bioihbjkbjnl/mcl2 huggingface dataset:
Direct Comparison of Altered States of Consciousness Induced by LSD and Psilocybin
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      LSD (lysergic acid diethylamide) and psilocybin (the active substance in "magic mushrooms")
      are widely used for recreational purposes. Both substances are also increasingly used in
      psychiatric and psychological research to induce and investigate alterations in waking
      consciousness and associated brain functions (functional brain imaging, "model psychosis") .
      However, it has never been studied whether there are differences in the alterations in mind
      produced by these two substances. Both LSD and psilocybin are thought to induce
      hallucinations primarily via stimulation of the 5-HT2A receptor. However, there are
      differences in the receptor activation profiles between the two substances that may also
      induce different subjective effects. LSD potently stimulates the 5-HT2A receptor but also
      5-HT2B/C, 5-HT1 and D1-3 receptors . Psilocin (the active metabolite of the prodrug
      psilocybin) also stimulates the 5-HT2A receptor but additionally inhibits the 5-HT
      transporter. In contrast to LSD, psilocybin has no affinity for D2 receptors. Both substances
      are used in neuroscience as pharmacological tools. However, there are no modern studies
      comparing these two substances directly within the same clinical study and research subjects
      and using validated psychometric tools. Therefore, the investigators will compare the acute
      effects of LSD, psilocybin and placebo.
    


Intervention name(s): LSD; LSD; Psilocybin; Psilocybin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): LSD 0.1 mg per os, single dose; LSD 0.2 mg per os, single dose; Psilocybin 15 mg per os, single dose; Psilocybin 30 mg per os, single dose
Intervention MeSH terms: Psilocybin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
The Effect of the Combination of Cleanser and Moisturizer Product K
Condition: Aesthetic; Cosmetic; Healthy
Study type: Interventional

Summary: 
      This study is conducted to evaluate the effectiveness of product K cleanser and moisturizer
      when use in combination for skin rejuvenation. The study duration is 8 weeks and the skin
      assessment will be carried out at baseline, week 2, week 4 and week 8.The main questions this
      study aims to answer are:

        1. The effect of cleanser and moisturizer K when use in combination on skin hydration.

        2. The effect of cleanser and moisturizer K when use in combination on skin elasticity.

        3. To observe any adverse effect occurrence with the usage of the products.
    


Intervention name(s): Product K cleanser and moisturizer
Intervention type(s): Other
Intervention description(s): Product K cleanser and moisturizer contain ingredients that may improve skin hydration and elasticity
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Microcirculation and Inflammatory Markers in Patients With Resistant, Stages 1/2 Hypertension and Normal Blood Pressure
Condition: High Blood Pressure
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Nailfold videocapillaroscopy (NVC), Venous occlusion Plethysmography (VOP) and inflammatory
      biomarkers have been used to study endothelial function in patients with resistant
      hypertension, stages 1 and 2 hypertension and normotensive. This was a cross-sectional study.
    

Detailed description: 
      Microcirculation determines peripheral resistance contributing to increased blood pressure.
      The nailfold videocapillaroscopy (NVC), Venous occlusion Plethysmography (VOP) and biomarkers
      can be used to evaluate the microcirculation in arterial hypertension (AH). The objective of
      this study is to analyze the behavior of serum inflammatory markers and study the
      microcirculation by nailfold videocapillaroscopy (NVC) and Venous Occlusion Plethysmography
      in patients with resistant hypertension (RH), with stages 1 and 2 hypertension (MMH ) and
      normotensive (CG). A cross-sectional study with 75 patients has been performed: 25 with
      resistant hypertension (RH), 25 with stages 1 and 2 hypertension (MMH) and 25 normotensive
      (CG). All underwent anamnesis, dosage serum markers and conducting NVC, VOP. Hypertensive
      patients without statin use and with controlled or uncontrolled blood pressure were also
      analyzed. For the statistical analysis were used: Kruskal -Wallis ANOVA, Dunn test and ANCOVA
      for correction of confusion factors such as age and BMI.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        First Day: Full clinical examination was performed, including measurements of at-rest blood
        pressure, weight and height in order to calculate Body Mass Index (BMI), waist and hip
        measurements.

        Second Day: drawing blood for laboratory analyses, Nailfold Videocapillaroscopy and Venous
        Occlusion Plethysmography.
      
Keywords: Nailfold Videocapillaroscopy; Venous Occlusion Plethysmography; Endothelial Function; Microcirculation; Inflammatory Biomarkers
Bone UltraSonic Scanner (BUSS) Clinical Optimization Study
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      The aim of this clinical study using Bone UltraSonic Scanner (BUSS) is to obtain clinical
      data which will help to optimize the BUSS examination procedure and its diagnostic algorithms
      for assessment of bone conditions.
    

Detailed description: 
      The specific aims of this clinical study are:

        1. To optimize the data collection technique and establish an examination procedure;

        2. To collect data necessary for assessing the performance of BUSS sensors;

        3. To evaluate the probe ergonomic design and participant tolerance to probe application;

        4. To assess the clinical suitability of the software interface in data collection;

        5. To adjust the BUSS diagnostic algorithms using dual-energy X-ray absorptiometry (DEXA)
           data as a "gold" standard in osteoporosis detection and characterization;

        6. To evaluate BUSS performance including ease of use and consistency.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Study participants will consist of groups with no history of osteoporosis, established
        osteoporosis and may include documented history of fracture.
      
Keywords: osteoporosis, bone fracture risk, bone ultrasonometry
A Study in Healthy Volunteers
Condition: Hepatitis B; Infectious Disease; Liver Diseases
MeSH terms: Hepatitis B; Communicable Diseases; Infections; Hepatitis; Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is three part study that will, in part one assess the safety, tolerability, and PK of a
      single dose of CRV431 in healthy volunteers. The second part of the study will be a single
      dose drug-drug interaction study in healthy volunteers with CRV431 co-treated with TDF. The
      third part of the study will assess the safety, tolerability, PK, and preliminary signal for
      antiviral efficacy and identification of clinically-relevant biomarkers of CRV431 with TDF in
      stable HBV patients.
    


Intervention name(s): CRV431; Placebo; TDF
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single or multiple dose(s) of CRV431; Single Placebo dose; Single or multiple dose(s) of TDF
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CRV431; Hepatitis B Virus; Hepatitis Virus
Compare Blood Sugar Level Between Lantus in the Morning and Other Insulins in Type 1 Diabetes Adolescents
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to compare the effect in blood sugar control between Lantus and
      twice daily intermediate acting insulins (NPH or Lente) when used as the basal insulin in a
      multiple daily injection setting with fast acting insulin (Lispro)
    


Intervention name(s): Lantus (insulin glargine [rDNA origin] injection); Humulin N; Humulin L; Lispro
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Insulin; Insulin Glargine; Insulin, Globin Zinc; Insulin, Isophane; Isophane Insulin, Human
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Laryngeal Disorders After Childhood Cardiac Surgery
Condition: Laryngeal Injury; Swallowing Disorder; Voice Disorders in Children; Surgery--Complications
MeSH terms: Deglutition Disorders; Voice Disorders; Laryngeal Diseases
Study type: Observational

Summary: 
      Laryngeal disorders after childhood cardiac surgery is a complication well described in the
      literature. However, the long term progression of the affected children has never been
      studied (all the studies stopped before 2 years of follow up).
    


Intervention name(s): Questionnaires
Intervention type(s): Other
Intervention description(s): To explore the quality of life, two questionnaires will be submitted to the parents and the child. The first one is the pediatric version of the VHI (Voice Handicap Index), which explore, using 23 items, the functional, physical and emotional aspects of the dysphonia. The second one is the PEDI-EAT-10 (Pediatric Voice Handicap Index - Eating Assessment Tool), which explore, through 10 items (ranging from 0 to 4), the risk of aspiration and assess the impact of possible dysphagia on quality of life.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children between 5 and 10 years old, having undergone a nasofibroscopy following cardiac
        surgery performed before their first year of life (between 01/01/2010 and 12/31/2015).
      
Keywords: Laryngeal dysfunction; Cardiac surgery
Staccato Loxapine Thorough QT/QTc Study
Condition: Thorough QT/QTc Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the present Phase 1 study was to assess the cardiac safety of Staccato
      Loxapine administered to healthy volunteers in a 3 period crossover study.
    

Detailed description: 
      Primary Objective: To assess the maximum effect of Staccato Loxapine on cardiac
      repolarization (QTc interval duration) at the anticipated maximum clinical dose compared to
      placebo in healthy volunteers.

      Secondary Objective: To assess the QTc versus loxapine concentration relationship following
      treatment with Staccato Loxapine in healthy volunteers.
    

Intervention name(s): Inhaled loxapine; Inhaled placebo; Oral moxifloxacin; Oral placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Inhaled Staccato Loxapine 10 mg single dose; Inhaled Staccato placebo single dose; Oral moxifloxacin 400 mg; Oral placebo similar in appearance to moxifloxacin 400 mg
Other intervention name(s): ADASUVE
Intervention MeSH terms: Moxifloxacin; Loxapine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Staccato loxapine; QT/QTc; healthy volunteers; Thorough QT/QTc study; ADASUVE; inhaled loxapine
Dual Diagnosis (Psychosis and Cannabismisuse): Comparison of Specialized Treatment Versus Unspecified Treatment
Condition: Psychotic Disorders; Marijuana Abuse; Intervention
MeSH terms: Marijuana Abuse; Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Intention of the study is to examine, if the symptomatology of dual diagnosis patients is
      less severe after a special indication training for reduction of cannabis consumption in
      comparison to unspecified trainings.

      Point of interest is psychopathology and consumerism.
    

Detailed description: 
      Dual diagnosis patients (psychosis and cannabis abuse) account for more clinical admissions
      than single diagnosis patients.

      Cannabis misuse is a known risk factor for recurrence of psychosis.

      A specified intervention on the basis of a manual for schizophrenic substance abusers is
      administered to inpatients in a specialized unit for young schizophrenic patients in a
      psychiatric hospital.

      The control group, same indication (psychotic disorder and cannabis misuse) receives social
      competence training (specified for schizophrenic patients as well).

      Admission to groups is randomly.
    

Intervention name(s): Cannabis-Consumption-Reduction-Training; Social competence Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 sessions within 4 weeks (twice a week, 45 minutes each) Cognitive behavioral therapy with focus on cannabis abuse; 8 sessions within 4 weeks (twice a week, 45 minutes) training to develop and ameliorate social competences
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: psychotic disorders; cannabis; intervention
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
Condition: Involutional Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with
      involutional osteoporosis.
    


Intervention name(s): ONO-5920
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ONO-5920, osteoporosis, bisphosphonate
A Study to Test Once-Weekly Doses of Odanacatib (MK0822) on Healthy Adult Females (0822-005)(COMPLETED)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, PK, and PD of a once weekly dose of MK0822
      in healthy postmenopausal women.
    


Intervention name(s): odanacatib; Comparator: placebo to MK0822
Intervention type(s): Drug; Drug
Intervention description(s): Panel A: MK0822 tablets 25 mg once weekly for 3 weeks. Panel B: MK0822 tablets 50 mg once weekly for 3 weeks. Panel C: MK0822 tablets 100 mg once weekly for 3 weeks. Panel D: MK0822 tablets 5 mg once weekly for 3 weeks. Panel E: MK0822 tablets 100 mg once weekly for 6 weeks.; Panel A: placebo to MK0822 tablets 25 mg once weekly for 3 weeks. Panel B: placebo to MK0822 tablets 50 mg once weekly for 3 weeks. Panel C: placebo to MK0822 tablets 100 mg once weekly for 3 weeks. Panel D: placebo to MK0822 tablets 5 mg once weekly for 3 weeks. Panel E: placebo to MK0822 tablets 100 mg once weekly for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy
Condition: Seizures
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed
      at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in
      patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).
    

Detailed description: 
      This Phase 3 study is being conducted in Europe, Israel, Australia, and South Africa to
      evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three
      equally divided doses, compared with placebo in patients with epilepsy who are receiving up
      to three established antiepileptic drugs (AEDs). The primary objective is to demonstrate a
      superior change in total partial seizure frequency for four weeks from baseline to the
      double-blind period. The proportion of responders (greater than or equal to 50% reduction in
      seizure frequency for four weeks from baseline to the double-blind period) will also be
      evaluated.
    

Intervention name(s): Retigabine; Retigabine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 3, patients will enter a 12 week maintenance phase.; Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 5, patients will enter a 12 week maintenance phase.; Oral tablet.
Other intervention name(s): GKE-841; D-23129; GKE-841; D-23129
Intervention MeSH terms: Ezogabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Partial Seizures; Complex Partial Seizures; Epilepsy; Potassium Channels; Anticonvulsant
Blood Collection to Validated New Therapeutics Strategies Against Preeclampsia
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational [Patient Registry]

Summary: 
      The aim of the study is to setup a collection of maternal plasma and serum from patients with
      preeclampsia and normal pregnancy for in vitro validation of new therapeutics based on
      extra-corporal removal of sFlt-1
    

Detailed description: 
      A collection of maternal plasma and serum from patients with preeclampsia (PE) and normal
      pregnancy (NP) :

        -  Between 20WG and 23WG+6D : 20 patients with PE and 30 patients with NP

        -  Between 24WG and 27WG+6D : 20 patients with PE and 30 patients with NP

        -  Between 28WG and 31WG+6D : 20 patients with PE and 30 patients with NP

        -  Between 32WG and 35WG+6D : 20 patients with PE and 30 patients with NP

        -  Between 36WG and 40WG+6D : 20 patients with PE and 30 patients with NP
    

Intervention name(s): A collection of maternal plasma and serum
Intervention type(s): Biological
Intervention description(s): A collection of maternal plasma and serum from patients with preeclampsia (PE) and normal pregnancy (NP)
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        pregnancy with preeclampsia and without preeclampsia
      
Biospecimen description: 
      Blood
    
Keywords: Preeclampsia; apheresis; sflt-1
Renal Function Determination in Patients With Liver Cirrhosis
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Observational

Summary: 
      We have several ways to appropriately determine renal function in healthy patients and in
      several diseases, in cirrhotic population we dont have a precise tool that has sufficient
      precision that reflects glomerular function, although it has been reported that cystatin C,
      because of its nature could improve diagnostic accuracy to determinate the renal function in
      this population.

      The investigators hypothesize that glomerular filtration obtained from cystatin-C-derived
      formulas are more accurate when compared to creatinine-derived formulas with DTPA-Tc99
      (diethylene-triamine-pentaacetate- technetium-99) as gold standard.
    

Detailed description: 
      The aim of the study is to determine if the formulas for glomerular filtration are close to
      the estimation of actual renal function in mexican cirrhotic patients of different
      etiologies.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The patients will be selected from the Liver Clinic from the Gastroenterology Department at
        a tertiary care center in Mexico
      
Keywords: liver cirrhosis; glomerular filtration; cystatin C
Response to Influenza Vaccine During Pregnancy
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is one project of a larger ongoing study related to the immune system's response to the
      flu virus. This study is designed to investigate the immune response to vaccination in
      pregnancy.
    

Detailed description: 
      This is a Phase I mechanistic study of licensed influenza vaccines with up to 50 pregnant
      female volunteers, 18-49 years of age. Investigator intends to collect blood from pregnant
      women and then from the same women a year later when they are not pregnant after routine
      seasonal influenza vaccination. By studying the blood of immunized pregnant women and in
      these same women after pregnancy, the investigator will gain a better understanding of the
      immune response to vaccination in pregnancy and after pregnancy.

      Each volunteer will participate for approximately 4 weeks including enrollment, vaccination,
      and completion of sample collection in 2 consecutive flu seasons. The Study has a total of 6
      visits over 2 Flu seasons.

      Study procedures:

      Year One:

      First Visit: Procedures during this visit are: Informed consent process, enrollment, study
      assessments, 20 ml blood draw, and vaccination.

      2nd and 3rd visits: 20 ml blood will be obtained

      Year Two:

      First Visit: Study assessments, 20 ml blood draw, and vaccination. 2nd and 3rd visits: 20 ml
      blood will be obtained
    

Intervention name(s): Quadrivalent inactivated influenza vaccine (IIV)
Intervention type(s): Biological
Intervention description(s): Quadrivalent inactivated influenza vaccine (IIV), Intramuscular Injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Influenza; Pregnancy; Quadrivalent inactivated influenza vaccine (IIV).