bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Temporomandibular disorders (TMDs) are one of the most common muco-skeletal disorders, seen
      in the dental clinics. Many factors work together to initiate or aggravate the condition, so
      it is a multifactorial disorder. The etiology of TMDs may be a result of parafunctional
      habits such as clenching and bruxism, acute trauma to the jaw, trauma from hyperextension
      e.g. after a long dental treatment, joint laxity, psychological distress, occlusal disharmony
      like presence of high crown or free-end saddle leading to joint instability or systemic
      diseases such as Rheumatoid arthritis or Osteoarthritis. The aim of this study was to
      evaluate the effects of naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, and
      naproxen sodium on pain in patients complaining from temporomandibular pain.
    


Intervention name(s): naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol
Intervention type(s): Drug
Intervention description(s): NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Other intervention name(s): Anaprox Double Strength (DS) + Codeine, Anaprox DS + Decadron, Anaprox DS, Parmol
Intervention MeSH terms: Acetaminophen; Dexamethasone; Naproxen; Codeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: naproxen sodium; codeine phosphate; dexamethasone; pain; temporomandibular joint
Effect of Sublimated Mare Milk Supplement on Gut Microbiome in Psoriasis Patients
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      This study evaluates the effect of dietary supplement consisting of sublimated mare milk on
      intestinal microbiota among psoriasis and healthy participants.
    

Detailed description: 
      The gut microbiome is believed to play an important role in the immune system regulation,
      since intestines are the largest lymphoid organ in a human body. Deviations from healthy
      composition of intestinal flora are associated with various diseases including allergy and
      autoimmunity. Psoriasis is the one of the long-lasting autoimmune diseases that is
      characterized by patches on the skin and further health complications throughout the life.
      However, lack of studies does not allow proper evaluation of role of gut microbiome in
      psoriasis patients. Therefore, potential interplay between gut microbiome and immune system
      in psoriasis would be studied in this clinical trial. Particularly, the investigators
      hypothesize that sublimated mare milk supplement can have an impact on gut immune system and
      gut microbiome composition in the psoriasis patients.

      In this trial, there will be two parallel groups: crossover psoriasis patients (standard
      treatment first for 3 months, next 3 months standard treatment plus sublimated mare milk
      supplement) and healthy volunteers group. Subsequently, association of intestinal flora with
      immune status will be analyzed and compared between these groups.
    

Intervention name(s): Sublimated mare milk
Intervention type(s): Dietary Supplement
Intervention description(s): The dietary supplement mare milk product, which is obtained from fresh (few hours) through sublimation process. This product is first mixed with warm water (37-38 degrees of Celsius) and then will be given to participants.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mare milk; gut microbiome; psoriasis; immune markers
Recovery and Muscle Function After Supplementation With Turmeric
Condition: Muscle Soreness; Pain; Muscle Damage
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      The objective of the study is to test the capacity of a five-day supplementation of Turmipure
      Gold® to improve exercise-induced muscle pain and function recovery in moderately active
      adults after exercise-induced muscle damage
    


Intervention name(s): Turmipure Gold®; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): TPG: Turmipure GOLD® - 1 capsule per day - as prescribed; Placebo: colored acacia gum - 1 capsule per day - as prescribed
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Turmeric; Curcuminoids; Sport performance & recovery
Study in Children With the Diagnosis of Congenital Diaphragmatic Hernia (CDH) and Oesophageal Atresia (EA)
Condition: Diaphragmatic Hernia; Oesophageal Atresia
MeSH terms: Esophageal Atresia; Hernias, Diaphragmatic, Congenital; Hernia; Hernia, Diaphragmatic
Study type: Observational

Summary: 
      Observational longitudinal study in children operated at birth on diaphragmatic hernia and/or
      oesophageal atresia : assessment of lung function parameters; assessment of quality of life
      and cognitive development; assessment of stress parenting and strategies of adaptation.
    

Detailed description: 
      Observational longitudinal study in children operated at birth on diaphragmatic hernia and/or
      oesophageal atresia : assessment of lung function parameters; assessment of quality of life
      and cognitive development; assessment of stress parenting and strategies of adaptation.

      Tools: Anamnestic-clinical questionnaire, Spirometry, Plethysmography, Fractional exhaled
      nitric oxide (FeNO) assessment (oral and alveolar ), 6-minutes walk test (WT 6'), Prick
      tests, Quality of life in children questionnaire(KINDL, quality of life), Psychological test
      for cognitive development (Raven Matrices)
    

Intervention name(s): Questionnaires
Intervention type(s): Other
Intervention description(s): For not collaborative patients, under the age of 4 years:
Standardized questionnaire collecting anamnestic-clinical data
Stress Parenting Index questionnaire and COPE brief questionnaire(Questionnaire assessing adaptation strategies of parents).
For collaborative patients, over the age of 4 years:
Standardized questionnaire collecting anamnestic-clinical data
Fractional exhaled nitric oxide (FeNO) assessment (oral and alveolar )
Spirometry
6-minutes walk test (WT 6')
Prick tests
Children Quality of life questionnaire (KINDL questionnaire)
Psychological test (Raven Matrices)
Stress Parenting Index questionnaire and COPE brief questionnaire (Questionnaire assessing adaptation strategies of parents)
Other intervention name(s): Standardized Questionnaires
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        33 Children operated at birth on diaphragmatic hernia and/or oesophageal atresia (age range
        : 5 months - 12 years old)
Distribution of Regional Lung Function by Vibration Response Imaging
Condition: Emphysema; COPD
MeSH terms: Pulmonary Emphysema; Emphysema
Study type: Observational

Summary: 
      Assessment of regional contribution of different areas of the lung to its integrated function
      is often required, such as prior to lung resection in the presence of tumor or emphysema.
      This assessment is derived from the proportion of zonal radionuclear perfusion or
      ventilation. The investigators hypothesized that lung VRI may provide an alternative approach
      to assess regional lung function.
    

Detailed description: 
      Patients diagnosed with moderate-to-severe COPD by lung function studies and clinical
      evaluation presented in stable clinical condition and were evaluated by lung sound recordings
      and quantitative V/Q lung scintigraphy. Regional signals (percentage of lung sounds) for left
      and right lungs were compared with the corresponding regional count percentages of each
      radionuclide scan, by V/Q scan regions of interest.
    

Intervention name(s): Observational study - no intervention
Intervention type(s): Other
Intervention description(s): Observational study - no intervention. Patients underwent VRI recordings and routine V/Q scan.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Males and females who were diagnosed with moderate-to-severe COPD by lung function studies
        and clinical evaluation
      
Keywords: Emphysema; COPD; lung sounds; vibration response imaging
S-1 in Combination With Abraxane in Treating Cholangiocarcinoma
Condition: Cholangiocarcinoma
MeSH terms: Cholangiocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II study was designed to evaluate the efficacy and safety of S-1 plus Abraxane as
      second-line treatment for cholangiocarcinoma.
    

Detailed description: 
      There are no standard second-line treatment for cholangiocarcinoma, new therapies are needed.
      The efficacy of S-1 as first-line treatment for cholangiocarcinoma was confirmed in several
      studies. The IMPACT study showed that Abraxane plus gemcitabine provide better survival than
      gemcitabine alone. Since cholangiocarcinoma displayed similar sensitivity to chemotherapy
      which was used in pancreatic carcinoma, we assume that S-1 plus Abraxane is effective and
      safe in treating cholangiocarcinoma.
    

Intervention name(s): S-1 plus Abraxane
Intervention type(s): Drug
Intervention description(s): Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8. S-1 chemotherapy was given based on the body surface area, <1.25 m2: 80mg/day, 1.25~1.5 m2: 100mg/day, ≧1.5 m2: 120mg/day. Given orally twice daily for 14 days, followed by 7 days without treatment.
Other intervention name(s): Paclitaxel Albumin-Bound Particles for Injectable Suspension; Gimeraciland Oteracil Porassium Capsules
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized Controlled Trial of ImmuKnow in Liver Transplantation
Condition: Liver Disease
MeSH terms: Liver Diseases
Study type: Interventional

Summary: 
      ImmuKnow detects cell-mediated immunity in solid-organ transplant recipients undergoing
      immunosuppressive therapy. Increasing ImmuKnow values indicate a decrease of
      immunosuppression and decreasing ImmuKnow values suggest an increase of immunosuppression.
      The test measures the amount of ATP produced in CD4+ lymphocytes as a biomarker of lymphocyte
      activation. This study uses the ImmuKnow assay to proactively adjust immunosuppressive
      therapy in adult liver transplant recipients to reduce the risk of adverse events
    

Detailed description: 
      We performed a randomized prospective interventional trial where the Interventional group had
      immunosuppression modified according to ImmuKnow values. Immunosuppression was decreased by
      25% if ImmuKnow values were less than 130 ng/mL ATP. Similarly, immunosuppression was
      increased by 25% if ImmuKnow values were greater than 450 ng/mL ATP. Immunosuppression of the
      Control group was managed by the Standard of Care at our institution. ImmuKnow was performed
      before liver transplant, after surgery and at each clinic visit with the approximate
      schedule: day 1; weekly, weeks 1-4; week 6; week 8; monthly, months 3-6; and months 9 and 12.
      ImmuKnow testing was repeated within 7 days of a suspected/confirmed rejection or infection
      and again within 1 week of resolution.
    

Intervention name(s): Tacrolimus regulation according to ImmuKnow values
Intervention type(s): Procedure
Intervention description(s): Tacrolimus dose was reduced by 25% when ImmuKnow values were below 130 ng/mL ATP and increased by 25% when ImmuKnow values exceeded 450 ng/mL. Further reductions or increases were made after serial measures until ImmuKnow values stabilized between 130 and 450 ng/mL ATP. The values of 130 and 450 ng/mL ATP were previously documented as thresholds for risks of infection and rejection, respectively with a value of 280 ng/mL corresponding with the greatest negative predictive value for either event
Other intervention name(s): Prograf
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: immune monitoring; immune cell function ImmuKnow; randomized controlled trial; immunosuppression management; infection; rejection; liver transplantation; Cylex
Cognitive Behavioural Therapy for Children With Autism Spectrum Disorder and Obsessive Compulsive Behaviour
Condition: Autism Spectrum Disorder; Obsessive-Compulsive Behavior
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Compulsive Behavior
Study type: Interventional

Summary: 
      Individuals with high functioning autism spectrum disorder (ASD) frequently experience
      obsessions and/or compulsions that are similar to those specified in Diagnostic and
      Statistical Manual of Mental Disorders (5th ed.; DSM-5) criteria for obsessive compulsive
      disorder (OCD). However, little research exists on effective interventions for OCD symptoms
      (referred to as OCBs) in ASD. In a randomized controlled trial, a manualized functional
      behavior-based cognitive-behavior therapy (Fb-CBT) consisting of traditional CBT components
      (psychoeducation and mapping, cognitive-behavioral skills training, exposure, and response
      prevention) as well as function-based behavioral assessment will be evaluated. Participants
      will be assigned randomly to Fb-CBT or treatment as usual (TAU). Primary and secondary
      outcome measures will be used to evaluate the efficacy of the treatment, and will be
      administered at pre and post-intervention as well as six month follow-up.
    


Intervention name(s): Functional Behavior-Based Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): Fb-CBT involved nine 2-hour weekly sessions with three to four children in each group and two therapists. Therapy consisted of group activities, individual work in parent-child dyads, group parent training, and social skills exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Behavioral Therapy
A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™
      with the existing formulation in infants. The primary hypothesis of the study is that the new
      formulation will be noninferior to the existing formulation on the basis of immunogenicity.
    


Intervention name(s): RotaTeq™ experimental formulation; RotaTeq™ existing formulation
Intervention type(s): Biological; Biological
Other intervention name(s): V260; V260
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Phase IIa Study Evaluating Safety and Efficacy of BL-8040 in Relapsed/Refractory AML Patients
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this clinical research study is to learn if BL-8040 in combination with
      cytarabine (Ara-C) can help to control the disease in patients with Acute Myeloid Leukemia
      (AML) that has relapsed or did not respond adequately to previous treatment. The safety of
      the study drug combination will also be studied.
    

Detailed description: 
      Open-label, multicenter, phase IIa, dose escalating study in subjects with
      relapsed/refractory AML, defined according to WHO criteria (1), including subjects who failed
      chemotherapy only and those who failed previous Autologous Stem Cell Transplantation (ASCT) /
      Allogeneic Stem Cell Transplantation (AlloSCT), provided at least 6 months have passed from
      transplant.

      Eligible subjects will receive subcutaneous (SC) injections of BL-8040 ("monotherapy period")
      over two days (one injection per day) followed by concurrent administration of BL-8040 with
      standard salvage chemotherapy ("combined period") over 5 days. During the "combined period,"
      BL-8040 will be administered 4 hours prior to chemotherapy. The chemotherapy will consist of
      cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age), administered intravenously (IV)
      over 3 hours, for 5 days and will not be escalated.

      The first part of the study (Part 1) will include escalating dose groups and be considered
      the 'escalation phase'. Six potential dose levels (see Table 1) will be investigated starting
      at dose level 1. Patients will be accrued in a conventional 3+3 design. Applying this study
      design, the first cohort of 3 patients will be treated at dose level 1 and evaluated for dose
      escalation.
    

Intervention name(s): Ara-C; BL-8040
Intervention type(s): Drug; Drug
Intervention description(s): IV; SC
Other intervention name(s): cytarabine; BL8040
Intervention MeSH terms: Cytarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML; Acute Myeloid Leukemia; Relapsed Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia
Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Giving the drugs in different combinations may kill more tumor
      cells.

      PURPOSE: This randomized phase II trial is studying combination chemotherapy containing
      irinotecan and oxaliplatin to see how well it works compared to two standard combination
      chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the efficacy, in terms of response rate (partial response and complete
           response), of irinotecan and oxaliplatin vs irinotecan, fluorouracil, and leucovorin
           calcium vs oxaliplatin, fluorouracil, and leucovorin calcium in patients with metastatic
           colorectal cancer.

        -  Compare the progression-free survival of patients treated with these regimens.

        -  Compare the tolerability of these regimens in these patients.

        -  Compare the quality of life of patients treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment
      arms.

        -  Arm I: Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on
           day 1.

        -  Arm II: Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2
           hours on day 1 and fluorouracil IV over 46 hours on days 1-2.

        -  Arm III: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2
           hours on day 1 and fluorouracil IV over 46 hours on days 1-2.

      In all arms, treatment repeats every 2 weeks for 26 courses in the absence of disease
      progression or unacceptable toxicity.

      Quality of life is assessed at baseline and then every 3 months for 1 year.

      Patients are followed at 2 months.

      PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.
    

Intervention name(s): FOLFIRI regimen; FOLFOX regimen; fluorouracil; irinotecan hydrochloride; leucovorin calcium; oxaliplatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Irinotecan; Calcium; Levoleucovorin
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage IV colon cancer; stage IV rectal cancer
Safety and Efficacy of EXC 001 in Subjects Who Have Participated in Prior Studies of EXC 001
Condition: Reduction in Severity of Skin Scarring
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to provide subjects who participated in prior studies of EXC 001
      the opportunity to have their hypertrophic scars surgically revised and treated with EXC 001.
    


Intervention name(s): EXC 001 (currently called PF-06473871)
Intervention type(s): Drug
Intervention description(s): Single dose administered by injection at four different times
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Skin scarring; cicatrix; hypertrophic scar; hypertrophic scar prevention
Medications Development for Drug Abuse Disorders
Condition: Opioid Related Disorders; Opioid Dependence; Opioid Addiction
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a study of tramadol as an agent for short-term opioid withdrawal treatment. A
      randomized, double blind clinical trial comparing the efficacy and safety of tramadol to
      clonidine and buprenorphine in the short-term treatment of opioid withdrawal will be
      conducted. Opioid dependent participants will be treated on a residential unit. The primary
      outcome measure is opioid withdrawal symptoms.
    


Intervention name(s): Buprenorphine/naloxone; Clonidine; Tramadol ER
Intervention type(s): Drug; Drug; Drug
Intervention description(s): up to 8/2 mg Sublingual (SL) per day; up to 0.8 mg per day (oral); up to 600 mg per day
Other intervention name(s): Suboxone; Catapres; Ultram
Intervention MeSH terms: Clonidine; Buprenorphine; Tramadol; Buprenorphine, Naloxone Drug Combination; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Study to Determine Safety and Efficacy of FPlus for Wrinkle Treatment
Condition: Facial Wrinkles and Rhytides Reduction
Study type: Interventional

Summary: 
      Patient demand for non-surgical, non-invasive, and no-downtime wrinkle and rhytides treatment
      procedures has grown dramatically over the past decade as new treatments and technologies
      have been introduced.

      This study was performed in order to evaluate the efficacy and safety of the Invasix FPlus
      System, an innovative noninvasive system intended for wrinkles and rhytides treatment.

      Subjects were treated for face wrinkles and rhytides reduction and followed for 3 months
      after last treatment. In order to evaluate treatment efficacy, pre and post treatment photos
      were introduced to three uninvolved physicians for blinded evaluation.
    


Intervention name(s): FPlus RF device for wrinkles and rhytide reduction
Intervention type(s): Device
Intervention description(s): Six RF weekly treatments for face wrinkles and rhytides reduction using the FPlus device.
Other intervention name(s): RF treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment