bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Guanfacine and Lidocaine Combination in Trigeminal Nerve Block for Pain Management in Trigeminal Neuropathy
Condition: Trigeminal Neuralgia
MeSH terms: Trigeminal Neuralgia; Trigeminal Nerve Diseases; Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      A phenome-wide association study (PheWAS) identified an association between a loss of
      function variant in the human alpha 2B adrenergic receptor gene and trigeminal nerve
      disorders. Guanfacine is the oldest alpha-2 adrenergic agonist in clinical use and is
      approved for hypertension and attention deficit hyperactivity disorder. We hypothesize that
      guanfacine will be an effective adjunct to lidocaine for the treatment of neuropathic pain by
      enhancing and prolonging pain relief due to its activation of alpha-2 adrenergic receptors.
      The objectives of the study will be to evaluate the efficacy and safety of guanfacine in
      combination with lidocaine for trigeminal nerve block procedures for pain management in
      trigeminal neuralgia patients. This study will evaluate the efficacy of guanfacine in
      reducing acute pain and extending duration of pain relief when delivered in combination with
      lidocaine as a trigeminal nerve block, measured by Visual Analog Scale (VAS) data collected
      at specific time points after each injection.
    


Intervention name(s): Lidocaine; Guanfacine
Intervention type(s): Drug; Drug
Intervention description(s): 6 mL of 1% lidocaine; 250 mcg
Other intervention name(s): Xylocaine
Intervention MeSH terms: Lidocaine; Guanfacine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Previous Abdominal Surgery and Obesity Does Not Affect Unfavorably the Outcome of Total Laparoscopic Hysterectomy
Condition: Laparoscopic Surgical Procedure; Obesity; Surgery--Complications
MeSH terms: Obesity
Study type: Observational

Summary: 
      Previous surgery and obesity has disputed as an unfavorable factor during Total Laparoscopic
      Hysterectomy. The aim of the investigator's study was to assess the effects of previous
      abdominal surgery and obesity on intra-operative and post-operative outcomes of TLH.
    

Detailed description: 
      Abstract:

      Objective: To assess the effects of previous abdominal surgery and obesity on the
      intra-operative and post-operative outcomes of total laparoscopic hysterectomy (TLH).

      Method: In this retrospective cohort study, women who underwent TLH for benign conditions
      between January 2011 and December 2016 in tertiary academic center were included. Patients
      were grouped according to previous abdominal surgery. The study group consisted of patients
      who had at least one previous abdominal surgery and the control group consisted of patients
      with no previous abdominal surgery. In a further analysis, a subgroup of obese patients with
      BMI (body mass index) ≥30 kg/m2 was evaluated. For this analysis, the obese patients who
      underwent TLH were picked up and the results were compared to the results of obese patients
      who underwent total abdominal hysterectomy (TAH) during the same time period. The main
      outcome parameters were duration of hospital stay and major complication rate.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All women who underwent TLH for benign conditions
      
Keywords: Complication; Previous surgery; Total laparoscopic hysterectomy; Obesity
An Extension Study to Demonstrate the Equivalence of Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, single-arm, multicenter, multiple single-dose intravenous (IV) infusion,
      efficacy, and safety extension study of the Phase 1 Study CT-P13 1.1 is designed to assess
      the long-term efficacy and safety of multiple doses of CT-P13.
    


Intervention name(s): Infliximab
Intervention type(s): Biological
Intervention description(s): CT-P13 (5mg/kg) administered as a 2-hour IV infusion per dose
Intervention MeSH terms: Infliximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AS; Biosimilar
A Comparative Study on Local Allergic Responses of Bee Venom and Essential Bee Venom Pharmacopuncture
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This double-blinded randomized clinical trial investigates any differences in allergic
      responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV).
    

Detailed description: 
      This double-blinded randomized clinical trial investigates difference in allergic responses
      elicited by Bee Venom (BV) and Essential Bee Venom (eBV). Twenty healthy volunteers aged
      20-40 years were randomly allocated to the 2 groups and administered eBV and BV on left and
      right forearm, respectively, in accordance with group allocation. Physician, participant, and
      outcome assessor were blinded to group allocation. Local pain, swelling, itching, redness,
      wheals and adverse reactions were recorded by timepoint before and after treatment.
    

Intervention name(s): Bee Venom (BV); Essential Bee Venom (e-BV)
Intervention type(s): Drug; Drug
Intervention description(s): Raw Bee Venom; Bee venom without Hyaluronidase, Lysophospholipase, α-D-glucosidase, PLA2, Adolapin
Other intervention name(s): Bee Venom pharmacopuncture; Bee Venom injection; Essential Bee Venom pharmacopuncture; Essential Bee Venom injection
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Single and Multiple Doses of Linagliptin Tablets in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study was to assess the effect of normal and impaired renal
      function on the safety, pharmacokinetics, and pharmacodynamics of linagliptin following oral
      administration of 5 mg daily for 7 days (Groups 1 to 3), 5 mg daily for 10 days (Groups 6 and
      7), or as a single dose (Groups 4 and 5)
    


Intervention name(s): Linagliptin - single dose; Linagliptin - Multiple dose
Intervention type(s): Drug; Drug
Intervention MeSH terms: Linagliptin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mesothelioma Avastin Plus Pemetrexed-cisplatin Study
Condition: Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of
      MPM will improve overall survival and quality of life beyond that achieved with chemotherapy
      alone.
    

Detailed description: 
      A phase II trial associating the reference chemotherapy (pemetrexed plus cisplatin) with
      bevacizumab is needed to ensure that no specific toxicity is induced by this association, and
      that this triplet have interesting activity. As pleural mesothélioma is a rare tumor, a phase
      III trial, using the survival data from the phase II part study, will be able to include a
      sufficient number of patients, in a reasonable period of time, to answer the question of
      efficacy of the anti-angiogenic triplet, providing the efficacy outcomes could be considered
      as favorable, at the end of the phase II part of the study.
    

Intervention name(s): Standard Chemotherapy (Pemetrexed and Cisplatin); Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab
Intervention type(s): Drug; Drug
Intervention description(s): Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation Day 1 (D1=D22, 6 cycles)
Cisplatin 75 mg/m² Day 1 (D1=D22, 6 cycles); Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation D1 (D1=D22, 6 cycles)
Cisplatin 75 mg/m2 D1 (D1=D22, 6 cycles)
Bevacizumab 15 mg/kg D1 (D1=D22, until progression)
Intervention MeSH terms: Bevacizumab; Cisplatin; Pemetrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Stress Reduction During In Vitro Fertilization
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The goal of this study is to determine the effect of Healing Touch (HT) on the stress,
      anxiety, and self-efficacy experiences of women undergoing in vitro fertilization (IVF) in a
      randomized, controlled design. HT is a gentle, non-invasive form of energy-balancing work
      that promotes relaxation.
    

Detailed description: 
      Once enrolled, each participant will be randomized to one of three groups: the Healing Touch
      (HT) treatment arm, the Desensitization Therapy (DT) arm, or the no-intervention arm.

      Subjects in Group 1 will receive three, 45-minute HT sessions during the first two weeks of
      their IVF cycle prior to oocyte retrieval. Group 2 will receive three, 45-minute DT sessions
      during the first two weeks of their IVF cycle prior to oocyte retrieval. Group 3 will receive
      no intervention. Subjects in Group 3 will be offered two HT sessions after completing study
      participation.

      All subjects and their partners will be asked to complete the Spielberger State Trait Anxiety
      Inventory (STAI), the Perceived Stress Scale (PSS) and the Infertility Self-Efficacy Scale
      (ISES) at three time points: 1) baseline 2) one day prior to oocyte retrieval and 3) 5-7 days
      post embryo transfer. In addition, subjects in all groups will complete a short pre-study
      questionnaire to assess expectation of therapeutic effect, and subjects in the two
      intervention groups will complete a short post-study questionnaire to evaluate their
      treatment experience. Demographic and pregnancy outcome data will be collected for all
      subjects.
    

Intervention name(s): Healing Touch; Desensitization Therapy
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Parietex Progrip Study
Condition: Hernia, Inguinal
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the study is to evaluate pain and disabling complications inducing social
      consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair
      with lightweight polypropylene mesh.
    

Detailed description: 
      -  Patients in ProGrip group will be treated with self-gripping lightweight Polyester and
           Polylactic acid meshes providing a sutureless fixation.

        -  Patients in Lichtenstein group will be treated with lightweight Polypropylene meshes
           requiring fixation by sutures.

        -  Study participation will start at signature of informed consent and each patient will be
           assessed before surgery. A close follow-up will be performed: 7 days (questionnaires and
           phone call), 1 month (clinical visit), 3 months (questionnaires and phone call), and
           final evaluation at 12 months (clinical visit) after surgery, which will end the
           participation to the study.

        -  600 adult males divided in 2 groups requiring primary uncomplicated elective inguinal
           hernia mesh repair will be included in the study. Patients will be stratified by center.
    

Intervention name(s): Parietex Progrip; Low weight polypropylene mesh
Intervention type(s): Device; Device
Intervention description(s): Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.; Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Uncomplicated primary inguinal hernias
Effect of Rosiglitazone on Myocardial Blood Flow Regulation in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The overall hypothesis to be tested is that increased insulin resistance contributes to
      abnormal cardiac blood flow regulation in type 2 diabetic patients, which can be reversed by
      6 months treatment with rosiglitazone. The planned experimental approach will be to utilize
      nuclear medicine techniques to evaluate whether the administration of rosiglitazone for 6
      months can reverse regional deficits in myocardial blood flow and glucose utilization in type
      2 diabetes in a randomized double blind controlled study. These studies will help elucidate
      the potential of rosiglitazone to correct deficits of myocardial blood flow complicating
      diabetes with the overall aim being the eventual prevention of sudden cardiac death.
    


Intervention name(s): Rosiglitazone; Glyburide
Intervention type(s): Drug; Drug
Intervention description(s): oral 8 mg/once daily for 6 months; 20 mg/ once daily for 6 months
Intervention MeSH terms: Rosiglitazone; Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: insulin resistance; type 2 diabetes; myocardial perfusion; nitrosative stress; thiazolidinediones
Risperidone and Divalproex Sodium With MRI Assessment in Pediatric Bipolar
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is to examine the null hypothesis that risperidone and divalproex sodium are
      equally effective in treating/stabilizing pediatric bipolar disorder.
    

Detailed description: 
      Pediatric Bipolar Disorder (PBD) severely impairs a child's emotional development, and is
      associated with alarming rates of suicide, school failure, aggression, risk taking behaviors
      and substance abuse (Geller et al, 1998; 2001; Carlson et al, 1998). At present, very little
      is known about the pathophysiology or optimal treatment of PBD. The long range goals of this
      proposal are threefold: to investigate a range of pharmacotherapeutic agents that are safe
      and efficacious for PBD, to use fMRI techniques to examine abnormalities in brain function in
      this disorder, as well as any change in brain function after treatment.

      In contrast to the adult literature, we are aware of only two prospective studies assessing
      the efficacy of standard mood stabilizers in a pediatric sample. In one, lithium was found to
      be moderately effective in PBD with comorbid substance abuse (Geller et al, 1998). In the
      other, divalproex sodium, lithium and carbamazepine produced a maximum of 50% symptom
      reduction (Kowatch et al, 2000). Subsequently, Kafantaris et al (2001) observed a
      potentiation of lithium's antimanic effect when combined with risperidone. Further, a
      prospective, open trial of olanzapine for PBD reported a 70% symptom reduction (Frazier et
      al, 2001) with a retention rate of 96% compared to only 7% with classic mood stabilizers
      (Kowatch et al, 2000).

      Thus, parallelling adult studies (Sachs et al, 2000), novel antipsychotics are a promising
      treatment in this population. Further, up to 60% of acute PBD episodes present with psychotic
      features (Geller et al, in press). Finally, the time to full effect with mood stabilizers is
      often 4 weeks in children (Kowatch et al, 2000; Geller et al, 1998; Kafantaris et al, 2001),
      whereas antipsychotics usually have a more rapid response onset (Pavuluri et al, in press).
      Given the potential efficacy of novel antipsychotics for PBD, the aim is to conduct a
      randomized trial comparing a novel antipsychotic to a standard mood stabilizer:
    

Intervention name(s): Divalproex Sodium; risperidone
Intervention type(s): Drug; Drug
Intervention description(s): Divalproex sodium is a mood stabilizer; Risperidone is a second generation antipsychotic and antimanic drug
Other intervention name(s): antiepileptic; valproic acid; antipsychotic; risperdal
Intervention MeSH terms: Valproic Acid; Anticonvulsants; Risperidone; Antipsychotic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Pharmacogenomics of Contraception: Genetic Variants and Etonogestrel Pharmacokinetics
Condition: Contraception
Study type: Observational

Summary: 
      The proposed study will investigate the relationship between genetic variants and serum
      contraceptive hormone levels, specifically the progestin etonogestrel. This study will
      provide the foundation for future pharmacogenomic investigations of more commonly used
      contraceptive methods with higher failure rates.
    

Detailed description: 
      Approximately 700 reproductive age women (18-45) with an Etonogestrel (ENG) contraceptive
      implant in place for more than 1 year will be enrolled. Participants will undergo a blood
      draw for measurement of ENG concentration (serum) and genotyping (whole blood) and complete a
      questionnaire regarding their demographics and contraceptive, gynecological, and obstetrical
      history. The research investigators will also consent participants for use of their genetic
      samples and clinical data in future unspecified research.

      The serum samples will be de-identified for ENG analysis, which will be done using a liquid
      chromatography-mass spectrometry method. Additional whole blood samples collected at the
      enrollment visit will undergo DNA extraction. A candidate gene study was conducted using the
      first 350 participants. The research investigators selected 120 genetic variants for 14
      target genes involved in progestin metabolism, regulation, and function for this candidate
      gene study. A Genome Wide Association Study will be performed using all 700 participants.
      Genotyping will be performed using a custom MultiEthnic Global Array chip through the
      Colorado Center for Personalized Medicine.
    

Intervention name(s): Blood draw
Intervention type(s): Procedure
Intervention description(s): The Investigators will collect serum and whole blood from participants.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        We will enroll 900 women of reproductive age (18-45 years) who have had an ENG
        contraceptive implant in place for 12-36 months.
      
Biospecimen description: 
      Whole blood samples will be collected at the enrollment visit and will undergo DNA extraction
      using commercial Qiagen® kits in Dr. Christina Aquilante's laboratory.
Photodynamic Therapy (PDT) Effect on Large Surface Photodamaged Skin
Condition: Actinic Keratosis; Photoaging; Solar Elastosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional

Summary: 
      In this study, 26 patients were selected and included for full-face photodynamic therapy
      sessions. All patients presented signs of photoaging skin and multiple actinic keratosis.
      Photographs and Biopsies were taken before and after the procedure. Clinical and histological
      aspects as well as immunohistochemical aspects regarding neocollagen induction and tumor
      expression were evaluated.
    

Detailed description: 
      Study design:

      Patients and methods:

      26 patients (16 females, 8 males) age 35-90 years, mean 59,4 y Skin types I-IV, severely
      photodamaged facial skin Multiples Aks on the face ( total 268) minimum of 3 per patient
      Approved by local ethical committee and informed consent given

      Treatment procedure:

      Prior curettage Full-face MAL application ( Metvix ®, Galderma France) 1,5 tube per treatment
      Incubation time 3 hs - in the first treatment session; and 1,5 h - in the 2 nd and 3 rd
      sessions Illumination LED (Aktilite® Photocure, Norway) 635 nm 37 J/cm2 3 treatments
      performed, one month apart Pain monitoring: forced air cooling device

      Evaluation:

      Clinical - 5 point scale based on Dover's and Zane's studies Dover JS et al. Topical ALA
      combined with IPL in photoaging. Arch Dermatol 2005; 141: 1247-52 Zane et al. Clinical and
      echographical analysis of MAL- PDT in photodamaged skin. Laser Surg Med 2007; 39: 203-9

      Histological - Hematoxilin- Eosin staining

      Immunohistochemical study- HP 53, Metalloproteinases, Procollagen I,
    

Intervention name(s): Methylaminolevulinate - photodynamic therapy
Intervention type(s): Other
Intervention description(s): Methylaminolevulinate cream 16% applied for 3 hours under occlusion on the face and then illuminated with red LED device
Intervention MeSH terms: Methyl 5-aminolevulinate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness Study of a Computer-Based Colorectal Cancer Screening Decision Aid
Condition: Colorectal Cancer; Health Literacy
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a multimedia educational computer program
      can increase colorectal cancer screening rates in low and adequate literacy patients.
    

Detailed description: 
      Results will be stratified by low/marginal and adequate literacy as determined by the Rapid
      Estimate of Adult Literacy in Medicine instrument.
    

Intervention name(s): CHOICE decision aid; YourMeds patient education program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): computer-based patient decision aid about colorectal cancer screening delivered immediately before a healthcare provider visit; computer-based patient education program about prescription drug safety seen immediately before a healthcare provider visit
Other intervention name(s): CHOICE; YourMeds
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Colorectal cancer; Screening; Health literacy; Patient education; Computer assisted instruction