bioihbjkbjnl/mcl2 huggingface dataset:
Study of LY3154207 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to measure how much of the study drug gets into the
      bloodstream and how long it takes the body to get rid of it. This study will involve a single
      dose of 14C radiolabelled LY3154207. This means that a radioactive substance C14 will be
      incorporated into the study drug, to investigate the study drug and its breakdown products,
      to find out how much of these pass from blood into urine, feces and expired air. The study
      will last about 4 weeks. Screening is required within 28 days prior to the start of the study
      and follow up is required approximately 7 days after discharge.
    


Intervention name(s): LY3154207; [14C]-LY3154207
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Identification of Clinically Relevant Markers of Deep Brain Stimulation Electrode Impedance
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The study will look into the changes of Deep Brain Stimulation (DBS) measured impedances in
      patients of Parkinson disease (PD) as a function of their functional state (lying, sitting
      and walking) and dopaminergic medication intake (levodopa or dopamine agonists).

      The goal is to use DBS measured impedance as a surrogate of the functional and medication
      states of PD patients.
    

Detailed description: 
      Subjects will be recruited from the population of patients who are already implanted with DBS
      for treatment of PD.

      At the patient's follow up visit they will be asked to come to the clinic in the "off
      medication" state. Off medication is defined as at least 8 hours since the last medication
      dosing. Data will be collected during three phases: "OFF" state, transitioning state, and
      "ON" state. Subjects will be asked to assume different functional states (lying, sitting or
      walking) for 1 minute each. During these functional states, multiple measures of impedance
      will be collected.

        -  "OFF" state data collection: The subject will be examined to assess his motor
           examination score using the UPDRS-III. Measurements of impedance will be collected
           multiple times in the lying down and sitting up states.

        -  Transition state data collection: The subject will be asked to take their dopamine
           medication. The medication will take approximately 1 hour to take full effect.
           Measurements of impedance will be collected every 10 minutes during this transition from
           the "OFF" state to the "ON" state. Patients will be asked to report at what point they
           felt the "ON: state (they can report the state as "OFF", "unsure", "transition" or
           "ON").

        -  "ON" state data collection: The "ON" state examination will start after 1 hour from
           medication administration. Subjects will be examined using the UPDRS-III. Measurements
           of impedance will be collected in the lying down, sitting and walking states.

      Summary of the study protocol:

      "OFF" state Transition state "ON' state UPDRS-III x x Impedance Lying down x x Sitting up x x
      x Walking x UPDRS I and II x Hoehn and Yahr x x
    

Intervention name(s): Impedance measurements
Intervention type(s): Other
Intervention description(s): Refer to study description
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Deep Brain Stimulation; Electric Impedance; Parkinson disease
Investigation of Efficacy of Secukinumab in Patients With Moderate to Serve Atopic Dermatitis
Condition: Dermatitis, Atopic; Eczema, Atopic; Neurodermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Neurodermatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall aim of this study is to assess the effects of a new treatment called Secukinumab
      in adults suffering from moderate to severe atopic dermatitis. Furthermore, the study shall
      support the extension of the approval for Secukinumab from psoriasis to atopic dermatitis.
      The effectiveness of Secukinumab is determined on the reduction of the eczema score EASI 50
      (Eczema Area and Severity Index, a tool to measure the severity of atopic dermatitis) at week
      4.
    

Detailed description: 
      Secukinumab is a humanized anti-IL-17A monoclonal antibody. Since Secukinumab is well
      established in the therapy of psoriasis with a highly favorable benefit to risk ration and
      IL-17 has been described in atopic dermatitis this study aims to investigate the effects of
      anti-IL-17 in atopic dermatitis.

      This is a randomized, placebo-controlled, multicenter, double-blinded study to evaluate the
      efficacy and safety of subcutaneous Secukinumab compared to placebo in 45 adults with atopic
      dermatitis.

      The study consists of 3 periods: a screening period of at least -14 days and up to -35 days,
      and a treatment period of 16 weeks and a follow-up period of additional 8 weeks. During the
      screening period eligibility of the patients is confirmed. Eligible patients are randomized
      2:1 to treatment arm A or B at Day -7 (+2 to -15) during the randomization visit. Secukinumab
      (Cosentyx®) will be used according to the official label and SmPC (Summary of Product
      Characteristics). Patients in treatment arm A receive 300 mg Secukinumab administered as 2
      subcutaneous injections of 150 mg (i.e. 2x 150 mg) at baseline day 1 and week 1, 2, 3, 4, 8,
      12 and injections with placebo at week 5, 6, 7 and 16. For assessments of the study endpoints
      visits are performed at weeks 20 and 24. Placebo will be administered as 2 subcutaneous
      injections. Patients in treatment arm B receive placebo until visit 3 (week 3) and will
      switch to Secukinumab 300 mg s.c. up from visit 4 (week 4), visit 5, 6, 7, 8, 12 and16. For
      assessments of the study endpoints visits are performed at weeks 20 and 24.
    

Intervention name(s): Secukinumab 300 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution for injection in pre-filled syringe; Solution for injection in pre-filled syringe
Other intervention name(s): COSENTYX ®; Placebo (for Secukinumab)
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: neurodermatitis; moderate to severe inflammatory reaction of the skin; Skin and Connective Tissue Diseases
SEEG Guided RF-TC v.s. ATL for mTLE With HS
Condition: Epilepsy, Temporal Lobe
MeSH terms: Epilepsy; Epilepsy, Temporal Lobe
Study type: Interventional

Summary: 
      Mesial temporal lobe epilepsy (mTLE) is the most classical subtype of temporal lobe epilepsy,
      which is the indication of surgical intervention after evaluation. Until now, anterior
      temporal lobectomy (ATL) is still the recommended treatment for mTLE. However, evidences are
      accumulated including post ATL tetartanopia and memory deterioration and new minimized
      invasive treatments are introduced. Stereotactic EEG (SEEG) guided radio-frequency
      thermocoagulation (RF-TC) is one of the option with lower seizure freedom but with higher
      neurological function reservation. This study is aiming at comparison of the efficacy and
      safety between SEEG guided RF-TC and classical ATL in the treatment of mTLE.
    

Detailed description: 
      Nowadays, more and more patients received SEEG implantation for the evaluation of intractable
      seizures. SEEG is not only a diagnostic method to locate the origin of the epileptic seizures
      but also a media to treat or to cure this disease. Using radiofrequency thermocoagulation, we
      are able to coagulate some part of the brain guided by SEEG. However, until now, we don't
      have high level evidence for the efficacy and safety of RF-TC. In our resent series, we found
      the 1 year seizure free rate of mTLE patients after RF-TC is about 80% without any notable
      complication.

      In this trail, we will compare the efficacy as well as the safety of anterior temporal
      lobectomy with RF-TC for the mTLE patients, including the 1 year Engel class, perioperative
      complications, cognitive function, visual field, etc. Thus we can provide more high level
      evidence on the usage of SEEG guided RF-TC on mTLE patients.
    

Intervention name(s): SEEG guided RF-TC; Anterior temporal lobectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): SEEG implantation after evaluation, record the interictal and ictal EEG, and perform RF-TC after the localization confirmation.; classical surgical treatment for mesial temporal lobe epilepsy, including the resection of neocortex for 5.5cm in non dominant hemisphere or 4.5cm in dominant hemisphere
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: temporal lobe epilepsy; hippocampus sclerosis (HS); radiofrequency thermocoagulation (RF-TC); cognitive status
Relational Development in Children With Cleft Lips and Palates: Influence of the Waiting Period Prior to the First Surgical Intervention and the Parents' Psychological Perception of the Abnormality
Condition: Cleft Palate
MeSH terms: Cleft Palate
Study type: Observational

Summary: 
      The treatment of patients suffering from cleft lip(s) with or without a cleft palate (CL/P)
      is multidisciplinary. The careful consideration of concerned families during the repetitive
      appointments required by these treatments show the importance of the psychological context
      and of the harmonious structuring of the parents-child relationships on the child's
      development. Yet the birth of a child affected by CL/P is a particularly stressing and
      traumatising event for the parents. The investigators' prospective, multidisciplinary and
      multi-centred research project aims to assess the psychological perceptions of parents of
      children affected by CL/P over the year following the birth and analyse the child's degree of
      psychological suffering as well as the parents-child relationships. The time of the first
      surgical intervention varies amongst the treatment centres. The investigators listed four
      centres that intervene at different times according to the more or less long waiting times
      between the child's birth and this first surgical intervention. The results obtained for each
      group will be compared to one another and according to two sub-groups: parents who found out
      about the CL/P through embryo diagnosis and those who found out at their child's birth. The
      mental and psychological dimension due to the malformation and its correction will be
      analysed in the parents group (importance of the prenatal diagnosis, relational development
      with the child, self-esteem, quality of life) but also in the child (likely distress and
      withdrawal symptoms).
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care centers (France) Two referent centers Two competent centers
      
Keywords: cleft palate
Safety and Efficacy Study of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to investigate the clinical effects of multiple (28 day)
      twice-daily doses of OC000459 in comparison to placebo on clinic lung function (FEV1) in mild
      to moderate asthmatics with an FEV1 of 60-80% of predicted and requiring only short acting
      inhaled B2-adrenergic agonists for symptomatic control.
    


Intervention name(s): OC000459; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): OC000459 capsules 2x100mg BID for 28 days; Placebo capsules to match OC000459 100mg capsules, 2 tablets BID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
24-week Study With Open Label Extension of VX-509, an Oral JAK3 Inhibitor, in Subjects Taking Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the safety and efficacy of VX-509, an oral JAK3 inhibitor,
      for treatment of subjects with active RA who have had an inadequate response to Methotrexate.
    

Detailed description: 
      VX-509 is an oral, selective Janus kinase 3 (JAK3) inhibitor being developed by Vertex. In
      autoimmune diseases, JAK3 is an essential component of the immune signaling cascade. This
      cascade ultimately contributes to abnormal immune response that results in chronic
      inflammation and, in the case of rheumatoid arthritis (RA), irreversible damage to cartilage
      and bones. Selective inhibition of JAK3 offers a new disease modifying approach to the
      treatment of RA, and a broad range of other autoimmune diseases.
    

Intervention name(s): VX-509; VX-509 matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg oral tablet; 0 mg oral tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Tdap Vaccine Safety for Plasma Donors
Condition: Tetanus
MeSH terms: Tetanus
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a prospective, open label, single-arm, multi-center, Phase 1 study measuring the
      safety and tetanus antibody responses to Tdap vaccine administered to plasma donors every 3
      months ±1 week for 12 months (5 vaccinations) with a 6 month follow-up after the last
      vaccination. After obtaining informed consent and screening for eligibility including
      plasmapheresis donor eligibility, subjects will have other baseline assessments performed and
      if eligible, will receive the scheduled vaccinations, will be assessed for adverse events
      (AEs) and have plasma samples collected for antibody titers each month thereafter for 11
      months, and then at 1 and 6 months after the last vaccination. As these subjects are
      participating in a standard donor plasmapheresis donor program, assessments for donor
      eligibility and routine plasmapheresis will be performed; however, only the data specifically
      required to meet the objectives of this study will be collected.
    


Intervention name(s): Adacel
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular
Other intervention name(s): Tdap Vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effective Treatment of Posttraumatic and Postoperative Edema
Condition: Edema
MeSH terms: Edema
Study type: Interventional

Summary: 
      Edema control after ankle- and hindfoot fractures is important. Multi-layer compression
      bandages or A-V Impulse compression may are more effective in reducing edema than ice.
    

Detailed description: 
      After ankle- and hindfoot fractures, edema has a major impact on the time point of surgical
      intervention and may increases the risk of wound complications and infection postoperatively.
      Effective treatment of edema, therefore, is of great importance. The aim of this study was to
      evaluate the efficacy of the multi-layer compression therapy and of the A-V Impulse
      compression (AVI) in reducing ankle- and hindfoot edema as compared to the standard treatment
      with ice.
    

Intervention name(s): ice gel pack; Multi-layer compression bandage; A-V Impulse compression
Intervention type(s): Behavioral; Other; Device
Intervention description(s): ice gel pack combined with elevation; Application of a multi-layer compression bandage to the foot and lower limb (two layers of wool followed by several layers of a short stretch bandage).; A-V Impulse compression dosage: 130mmHg exerted to the sole of the foot for one second, every twenty second.
Other intervention name(s): Artiflex; Comprilan; A-V intermittent Impulse compression device.; AVI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: edema reduction; ice; multi-layer compression bandage; A-V Impulse compression; ankle
Safety and Efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine for Facial Augmentation in Asian Population
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Restylane Lidocaine and
      Restylane Perlane Lidocaine after the first and second treatment when used for facial
      augmentation in Asian population.
    


Intervention name(s): Restylane; Perlane
Intervention type(s): Device; Device
Intervention description(s): Facial tissue augmentation; Facial tissue augmentation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the bioequivalence
      of two formulations of biphasic insulin aspart 70 in healthy male subjects.
    


Intervention name(s): biphasic insulin aspart 70
Intervention type(s): Drug
Intervention description(s): A single dose administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-12 days will take place between dosing visits
Intervention MeSH terms: Insulin Aspart; Biphasic Insulins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Circulating Progenitor Cells Levels in Periodontal Disease Patients
Condition: Metabolic Disease
MeSH terms: Periodontal Diseases; Metabolic Diseases
Study type: Observational

Summary: 
      Recently, a key role played in the ethiology of periodontitis has been highlighted by a
      subtype of stem cells derived from bone marrow, the circulating endothelial progenitor cells
      (EPCs). EPCs possess the ability to express surface antigens of endothelial and hematopoietic
      stem cells and to assist in maintaining vascular integrity and the repair mechanism of the
      endothelium. Among the main markers for the analysis of EPCs levels are CD34+, CD133+ and the
      kinase insert domain-containing receptor (KDR). CD34+ and CD133+ originate from hematopoietic
      stem cell antigens whereas KDR is a specific marker of endothelial cells. More specifically,
      CD34+ and CD133+/ KDR+ allows less mature and mature EPCs to be evaluated.
    

Detailed description: 
      The aim of the present study was to investigate the association between endothelial
      progenitor cells (EPCs) levels subtype (CD133+/KDR+), in patients with periodontitis.

      Furthermore, the objective was to determine if the periodontal status influenced CD133+/KDR+
      levels.
    

Intervention name(s): Observation
Intervention type(s): Other
Intervention description(s): Evaluation of endothelial progenitor cells level and correlation of endothelial progenitor cells level with periodontal and cardiovascular disease
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        79 healthy subjects, 88 patients with CP. Lipid profile and levels of CD133 and C-reactive
        protein (CRP) were evaluated.
Mobile Health App to Mitigate the Metabolic Effects of Androgen Deprivation Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This research study seeks to develop and evaluate a mobile health app which aims to provide
      patients who are about to initiate androgen deprivation therapy for prostate cancer with an
      exercise program and better eating habits.
    

Detailed description: 
      This research study seeks to develop and evaluate a mobile health app which aims to provide
      patients who are about to initiate androgen deprivation therapy for prostate cancer with an
      exercise program and better eating habits. The first phase of the research study seeks to
      evaluate the experience of the first version of the mobile health app within a group of
      participants and what they think of it.

      The investigators are interested in how individuals react to the use of a developed mobile
      health app and what they think of it.
    

Intervention name(s): Mobile Health App; Usual care
Intervention type(s): Other; Other
Intervention description(s): mobile health app aims to provide patients who are about to initiate androgen deprivation therapy for prostate cancer with an exercise program and better eating habit; Usual care per hospital guidelines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Prostate Cancer
Vaginal Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the effectiveness of vaginal isonicotinic acid hydrazide with placebo in
      minimizing the pain experienced by primarily infertile patients during diagnostic ofﬁce
      hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the
      hysteroscopist.
    

Detailed description: 
      hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as
      polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during
      the removal of an intrauterine device or foreign body. Cervical ripening is made possible by
      the use of medication through different routes.
    

Intervention name(s): INH; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 vaginal tablet of isonicotinic acid hydrazide 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy.; 3 vaginal tablet of Placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.
Other intervention name(s): isonicotinic acid hydrazide
Intervention MeSH terms: Isoniazid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blind randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of MND-2119 at a dose of
      2g/day or 4g/day for 52 weeks in patients with hypertriglyceridemia.
    


Intervention name(s): Icosapent
Intervention type(s): Drug
Intervention description(s): Icosapent (MND-2119) capsules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment