bioihbjkbjnl/mcl2 huggingface dataset:
A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This first in human study will evaluate the safety, tolerability, pharmacokinetics (PK), and
      pharmacodynamics (PD) of PF-06826647 in healthy subjects and subjects with plaque psoriasis.
    


Intervention name(s): PF-06826647 tablet; PF-06826647 oral suspension; Placebo oral solution/suspension; Placebo tablet
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): PF-06826647 tablet for oral administration; PF-06826647 suspension for oral administration (oral suspension to be administered to the 3mg starting dose cohort only); placebo oral solution for the single ascending dose, first cohort only; Matching placebo tablet
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Combination single and multiple ascending dose design. Cohorts of participants are assigned to receive interventions based on acceptable safety, tolerability, and pharmacokinetics of previous dose cohort
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System 0.025 mg/Day and Climara® Transdermal System 0.025 mg/Day
Condition: Healthy
MeSH terms: Tissue Adhesions
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study was to compare the adhesive quality of a new formulation
      of the Mylan Estradiol Transdermal System with that of Climara® Transdermal System following
      a single system application in 80 healthy postmenopausal female volunteers. As a secondary
      objective, primary dermal irritation was assessed after removal of each transdermal system.
    


Intervention name(s): Mylan Estradiol Transdermal System 0.025 mg/day; Climara® Transdermal System 0.025 mg/day
Intervention type(s): Drug; Drug
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Ultrasound-guided Neuromodulation Percutaneous
Condition: Low Back Pain
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      Chronic low back pain (LBP) is one of the most familiar musculoskeletal pains and alone has
      been the main origin of years lived with disability for the past three decades. LBP is
      identified as a nonspecific, painful or mechanical situation in the lower back, buttocks, or
      hips. Although an underlying origin in chronic LBP has been proposed to be due to a multitude
      of factors, a muscle hip disbalance has been recognized5. A limited hip internal rotation
      range of motion (IR-ROM) and hip abductor weakness were found in patients with LBP symptoms7

      In the field of Physiotherapy, ultrasound-guided Percutaneous Neuromodulation (PNM) is
      defined as the application through a needle with ultrasound guidance of an electrical current
      at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve
      in some point of its trajectory, or of a muscle in a motor point, with a therapeutic
      objective. However, authors hypothesize that neuromodulation (especially the US-guided PNM
      technique) may be used to obtain more therapeutic effects, including pain relief.

      The main aim of this study was to investigate the effect of hip muscle strengthening by a
      simple single-shot procedure with the US-guided PNM technique in people with LBP. A second
      purpose was to discover if the stimulation point in the sciatic nerve territory may influence
      the change of strength in these patients Sixty subjects will be recruited, which will be
      divided into 3 groups: group 1 to which PNM will be applied to the sciatic nerve in the
      gluteus region; group 2 to which PNM will be applied to the sciatic nerve in the middle of
      the thigh; and group 3 to which PNM will be applied to the sciatic nerve before popliteus
      region. The PNM intervention with NMP will consist in the single application of an asymmetric
      rectangular biphasic current (250 microseconds, 3 Hz) during 90 seconds
    


Intervention name(s): NMP
Intervention type(s): Other
Intervention description(s): Participants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, with 3 Hz frequency and a 250µs pulse width, at the maximal tolerable intensity, to cause an tolerable muscle contraction. The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations. A trained physiotherapist performed the PNM intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Analysis of Diphenylcyclopropenone (DPCP) in Normals
Condition: Healthy Volunteers
Study type: Observational

Summary: 
      The drug diphenylcyclopropenone, or DPCP, modifies the immune system and has been shown to be
      effective in treating certain kinds of cancer. This study hopes to improve our understanding
      of how this drug helps create an effective immune response.
    

Detailed description: 
      The immune system is the primary line of defense against infections and other things
      perceived as foreign to the body. Unfortunately, this immune system often fails to eliminate
      tumors or other cancerous growths. The drug diphenylcyclopropenone, or DPCP, modifies the
      immune system and has been shown to be effective in treating certain kinds of cancer. This
      study hopes to improve our understanding of how this drug helps create an effective immune
      response. In order to reach this goal, normal volunteers will be given the DPCP drug in the
      form of a gel or a placebo gel (gel without the active chemical) on a few small areas of
      skin. Then, biopsies will be taken of the skin at the sites where the active drug was placed.
      Also, small biopsies will be taken from opposite areas of skin which received placebo gel to
      serve as controls. The biopsied skin samples will then be studied by methods such as
      immunohistochemistry and microarray analysis which will help define the immune reaction
      caused by DPCP. The rationale for the study is to better understand how the immune system can
      be activated to produce cells that may fight infections or cancers.
    

Intervention name(s): Diphenylcyclopropenone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Topical administration; Placebo
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy Volunteers
      
Biospecimen description: 
      Skin Biopsy
Neuroimaging Study of Factors Related to Exercise
Condition: Obesity
Study type: Interventional

Summary: 
      This study aims to support the hypothesis that brain processes underlying reward processing
      and impulse control contribute to obesity and to adherence in a new exercise regimen.
    

Detailed description: 
      This is a nonrandomized trial with groups being defined by BMI and adherence status to the
      exercise intervention.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: reward processing; impulse control; obese; clinically obese
Postoperative Pain and Discomfort After Orbital Decompression
Condition: Surgery; Anesthesia; Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the postoperative pain and discomfort using
      flurbiprofen axetil or nalbuphine administration after orbital decompression under general
      anesthesia.
    

Detailed description: 
      To investigate postoperative analgesia achieved with intraoperative administration of
      intravenous nalbuphine and flurbiprofen axetil in patients undergoing orbital decompression
    

Intervention name(s): Nalbuphine; Flurbiprofen Axetil; Nalbuphine and Flurbiprofen Axetil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Nalbuphine administration during surgery; Flurbiprofen axetil administration during surgery; Nalbuphine and Flurbiprofen Axetil administration during surgery
Intervention MeSH terms: Flurbiprofen; Flurbiprofen axetil; Nalbuphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: postoperative pain; general anesthesia; postoperative discomfort
Outcome After TIPS
Condition: Hypertension, Portal; Liver Cirrhosis; Variceal Hemorrhage; Ascites Hepatic
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Hemorrhage; Ascites
Study type: Observational

Summary: 
      This clinical trial is a retrospective single-centre study. Research data will be acquired
      via patient histories stored in the hospital data system. Data of patients who received a
      Transjugular Intrahepatic Portosystemic Shunt (TIPS) at the University Hospital Graz between
      1.1.2004 and 31.12.2017 will be included into the study. The aim is to investigate the
      outcome (transplantation free survival, time to (re)occurrence of ascites, occurrence of
      hepatic encephalopathy) of patients with portal hypertension after TIPS.
    

Detailed description: 
      The implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS) is a valuable
      measure to reduce portal hypertension and prevent portal hypertension-related complications.
      It can be used as a symptomatic treatment in patients with chronic portal hypertension as
      well as for the treatment of active variceal bleedings or large gastrointestinal varices that
      go along with threatening bleeding danger.

      However, this invasive procedure carries a high risk for complications. 30-days mortality
      after TIPS implantation amounts between 4% and 45%.

      A common complication is the (initial) manifestation or deterioration of hepatic
      encephalopathy, which occurs in 33-46 % after TIPS implantation.

      Other complications that are directly related to the intervention are bleeding, infections
      and stent migration.

      Aim of this retrospective single centre study is to investigate the long-term outcome after
      TIPS implantation with regard to transplantation free survival and time to (re-) occurrence
      of portal hypertension-related complications, especially ascites and hepatic encephalopathy.

      Intervention-related complications as well as long-term effects should be evaluated to
      facilitate the decision for or against TIPS.
    

Intervention name(s): no intervention - retrospective analyses
Intervention type(s): Other
Intervention description(s): retrospective data examination, there are no study related interventions
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients at the age of 18-90 years who received a Transjugular Intrahepatic Portosystemic
        Shunt at the University Hospital of Graz/Austria between 1.1.2004 and 31.12.2017
Impact of Health Education Learning Package Against Intestinal Parasitic Infections Among Orang Asli Children
Condition: Intestinal Parasitic Infections; Knowledge, Attitudes, Practice
MeSH terms: Infections; Communicable Diseases; Parasitic Diseases; Intestinal Diseases, Parasitic
Study type: Interventional

Summary: 
      A health education learning package (HELP) has been improved and evaluated for its impact
      against intestinal parasitic infections among Orang Asli schoolchildren in West Malaysia. 13
      schools were allocated into two groups (intervention and control groups) and the impact of
      HELP was evaluated after 3 and 6 months of baseline assessment and HELP intervention.
    

Detailed description: 
      This study was conducted to evaluate the impact of an improved health education learning
      package (HELP) against intestinal parasitic infections among Orang Asli schoolchildren in
      West Malaysia. The package has been tested by a pilot study in 2013 among children in 2
      schools in Pahang state.

      In the current study, HELP package has been improved and children from 13 primary schools in
      11 districts of six states in Peninsular Malaysia were allocated into two groups
      (intervention and control groups) and the impact of HELP was evaluated after 3 and 6 months
      of baseline assessment and HELP intervention.

      The evaluation involved soil-transmitted helminth infections and intestinal protozoa
      infections.
    

Intervention name(s): Health education learning package
Intervention type(s): Other
Intervention description(s): Health education learning package (HELP) was introduced to children in the selected schools. The package involved different items and activities during the study period, e.g. comic booklet on the intestinal parasitic infections, stand banners, posters, lectures, songs, drawing competition, puppet show, lectures, with a toolkit that involved soap, slipper (plastic clogs shoes), & nail clipper).
Other intervention name(s): HELP
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups; intervention group that involved schools where HELP will be administered and control group that involved schools that will not receive health education.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Intestinal Parasitic Infections; Soil-transmitted helminth infections; Health education
FOLFOXIRI With or Without Cetuximab as First-line Treatment of Patients With Non-resectable Liver - Only Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      PURPOSE:

      A primary aim of phase II FOCULM study is to explore whether cetuximab in combination with
      FOLFOXIRI as first treatment could improve surgical conversion in patients with KRAS/NRAS
      wild-type, unresectable liver - only metastases of colorectal cancer. The first secondary aim
      is to evaluate the safety and tolerability of the chemotherapy of FOLFOXIRI plus Cetuximab
      targeted therapy regimen in this patient population.

      Secondary aims include determination of objective response rate, progression free survival,
      quality of life and time to recurrence for patients undergoing complete resection and/or
      ablation of liver.
    

Detailed description: 
      Patients will be randomized to two therapy groups:

      Experimental arm A: Chemotherapy with FOLFOXIRI + Cetuximab Standard arm B: Chemotherapy with
      FOLFOXIRI
    

Intervention name(s): FOLFOXIRI + Cetuximab; FOLFOXIRI
Intervention type(s): Drug; Drug
Intervention description(s): Cetuximab 500mg/m² + irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle until PD or resectability or to max. 12 cycles; Irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle until PD or resectability or to max. 12 cycles
Other intervention name(s): Cetuximab; Irinotecan; Oxaliplatin; Leucovorin; 5-Fluorouracil; Irinotecan; Oxaliplatin; Leucovorin; 5-Fluorouracil
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Irinotecan; Cetuximab; Levoleucovorin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colorectal cancer; Metastatic colorectal cancer; Liver metastases; Liver resection; Liver ablation; Conversion therapy; FOLFOXIRI; Cetuximab; Oxaliplatin; Irinotecan; Leucovorin
Characterization of Placebo Responses in Stable Asthma
Condition: Asthma Placebo Effects
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The investigators hypothesize that different placebos will have different effects on
      subjective and objective asthma outcomes compared with actual therapy and natural history. .

      Subjects with asthma are randomly treated with placebo inhaler, placebo acupuncture,
      albuterol inhaler, or "no treatment" in random order, on three different occasions each. At
      each of the 12 visits, spirometry is performed repeatedly over 2 hours. Maximum FEV1 achieved
      and an 11-point, self-reported scale of improvement are examined.
    


Intervention name(s): albuterol; placebo inhaler; placebo acupuncture
Intervention type(s): Drug; Drug; Procedure
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Genetic & Environmental Determinants Of Immune Phenotype Variance: A Longitudinal Assessment
Condition: Healthy Subjects
Study type: Observational

Summary: 
      Effects of aging, genetics and environmental exposures on immune variation in a previously
      well-defined healthy population (NCT03905993).
    

Detailed description: 
      Susceptibility to infections, disease severity, and response to medical therapies and
      vaccines are highly variable from one individual to another.

      Individual heterogeneity in the immune response can have an enormous impact on the likelihood
      to respond to therapy or the development of side effects secondary to vaccine administration.
      Because of the complexity of immune responses in the individual and within the population, it
      has not been possible thus far to define the parameters (genetic or environmental) that
      constitute a healthy immune system and its natural occurring variability.

      The overall aim of the Milieu Intérieur study (NCT03905993) is to define the parameters that
      characterise a healthy immune response and its natural variation across individuals, and in
      doing so, inform clinical strategies for managing disease. To achieve this, in 2012, a total
      of 1000 healthy volunteers, descendants of mainland French persons for at least three
      generations, split equally by sex (1:1 sex ratio) and stratified across five-decades of life
      were recruited.

      With the first data collection (clinical study), key fundamental insights were gained. The
      project has also established a rich sample and data repository, supporting ongoing
      integrative research in systems immunology and personalized medicine.

      To provide a longitudinal assessment of the immune variation observed in the Milieu Intérieur
      cohort, this research aim to perform a follow-up study of the cohort, 10 years after the
      initial study.
    

Intervention name(s): Human Biological Samples
Intervention type(s): Other
Intervention description(s): Blood, urine, nasal swab, fecal samples
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults subjects, aged from 30 to 79 years old that provided samples for the initial
        Milieu Intérieur study
      
Biospecimen description: 
      serum, plasma, urine, nasal swab, fecal samples
    
Keywords: Immune response; Immune system; genotype-to-phenotype association; genetic variability; reference-based population
Antibiotic Treatment to Patients With Low Back Pain
Condition: Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      A large proportion of patients with Low Back Pain (LBP) (80 %) are classified as
      "non-specific", due to the lack of a patho-anatomical diagnosis. This term is not
      satisfactory, since it implies uncertainty for both the patient and the clinician. Modic
      changes have recently been identified as a pain giving patho-anatomical diagnosis for a
      considerable percentage (20-30 %) of LBP patients. The causes of these Modic changes have not
      been determined conclusively but bacterial infection is among the plausible causes for those
      following a disc herniation.

      Purpose The aim of this study is to assess the clinical effect of antibiotic treatment
      compared to placebo, in patients with LBP and Modic changes following a lumbar herniated
      disc.

      Design A double blind prospective clinically controlled trial. Patients will be randomized by
      a blinded observer to either Group A: 1 antibiotic tablet 45 patients Group B: 1 placebo
      tablet 36 patients Group C: 2 antibiotic tablets 45 patients Group D: 2 placebo tablets 36
      patients

      The patients will take the drug three times a day for 100 days.
    


Intervention name(s): Bioclavid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500 + 125 mg times 3 or 6
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low Back Pain,
Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression
Condition: Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study patients with treatment resistant depression, as defined by Harold Sackeim, is
      subjected to daily sessions, for eight weeks, with Pulsating ElectroMagnetive Treatment
      (PEMF). Treatment is given two times a day, in the morning and in the afternoon. Patients are
      randomized into two groups. In group A patients receive active treatment both morning and
      afternoon. In group B patients receive one sham and one active treatment. The study is
      double-blind as neither the assessors or patients are aware of treatment allocation. Each
      session lasts 30 minutes. Patients are psychometrically assessed weekly for depression
      severity and side effect. After this intervention period patients are followed for further
      three weeks without PEMF treatment. Patients are on unchanged medication for the whole of the
      study period.
    


Intervention name(s): Re5 Pulsating ElectroMagnetic Fields; Re5 Pulsating ElectroMagnetic Fields (PEMF)
Intervention type(s): Device; Device
Intervention description(s): Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF):
30 minutes of active PEMF therapy in the morning and 30 minutes of active PEMF therapy in the afternoon; Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF):
30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)
Other intervention name(s): T-PEMF = Transcranially applied PEMF; T-PEMF = Transcranially applied PEMF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized Controlled Trial; Major depression; Hamilton; PEMF