bioihbjkbjnl/mcl2 huggingface dataset:
Patient Expectations and Dry Needling
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Dry needling (DN) is a treatment technique used for treating musculoskeletal pain conditions.
      DN has shown to be effective on pain and function in patients with mechanical neck pain.
      Potential effects of DN can be related to several mechanisms, including physical, cognitive
      and emotional factors. This study will evaluate the role of the patient expectances related
      to the evolution (progress) of the condition, in this case, mechanical neck pain, in the
      effects of real or sham dry needling in sensitivity outcomes such as pain intensity or
      pressure pain sensitivity. Expectation of each patient in both groups will be considered
      positive, neutral or negative based on the outcomes of the Patient Shoulder Expectancies
      (PSOE) questionnaire which was adapted to the cervical spine.
    


Intervention name(s): Dry Needling; Sham Needling
Intervention type(s): Device; Device
Intervention description(s): Real dry needling will be conducted according to the fast-in and fast-out principle. The intervention will be applied until a total of four local twitch responses will be elicited; Sham dry needling with be conducted with a sham needle device. This needle has a blunt tip and retractable handle that created the illusion of a needle penetrating the skin. When this needle touches the skin, a pricking sensation will be created. However, when pressure will be increased, the shaft of the needle disappears into the handle creating a sensation on the patient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neck Pain; Needling; Expectance
The Effect of Low Dose Ketamine on Narcotic Consumption in Patients Undergoing Laparoscopic Cholecystectomy
Condition: Cholelithiasis
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones
Study type: Interventional

Summary: 
      This double-blinded randomized control trial aims to analyze the effect of low dose Ketamine
      on narcotic consumption, in patients undergoing Laparoscopic cholecystectomy.
    


Intervention name(s): Ketamine Hydrochloride
Intervention type(s): Drug
Intervention description(s): Ketamine was given prior to wound closure.
Other intervention name(s): ketasol
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized control trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study of Multiple Doses of HM15211 in Obese Subjects With NAFLD
Condition: NAFLD
MeSH terms: Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a phase 1 study to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of multiple doses of HM15211 in obese subjects with NAFLD
    


Intervention name(s): HM15211; Placebo of HM15211
Intervention type(s): Drug; Drug
Intervention description(s): A sterile solution of HM15211 contained in pre-filled syringes; A sterile, matching solution in pre-filled syringes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Acute Effects of Propylene Glycol/Glycerol Intake on Blood Parameters
Condition: Metabolic Complication
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the acute effect of propylene glycol and glycerol intake
      on cardiorespiratory blood parameters.
    

Detailed description: 
      Background : Propylene glycol/glycerol intake is increasingly popular. Acute effect of
      propylene glycol and glycerol intake on cardiorespiratory blood parameters is unknown. The
      investigators postulate that intake of propylene glycol and glycerol could modifiy
      cardiorespiratory blood parameters.

      Aims of this study : to test the following hypotheses :

      1) Acute intake of propylene glycol and glycerol modifies cardiorespiratory blood parameters.

      To test this hypothesis, we will perform blood samples before and after intake of propylene
      glycol and glycerol. Participants will be tobacco smoker between 18 and 70 years old, with
      multiple cardiovascular risk factors, and who will undergo a cardiac catherization. After the
      cardiac catherization, the catheter will be used to perform serial blood samples.
    

Intervention name(s): Propylene glycol and Glycerol intake; Mimicking intake
Intervention type(s): Other; Device
Intervention description(s): Intake of 1 gram of propylene glycol/Glycerol mix (50:50). Blood sample before, 5 minutes and 20 minutes after intake.; Mimicking propylene glycol/glycerol intake with the device turns off. Blood sample before, 5 minutes and 20 minutes after intake.
Intervention MeSH terms: Glycerol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Network Dysregulation Among Individuals With Comorbid Tinnitus and PTSD
Condition: Stress Disorders, Post-Traumatic; Tinnitus
MeSH terms: Tinnitus; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Evaluation of the overlap between tinnitus-related distress and symptoms of Post Traumatic
      Stress Disorder (PTSD), to identify functional covariance among resting-state networks among
      individuals with tinnitus and PTSD
    

Detailed description: 
      The purpose of this study is to characterize tinnitus and PTSD symptomatically,
      neurobiologically, and causally, applying causal modeling to psychometric and neurofunctional
      data. We will enroll 30 individuals with both tinnitus and PTSD. Participants will be asked
      to complete baseline assessments of subjective tinnitus distress, PTSD, depression, and
      resting-state fMRI at baseline. Individuals with comorbid tinnitus and PTSD who are eligible
      for the study will receive 12 sessions of Cognitive Processing Therapy (CPT) over a 6- to
      15-week period. CPT is a trauma-focused treatment for PTSD that guides individuals on how to
      recognize and challenge thoughts that are erroneous and dysfunctional. One-month follow-up
      assessments of tinnitus-related distress, PTSD, depression, and anxiety will be conducted,
      along with resting-state functional magnetic resonance imaging (fMRI).
    

Intervention name(s): Cognitive Processing Therapy (CPT)
Intervention type(s): Behavioral
Intervention description(s): CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions. CPT is delivered in three phases: education, processing, and challenging.
Other intervention name(s): CPT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety of a Herpes Simplex Candidate Vaccine (gD2t) With MPL and Its Efficacy to Prevent Genital Herpes Disease
Condition: Herpes Simplex
MeSH terms: Herpes Simplex; Herpes Genitalis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the safety of Herpes Simplex candidate vaccine (gD2t)
      with adjuvant and its efficacy to prevent genital herpes disease in HSV positive or negative
      consorts of subjects with genital herpes disease.
    

Detailed description: 
      This study was monitored by a Data Safety Monitoring Board At the time of conduct of this
      study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
    

Intervention name(s): Herpes simplex candidate vaccine- adjuvanted GSK208141; Placebo injection
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, 3 doses; Intramuscular injection, 3 doses
Other intervention name(s): Herpes simplex candidate vaccine- adjuvanted GSK208141
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Herpes simplex candidate vaccine; Herpes simplex
Ultrasound B Mode Imaging and Elastography
Condition: Dupuytren's Contractures
MeSH terms: Dupuytren Contracture; Contracture
Study type: Observational

Summary: 
      A Pilot Study on Ultrasound B mode Imaging and Elastography during administration of Xiaflex
      (collagenase clostridium histolyticum) for Dupuytren's contracture.
    

Detailed description: 
      Ultrasound analysis will be obtained on patient that receives Xiaflex as standard of care for
      Dupuytren's contracture
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Three groups of people will take part in the research:

        5-Normal subjects without a Dupuytren's contracture 5-Subjects that have a hand Dupuytren's
        contracture that will not receive tx 10-Subjects that have a hand Dupuytren's contracture
        that will receive tx
Study of Na-APR-1 (M74)/Alhydrogel® Co-administered With Na-GST-1/Alhydrogel in Brazilian Adults
Condition: Hookworm Infection; Hookworm Disease
MeSH terms: Hookworm Infections; Ancylostomiasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Na-GST-1 and Na-APR-1 are proteins expressed during the adult stage of the Necator americanus
      hookworm life cycle that are thought to play a role in the parasite's degradation of host
      hemoglobin for use as an energy source. Vaccination wtih recombinant GST-1 or APR-1 has
      protected dogs and hamsters from infection in challenge studies. This study will evaluate the
      safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy Brazilian
      adults living in an area of endemic hookworm infection.
    

Detailed description: 
      Double blind, randomized, controlled, dose-escalation Phase 1 clinical trial in hookworm
      exposed adults living in the area of Americaninhas, Minas Gerais, Brazil. Subjects will
      receive three doses of the assigned vaccine delivered intramuscularly on approximately Days
      0, 56, and 112.

      Safety will be measured from the time of each study vaccination (Day 0) through 14 days after
      each study vaccination by the occurrence of solicited injection site and systemic
      reactogenicity events.

      Unsolicited non-serious adverse events (AEs) will be collected from the time of the first
      study vaccination through approximately 1 month after each study vaccination. New-onset
      chronic medical conditions and Serious Adverse Events (SAEs) will be collected from the time
      of the first study vaccination through approximately 9 months after the third study
      vaccination (final visit). Clinical laboratory evaluations for safety will be performed on
      venous blood collected approximately 14 days after each vaccination.

      Immunogenicity testing will include IgG antibody responses to each vaccine antigen, by an
      indirect enzyme-linked immunosorbent assay (ELISA) and also by ImmunoCAP, on serum obtained
      prior to each study vaccination and at time points after each vaccination; antibody affinity
      by Surface Plasmon Resonance; functional activity of vaccine-induced antibodies via in vitro
      enzyme neutralization assays; and, antigen-specific memory B cell responses.

      Recruitment and enrollment into the study will occur on an ongoing basis, with each group
      being recruited and vaccinated in sequence.

      60 subjects will be enrolled into 6 groups of 10.
    

Intervention name(s): Na-GST-1/Alhydrogel plus GLA-AF; Na-APR-1 (M74)/Alhydrogel; Na-APR-1 (M74)/Alhydrogel plus GLA-AF; Sterile Saline Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hookworm Vaccine; Na-APR-1 (M74)/Alhydrogel® Hookworm Vaccine; Na-GST-1/Alhydrogel® Hookworm Vaccine
Temozolomide Plus Bevacizumab in Patients With Metastatic Melanoma Involving the Central Nervous System
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This research is being done because melanoma in the brain is very difficult to treat because
      it does not respond to radiation or to chemotherapy, such as temozolomide. One of the reasons
      for this is that the melanoma can make chemicals that signal the brain to provide new blood
      vessels for the tumor. The main signal is called VEGF. Bevacizumab is an antibody that blocks
      VEGF. The investigators want to see if the combination of bevacizumab and temozolomide will
      stop the melanoma from growing.
    

Detailed description: 
      This study proposes the use of a combination of temozolomide and bevacizumab in a carefully
      selected group of patients with metastatic melanoma to the brain. This combination has been
      tested in primary brain tumors and in melanoma not involving the brain. The 6-week on, 2-week
      off low-dose schedule proposed in this trial capitalizes on preclinical data demonstrating
      that temozolomide inhibits angiogenesis at low, non-toxic doses that correspond to the plasma
      concentrations achieved by an oral administration, a so-called 'metronomic' scheduling. The
      precise mechanism of its antiangiogenic action remains to be elucidated. This potential
      synergistic mechanism, together with the bulk of evidence for activity presented above
      suggests that the combination will be well-tolerated, safe and possibly more effective.
    

Intervention name(s): Temozolomide; Bevacizumab
Intervention type(s): Drug; Drug
Intervention description(s): Temozolomide 75mg/m2 for six continuous weeks; Bevacizumab 10mg/kg every 2 weeks without interruption
Intervention MeSH terms: Bevacizumab; Temozolomide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Melanoma; Brain mets; Bevacizumab; Temozolomide; Avastin; Temodar; Melanoma with brain mets
AVAVA SR-1 Wrinkles and BPL Study
Condition: Wrinkle; Benign Pigmented Lesion
Study type: Interventional

Summary: 
      This study is being conducted to evaluate the safety and efficacy of a laser called the SR-1
      Skin Treatment System, or SR-1 Laser, for the treatment of wrinkles and pigmented spots.
      Participants will be treated with the SR-1 Laser 3 or 4 times with each treatment spaced 4-6
      weeks apart. The improvement in wrinkles and pigmented spots will be evaluated 1 and 3 months
      after the final treatment.
    


Intervention name(s): SR-1 Laser
Intervention type(s): Device
Intervention description(s): 3-4 treatments at 4-6 week intervals
Other intervention name(s): SR-1 Skin Treatment System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Survey of Body Mass Index in People With Spinal Cord Injury.
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      This study is a prospective national survey of body mass index, and includes all patients
      with a new spinal cord injury hospitalized at Clinic for Spinal Cord Injuries, Rigshospitalet
      and Spinal Cord Injury Center of Western Denmark during a period of 9 months. Informed
      consent is retrieved from all participants.
    

Detailed description: 
      The current study is a sub- study in a Ph.D project containing 4 sub- studies. The protocol
      for the current study includes all four sub- studies, and each of the other three sub-
      studies will be registered ongoing individually. The current study is a prospective national
      survey of body mass index (BMI), and includes all patients with a new spinal cord injury
      hospitalized at Clinic for Spinal Cord Injuries, Rigshospitalet (CSCI) and Spinal Cord Injury
      Center of Western Denmark during a period of 9 months whereby 100 patients are expected to
      participate. Data are collected at admission and discharge. At CSCI BMI is collected every 6
      weeks and all outcome measures will also be collected at follow up 6 months after discharge.
      A VO2peak test at discharge is performed as well, and in some participants accelerometry is
      performed in order to describe the amount and intensity of physical activity. Test- retest
      reliability of the VO2peak test and accelerometry is investigated as well. Patients with a
      new Spinal Cord Injury within the last 12 months, who are admitted for rehabilitation several
      months after the time of injury are also included in the prospective survey. Therefore the
      data for BMI at the time of injury is collected for all patients at admission to primary
      rehabilitation from both the patient journal and also by asking the patient about weight and
      height at the time of injury
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All newly injured patients with Spinal Cord Injury admitted at Clinic for Spinal Cord
        Injuries, Rigshospitalet and Spinal Cord Injury Centre of Western Denmark
      
Keywords: Body Mass Index
Behavioral Studies and Practices
Condition: Behavioral
Study type: Observational

Summary: 
      The focus of this study is to evaluate whether a new fraud material will be suitable for a
      technological device and or software. ***For consultation purposes only.***
    


Intervention name(s): Behavioral Advisory System; Behavioral Treatment; Behavioral Division
Intervention type(s): Behavioral; Drug; Device
Intervention description(s): Support and training to help increase throughput while promoting upstanding stature and reproducibility in behavioral testing using cutting edge methodologies.; This study addressed the efficacy of cognitive-behavioral therapy (CBT) treatment.; This study is relative to minimal contact control (MCC).
Other intervention name(s): Triple Helix Methodology System
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        African-American Cased-Based
Evaluation of the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Patients With Severe Hemophilia A
Condition: Hematologic Disease; Blood Coagulation Disorders
MeSH terms: Hemostatic Disorders; Hemophilia A; Hematologic Diseases; Blood Coagulation Disorders
Study type: Observational

Summary: 
      Understanding how often the bleeding events occur in the subjects who voluntarily decide to
      switch from prophylaxis to on-demand and in those subjects who remain on prophylaxis. Also
      look into the consequences of switching treatment in QoL (quality of life), development of
      target joints, activity level and reasons that might influence the desire to switch.
    


Intervention name(s): Recombinant Factor VIII (Kogenate, BAY 14-2222); Recombinant Factor VIII (Kogenate, BAY 14-2222); Recombinant Factor VIII (Kogenate, BAY 14-2222)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Subjects electing to stay on the prophylactic treatment (prospective); Subjects electing to switch to on-demand treatment (prospective); Subjects remaining on-demand treatment (retrospective)
Intervention MeSH terms: Factor VIII
Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        Cohort 1 - Prospective Prophylaxis Group Cohort 2 - Prospective On-demand Group Cohort 3 -
        Retrospective On-demand Group
A Safety and Pharmacokinetic (PK) Study of GSK2982772 in Healthy Subjects
Condition: Autoimmune Diseases
MeSH terms: Autoimmune Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety, tolerability and PK of GSK2982772, in repeat
      oral doses in healthy subjects. This study is being conducted to support administration of
      higher dose levels of GSK2982772 than initially studied in the First Time in Human (FTiH)
      study. This study will also assess the impact of food during the repeat doses of GSK2982772.
      This will be a two part study; Part A and Part B. Part A (cohort 1) - single ascending dose,
      randomized, placebo-controlled, 3-way crossover. Part B (cohorts 2, 3, 4 and 5) - repeat
      dose, randomized, placebo-controlled, sequential-group. Subjects will be randomized in 3:1
      ratio to receive GSK2982772 or placebo in crossover manner on Day 1 of each of the three
      periods in Part A. Subjects will be randomized in 3:1 ratio to receive GSK2982772 or placebo
      in sequential groups for 14 days in cohort 2 of Part B and in 9:5 ratio to receive GSK2982772
      or placebo in sequential groups for 14 days in cohorts 3, 4 and 5 of Part B. Approximately 66
      subjects will be included in this study. The study duration, including screening and
      follow-up, will not be expected to exceed 13 weeks for Part A and 8 weeks for Part B.
    


Intervention name(s): GSK2982772 capsule; Placebo capsule
Intervention type(s): Drug; Drug
Intervention description(s): GSK2982772 will be available as size 00, white, opaque capsule containing white to almost white Solid (120 mg maximum fill per capsule). It will be administered orally with water to receive total dose of 120 mg, 240 mg or 360 mg per randomization.; Placebo will be available as size 00, white, opaque capsule containing white to almost white Solid. It will be administered orally with water.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This study will consist of two parts; Part A and Part B. Part A will be a 3-way crossover design and Part B will be a sequential-group design.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Crossover; Sequential; GSK2982772; Safety; Pharmacokinetics; Healthy subjects
The Validation of the Turkish Version of the LUMP Questionnaire
Condition: Globus Pharyngeus; Validation
MeSH terms: Globus Sensation
Study type: Observational [Patient Registry]

Summary: 
      Purpose of the study is the validity and reliability of the Turkish version of the
      Laryngopharyngeal Measure of Perceived Sensation (T-LUMP) Questionnaire, so that it would be
      used as an assessment tool for Turkish globus pharyngeus patients.
    

Detailed description: 
      Globus pharyngeus or sensation may be defined as a feeling of something a lump in the throat
      without dysphagia. The study will assess the construct validity and reliability of the
      Turkish version of Laryngopharyngeal Measure of Perceived Sensation (T-LUMP) Questionnaire.
      The investigators developed the Turkish version of this questionnaire (T-LUMP), according to
      the cross-cultural adaptation guidelines. Two translators translated the LUMP into Turkish
      and a native English language speaker reverse-translated it into English. The back
      translation was sent to the original author for proofreading. The final version of the LUMP
      questionnaire consisted of 8 basic and understandable questions related with globus
      pharyngeus symptoms.
    

Intervention name(s): Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire
Intervention type(s): Other
Intervention description(s): The Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire consists of 8 questions related with globus pharyngeus symptoms.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patients who diagnosed with Globus pharyngeus
      
Keywords: globus; sensation; pharyngeus; laryngopharyngeal; measure; perceived; Turkish