bioihbjkbjnl/mcl2 huggingface dataset:
Association of Transcutaneous Pulse CO-oximetry With Inflammatory Lung Diseases
Condition: Asthma; Allergic Rhinitis; Cystic Fibrosis; Pneumonia
MeSH terms: Pneumonia; Rhinitis; Cystic Fibrosis; Lung Diseases; Rhinitis, Allergic; Fibrosis
Study type: Observational

Summary: 
      This is a pilot cross-sectional study of measured transcutaneous CO-oximetry in children with
      inflammatory and non-inflammatory conditions.
    

Detailed description: 
      Children and young adults age 6-24 with the following conditions: asthma, pneumonia, allergic
      rhinitis, cystic fibrosis, and well child (without inflammatory illness) will be recruited.

      Subjects will be asked to complete a brief screening survey to determine if they meet
      inclusion criteria. Enrolled subjects will be asked to complete questionnaire forms to
      characterize their health, current symptoms, medications, and common exposures.
      Transcutaneous carboxyhemoglobin will be recorded.

      This study is cross-sectional and will only require one visit coinciding with the clinical
      visit. Analysis will determine the pairwise differences in SpCO between conditions tested.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Age range 6-24years old. All genders, races, and ethnicities were sampled, provided they
        could complete the study requirements.
      
Keywords: Asthma; Allergic rhinitis; Rhinitis; Pneumonia; Cystic fibrosis
Role of Anti-Inflammatory Agents in Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Psychosis Not Otherwise Specified; Schizophreniform Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      There is some evidence that anti-inflammatory treatment may have beneficial effects in
      schizophrenia and major depression. Cox-2 inhibitors have been tested in preliminary clinical
      trials for schizophrenia and depression, showing favourable effects compared to placebo
      (Muller and Schwarz et al 2009).

      Statins were introduced as cholesterol-lowering agents but have found much wider usage. They
      are anti-inflammatory agents and thus similar to the Cox-2 inhibitors, which have shown some
      ability as adjuncts to improve the symptoms of schizophrenia in preliminary studies. The
      statins are also known to decrease C-reactive protein (CRP), which has been shown in an
      SMRI-funded study to be elevated in a study of individuals with schizophrenia. Fan et al
      (2007) demonstrated in a small study in patients with schizophrenia that higher than normal
      levels of CRP (>0.50 mg/dl) was associated with marked negative symptoms and higher total
      PANSS scores.

      Ondansetron is a serotonin (5-HT3) receptor antagonist that is generic and widely used to
      prevent nausea and vomiting in patients receiving chemotherapy for cancer. GSK did a small
      study on it as an antipsychotic in the 1980s. Since then, several small studies have
      suggested that it is effective as an adjunct drug in improving the symptoms of schizophrenia.

      Statins are widely used in schizophrenia sufferers, particularly those taking second
      generation antipsychotics, to treat hypercholesterolemia. Both drugs are well tolerated and
      their side effect profiles well understood.

      We propose to conduct a feasibility study in patients with chronic schizophrenia to explore
      the adjunct use of simvastatin and ondansetron on positive, negative and general
      psychopathology in comparisons to treatment as usual (TAU) over a 12 week period.
    


Intervention name(s): Ondansetron; Simvastatin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ondansetron added to TAU Ondansetron will be administered in 8mg once daily dose; Simvastatin added to TAU Simvastatin 20mg taken as once daily dose; Placebo added to TAU
Intervention MeSH terms: Ondansetron; Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Anti inflammatory; Schizophrenia; Simvastatin; ondansetron
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride
      Tablets 1 × 45 mg and Actos® Tablets 1 × 45 mg of Takeda Pharmaceuticals America, Inc. Dosing
      periods of studies were separated by a washout period of 12 days and 11 days respectively.

      Study Design:

      Randomized, Two-Way Crossover, Single-Dose, and Open-Label
    


Intervention name(s): Torrent's Pioglitazone Hydrochloride Tablets 45 mg
Intervention type(s): Drug
Intervention MeSH terms: Pioglitazone
Effect of Air Pollution on the Cognitive Function of Adolescents
Condition: Attention Impaired; Risk-Taking; Risk Behavior; Social Preferences; Decision Making; Attention
Study type: Interventional

Summary: 
      Previous observational studies have reported an association between higher air pollution
      exposure and lower attention in children. With this project, the investigators aim to confirm
      this association in adolescents using an experimental design. In addition, the study will
      assess the relationship between air pollution exposure and individual preferences with
      respect to risk, time and social considerations. High school students in 3rd grade (ESO,
      14-15 years of age) in different high schools in the Barcelona province (Spain) will be
      invited to participate. For each class in each high school, participating students will be
      randomly split into two equal-sized groups. Each group will be assigned to a different
      classroom where they will complete several activities during two hours, including an
      attention test (Flanker task) and a reduced version of the Global Preferences Survey. One of
      the classrooms will have an air purifier that will clean the air. The other classroom will
      have the same device but without the filters, so it will only re-circulate the air without
      cleaning it. Students will be masked to intervention allocation. The investigators
      hypothesize that students assigned to the clean air classroom will have better scores in the
      attention test, and that decision-making will also present differences in the two classrooms.
    


Intervention name(s): Purifying the air with a Pure Airbox device (Zonair 3D); Using a sham air purifier (same device without filters)
Intervention type(s): Other; Other
Intervention description(s): Purifying the air of the classroom where the experiment is conducted using a Pure Airbox device (Zonair 3D); Use the air purifier (Pure Airbox, Zonair 3D) without filters in the classroom where the experiment is conducted
Other intervention name(s): Air filtering; Air cleaning; Sham air cleaner
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Attention; Air pollution; Black carbon; Particulate matter; Risk behavior; Social preferences; Decision making; Air purifier; Air cleaner
Added Sugar Intake, Sweet Taste Phenotypes and Biomarkers
Condition: Healthy
Study type: Observational

Summary: 
      The goals of this cross-sectional study on a racially diverse group of children (3-10y) and
      their mothers are to determine whether the relationship between sweet taste phenotypes
      differed among mother-daughter and mother-son dyads and to determine the predictive value of
      a hair biomarker (delta13C). Given the widespread overconsumption of added sugars, and the
      associated burden of disease, improving surveillance measures and developing strategies to
      reduce added sugar intake, especially among the youngest members of society, are public
      health priorities.
    

Detailed description: 
      This is a single-site cross-sectional study designed to investigate the relationship of sweet
      taste phenotypes among mother-child dyads and assess the predictive value of a hair biomarker
      for sweet taste phenotypes. For each participant, we will collect 2-day 24-hour dietary
      recalls to determine added sugar intake; directly assess the level of sweet taste most
      preferred; measure liking/disliking of sweet tasting foods and beverages; collect
      anthropometric measures; and collect at least 3 cm of hair for biomarker analyses. Mothers
      will also complete a variety of questionnaires on parenting and child behavior.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults and children
      
Keywords: taste; children; dietary intake; biomarker; adult; sugar
Drain After Elective Laparoscopic Cholecystectomy
Condition: Cholelithiasis
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones
Study type: Interventional

Summary: 
      The trial aims to assess the value of drains in elective laparoscopic cholecystectomy.
    

Detailed description: 
      After laparoscopic gallbladder removal patients are randomized to have a suction drain
      positioned in the subhepatic space or to have a sham drain in the subhepatic space. The
      primary outcome measure will be the presence of subhepatic fluid collection at
      ultrasonographic examination on the first postoperative day. Secondary outcome measures will
      be postoperative abdominal and shoulder tip pain, use of analgesics, nausea, vomiting and
      morbidity
    

Intervention name(s): no drain; drain positioned; drain not positioned
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): drain positioned on the skin; drain positioned in the subhepatic space; Drain positioned in the abdominal wall
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Laparoscopy; cholecystectomy; drainage
The Effect of Navy Beans and Yellow Peas on Satiety in Children
Condition: Food; Eating; Satiety; Physical Comfort
Study type: Interventional

Summary: 
      The frequent consumption of pulses is associated with multiple cardiometabolic benefits in
      adults including a lower risk for overweight and obesity. However, it remains unclear whether
      these effects are mediated through the short-term mechanisms, including enhanced satiety and
      reduced food intake (FI), or through the long-term metabolic effects triggered by regular
      consumption of pulses. The objective of this study is to investigate the short-term effect of
      cooked pulses served in the amount similar to their recommended serving of 175ml (3/4 cup) on
      food intake in 12-14y children, and gastrointestinal comfort over 2-hours. The secondary
      objective is to evaluate how children perceive the sensory characteristics of the meals made
      with the whole pulses.
    


Intervention name(s): Food-1; Food-2; Food-3
Intervention type(s): Other; Other; Other
Intervention description(s): Cooked whole navy beans (300 kcal); Cooked whole yellow split peas (300 kcal); Cooked rice considered as control (300 kcal)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pulses; Satiety; Food intake; Appetite; Beans; Peas
A Comparison Between Short vs. Long Biliopancreatic Limb Gastric Bypass
Condition: Bariatric Surgery; Metabolic Surgery; Roux-en-Y Gastric Bypass
Study type: Interventional

Summary: 
      Prospective study including patients submitted to RYGB (n=94) and L-RYGB (n=94) at a single
      institution. The aim was to compare the effect on comorbidities and weight loss of a long
      biliopancreatic limb Roux-en-Y gastric bypass (L-RYGB), compared with a standard RYGB.
      Procedure selection was randomly assigned (1:1), and surgeries were performed, during 24
      months (2016-2017). Weight loss, comorbidities control and nutritional status were assessed
      at baseline and 12 months.
    


Intervention name(s): Long biliopancreatic limb Roux-en-Y gastric bypass.; Standard Roux-en-Y gastric bypass
Intervention type(s): Procedure; Procedure
Intervention description(s): Long biliopancreatic limb Roux-en-Y gastric bypass.; Standard Roux-en-Y gastric bypass
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Safety and Effectiveness Study of Acetaminophen (4000 mg/Day) and Naproxen (750 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee
Condition: Osteoarthritis, Hip; Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the long-term safety and effectiveness of
      acetaminophen (4000 mg per day) and naproxen (750 mg per day) in the treatment of
      osteoarthritis of the hip or knee.
    

Detailed description: 
      This is a randomized, double-blind study to compare the long term safety profile and
      effectiveness of acetaminophen, given at a dose of 1000 mg every four to six hours, and
      naproxen, given at a dose of 375 mg twice daily (with matching placebo given four times daily
      to maintain the blind), in the treatment of osteoarthritis of the hip or knee. There are two
      groups of subjects. Group 1 has approximately 480 subjects randomized and a treatment
      duration of 12 months. Group 2 has approximately 80 subjects randomized and a treatment
      duration of 6 months. The primary measure of efficacy is the change from baseline in the
      WOMAC Osteoarthritis Index pain subscale at month 6. Safety evaluations, throughout the
      course of the study, include monitoring adverse events, laboratory tests and assessments of
      vital signs including respiration rate, pulse, blood pressure, and body weight. Subjects are
      instructed to take a dose of medication orally, every 4-6 hours. The acetaminophen subjects
      take a total daily dose of 4 g of acetaminophen. The naproxen subjects a total daily dose of
      750 mg of naproxen. The treatment duration is 12 and 6 months in Group 1 and Group 2,
      respectively.
    

Intervention name(s): acetaminophen; naproxen; acetaminophen; naproxen
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 4 grams daily for six months; 750 mg daily for 12 months; 4 grams daily for 12 months; 750 mg daily for six months
Intervention MeSH terms: Acetaminophen; Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: osteoarthritis hip; osteoarthritis knee; acetaminophen, naproxen
Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI)
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      The aim of this study is to evaluate the clinical performance on Analgesia/Nociception Index
      (ANI) in the assessment of immediate postoperative analgesia in PACU in adult patients
      undergoing general anesthesia.
    

Detailed description: 
      Evaluation of the relationship between ANI and numerical rating pain scale (NRS) by linear
      regression.

      Assessment of the performance of ANI to detect NRS>3 and NRS>=7 by building ROC curves.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients underoing surgical or endoscopic procedures performed on general anesthesia
      
Keywords: Analgesia/Nociception index
Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation
Condition: Graft vs Host Disease; Congenital Aniridia; Chemical Burns; Stevens-Johnson Syndrome; Congenital Glaucoma
MeSH terms: Stevens-Johnson Syndrome; Aniridia; Hydrophthalmos; Graft vs Host Disease; Burns, Chemical
Study type: Interventional

Summary: 
      The ARGOS-IO pressure sensor is intended to be implanted in the human eye in combination with
      Boston Keratoprosthesis (BKPro) surgery and to remain in place indefinitely. It is intended
      to be used together with the hand-held Mesograph reading device to telemetrically measure the
      intraocular pressure (IOP) of patients with a BKPro.

      The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system in
      patients undergoing concomitant implantation of a BKPro and an ARGOS-IO sensor over the 12
      month period beginning at implantation.
    


Intervention name(s): ARGOS-IO system
Intervention type(s): Device
Intervention description(s): This study will enroll a minimum of 10 and a maximum of 15 patients. It is anticipated to be large enough to provide an initial estimate of common safety events and assessment of performance. Any adverse event (AE), serious adverse event (SAE), ADE (adverse device event) and SADE (serious adverse device event) will be listed. Incidence will be estimated with a 95% confidence interval (Pearson-Clopper, two-sided). The Bland-Altman method will be used to assess the limits of agreement between the IOP measurements ARGOS-IO and surgical manometry. When appropriate, two-sided 95% confidence intervals, for these limits will be calculated accounting for repeated measurements based on the method proposed by Zou (2011). Other secondary performance endpoints will be analyzed by descriptive and explorative statistical methods.
Other intervention name(s): ARGOS-IO pressure sensor implant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Boston Keratoprosthesis
Qigong and Social Isolation: Mental Health Benefits
Condition: Mental Health Wellness 1
Study type: Interventional

Summary: 
      The objective of the study is to understand if Qigong may be useful in controlling the
      psychological state of participants in relative social isolation (during Covid-19
      governmental imposed isolation procedures) The sessions are conducted live by the internet by
      a professional instructor-therapist with the duration of 2 months and a regular minimum of 2
      sessions a week.
    

Detailed description: 
      The study's objective is to understand if Qigong may be helpful on the psychological state
      control of the participants in a relative state of isolation imposed by the government on the
      fight against Covid-19.

      Data is gathered via the Mental Health Inventory (MHI) adapted to the Portuguese population
      to assess quantitative mental health scores and a simple structured interview to assess
      qualitative mental health benefits of Chikung (Qigong).

      Qigong was the chosen technique to be studied as an intervention. Qigong is a Traditional
      Chinese Medicine therapeutic tool that has been studied for its several health benefits. As a
      traditional vegetative biofeedback therapy, Qigong can be useful for the maintenance of
      mental health of people with several conditions such as anxiety and depression, autism
      spectrum disorder and even conditions related to behavioral control.

        -  Group 1 was composed of Qigong practitioners (for at least 3 months).

        -  Group 2 was composed of participants who would receive the Qigong intervention (never
           practiced Qigong).

        -  Group 3 was composed of control participants (who would not receive the intervention).
    

Intervention name(s): Qigong
Intervention type(s): Other
Intervention description(s): Qigong as a traditional chinese medicine technique, composed of several types of exercises: Baduanjin, taijiquan, yijinjing, baojiangong.
Other intervention name(s): Traditional vegetative biofeedback therapy; Chikung; Taichi
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Qigong; Mental health; social isolation; Traditional vegetative biofeedback therapy
Effect of Green Tea (Epigallocatechin Gallate) on Albuminuria in Patients With Diabetic Nephropathy.
Condition: Diabetic Nephropathy; Hypertension
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Albuminuria
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and effect of green tea
      (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy.
    

Detailed description: 
      Clinical, prospective, randomized, double-blind, placebo-controlled, with analysis by
      intention to treat.

      50 individuals will be selected with a diagnosis of diabetes / hypertension and has been
      followed in Diabetic Nephropathy Clinic of the Faculty of Medical Sciences, University of
      Campinas (UNICAMP). Participants are divided into 02 groups: 1) 25 patients treated with
      maximum dose of ACE-I and / or angiotensin II receptor blocker (ARBs) + Placebo (absence of
      epigallocatechin gallate) and 2) treated 25 patients with maximum dose of ACE-I and / or ARBs
      + green tea (epigallocatechin gallate).

      The patients will receive four capsules Polyphenol E - epigallocatechin gallate (Polyphenon
      Pharma, NY) per day, corresponding to 800 mg of epigallocatechin gallate (EGCG), or placebo
      (no epigallocatechin gallate) for 3 months. Patients will not be aware of the treatment they
      are receiving. The subjects will be allocated for the treatment or placebo, stratified by
      sex. To avoid the influence of researchers, the randomization list will be generated and
      maintained by trained personnel in a different location from the study. Before treatment and
      immediately after 3 months of treatment will be obtained in the primary outcome measures
      (albuminuria) and secondary (plasma metabolites of flavonoids, level of urinary
      F2-isoprostane and 8-hydroxydeoxyguanosine). In these same times will be obtained: blood
      biochemistry (glucose, glycosylated hemoglobin, urea, creatinine, sodium, potassium, blood
      count, calcium, phosphorus, cholesterol, LDL, HDL, triglycerides, uric acid), 3 samples of
      first morning urine to determine albuminuria, glomerular filtration rate (GFR), blood
      pressure measurement of 24 h, physical examination, weight, blood pressure and heart rate.
      Adherence to the study will be evaluated by weekly phone and the expected increase in plasma
      of flavonoids using the green tea (epigallocatechin gallate). The antihypertensive drug may
      be adjusted to obtain the desired pressure (<130/80 mmHg).
    

Intervention name(s): Green tea extract
Intervention type(s): Drug
Intervention description(s): 200mg/capsule Administered orally 4 capsules per day For 3 months
Other intervention name(s): Epigallocatechin gallate; Polyphenol e
Intervention MeSH terms: Epigallocatechin gallate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Proteinuria; Oxidative stress; Epigallocatechin gallate