bioihbjkbjnl/mcl2 huggingface dataset:
Acute Effect of Topical Menthol on Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Topical menthol gels are classified 'topical analgesics' and are used to relieve pain of the
      musculoskeletal system. However, double-blind randomized controlled trials are lacking. Here
      the investigators examine - in a double-blind randomized controlled cross-over trial - the
      acute effect of topical menthol (Biofreeze) and placebo (gel with a menthol scent) on pain
      symptoms in slaughterhouse workers with symptoms of Carpal Tunnel Syndrome.
    


Intervention name(s): Menthol; Placebo
Intervention type(s): Other; Other
Intervention description(s): The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm; The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm
Other intervention name(s): Topical analgesic
Intervention MeSH terms: Analgesics; Menthol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Carpal tunnel syndrome; hand pain; wrist pain; arm pain; topical menthol
Alternative Treatment of Giant Spinal Schwannomas
Condition: Spinal Cord Neoplasms
MeSH terms: Neurilemmoma; Spinal Cord Neoplasms
Study type: Observational

Summary: 
      Schwannomas are benign tumors that can reach giant sizes. The diagnosis and treatment of
      these cases differ from those of small schwannomas. The aim of this study was to review the
      diagnoses and surgical approach characteristics of the giant spinal schwannomas (GSS) of
      patients who underwent surgery.
    


Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients, who underwent surgery for benign spinal schwannoma Sridhar Type III, IV and V
        (all tumors were larger than 2.5 cm).
Vestibular Nerve Stimulation to Improve Sleep
Condition: Insomnia; Sleep; Sleep Disorders, Circadian Rhythm
MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
Study type: Interventional

Summary: 
      A randomized, double blind sham controlled clinical trial to evaluate the efficacy of
      vestibular nerve stimulation (VeNS) compared to a sham control a as a means of improving
      sleep as measured by ISI scores and EEG recordings

      The purpose of this investigation device study is to collect data that will be used to design
      appropriate pivotal studies that can be used for regulatory submissions, primarily in the
      United States of America (USA), but it may also be used to support submissions in other
      regions, including the European Union (EU).
    


Intervention name(s): VeNS; Placebo device
Intervention type(s): Device; Device
Intervention description(s): Non-invasive electrical vestibular nerve stimulation; Sham non-invasive electrical vestibular nerve stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study Evaluating Pyrotinib in Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors. This
      study is designed to evaluate the safety and tolerability of Pyrotinib in combination with
      capecitabine in patients with HER2 positive metastatic breast cancer:

      To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose (MTD) To
      determine the dose-limiting toxicity (DLT) To determine the pharmacokinetic profile of
      Pyrotinib To assess preliminary antitumor activity To determine preliminary regimen dose for
      phase II study
    


Intervention name(s): pyrotinib combined with capecitabine
Intervention type(s): Drug
Intervention MeSH terms: Capecitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacological Regulation of Fat Transport in Metabolic Syndrome
Condition: Obesity; Lipid Disorders; Hypertriglyceridemia; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome; Hypertriglyceridemia; Lipid Metabolism Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether atorvastatin and fenofibrate are effective
      in the treatment of lipid disorders in obese, insulin resistant subjects.
    

Detailed description: 
      Insulin resistance is a heterogeneous metabolic disorder of complex etiology. It underpins
      dyslipoproteinemia, a key feature of the metabolic syndrome (MetS) that independently
      predicts cardiovascular disease (CVD). Hypertriglyceridemia, the most consistent lipid
      disorder in subjects with obesity and type 2 diabetes mellitus, is chiefly a consequence of
      overproduction and delayed clearance of triglyceride-rich lipoproteins (TRLs). Although the
      precise mechanisms involved are incompletely understood, experimental and clinical evidence
      suggests that elevated apolipoprotein (apo) C-III may play a crucial role in the
      dysregulation of TRL metabolism. investigating the effects of these agents on VLDL-apoC-III
      kinetics. In this study, we aimed to examine the effect of two lipid-regulating agents,
      atorvastatin and fenofibrate on VLDL-apoC-III transport. We hypothesized that atorvastatin
      and fenofibrate would have similar effects on apoC-III transport by decreasing the production
      and increasing the catabolism of VLDL-apoC-III.
    

Intervention name(s): Atorvastatin and fenofibrate
Intervention type(s): Drug
Intervention description(s): atorvastatin (40mg/day) fenofibrate (200mg/day)
Other intervention name(s): Lipitor; Lofibra
Intervention MeSH terms: Atorvastatin; Fenofibrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Interstitial Cystitis and Urinary pH
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Study type: Observational

Summary: 
      This is a pilot study to assess the correlation between urinary pH and Interstitial Cystitis
      (IC) pain, with emphasis placed on exploring the type and severity of pain.
    

Detailed description: 
      Subjects who agree to participate in the study will meet with a research team member who will
      review the study with them, obtain informed consent sign the HIPPA form, and provide study
      materials (void diary for urine quantification and recording of IC symptoms, pH strips to dip
      urine, "hat" to measure urine). Medical charts will be reviewed to determined how
      Interstitial Cystitis was diagnosed, medications, medical/surgical history, and demographics
      such as weight, height, BMI, race, age, marital status, education, insurance, tobacco or
      alcohol use. Subjects will need to dip pH paper into the urine and specific gravity reagent
      strip, and, by color comparison between the strips and the corresponding scales, determine
      and record urine pH and specific gravity. They will need to fill out the corresponding
      section in the voiding diary that is a survey to type and severity or pain as well as other
      symptoms of IC. The research team member will teach the subject how to measure the volume of
      their urine and how to measure and record specific gravity and pH. When not practical to
      record the volume of the urine (when patients are at work or away from home) they will still
      be asked to record pH, specific gravity and experienced symptoms. Subjects will be asked to
      perform the above described protocol with each episode of micturition for 3 days.

      After enrollment, subjects will complete the O'Leary-Sant pain (symptom and problem index)
      questionnaire, if subjects have a combined score greater than or equal to 12 they are
      considered to have problematic or symptomatic IC. The voiding diary that include pH and
      specific gravity measurement measurements, times, volume, and survey of symptoms will be
      returned 1-2 weeks following completion of 3 day void diary for a face-to-face meeting with a
      research team member. Attempts will be made to have those meetings coincide with a clinical
      visit to minimize study burden to the subject(e.g. - at the time of cystoscopy or follow-up
      visit. )
    

Intervention name(s): Pain and Urinary pH
Intervention type(s): Other
Intervention description(s): assess the correlation between urinary pH and Interstitial Cystitis (IC) pain, with emphasis placed on exploring the type and severity of pain
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women with symptomatic diagnosed Interstitial Cystitis
Pharmacokinetic Equivalence and Safety Study of RPH-001 and Avastin®
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to confirm pharmacokinetic equivalence and compare clinical
      safety profile of RPH-001 and Avastin®.
    

Detailed description: 
      The study will be conducted in one specialized clinical site in Russia. It is planned to
      randomize 80 healthy male volunteers in this study. After screening period, not exceeding 15
      days, all eligible subjects will be hospitalized to the site and randomized to receive
      RPH-001 or Avastin in 1:1 ratio. After a single-dose of investigational drugs administration
      subjects will remain under the observation in clinical site for 8 days and then will be
      discharged. The out-patient follow up period will include at least 8 scheduled subject's
      visits to the site. The study will consider completed for each subject at Day 100 visit after
      all clinical study procedures completion.
    

Intervention name(s): RPH-001; Avastin
Intervention type(s): Biological; Biological
Intervention description(s): Concentrate for preparation solution for infusion in ampules, 25 mg/mL; Concentrate for preparation solution for infusion in ampules, 25 mg/mL
Other intervention name(s): Bevacizumab; Bevacizumab
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bevacizumab; oncology; VEGF receptor
Vaccine Therapy in Treating Patients With Metastatic Melanoma Who Are Undergoing Surgery for Lymph Node and Tumor Removal
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Vaccines made from a person's white blood cells and melanoma cells may make the
      body build an immune response and kill the tumor cells.

      PURPOSE: Randomized phase I/II trial to study the effectiveness of vaccine therapy made from
      white blood cells and melanoma cells in treating patients with metastatic melanoma who are
      undergoing surgery for lymph node and tumor removal.
    

Detailed description: 
      OBJECTIVES: I. Determine the safety and toxicity of intravenous injections of autologous
      cultured dendritic cells pulsed with either gp100 and tyrosinase peptides or autologous
      melanoma tumor cell lysates in patients with metastatic melanoma. II. Determine whether
      treatment with melanoma tumor antigen pulsed autologous dendritic cells results in increased
      in vitro tumor specific cytotoxic T-cell responses. III. Determine whether this treatment can
      induce positive skin test responses to tumor antigens. IV. Evaluate the disease free and
      overall survival of these patients.

      OUTLINE: This is a randomized, dose escalation study. Approximately 1-2 weeks following
      surgical lymphadenectomy, patients undergo leukapheresis to collect dendritic cells and are
      then divided into 3 groups. Group A consists of patients without adequate tumor for
      preparation of tumor lysate and who have tumors that express tyrosinase or gp100 with types
      HLA-A1, A2, or A3. Group B consists of the patients who have adequate tumor for lysate
      preparation but who do not type for HLA-A1, A2, or A3 (required for the peptide pulsed
      protocol). Group C are the patients with adequate tumor who are eligible for the peptide
      pulsed protocol. Group A patients receive autologous dendritic cells pulsed with appropriate
      peptide antigens. Group B patients are treated with autologous dendritic cells pulsed with
      autologous tumor cell lysates. Group C patients are randomized to receive dendritic cells
      pulsed with either peptide antigens or tumor lysate. All patients are administered
      intravenous active immunotherapy for 4 monthly intervals. The dose of the immunizations is
      escalated for each cohort of three patients that is accrued in each of the groups mentioned
      above. Each immunization at each dose level is followed by three days of interleukin-2
      administered subcutaneously twice daily. Patients are followed at least 5 years for survival.

      PROJECTED ACCRUAL: There will be 100 patients accrued in this study over 2 years. There will
      be 50, 20, and 30 patients in groups A, B, and C, respectively.
    

Intervention name(s): aldesleukin; gp100 antigen; tyrosinase peptide
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: Aldesleukin
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage IV melanoma; recurrent melanoma
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK001
Condition: Atopy
Study type: Interventional
Phase: Phase 1

Summary: 
      This first-in-human study will evaluate the safety and tolerability of single doses of AK001
      across a range of potentially active doses. Early signals of pharmacodynamic activity will
      also be evaluated.
    

Detailed description: 
      AK001 is a monoclonal antibody which may be useful in the treatment of patients with severe
      allergic diseases.
    

Intervention name(s): AK001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Given parenterally.
Other intervention name(s): Saline solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Visceral Manipulation Treatment to Patients With Non-specific Neck Pain With Functional Dyspepsia
Condition: Neck Pain; Functional Dyspepsia
MeSH terms: Neck Pain; Dyspepsia
Study type: Interventional

Summary: 
      Background: Non-specific neck pain (NS-NP) is characterized by pain in structures located in
      the region between the superior nuchal line and the spinal process of the first thoracic
      vertebra, without association with any specific systemic disease provided by multifactorial
      and/or little known causes.

      Objective: The objective of the present study will be to verify the clinical effects of MV
      through visceral nociceptive inhibition in NS-NP patients with functional dyspepsia.

      Methods: In this study sixty NS-NP patients with functional dyspepsia (age: 18 and 50 years)
      will be randomized in into two groups: visceral manipulation group (VMG) (n =30) and control
      group (CG) (n =30). The VMG will be treated with visceral manipulation to the stomach and
      liver wile CG received placebo treatment. The immediate effects and 7 days after treatment
      will be evaluated through pain, cervical range, and electromyographic activity of the upper
      trapezius.
    


Intervention name(s): Visceral manipulation; Control group (CG)
Intervention type(s): Other; Other
Intervention description(s): Participants will be instructed to lie down comfortably on a stretcher in the supine position, with lower limbs flexed and abdomen exposed, and the physiotherapist positioned to the right side of the patient. The therapeutic intervention will be began with the left hand of the physiotherapist in contact with the lower region of the stomach, to which a force will be applied so that the organ was moved in an upper and lateral left direction while the right hand controlled and directed the knees of the patient to the right side until the moment when the physiotherapist notice an increase in tension in the stomach region. For the liver manipulation, the same procedures will be followed, however, with contact in the right epigastric region and the knees directed to the left side. The same position will be maintained for each organ treated until the physiotherapist could feel, through touch, a decrease in the tension of the viscera. The mean treatment time will 5 minutes.; The CG will be received placebo treatment. In the placebo treatment, the therapist should place the hands over the navel region without exerting any local tension for 1 minute.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double-blinded, sham-controlled, study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neck pain; visceral manipulation; functional dyspepsia; electromyography; pain
Octreotide in Severe Polycystic Liver Disease
Condition: Polycystic Kidney, Autosomal Dominant; Polycystic Liver Disease; Hepatomegaly; Liver Diseases; Kidney, Polycystic; Abdominal Pain
MeSH terms: Cysts; Liver Diseases; Hepatomegaly; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant; Abdominal Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will evaluate the effect of Octreotide LAR® on the liver volumes of patients with
      severe polycystic liver disease who are not candidates or decline surgical treatments such as
      liver cyst fenestration, liver resection or liver transplantation. A total of 42 patients
      will be recruited -14 who will receive placebo and 28 the study drug. Preliminary evidence
      indicates that this drug is safe and non-toxic in other disease states. Treatment with this
      drug holds promise not only for individuals with liver involvement, but also for many more
      patients with polycystic kidney disease.
    

Detailed description: 
      The primary aim of this study is to compare the effect of Octreotide LAR® Depot on the liver
      volume of patients with severe polycystic liver disease who are not candidates or decline
      surgical treatments such as liver cyst fenestration, liver resection or liver transplantation
      compared with placebo. The secondary aims of the study are: (1)Assess the effect of
      Octreotide LAR® Depot on the total kidney volume and iothalamate clearance in patients with
      polycystic kidney disease associated with severe polycystic liver disease who are not
      candidates or decline surgical treatments such as liver cyst fenestration, liver resection or
      liver transplantation. (2)Evaluate quality of life changes associated with the administration
      of Octreotide LAR® Depot in these patients. (3)Assess toxicity of Octreotide LAR® Depot in
      patients with polycystic liver disease (PLD).

      Note: Subjects who completed this 1 year randomized trial were offered enrollment into an
      open-label (all subjects received Octreotide) extension trial for an additional two years of
      treatment.
    

Intervention name(s): Octreotide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants received Octreotide LAR® Depot injections (up to 40 mg)intramuscularly every 28 days (+/- 5 days) for one year; Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
Other intervention name(s): Octreotide LAR® Depot; Placebo injection
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pharmacokinetics of Rifabutin Combined With Antiretroviral Therapy in Patients With TB/HIV Co-infection in Vietnam
Condition: HIV Infections; Tuberculosis
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall aim of the project is to evaluate rifabutin (RBT) as a replacement for rifampicin
      (RMP), for the combined treatment of tuberculosis and HIV infection. RBT represents an
      alternative to RMP for HIV infected patients as its half-life is longer and the enzymatic
      induction effect appears to be less important on the associated antiretroviral therapy (ART)
      drugs.

      This phase II trial is to determine precisely the pharmacokinetics parameters of RBT in
      combination with different ART regimens in Vietnamese HIV infected patients with pulmonary
      tuberculosis, in order to define optimal doses that will be further tested in a larger phase
      III trial comparing safety, tolerability and efficacy of RBT and RMP regimens.
    

Detailed description: 
      Patients will be offered to participated in the study when they start TB treatment. All the
      enrolled patients will immediately be switched to rifabutin and randomized, to one of the RBT
      doses that will be then adapted to the allocated RBT regimen according to a cross over
      scheme. Three full pharmacokinetics profile will be performed at different time point :
      before initiation of ARV, after three weeks of the first RBT dosage and after three weeks of
      the secondRBT dosage. Patients will then be referred to the national program for further
      treatment. A follow-up visit will be planned at the end of the antiTB treatment.
    

Intervention name(s): rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 1; rifabutin in combination with lopinavir boosted by ritonavir - dosing schedule 2
Intervention type(s): Drug; Drug
Intervention description(s): 3TC(300mg)/D4t(60mg)/LPV/r(800mg/200mg)+INH/PZA/EMT/Rifabutin(150 mg TPW 3 wks switch to 150 mg OD 4 wks);; 3TC(300mg)/D4t(60mg)/LPV/r(800mg/200mg)+INH/PZA/EMT/Rifabutin(150 mg OD 3 wks switch to 150 mg TPW 4 wks);
Intervention MeSH terms: Ritonavir; Lopinavir; Rifabutin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Tuberculosis; Rifabutin; Pharmacokinetics; Vietnam
Evaluation of Preoperative N1539 in Colorectal Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of
      preoperative dosing of N1539 30 mg in subjects undergoing colorectal surgery, including
      clinical laboratory tests, wound healing evaluation, incidence of anastomotic leaks, and
      incidence of Adverse Events (AEs) and Serious AEs (SAEs).
    


Intervention name(s): N1539; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once Daily; Once Daily
Other intervention name(s): Intravenous meloxicam; Intravenous placebo
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Colorectal surgery; Pain; Analgesia; N1539; Phase 3b