bioihbjkbjnl/mcl2 huggingface dataset:
Chiropractic Adjustment on Physiological Measurements
Condition: Healthy
Study type: Interventional

Summary: 
      This research is designed to study the effects of chiropractic adjustment on the
      physiological responses (EEG, EMG, HRV, skin temperature, and respiration) of college student
      and faculty population.
    


Intervention name(s): ProAdjuster
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This 3 arm study will determine the dose of R1507 which will achieve a mean drug exposure in
      children and adolescents with advanced solid tumors equivalent to the exposure achieved in
      adults at the recommended dose of 9mg/kg/week. It will also determine the maximum tolerated
      dose (if appropriate) and the pharmacokinetic profile of R1507. Groups of patients will be
      sequentially enrolled in one of up to 3 dose levels (3,9mg/kg or a PK-derived dose, not to
      exceed 16 mg/kg) of R1507 administered weekly by intravenous infusion.An expanded cohort of
      patients will be enrolled at the optimal dose/MTD. The anticipated time on study treatment is
      until disease progression or dose limiting toxicity, and the target sample size is <100
      individuals.
    


Intervention name(s): RG1507; RG1507; RG1507
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3mg/kg iv weekly; 9mg/kg iv weekly; Pharmacokinetic-derived dose, <=16mg/kg iv weekly
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mental and Psychological Problems and Insomnia Disorder of Medical Staff in Hospital With Infected COVID-19 Patients
Condition: Depression Unipolar; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Observational

Summary: 
      The objective of this study is to clarify the severity of psychological problems and insomnia
      and the two's relationship with time of hospital medical staff in hospital where its staff
      are infected with COVID-19.
    

Detailed description: 
      A cross-sectional questionnaire survey method was adopted to conduct investigations of
      medical staff in the researched hospital within one week (baseline) and one year (follow-up)
      after the discovery of COVID-19 infection cases. 360 subjects were included in the baseline.
      Then, after one year, 199 subjects who participated in the survey at baseline were included
      as follow-up. The HADS, ASDS and ISI scales were used to assess the anxiety and depression
      level, acute stress disorder symptoms, and the severity of insomnia of hospital medical
      staff; self-made questionnaires was to collect demographic information and descriptive
      content. Comparing the follow-up medical staff with the baseline, the total scores of ASDS,
      HADS and ISI, each item scores on the ASDS, HADS and ISI. All of above scales are compared
      between the quarantined and non-quarantined groups, different quarantined groups (home,
      hotel, hospital) and non-quarantined groups.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        There were 644 medical staff on duty in the hospital, of which 360 people participated in
        the baseline survey, accounting for 55.90%. In the follow-up survey after one year, 199 out
        of 360 people in the baseline participated, accounting for 55.28% of the baseline.
Non-invasive Evaluation of Volume Status Using Exhaled Carbon Dioxide and Pulse Contour Analysis
Condition: Changes in Cardiac Output
Study type: Interventional

Summary: 
      The investigators hypothesize that changes in blood circulation can be reflected by exhaled
      CO2 provided CO2-production in the tissues and ventilation from the lungs are stable. The
      investigators want to explore changes in cardiac output (the amount of blood being pumped out
      of the heart each minute) in patients using different devices: an esophagus ultrasound device
      measuring cardiac output, a finger cuff measuring blood pressure and cardiac output, and
      exhaled carbondioxide in the patients' breath measured by the ventilator.

      The investigators investigate patients after bypass surgery or heart valve replacement, and
      induce changes in cardiac output with passive leg raise or ventricular pacing.
    

Detailed description: 
      Measurements with the finger cuff (pulse contour analyses) were aborted due to technical
      difficulties.
    

Intervention name(s): Ventricular pacing and passive leg raise
Intervention type(s): Other
Intervention description(s): Ventricular pacing and passive leg raise
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cardiac output; Exhaled CO2; Nexfin; Esophageal Doppler
An Investigation Into a 21-Day Detoxification Diet With a Seven-Day Continuation
Condition: Detoxification
Study type: Interventional

Summary: 
      Detoxification diets aim to remove chemicals from the body that may cause short or long-term
      harm. However, little is known about detoxification diets from well-designed clinical trials.
      This trial examines the efficacy of Chef V's 21-Day Starter Challenge Detox diet.
      Participants will use Chef V's 21-Day Starter Challenge Detox as directed for the first 21
      days of the trial and continue to use the Chef V Green Drink Supplement for an additional
      seven days. The primary outcomes of interest are the participant's perceptions of their
      health improvements and biomarkers that will be measured via blood draws.
    


Intervention name(s): 21-Day Detox and Green Drink supplement
Intervention type(s): Other
Intervention description(s): Detox plan description:
7AM Water 16oz. 8AM Green Drink 16oz. 9AM Ultra Shake 16oz. 9-12PM Water 24 - 48oz. 12PM Green Drink 16oz. 12:30 - 2PM Water 24 - 48oz. 2PM Green Drink 16oz. 3PM Ultra Shake 16oz. 3:30- 6PM Water 24 - 48oz. 6PM Green Drink 16oz. 7PM Detox Soup 16oz. 7:30 - 10PM Water 24 - 48oz. This 21-day period will be followed by 7 days of consuming the Green Drink Supplement.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Raltegravir Kaletra Pharmacokinetics
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female
      subjects of the pharmacokinetic interaction between raltegravir and Kaletra.
    

Detailed description: 
      This will be an open-label, 3-period, fixed sequence study in young, healthy, male and female
      subjects. The initial cohort, to be studied simultaneously, will be 15 subjects with
      intention to collect complete data from 12 subjects. Replacements will be subsequently
      enrolled if necessary. Subjects will be reimbursed.

      The periods will be

        -  Period 1: Raltegravir (RAL) 400 mg q12h for 4 days (7 doses of RAL).

        -  Period 2: Kaletra 200 mg 2 pills bid for 10 days (19 doses of Kaletra).

        -  Period 3: both regimens for 4 days (7 doses of both drugs). All morning doses will be
           observed at Prism Research, Inc. Evening doses will be distributed each morning. 12 hour
           PK studies will be done on the last day of each period. Specimens will be obtained 0,
           0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours after the morning dose of the last dosing
           day of each period.
    

Intervention name(s): Raltegravir, lopinavir, ritonavir
Intervention type(s): Drug
Intervention description(s): 4 days of raltegravir, then 10 days of Kaletra, then 4 days of both with 12 PK sampling at the end of each period.
Other intervention name(s): Isentress; Kaletra
Intervention MeSH terms: Ritonavir; Lopinavir; Raltegravir Potassium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: raltegravir; lopinavir; ritonavir; pharmacokinetics
18842 - Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor (SPF) efficacy on human skin.
    


Intervention name(s): Coppertone (BAY987517)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.(Formulation- SR16-08)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
High Dose Candesartan Versus Quinapril for Restenosis Prophylaxis After Stent Angioplasty
Condition: Arterial Occlusive Diseases
MeSH terms: Arterial Occlusive Diseases
Study type: Interventional

Summary: 
      The study is designed to test the hypothesis that high dose candesartan treatment compared to
      quinapril is able to reduce intima hyperproliferation and the restenosis rate after stent
      angioplasty in peripheral occlusive artery disease.
    

Detailed description: 
      Patients are randomly assigned to treatment with either candesartan 32 mg/d or Quinapril 20
      mg/d before the angioplasty. Walking distance, intima media thickness and crurobrachial
      pressure ratios are compared after 6 weeks, 3 months and 6 months. After 6 months an
      angiographic control is performed.
    

Intervention name(s): candesartan (drug) or quinapril (drug)
Intervention type(s): Drug
Intervention MeSH terms: Candesartan; Candesartan cilexetil; Quinapril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: restenosis; intima hyperproliferation; stent angioplasty; pain-free walking distance
The Effect of Resistance Training on Proprotein Subtilisin Convertase Kexin 9 Level After Coronary Bypass Surgery
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      This research add resistance training to patients who undergo cardiac rehabilitation program
      after coronary bypass surgery, comparing the level of PCSK9 level on that group to another
      group who receives conventional rehabilitation program (only aerobic exercise)
    

Detailed description: 
      The PCSK9 level measured before and after cardiac rehabilitation program (around 3-4 weeks),
      and compared between two groups. ELISA method will be used to measure plasma PCSK9 level.

      Resistance training will be given by professional trainer in gymnasium of National
      Cardiovascular Center Harapan Kita supervised by cardiologists, following rules from American
      College of Sports Medicine guideline regarding to exercise after cardiac event.
    

Intervention name(s): resistance training; aerobic training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session was held for around 30 minutes.; aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: resistance training, PCSK9, coronary artery bypass grafting
Evaluation of Adherence of Women With Fibromyalgia to Walking Prescriptions
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Observational

Summary: 
      Although there are many studies evaluating adherence to supervised walking programs in
      patients with fibromyalgia (FM), there are limited studies evaluating adherence to
      unsupervised walking programs.
    

Detailed description: 
      Although there are many studies evaluating adherence to supervised walking programs in
      patients with fibromyalgia (FM), there are limited studies evaluating adherence to
      unsupervised walking programs.

      Purposes of this study were (1) to assess whether walking as exercise was prescribed by their
      physiatrist in Turkish women with FM who received pharmacological therapy, (2) to illustrate
      the frequency of patients who walk regularly as exercise, (3) to clinically compare patients
      who walk regularly as exercise and those who do not, and (4) to determine factors related to
      adherence to walking prescriptions.
    

Intervention name(s): Evaluation of adherence to walking prescriptions
Intervention type(s): Other
Intervention description(s): Adherence to walking prescriptions was evaluated according to a specific criterion (walking at least 30 min, in bouts of 15 min, with a small rest between bouts, twice a week, over a minimum of six consecutive weeks) based on previous recommendations.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with FM according to the criteria of the American College of
        Rheumatology (ACR) and recommended pharmacological therapy within the last 1 year
      
Keywords: Fibromyalgia; Walking; Adherence
Catatonia in Nodding Syndrome and Lorazepam Treatment
Condition: Catatonia; Nodding Syndrome
MeSH terms: Catatonia; Nodding Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      Nodding Syndrome is an enigmatic neuropsychiatric syndrome affecting children and adolescents
      mostly in Eastern Africa. The symptoms of Nodding Syndrome and catatonia seem to overlap. The
      researchers' objectives in this study were to investigate the presence and types of catatonic
      symptoms in children with Nodding Syndrome and observe their response to one or two doses of
      lorazepam, the first-line treatment for catatonia.
    

Detailed description: 
      In this pilot study, the investigators examined a convenient sample of children and
      adolescents with Nodding Syndrome (NS) for catatonic symptoms using standardized criteria.
      The investigators also tested whether oral lorazepam (LZP) administered to those who
      qualified to have pediatric catatonia would alleviate symptoms. This was a cross-sectional
      descriptive study of catatonia in NS patients in Northern Uganda and an exploratory study of
      using one or two doses of lorazepam as a catatonia test.

      All the children with confirmed NS that had 2 or more of symptoms of catatonia were recruited
      to undergo the catatonia test using oral Lorazepam EG® (n.v. Eurogenerics s.a. Brussels,
      Belgium) using the 1 mg formulation tablets. It was proposed to perform a catatonia test
      using Lorazepam (LZP) as first choice medication, as this is the medication that has been
      used most commonly in pediatric catatonia.

      The amount of drug given was based on the weight of the child. The lower dose (0.5 mg) was
      used as starting dose for patients with <30 kg body weight, while the higher dose (1 mg) as
      the starting dose for patients with >30 kg body weight.

      A positive response to a catatonia test consisted of a reduction in catatonic symptoms, 30 or
      60 minutes later, by at least 50% .Positive responses were documented by video footage before
      and after administration of LZP.

      If no response to the initial dose of LZP, was observed after one hour, a second
      administration of the same medication at double the dose was given. Catatonia was again
      assessed at 30 and 60 minutes thereafter. If no response was observed, the test was
      considered negative.
    

Intervention name(s): Lorazepam
Intervention type(s): Drug
Intervention description(s): Lorazepam was given based on the weight of the child with Catatonia. The lower dose (0.5 mg) was used as starting dose for patients with <30 kg body weight, while the higher dose (1 mg) as the starting dose for patients with >30 kg body weight.
Other intervention name(s): Ativan
Intervention MeSH terms: Lorazepam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Correlation Between Aqueous Protein Level and Clinical Grading of Flare and Flaremetry.
Condition: Uveitis
MeSH terms: Uveitis
Study type: Interventional

Summary: 
      The purpose of this study is to compare flaremetry readings with the protein content of the
      aqueous humor and the clinical grading of flare.
    

Detailed description: 
      A total of 20 patients will be included. 10 patients with uveitis and 10 control patients
      scheduled for phacoemulsification. Each patient will undego complete ophthalmic examination
      and clinical biomicroscopic grading of the anterior chamber flare applying the SUN working
      group grading system. Aqueous specimens will be obtained by anterior chamber paracentesis for
      protein analysis. Each Patient will undego paracentesis and 0.2 ml of aqueous will be
      obtained. The aqueous sample will be stored at -70°C until the time of analysis for protein
      content. Objective assessment of flare will be done.
    

Intervention name(s): Paracentesis of the anterior chamber
Intervention type(s): Procedure
Intervention description(s): Aqueous humor parenthesis for quantitative protein analysis in patients with and without uveitis.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: flaremetry; aqueous proteins; clinical grading; Compare flaremetry readings with the protein content of the aqueous; Compare flaremetry readings with clinical grading of flare
Assessment of Serum Levels of Vitamin D, Vitamin B12 and Folic Acid Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
Condition: Vitamin D, Vitamin B12 and Folic Acid Among Patients With Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Interventional

Summary: 
      Therefore, this study will aim to assess serum levels of vitamin D, vitamin B12 and folic
      acid among patients with lifelong PE and non-responding to dapoxetine treatment.
    

Detailed description: 
      We will consider the patients with LPE non-responding to dapoxetine treatment when they used
      the optimum dose (30 and 60mg) dapoxetine for 4 separate times with no response.

      Serum vitamin D, vitamin B12, and folic acid levels will be assessed in all subjects included
      in the study. Venous blood samples will be drawn and kept into EDTA bottles in the morning
      between 8 and 10 a.m. after an overnight fast of about 10-14 hr.
    

Intervention name(s): Serum vitamin D, vitamin B12, folic acid
Intervention type(s): Diagnostic Test
Intervention description(s): Serum vitamin D, vitamin B12, and folic acid levels will be assessed
Other intervention name(s): Serum vitamin D, vitamin B12, folic acid levels
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Folic Acid; Vitamin B 12; Hydroxocobalamin; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: assess serum levels of vitamin D, vitamin B12 and folic acid among patients with lifelong PE and non-responding to dapoxetine treatment.
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Premature Ejaculation
Transcranial Alternating Current Stimulation
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the efficacy of using transcranial alternating current stimulation (tACS) to
      enhance the regaining of neurological function among post-stroke patients.
    

Detailed description: 
      Sixty post-stroke patients were randomly assigned to receive 15 sessions of the usual
      rehabilitation programme with or without tACS. The NIH Stroke Scale (NIHSS) and the mean
      blood flow velocity (MFV) and Gosling pulsatility index (PI) captured for the middle,
      anterior, and posterior cerebral artery were the outcome measures.

      Fifteen 30-minute sessions of tACS appear to be effective for enhancing post-stroke patients'
      neurological function. The haemodynamic measures taken indicated that the regaining of
      function among the patients was largely attributed to a lowering of the vascular
      autoregulatory activity together with an increase in blood flow velocity at the middle
      cerebral artery. Future studies should explore the underlying mechanisms mediating the
      positive effects brought about by tACS in post-stroke rehabilitation.
    

Intervention name(s): transcranial alternating current stimulation (tACS)
Intervention type(s): Device
Intervention description(s): Patients in the tACS group received a total of 15 sessions of brain stimulation. The sessions were conducted on weekdays (from Monday to Friday) for three consecutive weeks. Each session lasted 30 minutes. The alternating current stimulations were generated by a CVFT-MG201 machine. Stimulations were delivered by two U-shaped electrodes (approximately 7 cm2) fixed on the patient's left and right mastoid regions (anode or cathode varied depending on polarity of the alternating current). The frequencies (supra-slow waves: < 1 Hz; theta to gamma), levels of intensities (0 to 3mA), and density function (follows a bell-shaped curve; mean intensity ~ 2.1mA) of the current were delivered according to the manufacturer's pre-set random protocol.
Other intervention name(s): CVFT-MG201(China Patent No. ZL98121951.9)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: brain electrical stimulation; sub-acute post-stroke; rehabilitation
Neurodevelopment After Early Iron Supplementation
Condition: Iron Deficiency; Anemia of Prematurity; Neurodevelopmental Delay
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Background: Iron deficiency in early childhood may impair neurodevelopment.

      Aim: To examine whether early iron supplementation improved neurodevelopment in preterm
      infants.

      Method: Children who participated in a clinical trial of iron supplementation were invited
      for a neurodevelopmental follow-up examination at the time of school entry.
    

Detailed description: 
      Children with a birth weight of < 1301g who participated in a randomized controlled trial of
      early versus late enteral iron supplementation were evaluated applying a standardized
      neurological evaluation, the Kaufmann Assessment Battery for Children, and the Gross Motor
      Function Classification Scale (GMFCS) at the age of school entry.

      Severe disability was defined as any of the following: any abnormal neurological examination
      associated with a severely impaired mobility (GMFCS>1), severe cognitive impairment (mental
      processing composite (MPC) <51), hearing loss requiring amplification, or blindness. The
      absence of disability was defined as normal neurological examination, normal mobility
      (GMFCS=0), and normal cognitive development (MPC>85) and the absence of any severe hearing
      and visual impairment.
    

Intervention name(s): Oral administration of ferrous sulphate
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Neurocognitive outcome; preterm infant; very low birth weight; iron deficiency; iron supplementation