bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Study to Investigate the Safety and Immunologic Activity AGS-004 an Autologous HIV Immunotherapeutic Agent.
Condition: HIV Seropositivity; Acquired Immunodeficiency Syndrome
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; HIV Seropositivity; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To Investigate the safety and immunologic activity of AGS-004, an autologous HIV
      Immunotherapeutic, in HIV-infected adults currently on stable antiretroviral therapy (ART)
      with durable viral suppression.
    

Detailed description: 
      Although an HIV infection can induce weak immune responses, current HIV immunotherapy using
      consensus antigens has not shown consistent clinical activity. The absence of clinical
      activity is associated with an inability to raise cytotoxic T lymphocytes (CTL) against HIV
      antigens and a failure to induce T cell memory. While strong immune responses may be
      generated to a consensus antigen, those responses do not offer antiviral protection against a
      patient's individual viral burden. The infecting virus' antigen variability likely prevents
      the establishment of effective CD4+ T cell memory and a strong CD8+ T cell effector arm.

      We are investigating the induction of CTL responses in HIV-infected subjects by a novel HIV
      immunotherapeutic agent (AGS-004) in an effort to overcome the lack of polyvalent specificity
      of the immune response for autologous HIV antigens which has been one of the primary reasons
      for the failure of HIV immunotherapy to date.

      This pilot study will investigate the safety and immunologic activity of AGS-004 an
      autologous HIV immunotherapeutic agent.
    

Intervention name(s): AGS-004
Intervention type(s): Biological
Intervention description(s): Four intradermal injections of AGS-004-001 immunotherapeutic, 4 weeks apart.
Other intervention name(s): AGS-004 immunotherapeutic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immunotherapeutic injection
Diabetes Coaching Study
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of the study is to compare the effect of telemedical coaching versus telemedical
      control on HbA1c, weight, BMI, blood pressure, blood lipids, medication, nutrition, physical
      activity and quality of life in type 2 diabetes patients with poor glycaemic control.
    


Intervention name(s): Telemedical coaching; Telemedicine
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
To Compare the Pharmacokinetics of Avanafil in Subjects With Mild and Moderate Renal Impairment to Subjects With Normal Renal Function.
Condition: Renal
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the pharmacokinetics of avanafil in subjects with
      mild and moderate renal impairment and to assess the safety and toleration of avanafil in
      subjects with mild and moderate renal impairment.
    


Intervention name(s): avanafil
Intervention type(s): Drug
Intervention description(s): 200 mg avanafil tablet QD
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: avanafil, renal, impairment, TA-1790
Acupuncture in Traumatic Brain Injury
Condition: Chronic Post-traumatic Headache; Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Post-Traumatic Headache; Tension-Type Headache; Headache; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of the study is to determine the effect of a low vs. high dose of acupuncture
      treatment in individuals with chronic post-traumatic headache (CPTH). A total of 36 people
      with mild traumatic brain injury (mTBI) suffering from CPTH will be enrolled in this study to
      receive acupuncture treatment for 5 weeks. Participants will be randomized into two groups:
      1) Low Acupuncture group (5 treatments) and 2) High Acupuncture group (10 treatments). It is
      hypothesized that both treatment groups will have decreased headaches, but that 10 treatments
      will greater alleviate headaches when compared to 5 treatments.
    


Intervention name(s): Acupuncture
Intervention type(s): Procedure
Intervention description(s): Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acupuncture
Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898)
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will investigate the safety and tolerability of a flexible dosing regimen of
      asenapine for the long-term treatment of manic or mixed episodes associated with bipolar
      disorder I in children and adolescents who completed study P06107.
    


Intervention name(s): Asenapine; Rescue medication
Intervention type(s): Drug; Drug
Intervention description(s): One flavored asenapine sublingual tablet (containing either 2.5, 5 or 10 mg asenapine) twice daily (BID), starting at 2.5 mg on Day 1 for three consecutive days. Normally on Day 4, the dose will increase to 5 mg BID beginning with the evening dose. Normally on Day 7, the dose will increase to 10 mg BID beginning with the evening dose. The dose may be up-titrated earlier than Days 4 and 7 at the investigator's discretion. Beginning on Day 8 (or after at least 1 day on 10 mg BID), asenapine dosing will be flexible (2.5, 5, or 10 mg BID) until up to Week 50.; For participants whose symptoms worsen or are not adequately controlled on assigned treatment, rescue medication may be administered during the trial in the following circumstances. For the control of agitation, anxiety, insomnia, restlessness, or akathisia and extrapyramidal symptoms (EPS) some benzodiazepines (i.e., lorazepam [up to 4 mg/day] or an equivalent dose of short-acting benzodiazepines) and EPS medications (i.e., anticholinergics) are allowed. Benadryl (diphenhydramine) and beta blockers are also permitted, provided that they are not taken within 8 hours of efficacy assessments.
Other intervention name(s): SCH 900274, ORG 5222
Intervention MeSH terms: Asenapine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trunkstability: a Predisposition for Armfunction
Condition: Trunk Stability
MeSH terms: Disease Susceptibility
Study type: Interventional

Summary: 
      Trunk stability is supposed to be an important predisposition for arm function. To the
      investors knowledge this is never been demonstrated.
    

Detailed description: 
      Fifty healthy subjects will execute a reaching movement in sitting. They will reach to a cone
      at a distance of little more than armlength.

      Electromyogram (EMG) and kinematics will be the outcome measures. Secondary outcome measures
      are: sex, dexterity, skillfulness, Fifty first time stroke patients will execute the same
      movements. Primery outcome is EMG and kinematics; secundary outcome measures are: side of
      hemiplegia, arm recuperation.
    

Intervention name(s): one time testing
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: stroke; reaching; ADL
Tolerability/PoP Study in Allergic Rhinitis After Intranasal Administration of AZD8848
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose is to investigate tolerability/safety of repeated weekly doses of AZD8848
      administered intranasally to seasonal allergic rhinitis patients.
    


Intervention name(s): AZD8848; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): nasal spray solution; 30 or 60 µg administered intranasally once weekly for one month; nasal spray solution. Once weekly intranasal administrations for one month.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: patients; allergic rhinitis; tolerability; safety; nasal symptoms
Surfacer System to Facilitate Access in Venous Occlusions
Condition: Chronic Venous Thrombosis; Venous Thrombosis Upper Extremity; Venous Thrombosis Upper Extremity Superficial Veins
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Observational [Patient Registry]

Summary: 
      Prospective, single-arm, multicentre, international Registry of the Surfacer System for the
      treatment of patients with limited or diminishing upper body venous access or pathology
      impeding standard access methods.The purpose of this post-market Registry is to assess the
      standard of care and clinical outcomes of the Surfacer System used in clinical routine
      according to the approved commercial indications.
    

Detailed description: 
      This is a prospective, single-arm, multicenter registry of the Surfacer System for patients
      with limited or diminishing upper body venous access or pathology impeding standard access
      methods. The need for long term access and lack of availability of veins has led to the
      development of the Surfacer System, which facilitates reliable and repeatable placement of
      central venous catheters and restores central venous access. Based on European legislation,
      this Registry is considered to be an observational study. No additional diagnostic or
      monitoring procedures as a result of the inclusion are applied to the patients. Available
      data will be collected in a protected database. Up to 30 patients will be enrolled in 5 sites
      in Europe. Patients requiring central venous access will be enrolled who meet inclusion and
      exclusion criteria and for whom the device is indicated.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients requiring central venous access for:

          -  dialysis

          -  chemotherapy nutrition

          -  delivery of any pharmacological therapy
3BNC117 Monoclonal Antibody in HIV-infected Subjects During Treatment Interruption
Condition: HIV-1 Infection
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the effects of two infusions of 3BNC117 in preventing or delaying
      rebound of viral load during a brief treatment interruption of standard ART and its safety
      during a brief analytical interruption of antiretroviral therapy.
    

Detailed description: 
      The proposed study is a Phase II, open label study to evaluate the safety and antiretroviral
      activity of two and four infusions of 3BNC117 in HIV-infected subjects on combination ART
      during a brief analytical treatment interruption.

      After meeting enrollment criteria sixteen subjects with 3BNC117 sensitive virus (<2μg/ml
      IC50) will receive two (Group A) or four (Group B) intravenous infusions of 3BNC117,
      administered at 30 mg/kg.

      In both dosing groups, antiretroviral therapy will be discontinued 2 days after the first
      3BNC117 infusion (day 2) until week 12. Combination ART will be resumed at week 12. ART will
      be resumed sooner if plasma HIV-1 RNA level is ≥ 200 copies/ml or if CD4+ count drops < 350
      cells/μl and either result is confirmed upon repeat measurement. Participants will be
      followed weekly until week 12 for safety assessments and for monitoring plasma HIV-1 RNA
      levels (viral load). CD4+ T cell counts will be monitored every 2 weeks until week 12.

      Participants may remain off antiretroviral therapy after week 12, with weekly viral load
      monitoring, if viral rebound does not occur by week 12. Participants will be followed for a
      total of 36 weeks.
    

Intervention name(s): 3BNC117; ART Interruption
Intervention type(s): Drug; Other
Intervention description(s): 3BNC117 infusions; Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12.
Other intervention name(s): 3BNC117 antibody; Treatment Interruption
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; 3BNC117; Broadly neutralizing antibody
Islet Transplantation Through an Indwelling Catheter in the Umbilical Vein
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Islet transplantation is one of the effective and promising options for type 1 diabetes
      mellitus treatment1-4. The liver is the primary target location for infusion and portal vein
      catheterization is generally used. Percutaneous transjugular, percutaneous transhepatic,
      laparoscopically transmesenteric and laparoscopically transumbilical approaches were often
      utilized to access the portal. Current islet infusion approach via portal vein of liver has
      various defects. Percutaneous trans-hepatic puncture is risk of possible severe hemorrhage
      and portal thrombosis. The laparoscopic entry techniques require longer surgical duration and
      have an increased rate of catheterization failure. Moreover, the catheters were not allowed
      to indwell for subsequent infusions.

      In the current study, the investigators aim to performed open surgery, catheterized the
      umbilical vein and infused islets into the portal vein. The catheter was indwelled for one
      month after surgery. Therapeutic effects, surgical parameters and complications were observed
      to evaluate feasibility and safety.
    


Intervention name(s): umbilical vein catheterization
Intervention type(s): Procedure
Intervention description(s): A 7 cm incision was made in the middle-right of upper abdominal. The umbilical vein was identified located 4cm beyond umbilicus, which was then half dissected transversely and the atresic venous lumen was recanalized with a common duct probe (3mm-5mm, BAKES). A breakthrough feeling would be sensed after approaching forward for 10-14cm and the umbilical vein was successfully recanalized. The common duct probe was pulled out. A catheter (single lumen central venous catheter, 16-20G, TUOREN, China) was then cannulated for 15cm into left branch of portal vein through umbilical vein. The procedure was observed with Doppler ultrasound (LOGIQ S6, GE).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Modum Bad Complex Posttraumatic Stress Disorder Study
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This study compares three established, manual based psychotherapies for Complex
      Post-traumatic Stress disorder (CPTSD) in patients with childhood trauma (e.g. sexual abuse,
      violence). The primary aim of the study is to compare phase-oriented treatment (Stabilization
      + Exposure) with two non-phased treatments, Exposure and Stabilization.
    

Detailed description: 
      Available treatment procedures for PTSD are largely developed within the context of adult
      trauma (e.g. accidents, natural disasters, rape or combat). The need for additional treatment
      options targeting dysfunctional affect regulation and interpersonal problems in patients
      suffering after childhood trauma is debated in research and clinical settings.

      96 patients will be recruited from referrals to an in-patient clinic in Norway called Modum
      Bad. After assessment, patients will be randomly assigned to one of three treatment arms.
      One-third will receive 10 weeks of Prolonged Exposure, one-third 10 weeks of Skills Training
      in Affect and Interpersonal Regulation (STAIR), and the last third a phase-based treatment
      lasting 16 weeks (STAIR + Narrative Therapy).
    

Intervention name(s): Psychotherapy
Intervention type(s): Behavioral
Intervention description(s): Three established psychotherapeutic models for treatment of complex posttraumatic stress disorders are compared in a residential care setting. Combination of group and individual sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-Protect)
Condition: Cervical Spondylotic Myelopathy
MeSH terms: Spinal Cord Diseases; Bone Marrow Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      CSM (Cervical spondylotic myelopathy) is the most common cause of spinal cord injury
      worldwide. While there is evidence from the recently completed SpineNet prospective study
      that surgical decompression is an effective treatment for CSM, it is clear that many patients
      have remaining neurological impairment. While surgery is relatively safe, approximately 3% of
      patients maintain a neurological problem. Given this background and data from preclinical
      models of non-traumatic and traumatic spinal cord injury, there is strong evidence to
      consider the potential benefit of adding a neuroprotective drug which aids in the treatment
      of patients with CSM whom are undergoing surgical decompression. Riluzole is FDA-approved for
      the treatment of amyotrophic lateral sclerosis, which has some similar clinical features to
      CSM. Riluzole is currently under investigation for traumatic spinal cord injury. Given this
      background, there is a strong basis to consider studying the potential neurological benefits
      of Riluzole as a treatment to surgical decompression in patients with CSM.
    


Intervention name(s): riluzole; Placebo medication
Intervention type(s): Drug; Drug
Intervention description(s): 50mg BID orally for 14 days prior to surgery and 28 days after the surgery; 50mg BID orally for 14 days prior to surgery and 28 days after the surgery
Other intervention name(s): Rilutek
Intervention MeSH terms: Riluzole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Investigation of Hyperhidrosis Treatment Using the Nd: YAG 1440nm Wavelength Laser
Condition: HYPERHIDROSIS
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the Nd:YAG 1440 nm
      wavelength laser for the treatment of primary hyperhidrosis of the axilla.
    


Intervention name(s): Nd:YAG Laser
Intervention type(s): Device
Intervention description(s): Nd:YAG 1440nm Laser
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis (Hay Fever)
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effect of reducing exposure to allergens in
      patients with hay fever by means of a nasal filter.
    


Intervention name(s): Nasal filter; Placebo nasal filter
Intervention type(s): Device; Device
Intervention description(s): Active nasal filter; Placebo nasal filter
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rhinitis; allergic; seasonal; double blind; doubleblind; randomized; randomised; placebo; crossover; clinical; nasal; filter; controlled; trial; hayfever; hay; fever; efficacy; safety; prevention; adult; grass; pollen; symptom; Total nasal symptom score; acoustic rhinometry
Egg-Banking and Ovo-donation
Condition: Egg Banking
Study type: Interventional
Phase: Phase 4

Summary: 
      Egg-banking would considerably simplify the logistics and means by which oocytes could be
      donated. These banks would make it easier to immediately provide oocytes that would be
      compatible to the recipient, shortening or even eliminating the problem of long waiting
      lists. Egg-banking would also allow the oocytes to be effectively quarantined, drastically
      diminishing the risk of transmission of infectious diseases in a fashion analogous to semen
      banks. The most essential prerequisite for a successful egg cryo-banking program is to have
      an efficient oocyte cryopreservation technology. Recent studies, including our own
      experience, have indicated that vitrified oocytes preserve intact their potential to
      fertilize and further develop into competent embryos, giving high clinical results as well as
      high survival rates. The aim of this study is to evaluate impact of the establishment of an
      egg-banking in our ovum donation program. Oocyte cryopreservation is carried out by Cryotop
      method. The study includes oocyte donation cycles conducted with fresh and vitrified oocytes.
      Recipients are allocated randomly into each group ("fresh vs. vitrified cycles"). Main
      outcome measures include survival, fertilization, embryo development and clinical outcome.
    


Intervention name(s): Vitrification of oocytes for IVF treatment; Protocolary IVF treatment with fresh donor oocytes
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Egg banking, clinical outcome
Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy
Condition: Hemophilia
MeSH terms: Joint Diseases; Hemophilia A
Study type: Observational [Patient Registry]

Summary: 
      Trial to assess the bilateral deficit phenomenon during dynamic plantar flexion task in
      patients with haemophilic arthropathy Describe the differences in terms of the physical
      variables (muscular strength, range of motion and proprioception) in patients with hemophilia
      who have conducted a home treatment with a digital tool.

      Bookmark the relationship between clinical history of joint bleeds and clinical
      manifestations in standing and walking.
    

Detailed description: 
      -  Assess the bilateral deficit phenomenon during dynamic plantar flexion task in patients
           with haemophilic arthropathy.

        -  Indicate the independent variables that influence the development of strength and
           contractile activity, with or without previous joint bleeds in haemophilia patients with
           minors.

        -  Observe the descriptive variables people influence the standing, the incorporation from
           sitting and jumping.
    

Intervention name(s): Patients with haemophilia
Intervention type(s): Other
Intervention description(s): Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with haemophilia
      
Keywords: Haemophilia; Arthropathy; Bilateral deficit phenomenon; Proprioception