bioihbjkbjnl/mcl2 huggingface dataset:
Mechanism-based Choice of Therapy for Neuropathic Pain
Condition: Pain
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      Mechanism-based choice of therapy for neuropathic pain:

      Can treatments success in neuropathic post-operative pain be coupled to psychophysical pain
      modulation profile?
    

Detailed description: 
      Neuropathic or idiopathic pain patients will be assessed with the variety of pain tests
      including the conditioned pain modulation (CPM) and temporal summation (TS). Then, they will
      be offered on the double-blind design a several weeks treatment with either pregabalin or
      duloxetine. Patients will be followed-up weekly by phone for their pain relief and will be
      re-assessed in the lab toward the end of the treatment. The investigators suggest that
      patients with less-efficient CPM (deficient pain inhibition) will "earn" more pain relief
      from the treatment with duloxetine, while the patients with the enhanced pain summation will
      response better to pregabalin.
    

Intervention name(s): Pregabalin; Duloxetine
Intervention type(s): Drug; Drug
Intervention description(s): Initial dose of 75x2mg/d for one week, and then fixed dose of 150x2mg/d for the following 5 weeks; Initial dose of 30 mg/d will be given for one week, in order to minimize possible side effects and drop outs, and then a fixed dose of 60 mg/d will be given for additional 5 weeks
Other intervention name(s): Calcium-channel blocker; SSNRI
Intervention MeSH terms: Pregabalin; Calcium Channel Blockers; Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Manual Therapy vs Stretching vs Routine Physical Therapy in Nonspecific Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The aim of this study is to analyze the effect of Mulligan technique vs stretching techniques
      and vs routine physical therapy on pain ,range of motion(ROM) and functional disability among
      restaurant chefs with non-specific chronic pain.
    

Detailed description: 
      Neck pain (NP) is one of the basic musculoskeletal issues. Neck pain can be due to stress
      about the musculoskeletal framework because of postural problems and may be related with
      different causes, such as: - Intervertebral disc herniation, -nerve compression -fracture.

      Nonspecific neck pain is a pain located in the lateral and posterior neck that does not show
      pathognomonic signs and symptoms. When the duration of symptoms is greater than 12 weeks of
      evolution, it acquires the value of chronicity, being denominated non-specific chronic neck
      pain (NCNP). It is a common disorder, which generates a great impact and socio-economic cost
      .

      In this study we evaluate the comparison of manual physical therapy vs routine physical
      therapy vs stretching physical therapy effects among restaurants chefs having non-specific
      chronic pain.
    

Intervention name(s): Routine physical therapy; Manual physical therapy with routine physical therapy; Stretching physical therapy with routine physical therapy
Intervention type(s): Other; Other; Other
Intervention description(s): Patients in this group will get every session routine physical therapy of 30 minutes 3 times per week on alternative days for 12 weeks; Patients in this group will get every session Manual physical therapy with routine physical therapy of 40 to 45 minutes 3 times per week on alternative days for 12 weeks; Patients in this group will get every session of Stretching physical therapy with routine physical therapy of 40 to 45 minutes 3 times per week on alternative days for 12 weeks
Other intervention name(s): Rehabilitation following Routine physical therapy; Rehabilitation following Manual physical therapy with routine physical therapy; Rehabilitation following Stretching physical therapy with routine physical therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neck pain; Manual therapy; Stretching exercises; Physical Therapy
ATX-101 Abdominoplasty
Condition: Characteristics of Subcutaneous Fat
Study type: Interventional
Phase: Phase 1

Summary: 
      Histopathological study of abdominal fat excised from subjects undergoing abdominoplasty
    


Intervention name(s): ATX-101
Intervention type(s): Drug
Intervention description(s): ATX-101 single doses
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Ropivacaine Though Laterosternal Catheters After Cardiac Surgery
Condition: Cardiac Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective double-blinded and randomised study involving patients undergoing
      cardiac surgery with median sternotomy, the effects on postoperative analgesia of a 48-hr
      continuous infusion of ropivacaine 2 mg.mL-1, at the rate of 4 mL.hr-1 through two catheters
      inserted at the lateral edges of the sternum will be studied, versus a control group in which
      normal saline will be infused in the same conditions.
    

Detailed description: 
      Diverse methods for infusion of local anaesthetics after cardiac surgery have been proposed,
      but none of them provided high-level evidence of efficacy. The catheters studied here are
      designed for a surgical insertion before closure of the sternotomy, with the aim of infusing
      the drug the closest possible of the terminations of intercostal nerves.
    

Intervention name(s): Ropivacaine (in one arm); catheterization (in both).
Intervention type(s): Drug
Intervention description(s): Parallel study with two groups:
ropivacaine (2 mg.mL-1), at the rate of 4 mL.hr-1 through two subcutaneous catheters lateral to the sternum, both alimented by an elastomeric pump.
same protocol, with normal saline instead of ropivacaine.
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Sternotomy; Pain; Respiratory function; Opiates; Patient-controlled; Scheduled cardiac surgery under general anaesthesia without any locoregional anaesthesia protocol other than this presently studied
Effect of Nutrition Education on Energy Availability, Body Composition, Eating Attitude and Sports Nutrition Knowledge
Condition: Relative Energy Deficiency in Sport
MeSH terms: Relative Energy Deficiency in Sport
Study type: Interventional

Summary: 
      In this study, we investigated the effect of series of nutrition education sessions given by
      a registered dietitian on energy availability, some anthropometric measurements, eating
      attitude and sports nutrition knowledge in young female endurance athletes (football,
      basketball, volleyball) aged 15-18 y (n=83) who train more than 10 hours per week.
    

Detailed description: 
      Participants were divided into two groups. Fifty participants took 6 physical nutrition
      education lectures and the other group (n=33) didn't have any nutrition education. All of
      them filled the LEAF-Q (Low energy availability in athletes questionnaire), EAT-26 (Eating
      Attitude Test) and SNKQ (Sports Nutrition Knowledge Questionnaire). Energy and nutrient
      intakes were assessed based on 3-day food records. 3 days activity logs were analysed to
      measure exercise energy expenditure. All of the tests have been repeated after 6 months
    

Intervention name(s): Nutrition education
Intervention type(s): Behavioral
Intervention description(s): Fifty participants took 6 physical nutrition education lectures and the other group (n=33) didn't have any nutrition education. Nutrition education was comprimised of 6 physical face to face 60 minutes sessions which was given every week in a school class. Each session was consisted of a different subject including energy metabolism in sport, energy balance, nutrition before and after training, low energy availability, macro and micronutrients, hydration and supplements. Participants also got written information as a printed booklet in order to be able to take notes under sessions and review after the sessions.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: A total of 83 adolescent female elite athletes from 3 different sport clubs (football n=34, basketball n=16 and volleyball n=33) between 15 and 18 years(mean 17.2 ± 2.0) were included in the study.They were divided into either the intervention or the control group. Fifty participants took 6 physical nutrition education lectures and the other group (n=33) didn't have any nutrition education. All of them filled the LEAF-Q (Low energy availability in athletes questionnaire),EAT-26(Eating Attitude Test)and SNKQ (Sports Nutrition Knowledge Questionnaire).Energy and nutrient intakes were assessed based on 3-day food records. Activity logs were analysed to measure exercise energy expenditure. All of the tests have been repeated after 6 months. Nutrition education was comprised of 6 physical 60 minutes sessions given every week in a school class. Each session was consisted of a different subject. Participants got written information as a printed booklet.
Masking: None (Open Label)
Primary purpose: Health Services Research
Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair
Condition: Children; Lacerations; Procedures; Child; Pain
MeSH terms: Lacerations
Study type: Interventional

Summary: 
      The purpose of this study is:

        -  To determine whether oral narcotic medication versus placebo improves the pain and
           anxiety scores for pediatric patients requiring laceration repair in the pediatric
           emergency department and receiving the standard of care with lidocaine treatment

        -  To evaluate for a statistical difference in pain scores in children during laceration
           repair

        -  To evaluate for a statistical difference in State-Trait Anxiety Inventory for Children
           (STAIC) scores during laceration repair
    

Detailed description: 
      A prospective, double-blind, placebo-controlled, randomized clinical trial in a tertiary care
      pediatric emergency department with an annual census of 80,000 visits per year. Patients will
      be randomized by a randomization table with block randomization in the pharmacy to the oral
      narcotic or placebo group, and the pharmacist will be the only person aware of the
      randomization status of the patient. Allocation concealment will be ensured by opaque, sealed
      envelopes kept in the Emergency Department Pharmacy. Guardians of patients age 2 to 17 years
      of age will be consented for enrollment.
    

Intervention name(s): hydrocodone/acetaminophen; Sugar water
Intervention type(s): Drug; Drug
Intervention description(s): 0.17 mg/kg hydrocodone component to max of 10 mg. If dose is vomited within 5 minutes, second dose may be administered.; An equal volume of sugar water will be dispensed, as for the weight based 0.17 mg/kg hydrocodone solution given for the study drug
Other intervention name(s): Lortab; Vicodin
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lacerations; sutures; pediatrics; child; pain; Anxiety
Resting Metabolic Rate Reliability
Condition: Resting Metabolic Rate Reliability
Study type: Observational

Summary: 
      This research is being conducted to study the reliability of a method used to measure resting
      metabolic rate, or how much energy a person expends while at rest.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will include up to 15 men and 15 women age 18 -65 years old with a BMI of 19 -
        40 kg/m2.
      
Keywords: RMR; Reliability; Obese; Energy Expenditure; Resting Energy Expenditure; Resting Metabolic Rate
Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin
Condition: Diarrhoea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to investigate the efficacy of the prophylactic treatment with
      rifaximin to prevent travellers diarrhoea.
    


Intervention name(s): Rifaximin; Lactose
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg per day, oral use, maximum duration 28 days; Coated Tablet, Oral Use
Other intervention name(s): Xifaxan; Normix; ATC code A07AA11; Chemical Abstracts Service (CAS) 80621814
Intervention MeSH terms: Rifaximin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Traveller's diarrhoea; Prevention
A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to generate data on key parameters associated with assessment of
      influenza vaccines in individuals 50-64 years of age

      Primary Objective:

        -  To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine
           (TIV) compared to TIV.

        -  To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as
           assessed by solicited adverse reactions collected for 7 days post-vaccination, and
           unsolicited adverse events (including Serious Adverse Events and Adverse Events of
           Special Interests) collected between Visit 1 and Visit 2
    

Detailed description: 
      Participants will be randomized to receive one dose of either High-Dose Trivalent Inactivated
      Influenza Vaccine or Trivalent Inactivated Influenza Vaccine. They will be followed up for
      safety for one month post-vaccination.
    

Intervention name(s): High-Dose Trivalent Inactivated Influenza Vaccine; Trivalent Inactivated Influenza Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Fluzone® High-Dose; Fluzone®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Trivalent Inactivated Influenza Vaccine; High-Dose Trivalent Inactivated Influenza Vaccine; Influenza vaccines
The Effect of Directional Specific Thoracic Spine Mobilization on Cervical Spine Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Hypothesis: There is no difference in directional specific manipulation of the thoracic spine
      for patients with neck pain.

      Patients seeking physical therapy for neck pain routinely have their thoracic spine
      manipulated. This study seeks to determine if directional limitations in the spine can be
      specifically determined and treated to decrease neck pain.
    

Detailed description: 
      Manipulation of the thoracic spine is the most commonly used manual therapy intervention by
      manual therapists. It is not known whether we can accurately assess and treat directional
      limitations in the thoracic spine to improve neck pain.

      One way is to assess where the limitation is and treat it. Another method is to distract the
      joint. We want to know if matching the limitation to the manipulation method will give
      patients with neck pain better results.

      The patient lays on their back. The therapist places a hand on the inferior vertebrae of the
      motion segment. The patient relaxes and the therapist pushes in an anterior to posterior
      direction either moving the vertebrae into flexion or entension.
    

Intervention name(s): thoracic spine manipulation
Intervention type(s): Other
Intervention description(s): a manual technique applied to the mid back to promote motion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Ascending Oral Dose Phase I Study With Px-102
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of the FXR agonist Px-102
      in healthy subjects after single oral dosing.
    

Detailed description: 
      The study is a single-centre, double-blind, randomized, placebo-controlled, parallel group
      phase I study with healthy male subjects receiving ascending single oral oral doses of Px-102
      to assess the safety and tolerability, pharmacokinetics and pharmacodynamics.
    

Intervention name(s): Px-102; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Px-102 drinking solution, 7 single ascending doses from 0.15 mg/kg up to 4.5 mg/kg; Oral drinking solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Evaluation of the Use of a Urin Test Strip to Determine the Spread of Schistosoma Infections in Areas Where Schistosomiasis Infections Are Low in Kenya
Condition: Schistosomiasis Mansoni; Circulating Cathodic Antigen Urine Based Dipstick
MeSH terms: Schistosomiasis; Schistosomiasis mansoni
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the use of a urine test strip in diagnose
      schistosoma mansoni in areas of Kenya where the rate of infections are low.

      The hypothesis is that the urine strip test is a superior tool to the conventional
      parasitological tools used to diagnose schistosomiasis mansoni infections in area where there
      is low transmission
    

Detailed description: 
      The study will compare the use of the urine test strip with the conventional method used and
      with a "golden standard" methode, in an area of Kenya where the infection transmission is
      low. Furthermore will the urine test strip be evaluatied in its ability to monitor the
      intensity of infections in school children before and after they are been treated for the
      infections.

      A total of 1100 school children in the age between 10 and 18 years will be included in the
      study. Children have to submitt a stool and a urine sample on three consecutive days.
      Children who are found to be infected with the schistosomiasis parasite will be offered
      treatment.
    

Keywords: schistosomiasis; Schistosoma mansoni; Circulating cathodic antigen urine dipstick
Sit-to-stand and Peripheral Muscle Strength in COPD
Condition: COPD
Study type: Interventional

Summary: 
      Background: Individuals with COPD may present reduced peripheral muscle strength, which leads
      to impaired mobility. Comprehensive pulmonary rehabilitation (PR) should include strength
      training, in particular to lower limbs. Furthermore, simple tools for the assessment of lower
      extremity muscles' performance are required. Objectives: To assess the muscle strength of
      COPD patients by the sit-to-stand test (STST) as compared to the one-repetition maximum
      (1-RM), considered as the gold standard in non-laboratory situations, and to evaluate the
      responsiveness of STST to a PR program with specific strength training (SPR), compared to
      usual PR program (UPR). Methods: 60 moderate-to-severe COPD inpatients were randomly included
      into either the SPR or into the UPR. 30-sec STST, 1-min STST, 1-RM and 6MWT were assessed
      before and after PRs.
    

Detailed description: 
      Background: Individuals with COPD may present reduced peripheral muscle strength, which leads
      to impaired mobility. Comprehensive pulmonary rehabilitation (PR) should include strength
      training, in particular to lower limbs. Furthermore, simple tools for the assessment of lower
      extremity muscles' performance are required. Objectives: To assess the muscle strength of
      COPD patients by the sit-to-stand test (STST) as compared to the one-repetition maximum
      (1-RM), considered as the gold standard in non-laboratory situations, and to evaluate the
      responsiveness of STST to a PR program with specific strength training (SPR), compared to
      usual PR program (UPR). Methods: 60 moderate-to-severe COPD inpatients were randomly included
      into either the SPR or into the UPR. 30-sec STST, 1-min STST, 1-RM and 6MWT were assessed
      before and after PRs.
    

Intervention name(s): rehabilitation
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sit-to-stand test; Muscle strength; Pulmonary rehabilitation
Prospective Study of Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer
Condition: Locally Advanced Rectal Carcinoma
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this clinical trial is to investigate total neoadjuvant therapy (TNT) using short
      course radiation therapy (SCRT) followed by full course of chemotherapy then surgery in
      locally advanced rectal cancer. The main questions it aims to answer are:

        -  Is total neoadjuvant treatment in this design safe & tolerable?

        -  Impact of this design on treatment related outcomes in terms of pathological and
           clinical responses.
    

Detailed description: 
      Patients will be assigned to an experimental arm in which preoperative short course 5 x 5 Gy
      radiation therapy is followed by six cycles of combination chemotherapy (capecitabine and
      oxaliplatin) and surgery within 4-6 weeks
    

Intervention name(s): short course radiation therapy followed by 6 cycles of CAPOX then surgery
Intervention type(s): Radiation
Intervention description(s): Short course RT 5 x5 Gy followed by 6 cycles CAPOX then surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: advanced rectal cancer- short course radiation - chemotherapy-surgery