bioihbjkbjnl/mcl2 huggingface dataset:
Tranylcypromine Treatment of Bipolar Depression
Condition: Bipolar Disorder I or II
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study seeks to investigate whether tranylcypromine (Parnate®) might be an effective
      treatment of bipolar depression. New treatments are needed, as there is little evidence that
      standard antidepressants are effective in treating this condition, and the two antipsychotic
      medications that have indications for bipolar depression can cause substantial side effects.
      This study will focus specifically on currently depressed outpatients having a bipolar
      history for whom at least one standard antidepressant medication was ineffective. Patients
      will be treated openly with tranylcypromine for 8-10 months, depending on treatment response.
    


Intervention name(s): Tranylcypromine
Intervention type(s): Drug
Intervention description(s): Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study
Other intervention name(s): Parnate®
Intervention MeSH terms: Tranylcypromine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depressive Episode; Depression NOS; Bipolar Disorder; Bipolar Disorder I; Bipolar Disorder II; Bipolar Depression; Major Depression
tDCS to Increase Aerobic Performance in Runners
Condition: Athletic Performance
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Many different factors affect running performance, transcranial direct current stimulation
      (tDCS) is a widely used and available neuromodulation tool and could hypothetically
      facilitate the supraspinal drive and thereby act upstream of the motor cortex to prolong the
      muscles work in time to exhaustion trials. While it appears to decrease the rating of
      perceived exertion (RPE) during cycling, little is known about the effects of tDCS on
      physiological performance parameters such as maximal oxygen consumption (VO2max), maximal
      aerobic speed (MAS) and lactate thresholds in runners.

      The aim of this prospective randomized sham-controlled clinical trial is to investigate the
      physiological effects of tDCS applied over the motor cortex on perceived exertion and
      performance-related parameters measured by an incremental treadmill test to exhaustion.

      This research thus aims at answering the following questions:

        1. Is active tDCS applied bilaterally over the motor cortex significantly more efficient
           than sham tDCS to improve the TTE?

        2. Does active tDCS decreases the RPE, as compared to sham?

        3. Is there any significant difference between active and sham tDCS on the physiological
           parameters measured during an incremental test to exhaustion, namely: VO2max, MAS,
           respiratory exchange ratio, blood lactate levels, maximal heart rate?

        4. Does the baseline level of physical fitness influences response to tDCS?

      The investigators hypothesize that 1) performance as measured by time to exertion will be
      increased following active and not sham tDCS due to a decreased perceived rate of exertion
      without significantly altering the other physiological parameters; and 2) performance as
      measured by incremental treadmill test to exhaustion will be more improved in recreational as
      compared to trained runners.
    


Intervention name(s): Transcranial Direct Current Stimulation (tDCS)
Intervention type(s): Device
Intervention description(s): The active session of tDCS will consist in applying two anodes over M1 bilaterally (C3 and C4 according to the 10-20 international EEG placement) and the cathodes over the occipital areas (O1 and O2), and to inject 2 mA for 20 minutes through sponge electrodes (35 cm²) placed on the scalp using the Startsim 8 (Neuroelectrics, Barcelona). The sham tDCS will use the same montage and device but direct current will only be injected for 30 seconds, with a ramp-up and ramp-down 15 seconds period, to mimic the somatosensory effects of active tDCS.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blind randomized sham controlled crossover
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)
Condition: Non Alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The study will determine the feasibility of using Bioenteric intragastric balloon (BIB) in
      the treatment of patients with Non alcoholic Steatohepatitis (NASH).
    

Detailed description: 
      The Bio-enteric Intra-gastric balloon (BIB) has been shown to be an effective treatment for
      weight reduction in obese patients. This study will determine the feasibility of using BIB in
      the treatment of patients with Non alcoholic Steatohepatitis (NASH). It will evaluate the
      efficacy of the BIB in improving histology of NASH in obese patients.
    

Intervention name(s): AHA diet plus exercise with BIB placement; AHA diet plus exercise with sham BIB placement
Intervention type(s): Procedure; Procedure
Intervention description(s): AHA diet plus exercise with BIB placement for 6 months; AHA diet plus exercise with sham BIB placement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Non alcoholic Steatohepatitis; Intra-gastric balloon
Administration of Human Chorionic Gonadotrophin Before Secretory Transformation of Frozen-thawed Embryo Transfer Cycles
Condition: hCG; FET; Frozen-thawed Embryo Transfe; Human Chorionic Gonadotrophin
Study type: Interventional
Phase: Phase 4

Summary: 
      Successful embryo implantation is complicated process that requires synchrony between
      good-quality embryos and receptive endometrium. Human chorionic gonadotropin (hCG), is one of
      the initial embryonic signals and the major embryoendometrial relationship regulator. This
      study will be conducted to to investigate the role of parenteral hCG used for the transfer of
      cryopreserved- thawed embryos with HRT cycles in the outcome of artificially prepared frozen
      embryo transfer (FET) cycles.
    


Intervention name(s): Human Chorionic Gonadotrophin Intramuscular injection 10.000 IU
Intervention type(s): Drug
Intervention description(s): From the 12th to 13th day of the cycle when endometrium reached the optimal thickness ≥8 mm, group 1 (hCG) will receive 10.000 IU hCG intramuscular injection in the morning then vaginal suppository progesterone 400 mg twice a day will be started in the afternoon
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate the Safety of CS20AT04 Inj. in Subjects With Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of conducting phase 1 trial to evaluate the safety and tolerability of allogenic
      bone marrow-derived mesenchymal stem cells(CS20AT04) in subjects with lupus nephritis.

      Evaluating DLT by IV injection according to dose-escalating in lupus nephritis patients.
    

Detailed description: 
      Lupus is a representative autoimmune disease that affects the whole body. It is occurred by
      generation of autoantibody and immune complex due to abnormal activation of the immune cells
      on the basis of abnormal immune responses.

      Although about 50% of lupus patients have lupus nephritis, there is no therapy product
      targeted for the lupus nephritis now.

      We have performed the pre-clinical and clinical studies using allogenic bone marrow derived
      mesenchymal stem cells in SLE.

      CS20AT04 has anti-inflammatory effects, controls activity of immune cells and reduces
      generation of autoantibodies. So, it is expected to have treatment effects of lupus
      nephritis.

      The clinical trial was designed as a single center, open-label, phase 1 clinical trials.

      If that subject's written informed consent form to participate in this clinical trial will be
      conducted the required examinations and tests in accordance with the study protocol within 56
      days investigational drug administration.

      Then, the register for each dose step. For the final 3 subjects in the inclusion / exclusion
      criteria and be administered a drug test.

      Check the adverse events for more than four hours after administration of the investigational
      drug, and will determine whether the expression of adverse drug reaction(ADR) by the visit
      after 3 days, 7 days and 28 days.

      Except for dose administration, all subject are tested in the same schedule. As a result of
      evaluating severity of AE divided into grades in accordance with the CTCAE (Version 4.0)
      standards.
    

Intervention name(s): allogenic bone marrow derived mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): Step -1 dose : 1.0x10^6cells/kg Step 1 dose : 2.0x10^6cells/kg Step 2 dose : 3.0x10^6cells/kg The single injection of CS20AT04 Inj. in the peripheral veins.(IV) The duration of follow up study following the single dose of CS20AT04 is 28 days
Other intervention name(s): CS20AT04
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Systemic lupus erythematosus; HLA-haplo-matching; allogenic bone marrow derived mesenchymal stem cell; Phase 1 clinical trial
Shockwave Therapy for Acute Low Back Pain
Condition: Acute Low Back Pain (Low Back Pain for Less Than 3 Months)
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether shockwave therapy is more effective in the
      treatment of unspecific acute low back pain than sham therapy.

      60 patients with acute low back pain will be recruited to a single-blinded, randomized,
      placebo-controlled trial. They are randomized to receive either shockwave therapy or sham
      treatment by a identically looking device for 4 weeks, twice a week. Additionally patients
      receive physiotherapy twice a week and are allowed to take an anti-inflammatory drug, if
      necessary for even 4 weeks. The primary outcome variable will be measured at day 0, every
      week during treatment (day 7; 14; 21 and 28) and up to 4 weeks after the last treatment. The
      clinical outcome will be primarily measured by pain intensity using a visual analogue scale.
      Secondary outcome measures are Oswestry Disability Index, Beck's Pain Depression Scale,
      Roland Morris Disability Questionnaire and the EQ-5D. Data will be analysed for the
      difference in change of scores between groups using one-way t-test.
    


Intervention name(s): shockwave therapy; placebo shockwave therapy
Intervention type(s): Device; Device
Intervention description(s): Shockwave therapy with 2000 impulses/treatment at 12 Hz; 8 treatment over 4 weeks, twice a week; sham shockwave therapy by an identically looking device without any function
Other intervention name(s): EMS Swiss Dolorclast® Classic (EMS Electro Medical Systems S.a.); CE Certificate: 0124
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Long-Term Effects of Repetitive, Low-Level Blast Exposure on Special Operations Forces Service Members
Condition: Traumatic Brain Injury; Blast Injuries
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Blast Injuries
Study type: Observational

Summary: 
      This is a pilot study to identify biomarkers that individually, and in combination,
      demonstrate the greatest sensitivity to repetitive, low-level blast exposure (RLLBE)
      neurotrauma in Special Operations Forces (SOF) personnel. The proposed cross-sectional,
      multimodal study will elucidate the potential effects of long-term RLLBE by comparing
      biomarkers across subjects.
    

Detailed description: 
      The proposal includes a comprehensive battery of assessments characterized by high-field
      neuroimaging, proteomics, and experimental cognitive and neurobehavioral evaluations, which
      will be implemented alongside standardized clinical diagnostic tools. The results will inform
      the design of a larger trial to validate the diagnostic utility of these biomarkers as well
      as their ability to predict RLLBE-related clinical outcomes. A secondary aim will be to
      define the underlying mechanisms, risk and resilience factors, and clinical phenotypes
      associated with RLLBE.

      Biomarkers assessed over the course of a two-day evaluation will include:

        1. 3 Tesla Connectome MRI to detect structural disruption of brain networks

        2. 7 Tesla MRI to detect functional disruption of brain networks

        3. Translocator protein (TSPO) PET - ligand [11C]-PBR28 to detect neuroinflammation

        4. Tau PET - ligand [18F]-MK6240 to detect tau deposition

        5. Neurocognitive assessments to detect signs of cognitive/behavioral dysfunction

        6. Self-report indicators of cognitive/behavioral dysfunction

        7. Blood biomarkers to detect evidence of blast injury using proteomics and metabolomics

      We hypothesize that a multimodal assessment using Connectome MRI, 7 Tesla MRI, TSPO PET, Tau
      PET, cognitive/behavioral tests, proteomics and metabolomics will identify biomarkers of
      RLLBE-related brain injury.
    

Intervention name(s): 3T Connectome MRI; 7 Tesla MRI; TSPO PET; Tau PET; Cognitive and Behavioral Assessments; Blood Biomarkers
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): MRI scan of structural connectivity; MRI scan of functional connectivity; PET scan of neuroinflammation; PET scan of tau deposition; Assessments of memory, attention, complex reasoning, mood and other cognitive/behavioral domains; Blood-based assessments of proteomic and metabolic biomarkers of brain injury
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        U.S. Special Operations Forces personnel
Jointly Managing JIA Online: An Internet-based Psycho-educational Game for Children With JIA and Their Parents
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      Arthritis in children is a long-term illness and it can make a child's life very difficult.
      In children 8-11 years old, the child and their family work together to deal with the
      problems that arthritis can cause. Learning to cope with and manage the problems that come
      with arthritis can stop it from getting worse. It is important to create programs that teach
      children and families how to cope with and manage arthritis. This study will develop and test
      an online game that helps children learn how to better manage their arthritis. The goal of
      these studies is to test: (1) how easy to use and acceptable the online game is; and (2) if
      children who play the game feel less pain, have fewer limitations, and a better quality of
      life compared to children who do not play the game.
    


Intervention name(s): Game; Usual Care
Intervention type(s): Behavioral; Other
Intervention description(s): In addition to standard medical care, children in the experimental group will receive the Match-3 game. The game will be designed for short individual gameplay sessions (as little as a few seconds), once to three times a day, over the course of 8 weeks, involving no more than 15 minutes per day in anticipated screen time. There is no way to "lose" the game. Through a structured series of daily interactions, the player will learn strategies and develop decision-making abilities that will assist with management of their own JIA. The Match 3 concept (similar to the game, Bejeweled) will require the player to successfully match the treatment strategy to the JIA symptom.; Children in usual care group receive standard medical care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study Assessing Safety, Immunogenicity and LDLc -Lowering Activity of 2 PCSK9 Targeting AFFITOPE Vaccines in Healthy Subjects
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Study AFF012 is a single blind, single-center, randomized, placebo-controlled, parallel
      group, phase I clinical trial of repeated administration by subcutaneous injection of a
      single dose of one of two different proprotein convertase subtilisin/kexin type 9 targeting
      AFFITOPE® vaccines or Placebo. This study will assess Safety, Immunogenicity and low density
      lipoprotein cholesterol-lowering activity of the two vaccines.

      72 healthy subjects are divided into three test groups (2 treatment groups, 1 placebo group),
      each consisting of 24 subjects. The subjects are randomized to receive either of two
      AFFITOPEs® (AT04A or AT06A, adsorbed to 1 mg aluminium oxyhydroxide) or placebo (1 mg
      aluminium oxyhydroxide).

      The study consists of 3 parts, part A, encompassing Visit 1 to Visit 8, covering 3 priming
      immunizations at a dose of 15μg at days 0, 28 and 56 and the immediate observation period
      extending to day 140; the prolonged observation period: part B, encompassing Visit 9 and
      Visit 10 at days 273 and 365; and part C consisting of 7 visits (V11 to V17). Study
      participants having received 3 priming vaccinations and having completed part B will receive
      in part C one boost immunization at a dose of 75μg, which will be applied one year after the
      3rd immunization (day 420). Probands will proceed directly from part A to part B and to part
      C. Continuation of parts B and C will be considered based on the part A results, primarily
      the immunological results. The following scenarios apply (provided that there is no safety
      issue). None of the two treatment groups exhibits a vaccine-specific antibody response over
      the placebo group at Visit 8 - this will lead to termination of the trial. One of the two
      groups fails to exhibit a vaccine-specific antibody response over the placebo group at Visit
      8 - this will lead to its discontinuation; the other treatment group and the placebo group
      will be continued.
    


Intervention name(s): AFFITOPE® AT04A+adjuvant; AFFITOPE® AT06A+adjuvant; Adjuvant without active component
Intervention type(s): Biological; Biological; Biological
Intervention description(s): subcutaneous injection; subcutaneous injection; subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Early Sensory Re-education of the Hand With a Sensor Glove Model
Condition: Peripheral Nerve Injuries
MeSH terms: Peripheral Nerve Injuries
Study type: Interventional

Summary: 
      The implementation of early sensory re-education (SR) techniques, aimed to preserve the
      cortical hand area, such as the use of audio-tactile interaction, becomes an important
      strategy to obtain also a better sensory function. The aim of this study was to investigate
      sensory function outcomes (threshold monofilaments, two-point discrimination test, STI and
      DASH) and cortical responses (fMRI) in patients submitted to an early protocol of SR of the
      hand with a sensor glove model. After surgical repair of median and/or ulnar nerves, 17
      participants were divided into two groups: the training group, trained on the protocol with
      the sensor glove model, and the control group, untrained. After six-month follow-up, no
      difference was observed between groups, related to sensory function, especially tactile
      gnosis. Despite this, the early training with this sensor glove model seems to provide some
      type of cortical audio-tactile interaction, contributing to previous studies that focus in
      early SR of the hand using the integration of different sensory modalities.
    


Intervention name(s): Early sensory re-education of the hand with a sensor glove model
Intervention type(s): Other
Intervention description(s): Training Group patients were submitted to application of a three-month protocol for early sensory re-education of the hand using the sensor glove model developed by Mendes et al. (2011). Patients also received conventional physical therapy for this type of injury in a specialized hand therapy center in a university hospital. Control Group patients received only conventional physical therapy treatment. No home sensory re-education program was established for any group and the CG patients were not submitted to any protocol for early sensory re-education of the hand.
Other intervention name(s): Physical Therapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peripheral nerves/lesions; hands; rehabilitation; fMRI
Clinical Phase II Trial to Evaluate CD34+ Cells Mobilization and Collection in Patients With Fanconi Anemia for Subsequent Transduction With a Lentiviral Vector Carring FANCA Gene. FANCOSTEM-1
Condition: Fanconi Anemia
MeSH terms: Fanconi Syndrome; Anemia; Fanconi Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Fanconi anemia (FA) is a congenital disease characterized by bone marrow failure and
      increased incidence of malignant tumors. The Project pursue the optimization of the
      collection of hematopoietic progenitor cells for later use in another clinical trial entitled
      "Clinical Trial Phase I/II to evaluate the safety and efficacy of the infusion of autologous
      CD34+ cells mobilized with mozobil and filgrastim, and transduced with a lentiviral vector
      carrying the FANCA gene (Orphan Drug) for patients with Fanconi Anemia Subtype A ". The
      objectives of this study are, therefore, to assess the safety and efficacy of CD34+ cells
      mobilization with mozobil and filgrastim, which is postulated the most efficient for the
      collection of CD34+ cells from FA patients.
    


Intervention name(s): filgrastim; plerixafor
Intervention type(s): Drug; Drug
Intervention description(s): G-CSF (12 μg/Kg/12 h) 8 days.; Plerixafor 0,24 mg/kg/day after the fourth day of G-CSF, and until 5 cells CD34+/μL, max 4 doses of plerixafor
Intervention MeSH terms: Plerixafor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
This Study in Healthy Men Tests How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How BI 1358894 Affects the Way the Body Breaks Down Midazolam
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the trial is to investigate the safety and tolerability of BI
      1358894 in healthy male subjects following oral administration of multiple rising doses over
      14 days.
    


Intervention name(s): BI 1358894; Placebo; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Film-coated tablet; Film-coated tablet; Solution for injection
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment