bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Controlled Trial of Conventional vs Theta Burst rTMS
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This trial will compare a novel form of rTMS, intermittent Theta Burst Stimulation to the
      standard conventional high frequency left sided stimulation protocol. The Left dorsolateral
      prefrontal cortex will be the site of stimulation in both treatment conditions. The site of
      stimulation will be targeted using MRI co-registration. The study seeks to determine if the
      two treatment protocols have similar effectiveness in treating major depression.
    


Intervention name(s): HFL rTMS; iTBS
Intervention type(s): Device; Device
Intervention description(s): Magventure Cool B70 Coil with either RX100 or RX30 Stimulator; Magventure Cool B70 Coil with either RX100 or RX30 Stimulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; magnetic; brain stimulation; treatment-resistant
Genetic Variability in CYP2D6 in U.S Active Duty Population
Condition: Pharmacologic Action
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigator proposes to 2D6 (Cytochrome P-450 Isoenzyme 2D6) genotype and phenotype a
      group of active duty service members and assess the effects on primaquine metabolism.
    

Detailed description: 
      The investigator propose to enroll a group of active duty service members in order to
      determine individuals' 2D6 isoenzyme genotype, an enzyme belonging to the hepatic cytochrome
      P450 oxidase system. The 2D6 isoenzyme is a key enzyme involved in the metabolism of many
      drugs including the anti-malarial drug primaquine (PQ). By knowing the genotype, the
      investigator can then categorize each volunteer by CYP2D6 phenotype i.e., expected impact on
      drug metabolism. In order to further substantiate the relationship between CYP2D6 activity,
      inadequate metabolism and subsequent primaquine failure, the investigator proposes to assess
      the effect of 2D6 genetic polymorphisms on PQ metabolism by measuring the PQ pharmacokinetics
      (PK) over 24 hours following a single 30 mg oral dose in a subset of these Active Duty
      subjects.
    

Intervention name(s): Primaquine
Intervention type(s): Drug
Intervention description(s): 30 mg oral primaquine one time
Intervention MeSH terms: Primaquine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: primaquine; metabolism; malaria; hypnozoite; vivax; CYP2D6; active duty personnel
Citicoline in Non-Arteritic Ischemic Optic Neuropathy
Condition: Non-arteritic Ischemic Optic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Optic Nerve Diseases; Optic Neuropathy, Ischemic; Ischemia
Study type: Interventional

Summary: 
      The investigators tested the hypothesis whether the treatment with Citicoline in oral
      solution (OS-Citicoline) would increase or stabilize visual acuity, retinal ganglion cells
      (RGCs) function and neural conduction along the visual pathways (neuroenhancement), and/or
      induce preservation of RGCs fibers' loss (neuroprotection) in an human model of
      neurodegeneration: non-arteritic ischemic optic neuropathy (NAION).
    

Detailed description: 
      The investigators enrolled 40 patients with bilateral or monolateral NAION and 20 age similar
      controls

      Twenty NAION patients received 500 mg/day of OS-Citicoline for a 6-months period followed by
      3-months of wash-out (19 patients completed the study, NC Group); 20 NAION patients were not
      treated (19 patients completed the studyNN Group) from baseline up to 9 months. In all
      subjects, at baseline, at 6 and 9-months of follow-up: Visual acuity (VA), Pattern
      Electroretinogram (PERG), Visual Evoked Potentials (VEP), retinal nerve fiber layer thickness
      (RNFL-T) and Humphrey 24-2 visual field mean deviation (HFA MD) were assessed. Mean
      differences were statistically evaluated by ANOVA between Groups, and correlations were
      verified by Pearson's test.
    

Intervention name(s): Citicoline
Intervention type(s): Dietary Supplement
Intervention description(s): Citicoline administered in oral solution
Intervention MeSH terms: Cytidine Diphosphate Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Citicoline; Non-arteritic ischemic optic neuropathy; Neuroprotection; Neuroenhancement
Intra Oral Kinetics of Fluoride Containing Dentifrices
Condition: Tooth Erosion
MeSH terms: Tooth Erosion
Study type: Interventional

Summary: 
      The aim of this study is to assess the impact of formulation differences on fluoride
      retention clearance with US levels of fluoride (1150 ppm of fluoride) by evaluating and
      comparing between treatments the concentrations of fluoride and calcium ions in saliva over
      60 minutes after a single brushing with US marketed fluoridated dentifrices and following a
      dietary acid challenge post 60 minutes of brushing with study treatment.
    


Intervention name(s): Test Dentifrice; Reference Dentifrice; Comparator Dentifrice; Orange Juice; De-ionised water
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3; Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3; Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3; Teeth will be rinsed with orange juice followed by rinsing with de-ionised water in test dentifrice and comparator dentifrice arms.; Teeth will be rinsed with de-ionised water followed by reference dentifrice and followed by rinsing with orange juice in test dentifrice and comparator dentifrice arms.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Phase 2, 3 Arm Study of NVN1000 Gel and Vehicle Gel in Subjects With Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 12 week clinical trial in subjects with acne vulgaris. Subjects will be randomized
      to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel twice daily. Safety, tolerability and
      efficacy will be assessed over the course of the study.
    

Detailed description: 
      This is a multi-center, evaluator and subject blinded, randomized, vehicle-controlled,
      parallel group, dose-ranging study to be conducted in approximately 150 subjects with acne
      vulgaris. Subjects who satisfy the entry criteria at the Baseline visit will be randomized to
      NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel in a 1:1:1 ratio. Efficacy assessments will
      include inflammatory and non-inflammatory lesion counts and investigator global assessments
      (IGA). Tolerability and safety assessments include cutaneous tolerability evaluation, adverse
      event collection, physical exams, and laboratory studies. Subjects will return for
      post-baseline evaluation at Weeks 2, 4, 8, and 12.
    

Intervention name(s): NVN1000 1% Gel; NVN1000 4% Gel; Vehicle Gel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Twice daily NVN1000 1% Gel for 12 weeks; Twice daily NVN1000 4% Gel for 12 weeks; Twice daily Vehicle Gel for 12 weeks
Other intervention name(s): NVN1000; NVN1000; Comparator Gel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: acne
Association of Coronary Artery Disease With Lewis and ABO Blood Group Phenotypes
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      Primary objective- To study the association of Lewis antigen and A, B, O blood group
      phenotypes with coronary artery disease patients attending the tertiary care hospital in
      Kerala.

      The secondary objective-To find the association of Lewis antigen and A, B, O blood group
      phenotypes with smoking, alcohol use, diabetes, hypertension and dyslipidemia.

      A case-control study to compare the prevalence of Lewis(a-b-) blood group among confirmed
      cardiac cases with the prevalence of the same among the general population and thereby find
      out if individuals with Lewis(a-b-) are more at risk of developing coronary artery disease.
      This may provide an economical and simple method for identifying subjects at increased risk
      for coronary artery disease and subsequently lead to more focused preventive measures and
      eventually to a specific treatment.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        70 cases attending the Cardiology department who satisfy the inclusion and exclusion
        criteria were taken as cases.

        140 (age and gender-matched) healthy blood donors who were eligible to donate blood as per
        the inclusion and exclusion criteria of Drugs and Cosmetics Rules, 1945 were taken as
        controls.
      
Keywords: ABO blood group system; Lewis negative phenotype; coronary artery disease
Effects of Vitamin D Supplementation on Lung Function in an Acute Pulmonary Exacerbation of Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      Vitamin D insufficiency is common in patients with cystic fibrosis. The investigators study
      will examine a large dose of vitamin D given to patients who have cystic fibrosis and are
      admitted to the hospital for a pulmonary exacerbation to determine whether vitamin D can
      improve clinical outcomes and whether the dose given is correct. The investigators hypothesis
      is that vitamin D therapy will improve production of anti-microbial peptides and will
      increase bacterial killing of microorganisms.
    

Detailed description: 
      Vitamin D insufficiency is common in CF patients. Treatment of vitamin D insufficiency in CF
      patients requires large doses of vitamin D. Adequate vitamin D status in CF is important for
      skeletal health and the prevention of osteoporosis. In addition to skeletal benefits of
      vitamin D, recent evidence has demonstrated that vitamin D plays an important role in the
      regulation of the immune system by increasing anti-microbial peptides in the lung and other
      barrier sites. Whether improving vitamin D status in CF patients would enhance the immune
      system has not yet been explored in a clinical study. This would have significant clinical
      impact in CF care since vitamin D status remains undertreated, especially in the setting of
      infection. The hypothesis of this proposal is that rapid correction of vitamin D
      insufficiency will result in improved innate immunity by increasing production of
      anti-microbial peptides resulting in more effective killing of bacteria. To address our
      hypothesis, the following two aims are proposed: 1) To evaluate the effect of rapid
      correction of vitamin D insufficiency as an adjunctive therapy on production of
      anti-microbial peptides in acute respiratory exacerbation in CF patients 2) To determine the
      effect of vitamin D treatment on bacterial killing in acute respiratory exacerbation in CF
      patients and to correlate with free LL-37 levels in sputum. The long term objective of this
      proposal and of our research group is to study the role of nutrition including vitamin D to
      improve the immune system in the setting of infection in CF.
    

Intervention name(s): Vitamin D3; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 250,000 IU of vitamin D3; Matching Placebo
Other intervention name(s): Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; Vitamin D; Anti-microbial peptides
Survival and Success of MIS C1 Implants- a Field Study
Condition: Failure of Osseointegration of Dental Implant
Study type: Interventional

Summary: 
      The aim of the present study is to evaluate the 1-year and 3-year survival and success of
      MIS® C1 implants with a length of 10-15mm.

      Specific Aims

        1. To study 1-year and 3-year implant survival rate C1 implants

        2. To study 1-year and 3-year implant bone level changes of C1 implants
    

Detailed description: 
      10 implants will be allocated to each of the twelve dentists, for a total of 120 implants.
      One test implant per patient will be allowed into the study for a total of 120 patients.

      The following data will be collected for each patient/implant:

        1. Patient data including birthdate, health, surgery date.

        2. Implant length, diameter

        3. Insertion torque

        4. Periapical radiographs (at insertion, and twelve months post surgery).

        5. Post operative complications and adverse events.

        6. Periodontal data around Ramfjord teeth (16, 21, 24, 36, 41, 44) : Plaque index, Gingival
           Index, Probing depth in six sites and Bleeding on probing in six sites, at baseline and
           twelve months post surgery.
    

Intervention name(s): Dental Implant (MIS Technologies)
Intervention type(s): Device
Intervention description(s): MIS Technologies Ltd. C1 Dental implants
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dental implants; bone loss
Effects of Different Anesthesia on Odor Memory
Condition: Smell Functions; Odor Memory
Study type: Observational

Summary: 
      This study aimed to research the effect of different general anesthesia administration on
      postoperative smell functions and memory.
    


Intervention name(s): butanol threshold test and smell identification tests
Intervention type(s): Diagnostic Test
Intervention description(s): no additional intervention
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        97
      
Keywords: General anesthesia management; propofol; sevoflurane; odor memory; smell functions
Glycemic and Metabolic Responses of Frozen Yogurt Containing Saskatoon Berry Powder in Healthy Males and Females
Condition: Healthy
Study type: Interventional

Summary: 
      A single site, blinded, randomized, controlled study designed to examine the glycemic and
      metabolic response of frozen yogurt containing Saskatoon berry powder in healthy males and
      females.
    

Detailed description: 
      A single site, blinded, randomized, controlled study designed to examine the glycemic and
      metabolic response of frozen yogurt containing Saskatoon berry powder in healthy males and
      females. Eligible participants will be asked to attend 4 in-person clinic visits for
      comparative testing of the frozen yogurt and frozen yogurt containing Saskatoon berry powder
      versus white bread. Separate visits for screening and for a fasting blood sample will also be
      requested (total of 6 visits).
    

Intervention name(s): Saskatoon Berry Frozen Yogurt; Frozen Yogurt; Control 1; Control 2
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Frozen yogurt containing a defined amount of powder prepared from Saskatoon berries (serving size = 25 g available carbohydrate); Unflavoured frozen yogurt (serving size = 25 g available carbohydrate); White bread (serving size = 25 g available carbohydrate); White bread (serving size = 25 g available carbohydrate)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glycemic Responses; Metabolic Responses; Males; Females
Acute Inflammation After Wisdom Tooth Removal
Condition: Tooth Impacted
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Third molar (wisdom teeth) extraction is one of the most frequent intervention in dentistry.
      Nevertheless, little is known about the level of general body inflammation of subjects with
      impacted or semi-impacted third molars. Moreover, The possible effects of surgical removal of
      wisdom teeth on the overall health are not known.

      Thus, a study in which 40 subjects has been designed. Twenty subjects were affected by
      bilateral wisdom tooth pathology necessitating for extraction of both teeth. Control group
      comprised 20 subjects with absence of wisdom teeth or completely erupted wisdom teeth without
      pathology associated to or history of previous extraction of both wisdom teeth.

      In both groups a medical and dental examination will be performed at the baseline and 3
      months after baseline for the control group or after the second third molar extraction in the
      control group. Blood will be also withdrawn to assess systemic inflammation and other
      systemic parameters.

      Parameter were evaluated via high sensitive c reactive protein (CRP), lipids, fibrinogen,
      oxidative stress and endothelial function analysis.
    

Detailed description: 
      Third molar extraction is one of the most frequent intervention in dentistry. Nevertheless,
      little is known about the systemic aspect of subjects with impacted or semi-impacted third
      molars and the possible effects of surgical removal on their systemic parameters. A
      case-control study of 40 subjects has been designed to evaluate i) the overall systemic
      inflammation and metabolism of subjects with bilateral third molars compared to subjects with
      no third molars and ii) the effect of bilateral removal in the immediate and medium
      postsurgical period. Systemic parameters are evaluated via high sensitive c reactive protein
      (CRP), lipids, fibrinogen, oxidative stress and endothelial function analysis.
    

Intervention name(s): Wisdom tooth removal
Intervention type(s): Procedure
Intervention description(s): After inferior dental and buccal nerve anesthesia a triangular full thickness flap with releasing incision on the mesio-buccal aspect of the second molar is designed. Ostectomy is then performed and tooth is sectioned and gently elevated. Once all the tooth components are extracted, the socket is carefully inspected and flap is sutured with interrupted sutures.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Case-control intervention trial: cases are treated for pathology. Controls do not have pathology.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: C-reactive protein; Systemic inflammation; Third molar; Wisdom tooth
The Effect of Bath Applied in Two Different Sequences on Stress Level and Physiological Parameters in Term Babies
Condition: Newborn
Study type: Interventional

Summary: 
      In this study, the bath applied to term babies in two different orders (first washing the
      body and lastly the head, and the classical method in which the whole body is washed starting
      from the head first), the babies' stress level, physiological parameters (body temperature,
      pulse, respiration, O2 saturation), procedure time (time of bathing). ) was planned to
      determine its effect on the calming time of babies.

      The effects of two different bathing methods given to healthy and term babies on the babies'
      stress level, physiological parameters (body temperature, pulse, respiration, O2 saturation),
      procedure time (bathing time), and calming time of the babies will be compared.
    

Detailed description: 
      The researcher will briefly talk about the scope and content of the research by meeting with
      the parents of babies who meet the selection criteria to apply the first bath of term and
      healthy babies before discharge, at the earliest 6 hours after birth.

      Healthy, term newborns will be divided into two groups, one group will be washed from body to
      head, and the other group will be washed from head to body, which is the traditional method.
      In the study, the stress levels of babies will be obtained by observing the newborns
      independently by two different observer nurses before, after and after the procedure, using
      the "Newborn Stress Scale", at the 5th, 15th and 30th minutes. Physiological parameters of
      the babies will be evaluated before the procedure, during the procedure, and at the 1st, 5th
      and 15th minutes after the procedure. Bathing will be done by the same person (researcher)
      for all babies in both the experimental and control groups.

      Pulse oximeter and stopwatch will be used to measure physiological parameters (heart rate,
      oxygen saturation, calming time).
    

Intervention name(s): take a bath
Intervention type(s): Other
Intervention description(s): The effects of two different bathtub bath methods on physiological parameters will be compared in babies divided into 2 different groups.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study was planned as a randomized controlled experimental study. Computer-assisted randomization will be used to create groups (https://www.randomizer.org/). Power analysis was performed using the G*Power (v3.1.9) program to determine the sample size. The power of the study is expressed as 1-β (β = probability of type II error) and in general, studies must have 80% power.
Masking: None (Open Label)
Primary purpose: Other
Keywords: baby health; stress; newborn bath; newborn
Non-invasive Ventilation System in Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive; Airflow Obstruction, Chronic; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive
Study type: Interventional

Summary: 
      When using the Breathe Technologies Ventilation System during simulated activities of daily
      living (ADLs), Subjects with moderate-to-severe chronic obstructive pulmonary Disease (COPD)
      will be comfortable and report acceptability.
    

Detailed description: 
      The primary objective of the study was to evaluate the Breathe Technologies Ventilator System
      with regard to subject acceptability, comfort, and effect on exercise and activities of daily
      living tolerance.

      Primary Hypothesis:

        1. When using the Breathe Technologies Ventilation System during simulated activities of
           daily living (ADL), Subjects with moderate-to-severe COPD will be comfortable and report
           acceptability.

           Secondary Hypotheses:

        2. When using the Breathe Technologies Ventilation System during simulated ADLs, Subjects
           with moderate-to-severe COPD will experience tolerable dyspnea as measured using the
           Borg Dyspnea Score (BDS) and a visual analog Comfort Scale (VACS).

        3. Subjects will prefer using the Breathe Technologies Ventilation System over standard
           oxygen therapy during exertion and during ADLs after using the ventilator therapy for
           five days.
    

Intervention name(s): Noninvasive Open Ventilation System
Intervention type(s): Device
Intervention description(s): Noninvasive ventilation system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care