bioihbjkbjnl/mcl2 huggingface dataset:
Therapeutic HIV Vaccine and Interleukin-2 to Increase the Immune System's Response to HIV
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate whether the HIV vaccine ALVAC vCP1452 given in combination with
      interleukin-2 (IL-2), also known as aldesleukin, can increase immune system function in
      people with HIV infection.
    

Detailed description: 
      While the advent of highly active antiretroviral therapy (HAART) has contributed to the
      increasing control of HIV infection and viral replication, ultimate control of HIV infection
      will require the development of effective HIV-specific immunity in HIV infected individuals.

      This trial will evaluate the use of the ALVAC vCP1452 vaccine in combination with IL-2 to
      increase HIV-specific immune responses in HIV infected patients. ALVAC vCP1452 vaccine is a
      recombinant canarypox HIV vaccine that is administered as a monthly intramuscular injection.
      The IL-2 is self administered as a daily subcutaneous injection at a low, non-toxic dose (2
      million units).

      Participants in this study are randomized to receive either ALVAC and IL-2 or placebo for the
      first 3 months of the study. During this time, participants will continue on their current
      antiretroviral medications and have monthly study visits. Study visits will include a brief
      medical interview and physical exam, administration of the vaccine, and blood tests. At the
      end of 3 months, participants will discontinue both their study medications (IL-2 and ALVAC
      or placebo) and their antiretroviral medications. This Diagnostic Treatment Interruption
      (DTI) will continue for a minimum of 3 months. During the DTI, participants will have weekly
      study visits in which viral and lymphocyte dynamics are monitored.
    

Intervention name(s): ALVAC HIV vaccine (vCP1452); Interleukin-2
Intervention type(s): Biological; Drug
Intervention MeSH terms: Interleukin-2
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single
Primary purpose: Treatment
Keywords: HIV Therapeutic vaccine; IL-2; Structured Treatment Interruption; Treatment Experienced
Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3
Condition: Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to conduct experiments to examine subjective and reinforcing
      effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug
      abusers and preference procedures will be used to assess reinforcing effects. To evaluate the
      acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide
      combinations in healthy volunteers.
    


Intervention name(s): 30% N2O; 0.2% isoflurane; 0.4% isoflurane; 100% oxygen
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Placebo
Intervention MeSH terms: Isoflurane
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: nitrous oxide; isoflurane; subjective effects; psychomotor; healthy volunteer; drug interaction
Celution Prepared Adipose Derived Regenerative Cells in the Treatment of Osteoarthritis of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety and feasibility of
      intraarticular injection of Celution prepared adipose-derived regenerative cells injected
      into knees of patients with chronic knee pain due to osteoarthritis.
    

Detailed description: 
      The ACT - OA Knee Clinical Trial is a prospective, randomized, multi-center device trial
      intended to assess safety and feasibility of intraarticular administration of Celution
      processed Adipose Derived Regenerative Cells (ADRCs). The study will include 90 patients in
      up to 15 sites in the United States.

      Subjects that have chronic knee pain due to idiopathic osteoarthritis of the knee (confirmed
      clinically and radiologically) will be evaluated for eligibility in this study. Following
      informed consent and screening evaluations, eligible subjects will undergo pre-operative
      testing. Subjects will then undergo fat harvest through small volume liposuction under local
      anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate
      ADRCs for immediate intraarticular administration. A dose escalation approach has been
      designed wherein the study is divided into two double-blind, randomized, placebo-controlled
      parts as follows:

      Part A:

      Low Dose (20,000,000 cells): 30 patients OR Placebo: 15 patients

      Part B:

      High Dose (40,000,000 cells): 30 patients OR Placebo: 15 patients

      Subjects randomized to placebo will undergo fat harvest and intraarticular injection of a
      placebo that has been visually matched to the active test substance. All subjects will
      undergo imaging studies, clinical evaluations, and laboratory testing prior to and after the
      procedure; patients will be followed for 48 weeks after intraarticular injections are
      performed.
    

Intervention name(s): Celution Device; Placebo
Intervention type(s): Device; Other
Intervention description(s): ADRCs Prepared using the Celution Device; Inactive Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteoarthritis; knee; adipose derived regenerative cells; ADRC; Celution; arthritis
A Repeat Dose Positron Emission Tomography Study With GSK1144814
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study described in the present protocol consists of two parts. Part A is a multiple
      ascending dose study to evaluate the safety, tolerability and pharmacokinetics of ascending
      doses of GSK1144814. Part B is an open label design in healthy male subjects to assess the
      GSK1144814 Neurokinin1 receptor occupancy.
    

Detailed description: 
      GSK1144814 is a dual Neurokinin 1 and Neurokinin 3 antagonist with the potential to treat
      schizophrenia and depression.

      This study described in the present protocol consists of two parts. Part A is a multiple
      ascending dose study to evaluate the safety, tolerability and pharmacokinetics of ascending
      doses of GSK1144814. The study is a single blind, randomised, placebo controlled design in
      healthy male and female (of non childbearing potential) subjects. Part B is an open label
      design in healthy male subjects to assess the GSK1144814 Neurokinin 1 receptor occupancy
      after repeat oral dosing by positron emission tomography scanning with [11C] GR205171.
    

Intervention name(s): GSK1144814; GSK1144814; GSK1144814
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Multiple daily doses of GSK1144814 for 28 days; Multiple daily doses of GSK1144814 for 14 days; Multiple daily doses of GSK1144814 for 7 days (or until steady state is reached)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; PET
A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 4

Summary: 
      The study objective is to investigate the efficacy of levocetirizine in reducing symptoms
      associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life
    


Intervention name(s): levocetirizine dihydrochloride; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5mg daily (oral tablet) for 14 days; 0mg (matching oral tablet)for 14 days
Other intervention name(s): Xyzal
Intervention MeSH terms: Levocetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: levocetirizine; Xyzal; Seasonal Allergic Rhinitis; total symptom score; quality of life
A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients
Condition: Nerve Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess whether a cross-over type study design in
      post-traumatic neuropathic patients can be used to assess the activity of potential analgesic
      agents
    

Detailed description: 
      Methodology study to evaluate a cross-over study design in post-traumatic neuropathic pain
      patients.
    

Intervention name(s): Pregabalin (Lyrica); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral, 75mg or 150mg capsules, BID; Oral, matched capsules, BID
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Chemotherapy w/wo WeiLeShu in Metastatic Colorectal Cancer
Condition: Microbial Colonization; Colorectal Cancer
MeSH terms: Communicable Diseases; Infections; Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      A total of 50 patients with metastatic colorectal cancer will be enrolled in the study. The
      patients were randomly divided into the WLS-intervention group and the control group. The two
      groups of patients were given the most appropriate medication according to the specific
      conditions of the disease. Patients in the intervention group received additional oral
      administration of Weileshu, a probiotics product (Tongchuang Biotechnology).
    


Intervention name(s): Weileshu; Chemotherapy
Intervention type(s): Drug; Drug
Intervention description(s): a probiotics products which help to rebuild homeostasis of gut microbiome; chemotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Biological and Functional Markers for Precision Astronautical Biomedicine
Condition: Muscular Atrophy
MeSH terms: Muscular Atrophy
Study type: Interventional

Summary: 
      In the current study the investigators will study early biomarkers of human degradation. In
      10-day horizontal bed rest the investigators will enroll 10 healthy male subjects
      (18-30years, BMI 20-28kg/m2). Pre-, mid- and post-bed rest the investigators will perform
      various measurements, some of them will be invasive (blood samples and muscle biopsies),
      which will be carefully taken by the medical staff. The subjects will be placed in hospital
      rooms and have 24-hour medical supervision, adequate hygiene, nutrition, passive exercise,
      entertainment and visits.
    

Detailed description: 
      Ten young male participants will undergo 10 days of horizontal bed rest. Before, during and
      after the investigators will monitor many biomechanical, metabolic, cardiovascular,
      biochemical responses.

      During the bed rest period there will be no interventions. subjects will be allowed to rotate
      freely, with no vertical stimulus of any-kind.
    

Intervention name(s): Bed rest
Intervention type(s): Other
Intervention description(s): 10-day of complete bed rest
Other intervention name(s): immobilization; bed rest confinement; prolonged physical inactivity
Intervention model: Single Group Assignment
Intervention model description: One group of 10 will undergo 10 days of horizontal bed rest without countermeasures.
Masking: None (Open Label)
Primary purpose: Treatment
Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to assess the safety of Lacosamide in subjects with uncontrolled Primary
      Generalized Tonic-Clonic (PGTC) seizures with Idiopathic Generalized Epilepsy.
    


Intervention name(s): Lacosamide
Intervention type(s): Drug
Intervention description(s): Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
Other intervention name(s): Vimpat®
Intervention MeSH terms: Lacosamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary Generalized Tonic-Clonic (PGTC) Seizures; Absence Seizures; Myoclonic Seizures; Idiopathic Generalized Epilepsy (IGE)
Oxytocin, Stress, Craving, Opioid Use Disorder
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Although stress has long been linked to substance use, craving and relapse, there are no
      available medications that target stress-induced substance use disorder (SUD). In particular,
      with the rise in opioid use, there is still a crucial need for developing effective
      pharmacological treatments that target and integrate the complexity of this disease. The long
      term goal of this project is to identify the key neuroendocrine pathways that are responsible
      for stress-induced craving in individuals with opioid use disorder (OUD) in order to better
      understand how they can be effectively treated.
    

Detailed description: 
      The goal of this research is to evaluate whether oxytocin, a hormone with anti-stress
      properties, dampens the effects of stress and opioid-associated cues on opioid craving and
      thus may be an effective adjunctive treatment for OUD.

      The central hypothesis of this research is that oxytocin will reduce stress-induced opioid
      craving in patients with OUD treated with buprenorphine/naloxone as opioid replacement
      therapy (ORT). This hypothesis is based on the model of addiction (Koob, Neuron 2008) in
      which chronic substance use and stress lead to neurobehavioral counter-adaptations that
      dysregulate biobehavioral response.

      In this double-blind, cross-over, placebo controlled, randomized trial, individuals with OUD
      (N=50 who are currently receiving treatment with buprenorphine/naloxone or methadone will be
      randomized to intranasal oxytocin (40 international units, IU) and oxytocin-matched placebo,
      administered twice/day for 7 days with a minimum of two days between the opposite condition
      (oxytocin or placebo). On days 5 and 7, and on days 14 and 16, participants will complete two
      counter-balanced sessions in which they receive yohimbine (32.4 mg) or yohimbine-matched
      placebo.
    

Intervention name(s): intranasal oxytocin, 40 IU, twice a day for 7 days
Intervention type(s): Drug
Intervention description(s): Adjunct therapy
Other intervention name(s): Pitocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects on cardiac repolarisation of
      supratherapeutic doses of AZD3480 compared to placebo in healthy male volunteers, subgrouped
      as extensive metabolisers and poor metabolisers according to CYP2D6 metabolic capacity, using
      moxifloxacin as positive control.
    


Intervention name(s): AZD3480; Moxifloxacin; PLACEBO
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsule, oral, single dose, 6 days; Capsule(encapsulated), oral, single dose; Capsule, oral, single dose
Other intervention name(s): TC-1734-226
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: TQT; ECG; QT; QTc; AZD3480; ECG(QTc effects)
Restorative Yoga for Stress Management
Condition: Stress; Anxiety
Study type: Interventional

Summary: 
      The study examined Restorative Yoga as a method of stress reduction for the HFA Addiction
      Medicine Clinic staff volunteers.
    

Detailed description: 
      The purpose of this study is to determine if there is a perceived benefit from adding a
      restorative yoga class as a method of stress reduction for the HFA Addiction Medicine Clinic
      staff. Working in a busy clinic can be very stressful. While it is not always possible to
      completely eliminate stress from our lives, it is known that stress reduction techniques help
      to diminish the negative consequences of stress. This study was designed to answer the
      following question "How much change in perceived stress is obtained through weekly
      Restorative Yoga sessions?" Study population were members of the HFA Addiction Medicine
      Clinic. All staff completed the Spielberger Job Stress Survey and the State-Trait Anxiety
      Inventory at baseline and at six months following intervention onset. Volunteers from the
      Addiction Medicine Clinic attended weekly restorative yoga sessions 45 minutes in length held
      over the noon hour. Serial State-Trait Anxiety Inventory and weekly questionnaire regarding
      the perceived effects of the restorative yoga on aspects fo patient care were completed by
      study volunteers.
    

Intervention name(s): Restorative Yoga
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stress; Yoga
Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Preliminary Efficacy of VIT-2763 in β-thalassaemia
Condition: Beta-Thalassemia; Non-transfusion-dependent Thalassemia
MeSH terms: Thalassemia; beta-Thalassemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomised, double-blind, placebo-controlled parallel group trial to investigate
      the safety, tolerability and efficacy of multiple doses of VIT-2763 versus placebo in
      participants with non-transfusion-dependent Beta-thalassemia (NTDT).
    

Detailed description: 
      The study includes a 12-week treatment period and a safety follow-up period of 4 weeks.

      About 36 participants (adults and adolescents) are expected to take part in this study at a
      number of different institutions internationally.

      Adult Participants (Cohort I) will be randomized to receive either VIT-2763 once daily (QD)
      or twice daily (BID) or placebo, at a dose of 120 mg or 60mg depending on their body weight.
      Following cohort I review, adolescent participants (Cohort II) will be randomized to the same
      study arms with the same interventions.

      The study medication will be given as oral capsules, containing 60 mg of VIT-2763 or placebo.
    

Intervention name(s): VIT-2763 once a day (QD); VIT-2763 twice a day (BID); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive VIT-2763 QD at a dose of 60 mg if their body weight is between 40 kg to 59 kg or at a dose of 120 mg if their body weight is between 60 kg and 100 kg, during 12 weeks.; Participants will receive VIT-2763 BID at a dose of 60 mg if their body weight is between 40 kg to 59 kg or at a dose of 120 mg if their body weight is between 60 kg and 100 kg, during 12 weeks.; Participants will receive hard capsules of Placebo, twice a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multiple dose, multicenter, double-blind, placebo-controlled parallel group study in adult and adolescent male and female subjects with non-transfusion dependent thalassemia (NTDT)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Beta-Thalassemia
Effect of Prophylaxy of Amiodarone and Propranolol and Amiodarone With Propranolol in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Atrial fibrillation is the most common arrhythmia post coronary bypass surgery, currently
      B-blockers are the class I indication to prevent AF post CABG. We decide to evaluate use of
      propranolol and amiodarone separately and together to find a better prophylaxis for AF
      peri-CABG
    

Detailed description: 
      In this double blind randomized study 240 consecutive patients underwent elective coronary
      artery bypass grafting, being randomized prospectively into three groups, propranolol (p)
      (n=80), amiodarone (A) (n=80) and amiodarone with propranolol (AP) (n=80).

      All groups received their medications from 7 days preoperatively and continued their
      medications for 5 days post CABG.
    

Intervention name(s): Amiodarone + Propranolol; Amiodarone; Propranolol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Amiodarone and Propranolol 7 days pre-operation to 5 days post CABG; Amiodarone treated 7 days pre-operation to 5 days post CABG; Propranolol from 7 days pre-operation to 5 days post CABG
Intervention MeSH terms: Propranolol; Amiodarone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Atrial fibrillation; coronary bypass; Amiodarone; Propranolol; Coronary Artery Bypass Graft (CABG)