bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Lumbar Stabilization Exercise and Gait Training on Lower Back Muscles- Electromyographic(EMG) Analysis
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effective exercise protocol in chronic low back
      pain patients.
    

Detailed description: 
      -  Design: Prospective study

        -  Setting: hospital rehabilitation department

        -  Intervention: Participants are randomly assigned 4 different exercise group: flexibility
           exercise, bracing exercise + stabilization exercise group, bracing exercise+ walking
           exercise group and bracing+ walking + stabilization exercise group

        -  Main outcome measures: Numeric rating scale(NRS), Oswestry disability index Peak torque
           of lumbar extensor by surface electromyography Time duration of capability of
           maintenance the posture
    

Intervention name(s): exercise
Intervention type(s): Behavioral
Intervention description(s): stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.
bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."
walking exercise: treadmill gait with tolerable gait speed
flexibility exercise: stretching exercise(control)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; exercise; electromyography
C-Reactive Protein as a Predictor of Stem Cell Transplant Complications
Condition: Cancer; Leukemia; Stem Cell Transplantation
MeSH terms: Leukemia
Study type: Observational

Summary: 
      The purpose of this study is to determine if C-Reactive Protein levels are predictive for
      complications post transplant.
    


Intervention name(s): C-Reactive Protein levels
Intervention type(s): Behavioral
Intervention description(s): Each patient enrolled in the study will have a serum quantitative c-reactive protein (crp) level drawn on the day of transplant, day 7 of transplant, and twice weekly after that until recovery of neutrophil count (approximately 20-25 days). Patients will be followed for 100 days post-transplant for the development of the following complications:
Sepsis- defined as fever, positive blood culture, need for fluid resuscitation and/or pressor support.
Acute GVHD > grade II defined according to the Seattle criteria
VOD- defined according to the modified Seattle criteria
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children undergoing a stem cell transplant
      
Keywords: cancer; leukemia; stem cell transplant; complications
Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Moist Wound Healing Dressing Alone in Accelerating the Epithelialization of Split Thickness Skin Graft Donor Sites
Condition: Accelerating the Epithelialization of Split Thickness Skin Graft
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study the wound reepithelialization of that part of the skin graft donor site, which
      is treated with Oleogel-S10 compared to that part of the wound, which is covered by moist
      wound healing dressing alone will be investigated.
    

Detailed description: 
      As a first step, an adequate size of the wound healing dressing (Mepilex) is taken and cut in
      half. Then, half of the SSG (split skin graft) wound is covered conventionally by applying
      one half of the Mepilex cut. Afterwards Oleogel-S10 is applied to the other half of the
      Mepilex cut, which is used to cover the other half of the SSG wound. Both parts of the
      Mepilex dressings are then covered by an additional conventional dressing.

      Oleogel-S10 is always applied to the same part of the SSG wound for each patient,
      respectively, depending on the randomization of the patient, either towards the periphery of
      the body, i.e. the lower part of the leg, or towards the centre part of the body, i.e. the
      upper part of the leg. In order to avoid a confusion about which part has to be treated with
      Oleogel-S10, the healthy skin next to the SSG wound will be marked with ink for indication of
      the Oleogel-treated part of the wound.

      Each day during the treatment period, whenever the wound dressing is changed, a clinical
      examination and assessment of the progress of epithelialization of the SSG wound will be
      conducted, including evaluation of tolerance, and photos of the wound without dressing will
      be taken.

      A blinded assessment of the efficacy is conducted by two independent investigators using the
      macro-photos of every day, when wound dressings were changed, and a final examination is
      done. In this assessment, the third part of the SSG wound that is in between the left and
      right parts is neglected.
    

Intervention name(s): Oleogel-S10; Moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor site
Intervention type(s): Drug; Procedure
Intervention description(s): Oleogel-S10 on one half of the skin graft donor site (each time when the wound dressing is changed during a time period of 14 days, normally once daily); wound is covered conventionally by applying one half of the Mepilex cut
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: wound reepithelialization
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC
      over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease
    


Intervention name(s): CT-P13 SC (Infliximab); Placebo SC
Intervention type(s): Biological; Other
Intervention description(s): Subcutaneous injection of CT-P13 SC; Subcutaneous injection of Placebo SC
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Lymphocyte Count as a Sign of Immunoparalysis and Its Correlation With Nutritional Status in Septic Pediatric Patients
Condition: Lymphopenia
MeSH terms: Lymphopenia
Study type: Observational

Summary: 
      Participants were classified as normal or malnourished according to anthropometric measures.
      Serum albumin and zinc were recovered on the 1st and 7th days of hospitalization. Lymphocyte
      count was also recorded on the 1st and 7th days.
    

Detailed description: 
      The investigators enrolled 14 consecutive patients with sepsis. Patients were classified as
      normal or malnourished according to anthropometric measures. As an additional evaluation of
      nutritional status, serum albumin and zinc were recovered on the 1st and 7th days of
      hospitalization. Lymphocyte count was also recorded on the 1st and 7th days. Investigators
      correlated nutritional status with lymphocyte count and zinc dosage.
    

Intervention name(s): lymphocyte count
Intervention type(s): Other
Intervention description(s): lymphocyte count
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        pediatric septic patients
      
Keywords: Nutrition; Lymphocyte Count; Immunoparalysis; nutritional status of septic patients
Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception
Condition: Pregnancy
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      The purpose of this study is to see if women presenting for emergency contraception (EC) are
      willing to accept the copper intrauterine device (IUD). This study will also compare the use
      of effective methods of contraception between women who selected the copper IUD or Plan B 6
      months after they received EC.
    

Detailed description: 
      This study seeks to estimate the acceptance of Copper IUD use amongst people presenting for
      EC. This will be accomplished by offering all women who present for EC at participating
      Planned Parenthood Association of Utah (PPAU) clinics during the study period the option of
      having the copper IUD or Plan B. Women who agree to study participation will be followed for
      6 months. The primary outcome for the study is the use of a reliable method of contraception
      6 months after presenting for EC.

      Secondary outcomes measured will be pregnancies, abortions, repeat Plan B use, presence of
      gonorrhea or Chlamydia infection at the time of presentation for EC, number of days to first
      bleeding episode and duration of that bleeding episode, further bleeding patterns, frequency
      of unprotected intercourse, use of a barrier method for prevention of sexually transmitted
      infections, patient satisfaction with the chosen method and symptoms possibly related to
      contraception use. Patients selecting the IUD will be assessed for IUD expulsion,
      perforation, and removal.
    

Intervention name(s): Copper T380 IUD; levonorgestrel
Intervention type(s): Drug; Drug
Intervention description(s): Copper T380 IUD; 1.5 mg
Other intervention name(s): Paragard IUD; Plan B
Intervention MeSH terms: Copper; Levonorgestrel
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: contraception; emergency contraception; pregnancy prevention after unprotected intercourse
Shared Decision Making in Rural Primary Care Lung Cancer Screening and Smoking Cessation
Condition: Lung Cancer; Smoking Cessation
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      The intervention is aimed to improve adherence to the lung cancer screening (LCS) guidelines
      and Centers for Medicare and Medicaid Services (CMS) coverage criteria to conduct shared
      decision-making (SDM) and provide smoking cessation services in rural primary care practices.
    

Detailed description: 
      The pilot intervention will engage no more than 300 patients using a pragmatic, pre-post
      design guided by an enhanced RE-AIM/PRISM framework. The primary goal of this intervention is
      to improve LCS practice by offering a formal SDM process and smoking cessation support
      aligned with the CMS coverage criteria. The investigators will conduct a type II
      effectiveness implementation hybrid trial using a stepped wedge design to evaluate the
      effectiveness (co-primary outcomes of LCS and decision quality) and implementation at four
      rural clinics. Space precludes discussion of pragmatic design features, but this study was
      designed to be pragmatic using the PRECIS-2 criteria and it scores highly on almost all
      PRECIS-2 dimensions.

      Each clinic will recruit the minimum of 9 patients eligible to LCS (based on CMS guidelines)
      every 2 months for the total of 8 months. The first period of 2 months is for baseline data,
      the second period of 2 months is for step 1 of the stepped wedge design, the third period of
      2 months is for step 2 and finally the last 4th period of 2 months is for step 3 of the
      stepped wedge design. Each participating patient will receive 2 surveys (one immediately
      after the doctor's visit and a second one a month later). The intervention will be in the
      form of patient decision aid (information flyer) the participant receives during a healthcare
      provider visit.
    

Intervention name(s): Patient decision aid
Intervention type(s): Other
Intervention description(s): Each subject will receive an informational flyer describing lung cancer screening options and smoking cessation from a trained person on the medical staff at each clinic. Staff will lead a shared decision-making discussion with the patient.
Other intervention name(s): Informational flyer
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: A type II effectiveness implementation hybrid trial will be conducted using a pre-post design to evaluate the effectiveness (co-primary outcomes of LCS and decision quality) and implementation at four rural clinics.
Masking: None (Open Label)
Primary purpose: Prevention
The Effects of Morphine on Desflurane Consumption and Recovery Time
Condition: Abdominal Hysterectomy (& Wertheim)
Study type: Interventional
Phase: Phase 4

Summary: 
      Combination of volatile and opioid agents are used to achieve unconsciousness, haemodynamic
      stability and analgesia for surgical prosedures. This prospective, randomized, double-blind,
      controlled study evaluates the effects of two different doses of morphine sulphate (0.1 mg/kg
      and 0.2 mg/kg), on desflurane consumption, recovery characteristics, postoperative analgesic
      requirements and side effects during total abdominal hysterectomy.
    


Intervention name(s): Morphine
Intervention type(s): Drug
Intervention description(s): Group Saline (Group S): Received i.v saline 0.9 % in 10 ml volume (n=30) Group Morphine 1 (Group M1): Received i.v morphine 0.1 mg kg-1 in 10 ml volume (n=30) Group Morphine 2 (Group M2): Received i.v morphine 0.2 mg kg-1 in 10 ml volume (n=30)
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Durvalumab Plus Chemotherapy in ES-SCLC (Oriental)
Condition: Small Cell Lung Carcinoma Extensive Disease
MeSH terms: Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      This will be an open-label, single-arm, multicenter, Phase IIIb study to determine the safety
      of durvalumab + etoposide and cisplatin or carboplatin as first-line treatment in patients
      with extensive stage small-cell lung cancer.
    


Intervention name(s): Durvalumab plus chemotherapy
Intervention type(s): Drug
Intervention description(s): Drug: Durvalumab IV infusions every 3 weeks for 4-6 cycles and every 4 weeks thereafter until PD or other discontinuation criteria.
Drug: Carboplatin 4-6 cycles every 3 weeks
Drug: Cisplatin 4-6 cycles every 3 weeks
Drug: Etoposide 4-6 cycles every 3 weeks
Intervention MeSH terms: Durvalumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Antidepressant Effects of Rellidep in Major Depressive Disorder
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators hypothesize that Rellidep will be effective in improving the symptoms of
      major depression. The available evidence strongly suggests that Rellidep contains a mood
      altering ingredient or ingredients. This open-label, non-randomized study sets out to
      validate its potential antidepressant activity.The study will include secondary aims of
      evaluating the effect of Rellidep on reducing symptoms of anxiety, a common symptom
      associated symptom of depression and improving quality of life.

      About twenty-five patients with major depressive disorder will be assigned to open-label
      Rellidep (2000 mg/day) for a period of 8 weeks. All patients will be assessed by various
      measures of global improvement, depression, quality of life, sexual experience, anxiety and
      measures of side effects as well as standard laboratory tests.
    


Intervention name(s): Rellidep
Intervention type(s): Drug
Intervention description(s): 2000 mg P.O. daily for 8 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: major depression; antidepressant; quality of life; anxiety
Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 With Neulasta
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess
      PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of
      CHS-1701 (Coherus pegfligrastim) or 6mg SC dose of Neulasta (pegfilgrastim) given during each
      period.
    

Detailed description: 
      This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess
      PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of
      CHS-1701 or 6mg SC dose of Neulasta given during each period.

      The screening period may occur up to 28 days prior to the confinement period. After
      screening, eligible subjects will be randomly assigned to one of three possible treatment
      sequences. Treatments will be spaced by not less than 28 days.
    

Intervention name(s): CHS-1701; Pegfilgrastim
Intervention type(s): Drug; Drug
Other intervention name(s): Neulasta
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: Bioequivalence
The Effect of Exercise on Gut Microbiota in Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus; Insulin Sensitivity/Resistance
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      To investigate whether targeted lifestyle intervention (exercise), induces a change in
      intestinal fecal microbiota related to improved glycemic control and systemic inflammation in
      patients with DM type 2.
    

Detailed description: 
      Diet and exercise are the most beneficial lifestyle interventions in patients with diabetes
      mellitus (DM) type 2, causing an increase in glucose tolerance.

      One of the mechanisms through which these treatment modalities work might be explained
      through changes in the gut microbiota. Recent studies show that the chronic inflammatory
      status causing insulin resistance in DM type 2, is triggered by an increase in circulating
      bacterial lipopolysaccharide (LPS). Strict lifestyle intervention, such as exercise, so
      called Diabetes Bootcamp (DB), may manipulate the gut microbiota, reducing circulating LPS,
      causing an improvement of the insulin-mediated
    

Intervention name(s): Combined aerobic and strength exercise
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gut microbiota
A Phase I, Dose-Escalation Study to Assess the Safety and Drug Levels in Blood of AZD4877 in Japanese Adult Patients
Condition: Cancer; Tumors; Carcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the safety and tolerability of AZD4877 on a
      weekly schedule in Japanese patients with advanced solid malignancies
    


Intervention name(s): AZD4877
Intervention type(s): Drug
Intervention description(s): 10 mg IV (3 weeks treatment 1 week rest)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: solid tumors; solid malignancies
Phase 3 Study of MAP0004 in Adult Migraineurs
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double blind, placebo controlled, parallel group study of MAP0004 in
      adult migraineurs. Subjects will self administer study drug in the outpatient setting.
    


Intervention name(s): MAP0004; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. Placebo treated patients will receive MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks only.; Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine
The Role of Dietary Tryptophan on Aryl Hydrocarbon Receptor Activation
Condition: Diet Modification
Study type: Interventional

Summary: 
      This study evaluates the role of dietary L-tryptophan, an essential amino acid, in the
      activation of a specific cellular component: the aryl hydrocarbon receptor.
    

Detailed description: 
      The Aryl hydrocarbon receptor (AHR) is a ligand-dependent transcription factor implicated in
      a range of key cellular events. In the gut, AHR is crucial for maintaining intestinal barrier
      immune homeostasis. The physiology of the AHR, however, is not completely understood; its
      precise gut luminal activators and functional consequences are unknown.

      Some AHR ligands originate from the diet. Commensals play crucial roles in metabolizing
      tryptophan and other amino acids such as tyrosine, with the subsequent production of
      tryptophan metabolites. Previous studies show that inflammatory bowel disease (IBD) patients
      have impaired production of AHR agonists by the microbiota. Furthermore, dietary
      supplementation with tryptophan ameliorates clinical parameters of colitis in rodent models.
      Whether these findings translate into human pathophysiology has not been explored.

      In the present study, the investigators will evaluate the effect of high- versus
      low-tryptophan diet on AHR activation in healthy participants. Briefly, participants will be
      instructed to follow a standardized low-tryptophan diet and will be randomized to a 3-week
      L-tryptophan supplement or placebo. Later, after a 2-week washout period, participants will
      crossover to the other arm. In addition, the effect of tryptophan and microbiota-derived
      metabolites on AHR activation will be analyzed.
    

Intervention name(s): L-tryptophan; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 g/day of L-tryptophan added to the standardized low-tryptophan diet. Duration: 3 weeks.; A placebo will be added to the standardized low-tryptophan diet. Duration: 3 weeks.
Intervention MeSH terms: Tryptophan
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All subjects will be following a standardized low-tryptophan diet and randomized to L-tryptophan supplements or placebo, for three weeks. After a 2 weeks washout period, subjects will crossover to the other arm.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: immunity; Aryl-hydrocarbon receptor; immune homeostasis; microbiota; tryptophan