bioihbjkbjnl/mcl2 huggingface dataset:
A Study of TB-403 in Pediatric Subjects With Relapsed or Refractory Medulloblastoma
Condition: Relapsed or Refractory Medulloblastoma (MB), Neuroblastoma (NB), Ewing Sarcoma (ES) and Alveolar Rhabdomyosarcoma (ARMS)
MeSH terms: Sarcoma; Neuroblastoma; Rhabdomyosarcoma; Sarcoma, Ewing; Medulloblastoma; Rhabdomyosarcoma, Alveolar
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability profile of TB-403
      (humanized monoclonal antibody against placental growth factor (PlGF)) in pediatric subjects
      with relapsed or refractory Medulloblastoma.
    

Detailed description: 
      The maximum tolerated dose of TB-403 will be determined in pediatric subjects with relapsed
      or refractory Medulloblastoma (MB) and as well Neuroblastoma (NB), Ewing Sarcoma (ES) and
      Alveolar Rhabdomyosarcoma (ARMS).
    

Intervention name(s): TB-403 20mg/kg; TB-403 50mg/kg; TB-403 100mg/kg; TB-403 175mg/kg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): bi-weekly intravenous doses of TB-403 20mg/kg; bi-weekly intravenous doses of TB-403 50mg/kg; bi-weekly intravenous doses of TB-403 100mg/kg; bi-weekly intravenous doses of TB-403 175mg/kg
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Test Different Doses of BI 1358894 and Find Out Whether They Reduce Symptoms in People With Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is open to adults with borderline personality disorder. The purpose of this study
      is to find out whether a medicine called BI 1358894 helps to reduce symptoms in people with
      borderline personality disorder. Four different doses of BI 1358894 are tested in the study.

      Participants are put into 5 groups by chance. Participants in 4 of the 5 groups take
      different doses of BI 1358894. Participants in the fifth group take placebo. Participants
      take BI 1358894 and placebo as tablets once a day. Placebo tablets look like BI 1358894
      tablets but do not contain any medicine.

      Participants are in the study for about 5 months. During this time, they visit the study site
      about 12 times and get about 6 phone calls. At the visits, doctors ask participants about
      their symptoms. The results between the BI 1358894 groups and the placebo group are then
      compared. The doctors also regularly check the general health of the participants.
    


Intervention name(s): BI 1358894; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Film-coated tablet; Film-coated tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Multi-centre, Prospective, Observational Study on Effectiveness and Safety of ZOLADEX® (Goserelin Acetate Implant) 10.8 mg and ZOLADEX® (Goserelin Acetate Implant) 3.6 mg in Chinese Patients With Localized or Locally Advanced Hormonal Treatment -naïve Prostate Cancer
Condition: Localized or Locally Advanced Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      This study is a multi-centre, prospective observational study. The study plans to enrol 500
      patients with localized or locally advanced prostate cancer who are eligible and intended to
      be prescribed Zoladex® (goserelin acetate implant) 10.8 mg or Zoladex® (goserelin acetate
      implant) 3.6 mg as monotherapy or in combination with androgen blockade (CAB) at 50 clinical
      sites in China. The effectiveness and safety data will be collected at baseline and each
      visit within 26 weeks after treatment of Zoladex®.
    

Detailed description: 
      Androgen Deprivation Therapy (ADT) is a standard treatment for locally advanced or metastatic
      prostate cancer. It is also increasingly used in patients with high-risk localized prostate
      cancer or in patients with prostate-specific antigen (PSA) relapse after local therapy.

      The luteinizing hormone-releasing hormone (LHRH) agonists, such as goserelin
      acetate(Zoladex®), have provided an effective and reversible means of suppressing androgen
      level. Zoladex® was originally formulated as a 3.6mg depot injection. Goserelin acetate
      10.8-mg depot, given once every 3 months, is pharmacodynamically equivalent to 3 consecutive
      monthly injections of the goserelin acetate 3.6-mg depot, offers a more convenient and
      cost-effective dosing regimen for patients.

      Goserelin acetate 10.8-mg depot has been available in China since 2012. However, data on the
      effectiveness and safety of the long-acting depot of Zoladex® (goserelin acetate depot)
      10.8mg specifically in a Chinese population is limited. A "real-world" observational study is
      proposed to establish the effectiveness and safety profile of Zoladex ® 10.8mg in Chinese
      patients with localized or locally advanced prostate cancer.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patients with localized or locally advanced prostate cancer who are prescribed Zoladex®
        (goserelin acetate implant) 10.8 mg or 3.6 mg as monotherapy or in combination with
        androgen blockade (CAB), either as first line treatment or adjuvant therapy to radical
        prostatectomy (RP) are eligible to be the study target population.
Dose-Escalation, Safety and Pharmacokinetic Study of IC14 in Motor Neurone Disease
Condition: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Ten patients with motor neurone disease (MND, also known as amyotrophic lateral sclerosis or
      ALS) will be successively enrolled to one of two dose levels of IC14 (human chimeric
      monoclonal anti-CD14) intravenously for four doses. Patients must be within 3 years of MND
      diagnosis and have adequate respiratory function. Safety, tolerability, immunogenicity, and
      PK/PD will be measured. To evaluate feasibility of the endpoints, additional endpoints of
      ALSFRS-R, respiratory function tests, disease biomarkers and patient-reported outcomes will
      be measured.
    

Detailed description: 
      The objectives of this study are to determine:

        -  The safety, tolerability and immunogenicity of IC14 in patients with motor neurone
           disease (MND).

        -  The pharmacokinetics and pharmacodynamics of IC14 in patients with MND.

        -  The preliminary effect of IC14 on the Revised Amyotrophic Lateral Sclerosis Functional
           Rating Scale (ALSFRS-R) in patients with MND.

        -  The preliminary effect of IC14 on forced vital capacity (FVC) and other clinical markers
           of disease severity in patients with MND.

        -  The preliminary effect of IC14 on patient-reported outcome measures.

        -  The preliminary effect of IC14 on disease biomarkers.

      Ten patients with MND will be sequentially assigned to receive one of two dose regimens of
      IC14 in an unblinded manner:

        -  For the initial 3 patients: IC14 at a dosage of 2 mg/kg on Study Day 1, then 1 mg/kg
           once daily on Study Days 3-5 for 4 total doses.

        -  For the subsequent 7 patients: IC14 at a dosage of 4 mg/kg on Study Day 1, then 2 mg/kg
           once daily on Study Days 2-4 for 4 total doses.

      Study participation will continue until 28 days after the last dose of study drug.
    

Intervention name(s): IC14
Intervention type(s): Biological
Intervention description(s): chimeric monoclonal antibody against human IC14
Other intervention name(s): monoclonal antibody against CD14
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Open-label, dose-escalation, safety and pharmacokinetic
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: motor neurone disease; amyotrophic lateral sclerosis; IC14 [anti-CD14 (cluster of differentiation 14) monoclonal antibody]; monoclonal antibody; anti-CD14
Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants
Condition: Tuberous Sclerosis Complex; Epilepsy
MeSH terms: Tuberous Sclerosis; Epilepsy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This phase I/II clinical trial is an open-label clinical trial design to verify safety and
      dosing for TAVT-18 (sirolimus) powder for oral solution in TSC infants (N=5).
    

Detailed description: 
      Tuberous Sclerosis Complex (TSC) is caused by genetic mutation in TSC1 or TSC2, resulting in
      dysregulation of the mechanistic target of rapamycin (mTOR) signaling pathway. Age at time of
      seizure onset in TSC infants has been linked to long-term neurodevelopmental outcome in this
      high-risk population. TAVT-18 is a novel formulation of sirolimus, an mTOR inhibitor. This
      study evaluates TAVT-18 as a targeted, disease-modifying drug therapy for preventing or
      delaying seizure onset in TSC using a rational, mechanism-based therapeutic approach.
    

Intervention name(s): TAVT-18 (sirolimus)
Intervention type(s): Drug
Intervention description(s): The investigational drug product to be used in this study is TAVT-18, a proprietary formulation of sirolimus in clinical development, by Tavanta Therapeutics, Inc. It is provided in a powder formulation in pre-measured vials.
Intervention MeSH terms: Sirolimus
Intervention model: Single Group Assignment
Intervention model description: This trial is a single stage, phase I/II clinical trial design. Treatment is open-label to verify safety and dosing for TAVT-18 in TSC infants.
Note that this clinical trial originally planned for a follow-up second stage employing a randomized, double-blind, placebo-controlled multisite design. In October 2021, the second stage of this study was replaced by the TSC-STEPS clinical trial (clinicaltrials.gov NCT05104983).
Masking: None (Open Label)
Primary purpose: Prevention
Study to Evaluate Safety and Efficacy of Early Calcineurin Inhibitor Withdrawal in Primary Renal Allografts
Condition: Primary Renal Allograft
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate the safety and efficacy of early corticosteroid withdrawal and simultaneous
      calcineurin inhibitor withdrawal in recipients of primary renal allografts maintained
      long-term on MMF and sirolimus.
    


Intervention name(s): mycophenolate mofetil; sirolimus
Intervention type(s): Drug; Drug
Intervention MeSH terms: Mycophenolic Acid; Sirolimus
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal; Kidney; Transplant
Alternative Medicine Approaches for Women With Temporomandibular Disorders
Condition: Temporomandibular Joint Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Temporomandibular disorders (TMD) are characterized by pain and tenderness in the muscles of
      mastication and/or the temporomandibular joint (TMJ), limitations of jaw opening often
      accompanied by deviations in mandibular path, and clicking, popping or grating TMJ sounds.

      TMD is often found in association with other problems: depression, anxiety, sleep
      disturbances, gastrointestinal symptoms, frequent infections, etc. This project proposes to
      holistically address patient symptoms through three different approaches, Naturopathic
      Medicine (NM), Traditional Chinese Medicine (TCM), and usual care at KPNW. We will conduct a
      pilot test and Phase II trial to evaluate the two alternative healing approaches, TCM (n=50)
      and NM (n=50) delivered by TCM and NM practitioners, are as effective as usual TMD care
      (n=50) provided by dental clinicians in the KPNW TMD Clinic. Subjects will be females 25-55
      years of age with multiple health problems (defined as patients who have had at least 4 organ
      system-grouped diagnoses in the past year, not including TMD). Subjects will be evaluated at
      baseline, 6 and 12 months after start of treatment. The primary endpoint is change from
      baseline in the Axis II Pain Related Disability and Psychological Status Scale. Clinical
      examinations, saliva samples to assess salivary cortisol levels, and responses to a series of
      questionnaires to assess pain, chronic pain, psychosocial functioning, and other physical
      symptoms will be used to assess outcomes. We will passively monitor health care utilization
      within KPNW using clinical, research, and administrative databases to determine whether the
      interventions have an impact on overall health care utilization. If either of these
      alternative interventions is shown to merit Phase III trial, our goal is to design and
      implement such a clinical trial to further evaluate the health consequences and costs of
      these alternative healing paradigms.
    

Detailed description: 
      See brief summary
    

Intervention name(s): Naturopathic Medicine; Traditional Chinese Medicine
Intervention type(s): Procedure; Procedure
Primary purpose: Diagnostic
Topical Aluminium Chloride vs OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)
Condition: Hyperhidrosis; Residual Limbs
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to demonstrate onabotulinumtoxinA superiority to aluminium chloride
      for the treatment of residual limb hyperhidrosis.
    

Detailed description: 
      After randomization patients will receive either OnabotulinumtoxinA once or topical aluminium
      chloride for 6 months. All patients will be evaluated during 3 study visits (week 4, week 12,
      week 24) and 1 phone call (week 18).
    

Intervention name(s): OnabotulinumtoxinA; Topical Aluminium Chloride (cosmetic product)
Intervention type(s): Drug; Other
Intervention description(s): OnabotulinumtoxinA in intradermal Injections on residual lower limb : 100 Units - 1 dose; Topical Aluminium Chloride (cosmetic product) : 1 quantity sufficient on the lower limb
Other intervention name(s): Botox
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 3

Summary: 
      In a previous trial (LOV111858/OM6), subjects received in a double-blind fashion either 4
      g/day of Lovaza® (omega-3-ethyl esters) [formerly known as Omacor] co-administered with
      simvastatin 40 mg/day or placebo co-administered with simvastatin 40 mg/day for 8 weeks. This
      extension trial, LOV111818/OM6X assessed the continued efficacy and safety of Lovaza®
      (omega-3-ethyl esters) co-administered with simvastatin 40 mg vs. switching from simvastatin
      plus placebo to simvastatin plus Lovaza® for lowering non-High Density
      Lipoprotein-Cholesterol (non-HDL-C) levels at 4 months (primary endpoint) and additionally at
      12 and 24 months.
    

Detailed description: 
      Two studies comprise this OM6 Program. Study LOV111858/OM6 (double-blind study) which is
      outlined in NCT00246701 and Study LOV111818/OM6X (open-label extension) outlined in this
      posting.
    

Intervention name(s): Simvastatin + Lovaza® (omega-3-acid ethyl esters)
Intervention type(s): Drug
Intervention description(s): Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor]
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: High triglycerides; Lovaza; simvastatin; omega-3-acid ethyl esters
Role of Subcutaneous Negative Pressure Suction Drain Placed for Ten Days on Wound Healing in Obese Patients Undergoing Midline Laparotomies
Condition: Postoperative Wound Healing
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the role of subcutaneous negative pressure drain placed
      for 10 days on wound healing in female obese patients undergoing midline exploratory
      laparotomies for ovarian cancer.
    


Intervention name(s): Subcutaneous negative suction drain for 10 days; No subcutaneous drain
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Manual-based Art Therapy for Adolescents With Depression
Condition: Depression; Depressive Disorder
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      There is a need to evaluate different interventions in order to meet young people's needs of
      treatment. The study's goal is to find out if manual-based art therapy is a useful method for
      young people with depression and thus increase the availability of methods of treatment for
      adolescents with depression in Child and youth psychiatry in Sweden.

      The aim is to investigate whether manual-based art therapy is useful as treatment for
      adolescents with depression by examining feasibility, acceptability and compliant to
      treatment. Secondary, preliminary study of adolescent depressive symptoms, quality of life
      and functional level is affected by the treatment.

      Method: Data from youths aged 13-17 years old and their parents will be collected with
      questionnaires and structured interviews. Measurements are taken before and after treatment.
      Acceptability and feasibility will be examined by participants' presence, drop out and
      cancellations and also by checking the art therapists' compliance to the manual and
      investigate their reasons to diverge from the manual
    


Intervention name(s): Manual-based Art Therapy
Intervention type(s): Behavioral
Intervention description(s): This is a manual-based treatment and consists of 10 one-hour weekly sessions. The treatment consist of detailed guidelines based on phenomenological art therapy. The sessions follow the same structure: Introduction, short relaxation, art-making, reflections about the image, and conclusions. Examples of comprised art tasks; lifeline, emotional scribbles, and different roles. The art tasks served as a prompt for painting.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: art therapy; program development; Adolescent Health
FitMi Plus Home Therapy for Stroke Patients
Condition: Cerebral Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The investigators will investigate the efficacy of a newly developed functional exercise
      device (FitMi Plus) for people in the chronic stage after a stroke compared to the FitMi
      Basic (i.e. without functional exercises). FitMi Plus combines objects commonly used during
      activities of daily living with sensors that can track and record the patient's direction and
      degree of movement as they perform specific functional tasks described on a computer.
    


Intervention name(s): FitMi Plus; FitMi Basic
Intervention type(s): Device; Device
Intervention description(s): A set of common objects that couple with a wireless sensor platform to allow the performance of functional exercises to be measured by a motivating software platform.; A wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
SYNCHRONOUS AND ASYNCHRONOUS TELEREHABILITATION METHODS IN PATIENTS WITH CERVICAL DISC HERNIATION
Condition: Cervical Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Interventional

Summary: 
      This was a randomized controlled trial conducted to examine the changes in the pain, physical
      function, quality of life, and kinesiophobia of participants with non-specific neck pain in
      Marmara University Physiotherapy and Rehabilitation Department. This study was approved by
      the Clinical Studies Ethics Committee of Marmara University Faculty of Health Sciences in
      January 2022 and was carried out in accordance with the Declaration of Helsinki. The
      participants were informed about the study and their consent was obtained.
    


Intervention name(s): Synchronous Exercise Program; Asynchronous Exercise Program
Intervention type(s): Other; Other
Intervention description(s): The exercise program consisted of exercises by recommended guidelines for nonspecific neck pain patients which includes various strengthening, stretching, and proprioceptive exercises with progression.; The exercise program consisted of exercises by recommended guidelines for nonspecific neck pain patients which includes various strengthening, stretching, and proprioceptive exercises with progression.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment