bioihbjkbjnl/mcl2 huggingface dataset:
Costal Cartilage Donor-site Pain: Does Abdominal Muscle Infiltration Analgesia Work?
Condition: Rectus Abdominis and External Oblique Muscle Infiltration Analgesia
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      Donor-site pain is an adverse effect of autologous ear reconstruction. A well-planned pain
      management protocol is needed. The objective of this study was to introduce rectus abdominis
      and external oblique muscle infiltration analgesia (RAM+EOM-IA) in autologous ear
      reconstruction and to evaluate its efficacy and safety.
    

Detailed description: 
      Patients were included in two cohorts: intermittent RAM+EOM-IA combined with intravenous
      patient-controlled anesthesia (IPCA) and IPCA alone. The primary outcome was the numerical
      rating score (NRS) of pain recorded during 48 h postoperatively. Secondary outcomes included
      the Barthel index and rescue analgesic consumption. Additionally, areas of sensory block were
      tested using a cold stimulus.
    

Intervention name(s): rectus abdominis(RAM) and external oblique muscle(EOM) infiltration analgesia; intravenous patient-controlled anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): After suturing the muscular fascia, an indwelling catheter was placed above the RAM and EOM and under the subcutaneous tissue and then sutured to the skin for fixation. Approximately 30 min before surgery completion, 1 mg/kg of 0.2% ropivacaine was infused through the indwelling catheter for IA. Additionally, 1 mg/kg of 0.2% ropivacaine was infused through the indwelling catheter every 12 h, starting 8 h postoperatively, injected four times.; After completion of the operation, the anesthesiologist used the IPCA device; it was programmed with a background infusion rate of 2 mL/h, a bolus volume of 2 mL, and a lockout interval of 15 minutes. The 100 mL total volume of the PCA consisted of normal saline, 2.0 ug/kg sufentanil, and adjuvant antiemetic (tropisetron).
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of the FGM Profiles in Patients of Type 2 Diabetes Treated With Sitagliptin and Acarbose
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of the study is to compare the FGM glycemic profiles in patients with type 2 diabetes
      mellitus treated with sitagliptin and acarbose.
    

Detailed description: 
      In this study, 60 patients with type 2 diabetes were randomly divided into group A or group B
      after stable glucose control. Flash Glucose Mornitoring(FGM) will be used in patients with
      two groups. Patients in group A were given sitagliptin and metformin for the first two weeks,
      and then were treated with acarbose and metformin for the second two weeks. FGM was used to
      monitor glycemic variations during the whole four weeks. The opposite therapy was true for
      patients in group B.
    

Intervention name(s): sitagliptin and acarbose
Intervention type(s): Drug
Intervention description(s): One group used first sitagliptin and metformin, then used acarbose and metformin. Another group used first acarbose and metformin, then used sitagliptin andmetformin.
Intervention MeSH terms: Sitagliptin Phosphate; Acarbose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia
Condition: Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of A-prexa compared to
      Zyprexa in patients with schizophrenia, schizophreniform disorder and schizoaffective
      disorder.
    


Intervention name(s): A-prexa; Zyprexa
Intervention type(s): Drug; Drug
Intervention description(s): A-prexa 5-20 mg for 6 weeks; Zyprexa 5-20 mg for 6 weeks
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Pilot Study to Investigate Filiation Between Primary and Secondary Lesions in Acne Patients
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      Exploratory, international, multi-centre, randomized, investigator blinded study in acne
    


Intervention name(s): CD0271 0.1%/CD1579 2.5% gel; CD0271 0.1%/CD1579 2.5% gel vehicle
Intervention type(s): Drug; Drug
Intervention description(s): one application (pea-sized amount according to the labelling) on a half-face, 5 to 7 days for 6 months; one application (pea-sized amount according to the labelling) on a half-face, 5 to 7 days for 6 months
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Molecular Variants Associated With Schizophrenia: Differential Analysis of Monozygotic Twins With Variable Phenotypic 22q11
Condition: Di George Syndrome
MeSH terms: DiGeorge Syndrome; Schizophrenia
Study type: Interventional

Summary: 
      The 22q11.2 microdeletion syndrome (22q11.2DS) is a rare disease with a psychiatric
      phenotype. Indeed, the diagnosis of schizophrenia is made in 5 to 10% of adolescents and 25
      to 40% of adults carrying the 22q11DS. Thus, although this pathology has been able to provide
      a genetically homogeneous model for the study psychosis etiology, it is not currently
      possible to establish a link between genomic rearrangement and psychotic symptoms. However,
      this robust model of genetic vulnerability could provide us a lot of translational
      informations about schizophrenia genetics. To go furthermore, twin studies have provided us
      precious data for the study of hereditary diseases. Combining this two approaches, the
      translational 22q11.2 project proposes a molecular study of two monozygotic 22q11.2DS twins
      discordant for the psychiatric phenotype -one carrying schizophrenia and the other having no
      psychiatric symptoms-.
    

Detailed description: 
      The main objective of the study is to propose a whole exome sequencing (WES), pan-genomic in
      whole genome sequencing (WGS), transcriptomic, epigenomic and intestinal microbiome
      approaches in order to determine specific molecular basis of psychotic symptoms in 22q11.2DS.
    

Intervention name(s): Molecular analyses
Intervention type(s): Genetic
Intervention description(s): Comparaison of the molecular profil between two monozygotic twins carrying a deletion 22q11.2
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: It's a study with a comparative monocentric cross-sectional analysis model.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 22q11.2 Microdeletional
Clinical Evaluation of Oral Rinse for Xerostomia
Condition: Xerostomia
MeSH terms: Xerostomia
Study type: Interventional

Summary: 
      Xerostomia causes a difficulty in eating, have irritated oral tissues, and a poor quality of
      life. The new oral rinse was designed to reduce the symptoms and improve the patient's
      quality of life. The objectives of the clinical study is to evaluate the effectiveness of the
      oral rinse comparing to the placebo product and the control product in the market.

      This is a randomized double-blind placebo controlled crossover study with 39 patients
      receiving treatment. Patients will be randomly allocated to three treatment groups. Patients
      will use the assigned oral rinse four times a day for two weeks. Dry mouth symptoms and other
      endpoints will be assessed subjectively and objectively at baseline and Day 14. Patients will
      be assigned to another treatment after one week wash-out period.
    


Intervention name(s): HYDRAL Oral Rinse; BIOTENE® Oral Rinse; Placebo Oral Rinse
Intervention type(s): Device; Device; Device
Intervention description(s): Application 4 times a day for two weeks; Application 4 times a day for two weeks; Application 4 times a day for two weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Exploring the Mechanism of a Probiotic Combination VSL#3 in Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Irritable bowel syndrome (IBS) is a very common chronic gastrointestinal disorder. Existing
      therapies for IBS are still far from satisfactory and new therapies are being constantly
      sought. Probiotics are promising candidate for the prevention and treatment of IBS. However,
      its efficacy and mechanism is still unclear. The current study aims to evaluate the effects
      of a combination probiotic, VSL#3, on symptoms and rectal sensitivity in patients with IBS.
      The underlying mechanism will also be investigated. We will recruit forty patients with Rome
      III IBS and randomized them, in a parallel group, double-blinded design, to take four VSL#3
      capsules or placebos, twice daily, for six weeks. Before and after treatment, patients will
      be assessed for their symptoms, rectal sensitivity, as well as saliva and fecal melatonin
      levels. Bowel symptom diary and weekly satisfactory relief of bowel symptoms will also be
      recorded and evaluated.
    


Intervention name(s): VSL#3; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dose: 4 capsules of VSL#3 daily for 6 weeks.; Identical looking preparation of placebo taken at the same dose regimen as the active comparator
Other intervention name(s): probiotics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: irritable bowel syndrome; rectal hypersensitivity; probiotics; melatonin; brain-gut axis
Thermoregulatory Reactions of Medical Workers Who Use Personal Protective Equipment From Biological Hazards
Condition: Overheating
MeSH terms: Heat Stroke
Study type: Observational

Summary: 
      This research will provide data on thermal condition, functional status and working
      conditions of medical workers who use personal protective equipment from biological hazards.
      Acquired data will be used to define acceptable period of use for these protective costumes.
    

Detailed description: 
      This research will recruit 14-20 volunteers. During 8 hours each subject will perform their
      work using protective costume. Heart rate, electrocardiogram, oxygenation, skin and air
      temperature under costume and hygrometric data will be registered. Also there will be
      questionnaires for volunteers for subjective assessment of thermal and moisture sensations
      and assessment of working conditions.
    

Intervention name(s): Personal protective equipment from biological hazard
Intervention type(s): Other
Intervention description(s): Includes: isolation clothing, mask, eyewear, overshoes
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Health workers
      
Keywords: Thermophysiology; Personal protective equipment from biological hazards; Medical workers; COVID-19; Working conditions
The Pectoral Block for Breast Augmentation Surgery
Condition: Pain, Postoperative; Anesthesia; Regional
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The pectoral block is a recently developed regional anesthetic technique that can be used for
      the treatment of postoperative pain after breast surgery. Injection of local anesthetic
      between the major and the minor pectoral muscles is defined as the pectoral (PEC) 1 block.
      This block has not been well characterized in terms of its blocking effects on motor and
      sensitive nerves (medial and lateral pectoral nerves and intercostal nerves). This clinical
      trial is divided into two sections: a volunteer study and a patient study.

      For the volunteer study, the aim is to assess the sensory territory affected by injection of
      local anesthetics through a PEC 1 block and to assess motor function in terms of strength of
      adduction of the affected limb using a dynamometer.

      In a prospective, randomized, controlled and double blind study, the aim is to assess the
      postoperative pain relieving properties of the PEC 1 block in patients undergoing bilateral
      breast augmentation surgery.
    


Intervention name(s): PEC 1 block; Bupivacaine with epinephrine; Normal saline
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Under echoguidance, injection of the substance of interest between the major and minor pectoral muscles.; Treatment group; Placebo group
Other intervention name(s): pectoral block; pecblock
Intervention MeSH terms: Epinephrine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessment of Dried Blood Spot Thyroglobulin and Urinary Iodine Concentration in Pregnant Women
Condition: Iodine Deficiency; Pregnancy Related
Study type: Observational

Summary: 
      To avoid iodine deficiency and its consequences in pregnant women and their offspring, women
      should reach a sufficient iodine intake long before conception. To monitor iodine status,
      median urinary iodine concentration (UIC) is widely used in pregnant women (PW).
      Thyroglobulin (Tg) us another marker used to assess iodine status . In this study, urine
      samples as well as dried blood spots will be collected to measure UIC and Tg (as well as
      other hormones to define thyroid function) in PW. The results shall be used to reassess the
      threshold which defines iodine status in PW according to UIC.
    


Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): this is a completely observational study, NO INTERVENTION
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy pregnant women aged from 18 to 44 years, living since 12 months or longer in the
        respective country.
A Study to Evaluate Safety, Tolerability and P-Glucose After Multiple Ascending Oral Doses of AZD1656 in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety and tolerability of AZD1656 after multiple
      repeated oral doses in patients with type 2 diabetes
    


Intervention name(s): AZD1656; AZD1656
Intervention type(s): Drug; Drug
Intervention description(s): Dose titration to 3 (alt 4) increasing dose-steps with oral suspension, 8 days treatment; Dose titration of oral suspension to a tolerable dose, 1 month treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Type 2 diabetes
A Comparison of the Effect of Olmesartan Medoxomil, Losartan Potassium, and Atenolol on the Ability of Overweight Patients With High Blood Pressure to Respond to Insulin
Condition: Hypertension; Insulin Resistance; Metabolic Syndrome
MeSH terms: Hypertension; Overweight; Metabolic Syndrome; Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      To examine the effect of three different blood pressure medications on the insulin
      sensitivity in overweight patients with high blood pressure.
    


Intervention name(s): Olmesartan medoxomil; Losartan potassium; Atenolol
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Losartan; Atenolol; Olmesartan; Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Rebamipide and Rabeprazole Effect Associated or Not to Prevent Naproxen-induced Gastric Lesions
Condition: Gastric Lesion
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical trial evaluated the gastroprotection obtained by the use of rebamipide 300 mg
      (2x daily) and rabeprazole 20 mg/day (1x daily) associated or not in the prevention of
      gastric lesions induced by naproxen 1100 mg/day) for 7 days to healthy volunteers of both
      sexes. This trial also assessed drugs safety and tolerability, the prostaglandin levels
      (PGE2) in biopsy specimens before and after treatment of each group and the histopathological
      changes induced by the treatment of each group.
    

Detailed description: 
      This phase III, single center, double-blind, randomised, multiple-dose trial was performed in
      a parallel-group design. The subjects were randomly assigned to one of the 4 possible
      treatments: treatment A - 550 mg naproxen 2x daily + 300 mg rebamipide 2x daily + 20 mg
      rabeprazole 1x daily over 7 days; treatment B - 550 mg naproxen 2x daily + placebo of
      rebamipide 2x daily + 20 mg rabeprazole 1x daily over 7 days; treatment C - 550 mg naproxen
      2x daily + 300 mg rebamipide 2x daily + placebo of rabeprazole 1x daily over 7 days; and
      treatment D - 550 mg naproxen 2x daily + placebo of rebamipide 2x daily + placebo of
      rabeprazole 1x daily over 7 days.

      Upper digestive endoscopy was performed before the beginning of the therapies and 12 hours
      after the last administration (8th day of the study), with collection of the biological
      samples (biopsies) in the antrum region and 5 in the gastric body at each examination. The
      samples were preserved in formalin solution and sent for histopathological examination.

      The safety and tolerability was assessed by signs and symptoms, adverse events, laboratory
      tests, vital signs and electrocardiogram (ECG).
    

Intervention name(s): 550 mg naproxen + 300 mg rebamipide + 20 mg rabeprazole.; 550 mg naproxen + placebo + 20 mg rabeprazole; 550 mg naproxen + 300 mg rebamipide + placebo; 550 mg naproxen + placebo + placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral administration of 550 mg naproxen 2x daily + 300 mg rebamipide 2x daily + 20 mg rabeprazole 1x daily over 7 days.; Oral administration of 550 mg naproxen 2x daily + placebo of rebamipide 2x daily + 20 mg rabeprazole 1x daily over 7 days.; Oral administration of 550 mg naproxen 2x daily + 300 mg rebamipide 2x daily + placebo of rabeprazole 1x daily over 7 days.; Oral administration of 550 mg naproxen 2x daily + placebo 2x daily + placebo of rabeprazole 1x daily over 7 days.
Intervention MeSH terms: Naproxen; Rabeprazole; Rebamipide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: gastroprotection; rebamipide; rabeprazole; naproxeno
Changes of Transforming Growth Factor b1 and Procollagen III in Patients With Acute Respiratory Distress Syndrome
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Observational

Summary: 
      Transforming Growth Factor-b1 (TGF-b1) is involved in the development of acute lung injury
      and in the fibroproliferation during acute respiratory distress syndrome (ARDS). Procollagen
      III Peptide (PIIINP) is a validated marker of fibroproliferation. PIIINP is associated with
      death in ARDS patients. The simultaneous changes of TGF-b1 and PIIINP were never studied in
      patients with ARDS. The relationships between TGF-b1 and the outcome of ARDS are unknown.

      The aim of the study is to analyse the changes of TGF-b1 and PIIINP during ARDS and to show
      the relationships between TGF-b1 - PIIINP and the outcomes of ARDS.
    

Detailed description: 
      Primary outcome: To analyse the changes of Transforming Growth Factor b1 and Procollagen III
      during the acute respiratory distress syndrome.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients whom suffered ARDS with a PaO2/FIO2 < 200 mmHg at a positive end-expiratory
        pressure (PEEP) ³ 5 cm H2O and for which ARDS criteria from less than 24 hours
Carotene and Retinol Efficacy Trial
Condition: Lung Cancer
Study type: Interventional
Phase: Phase 4

Summary: 
      The Carotene and Retinol Efficacy Trial (CARET) was a randomized, double-blind,
      placebo-controlled trial of the cancer prevention efficacy and safety of a daily combination
      of 30 mg of beta-carotene and 25,000 IU of retinyl palmitate in 18,314 persons at high risk
      for lung cancer. CARET began in 1985, and the intervention was halted in January 1996, 21
      months ahead of schedule, with the twin conclusions for definitive evidence of no benefit and
      substantial evidence of a harmful effect of the intervention on both lung cancer incidence
      and total mortality. CARET continued to follow and collect endpoints on their participants
      through 2005. During the active intervention phase of CARET, serum, plasma, whole blood, and
      lung tissue specimens were collected on participants. These biospecimens make up the CARET
      Biorepository.

      The CARET Biorepository is a valuable resource for population-based studies of the major
      human cancers. During CARET's twenty years of follow-up (1985-2005), we have received reports
      of 1,445 participants with lung cancer, 901 with prostate cancer, 433 with breast cancer, 334
      with bladder cancer, 332 with colon cancer, and 1,429 with other cancers. CARET is one of the
      few trials that has prospectively collected serum, plasma, whole blood, blood spots (for
      DNA), and lung cancer tumor specimens, as well as smoking history and serial food frequency
      questionnaires (in some individuals for up to 12 years) in populations at high risk for lung
      cancer. This wealth of information in over 18,000 individuals makes the CARET Biorepository a
      special resource for cancer researchers.
    


Intervention name(s): Beta Carotene and Retinol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Pilot participants (ppts):
Asbestos-Exposed--15 mg/day beta-carotene + 25,000 IU/day retinol Heavy Smokers--30 mg/day beta-carotene + 25,000 IU/day retinol
Vanguard & Efficacy ppts:
Asbestos-exposed AND heavy smokers--30 mg/day beta-carotene + 25,000 IU/day retinol; Two placebos, one each/day
Intervention MeSH terms: Beta Carotene; Vitamin A; Carotenoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention