bioihbjkbjnl/mcl2 huggingface dataset:
Quantitative Analysis of Different Acupuncture Needle Manipulation to Treat Chronic Shoulder Pain
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      The plan " Quantitative analysis of different acupuncture needle manipulation to treat
      chronic shoulder pain "includes an objective observation of acupuncture operation (movement
      in the form of acupuncture needles, intensity, etc.) and the body (acupoints) reactions.
      Patients during 20-55 years old suffered shoulder pain more than six weeks with numerical
      rating scale (NRS) pain intensity more than 5 points, and the previous month were not taking
      medicine or Western medicine were included. Then use of distal acupoints GB34 and GB39,
      giving once acupuncture manipulation therapy.
    

Detailed description: 
      Numerical rating scale (NRS) and pain pressure algometer were used to objective and
      quantitative assessment of the patient's pain. And shoulder pain and disability index-SPADI
      was used to objectively assess the functional changes of acupuncture treatment in patients
      with chronic shoulder pain. Massachusetts General Hospital Acupuncture Sensation Scale - MASS
      was used to get objectively record of de-qi when needle manipulation for the the body
      (acupoints) reactions. Acusensor2 was used to get objective observation reaction during
      needling manipulation, the sensor provided measurement parameters such as the lift and
      thrust, twisting, strength and torque during needle manipulation. Investigators will study
      and analysis associated clinical outcome with needling process, the needle manipulation by
      lifting-thrusting or twisting-rotating during the process of reinforce method or reducing
      method to study its dynamics and kinematics.
    

Intervention name(s): "Dragon and Tiger warring" in lifting and thrusting; "Dragon and Tiger warring" in twisting-rotating
Intervention type(s): Procedure; Procedure
Intervention description(s): "Tight press" slow insert in each acupoint through the superficial,intermediate, deep layer, then "tight lifting" slow withdraw needle through the deep, intermediate, superficial layer . Two acupoints (GB34, GB39) are manipulation in the process three times each during one minute, then let patients lift shoulder up and down for three times, then draw out the needle 20 minutes later.; When needle insert in each acupoint through the superficial,intermediate, deep layer, within each layer twisting thumb forward nine times, then twisting backward six times. Two acupoints (GB34, GB39) are manipulation in the process during one minute, then let patients lift shoulder up and down for three times, then draw out the needle 20 minutes later.
Intervention MeSH terms: Camphor; Salicylates; Methyl salicylate; Menthol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional

Summary: 
      To demonstrate that the BioMimics 3D Stent System meets the performance goals defined by VIVA
      Physicians, Inc. for the safety and effectiveness of Nitinol stents used in the treatment of
      symptomatic disease of the femoropopliteal artery. It is a prospective, single-arm,
      multicenter clinical trial.
    

Detailed description: 
      The BioMimics 3D stent is intended to improve luminal diameter in the treatment of
      symptomatic de-novo, obstructive or occlusive lesions in native femoropopliteal arteries with
      reference vessel diameters ranging from 4.0 - 6.0 mm. Subjects with symptomatic
      atherosclerotic disease of the femoropopliteal artery who comply with all study eligibility
      criteria may be considered for enrollment.
    

Intervention name(s): BioMimics 3D Vascular Stent System
Intervention type(s): Device
Intervention description(s): Femoropopliteal stenting
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PAD; PVD; SFA stent
A Comparison of XELOX Regimen and EOX Regimen as Neoadjuvant Chemotherapy Regimen for Locally Advanced Gastric Cancer.
Condition: Locally Advanced Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      This study is designed to assess what is the better neoadjuvant chemotherapy regimen for
      patients with initially unresectable locally advanced gastric cancer.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        242
Pilot Study With GFT505 (80mg) in Patients With Insulin Resistance and Abdominal Obesity
Condition: Insulin Resistance; Abdominal Obesity
MeSH terms: Obesity; Insulin Resistance; Obesity, Abdominal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to demonstrate the efficacy on insulin sensitivity of GFT505 at
      80mg/d in male patients with insulin resistance and abdominal obesity. Evaluation will be
      made using a glucose clamp technique.
    

Detailed description: 
      The study period per patient is 26 weeks: a selection period will precede a 8-week treatment
      period, a 6-week wash out period, a second 8-week treatment period in the second arm of
      treatment and a 2- week follow-up period.

      Schedule:

        -  Selection visit prior to treatment period (D-14 and D-1)

        -  D0 : randomisation visit

        -  Period T1: first period of treatment with GFT505 80mg or placebo for 8 weeks (D1 to D56)

        -  Wash out period for 6 weeks (D57 to D98)

        -  Period T2: second period of treatment with GFT505 80mg or placebo for 8 weeks (D99 to
           D154)

        -  Follow up period for 2 weeks (D155 to D169)
    

Intervention name(s): GFT505 80mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast; hard gelatin capsules, oral administration, 4 capsules per day before breakfast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pre-diabetes; Clamp technique; PPARs; Insulin resistance
Safety, Tolerability and Pharmacokinetic Study of KL1333 in Healthy Male Volunteers
Condition: MELAS Syndrome; Mitochondrial Respiratory Chain Deficiencies
MeSH terms: MELAS Syndrome; Mitochondrial Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this First In Human study is to investigate the safety and tolerability of
      KL1333 after a single oral dose and to investigate the pharmacokinetic characteristics of
      KL1333 after a single oral dose.
    


Intervention name(s): KL1333 25 mg; KL1333 50 mg; KL1333 100 mg; KL1333 200 mg; KL1333 400 mg; KL1333 600 mg; KL1333 800 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral administration, single dose, 25 mg 1 tab; oral administration, single dose, 25 mg 2 tabs; oral administration, single dose, 100 mg 1 tab; oral administration, single dose, 100 mg 2 tabs; oral administration, single dose, 100 mg 4 tabs; oral administration, single dose, 100 mg 6 tabs; oral administration, single dose, 100 mg 8 tabs; oral administration, placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation
Time Restricted Feeding on Nonalcoholic Fatty Liver Disease ( TREATY-FLD )：a 12-month Follow-up Study
Condition: Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Time restricted feeding (TRF) is a novel type of intermittent calorie restriction diet that
      involves eating a daily period of 8 hours or less. This is a 6-month follow-up study of
      TREATY-FLD trial to evaluate the effect of time restricted feeding (TRF) on hepatic fat
      contents and cardiometabolic risk factors in obese adults over 6 months compared to
      continuous energy restriction (CER).
    


Intervention name(s): Time restricted feeding; Continuous Energy Restriction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women during a window of 8 h/d (8 am to 4 pm).; Participants will follow receive a diet of 1500-1800kcal/ d for men and 1200-1500kcal/d for women, without restriction on feeding time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nonalcoholic Fatty Liver Disease; Time restricted feeding; Calorie restriction
Drug-drug Interaction Study of Rosuvastatin and AT-527 (R07496998)
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      Drug-drug interaction study of rosuvastatin and AT-527 (R07496998)
    


Intervention name(s): Drug: AT-527 + rosuvastatin; AT-527 + rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Day 1: A single dose of rosuvastatin will be administered.
Day 8: A single dose of AT-527 and rosuvastatin will be co-administered.; Day 1: A single dose of rosuvastatin will be administered.
Day 8: A single staggered dose of AT-527 and rosuvastatin will be administered (2 hours later)
Other intervention name(s): AT-527 is also know as R07496998; AT-527 is also know as R07496998
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mallampati Score Before and After Cesarean Delivery
Condition: Alteration of Modified Mallampati Score
Study type: Observational

Summary: 
      Mallampati class change has not been well evaluated during the cesarean delivery. Various
      factors regarding to cesarean delivery might influence this changes. The aim of this study
      was to evaluate the Mallampati class before and after cesarean delivery and to identify
      predictive factors of the changes..

      Study Type: Observational Cross-sectional study
    

Detailed description: 
      Mallampati class, thyromental distance, neck circumference, and upper lip bite test were
      evaluated at four time intervals : during pre-anesthetic visit (T0), 1-hour (T1), 6-hour
      (T2), and 24-hour after delivery (T3).
    

Intervention name(s): Evaluate upper airway changes
Intervention type(s): Other
Intervention description(s): Evaluate upper airway changes at several point of time before and after cesarean delivery
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Thai pregnant women scheduled for cesarean section, age ≥ 18 y at gestational age ≥ 37
        weeks giving written informed consent.
      
Keywords: Modified Mallampati score; Cesarean delivery
Gustatory Dysfunction Among a Sample of Depressed Egyptian Adults Under Anti-depressants Therapy
Condition: Taste Disorders
MeSH terms: Taste Disorders
Study type: Observational

Summary: 
      - Assess gustatory thresholds among a sample of depressed Egyptian adults (age from 20 to 50
      years old) under anti-depressants therapy ( for at least 3 months) using filter paper
      disc(FPD) method through a scoring system. - Determine the taste intensity at supra-threshold
      among these patients using a psychophysical method through a scoring system. - Identify
      possible modulators for developing gustatory dysfunction among these patients using a
      questionnaire ( appendix) with a binary measuring unit (yes/no).
    

Detailed description: 
      PECO

        -  P Population: depressed Egyptian adults under anti-depressants therapy

        -  E1 Exposure 1: commonly prescribed tricyclic antidepressants (Imipramine, Amitriptyline,
           Clomipramine HCL)

        -  E2 Exposure 2: commonly prescribed Selective Serotonin Re-uptake inhibitors
           antidepressants ( Fluoxetine, Fluvoxamine, Sertraline, Citalopram, Paroxetine)

        -  C control (non exposure) : non-pharmacological treatment ( psychotherapy)

        -  O Outcome:

      Primary 1ry : Assess gustatory thresholds among a sample of depressed Egyptian adults (age
      from 20 to 50 years old) under anti-depressants therapy ( for at least 3 months) using filter
      paper disc(FPD) method through a scoring system.

      Secondary 2ry: - Determine the taste intensity at supra-threshold among these patients using
      a psychophysical method through a scoring system. - Identify gustatory dysfunction modulators
      among these patients using a questionnaire ( appendix) with a binary measuring unit (yes/no).
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Depressed Egyptian adults under anti-depressants therapy The patients will be recalled
        using their phone numbers recorded in their follow up records in order to come to the
        Diagnosis center at the faculty of Dentistry, Cairo University to be assessed for gustatory
        functions and will be given identification numbers and divided into three groups, to which
        the operator shall be blinded.
Gastrointestinal Transit Time in Patients With Severe Acquired Brain Injury
Condition: Brain Injury; Constipation
MeSH terms: Brain Injuries; Constipation; Wounds and Injuries
Study type: Observational

Summary: 
      Empirically patients with acquired brain injury (ABI) are often constipated. This is a major
      clinical issue. Nevertheless, this has only been sparsely studied.

      The investigators will measure gastrointestinal transit time (GITT) in 30 patients with ABI,
      and compare this to healthy controls. Secondly heart rate variability (HRV) is measured in
      these patients, and associations between HRV and GITT are investigated.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients at Hammel Neurocenter and University Clinic, during rehabilitation after aquired
        brain injury
Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation
Condition: Constipation - Functional
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to < 18 years
      diagnosed with functional constipation.
    

Detailed description: 
      To assess the long-term safety and tolerability of oral lubiprostone 12 or 24mcg capsules
      dosed twice daily (BID) when administered orally for 24 weeks in pediatric participants with
      functional constipation. Evaluation of lubiprostone safety and tolerability is the primary
      objective in this study.
    

Intervention name(s): Lubiprostone
Intervention type(s): Drug
Intervention description(s): 12 or 24 mcg soft capsules for oral administration.
Other intervention name(s): Amitiza
Intervention MeSH terms: Lubiprostone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Peripheral Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      Peripheral neuropathic pain is a disabling chronic pain condition that is difficult to treat.
      Repetitive transcranial magnetic stimulation (rTMS) to the motor cortex is a treatment method
      with growing evidence in its ability to alleviate neuropathic pain. This also applies to new
      deep rTMS coils which permits stimulation of larger cortical areas and with deeper
      penetration. The aim of this study is to investigate the analgesic efficacy of 5 days of deep
      rTMS compared to sham stimulation. We will also assess effects of deep rTMS on sleep,
      psychological fatctors, everyday functioning, and executive functioning.
    


Intervention name(s): repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): Deep rTMS is delivered with the Brainsway H7-coil (Brainsway, Jerusalem, Israel) applied via a helmet placed on the head targeting the primary motor cortex of the leg.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients undergo stimulation with deep rTMS in a double blinded randomised controlled trial (RCT) with a 2 x 2 cross-over design, receiving both active and placebo stimulation. Patients are randomly assigned in a 1:1 ration to one of two counterbalanced arms: either they first receive active rTMS and then sham rTMS after a 9 week washout period, or the first receive sham rTMS and then active rTMS after 9 weeks of washout.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Repetitive Transcranial Magnetic Stimulation
Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Prospective, multi-center, open-label, single-arm, Phase 3b extension study of macitentan in
      patients with PAH.

      To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension
      (PAH) beyond treatment in the AC-055-310 study.
    

Detailed description: 
      To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension
      (PAH) beyond treatment in the AC-055-310 study.
    

Intervention name(s): Macitentan
Intervention type(s): Drug
Intervention description(s): 10 mg once daily
Other intervention name(s): ACT-064992
Intervention MeSH terms: Macitentan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pulmonary arterial hypertension; PAH-SYMPACT; PAH; psychometric instrument
Kinesio Taping on Trapezius Trigger Points After Integrated Neuromuscular Inhibition Technique (INIT)
Condition: Trigger Points
Study type: Interventional

Summary: 
      The aim of this research is to see the effects of kinesio taping after integrated
      neuromuscular inhibition technique on pain, disability, pain-pressure threshold and muscle
      length in patients with upper trapezius trigger points. There will be two groups experimental
      and control. One study group will receive kinesiotaping after integrated neuromuscular
      inhibition technique and the other group will only receive integrated neuromuscular
      inhibition technique.
    

Detailed description: 
      This study is Randomized controlled trail done at physiotherapy department of Railway General
      Hospital Rawalpindi. The sample size of 26 individuals calculated using open epi tool.
      Sampling technique applied was convenience sampling. Randomization in groups by sealed
      envelope method. The subjects were divided into two groups with 13 patients each. Both groups
      were treated with Integrated neuromuscular inhibition technique (Muscle energy Technique,
      sustain pressure, Strain counter-strain) while Kinesio tape was applied after INIT in only
      experimental group. Study duration was of 6 months. Individuals having age between 20-40
      years, upper trapezius active or latent trigger points, limited side bending were included in
      this study. Tools used in the study were neck disability index (NDI), algometry, numeric pain
      rating scale (NPRS) and muscle length (side bending through inclinometer). Assessments were
      taken on 1st day pre and post intervention and on 4th day.
    

Intervention name(s): Kinesiotaping; Integrated Neuromuscular Inhibition Technique
Intervention type(s): Other; Other
Intervention description(s): Total of 4 sessions on upper trapezius trigger points on alternate days.; Sustain Pressure. Strain Counter-strain (for 90 sec) Passive Isometric Relaxation (PIR) (6-10 sec hold, 4 reps)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Myofascial trigger points; Kinesiotaping; Integrated Neuromuscular Inhibition Technique
CCK1R Function in Patient Leukocytes
Condition: Obesity; Diabetes Mellitus, Type 2; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The type 1 cholecystokinin receptor (CCK1R) is a potential target for the treatment of
      obesity, due to the ability of this GI hormone to elicit satiety. However, this receptor has
      been shown to be sensitive to the cholesterol content of the membrane in which it is
      expressed. Because some patients who might be candidates for the use of CCK agonists to treat
      their obesity and co-morbidities, the goal of this study is to determine how metabolic
      abnormalities might affect the responsiveness of this receptor to CCK. Because the normal
      site mediating CCK-stimulated satiety is on vagal afferent neurons that cannot easily be
      studied, we will collect buffy coat cells from a peripheral blood sample from patients
      involved in the Sangre Por Salud Biobank at Mountain Park Medical Center. Ex vivo, the CCK1R
      will be expressed on these cells and will be functionally characterized, and the cholesterol
      content of the cells will be assayed. These data will be correlated with the clinical,
      biochemical, and metabolic phenotypic data collected as part of the parent study.
    

Detailed description: 
      Subjects are volunteers who provide prospective informed consent to be entered into the
      Sangre Por Salud Biobank at Mountain Park Medical Center. These include men and women age
      18-85 of Hispanic/Latino descent, who are not pregnant or have given birth in the previous 12
      months, or who are nursing, and who have not been diagnosed with cancer in the previous three
      years. Two groups of patients are included, representing those who have not been diagnosed as
      having diabetes, and those with diabetes. Subjects undergo entry physical examination and
      standard metabolic phenotyping, with the non-diabetics also undergoing a 2-hour glucose
      tolerance test. Blood samples are also banked and available for other studies, such as the
      one now being described.

      For the current study, 5 ml of blood will be coded and delivered in an anonymized form. Buffy
      coat cells will be isolated and infected ex vivo with a viral construct including the wild
      type CCK1R tagged with a fluorescent tag. Cells will be placed in culture overnight and
      harvested for quantitation of receptor expression and determination of CCK responsiveness and
      cholesterol content. These data will be correlated with selected relevant clinical,
      biochemical, and morphometric data.
    

Observational model: Case-Only
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        subjects in Sangre Por Salud Biobank