot study in healthy college students aims to explore
      the acceptability and preliminary outcomes of two novel and complementary interventions that
      may improve stress and sleep: transcutaneous vagus nerve stimulation (tVNS) and a mobile
      mindfulness intervention.
    


Intervention name(s): tVNS; Mindfulness; sham tVNS; Number Puzzle
Intervention type(s): Device; Behavioral; Device; Other
Intervention description(s): transcutaneous vagus nerve stimulation; Brightmind mobile mindfulness application; sham transcutaneous vagus nerve stimulation; Control number puzzle task delivered via mobile device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%
Condition: Secondary Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men
      with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm
      Concentration Following Treatment with the 12.5 mg or 25 mg Androxal or AndroGel 1.62%.
    


Intervention name(s): Androxal 12.5 mg or 25 mg; AndroGel 1.62%; Placebo Capsules; Placebo Gel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Enclomiphene; Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Low Testosterone
Cytopenias in Hospitalized Patients of Corona Virus Infection(COVID-19) During First and Other Waves
Condition: Corona Virus Infection
MeSH terms: Infections; COVID-19; Virus Diseases; Coronavirus Infections
Study type: Observational

Summary: 
      Demographic, Clinical and laboratory data as well as outcome of total 202 COVID-19 patients
      who were Polymerase Chain Reaction (PCR) positive and admitted in Fatima memorial Hospital,
      Lahore, Pakistan, was collected during first and other waves. Data of First wave is from May
      2020 to July 2020, second wave from early November to Mid December 2020 and third wave from
      Mid march to June 2021. Investigator analyzed the data on basis of Systemic immune
      inflammatory index (SII) as well hematological parameters of First Wave were compared to
      other waves of COVID-19.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        COVID-19 Positive Hospitalized patients, of all genders and all age group.
      
Keywords: COVID-19; Cytopenia; Thrombocytopenia; Anemia; Leucopenia
Improvement Project To Optimizing Nutrition With Higher Protein and Calorie Pediatric Tube Feeding
Condition: Critically Ill Children
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      This quality improvement project will include a practice change based on national guidelines
      for the nutritional management of PICU patients.
    

Detailed description: 
      This quality improvement project will include a practice change based on national guidelines
      for the nutritional management of PICU patients. The primary aim of this quality improvement
      project is to better meet protein needs of ICU critically ill children
    

Intervention name(s): Peptide-based enteral formula; Retrospective review of enteral tube feeding formula
Intervention type(s): Other; Other
Intervention description(s): Peptide-based, higher protein and higher calorie enteral formula; Enteral formula tube feeding will be retrospectively reviewed
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged 1-13 years with enteral feeding access
Trial of a Vaccination With Tumor Antigen-loaded Dendritic Cell-derived Exosomes
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Lung cancer is the worldwide leading cause of cancer death. In France, with 28,000 new cases
      per year, lung cancer is the 4th in terms of incidence but remains the leading cause of
      cancer death. The 5-year survival of lung cancer, all stages and all types, is very low,
      estimated at 12% among men and 16% among women in France. In advanced unresectable non small
      cell lung cancer, standard treatment relies on platinum-based induction chemotherapy. The
      median progression-free survival (PFS) in patients responding or stabilized after 4
      chemotherapy cycles ranges from 2 to 2.8 months. Gustave Roussy and Curie institutes have
      developed an immunotherapy involving metronomic cyclophosphamide (mCTX) followed by
      vaccinations with tumor antigen-loaded dendritic cell-derived exosomes (Dex). mCTX inhibits
      Treg functions restoring T and NK cell effector functions and Dex are able to activate the
      innate and adaptive immunity. Phase I trials showed the safety and feasibility of Dex
      vaccines but no induction of T cells could be monitored in patients. Since 2007, we validated
      a new process for isolation of second generation Dex with improved immune stimulatory
      capacities. We propose a maintenance immunotherapy in 47 advanced unresectable NSCLC patients
      responding or stabilized after induction chemotherapy with Dex-based treatment to improve PFS
      rate at 4 months in these patients.
    


Intervention name(s): Dex2
Intervention type(s): Biological
Intervention description(s): Metronomic dosage of Cyclophosphamide during 3 weeks (50mg/day orally) as reported 15, before specific treatment.
Induction immunotherapyIntradermal injections of Dex once a week during 4 consecutive weeks.(Peptides pulsed onto DC, sources of Dex: PRS pan-DR, MAGE-3 DP04, MAGE-1 A2, MAGE-3 A2, NY-ESO-1 A2 et MART-1 A2)
Continuation Immunotherapy: Intradermal injections of Dex every two weeks during 6 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced unresectable non small cell lung cancer; Responding or stabilized after induction chemotherapy
A PK/PD Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The overall goal of this investigator-initiated trial is to evaluate the impact of platform
      algorithm products designed to rapidly identify pharmacokinetic (PK) and/or pharmacodynamic
      (PD) genomic variation on treatment outcome of depression in adolescents. This new technology
      may have the potential to optimize treatment selection by improving response, minimizing
      unfavorable adverse events / side effects and increasing treatment adherence
    

Detailed description: 
      Treatment seeking adolescent patients with a moderate to severe major depressive episode
      defined as a 40 or greater on Childhood Depression Rating Scale-Revised (CDRS-R) will be
      invited to participate in this study evaluating the GeneSight® platform. This new technology
      can rapidly assess PK and PD genetic variation that can potentially impact antidepressant,
      anti-psychotic, and stimulant treatment selection. These patients will have GeneSight®
      testing and will be randomized to one of two groups. In Group 1 (n=138), GeneSight® testing
      results will be available to the patient's treating clinician prior to treatment selection.
      In Group 2 (n=138), testing results will not be available to the patient's research treating
      clinician. However, all testing results will be made available to all participants and
      clinicians after the 8-week trial (upon completion of blinded assessments at week 8). The
      patients and the clinical raters will be blinded to group assignment.
    

Intervention name(s): AssureRx GeneSight genotyping results; Treatment as usual
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression; Genotyping; Pharmacokinetic; Pharmacodynamic
Safety and Efficacy of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD) - a US Study
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia; Premature Birth; Hyperplasia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      PNEUMOSTEM® consists of ex vivo cultured allogeneic, unrelated, human umbilical cord
      blood-derived mesenchymal stem cells (hUCB-MSCs) and it is intended for use as a cellular
      therapy product for prevention of Bronchopulmonary Dysplasia (BPD). This study is an
      open-label, single-center, dose escalation study to evaluate of safety and efficacy of
      PNEUMOSTEM® in premature infants at high risk for BPD.
    


Intervention name(s): Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells
Intervention type(s): Biological
Intervention description(s): Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells:
Dose A: 10 million cells per kg / Dose B: 20 million cells per kg
Other intervention name(s): PNEUMOSTEM®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Mesenchymal Stem Cells; Human Umbilical Cord Blood; Premature Infants; Bronchopulmonary Dysplasia; Chronic Lung Disease; Cell Therapy
DIetary REstriction as an Adjunct to Neoadjuvant ChemoTherapy for HER2 Negative Breast Cancer
Condition: Fasting Mimicking Diet; Breast Cancer; Neoadjuvant Chemotherapy; Pathological Complete Response
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Preclinical studies provide strong support for the concept that fasting evokes resistance to
      multiple forms of stress. Fasting reduces plasma levels of growth factors and modulates
      intracellular nutrient sensing systems, thereby diverting energy from growth to maintenance.
      Accordingly, the currently available preclinical evidence suggests that short-term fasting
      protects normal cells against the perils of chemotherapy. In contrast, cancer cells are not
      protected, as a result of their self-sufficiency in growth signals. This phenomenon is termed
      Differential Stress Resistance (DSR). DSR reduces the severity of toxic side-effects of
      chemotherapy and interestingly, it simultaneously renders cancer cells more vulnerable to
      chemotherapeutics. Importantly, extensive preclinical evidence and preliminary clinical data
      indicate that a specifically designed very low calorie, low amino acid substitution diet
      ("Fasting Mimicking Diet, FMD") has effects on cancer therapy that are very similar to those
      of fasting. This study aims to evaluate the impact of the FMD on tolerance to and efficacy of
      neoadjuvant chemotherapy in women with stage II or III breast cancer.
    


Intervention name(s): Fasting mimicking diet
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study on the Safety, Anti-tumor Activity and Pharmacology of IPH2101 Combined With Lenalidomide in Patients With Multiple Myeloma Experiencing a First or Second Relapse
Condition: Patients With Multiple Myeloma Experiencing a; First or Second Relapse
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the clinical study is to evaluate, in patients who experience a
      first or second relapse of their multiple myeloma, the safety of escalating doses of IPH2101
      combined with lenalidomide
    


Intervention name(s): IPH2101 combined to lenalidomide
Intervention type(s): Drug
Intervention description(s): Dose level 1 : 0.2 mg/kg IPH2101(with Lenalidomide 10 mg/day) Dose level 2 : 0.2 mg/kg IPH2101(with Lenalidomide 25 mg/day) Dose level 3 : 1 mg/kg IPH2101(with Lenalidomide 25 mg/day) Dose level 4 : 2 mg/kg IPH2101(with Lenalidomide 25 mg/day)
Extension cohort: 6 patients at the Maximum Tolerated Dose (MTD)
Intervention MeSH terms: Lenalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PK Study in Adult Healthy Volunteers to Assess QD Dosing With the Selected Age-appropriate MR Formulations
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, open label, 4-period, 6-sequence, partial cross-over,
      single-dose study to evaluate the PK of age-appropriate tofacitinib MR formulations (release
      rates: MR-Slow, MR-Moderate, and MR-Fast) compared to tofacitinib IR solution under fasting
      conditions. The effect of food on the PK of MR-Slow and MR-Fast will also be assessed.
    


Intervention name(s): 10 mg dose MR formulations,10 mg dose of tofacitinib IR solution
Intervention type(s): Drug
Intervention description(s): For the the relative bioavailability (BA) assessment , the investigational product(s) are:
Test: 10 mg dose of age-appropriate MR formulations (MR-fast, MR-moderate, MR-slow). Each formulation contains 0.025 mg of tofacitinib/mg of microsphere. Reference: 10 mg dose of tofacitinib IR solution (1 mg of tofacitinib/mL).
For the the food effect assessment, the investigational product(s) are:
Test: 10 mg dose of age-appropriate MR formulations (MR-fast or MR-slow) c-oadministered with high-fat FDA breakfast. Reference: 10 mg dose of age-appropriate MR formulations (MR-fast or MR-slow) administered under fasted state.
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mucosal Impedance Balloon in Diagnosis and Treatment of Eosinophilic Esophagitis (EoE)
Condition: Eosinophilic Esophagitis; Healthy
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Observational

Summary: 
      This study will evaluate the role the balloon mucosal impedance may have in diagnosing and
      monitoring the patients with Eosinophilic Esophagitis. We will compare the results of the
      balloon mucosal impedance in patients with Eosinophilic esophagitis and controls.
    

Detailed description: 
      The standard diagnostic evaluation for EoE includes upper endoscopy with esophageal biopsies.
      Recently we completed the study "Mucosal impedance in eosinophilic esophagitis and the effect
      of treatment" using a new technology allowing for direct assessment of mucosal impedance at
      the time of routine upper endoscopy to assess esophageal integrity and disease activity and
      alevate the need for biopsies.

      For this study, Sandhill Scientific has customized a Mucosal Impedance balloon (MI) assembly
      to provide precise measurements over a broad area of esophageal epithelium, while eliminating
      the fluids and spanning across a 10 mm luminal area using the same direct assessment as the
      mucosal impedance at the time of routine upper endoscopy.
    

Intervention name(s): Mucosal Impedance Balloon catheter
Intervention type(s): Device
Intervention description(s): During the clinical endoscopy (a standard procedure that allows your doctor to look at the inside of your swallowing tube), the 2 mm catheter (tiny tube), called an Intraluminal Impedance Balloon, will be passed through the channel of the standard endoscope.
o The catheter (tiny tube) will be placed through the endoscope in your esophagus (swallowing tube) for two minutes, readings from the catheter will be recorded.
Other intervention name(s): Impedance balloon testing
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Eosinophilic Esophagitis having an upper endoscopy. Patients having an upper
        endoscopy for dysphagia or GERD