bioihbjkbjnl/mcl2 huggingface dataset:
Health Effects of Silver-Mercury Dental Fillings
Condition: Caries, Dental
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether there are detectable health effects of
      low-level mercury exposure (from normal exposure to mercury-containing dental fillings) in
      the known target organs/systems affected by elemental mercury exposure.
    

Detailed description: 
      The Casa Pia Study of the Health Effects of Dental Amalgam in Children is a randomized,
      prospective clinical trial with the overall goal of determining if there are detectable
      health effects due to exposure from mercury-containing dental amalgam fillings. Children,
      thought to be the population most susceptible to any possible health effects, were randomly
      assigned to one of two treatment groups (total n=507). Subjects were originally enrolled at
      ages between 8-10 years of age. To participate, subjects must have: Dental caries in at least
      one posterior tooth; no prior exposure to dental amalgam; a blood lead of <15ug/L; a urinary
      mercury level of <10ug/L; an IQ as measured by the CTONI of >67; and no prior or existing
      serious medical or neurologic condition. One group received only dental filling materials
      other than those containing mercury (plastic and ceramic composites), while the other group
      received mercury amalgam fillings where appropriate (in large restorations in back teeth),
      but the alternative materials everywhere else. Both treatment regimens are standard-of-care
      throughout the world. Subjects receive ongoing dental care via the study clinics, and
      continue to receive dental fillings as needed based on group assignment. The target organs of
      mercury exposure are renal and neurological. Baseline and annual repeated measures are taken
      on all subjects for renal function, nerve conduction velocity and a large battery of
      neurobehavioral tests. Follow-up is planned for a period of 7 years
    

Intervention name(s): Dental amalgam restorations
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: neurologic; nerve conduction; neurobehavioral; renal disease
Effects of Home-based or Center-based Aerobic Exercise in Patients With Chronic Kidney Disease
Condition: Chronic Renal Failure; Obese
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Patients will be randomly assigned to perform the training program in center or home-based .
      The training program will be conducted in accordance with the recommendations of the American
      College of Sports Medicine. All training sessions will be preceded by stretching of large
      muscle groups and heating (5 minutes) and at the end by cool down and stretching (5 minutes).
      The program will consist of 24 weeks with three sessions per week on alternate days. The
      aerobic training will be continuous, with an increment of 10 minutes in duration every 4
      weeks. The intensity will be prescribed according to ventilatory threshold, characterized by
      the highest intensity of physical exertion fully maintained by aerobic energy pathways. The
      intensity control was done by means of the heart rate value obtained at ventilatory
      threshold.

      Both groups receive the same intervention. However, a group exercise held in the center on a
      treadmill with the direct supervision of a physical education teacher. The other group will
      exercise at home with telephone follow-up weekly and once a month will be held at the
      training center under the supervision of a physical education teacher.

      It will also constituted a control group remain without performing any activity during the
      study period. After 24 weeks patients receive the same advice the team conducting the
      training at home.
    


Intervention name(s): Aerobic exercise
Intervention type(s): Other
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Therapeutic Rainforest Study in Generating Positive Energy Among Undergraduate Students
Condition: Stress; Anxiety
Study type: Interventional

Summary: 
      This study looked into how therapeutic forest walking will impact the well-being of
      undergraduate students at the National University of Singapore. A three-arm randomized
      control trial on 108 participants is being planned for this study. The primary aim of this
      study is to assess the feasibility and primary effect of the Therapeutic Rainforest Walking
      in generating positive energy among undergraduate students project in enhancing the quality
      of life, physical, mental, and psycho-social well-being among University students.
    


Intervention name(s): Therapeutic rainforest mindful walking; Therapeutic rainforest walk; Campus Green walk
Intervention type(s): Other; Other; Other
Intervention description(s): A two-kilometer trail curated by the National Parks Board, Singapore. The walk will be led by Mindfulness Practitioner who volunteered to be guides for this study.; A two-kilometer trail curated by the National Parks Board, Singapore. The walk will be led by volunteer guides recruited by the research team.; A two-kilometer trail curated by the Office of Facility Management, NUS. The walk will be led by volunteer guides recruited by the research team.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The first arm of the study includes the use of mindful walking through the therapeutic rainforest trail from Kent Ridge Park to Hort Park and Hort Park back to Kent Ridge Park.
The second arm of the study includes a walk through the therapeutic rainforest trail from Kent Ridge Park to Hort Park and Hort Park back to Kent Ridge Park.
The third arm of the study includes a walk through the Kent Ridge Road Trail curated by the Office of Facility Management.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Mental health; well-being; stress;
Anxiety Sensitivity Program for Smoking Cessation
Condition: Smoking Cessation
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of this study is to develop and test a smoking cessation intervention for persons
      who are specifically sensitive to anxiety and anxiety-related bodily sensations.
    


Intervention name(s): Anxiety Sensitivity Program for Smoking Cessation
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anxiety Sensitivity
Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) With Ultravist 370 INJ.(Iopromide 768.86mg) in Abdominal CT
Condition: Abdominal CT
Study type: Observational [Patient Registry]

Summary: 
      Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) with Ultravist 370 INJ.(Iopromide
      768.86mg) in abdominal CT
    


Intervention name(s): NEOVIST 370 INJ.(Iopromide 768.86mg); Ultravist 370 INJ.(Iopromide 768.86mg)
Intervention type(s): Drug; Drug
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subject who performed scheduled CT scan, mostly postoperative state of stomach cancer
      
Keywords: Qualitative Evaluation of abdominal CT image using 4 point scale: Excellent(4)/ Good(3) / Fair(2) / Unacceptable(1)
Single Dose Comparative Bioavailability Study Of MGCD265 In Healthy Male And Female Volunteers
Condition: Healthy
Study type: Observational

Summary: 
      The objective of this study is to assess the bioavailability of the MGCD265 formulation
      following oral administration under fed conditions (Treatment-1) as compared to fasting
      conditions (Treatment-2) in healthy male and female volunteers.
    

Detailed description: 
      The study objective is to assess the bioavailability of the MGCD265 formulation following
      oral administration under fed conditions (Treatment-1) as compared to fasting conditions
      (Treatment-2) in healthy male and female volunteers.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy male and female volunteers.
      
Biospecimen description: 
      Pharmacodynamic analysis
    
Keywords: Food effect on MGCD265 bioavailability in healthy volunteers
Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery
Condition: Kidney Failure, Acute; Acute Kidney Insufficiency
MeSH terms: Acute Kidney Injury; Renal Insufficiency
Study type: Interventional

Summary: 
      This study proposes to investigate whether treatment with minocycline pre-operatively in
      patients with mild to moderate chronic kidney disease undergoing cardiac surgery will reduce
      the occurence of kidney injury.
    


Intervention name(s): minocycline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses; placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: renal; kidney; injury; acute; bypass; cardiac; minocycline; prevention; Acute Kidney Failure
Postoperative Effects of Preoperative Anxiety
Condition: Anxiety; Pain, Postoperative
MeSH terms: Pain, Postoperative; Anxiety Disorders
Study type: Observational [Patient Registry]

Summary: 
      INTRODUCTION Patients who will have obesity surgery have about %48 psychiatric illnesses like
      anxiety disorder. Studies which analyze the relationship between preoperative anxiety level
      and postoperative pain had reported conflicting results. The aim of this study is to search
      the relationship between preoperative anxiety level and postoperative pain and analgesic
      consumption in patients who had laparoscopic sleeve gastrectomy surgery.

      MATERIAL AND METHODS Our prospective double-blind study is planned to require 86 female
      patients aged between 18-65 years old, American Society of Anesthesiologists (ASA) I-II and
      Body mass index (BMI) ≥40 kg/m^2. Patients having a psychiatric or neurologic disease, brain
      damage, using psychiatric medications (antidepressants, anxiolytics) and chronic alcohol,
      known allergy to medications used in the study protocol, inability to provide informed
      consent will be excluded. Patients will be wanted to fill the Spielberger's State-Trait
      Anxiety Inventory the night before the surgery. The analgesic consumption of the patients
      will be recorded by evaluating the pain with Visual analog scale (VAS) and sedation status
      with Ramsay's sedation scale in the 1st, 4th, 12th and 24th hour of postoperative period.

      EXPECTATIONS AND SCIENTIFIC CONTRIBUTIONS More satisfying postoperative analgesia may be
      provided in this group of patients by determining correlation between preoperative anxiety
      level and postoperative pain and analgesic consumption in patients who had laparoscopic
      sleeve gastrectomy. Morbidity rate related with pain may be decreased and patient
      satisfaction may be increased.
    


Intervention name(s): Spielberger's State-Trait Anxiety Inventory; Visual analog scale, Ramsay's sedation scale; Tramadol, paracetamol, diclofenac sodium
Intervention type(s): Diagnostic Test; Other; Drug
Intervention description(s): Patients will be wanted to fill the Spielberger's State-Trait Anxiety Inventory the night before the surgery.; The analgesic consumption of the patients will be recorded by evaluating the pain with VAS (Visual analog scale) and sedation status with Ramsay's sedation scale in the 1st, 4th, 12th and 24th hour of postoperative period.; The analgesic consumption of the patients will be recorded
Intervention MeSH terms: Acetaminophen; Diclofenac; Tramadol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Female patients aged between 18-65 years old, ASA I-II, which BMI ≥35 kg/m^2 and have
        bariatric surgical indications because of morbid (type III) obesity
      
Keywords: Preoperative anxiety level; Postoperative pain; Laparoscopic sleeve gastrectomy
Cariprazine Pediatric ASD PK Study
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a multi-center, open-label, parallel-group, multiple-dose study in up to
      24 male and female participants aged 5 through 17 years, inclusive, with Autism Spectrum
      Disorder (ASD). The 24 participants will be enrolled into 1 of 4 cohorts (6 participants per
      cohort).
    


Intervention name(s): Cariprazine
Intervention type(s): Drug
Intervention description(s): Oral Solution
Intervention MeSH terms: Cariprazine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ASD; Autism
Gender-Responsive Treatment for Women Offenders - 1
Condition: Substance Abuse Problem
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether substance abuse treatment designed
      specifically for drug-dependent women offenders provides better outcomes than standard drug
      court treatment (mixed-gender programs).
    

Detailed description: 
      In this five-year study, a total of 300 women entering court-referred treatment throughout
      Los Angeles County and who agree to participate in the study will be randomly assigned to a
      women-focused or to a mixed-gender outpatient treatment program. The study will assess the
      impact of women-focused substance abuse treatment using outcome measures including
      recidivism, substance abuse and relapse, and social adjustment (e.g., employment, parenting
      behaviors, psychological improvement, and HIV risk reduction behaviors), compared to the
      impact of traditional mixed-gender programs. Assessments will occur at baseline and at 1
      month, 12 months, and 24 months after admission.
    

Intervention name(s): Women-Only
Intervention type(s): Behavioral
Intervention description(s): Gender-responsive treatment for women only
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gender-responsive substance abuse treatment
Evaluation of an Integrative Medicine Outpatient Clinical Setting for Post-COVID-19 Patients
Condition: COVID-19; Fatigue
MeSH terms: COVID-19; Fatigue
Study type: Interventional

Summary: 
      The study aims to identify whether a multimodal integrative naturopathy outpatient clinical
      concept can improve the symptoms of patients suffering from post-COVID-Syndrome. Main outcome
      is fatigue. The outpatient clinical programme consists of 11 weeks wherein patients visit the
      clinic one day per week. The pillars of classical naturopathy are combined with extended
      naturopathy and complementary procedures. Previous naturopathical studies on patients with
      chronic fatigue syndrome could find numerous indications that different types of naturopathy
      can help patients with fatigue.
    


Intervention name(s): outpatient clinic with multimodal integrative medicine and naturopathy for post-COVID-19 patients; waiting group
Intervention type(s): Behavioral; Other
Intervention description(s): Patients receive multimodal integrative medicine and naturopathy applications with focus on mind-body-medicine and whole body hyperthermia to reduce fatigue and improve quality of life.; Patients receive no intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel to the treatment group that visits the outpatient clinic on one day of the week for 11 weeks, the waiting group only fills in a diary and the questionnaires at two timepoints. Diary and questionnaires are the same for both groups.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Covid-19; fatigue; outpatient clinic; integrative naturopathy; integrative medicine
Weight-bearing Training in Stroke Patients.
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      1. Are there differences in weight-bearing (WB) and WB symmetry immediately following STS and
      stepping training with or without using external feedback in ambulatory patients with stroke?

      1. Are there differences in mobility immediately following STS and stepping training with or
      without using external feedback in ambulatory patients with stroke?
    

Detailed description: 
      Subjects are patients with stroke, the age of over 40 years to 74 years, both males and
      females who are able to walk independently at least 10 meters. Most of them will be recruited
      from a tertiary rehabilitation center and communities. Subjects have to participate in STS
      and stepping training with and without using the external feedback for 1 time/condition with
      a wash-out period for 2 weeks (crossover design). The outcomes will be measured in terms of
      WB ability during STS and stepping, walking speed, and balance ability.

      The primary outcomes were WB ability on the affected limb and WB symmetry. Secondary outcomes
      were walking speed and balance ability.
    

Intervention name(s): WB Training with external feedback; WB Training without external feedback
Intervention type(s): Other; Other
Intervention description(s): WB during sit-to-stand and stepping with external feedback, follow by overground walking.; WB during sit-to-stand and stepping without external feedback, follow by overground walking.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cerebrovascular disease; rehabilitation; walking; balance; mobility
An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open label study in opioid dependent subjects maintained on a stabilized dose of
      Suboxone tablets or films. The purpose is to assess the safety and tolerability of BEMA
      Buprenorphine NX administered once daily for 12 weeks to opioid dependent subjects stabilized
      on Suboxone (buprenorphine/naloxone) tablets or films.

      Eligible subjects will be converted to an approximately equal dose of BEMA Buprenorphine NX.
      This dose will be taken throughout the 12-week treatment period with dose adjustments as
      clinically indicated for either the control of opioid dependence or adverse events (AEs).
    

Detailed description: 
      This is an open label study in opioid dependent subjects maintained on a stabilized dose of
      Suboxone tablets or films.

      Eligible subjects will be converted to an approximately equal dose of BEMA Buprenorphine NX.
      This dose will be taken throughout the 12-week treatment period with dose adjustments as
      clinically indicated for either the control of opioid dependence or adverse events (AEs).
      Subjects will be monitored for evidence of buccal irritation attributed to the application of
      the BEMA Buprenorphine NX film and opioid dependence control according to the Clinical
      Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction - A Treatment
      Improvement Protocol (TIP 40) guidelines for the use of buprenorphine in the management of
      opioid dependence.

      The total duration of participation for each subject will be up to approximately 18 weeks and
      includes a Screening period (subjects continue to take Suboxone tablets or films), Baseline
      visit, a 12-week open label treatment period (subjects take BEMA Buprenorphine NX films and
      at the Day 84 visit, subjects will return to their prior Suboxone treatment), and a Follow-up
      Visit.

      Vital signs, pulse oximetry, opioid withdrawal symptoms, adverse events (AEs), oral
      examinations, and concomitant medications will be assessed at intervals throughout the study.
      Clinical laboratory assessments, urine toxicology and buprenorphine testing, and 12-lead
      electrocardiograms (ECGs) will also be performed.
    

Intervention name(s): BEMA Buprenorphine NX films
Intervention type(s): Drug
Intervention description(s): BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively.
Other intervention name(s): BNX
Intervention MeSH terms: Buprenorphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opioid dependence; Suboxone; addiction; BEMA Buprenorphine NX; oral transmucosal
First in Human Study of an Anti-IFN Gamma Monoclonal Antibody in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic
      profiles of a novel therapeutic drug when administered to healthy volunteers.
    


Intervention name(s): NI-0501; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effects of Five Days of Physical Inactivity on Endothelial Function in Healthy Humans
Condition: FMD
Study type: Interventional

Summary: 
      Physical inactivity is a significant predictor of major non-communicable diseases such as
      type 2 diabetes (7%), cardiovascular disease (6%), musculoskeletal disorders and some types
      of cancer, and has been proposed to be the 4th leading cause of death worldwide. The
      investigators aim is to assess the vascular (endothelial) function before and after a 5-day
      period of reduced activity of upper and lower limbs via an arm sling and daily step counts
      reduction, respectively, in healthy participants. Twelve young (ages of 18 - 35 years),
      healthy, males and females, recreationally active with a body mass index between 18 and 27
      kg/m2 will be recruited. The participants will then randomly undergo two 5-day interventions:
      (A) 5 consecutive days of habitual daily levels of physical activity and matched food intake
      (Control trial). (B) 5 consecutive days of reduced step count by 80% compared to the Control
      trial combined with their non-dominant arm placed in a sling and a reduction in food (energy)
      intake (~20%) to match the reduction in energy expenditure induced by inactivity (Inactivity
      trial). On days 1 and 6 of each experimental trial, the endothelial function of the brachial
      and popliteal arteries, and hand grip strength will be measured.
    


Intervention name(s): Inactivity
Intervention type(s): Behavioral
Intervention description(s): On days 1 and 6 of each main trial, the participants will be asked to attend the laboratory after an overnight fast of at least 8 to 12h to undergo brachial and popliteal arteries FMD measurements (30 min apart) using duplex-Doppler ultrasound, followed by assessment of the hand grip strength of their non-dominant hand using a hand dynamometer.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic