bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis
Condition: Mesenchymal Stromal Cells; Psoriasis; Drug Toxicity; Drug Effect
MeSH terms: Psoriasis; Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Adipose-derived
      Mesenchymal Stem Cells (AD-MSCs) with moderate to severe psoriasis. Any adverse events
      related to AD-MSCs infusion will be monitored. Safety is assessed using incidence of Adverse
      Events(AEs) and Serious Adverse Events (SAEs). Efficacy is assessed via the proportion of the
      improvement of PASI (Psoriasis Area and Severity Index), relapse rate in treatment period,
      changes in PASI score and BSA, as well as DLQI.
    

Detailed description: 
      Psoriasis is an immune-mediated, genetic disease manifesting in the skin or joints or both.
      Numerous topical and systemic therapies are available for the treatment of psoriasis.
      Treatment modalities are chosen on the basis of disease severity, relevant comorbidities,
      patient preference. For moderate to severe psoriasis, phototherapy, systemic therapy and
      biologic immune modifying agents are recommended, but all of them have some drawbacks or
      limitations. Until now, no curative treatment is available. Therefore, it is important to
      find new treatment for psoriasis.

      Mesenchymal stem cells (MSCs) are a kind of adult stem cells that can differentiate into
      bone, cartilage and adipose cells. Adipos-derived Mesenchymal Stem Cells(AD-MSCs) were
      isolated from fat tissues and were reported to treat moderate to severe psoriasis vulgaris
      and psoriasis arthritis successfully by case reports. For the mechanism of the disease,
      involvement of the immune system in psoriasis is now widely accepted. Mesenchymal stem cells
      (MSCs) are found to have the function of immunomodulation, migration to skin lesions,
      limitation of autoimmunity. Therefore, investigators supposed that the injection of AD-MSCs
      could be beneficial for treatment of moderate to severe psoriasis.
    

Intervention name(s): adipose-derived multipotent mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 0.5 million cells/kg.
Other intervention name(s): AD-MSCs
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Non Invasive Diagnostic of Endometrial Receptivity
Condition: Endometrial Receptivity Failure
Study type: Interventional

Summary: 
      The purpose of this study is to determine a lipidomic profile on the endometrial fluid, that
      can predict endometrial receptivity.
    


Intervention name(s): Lipid identification
Intervention type(s): Other
Intervention description(s): The lipids are identified using Mass Spectrometry
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Trial of Fecal Microbiome Transplantation in Parkinson's Disease Patients
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      48 PD patients (age 35-75y; H&Y 1-3) testing positive in a stool PD-dysbiosis test will be
      randomized in a 2:1 ratio to receive either donor FMT or their own stool through intracaecal
      infusion. The main outcome measure will be the sum of MDS-UPDRS I-III at 6 months to cover
      motor and non-motor symptom changes. A wide array of secondary clinical outcome measures will
      be assessed longitudinally and a large array of measurements, biospecimens (stool, urine,
      blood, colonic biopsies), and imaging data will be collected for further analysis at
      baseline, 1, 6, and 12 months.
    


Intervention name(s): Administration of donor FMT; Administration of placebo
Intervention type(s): Other; Other
Intervention description(s): Intracaecal infusion of FMT; Intracaecal infusion of carrier solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; FMT; microbiota; gut-brain axis
Feasibility Study Into the Contraceptive Effect of Estetrol
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open study in 50 young, healthy, female volunteers. Women who want to participate
      and who are using hormonal contraception stop using their hormonal contraceptive and wait for
      their first spontaneous menstruation (i.e. after a wash-out cycle). Women who do not use
      hormonal contraception wait for their next menstruation. From the 9th day after start of the
      menstruation onwards follicle growth will be monitored by ultrasonography until ovulation
      occurs or until day 24 after start of their menses. Women who ovulate within 24 days after
      start of their menses will be eligible to participate and will be stratified in one of 4
      groups: 10 mg estetrol (E4) alone, 20 mg E4 alone, 20 mg E4 combined with 150 mcg desogestrel
      and 20 mg E4 combined with 200 mg progesterone. The subjects will be treated for 28 days.
      Treatment will start on the first day of their menses after the pre-treatment cycle.

      During the study period (28 days) the activity of the hypothalamic-pituitary-ovarian (HPO)
      axis will be investigated by measuring follicular development using ultrasonography and by
      determining serum concentrations of Follicle Stimulating Hormone (FSH), Luteinising Hormone
      (LH), estradiol (E2) and Progesterone (P).
    


Intervention name(s): estetrol; estetrol; estetrol and desogestrel; estetrol and progesterone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 mg orally per day for 28 days; 20 mg orally per day for 28 days; 20 mg estetrol and 150 microg desogestrel orally per day for 28 days; 20 mg estetrol and 200 mg progesterone orally per day for 28 days
Intervention MeSH terms: Desogestrel; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy female volunteers will participate in this study
A Clinical Trial to Evaluate the Effect of Nilotinib on the PK/PD of Meformin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to evaluate the effect of nilotinib on the pharmacokinetics and
      pharmacodynamics of metformin in healthy male adults
    

Detailed description: 
      Pharmacokinetics and pharmacodynamics of metformin without coadministration of nilotinib will
      be compared with those after administration of nilotinib.
    

Intervention name(s): Metformin; Metformin + Nilotinib
Intervention type(s): Drug; Drug
Intervention description(s): Single administration of metformin; Coadministration of metformin and nilotinib
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted in subjects with established Parkinson's disease in 2 parts.
      Part A will examine the tolerability, safety, and pharmacokinetics of AZ-009 dose escalation
      ; and Part B will assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of
      AZ-009 compared with placebo in a crossover design
    

Detailed description: 
      This study will be conducted in subjects with established Parkinson's disease in 2 parts.

      Part A will examine the tolerability, safety, and pharmacokinetics of daily doses of AZ-009
      for 5 days followed by 3 doses on each of days 6 and 7 in dose escalation through 3 cohorts

      Part B will assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of AZ-009
      compared with placebo in subjects with established Parkinson's disease experiencing regular
      OFF episodes
    

Intervention name(s): 009-A1; 009-A2; 009-A3; 009-A0; 009-B1 (active --> placebo) crossover; 009-B2 (placebo --> active) crossover
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Inhaled apomorphine via Staccato aerosol, Dose 1 (low dose) each day for first 5 days, then 3 doses Dose 1 (low dose) q 2 hr on Day 6; Inhaled apomorphine via Staccato aerosol, Dose 2 (middle dose) each day for first 5 days, then 3 doses Dose 2 (middle dose) q 2 hr on Day 6; Inhaled apomorphine via Staccato aerosol, Dose 3 (high dose) each day for first 5 days, then 3 doses Dose 3 (high dose) q 2 hr on Day 6; Inhaled placebo via Staccato aerosol, Dose 0 (placebo) each day for first 5 days, then 3 doses Dose 0 (placebo) q 2 hr on Day 6; Up to 2 doses (Dose 3) ; minimum of 2 hrs between doses, on Day 1, followed by Up to 2 doses (placebo) ; minimum of 2 hrs between doses, on Day 2; Up to 2 doses (placebo) ; minimum of 2 hrs between doses, on Day 1, followed by Up to 2 doses (Dose 3) ; minimum of 2 hrs between doses, on Day 2
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will be conducted in subjects with established Parkinson's disease in 2 parts. Part A will examine the tolerability, safety, and pharmacokinetics of AZ-009 dose escalation ; and Part B will assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of AZ-009 compared with placebo in a crossover design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Immunogenicity of a Plasmid HIV Vaccine in HIV Uninfected Adults
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and immune response to a investigational
      DNA Plasmid HIV vaccine, ADVAX e/g + ADVAX p/n-t (ADVAX), at three different dosage levels,
      in adults who are not infected with HIV.
    

Detailed description: 
      This is a dose escalation trial. Study site staff and volunteers will be blinded, blinding
      will not apply to the assignment of dose levels (low, middle or high).

      Volunteers will be screened up to 42 days before vaccination and will be followed for 18
      months after the first vaccination.

      15 volunteers will be randomized in a 4:1 ratio of active vaccine to placebo. Safety and
      tolerability of the ADVAX e/g + ADVAX p/n-t investigational product will be evaluated at
      least 14 days after the tenth volunteer in the lower dosage group receives the second
      injection before proceeding to the nextdosage group.
    

Intervention name(s): ADVAX
Intervention type(s): Biological
Other intervention name(s): DNA HIV vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED)
Condition: Hypercholesterolemia; Coronary Arteriosclerosis
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Arteriosclerosis; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe
      10 mg coadministered with atorvastatin 10 mg versus atorvastatin 10 mg in Indonesian
      population with primary hypercholesterolemia.
    


Intervention name(s): Ezetimibe; Placebo; Atorvastatin 10 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg ezetimibe, orally, daily for 6 weeks, added to ongoing treatment with 10 mg atorvastatin; 10 mg/day matching placebo to ezetimibe, orally, daily for 6 weeks, added to ongoing 10 mg atorvastatin; 10 mg/day atorvastatin, orally, (ongoing treatment in participants)
Intervention MeSH terms: Atorvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old
Condition: Sedation
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to compare safety and efficacy of inhaled isoflurane delivered by the
      AnaConDa-S versus intravenous midazolam for sedation in mechanically ventilated children
      admitted to an intensive care unit.
    

Detailed description: 
      This is a phase III, multi-centre, prospective, randomized, active-controlled, assessor-blind
      study. Primary endpoint: percentage of time of adequately maintained sedation, in absence of
      rescue sedation, within the COMFORT-B interval (light, moderate, or deep sedation) prescribed
      at randomization, monitored every 2 hours for an expected minimum of 12 hours (up to 48
      hours).
    

Intervention name(s): Midazolam; Isoflurane
Intervention type(s): Drug; Drug
Intervention description(s): Solution for Injection/Infusion; Inhalation vapour, liquid. Isoflurane delivered by the AnaConDa-S (Anaesthetic Conserving Device)
Intervention MeSH terms: Midazolam; Isoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: sedation; isoflurane; mechanically ventilation; pediatric; midazolam
Glottic Visualisation During Laryngoscopy
Condition: Intubation
Study type: Interventional

Summary: 
      In this study, we aimed to investigate the effects of head and neck positions on the
      visualization of glottis and the success of intubation during videolaryngoscopy in obese
      patients.
    

Detailed description: 
      Tree different head and neck positions will compare for glottic visualization and intubation
      success rates in obese patients (BMI> 30 kg / m2) who required endotracheal intubation for
      general anesthesia between 18-65 years of age.
    

Intervention name(s): Mcgrath Mac Videolaryngoscope
Intervention type(s): Device
Intervention description(s): Patient's laryngoscopy will be done using McGrath Mac video laryngoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Screening
Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lower Limb Pain
Condition: Pain, Chronic; Pain, Back; Pain, Radiating
MeSH terms: Back Pain; Chronic Pain; Pain
Study type: Interventional

Summary: 
      This study is a prospective, single-arm, open label, single center to confirm the
      effectiveness and safety of an ultra-high frequency (500 KHz) spinal cord stimulation in
      patients with chronic back pain or lower limb pain.
    

Detailed description: 
      This study is a prospective, single-arm, open label, single center to confirm the
      effectiveness and safety of an ultra-high frequency (500 KHz) spinal cord stimulation in
      patients with chronic back pain or lower limb pain. The trial length is 14 days. Patients
      will be given ultrahigh frequency pulse stimulation, up to 3 times in every 24 hours, and VAS
      will be obtained at least once a day. Compared to previous study conducted last year, patient
      can now have two lead implant sites for different pain locations. The electrode implantation
      site will be epidural space instead of Dorsal Root Ganglion (DRG).
    

Intervention name(s): GiMer Medical MN 1000 External Stimulator
Intervention type(s): Device
Intervention description(s): Trial stimulator (GiMer Medical Model 1000 External Stimulator) to generate pulsed ultrahigh frequency (>200KHz) electrical stimulation, delivered via lead in epidural space, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of R0.6C Vaccine
Condition: Malaria; Malaria,Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human phase I, open-label, single-site, dose escalation study to determine
      the safety, tolerability and Plasmodium falciparum transmission reducing activity of the
      R0.6C vaccine in two different adjuvant combinations.
    

Detailed description: 
      Thirty-two healthy adult volunteers will be recruited and divided over the study arms that
      will receive four vaccinations on days 0, 28, 56 and 168 with either 30μg or 100μg of R0.6C
      adjuvanted with Alhydrogel alone, or combined with Matrix-M1.

      Three volunteers (Group 1A, n=3) will receive four vaccinations with the lower dose of 30μg
      R0.6C with Alhydrogel, and, in parallel, three volunteers (Group 1B, n=3) will receive four
      vaccinations with the lower dose of 30μg R0.6C with Alhydrogel and Matrix-M1. Volunteers will
      be closely monitored for adverse events for a period of minimally 14 days after the first
      vaccination. If safe, an additional 5 volunteers per adjuvant arm (groups 2A and 2B) will
      then receive four vaccinations with the lower dose (30μg R0.6C). If considered safe following
      a minimum of 14 days of follow-up after the first R0.6C administration of groups 2A and 2B,
      three volunteers per adjuvant arm (groups 3A and 3B) will start the vaccination regimen with
      the higher dose of 100μg R0.6C. Finally, a minimum of 14 days after administration of the
      first vaccination in groups 3A and 3B, if considered safe, an additional 5 volunteers per
      adjuvant arm (groups 4A and 4B) will initiate the vaccination regimen with the higher dose of
      100μg R0.6C. There will be no placebo group. All volunteers will be followed up for adverse
      events until 84 days after the last immunisation. Total trial duration is approximately 8
      months for each subject. Blood will be collected to assess functional Plasmodium falciparum
      transmission reducing activity (TRA) and transmission blocking activity (TBA) by standard
      membrane feeding assay (SMFA), as well as immunogenicity, at pre-specified time points after
      R0.6C vaccinations compared to pre-vaccination values.
    

Intervention name(s): R0.6C transmission blocking vaccine
Intervention type(s): Biological
Intervention description(s): Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Study groups will be assigned sequentially to low and high doses of R0.6C Vaccine. Within each dose group, participants will be assigned randomly (1:1) to one of two adjuvant arms (either Alhydrogel alone or Alhydrogel + Matrix-M).
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Transmission; Transmission blocking vaccine; Malaria; Plasmodium falciparum; R0.6C; Vaccine
Pregabalin Stabilize Cardiovascular Response to Intubation
Condition: Effect of Laryngoscopy and Tracheal Intubation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate whether Pregabalin is safe and effective in
      stabilizing cardiovascular response to laryngoscopy and tracheal intubation of patients under
      general anesthesia.
    


Intervention name(s): Pregabalin
Intervention type(s): Drug
Intervention description(s): the patients receive 150mg or 300mg pregabalin 60 minutes prior to the surgery
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Surgical Approach for Retrorectal Tumors Cohort
Condition: Malignant Tumor
MeSH terms: Neoplasms
Study type: Observational

Summary: 
      Aim of the study :

      To evaluate postoperative outcomes of all surgical approach for retrorectal tumors.

      Methods :

      From 2005 to 2020, all consecutive patients who underwent surgery for a retrorectal tumor in
      two referral tertiary center were prospectively collected.

      Considering our exlusion criterias, data from XX patients were analyzed. The cohort was
      separated into 2 groups according to tumor localization regarding the third sacral vertebra.

      Short and longterm outcomes were compared between the two groups.

      Primary outcome :

      90 days postoperative morbidity rate
    

Detailed description: 
      Retro-rectal tumors are a group of heterogeneous and rare lesions. The actual incidence has
      been estimated to be approximately one case per 40,000 admissions. It is most often a benign
      tumor that affects young women and the origin is congenital in 60% of cases. The most common
      benign lesion is a tailgut cyst. Chordoma is the most common malignant lesion. They are
      mostly asymptomatic or pauci-symptomatic. This is why their diagnosis is regularly
      accidentaly after a morphological examination such as an abdominal ultrasound or a CT scan.
      MRI is the gold standard for determining the structure of the lesion, its origin, its
      topography, its extension in relation to adjacent organs, parameters that are essential to
      define the type of surgery and its approach.

      When a retro-rectal tumor is diagnosed, the standard treatment is surgical resection. A
      biopsy is not helpful if there is no suspicion of a degenerate lesion. Usually, lesions
      located under the third sacral vertebra (S3) are approached by dorsal transsacrococcygeal,
      perineal or combined approach (abdominal and perineal approach) while those located above S3
      the approach is abdominal (laparotomy or laparoscopy). As these lesions are, in the majority
      of cases, benign, the functional impact of surgery is essential. Based on our experience in
      minimally invasive surgery and in particular in retro-rectal tumors, laparoscopy has become
      our first-line approach regardless of the location of the lesion compared to S3. Our
      hypothesis is that the minimally invasive approach is reliable, safe and allows satisfactory
      histological results to be obtained while limiting postoperative pain and functional
      sequelae.
    

Intervention name(s): Resection of the retrorectal tumor
Intervention type(s): Procedure
Intervention description(s): Surgical resection of the retrorectal mass
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting a retrorectal tumor who underwent surgical excision
      
Keywords: Retrorectal tumor; Tail gut cyst; Benign tumor; Mini-invasive approach; Open approach; Perineal approach