bioihbjkbjnl/mcl2 huggingface dataset:
Pressure Intensity of a Chinese Massage Technique for Treating Low Back Pain
Condition: Low Back Pain, Mechanical
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The Investigators conduct this study to compare two different massage methods with "buffalo
      horn technique": the deep massage and the superficial massage. To explore the effects of the
      two interventions on low back pain, the investigators evaluated the outcome measurements
      regarding pain severity and physical functions before and after 6 times of treatment through
      a 3-week period.
    

Detailed description: 
      Background: Nonspecific lower back pain is an important global health issue, with high
      prevalence over the world and causing huge economic loss.

      This research is a double-blind randomized controlled trial. In this study the investigators
      introduce a technique derived from traditional Chinese massage using a special tool made from
      buffalo's horns to perform the massage, so called "buffalo horn technique". The tool is like
      a short rod in about 15-cm length with a cone-like end. During the massage, the therapist
      presses the cone-like end against the painful region of back. Because the cone-like end has a
      small contact area with the participant's body surface, it may release deep layer fascia with
      higher pressure produced by the therapist toward the treatment area. During the intervention
      of shallow massage, the therapist applies a lower force then that used in the deep massage.
      Thus it produces a lower pressure on the painful region due to a larger contact surface when
      pressing the rod end against the body of the participant.

      Participants are randomly assigned to either deep-massage group (DM) or superficial-massage
      (SM) group. The participants received two sessions a week for a total six sessions. The
      outcome measures include the structured questionnaire to investigate the pain-related
      outcomes and back pain-related disabilities. The investigators also perform the clinical
      assessments such as range of motion of trunk. All the outcomes are assessed
      before-intervention (pretest) and after the end of intervention (posttest).
    

Intervention name(s): Buffalo horn technique
Intervention type(s): Other
Intervention description(s): The participants receive a 30-min massage session, twice a week for a total 6 sessions.
Other intervention name(s): Massage with a Chinese therapeutic tool
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients are randomly assigned into two treatment arms.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alternative therapy; Massage; Manual therapy; Myofascial
Phase 2 Study in Adults Sensitized to Cat
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to identify an effective dose of allergen-specific immunotherapy
      for cat hair (Felis domesticus) administered by the oral/sublingual route.
    

Detailed description: 
      This was a phase 2, randomized, double-blind, placebo-controlled, parallel groups study
      conducted in 3 centers in the US (NCT00689299). Study drug was sublingually dosed once daily
      as 0.15 mL of US standardized cat hair extract dosed either undiluted, as 1:10 dilution, or
      placebo. Target dose was obtained on Day 3 of dose titration escalating through 1:100 and
      1:10 dilutions on Day 1 and Day 2 in the high dose group or placebo and 1:100 dilutions in
      the low dose group. Treatment duration was 20 weeks. Adult (>18 years) study subjects had
      positive history for cat allergy without asthma, positive skin test to cat allergen, absence
      of immunotherapy during the prior 2 years, and absence of other confounding baseline
      conditions. The primary outcome parameter was average Total Symptom Score (TSS) during a
      1-hour cat chamber exposure. TSS is the sum of 7 items rated from 0 - 3 (none to severe) for
      nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) and non-nasal
      symptoms (eye watering, eye itching, and itching palate/ ear/ throat).
    

Intervention name(s): Standardized Allergenic Extract, Cat Hair; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Standardized Cat Hair Allergenic Extract sublingual drops; Placebo Sublingual Drops
Other intervention name(s): Standardized Cat Hair Allergenic Extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sublingual Immunotherapy (SLIT); Non-seasonal allergic rhinitis; Immunotherapy; Allergic rhinitis; Cat; Perennial allergy; Non-seasonal allergy
Endoscopic Assisted Calcium Electroporation in Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      In this pilot study, patients with non-curable esophageal cancer will be treated with
      endoscopic assisted calcium electroporation (CaEP). CaEP is a novel cancer treatment where
      intratumoral injection with calcium is combined with locally applied electrical pulses, in
      order to increase calcium influx which leads to tumor necrosis.

      It is hypothesized that:

        -  Endoscopic assisted CaEP is a safe and feasible procedure in patients with non-curable
           esophageal cancer

        -  CaEP debulks the tumor, facilitating the patient's ability to eat and drink

      In this single-arm pilot study, eight patients will be treated.
    

Detailed description: 
      Electroporation facilitates the transport of molecules across the cell membrane and into the
      cell by means of electrical pulses. An electric field applied to the cell destabilizes the
      cell membrane forming cracks, which reseals after a few minutes. During this time slot,
      molecules which normally are impermeable to the cell membrane are able to cross into the
      cytosol of the cell. Within the last ten years, studies have shown that the combination of
      intratumoral injection of calcium and electroporation (Calcium electroporation/CaEP) is an
      effective method in killing cancer cells. CaEP has been evaluated in clinical studies in
      colorectal cancer, carcinomas in the head and neck area, and in cutaneous metastases with
      promising results.

      In this single-arm pilot study, eight patients with non-curable esophageal cancer will be
      included.

      It is hypothesized that:

        -  Endoscopic assisted CaEP is a safe and feasible procedure in patients with non-curable
           esophageal cancer

        -  CaEP debulks the tumor, facilitating the patient's ability to eat and drink

        -  CaEP induces a systemic immunological response

      The primary objective is to evaluate the safety of CaEP for esophageal cancer. Adverse Events
      (AE) and Serious Adverse Events (SAE) will be evaluated.

      Secondary outcomes include:

        -  dysphagia (Mellow Pinkas dysphagia score)

        -  pain (Numeric Rating Scale, NRS)

        -  quality of life (QoL) (EORTC QLQ-C30)

        -  tumor response evaluated from computed tomography (CT) and upper endoscopy

        -  immunologic response

      Tertiary outcomes include:

      ✓ 90-days survival

      Participants are initially treated once according to protocol. If well-tolerated, the
      treatment can be repeated.
    

Intervention name(s): Calcium Gluconate
Intervention type(s): Drug
Intervention description(s): Calcium electroporation
Intervention MeSH terms: Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Evaluation of Immune Signaling Networks in Healthy Human Volunteers
Condition: Normal Immune Cell Function
Study type: Observational

Summary: 
      The purpose of this study is to better understand whether and to what extent the activity of
      immune cells in blood varies over time under normal conditions as assessed in healthy
      subjects. Results of this study will provide the foundation for helping us evaluate changes
      in immune cell activities in response to surgery and drugs used in anesthesia. The overall
      purpose of our research is to understand immune health in the context of anesthesia and
      surgery.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study population consists of a community sample.
Study of the Choroidal and Retinal Thickness in Relation to Axial Length.
Condition: Healthy
Study type: Observational

Summary: 
      The aim of the study is the non-invasive morphological evaluation of the choroid and the
      retina in relation to the length of the eyeball in healthy, young man and women.
    

Detailed description: 
      The choroid is responsible for the oxygen supply of the outer retina, hence many diseases
      that affect the retina are originating from the choroid or at later stages influence the
      choroid as well. The functional efficiency of the choroid in a healthy subject is important.
      The thickness of the choroid is a marker for the extent of the vessels inside.

      With optical coherence tomography (OCT) non-invasive and non-contact measurement of the
      choroidal and retinal thickness is possible. Swept-source OCT is one the latest developments
      of OCTs. Its increase wavelength allows deeper penetration than previous models and allows
      high resolution imaging.

      OCTs are FDA approved machines, they are not considered experimental. The swept-source OCT
      machine (DRI OCT-1 Model Triton (plus), Topcon, Tokyo, Japan) used in the study is a CE
      marked commercially available medical device.

      The goal of the study is to evaluate the choroidal and the retinal morphology in relation to
      the length of the eyeball (axial length - AL) in healthy, young adults.

      There are several publications on this topic, most of them on asian populations.

      In the study healthy, Caucasians in their twenties are recruited to minimize the aging effect
      on choroidal thickness.

      Following informed consent, demographics are recorded, refraction is taken, axial length is
      measured with IOL Master 500 (Carl Zeiss AG, Germany) then OCT is performed.

      Pupil dilation is not necessary. Images are stored digitally by abiding corresponding laws on
      personal data protection. Results are processed with statistical analysis.
    

Intervention name(s): AL measurement; OCT
Intervention type(s): Device; Device
Intervention description(s): IOL Master 500 (Carl Zeiss AG, Germany); Choroidal and retinal thickness measurement (DRI OCT-1 Model Triton (plus), Topcon, Tokyo, Japan)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy subject with no eye diseases.
Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole
Condition: Short Stature
MeSH terms: Dwarfism
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine if there are differences in the final height or
      hormone profile of short pubertal boys placed on different forms of aromatase inhibitor now
      routinely used to increase stature: Anastrozole and Letrozole. It also should determine if
      there are differences in the side effect profiles of the two drugs to be used.
    


Intervention name(s): Letrozole; Anastrozole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Letrozole; Anastrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease
Condition: Primary Sjogren Syndrome; Secondary Sjogren Syndrome; Aqueous Deficient Dry Eye Disease; Evaporative Dry Eye Disease
MeSH terms: Sjogren's Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      In the present study the investigators aim to determine the efficacy of an immunomodulating
      topical medication, compared with a topical lubricant, on the treatment of dry eye disease
      (DED) due to primary or secondary Sjögren's syndrome (aqueous deficient DED) and evaporative
      DED.
    

Detailed description: 
      Dry eye disease (DED) is a multifactorial disease of the tears and ocular surface that
      results in symptoms of discomfort, visual disturbance, and tear film instability with
      potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear
      film and inflammation of the ocular surface. DED prevalence is estimated around 15 -35% of
      the population over 50 years old. There is a wide variety of topic medications for the
      treatment of DED, though few aim the re-establishment of tear osmolarity equilibrium and
      reduction of damages to the ocular surface. The treatment of DED can include a medical
      treatment, such as tear substitution, tear preservation, production stimulation,
      anti-inflammatory; it can also include surgical treatment, as tarsorrhaphy and salivary gland
      transplant. Considering tear substitutes and anti-inflammatory topical treatments, the
      purpose of our study is to determine efficacy of an immunomodulating topical medication
      containing 0.05% cyclosporine A (CsA), compared to a topical lubricant (vitamin A, Refresh
      Endura®), on the treatment of dry eye disease (DED) due to primary or secondary Sjögren's
      syndrome (aqueous deficient DED) and evaporative DED.
    

Intervention name(s): Restasis; Refresh Endura
Intervention type(s): Drug; Drug
Intervention description(s): Restasis is an ophthalmic emulsion containing cyclosporine 0.5 mg/mL, produced by Allergan Inc.; Refresh Endura is a topical lubricant produced by Allergan, Inc.
Other intervention name(s): Cyclosporine 0.05%; Castor oil
Intervention MeSH terms: Cyclosporine; Castor Oil; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Evaporative; Aqueous deficient; Dry eye disease
Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 3

Summary: 
      Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma
      causing overproduction of growth hormone which leads to acromegaly. The objective of this
      study is to assess the safety and efficacy of long-acting repeatable formulation of
      octreotide and to compare it to the safety and efficacy of surgery in patients with
      acromegaly who have not had any previous treatment for acromegaly.
    


Intervention name(s): Octreotide LAR
Intervention type(s): Drug
Other intervention name(s): SMS995
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acromegaly; Untreated; Newly diagnosed; Octreotide LAR; Pituitary surgery
Change of Depth in a RAE Tube: Tube Fixation at the Midline or Angle and in a Neutral or Neck Extended Position
Condition: Depth of Tracheal Tube
Study type: Observational

Summary: 
      The investigators compared the depth of the RAE tube [Preformed oral tracheal tubes were
      first described by Ring, Adair and Elwyn (therefore called RAE tubes)] when fixed at the
      midline and at the angle of the mouth, and after fixing the tube at the angle.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adult patients who are scheduled for elective surgery under general anesthesia
The Effect of Maximal Exercise on MMP9 and TIMP1 and The Role of MMP9 -1562 C/T and TIMP1 372 T/C Polymorphisms
Condition: MMP9; TIMP1; MMP9 -1562 C/T; TIMP1 372 T/C
Study type: Interventional

Summary: 
      Matrix metalloproteinases (MMPs) play a critical role in the remodeling and regeneration of
      skeletal muscle. Studies which investigate exercise and effects of MMPs and tissue inhibitors
      of matrix metalloproteinases (TIMPs) are contradictory. Also the role of MMP9 -1562 C/T and
      TIMP1 372 T/C polymorphisms on exercise are unclear. In accordance with this conditions the
      hypothesis of the study are as follows:

        1. Levels of basal serum MMP9 and TIMP1 are different between athletes (volleyball,
           basketball, handball) and sedentary people.

        2. Levels of serum MMP9 and TIMP1 response to maximal exercise are different between
           athletes (volleyball, basketball, handball) and sedentary people .

        3. Relationship between levels of serum MMP9 and TIMP1 response to maximal exercise are
           different between athletes (volleyball, basketball, handball) and sedentary people.

        4. Levels of basal serum MMP9 and TIMP1 are related to MMP9 -1562 C/T and TIMP1 372 T/C
           polymorphisms.

        5. Relationship between levels of serum MMP9 and TIMP1 response to maximal exercise and
           MMP9 -1562 C/T and TIMP1 372 T/C polymorphisms are different between athletes
           (volleyball, basketball, handball) and sedentary people.
    


Intervention name(s): Yo-Yo Intermittent Recovery Test Level 1
Intervention type(s): Other
Intervention description(s): The test is a standard test battery with progressively increasing speeds. After every 40-m run (2x20 m), active rest is performed by walking or jogging at a distance of 10 m (2x5 m). for 10 seconds. Participants are trying to adjust their speed according to incoming audio signals.The test is terminated when the participants can not reach the signal twice. The test ends in 10-20 minutes depending on the level of participants.
Reference Bangsbo, J., Iaia, F. M., & Krustrup, P. (2008). The Yo-Yo intermittent recovery test. Sports medicine, 38(1), 37-51.
Krustrup, P., Mohr, M., Amstrup, T., Rysgaard, T., Johansen, J., Steensberg, A., ... & Bangsbo, J. (2003). The yo-yo intermittent recovery test: physiological response, reliability, and validity. Medicine & Science in Sports & Exercise, 35(4), 697-705.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: There are 2 groups in the study: Athletes and sedentary people.They will apply the same acute exercise protocol (The Yo-Yo Intermittent Recovery Test Level 1). A blood test will conduct before and after the acute exercise protocol.
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of Possible Drug-drug Interactions Between Stiripentol or Valproate and Cannabidiol in Patients With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The
      blinded phase only will be described in this record. Participants will be randomized in a 4:1
      ratio to receive GWP42003-P or matching placebo. The hypothesis is that levels of stiripentol
      (STP) or valproate (VPA) may be altered (increased or decreased) as a result of using
      GWP42003-P.
    


Intervention name(s): GWP42003-P; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Clear, colorless to yellow solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.; Clear, colorless to yellow solution containing the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Other intervention name(s): Cannabidiol; CBD; Epidiolex
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cannabidiol; GWP42003-P; Epidiolex; Stiripentol; Valproate
A Study to Assess the Effects of a Light Breakfast on the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety and tolerability of single doses of odanacatib (MK0822)
      when administered with a light breakfast.
    


Intervention name(s): odanacatib; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single oral dose of 100 mg odanacatib administered with a light meal in one treatment period and without a meal in the other treatment period. There will be 10 days between treatment periods.; A single oral dose of Placebo to odanacatib administered with a light meal in one treatment period and without a meal in the other treatment period. There will be 10 days between treatment periods.
Other intervention name(s): MK0822
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder (PTSD) and Gulf War Fibromyalgia (GWF)
Condition: Post-traumatic Stress Disorder; Persian Gulf Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Persian Gulf Syndrome; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      An open-label clinical outcomes study to determine the safety and efficacy of Sentra AM® and
      Sentra PM® for post-traumatic stress disorder (PTSD) and Gulf War fibromyalgia (GWF).
    

Detailed description: 
      Male and female military veterans age 18 to 75 experiencing moderate to severe PTSD symptoms
      including cognitive dysfunction, sleep disorders and mood disorders.

      Open-label internet questionnaire-based clinical outcomes study. 250 subjects. 60 days from
      enrollment initiation to completion and study close. Sentra AM- two capsules given orally
      once daily in the morning for 30 days. Sentra PM- two capsules given orally once daily thirty
      minutes before bedtime for 30 days.

      To measure improvement in quality of life determined by the change in short form-36 (SF-36)
      general health survey.

      Improvements in daytime sleepiness determined by the Epworth Sleepiness Scale (ESS),
      improvement in cognitive and emotional function using the Cognitive emotion regulation
      questionnaire - short (CERQ-Short), change in PTSD symptoms with the Primary Care - PTSD
      (PC-PTSD), Psychopathy Checklist- Military (PCL-M). Heart rate variability (HRV) data
      variation will be measured in a group of twenty subjects.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female military veterans age 18 to 75 experiencing moderate to severe PTSD
        symptoms including cognitive dysfunction, sleep disorders and mood disorders.
      
Keywords: PTSD; Military veteran; Gulf War; Fibromyalgia; Gulf War Syndrome