bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity of the Human Cytomegalovirus (CMV) Vaccine (V160) in Healthy Japanese Men (V160-003)
Condition: Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety and tolerability of a 3-dose regimen of V160
      administered by intramuscular (IM) injection in healthy Japanese male participants by
      cytomegalovirus (CMV) serostatus. There is no formal hypothesis.
    


Intervention name(s): V160; Placebo
Intervention type(s): Biological; Other
Intervention description(s): V160 administered as a 0.5 mL (100 Units) IM injection containing 225 mcg aluminum phosphate adjuvant (APA); Saline solution (0.9% sodium chloride [NaCl] administered as a 0.5 mL IM injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Comparing the "Snifing Position" , "Simple Head Extension" and "Neutral Position"
Condition: Therapeutic Procedural Complication
Study type: Interventional

Summary: 
      The simple head extension is recommended for optimization of glottic visualization during
      Nasotracheal intubation via fiberoptic bronchoscope (FOB) . However, no study confirmed its
      superiority over"snifing position" and "Neutral Position". In a prospective, randomized
      study, the authors compared the snifing position , simple head extension and "Neutral
      Position" in Nasotracheal intubation via fiberoptic bronchoscope.
    

Detailed description: 
      The study included ninety patients with anticipated difficult airways. The snifing position
      was obtained by placement of a 7-cm cushion under the head of the patient; the extension head
      position was obtained by placement of a 7-cm cushion under the shoulder; the neutral position
      with the occiput close to the operating table. The head position was randomized as follows:
      neutral position group (NP group), sniffing position group (SP group) or extension position
      group (EP group). Randomization (1:1:1) was based on the codes generated by Excel software,
      which were kept in sequentially numbered opaque envelopes until the began of study.
    

Intervention name(s): Head position
Intervention type(s): Other
Intervention description(s): Influence of different head position on nasal endotracheal intubation
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Snifing Position; Simple Head Extension; neutral position; Nasotracheal intubation
Evaluation of the EarEEG System for Detection of Hypoglycaemia-induced Changes in the EEG in Subjects With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      The EarEEG system is a novel non-invasive, unobstructed and discrete method for recording EEG
      in which the signal is recorded using dry-contact electrodes embedded on a customised ear
      piece. One intended medical indication of the EarEEG system is the detection of
      hypoglycaemia-induced changes in the EEG in patients with type 1 diabetes. Currently, no
      studies exist investigating the detection of hypoglycaemic episodes by use of ear electrodes.
      While a finger prick test accurately measures the blood glucose level, it does not provide
      continuous measurements, and hence it is unreliable as a hypoglycaemia alarm. Recent studies
      have indicated that the use of continuous glucose monitoring (CGM) reduces the risk of severe
      hypoglycaemia. However, some find these devices troublesome to use and utilisation of CGM has
      remained limited to date. Observational data show that only a small percentage of patients
      with type 1 diabetes are using CGM on an ongoing basis. Thus, there is a medical need for a
      reliable hypoglycaemia detection device which is easy and convenient to use.

      This clinical study aims at investigating the feasibility of measuring hypoglycaemia induced
      changes in the EEG by use of the EarEEG system.
    


Intervention name(s): Ear-EEG system
Intervention type(s): Device
Intervention description(s): Measurement of the neural activity in the brain by use of the Ear-EEG device, which is a customized earplug containing 6 embedded dry electrodes placed inside the ear canal and in the concha of the ear.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1517 and Lanthanum Carbonate Hydrate
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the effect of lanthanum carbonate hydrate on the
      pharmacokinetics (PK) of ASP1517 in non-elderly healthy male subjects.
    


Intervention name(s): ASP1517; Lanthanum carbonate hydrate
Intervention type(s): Drug; Drug
Intervention description(s): Oral dose; Oral dose
Other intervention name(s): Fosrenol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ASP1517; Pharmacokinetics; Drug-drug interaction
Salivary Bmp-2 Levels & Radiographic Measurement Of Bone Density at Extracted Tooth
Condition: Bone Injury
Study type: Interventional
Phase: Phase 4

Summary: 
      Salivary Bmp-2 Levels & Radiographic Measurement Of Bone Density were evaluated At Extracted
      Tooth Socket in patients With & Without topical Application Of Simvastatin
    

Detailed description: 
      Objective: The objective of this study was to compare:

      'The salivary BMP-2 levels in the experimental and the control groups with and without
      topical simvastatin application on wound of extracted tooth socket.

      The bone density at extracted tooth socket by measuring mean gray value from Intra oral
      periapical (IOPA) radiographs in the experimental and the control groups.

      Method: Twenty four patients either male or female without any systemic disease, aged between
      18 years to 25 years were selected. The patients were equally divided by random computer
      generated numbers into experimental and control groups. In the experimental group, tooth
      extraction was followed by placement of simvastatin (containing 10 mg of drug). In the
      control group, only tooth extraction was done. Saliva sample was collected from patients on
      days 0, 3, 7 and 40 and levels of salivary biomarker BMP-2 were measured with the ELISA
      technique. IOPA radiographs were taken on days 0 and 40 to determine the bone density by
      measuring mean gray values with the help of ImageJ software. The data was entered in SPSS
      version 25 and analyzed. P-value of ≤ 0.05 was considered as statistically significant.
    

Intervention name(s): Simvastatin 10mg
Intervention type(s): Drug
Intervention description(s): Atraumatic Extraction and administration of SIM (10 mg tablet grounded and added with normal saline, with gelatin sponge as a transporter) into the socket to observe alveolar bone healing.
Other intervention name(s): SIM
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Simvastatin; Salivary BMP-2; Radiographic Bone density
Study Assessing Safety and Immunogenicity of IC43 Vaccination Against Pseudomonas Aeruginosa in Healthy Volunteers
Condition: Healthy
MeSH terms: Pseudomonas Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective is to confirm the optimal dose of IC43 in regard to immunogenicity, safety and
      tolerability.
    

Detailed description: 
      The study will be designed as a multi-center, observer-blinded, randomized, placebocontrolled
      phase 1 study in healthy adult subjects of 18 to 65 years of age. A total of 160 healthy male
      and female subjects is planned to be enrolled and randomized in five groups receiving
      different dosages and formulations of IC43 or placebo.
    

Intervention name(s): IC43; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): The study consists of a screening visit within 14 days before the administration of the investigational medicinal product (IMP), an experimental part of 180 days with seven outpatient visits on days 0, 3, 7, 14, 28, 90 and 180 and with vaccinations on days 0 and 7. IC43 vaccine will be administered intramuscularly during study visit 0 and 7 at three different doses, adjuvanted with Al(OH)3, or in one dose without Al(OH)3. Injection volumes will be 0.5 mL, 1 mL or 2 mL. Placebo will be administered intramuscularly at a dosage of 1 mL.; The study consists of a screening visit within 14 days before the administration of the investigational medicinal product (IMP), an experimental part of 180 days with seven outpatient visits on days 0, 3, 7, 14, 28, 90 and 180 and with vaccinations on days 0 and 7. IC43 vaccine will be administered intramuscularly during study visit 0 and 7 at three different doses, adjuvanted with Al(OH)3, or in one dose without Al(OH)3. Injection volumes will be 0.5 mL, 1 mL or 2 mL. Placebo will be administered intramuscularly at a dosage of 1 mL.
Other intervention name(s): IC43 Pseudomonas Aeruginosa; NaCl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pseudomonas Aeruginosa
A Biosensor for Tracking Seizures: Linking a Wrist Accelerometer to an Online Epilepsy Diary
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Observational

Summary: 
      This study will assess whether a movement detecting wristwatch can accurately detect seizures
      and seizure characteristics and record them into an online epilepsy diary. The patients may
      manually record a description into the online epilepsy diary of the symptoms they experienced
      before, during or after the seizure.
    

Detailed description: 
      Typically, health care providers receive inaccurate patient self- reports. This pilot trial
      will document the feasibility of accurately recording and logging seizures into a cloud-based
      diary, under circumstances of controlled video-EEG monitoring to serve as a comparison "gold
      standard." More explicitly, we are testing the efficacy of the wristwatch in capturing
      movement parameters correlated with seizure activity and whether these parameters can be
      accurately uploaded into an online epilepsy diary. In the future, biosensor data could be
      valuable to more precisely obtain seizure data for clinical decision making as well as use in
      clinical trials.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with epilepsy over the age of 18 enrolled at the Stanford Epilepsy Monitoring Unit.
      
Keywords: Epilepsy; Seizures; Wrist accelerometer; Epilepsy diary; Seizure detection; Biosensor
Comparative Pharmacokinetic, Pharmacodynamic, Safety and Efficacy Study of Three Anti-CD20 Monoclonal Antibodies in Patients With Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will compare the plasma pharmacokinetic profile and the change in disease activity
      score in patients with active rheumatoid arthritis following treatment with two 1000 mg doses
      of DRL_RI or one of two sources of rituximab (Rituxan® or MabThera®). Patients will also be
      monitored for safety, B cell depletion and recovery, and for the development of immune
      responses to the administered study drugs
    


Intervention name(s): DRL_RI; Rituxan; MabThera
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Two 1000 mg intravenous infusions, one each on Day 1 and Day 15; Two 1000 mg intravenous infusions, one each on Day 1 and Day 15; Two 1000 mg intravenous infusions, one each on Day 1 and Day 15
Other intervention name(s): Rituximab; Rituximab
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis; Rituximab; Pharmacokinetics
Oocyte Vitrification Aided With Latrunculin A
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Using cytoskeleton Stabilizer the Latrunculin A would improve the outcome of oocyte
      vitrification
    


Intervention name(s): Latrunculin A supplemented vitrification medium
Intervention type(s): Other
Intervention description(s): Vitrification of human oocyte in medium supplemented with Latrunculin A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Binge Eating and Chromium Study
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to test the feasibility and preliminary efficacy of a 6-month
      chromium picolinate (CrPic) treatment trial in binge eating disorder (BED).
    

Detailed description: 
      Binge eating (i.e., the consumption of unusually large amounts of food with a sense of loss
      of control) is a common problem with serious public health implications in large part due to
      its role in obesity. Binge eating leads to weight gain and is common in overweight
      individuals. Current treatments for binge eating disorder (BED) are inadequate, and previous
      randomized treatment trials have suffered from high drop out rate due to the adverse effects
      of pharmacological agents. Chromium picolinate is a dietary supplement that has been shown to
      reduce symptoms of depression and appetite regulation problems in patients with atypical
      depression; chromium picolinate also affects insulin regulation and has been shown to improve
      glucose levels in patients with type-2 diabetes. This pilot study will evaluate the effect of
      chromium picolinate on binge eating, mood, body weight, and glucose regulation in overweight
      individuals with BED.
    

Intervention name(s): Sugar Pill; chromium picolinate; chromium picolinate
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): placebo oral tablet taken once per day; 1000 ug/day chromium picolinate for 6 months; 600 ug/day chromium picolinate
Intervention MeSH terms: Chromium; Picolinic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: binge eating; chromium; mood; glucose; appetite
Study Evaluating the Effects of IMA-638 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary purpose of the protocol is to determine if IMA-638 prevents a mild asthma attack by a
      subject with mild asthma inhaling an allergen.
    


Intervention name(s): IMA-638 is a biologic
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase 3 Study to Evaluate the Efficacy & Safety of Self-Administered Injections of BMN165 by Adults With PKU
Condition: Phenylketonuria (PKU)
MeSH terms: Phenylketonurias
Study type: Interventional
Phase: Phase 3

Summary: 
      The BMN 165 clinical development program has been designed to demonstrate the safety and
      efficacy of BMN 165 in reducing blood Phe concentrations in adults with PKU.
    

Detailed description: 
      165-302 is a Phase 3, 4 Part, Randomized, Double-Blind, Placebo-Controlled, Discontinuation
      Study to Evaluate the Efficacy and Safety of Self Administered Subcutaneous Injections of BMN
      165 by Adults With PKU.

      This study is open only to adults who have been exposed to BMN165 in a previous study.

      Study BMN 165-302 is a four-Part, Phase 3 study.

        -  Part 1: Open-label period

        -  Part 2: A Randomized, double-blind, placebo-controlled period of 8 weeks

        -  Part 3: Two sub-Parts to Part 3:- Part 3A - BMN 165 administered using vial and syringe
           during this open label period. Part 3B - BMN 165 administered using prefilled syringe
           during this open-label period.

        -  Part 4: A long-term, open-label extension period.
    

Intervention name(s): BMN165 20mg/day; BMN165 40mg/day; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BMN165 20mg/day self-administered daily; BMN165 40mg/day self-administered daily; Non-drug placebo, self-administered daily
Other intervention name(s): PEG-PAL; PEG-PAL; Dextran 40
Intervention MeSH terms: Dextrans
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: PKU; PEG-PAL; Prism; BioMarin; rAvPAL-PEG; BMN165
Effect of Exercise on Spread of the Miconozole Nitrate OVULE in the Vagina
Condition: Health; Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Study type: Interventional
Phase: Phase 4

Summary: 
      This study uses MRI to detect the spread of the Miconozole Nitrate OVULE within the vagina.
      The effect of moderate amounts of physical activity on the spread will be evaluated, and
      compared to no physical activity.
    


Intervention name(s): Miconazole nitrate; Magnetic resonance imaging; Moderate levels of exercise
Intervention type(s): Drug; Procedure; Behavioral
Intervention MeSH terms: Miconazole; Clotrimazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
HAL-MPE1 Safety and Tolerability Study
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to confirm safety and tolerability of incremental doses of HAL-MPE1
      subcutaneous immunotherapy (SCIT) in peanut allergic adults, and subsequently assess the
      safety and tolerability in adolescents and children with peanut allergy.
    

Detailed description: 
      At the time of the study there was no effective treatment available for peanut allergy other
      than avoidance of peanut allergens. There was high unmet medical need for a disease modifying
      treatment for peanut allergy, especially for peanut allergic children, since this age group
      is at highest risk of peanut-related anaphylaxis requiring hospitalization. A chemically
      modified, aluminum hydroxide adsorbed peanut extract (HAL-MPE1) for subcutaneous
      administration has been developed. The safety and tolerability of HAL-MPE1 have been
      established in a First-in-human (FIH) study in adults.
    

Intervention name(s): HAL-MPE1; HAL-MPE1 placebo
Intervention type(s): Biological; Drug
Intervention description(s): Weekly subcutaneous administrations of HAL-MPE1; Weekly subcutaneous administrations of HAL-MPE1 placebo
Other intervention name(s): Modified peanut extract; Placebo for modified peanut extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C)
      in patients with depression.

      The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to
      placebo in patients with depression.

      The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy
      of saredutant on disability and quality of life in patients with depression, and to evaluate
      blood levels of saredutant.
    

Detailed description: 
      The study is a multicenter, multicountry, randomized, parallel-group, double blind, placebo
      and paroxetine-controlled study consisting of three segments (A, B, and C). Segment A is a
      1-week, placebo, single-blind period and Segment B is an 8-week, double blind period.
      Patients completing Segment B may be eligible for enrollment into Segment C, a 44-week,
      double blind extension. All randomized patients must complete a post-study visit 1 week after
      intake of the last dose of study medication.
    

Intervention name(s): Saredutant succinate (SR48968C)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: depression; antidepressive agents; controlled clinical trial
Short-Term Anti-plaque Effect of Cymenol Mouthwash Analysed Using Dentius Deep Plaque Software
Condition: Healthy; Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this project was to investigate the short-term in situ anti-plaque effect of
      cymenol, using the Dentius Deep Plaque software
    


Intervention name(s): Placebo Mouthwash; Cymenol mouthwash
Intervention type(s): Drug; Drug
Intervention description(s): Application of mouthwashes; Application of mouthwashes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Effect of Mastiha Oil in Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Mastiha Oil is a 100% natural product of the Mediterranean, extracted from the resin of
      Mastiha. Over 90 compounds have been identified in Mastiha oil, with monoterpenes exhibiting
      favorable effects in regulating mechanisms of oxidative stress and inflammation. The aim of
      this study is to determine the effect of Mastiha oil in adults with Metabolic Syndrome. 90
      participants will be allocated to two groups, (45 in intervention group and 45 in control
      group). Mastiha oil will be provided in the form of soft gel capsules to the intervention
      group, whereas the control group will not consume the capsules. Both groups will receive
      standard nutritional counselling. The intervention will last 3 months.

      The effects of the intervention will be evaluated via clinical and laboratory markers.
    


Intervention name(s): Mastiha oil
Intervention type(s): Dietary Supplement
Intervention description(s): 1 soft gel capsule of Mastiha oil every day for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention