bioihbjkbjnl/mcl2 huggingface dataset:
Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial Matrix Metalloproteinases
Condition: Breakthrough Bleeding
MeSH terms: Metrorrhagia
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects (good and bad) of subantimicrobial dose
      doxycycline on the irregular bleeding women experience when taking continuous oral
      contraceptive pills. This research is being done because currently, there is no effective
      treatment for this condition. Findings from this study could help to decrease the side
      effects of birth control pills and decrease unplanned pregnancies.
    

Detailed description: 
      Continuous oral contraceptive administration entails women taking hormonally active pills for
      28 days without a seven day placebo week to avoid hormonal withdrawal bleeding.
      Unfortunately, with continuous administration, timed, regular bleeding can be replace by
      irregular, unscheduled bleeding, which often leads to dissatisfaction, discontinuation and
      the possibility of unplanned pregnancy.

      Matrix Metalloproteinases, a group of zinc-dependant proteases, are hypothesized to play a
      role in endometrial degradation. The purpose of this study is to describe the expression of
      Matrix Metalloproteinases in endometrial biopsy specimens collected 1) prior to initiating
      oral contraceptives 2) while taking cyclic oral contraceptive 3) while taking continuous oral
      contraceptives and 4) while taking continuous oral contraceptives along with
      sub-antimicrobial doxycycline.
    

Intervention name(s): Doxycycline
Intervention type(s): Drug
Intervention description(s): 40 mg orally at the start of cycle 3 (study day 57) for 28 days.
Other intervention name(s): Oracea
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: continuous oral contraceptives; Matrix Metalloproteinase expression
Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
Condition: Prostatic Neoplasm
MeSH terms: Neoplasms; Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate a short course (five radiation treatments) of very
      focused ("stereotactic") external beam radiation therapy for the treatment of early stage
      prostate cancer.
    

Detailed description: 
      External beam radiation therapy for prostate cancer, while effective, takes up to 9 weeks to
      deliver on a Monday through Friday basis. Recent phase I/II studies from Seattle and Palo
      Alto using stereotactic guidance to deliver high doses of radiation to the prostate over a 1
      to 2 week period of time suggest that outcomes may be equal or superior to standard
      approaches. These data, combined with markedly improved convenience for patients, make
      radiosurgery (SBRT) for early-stage prostate cancer an enticing option. The goal of this
      study is to offer a radiosurgical option to patients within the Sharp system under the
      umbrella of an IRB-approved study.
    

Intervention name(s): radiation therapy
Intervention type(s): Radiation
Intervention description(s): Stereotactic Body Radiation Therapy
Intervention model: Single Group Assignment
Intervention model description: Radiotherapy
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neoplasms; Urogenital neoplasm; Genital neoplasms, male
Retroview Colonoscope for the Evaluation of Colon Mucosa Study
Condition: Colonic Diseases
MeSH terms: Colonic Diseases
Study type: Observational

Summary: 
      Colonoscopy is the "gold standard" technique for diagnosis and treatment of colonic lesions.
      Moreover, high definition colonoscopes (HD) associated to digital chromoendoscopy had shown
      better results regarding adenoma and polyps detection when compared to standard non HD
      scopes. However, evidence shows that during standard colonoscopy many lesions could be
      missed, including polyps, cancer and other kind of lesions. This could be correlated to many
      factors and recently reports show evidence that lesions behind the folds could be missed
      because the limitation of a forward view examination. Until know, a new auxiliary imaging
      device called "Third Eye Retroscope" had demonstrated more lesions detection during
      colonoscopy using a retro view, but with some limitations as absence of HD vision, the need
      of additional equipment and the fact the device occupies the accessory channel, limiting
      therapeutic efficiency. Recently a new HD colonoscope called "RETROVIEW" (PENTAX Medical) has
      been developed. It permits visualization of colonic mucosa in forward view, in retroflex view
      and allows for performance of diagnostic and therapeutics in a single colonoscope.
    

Detailed description: 
      Primary outcome:

      To determine the safety and feasibility of the retro view during colonoscopy using RETROVIEW
      colonoscope. Safety was measured by the number of bleeding or perforation rates as adverse
      event during the procedure. Feasibility was measured by the number of cases that is possible
      to achieve a retroflexion in the colon Secondary outcome: withdrawal phase time and total
      procedure time.
    

Intervention name(s): RETROVIEW colonoscope
Intervention type(s): Procedure
Intervention description(s): withdrawal in retro vision and forward vision was performed by segments (right, transverse, left, sigmoid colon and rectum). Retroflexed therapeutics procedures were executed when needed.
Other intervention name(s): Retro view colonoscopy; Retroflexion during colonoscopy
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        consecutive patients undergoing for colonoscopy at the Instituto Ecuatoriano de
        Enfermedades Digestivas
      
Biospecimen description: 
      biopsies, tissue from colonic mucosa: inflammatory, polyps
    
Keywords: retroview colonoscope; retroflexion colonoscopy; colonoscopy
Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized, multicenter, double-blind, double-dummy, active-controlled, parallel-design study
      in approximately 201 postmenopausal women. A subset of subjects (approximately 102) will also
      participate in a pharmacokinetic (PK) component of the study. Each subject will be randomized
      to 1 of 3 treatment regimens for 3 months.
    


Intervention name(s): 150 mg; 75 mg; 100 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast.; 75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast; 100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Trial to Assess the Efficacy of Neuroprotective Drugs Administered Topically to Prevent or Arrest Diabetic Retinopathy
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine)
      are able to prevent or arrest the development and progression of neurodegenerative changes
    

Detailed description: 
      To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine)
      are able to prevent or arrest the development and progression of neurodegenerative changes
      related to diabetic retinopathy.
    

Intervention name(s): COLIRIOBCN070660; Placebo; Brimonidine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One drop per eye twice a day during 24 months; One drop per eye twice a day during 24 months; One drop per eye twice a day during 24 months
Other intervention name(s): Somatostatin eye drops; placebo eye drops; Brimonidine eye drops
Intervention MeSH terms: Brimonidine Tartrate; Ophthalmic Solutions; Somatostatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: diabetic retinopathy
A Placebo-Controlled Study of a Combination of Metyrapone and Oxazepam in Cocaine Addiction
Condition: Cocaine Dependence; Cocaine Addiction
MeSH terms: Cocaine-Related Disorders; Behavior, Addictive
Study type: Interventional

Summary: 
      Subjects will be randomly assigned to receive either one of the two potential dose
      combinations of the study medications or placebo over 6 weeks. The study will include twice
      weekly visits to the research clinic for laboratory studies, safety assessments and urine
      drug screens. Subjects will also be questioned regarding drug craving and mood symptoms.
    


Intervention name(s): Metyrapone; Oxazepam; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Twice daily; Twice Daily; Twice daily
Other intervention name(s): Metopirone; Serax
Intervention MeSH terms: Oxazepam; Metyrapone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cocaine; Dependence; Addiction; Cortisol; GABA
Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation of Antigen/Adjuvant
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      Fimaporfin (TPCS2a) is a photosensitiser drug being developed by PCI Biotech AS for use in
      novel Photochemical Internalisation (PCI) technology. PCI technology is designed to enhance
      the effects of other drugs in a site-specific, light-directed manner and is used to
      re-localise endocytosed molecules from endosomes to cytosol. This research study is
      evaluating the use of the PCI Technology in combination with adjuvant and vaccine antigens
      for safety and induction of immune responses.
    


Intervention name(s): Fimaporfin (Photosensitizer); Hiltonol (Poly-ICLC); HPV E7 (Human Papilloma Virus E7) peptides; KLH (Keyhole Limpet Hemocyanin)
Intervention type(s): Drug; Biological; Biological; Biological
Intervention MeSH terms: Photosensitizing Agents; Poly ICLC; Keyhole-limpet hemocyanin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vaccine; Photochemical Internalisation; Immune Response; Peptide vaccine; Anti cancer vaccine
Safety, Reactogenicity and Immunogenicity Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of
      different formulations of a single intramuscular dose of GSK Biologicals' investigational RSV
      vaccine, in healthy, non-pregnant women aged 18 to 45 years.
    


Intervention name(s): RSV vaccine GSK3003895A (formulation 1); RSV vaccine GSK3003898A (formulation 2); RSV vaccine GSK3003899A (formulation 3); Boostrix
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm; Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm; Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm; Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine; Immunogenicity; Safety; Respiratory syncytial virus (RSV); Reactogenicity
Impact of Nitrate Ingestion on Protein Synthesis
Condition: Muscle Protein Synthesis
Study type: Interventional

Summary: 
      A diet rich in leafy green vegetables has been shown to reduce the risk of developing chronic
      metabolic disease. The health benefits from these particular vegetables may be attributed to
      their high nitrate content. Recent work suggests that dietary nitrate triggers endogenous
      nitric oxide release, thereby stimulating vasodilation and improving muscle perfusion in an
      insulin-independent manner. We hypothesize that in an insulin-resistant state, nitrate
      co-ingestion will increase muscle perfusion, thereby improving post-prandial delivery of
      nutrients to skeletal muscle tissue. Specifically, a more efficient delivery of food derived
      amino acids will stimulate post-prandial muscle protein synthesis and, as such, compensate
      for a blunted muscle protein synthetic response to food intake in the elderly. This proposal
      will investigate the efficacy of nitrate co-ingestion as a means to augment muscle protein
      synthesis in elderly, type 2 diabetes patients and may lead to a novel therapy in the
      clinical care of type 2 diabetes patients.
    


Intervention name(s): Nitrate; Sodium chloride
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 0.15 mmol/kg body weight sodium nitrate (dissolved in 250 mL water); 0.15 mmol sodium chloride dissolved in 250 mL water.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: type II diabetes; protein synthesis; nitrate; elderly
Project A3sc - An Atlas of Airways at a Single Cell Level
Condition: Respiratory System
Study type: Interventional

Summary: 
      The increasing incidence of chronic respiratory diseases is a public health problem affecting
      hundreds of thousands of people around the world, including children. Directly exposed to
      atmospheric aerocontaminants (pollution, allergens), the respiratory tracts represent a
      complex ecosystem that involves different cells that develop complex interactions with the
      surrounding connective tissue but also with their rich immune environment and with the
      microbiota. Although a pathophysiological continuum is postulated between the nasal and
      bronchial airways in certain diseases, such as allergic diseases, we have identified broad
      gradients in gene expression between nasal and bronchial samples. This is why cellular
      variability throughout the respiratory tree needs to be studied in detail.

      The sequencing of RNAs specifically present in a particular cell, and its comparison with
      neighboring cells, allows us to document precise cellular contributions and intercellular
      relationships. Our project will establish protocols to stabilize airway swabs by brushing
      and/or biopsy, under conditions that will then allow the analysis of gene expression profiles
      at the single cell level (single cell RNA sequencing).

      The development of the "single cell" stabilisation and analysis protocol will first be
      carried out on primary respiratory epithelium cultures and then extended to respiratory
      specimens taken from healthy volunteers. Through sampling at several levels of the
      respiratory tree, variations in expression along the tracheobronchial axis will be fully
      documented. Finally, the interaction between the epithelial compartment and the immunological
      compartment will be studied by analyzing gene expression on a single cell in different
      physiopathological contexts.
    


Intervention name(s): Bronchoscopy
Intervention type(s): Procedure
Intervention description(s): Multiple level sampling of the respiratory mucosa (cytology brush and biopsies forceps)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: lung, nasal mucosa, respiratory mucosa
A Trial to Evaluate Ad35-GRIN/ENV HIV Vaccine in Healthy Adult Volunteers
Condition: HIV; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of Ad35-GRIN/ENV HIV
      vaccine and Ad35-GRIN HIV vaccine administered intramuscularly at 0 and 6 months.
    

Detailed description: 
      This study is a phase I dose-escalation randomized, placebo-controlled study designed to
      evaluate the safety and immunogenicity of Ad35-GRIN and Ad35-ENV filled in the same vial and
      administered as a single, combined vaccine. This is the first administration of this vaccine
      in humans. The study will be double blind with respect to vaccine or placebo. The vaccine
      will be administered intramuscularly at months 0 and 6 at three dose levels: 2 x 10^9, 2 x
      10^10, and 2 x 10^11 vp per dose. Volunteers will be randomized to vaccine: placebo in a 10:4
      ratio in each group. A fourth group was added as a protocol amendment to study Ad35-GRIN HIV
      vaccine alone at 1x10^10 vp in 14 volunteers (10:4 vaccine:placebo).

      Volunteers will be screened up to 42 days before vaccination (90 days for Ad35 neutralizing
      antibody screening) and will be followed for 12 months after the last vaccination (18 months
      total study participation). Estimated enrollment will take approximately 5 months. Thus, the
      total duration of the study would be approximately 23 months.
    

Intervention name(s): Ad35-GRIN/ENV; Ad35-GRIN
Intervention type(s): Biological; Biological
Intervention description(s): This is a dose-escalation trial. Each group will receive the Ad35-GRIN/ENV vaccine at different dosage levels.; This is a dose-escalation trial. Group D will receive the Ad35-GRIN vaccine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV; Human Immunodeficiency Virus; HIV Seronegativity; Preventive Vaccine
Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Effect of hetrombopag on the pharmacokinetics of rosuvastatin in healthy subjects.
    

Detailed description: 
      The primary objective of the study is to evaluate the effect of hetrombopag on
      pharmacokinetics of healthy Chinese adult subjects after oral administration of rosuvastatin
      calcium tablets. The secondary objective of the study is to evaluate the safety of
      rosuvastatin alone and when co-administered with hetrombopag.
    

Intervention name(s): Rosuvastatin; Hetrombopag
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose of rosuvastatin on Day 1 or co-administered with hetrombopag on Day 11.; 7.5 mg hetrombopag was administered on Day 6 to Day 11.
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Sequential Assignment
Intervention model description: rosuvastatin alone and then in combination with hetrombopag
Masking: None (Open Label)
Primary purpose: Basic Science
Long-term Efficacy of Orthokeratology Contact Lens Wear in Controlling the Progression of Childhood Myopia
Condition: Myopia, Progressive; Children, Only
MeSH terms: Myopia; Myopia, Degenerative
Study type: Interventional

Summary: 
      To assess the long-term efficacy of the Menicon Z Night orthokeratology contact lens in
      controlling the progression of childhood myopia
    

Detailed description: 
      This prospective, controlled, parallel, longitudinal study compared the axial length growth
      of white European myopic children wearing Menicon Z Night orthokeratology contact lenses to a
      control group over a 7-year period.
    

Intervention name(s): Menicon Z Night; Control
Intervention type(s): Device; Device
Intervention description(s): Children wearing Menicon Z Night orthokeratology contact lenses; Children wearing distance single-vision glasses or distance single-vision soft contact lenses
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Peri-neural Dexmedetomidine as an Adjuvant to Bupivacaine Induced Paravertebral Block in Patients Undergonig Thoracotomy
Condition: Acute Post-thoracotomy Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the effect of adding dexmedetomidine as an adjuvant to bupivacaine in
      patients undergoing thoracotomy when administered peri-neurally in thoracic paravertebral
      space.
    

Detailed description: 
      Thoracotomy is associated with severe postoperative pain that could be reduced with an
      aggressive analgesic therapy in the early postoperative period. The use of thoracic
      paravertebral block is an effective analgesic approach for post-thoracotomy pain. Several
      local anesthetic adjuvants have been reported to extend the duration of paravertebral block.

      Alpha-2 agonists including dexmedetomidine appear to be the most effective in this context.
      The study will include an intervention group which will receive a combination of 20 ml
      bupivacaine 0.5% and dexmedetomidine 0.5 ml (50 microgram). The control group will receive 20
      ml bupivacaine 0.5% plus 0.5 ml normal saline perineurally. Thoracic paravertebral catheter
      will be inserted preoperatively. Visual analogue pain score will be assessed at different
      intervals.
    

Intervention name(s): dexmedetomidine bupivacaine; Bupivacaine saline
Intervention type(s): Drug; Drug
Intervention description(s): perineural dexmedetomidine as an adjuvant to bupivacaine induced thoracic paravertebral block; perineural bupivacaine saline mixture in the thoracic paravertebral catheter
Intervention MeSH terms: Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment