bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple
      ascending doses of AZD9567.
    

Detailed description: 
      This is a phase 1, randomised, single-blind, multiple ascending dose, double-dummy sequential
      group study in healthy subjects .

      The study is planned to have 6 cohorts with the option to include up to two additional
      cohorts if deemed necessary. Nine subjects participated in the first cohort (7 subjects
      randomised to receive AZD9567 and 2 subjects randomised to receive prednisolone 20 mg)and
      eleven subjects will participate in subsequent 3 cohorts (7 subjects will be randomised to
      receive AZD9567 and 4 subjects randomised to receive prednisolone 20 mg). A cohort 5 was
      included in the study in version 4.0 of the CSP. In this cohort two doses of prednisolone was
      tested, 5 mg and 20 mg. Up to six dose levels of AZD9567 are planned to be tested in the
      study and an additional cohort will be used in case any previous dose needs to be repeated or
      a new lower dose explored (ref CSP 5.0).

      Therefore a maximum of 95 individuals could be included in the study (as stated in version
      5.0 of this protocol). Subjects will be dosed for 5 consecutive days and a follow-up visit
      will occur 10-14 days after the last dose.
    

Intervention name(s): AZD9567 10 mg; AZD9567 20 mg; AZD9567 40 mg; AZD9567 80 mg; Prednisolone 20 mg; AZD9567 125 mg; AZD9567 155 mg; Prednisolone 5 mg; Prednisolone 40 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral suspension Multiple doses 5 days of treatment Once daily; Oral suspension Multiple doses 5 days of treatment Once daily; Oral suspension Multiple doses 5 days of treatment Once daily; Oral suspension Multiple doses 5 days of treatment Once daily; Oral Multiple doses 5 days of treatment Once daily; Oral Multiple doses 5 days of treatment Once daily; Oral Multiple doses 5 days of treatment Once daily; Oral Multiple doses 5 days of treatment Once daily; Oral Multiple doses 5 days of treatment Once daily
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Obese; Insulin Resistant Subjects; Rheumatoid Arthritis
PK and Safety Study of BIIB074 in Healthy Japanese and Caucasian Participants
Condition: Healthy; Trigeminal Neuralgia
MeSH terms: Trigeminal Neuralgia; Neuralgia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are: To evaluate pharmacokinetics (PK) properties of
      BIIB074 administered as a single oral dose in healthy Japanese and Caucasian participants;
      and To evaluate the PK properties of BIIB074 administered as repeated oral doses in healthy
      Japanese participants. The secondary objective of this study is to assess the safety and
      tolerability of BIIB074 administered as a single oral dose (Japanese and Caucasian
      participants) and as repeated oral doses (Japanese participants).
    


Intervention name(s): BIIB074; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm; Matched Placebo
Other intervention name(s): CNV1014802
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Long Term Safety of Cooling Anesthesia for Intravitreal Injection
Condition: Anesthesia, Local; Intravitreal Injection; Macular Edema; Macular Degeneration; Diabetic Retinopathy; Diabetic Macular Edema
MeSH terms: Macular Degeneration; Macular Edema; Diabetic Retinopathy; Edema
Study type: Interventional

Summary: 
      The purpose of this clinical study is to evaluate the long term safety and efficacy of
      cooling anesthesia application to the eye as anesthesia for intravitreal injection using a
      novel cooling anesthesia device.
    

Detailed description: 
      Intravitreal injections have become the standard of care for administering medications for
      retinal diseases such as age related macular degeneration and diabetic macular edema.

      There is considerable apprehension among patients receiving these injections, primarily
      revolving around adequate anesthesia during the injection. Current methods of anesthesia
      involve topical anesthetic drops, lidocaine gels, or subconjunctival injections of lidocaine,
      which suffer from either poor anesthetic effect, corneal irritation, or subconjunctival
      hemorrhage, as well as significant time for the onset of anesthesia.

      Recens Medical has developed a novel medical device which can precisely and rapidly cool the
      surface of the eye This device cools to a temperature around -5 to -15 degrees Celsius, about
      the temperature of a cold ice cube, and thus has an excellent safety profile compared to
      conventional ophthalmic cryotherapy units. The value of such a device is both improved
      patient comfort, as well as increased efficiency and workflow for retina specialists
      administering intravitreal injections.

      This device has been extensively tested in animal safety studies as well as pilot human
      studies and has not demonstrated any serious adverse effects and has shown anesthetic effects
      comparable to current standard of care.

      The purpose of this clinical study is to evaluate the long term safety and efficacy of
      cooling anesthesia application to the eye as anesthesia for intravitreal injection using a
      novel cooling anesthesia device.
    

Intervention name(s): Recens Cooling Anesthesia Device
Intervention type(s): Device
Intervention description(s): Application of cooling anesthesia device prior to intravitreal injection
Intervention MeSH terms: Anesthetics
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: A long term safety, dose escalation study design of differing temperatures and duration to test safety and efficacy of cooling anesthesia for intravitreal injection.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intravitreal Injection; Anesthesia; Macular Degeneration; Diabetic Macular Edema
Use of Dexamethasone in Uterine Artery Embolization
Condition: Uterine Myoma; Adenomyosis
MeSH terms: Leiomyoma; Myofibroma; Adenomyosis
Study type: Interventional

Summary: 
      The primary purpose of this study is to investigate the effects of dexamethasone on
      inflammatory reactions after uterine artery embolization. The secondary purpose of this study
      it to investigate the effects of dexamethasone on postembolization syndrome (severe pain,
      nasea and vomiting).
    


Intervention name(s): Dexamethasone; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Administration of dexamethasone 10 mg IV 1 h before UAE; Administration of normal saline 2 mL IV 1 h before UAE
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of maraviroc therapy in obese insulin
      resistant subjects on:

        1. Plasma triglyceride concentration

        2. Plasma HDL-cholesterol and LDL-cholesterol concentrations

        3. Plasma markers of cardiometabolic risk and inflammation
    

Detailed description: 
      The purpose of this study is to determine, in obese insulin resistant subjects, the effect of
      maraviroc therapy, a selective antagonist of the human chemokine receptor CCR5, on:

        1. Plasma triglyceride concentration

        2. Plasma HDL-cholesterol and LDL-cholesterol concentrations

        3. Plasma markers of cardiometabolic risk and inflammation
    

Intervention name(s): Maraviroc; placebo
Intervention type(s): Drug; Other
Intervention description(s): dosage will be a 300mg Maraviroc pill twice a day for 12 weeks; subjects will be given placebo pills with instructions to take one pill twice a day for 12 weeks.
Other intervention name(s): Selzentry; Celsentri; control
Intervention MeSH terms: Maraviroc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: hypertriglyceridemia; triglyceride; cholesterol; Maraviroc
Periimplant Mucosa Dynamics Around Divergent and Concave Atlantis Abutment Transition Profiles
Condition: Dental Implant, Single-Tooth; Esthetics, Dental
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effect of two different implant abutment designs
      on gum tissue volume changes over time after implant placement.
    

Detailed description: 
      This is a randomized, prospective, controlled clinical trial comparing the facial gingival
      profiles around Atlantis™ abutments that have either a linear "divergent" or "concave"
      transitional profile on the facial and proximal aspect of the abutments.

      Sixty study subjects requiring replacement of a single-rooted tooth with an implant-supported
      restoration will be recruited.

      The Osseospeed™ Plus implant will be placed for all 60 subjects, with the use of Uni healing
      abutments to minimize lateral tissue displacement during healing. After implant placement,
      but before final impressions are obtained (8 weeks post-placement), subjects will be
      randomized to either a "divergent" or a "concave" transmucosal abutment design. For
      fabrication of the experimental abutment, Atlantis™ engineers will initially design a control
      "divergent" prototype that will be modified with a concavity on the facial and proximal
      transition zones to obtain an abutment that will otherwise retain all the features of the
      control abutment. Engineers will measure the linear topographical changes (ΔL=Lc-Ld) of the
      transition zone, as well as the volumetric change (x) on the mid-facial aspect of the
      abutment induced by the formation of a submucosal concavity. The primary outcome of the study
      will be the apico-coronal change of the peri-implant mucosal zenith from prosthesis delivery
      to one year.
    

Intervention name(s): Concave Transition Profile; Divergent Transition Profile
Intervention type(s): Device; Device
Intervention description(s): An Atlantis abutment is delivered with a concave transition profile.; An Atlantis abutment is delivered with a linear transition profile
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Implant Abutments; Oral Mucosa Changes; Implant Esthetics
AdHerencE to Treatment and quAlity of Life in COPD
Condition: Chronic Obstructive Pulmonary Disease; Compliance, Patient; Quality of Life
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The present non-interventional observational study in the Greek population aims at collecting
      the characteristics of COPD patients selected to be given the inhaled combination of
      fluticasone propionate and salmeterol in doses of 100 μg mcg (250 μg) mcg (500 g) mcg through
      the Elpenhaler® device, to investigate (a) the effectiveness of the treatment for compliance
      and the quality of life of the patients; and (b) the safety of the drugs in patients whose
      disease is treated either in a hospital or in a private physician.
    

Detailed description: 
      Rolenium® is an inhalable combination the active ingredients of which is the inhaled
      combination of fluticasone propionate and salmeterol in doses (100 + 50) mcg, (250 + 50) mcg,
      (500 + 50) mcg administered via the Elpenhaler ®, developed by ELPEN. It has been approved as
      a bronchodilator therapy for COPD (a fast-exiting volume in the first second (FEV1) after a
      bronchodilator less than 60% predicted) with a history of repeated seizures that have
      significant symptoms despite regular bronchodilator therapy. For COPD in adults an inhalation
      of 500 micrograms of fluticasone propionate and 50 micrograms of salmeterol twice daily is
      recommended4. More information on the efficacy and safety of the investigational medicinal
      product is provided in the Summary of Product Characteristics (SPC).
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        COPD patients
Safety Tolerability and Pharmacokinetics of ALD403
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability and pharmacokinetics of
      ALD403, a monoclonal antibody, administered by intravenous infusion and subcutaneous
      injection.
    


Intervention name(s): ALD403; ALD403; Sumatriptan
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single Dose IV infusion on Day 1; Single Dose subcutaneous injection on Day 1; Single Dose subcutaneous injection on Day 1
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Migraine Disorders; Phase 1; ALD403
A Study to Assess the Relative Bioavailability of TMC207 Following Single-Dose Administrations of Two Pediatric Formulations in Healthy Adult Participants
Condition: Healthy; Biological Availability
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the relative bioavailability (extent and rate to which a
      drug is taken up by the body) of TMC207 following the administration of two pediatric
      formulations of TMC207 taken with and without food in healthy adult participants.
    

Detailed description: 
      This is an open-label (all study staff and participants know the identity of treatments
      assigned), 3-way cross-over (method used to switch participants from one treatment to another
      treatment) study. Three panels of 12 healthy adult participants each will be enrolled. Within
      each panel, participants will be randomly (by chance) assigned to 1 of 6 treatment sequences
      to receive each of the 3 formulations of TMC207 in a randomized order. The 3 formulations of
      TMC207 will be referred to as Treatments A, B, and C. In Treatment A, participants will
      receive a single 100-mg dose of TMC207 formulated as a 100-mg tablet (reference formulation).
      In Treatment B, participants will receive a single 100-mg dose of TMC207 formulated as 20-mg
      water dispersible (dissolvable) tablets (i.e. 5 tablets) (pediatric formulation 1). In
      Treatment C, participants will receive a single 100-mg dose of TMC207 formulated as granules
      5 grams (20 mg/g) (pediatric formulation 2). Each treatment will be separated by 4 weeks.
      Participants in Panel 1 will receive each treatment with a standardized breakfast, Panel 2
      will receive each treatment with yogurt, and Panel 3 will receive each treatment after a
      10-hour overnight fast (without food). The duration of the treatment period in this study
      will be 8.5 weeks (includes 4 weeks between treatments).
    

Intervention name(s): Treatment A (reference); Treatment B; Treatment C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One tablet equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.; Five 20-mg water dispersable tablets equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.; 5 grams (ie,20mg/g) equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Biological Availability; Bioavailability; TMC207; Bedaquiline; R207910
Evaluation of Depression and Sleep Disorders in Endometriosis Patients
Condition: Endometriosis; Sleep; Depression
MeSH terms: Sleep Wake Disorders; Parasomnias; Endometriosis; Depression; Depressive Disorder
Study type: Observational

Summary: 
      The aim of this study was to compare the depression and sleep disturbances of operated
      endometriosis patients before and after the operation. The main objective here is to provide
      data on how patients' psychological states and sleep patterns are affected by the symptoms of
      endometriosis and how these effects can be corrected. In this way, it is aimed to determine
      whether the patients have psychological support needs and to give the planned treatment due
      to endometriosis in the early period. As a secondary goal, it is planned to keep the patients
      in follow-up with their improved sleep and psychological conditions, and to improve their
      adherence to treatment and quality of life.
    


Intervention name(s): Beck Depression Scale and Pittsburgh Sleep Quality Index
Intervention type(s): Behavioral
Intervention description(s): postoperative depression and sleep disorders in patients with endometriosis will be evaluated
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study group included patients with indications for operation and who agreed to test for
        depression and sleep disorders.
Safety Study of Candidate Malaria Vaccine FMP1/AS02A in Healthy Adults in Bandiagara, Mali
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This study tested the safety of a new malaria vaccine in adults in Mali, West Africa, and
      measured the ability of the vaccine to stimulate antibodies directed against the malaria
      protein that the vaccine is based on. Forty adults were randomly assigned to get either the
      experimental malaria vaccine or a rabies vaccine, for comparison.
    

Detailed description: 
      The study was a randomized, controlled trial in which participants and clinical investigators
      were blinded to vaccine group assignment. Forty adults were randomized in a 1:1 ratio to
      receive either FMP1/AS02A or the control rabies vaccine. The aims of the control group were
      to account for baseline morbidity and the impact of seasonal malaria transmission on the
      dynamics of anti-MSP-1 antibodies, and to minimize bias in assessment of adverse events.
      Vaccines were given on a 0-, 1- and 2-month schedule. The first immunization was given in
      early July just as malaria transmission began; the second dose at the end of July as
      transmission was increasing; and the third dose in late August near the peak of malaria
      transmission intensity. Study day 90 was in October, shortly after transmission crests and
      when severe and uncomplicated malaria disease episodes peak, study day 180 was at the end of
      the malaria season, and study day 272 was at the height of the dry season. The final study
      follow-up on day 364 coincided with the beginning of the 2004 malaria season. Interim safety
      analyses were reviewed by an independent Safety Monitoring Committee before the second and
      third immunizations.
    

Intervention name(s): FMP1/AS02A; Imovax Rabies Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid.; Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, <150g of neomycin sulfate, and >2.5 IU of rabies antigen.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Plasmodium falciparum; malaria; merozoite surface protein-1
Clinical and Biological Study of Sub-pigmentation During Infantile Cystinosis
Condition: Cystinosis
MeSH terms: Cystinosis
Study type: Interventional

Summary: 
      The purpose of this study is to determine the molecular mechanism of this disease and to
      research the relationship between cystinosis and skin phenotype.
    


Intervention name(s): analysis of pigmentation
Intervention type(s): Other
Intervention description(s): cutting hair, skin description, skin biopsy for only 4 patients
Other intervention name(s): surgical biopsy; skin examination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science