bioihbjkbjnl/mcl2 huggingface dataset:
Botanical Oils Study to Determine Genetic Differences in the Way Your Body Processes Fats in Edible Oils
Condition: Genetic Differences of Lipid Metabolism/Healthy Subjects
Study type: Interventional

Summary: 
      A randomized, controlled, cross-over clinical trial of borage oil vs soybean oil to determine
      whether the metabolism and/or impact of medium chain-polyunsaturated fatty acids (MC-PUFAs)
      in botanical oil supplements are changed in relationship to specific genotypes in a SNP
      (rs174537) strongly associated with FADS1 activity and PUFA metabolism.
    

Detailed description: 
      The study will be a randomized, controlled, cross-over clinical trial of borage oil and
      soybean oil to determine whether the metabolism and/or impact of MC-PUFAs in botanical oil
      supplements are changed in relationship to specific genotypes in a SNP (rs174537) strongly
      associated with FADS1 activity and PUFA metabolism. Subjects previously genotyped at rs174537
      will be given supplements and both blood PUFA (serum and erythrocyte membranes), urinary
      eicosanoids and eicosanoid release from whole blood (leukocyte generation) will be measured
      as biochemical determinants of genotype impact on supplement metabolism.

      To evaluate the effect of genotype at the rs174537 locus on the metabolism of MC-PUFAs in
      borage and soybean oil to long chain polyunsaturated fatty acids (LC-PUFAs), including
      arachidonic acid, the investigators will utilize a double blind, randomized, crossover
      design. There will be three study groups based on the genotype of the healthy volunteer at
      rs174537. Individuals within each genotype will be consented and screened up to 8 weeks prior
      to randomization and the start of the intervention. Subjects will be randomized to begin with
      4 weeks of either borage oil or soybean oil followed by an 8 week washout period, and then
      another 4 week period in which they take the second oil. Study visits will occur at 0, 2, and
      4 weeks during each oil supplementation period, in addition to the consenting visit, for a
      total of 7 visits during the study.
    

Intervention name(s): soybean oil and borage oil
Intervention type(s): Dietary Supplement
Intervention description(s): Compare the capacity of humans with GG, GT and TT genotypes at rs174537 taking soybean and borage oils to metabolize medium chain PUFAs.
Other intervention name(s): Botanical oil
Intervention MeSH terms: Borage oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Evaluation Study for the Programme DiaNe for People With Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designated to evaluate the effect of a patients' educational program called
      DiaNe® for consultation and support people with diabetic kidney disease in an early stage.
      The aim of the study is to examine if the program is suitable to stop deterioration of kidney
      function and to maintain or improve glycemic control. The consultation and support program
      DiaNe® substantially contributes to a better understanding of the affected clients for this
      complex clinical picture, allows them for specific interventions and creates the rationale
      for an active therapeutic relationship.
    

Detailed description: 
      According to statistics diabetes mellitus is considered to be the leading cause for end stage
      renal disease in Germany, approximately 35% of the patients starting on dialysis are affected
      by diabetes-induced nephropathy. This can be seen in countries all over the world. This
      situation has been known for years. To date, neither structured intervention methods nor
      educational programs have been designed for and targeting those affected, which would
      consequently allow for structured, multifactorial intervention at an early stage of diabetic
      nephropathy. Multifactorial interventions, as published in the Steno-2 trial, appear to be
      highly effective with regard to long-term complications of diabetes. In order to realize this
      approach for the affected as well as the medical staff caring for patients with
      diabetes-induced nephropathy we developed DiaNe®, a consultation and support program, which
      is designed to give detailed information to the affected in order to induce behavioral
      changes. We were able to show a clinically significant reduction of microalbuminuria within a
      first monocenter evaluation trial. We wanted to verify this effect by means of a prospective
      multicenter randomized cohort trial according to GCP-ICH guidelines.
    

Intervention name(s): DiaNe consultation and support program
Intervention type(s): Behavioral
Intervention description(s): the DiaNe consultation and support program for clients with diabetic nephropathy consists of 4 sessions at 90-120 minutes conducted every week in a period of 4 weeks
Other intervention name(s): DiaNe program, DiaNe(R)
Intervention MeSH terms: Cyproterone Acetate; Cyproterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: diabetes mellitus; diabetic nephropathy; hypertension
Intermittent Naltrexone Among Polysubstance Users
Condition: Methamphetamine; Alcohol
Study type: Interventional
Phase: Phase 2

Summary: 
      Naltrexone, a µ-opioid receptor antagonist, is a promising agent for methamphetamine-using
      and binge-drinking men who have sex with men (MSM). Naltrexone has shown efficacy in reducing
      relapse to amphetamines and is FDA-approved for alcohol dependence. Oral naltrexone is
      inexpensive and has few toxicities but the standard daily regimen for naltrexone is
      problematic as patients forget to take the medication. Given the challenges in daily dosing,
      alternate regimen schedules have been proposed to increase efficacy and expand the population
      that may benefit from this pharmacologic agent. One approach is intermittent targeted
      administration of naltrexone, whereby individuals take the medication as-needed in
      anticipation of substance use or during periods of craving. Administration of naltrexone
      prior to exposure to amphetamines significantly attenuates craving and targeted naltrexone
      has shown efficacy in reducing heavy alcohol use. However, there have been no studies
      assessing intermittent targeted dosing of naltrexone among methamphetamine-using and
      binge-drinking MSM. Polysubstance use patterns are common among MSM, and studies among those
      who abuse more than one substance are urgently needed. The aims of this study are to
      determine whether targeted dosing of naltrexone is feasible, tolerable and acceptable among
      non-dependent methamphetamine-using and binge-drinking MSM.
    


Intervention name(s): Intermittent Oral Naltrexone; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: methamphetamine; alcohol; HIV; sexual behavior
Cystic Fibrosis Related Bone Disease: the Role of CFTR
Condition: Cystic Fibrosis Related Bone Disease
MeSH terms: Bone Diseases; Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      The purpose of this study is to determine whether ivacaftor, a recently FDA-approved CFTR
      potentiator, improves bone micro-architecture and strength in patients with cystic fibrosis
      with at least one G551D CFTR mutation.
    

Detailed description: 
      Ivacaftor, a CFTR potentiator, has recently been FDA approved for the treatment of cystic
      fibrosis in patients with at least one G551D CFTR mutation. Given the possible role of CFTR
      in bone, we hypothesize that this medication may also improve bone health in CF patients. The
      purpose of this study is to test this hypothesis using high resolution peripheral
      quantitative computed tomography, a research tool that measures bone micro-architecture and
      volumetric bone density and has the ability to detect small changes in bone that might
      otherwise be missed with standard bone imaging techniques such as bone density testing.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with CF will be recruited from the Cystic Fibrosis Centers at Children's Hospital
        Boston and Massachusetts General Hospital. Healthy subjects will be a community sample
        recruited from nearby communities.
      
Biospecimen description: 
      Plasma and urine
    
Keywords: Cystic fibrosis related bone disease; Cystic fibrosis; Ivacaftor
Cemented K-wire Fixation vs Open Transfixion Pinning
Condition: Closed Fracture of Finger; Finger Fracture
MeSH terms: Fractures, Bone; Fractures, Closed
Study type: Interventional

Summary: 
      To introduce a novel external-fixation technique using the combination of K-wires and cement,
      and the objective of this report is also to compare the technique with conventional open
      transfixion pinning.
    

Detailed description: 
      Shaft fractures of the middle phalanx are common injuries that are often difficult to treat.
      Currently, fracture fixation is usually achieved by using K-wire, but pin configurations are
      controversial.The objective of this report is to introduce treatment of shaft fractures of
      middle phalanx with a novel external-fixation technique using combined K-wires and cement.
      For comparison, we also included another group of patients who were treated using open
      transfixion pinning.A total of 98 patients (98 fingers) with shaft fractures of middle
      phalanx were randomly allocated to group A (n=51) and B (n=47). Fingers in group A were
      treated with cemented K-wire fixation, and fingers in group B were treated using conventional
      open transfixion pinning. Time of bone healing, range of motion of the fingers, and joint
      motion were assessed. A p<0.05 was considered statistically significant.
    

Intervention name(s): Cemented K-wire; Transfixion Pinning
Intervention type(s): Device; Device
Intervention description(s): Fracture of proximal phalanx was treated with Cemented K-wire.; Fracture of proximal phalanx was treated with transfixion pinning.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with middle proximal fractures of fingers
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Reduction, Fracture
Short Term Group Therapy for OCD
Condition: Obsessive Compulsive Disorder
MeSH terms: Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      Assessing OCD before and after group therapy
    


Intervention name(s): Group therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 2

Summary: 
      1. Evaluate the efficacy and safety of taking thalidomide tablets once daily in the
           treatment of active ankylosing spondylitis.

        2. To explore dose-effect relationships of taking thalidomide tablets once daily in the
           treatment of active ankylosing spondylitis, as well as selecting the appropriate dose
           for the further larger scale clinical trials.
    


Intervention name(s): Thalidomide 150mg; Thalidomide 100mg; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Thalomid; Fan Ying Ting; Thalomid; Fan Ying Ting
Intervention MeSH terms: Thalidomide; Tolnaftate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ankylosing spondylitis; thalidomide
Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow
Condition: Skin Laxity; Wrinkle; Brow Lifting
MeSH terms: Cutis Laxa
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, open label, multi-center, self-controlled clinical study to
      demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental
      and neck zones and to lift the eyebrow.
    

Detailed description: 
      This is a prospective, open label, multi-center, self-controlled clinical study to
      demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental
      and neck zones and to lift the eyebrow.

      Up to 112 healthy candidates who are seeking treatment from participating investigators will
      be enrolled at up to 5 participating study sites. Patients will receive 2 treatments (4-6
      weeks ± 2 weeks apart) with the SofWave system and will be followed up to 3 months post the
      last treatment (FU2).
    

Intervention name(s): Sofwave Treatments
Intervention type(s): Device
Intervention description(s): The device used in this study will be the SofWave system manufactured by SofWave Medical ltd. The SofWave device is an ultrasonic system combined with an inherent cooling system that generates High Intensity non-focused Ultrasonic pulses (HIUS), causing a controlled thermal damage by elevating the temperature to 60-70°C in the dermis layer while sparing the epidermal layer using surface cooling. Each patient would receive 2 Sofwave treatments on the face and/or the neck.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Skin Laxity; Submental; Neck; Brow Lifting; Laxity; Saggy
Phase I Dose Escalation of i.v. BI 836909 Monotherapy in Last Line Multiple Myeloma Patients
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to determine the maximum tolerated dose (MTD) of BI
      836909 administered by continuous i.v. infusion in patients with relapsed and/or refractory
      multiple myeloma. If the MTD is not reached based on safety findings, a recommended dose for
      further development will be determined. This will depend on the safety data,
      pharmacokinetic/pharmacodynamics data and potentially preliminary efficacy data. Secondary
      objectives are to document the safety and tolerability of BI 836909, to perform
      pharmacokinetic and pharmacodynamic analyses and to evaluate relevant biological effects in
      terms of parameters of efficacy.
    


Intervention name(s): BI 836909
Intervention type(s): Drug
Intervention description(s): Intravenous Infusion of BI 836909.
Other intervention name(s): AMG 420
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase II Study of Anlotinib in STS Patients
Condition: Cancer
Study type: Interventional
Phase: Phase 2

Summary: 
      Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug
      Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,
      Ltd.

      ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and
      VEGFR3. It has the obvious resistance to new angiogenesis. The protocol is to explore ALTN
      for the effectiveness of advanced soft tissue sarcoma and security.
    


Intervention name(s): Anlotinib
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pupillary Dilation After Incremental Tetanic Stimulations Under Ketamine Sedation
Condition: Pain; Anesthesia
Study type: Interventional

Summary: 
      The aim of the study was to describe the relationship between the intensity of a standardized
      tetanic stimulation and the associated reflex pupillary dilation in patients under ketamine
      sedation.

      After an intravenous bolus of 1 mg/kg of ketamine, tetanic stimulations were performed every
      minute at increasing intensities of 10, 20, 30, 40 and 60 milliamps (similar to the
      stimulations of neuromuscular blocking agents monitoring). Pupillary diameter was measured
      before and after each stimulation.
    


Intervention name(s): ketamine; Tetanic stimulations of incremental intensities
Intervention type(s): Drug; Procedure
Intervention description(s): bolus 1 mg/kg; 10-20-30-40-60 milliamps on the patient's left forearm
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Safety and Efficacy of Lacrimal Silicone Intubation for the Management of Epiphora
Condition: Epiphora
MeSH terms: Lacrimal Apparatus Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of study is to investigate the safety and efficacy of lacrimal silicone
      intubation for the management of epiphora.
    

Detailed description: 
      Epiphora is an overflow of tears,usually caused by insufficient drainage of the tear film
      from the eye.The most common cause is a blockage of the lacrimal ducts located next to the
      nose, but the condition may also result from the excessive production of tears. Epiphora is a
      symptom rather than a disease and may be caused by a variety of conditions.

      30 subjects will be recruited for this study, informed consent will be taken from the willing
      subjects. Complete ophthalmic evaluation would be performed including visual acuity.
      Diagnosis would be made on history of epiphora, regurgitation test, lids examination, nasal
      examination, probing and syringing. Standard procedure of Dacryocystorhinostomy (DCR) would
      be adopted in all cases with lacrimal intubation.

      Syringing will be done on first follow up visit and skin sutures will also be removed.
      Tightness and mobility of the silicone tube will be checked. The tube is kept in place for
      3-6 months according to need and then finally removed. The patency of lacrimal passage will
      be investigated by irrigation. A successful outcome will be defined as resolution of symptoms
      like epiphora and discharge and a patent lacrimal system on irrigation.
    

Intervention name(s): Lacrimal Tube
Intervention type(s): Device
Intervention description(s): Lacrimal Tube
Other intervention name(s): Auro-lac
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dacryocystorhinostomy
A Study of Famitinib in Patients With Advanced Colorectal Cancer
Condition: Colorectal Cancer; Colorectal Cancer Metastatic; Colorectal Cancer Recurrent
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and
      Flt3, and it's anti-angiogenesis effect has been viewed in preclinical tests. Phase I study
      has shown that the toxicity is manageable.

      The purpose of this study is to determine whether Famitinib can improve progression free
      survival compared with placebo in patients with advanced colorectal cancer who failed in
      previous at least two lines of chemotherapy.
    


Intervention name(s): Famitinib; placebo
Intervention type(s): Drug; Other
Intervention description(s): Famitinib 25 mg p.o. qd; p.o. qd
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CRC; Famitinib; Phase II; Colorectal Cancer
Neuroimaging Studies of Reward Processing in Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Observational

Summary: 
      This study investigates stress-related signaling of glutamate and dopamine within the
      reward-processing circuit in Major Depressive Disorder (MDD), and whether they can be used to
      predict depressive symptoms in the future. This will be achieved through various neuroimaging
      tools (MRS, fMRI, PET), behavioral tasks, and a naturalistic follow-up design.
    

Detailed description: 
      The overarching goals of this research are to investigate: (1) stress-induced glutamatergic
      abnormalities and their relation to disruption within the corticostriatal valuation circuit
      in MDD; (2) stress-induced DA signaling disruptions in MDD; and (3) the predictive validity
      of these two pathophysiological mechanisms. This will be achieved through an innovative
      integration of (1) proton magnetic resonance spectroscopy (MRS)-based assessments of
      glutamatergic metabolites in the mPFC; (2) functional magnetic resonance imaging (fMRI)
      probes of the corticostriatal valuation circuit with well-established stress manipulations
      (MAST) and assessments (cortisol and inflammatory markers); (3) positron emission tomography
      (PET)-based measurement of striatal DA release with well-established stress manipulations and
      assessments (cortisol and inflammatory markers); and (4) a naturalistic follow-up design.
    

Intervention name(s): PET Scan with Raclopride
Intervention type(s): Radiation
Intervention description(s): A subsample (21 per group) will complete the PET imaging.
Intervention MeSH terms: Raclopride
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Current Major Depressive Disorder (MDD), or Remitted Major Depressive Disorder (rMDD)
      
Biospecimen description: 
      blood samples, saliva samples
    
Keywords: Depression; MRI; PET; Reward
A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old
Condition: SARS-CoV-2; Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary goal of this study is to evaluate the safety, reactogenicity, and immunogenicity
      of mRNA-1073 compared to co-administered mRNA-1010 and mRNA-1273 vaccines and to the
      individual vaccines alone in healthy participants.
    


Intervention name(s): mRNA-1073; mRNA-1010; mRNA-1273; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Sterile liquid for injection; Sterile liquid for injection; Sterile liquid for injection; 0.9% sodium chloride (normal saline) injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment