bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial of Rapamycin and Irinotecan in Pediatric Patients With Refractory Solid Tumors
Condition: Refractory Solid Tumors in Children
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Therapeutic solutions to treat solid tumors that are resistant to conventional treatments are
      now limited. Laboratory data in animals (on pediatric tumors such as brain tumors, sarcomas
      and neuroblastomas) have shown that the combination of irinotecan (HIF1alpha inhibitor) and
      rapamycin (mTOR inhibitor) allowed to block development of blood vessels in the tumor and
      could, in some cases, stop its progression. This drug combination has already been tested in
      adult patients with refractory tumors and seems to give encouraging results with
      stabilization of the tumor. The dose and toxicity of irinotecan and rapamycin are known when
      these drugs are administered separately and in a context different from that of refractory
      tumors. RAPIRI is a phase I clinical trial whose principal objectives are to determine the
      maximum dose at which these two molecules may be administered and to assess the safety of
      this new combination of drugs.
    


Intervention name(s): Combined administration of irinotecan and rapamycin
Intervention type(s): Drug
Intervention description(s): This phase I trial is a dose escalation study of irinotecan + rapamycin with a 3+3 statistical design.
Intervention MeSH terms: Sirolimus; Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Physiological Complexity of Gait Over the First Six Months Post Stroke
Condition: Stroke, Acute
MeSH terms: Stroke
Study type: Observational

Summary: 
      Physiological complexity of gait, a measure of the interaction of multiple control mechanisms
      for walking within a biological system, is decreased in persons with chronic stroke compared
      to those without disability. Thus, it is assumed that the quantification of gait complexity
      represents the adaptability and health of the individual. However, it is unknown if the level
      of gait-related complexity improves over time with recovery from stroke. Therefore, the
      primary purpose of this study is to determine if the physiological complexity of gait changes
      over the first six months post stroke within the contemporary healthcare environment.
      Secondary aims include 1) determining if there is a difference between the amount of
      physiological complexity of gait and lateralization of hemispheric damage after stroke and 2)
      exploring the relationship of complexity to lower extremity motor impairment, walking speed
      and balance. Sixty individuals within one month post stroke from the greater Indianapolis
      area will be recruited for this prospective, longitudinal outcomes study. Testing sessions
      will occur at intervals across the first six months post stroke: within 1 month, at 3 months,
      and at 6 months post stroke. During each testing session, participants will complete a
      2-minute walking task during which accelerometer signals from wireless inertial measurement
      units will be collected and converted to sample entropy to quantify the physiological
      complexity of gait. Additionally, measures to quantify lower extremity motor impairment,
      walking speed and balance will be collected and analyzed. Changes in complexity of gait from
      early to later stages of stroke recovery may serve as a foundation for prognosticating
      outcomes, such as predicting capacity for community mobility and/or risk of fall. The
      proposed study will meet a critical need to develop methods that differentiate among
      capacities for adapting movement patterns in individuals with neurological dysfunction. This
      work will ultimately build upon evidence that will assist therapists in tailoring
      interventions in such a way to optimize function.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 60 adults with acute stroke will be enrolled in this prospective, longitudinal
        cohort study.
      
Keywords: stroke, acute; gait, complexity
Naltrexone and Clonidine Combination (ATNC05) in the Treatment of Chronic Back Pain
Condition: Back Pain; Lower Back Pain; Cervical Pain
MeSH terms: Back Pain; Low Back Pain; Neck Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The study includes back pain of the cervical, thoracic, and the lumbar regions.
    


Intervention name(s): Naltrexone and Clonidine Combination; placebo
Intervention type(s): Drug; Drug
Intervention description(s): subjects will receive 1 study drug capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.; subjects will receive 1 placebo capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.
Other intervention name(s): ATNC05
Intervention MeSH terms: Clonidine; Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: back pain; cervical pain; neuropathic pain; radicular pain
Abobotulinumtoxina Efficacy in Post-Traumatic Headache
Condition: Post-Traumatic Headache
MeSH terms: Post-Traumatic Headache; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy of abobotulinumtoxina on Veterans with post-traumatic
      headache
    

Detailed description: 
      A significant proportion of headaches occur following head trauma, and therefore are referred
      to as post-traumatic headaches (PTH). Traumatic brain injury (TBI) is highly prevalent in the
      Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) population and consequently
      there has been a rise in PTH in the clinical setting at VA hospitals. Botulinum toxin type A
      (BoNT-A) has been shown to be effective in treating chronic migraine and chronic daily
      headache. It is therefore reasonable to predict that BoNT-A may also be effective in treating
      PTH. This study proposes that PTH and its associated symptoms may respond positively to
      BoNT-A treatment due to its similar pathophysiology and clinical resemblance to other
      headache disorders including tension type headache, typical migraine with or without aura,
      and chronic daily headache.

      Study Design: Veterans with mild, moderate or severe brain injury with a headache developing
      within 7 days after head trauma and persisting greater than 3 months were recruited from the
      Veterans Affairs Greater Los Angeles Healthcare System. The study is a prospective,
      double-blind, randomized, placebo-controlled, cross-over trial.
    

Intervention name(s): AbobotulinumtoxinA; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Subjects were injected with 0.1 ml (12.5 units of Abobotulinumtoxina) into 31 distinct muscle locations in the head and neck; Subjects were injected with 0.1 ml of preservative free normal saline into 31 distinct muscle locations in the head and neck
Other intervention name(s): Dysport
Intervention MeSH terms: abobotulinumtoxinA; Botulinum Toxins, Type A
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-Platelet Therapy, in Patients With Unstable Angina Not Responding to Standard Medical Therapy Who Are Eligible for Coronary Angioplasty
Condition: Angina, Unstable; Angioplasty, Transluminal, Percutaneous Coronary
MeSH terms: Angina Pectoris; Angina, Unstable
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of abciximab, an
      anti-platelet therapy, versus placebo in patients with unstable angina who are not responding
      to standard medical therapy and who are eligible for coronary angioplasty.
    

Detailed description: 
      This is a randomized, placebo-controlled study to evaluate the safety and efficacy of
      abciximab, an anti-platelet therapy, in patients with unstable angina who are not responding
      to standard medical therapy and who are eligible for coronary angioplasty. The primary
      outcomes of the study include any of the following within 30 days: the number of deaths from
      any cause, myocardial infarctions or the number of recurrent ischemic events requiring urgent
      intervention (such as a coronary artery bypass surgery, repeat coronary angioplasty, coronary
      stent placement, or intra-aortic balloon pump). Please see attached results.

      Patients will be treated with abciximab or matching placebo.
    

Intervention name(s): Abciximab; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): c7E3 Fab
Intervention MeSH terms: Abciximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Angina, unstable; Angioplasty, transluminal, percutaneous coronary; Abciximab
High-Intensity Focused Ultrasound Ablation in Treating Patients With Localized Prostate Cancer
Condition: Prostate Cancer; Sexual Dysfunction; Urinary Incontinence
MeSH terms: Prostatic Neoplasms; Urinary Incontinence; Enuresis
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Highly focused ultrasound energy may be able to kill tumor cells by heating the
      tumor without affecting the surrounding tissue.

      PURPOSE: This phase II trial is studying the side effects and how well highly focused
      ultrasound energy works in treating patients with localized prostate cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To evaluate feasibility, side effect profile, and patient acceptability of
           high-intensity focused ultrasound ablation in patients with organ-confined, MRI and
           histologically proven adenocarcinoma of the prostate.

      Secondary

        -  To determine the effectiveness of therapy via biopsy, MRI, PSA level and estimated time
           to PSA nadir, and by recording the need for secondary or adjuvant treatment following
           therapy.

      OUTLINE: A probe is inserted into the rectum. High-intensity focused ultrasound (HIFU) energy
      using the Sonablate system is delivered to the prostate tissue over approximately 2 hours.
      Patients are then evaluated over a 12-month period.

      Patients undergo multi-sequence MRI within 10-20 days after HIFU to assess the extent and
      volume of tumor necrosis and again at 6 months to assess for disease recurrence. Blood is
      collected for PSA levels at baseline and then at 1, 3, 6, 9, and 12 months. Patients also
      undergo transrectal ultrasound biopsy at 6 months to evaluate disease response.

      Patients complete questionnaires at baseline and at 1, 3, 6, 9, and 12 months to evaluate
      erectile and sexual function, urinary flow and continence, and quality-of-life.
    

Intervention name(s): questionnaire administration; biopsy; high-intensity focused ultrasound ablation; magnetic resonance imaging; quality-of-life assessment
Intervention type(s): Other; Procedure; Procedure; Procedure; Procedure
Primary purpose: Treatment
Keywords: sexual dysfunction; urinary incontinence; adenocarcinoma of the prostate; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer
To Test Bioequivalence Between Two Tablet Formulations in the Treatment of Allergy
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess bioequivalence between two products used for treatment of
      allergy.
    

Detailed description: 
      This study is designed to evaluate if a test formulation of cetirizine 10 mg orodispersible
      tablet (ODT) taken with and without water is bioequivalent to a marketed reference
      formulation of cetirizine 10 mg tablet (Benadryl One A Day, McNeil Products Ltd, UK) taken
      with water. This study will also evaluate the tolerability of test and reference
      formulations.
    

Intervention name(s): Cetirizine; Cetirizine
Intervention type(s): Drug; Drug
Intervention description(s): A single 10 mg dose of an experimental Cetirizine Orodispersible Tablet (ODT), with a 7-day washout period between visits; A single 10 mg dose of a marketed Cetirizine Film-Coated Tablet (FCT), with a 7-day washout period between visits
Other intervention name(s): Not yet marketed; Benadryl One A Day 10 mg Film-Coated Tablet
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
The Efficacy of KIDNET in the Treatment of Traumatized Refugee Children in Germany
Condition: PTSD
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the effectiveness of KIDNET in treating traumatized
      refugee children in Germany
    


Intervention name(s): KIDNET
Intervention type(s): Behavioral
Intervention description(s): Narrative Exposure Therapy for Children
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: PTSD; Children; trauma-focused Treatment; KIDNET; Narrative Exposure Therapy for Children
Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers
Condition: Normal Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study.
      The primary objective of this study is to assess the safety and tolerability of single and
      7-day repeat oral doses NIM-1324 in healthy adult volunteers.
    


Intervention name(s): NIM-1324; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once daily oral tablet; Once daily oral tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
High-dose Etoposide Could Discriminate Patients With Refractory/Relapsed Lymphoma Benefit From APBSCT
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Observational [Patient Registry]

Summary: 
      patients with refractory /relapsed lymphoma received high-dose etoposide for hematopoietic
      stem cell (HSC) mobilization.All patients received high-dose etoposide 20-25 mg/kg/d
      intravenously for two consecutive days followed by rhG-CSF10ug/kg/day subcutaneously at 48
      hours after chemotherapy; rhG-CSF was continued until the end of harvesting for HSCs/HPCs.
      Peripheral blood counts were performed daily for all patients following the initiating of
      rhG-CSF. Leukapheresis was performed when peripheral blood white blood count exceeded 4×109/L
      with blood cell The harvested cells reached at least 2*108/kg for mononuclear cells and/or
      2*106/kg for CD34+ cells with once to twice leukapheresis. The final product was kept frozen
      in liquid nitrogen.Auto-PBSCT
    


Intervention name(s): high-dose etoposide
Intervention type(s): Drug
Intervention description(s): an epipodophyllotoxin, is one of the most common chemotherapy agents for lymphoma without reciprocal resistance with other kinds of agents.
Intervention MeSH terms: Etoposide
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with refractory/relapsed lymphoma
      
Keywords: high-dose etoposide,autologous peripheral blood stem cell transplantation
Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Nerve Degeneration
Study type: Interventional
Phase: Phase 4

Summary: 
      Alemtuzumab is the active agent of a drug called Lemtrada®. In the European Union, Lemtrada®
      is approved for the treatment of a particular form of multiple sclerosis (the so called
      relapsing remitting form). The excellent efficacy of the drug justifies its administration
      albeit a high risk of considerable side effects. In this context, so called secondary
      (occurring after the administration of Lemtrada®) autoimmune diseases are of particular
      importance. In these diseases the immune system acts against structures of the body itself;
      the reasons are still unknown. Autoimmune diseases may even occur several years after
      treatment with Lemtrada®. Therefore, patients who once received the drug need to undergo
      intensive long term health monitoring.

      This study aims to elucidate which mechanisms cause to the positive and negative effects of
      Lemtrada®.

      The study includes patients only, who suffer from multiple sclerosis and are indicated to be
      treated with Lemtrada®. All patients receive the drug according to the official
      recommendations.
    


Intervention name(s): Alemtuzumab
Intervention type(s): Drug
Intervention MeSH terms: Alemtuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
REsPonse to Interferon-Alpha in InterfeRon-β Neutralizing Antibody Positive Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine if Interferon-alfa is effective and safe in multiple
      sclerosis patients who developed neutralizing antibodies for Interferon-beta.
    

Detailed description: 
      Patient with NAbs developed during IFN-β therapy do not have any longer beneficial effect of
      any IFN-β preparation and IFN-β has to be replaced with another therapy that may be less
      effective or carry along serious adverse effects. Hence, many NAb positive patients wish to
      continue IFN therapy, and these patients might benefit from treatment with IFN-α as both
      IFN-α and IFN-β are type I interferons that bind to the same interferon receptor (IFNAR). A
      full in vivo response to human IFN-α (Multiferon) comparable to that seen after IFN-β
      induction would suggest that the same therapeutic effect could be obtained with human IFN-α
      (Multiferon).We measure in vivo response of MxA 9-12 hours after administration of human
      IFN-α (Multiferon) and four other known IFN response markers measured with rt-PCR.

      As controls, NAb negative MS patients with a full in vivo MxA response will be studied.
    

Intervention name(s): Interferon-beta and human leukocyte Interferon-α
Intervention type(s): Drug
Intervention description(s): One single injection of interferon(IFN)- β and one single injection of human leukocyte IFN-α (Multiferon® ) 6 MIU s.c. with 1-7 days follow-up.
Other intervention name(s): IFN-beta : Rebif, Betaferon; IFN-alfa: Multiferon®
Intervention MeSH terms: Interferons; Interferon-beta; Interferon-alpha; Interferon beta-1b
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MS
Efficacy of Gabapentin vs. Placebo for Adjuvant Pain Control Following Acute Rib Fractures
Condition: Acute Pain
MeSH terms: Acute Pain; Rib Fractures
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A Multi-center, Randomized Controlled Trial of the Efficacy of Gabapentin vs. Placebo for
      Adjutant Pain Control Following Acute Rib Fractures.
    

Detailed description: 
      Traumatic rib fractures are a tremendous source of pain which can limit respiratory function
      and overall recovery. Numerous multimodal pain management strategies have been employed with
      varying success; however, narcotics remain the mainstay of treatment. Beyond the acute side
      effects of narcotics, including altered mental status, depression of respiratory drive, and
      constipation, there is a substantial risk of long term dependency. Recently, loco-regional
      blockade and non-narcotic adjuncts have received increasing support within the literature.
      Gabapentin has been used extensively as a non-narcotic adjunct to analgesia regimens in the
      acute and chronic settings, however its ability to better control pain secondary to traumatic
      rib fractures has never been studied .

      The primary aim is to assess the efficacy of gabapentin as an analgesic after rib fractures.
      Secondary aims are to assess the effect on pulmonary function and other known complications
      following rib fractures.

      The hypothesis is gabapentin will improve pain control as measured by lower pain scores and
      lower narcotic needs. The investigators plan to test this hypothesis by recruiting trauma
      patients with rib fractures, and randomly assign them to gabapentin versus a placebo.
    

Intervention name(s): Gabapentin
Intervention type(s): Drug
Intervention description(s): Gabapentin 300 mg three times daily x30 days
Other intervention name(s): neurontin
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease
Condition: Adenomatous Polyp; Crohn Disease; Familial Adenomatous Polyposis; Hereditary Intestinal Polyposis Syndrome; Recurrent Colon Cancer; Stage I Colon Cancer; Stage IIA Colon Cancer; Stage IIB Colon Cancer; Stage IIC Colon Cancer; Stage IIIA Colon Cancer; Stage IIIB Colon Cancer; Stage IIIC Colon Cancer
MeSH terms: Colonic Neoplasms; Adenomatous Polyposis Coli; Adenomatous Polyps; Peutz-Jeghers Syndrome; Crohn Disease; Intestinal Polyposis
Study type: Interventional

Summary: 
      This study is being done to evaluate single incision laparoscopic surgery (SILS) for
      colorectal diseases, compared to multi-port laparoscopic surgery. This study is also intended
      to standardize the SILS technique for colorectal diseases
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To report the experience of SILS procedure in the treatment of colorectal disease.

      II. To standardize the SILS technique.

      OUTLINE:

      Patients undergo single incision laparoscopic surgery with GelPort® attachment.

      After completion of study treatment, patients are followed up at 2 weeks, 3 and 6 months, and
      at 1 year.
    

Intervention name(s): therapeutic laparoscopic surgery
Intervention type(s): Procedure
Intervention description(s): Undergo single incision laparoscopic surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colorectal Disease; SILS; colorectal surgery
A Treatment Study of Mucopolysaccharidosis Type IIIB
Condition: MPS III B; Mucopolysaccharidosis Type IIIB
MeSH terms: Mucopolysaccharidoses; Mucopolysaccharidosis III
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study's primary objectives are to evaluate the safety and tolerability of AX 250
      administered to subjects with MPS IIIB via an ICV reservoir and catheter and to evaluate the
      impact of AX 250 on cognitive function in patients with MPS IIIB as assessed by the
      Development Quotient.
    


Intervention name(s): AX 250
Intervention type(s): Drug
Intervention description(s): Chimeric fusion of recombinant human alpha-N-acetylglucosaminidase and truncated human insulin-like growth factor 2 (rhNAGLU-IGF2)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sanfilippo Syndrome Type B