bioihbjkbjnl/mcl2 huggingface dataset:
The Lung Microbiome in Sarcoidosis
Condition: Sarcoidosis
MeSH terms: Sarcoidosis
Study type: Observational

Summary: 
      The objective of this study is to determine the presence of bacterial species, and the
      immunologic and molecular mechanisms of granuloma formation that might be involved in the
      pathogenesis of sarcoidosis. The investigators will collect peripheral blood and
      bronchoalveolar lavage fluid samples to isolate bacterial DNA and blood monocytes and
      lymphocytes. Specimens will be obtained from patients with sarcoidosis, with non-sarcoid lung
      disease, and healthy volunteers to directly compare the bacterial species present and the
      characteristics of cells thought to be involved in granuloma formation.
    


Intervention name(s): Blood draw; Bronchoscopy; Questionnaires
Intervention type(s): Other; Procedure; Behavioral
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Potential subjects will be patients with sarcoidosis (involving any organ system), with
        non-sarcoid interstitial lung disease, and healthy controls.
Study to Assess the Safety and Efficacy of the IUB SEAD™ Device
Condition: Abnormal Uterine Bleeding
MeSH terms: Uterine Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      Pre-pivotal, randomized study to assess the safety and efficacy of the IUB SEAD™ device in
      women suffering from abnormal uterine bleeding.
    

Detailed description: 
      Chronic abnormal uterine bleeding (AUB), involving menstrual bleeding of abnormal quantity,
      duration, or schedule, is experienced by 10-35% of women, and can markedly impact everyday
      activities, can lead to iron deficiency and in severe cases, can necessitate emergency
      medical care.

      While pharmacologic treatment options exist, some women desire a treatment that requires less
      maintenance or is definitive. Endometrial ablation is a minimally invasive approach applied
      to manage AUB and can be performed using resectoscopic instruments or with a
      non-resectoscopic approach, in which the device is inserted into the uterine cavity and
      delivers energy to uniformly destroy the uterine lining. Non-resectoscopic endometrial
      ablation has become an accepted office-based procedure, but requires training in
      administration and response to complications of conscious sedation and of assisting
      personnel.

      The IUB SEAD™ device is a novel Spherical Endometrial Ablation Device, developed to allow for
      a simple, office-based chemical endometrial ablation to treat AUB. The suggested procedure is
      expected to be simpler than the currently available ablation methods and to result in a
      clinically meaningful delay or abolishment of the need for hysterectomy
    

Intervention name(s): SEAD treatment
Intervention type(s): Device
Intervention description(s): up to two 30-min endometrial ablation sessions using the IUB SEAD™ device, in a hospital outpatient clinic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Incidence of Hypoglycemia in Insulin Glargine-Treated Subjects With Diabetes Mellitus Upon Switching Between Bedtime and Morning Dosing
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Hypoglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the percentage of subjects with a glucose measurement < than or = to 56 mg/dL at
      any point of the 8-point glucose profiles during 3 consecutive days before vs. 3 consecutive
      days after switching insulin glargine dosing time from bedtime to morning and vs. 3
      consecutive days after switching back to bedtime dosing of insulin glargine.
    


Intervention name(s): INSULIN GLARGINE
Intervention type(s): Drug
Intervention MeSH terms: Insulin Glargine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Outcomes of Circuit Training and Low Carbohydrates Diet in the Young Obese Male in KSA
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Obesity is one of the common public problems that its prevalence increase incredibly in the
      last three decades in KSA. Thirty obese males aged 20 to 39 years will participate in the
      study. The participants will be evaluated on skinfold thickness, percent of body fat, lipid
      profile, and exercise capacity. All participants will perform a circuit training of aerobic
      and resistance exercises and be instructed to follow a low carbohydrate diet for eight weeks.
    


Intervention name(s): Circuit training exercise; Healthy high Fiber diet
Intervention type(s): Other; Dietary Supplement
Intervention description(s): circuit training exercise start with 5 minutes of warming-up then followed by a 30-minute conditioning protocol formed 20 minutes of aerobic exercise and 10 minutes of resisted exercise. The cool-down period is doing in form of walking on a treadmill in low intensity for 5 minutes.
Aerobic exercise will be performed on an electronically-braked cycle ergometer (Quinton Excalibur, QuintonInstrument Company, Bothell, WA). resistance exercise (RT) in the form of eight different exercises will be performed during each workout: military press, leg extension, bench press, standing leg curl (ankle weights), lateral pull-down, dumbbell triceps push-down, dumbbell seated biceps curl, and sit-ups (abdominal curls).
The participant will do 10 minutes for Aerobic exercise followed by 10 minutes of resistance exercise then 10 minutes for Aerobic exercise. This cycle training will perform five days per week for eight weeks.; The diet will be tailor-made for the individual for the body type and obesity in consultation with the nutritionist.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Seventy young males with obesity participated in this study. They were divided randomly into two groups. Group 1 received circuit training with low-carbohydrate (LC) diet intervention and Group 2 was the control group. The study variables such as exercise capacity, body composition, skinfold thickness, percentage of body fat (BF%), and lipid profile were measured at the baseline and at the end of a 12-week intervention.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Prediction of the Risk of Placental Vascular Pathology and Venous Thromboembolic Disease
Condition: Placental Vascular Pathologies; Venous Thromboembolism Diseases
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Observational

Summary: 
      Venous thromboembolic (VTE) disease is the first cause of maternal mortality in the world.
      Some other pregnancy pathologies called Placental Vascular Pathologies (PVP) are linked to
      VTE by biological thrombophilia and are the principal cause of perinatal mortality. the
      identification of predictive factors of risk of occurrence or recurrence of two pathologies
      could enable us to propose an appropriate monitoring of patients at risk.
    

Detailed description: 
      Main aim: To evaluate echographic, doppler and biological markers in a prospective manner as
      a potential predictive factor of risk of PVP and VTE.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community sample
      
Biospecimen description: 
      plasma and serum samples
    
Keywords: preeclampsia; eclampsia; retroplacental hematoma; vascular IUGR; IUFD; VTE
Estimating Usual Iodine Intake From Spot Urinary Iodine Concentrations
Condition: Iodine Deficiency
Study type: Observational

Summary: 
      The overall objective of this study is to develop a reliable method to obtain habitual iodine
      intakes from spot urinary iodine concentration (UIC) and to assess the prevalence of
      inadequate iodine intake in school-age children and women of reproductive age. We will
      evaluate different methods to estimate iodine intake from UIC and estimate the prevalence of
      inadequate and excess iodine intake in UIC studies conducted in populations with low,
      adequate and high iodine intakes using the the established estimated average requirement
      (EAR)/Tolerable Upper Intake Level (UL) cut-point method.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Apparently healthy school-age children and women of reproductive age
      
Biospecimen description: 
      Spot urine samples Dried blood spots
    
Keywords: Iodine
Bioequivalence Study of Etodolac Extended Release Tablets USP 600mg Under Fed Condition
Condition: Fasting
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,
      two-period, crossover, oral pivotal bioequivalence study. The purpose of this study is to
      assess the bioequivalence between Test Product and the corresponding Reference Product under
      fed condition in healthy, adult human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Etodolac Extended Release Tablets USP 600mg of Ipca Laboratories Limited, India and the
      corresponding Reference Product: Etodolac Extended Release Tablets 600 mg of Teva
      Pharmaceutical Ind. Ltd., USA under fed condition in healthy, adult, human subjects in a
      randomized crossover study.

      The study was conducted with 36 healthy adult subjects. In each study period, a single 600 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 15 days including washout period of 11
      days between administrations of study drug in each study period.
    

Intervention name(s): Etodolac Extended Release Tablets USP 600mg; Etodolac Extended Release Tablets 600mg
Intervention type(s): Drug; Drug
Intervention description(s): Etodolac Extended Release Tablets USP 600mg once a day; Etodolac Extended Release Tablets 600mg once a day
Other intervention name(s): Test product; Reference product
Intervention MeSH terms: Etodolac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Renal Allograft Tolerance Through Mixed Chimerism (Belatacept)
Condition: Kidney Failure, Chronic; Renal Insufficiency
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the safety and effectiveness of a combination kidney and bone marrow
      transplant from a haplo-identical related donor. An investigational medication and other
      treatments will be given prior to and after the transplant to help protect the transplanted
      kidney from being attacked by the body's immune system
    


Intervention name(s): Belatacept; ATG; Rituximab; Total Body Irradiation; Thymic Irradiation; Combined Bone Marrow/Kidney Transplantation
Intervention type(s): Drug; Drug; Drug; Radiation; Radiation; Procedure
Intervention description(s): A selective T-cell (lymphocyte) costimulation blocker; A T-Cell Depleting Agent; B-Cell Depleting Agent
Intervention MeSH terms: Rituximab; Abatacept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ESRD
Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating Pegfilgrastim Hospira Compared to Neulasta (Amgen) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compared the pharmacokinetics, pharmacodynamics and the safety of Pegfilgrastim
      Hospira and Neulasta® following a single dose of 6 mg of each product administered
      subcutaneously in Treatment Periods 1 and 2, respectively, in healthy volunteers.
    


Intervention name(s): Pegfilgrastim Hospira; Neulasta (Amgen)
Intervention type(s): Drug; Drug
Intervention description(s): Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.; Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy volunteers
Study of the Prevalence and Associated Factors With Hypogonadism in HIV + Men
Condition: Hypogonadism; HIV
MeSH terms: Hypogonadism
Study type: Observational

Summary: 
      Testosterone deficiency is classically associated with the development of metabolic syndrome,
      osteoporosis, erectile disorder and / or a reduced libido, a depressive syndrome and
      alteration of the quality of patients life.

      Chronicity of HIV infection leads to several disorders as fever, chronic stress, weight loss
      and cachexia which are the cause of hypogonadotropic hypogonadism. On the other hand,
      abnormal secretion of cytokines, secondary to the infection may alter the Leydig cells
      causing a hypergonadotropic hypogonadism and disrupts steroidogenesis. Cases of testicular
      invasion by lymphoma or Kaposi's syndromes have also been described.

      The advent of antiretroviral therapy has reduced the prevalence of hypogonadism in patients
      infected with HIV that is currently about 20%. This prevalence remains about 20%, regardless
      of the antiretroviral therapy and CD4-T cell count.

      No study to our knowledge has so far assessed exhaustively the clinical features, biological,
      therapeutic and paraclinical of hypotestosteronemiae while assessing the level of total serum
      testosterone, SHBG and serum free testosterone, among HIV infected patients in the European
      population.
    

Detailed description: 
      Assess the prevalence and clinical, biological, paraclinical and therapeutic factors
      associated with primary or secondary hypogonadism in HIV treated and virologically suppressed
      patients.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        HIV-infected men, treated by cART and presenting an undetectable viral load
      
Biospecimen description: 
      HIV-DNA quantification on PBMCs sample
    
Keywords: HIV; Hypogonadism; Metabolic Syndrom; Reservoirs; Osteodensitometry; Erectil dysfonction; Depression
Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      A 12-month study to compare the efficacy and safety of abaloparatide-solid microstructured
      transdermal system (sMTS) with abaloparatide-subcutaneous (SC).
    

Detailed description: 
      This study aims to evaluate the non-inferiority of abaloparatide-sMTS 300 micrograms (mcg)
      compared to abaloparatide-SC 80 mcg based on lumbar spine bone mineral density (BMD) at 12
      months and to evaluate the safety and tolerability of abaloparatide-sMTS in the treatment of
      postmenopausal women with osteoporosis.
    

Intervention name(s): abaloparatide; abaloparatide solid microstructured transdermal system
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.; Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto a sMTS array for transdermal administration of abaloparatide.
Other intervention name(s): TYMLOS®; BA058; abaloparatide-SC; BA058; abaloparatide-transdermal
Intervention MeSH terms: Abaloparatide; Parathyroid Hormone-Related Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoporosis; transdermal delivery; microneedle; solid microstructured transdermal system; abaloparatide-sMTS; patch; abaloparatide; fracture; bone loss; TYMLOS®
Eradication Rate Between 1- and 2-Week Helicobacter Pylori Eradication Therapy
Condition: H.Pylori Gastrointestinal Disease
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      It is recommended as the first line treatment regimen to eradicate Helicobacter pylori (HP),
      7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one
      PPI and two antibiotics, clarithromycin and amoxicillin. In the case of treatment failure, 7
      or 14 days of quadruple therapy (PPI＋metronidazole＋tetracycline＋bismuth) is recommended.

      This study aims to investigate which duration would be better for eradication of HP. The
      study design is a randomized controlled trial. The patients were randomly assigned to 7 days
      or 14 days treatment groups. Primary endpoint was the eradication rate of PPI based triple
      therapy. Secondary endpoints were to compare the rate of drug compliance and side effects in
      both groups.
    

Detailed description: 
      The recommended duration of triple therapy is typically 10 to 14 days in the United States
      and 7 days in Europe. In Korea, it is recommended as the first line treatment regimen, 7 or
      14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI
      and two antibiotics, clarithromycin and amoxicillin. In case for treatment failure which is
      often related to Helicobacter pylori (HP) resistance to clarithromycin or metronidazole,
      bismuth-based quadruple therapy is commonly used as second-line therapy, however, the
      eradication rates was widely ranged according to the treatment duration.

      The objective of the study is to investigate whether treatment duration would affect the
      eradication rate of HP as a PPI based triple therapy (1st line therapy) and a bismuth-based
      quadruple therapy (2nd line therapy).
    

Intervention name(s): Duration of HP therapy
Intervention type(s): Other
Intervention description(s): the comparison of HP eradication rate between 7 days and 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study on the Usage, Dosing, Tolerability, and Effectiveness of Kaletra Tablet
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Observational

Summary: 
      The objective of this study is to observe and collect data on the usage, dosing,
      tolerability, and effectiveness of Kaletra (lopinavir/ritonavir) tablets in human
      immunodeficiency virus (HIV)-infected patients. In some patients, the study is to show the
      impact on tolerability of changing therapy to Kaletra tablets from other regimens.
    

Detailed description: 
      This study was designed as a non-interventional observational study. Kaletra was prescribed
      in the usual manner in accordance with the terms of the local market authorization with
      regards to dose, population and indication as well as local guidelines.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  Community sample; HIV-infected patients

          -  For Belgium: AIDS references centers (probability sample)
      
Keywords: Tablets; Infection; Non Nucleoside Reverse Transcriptase Inhibitor; Tolerability; Viral load; Human immunodeficiency Virus; Effectiveness; Treatment-naïve
Peripheral Vascular Disease and Coronary Artery Disease
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Observational

Summary: 
      This study aims at evaluating the relationship between peripheral artery plaque
      characteristics evaluated by ultrasound and coronary culprit lesion characteristics evaluated
      by OCT in ACS patients.
    

Detailed description: 
      Patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention
      (PCI) and optical coherence tomography (OCT) are included in this study. Two skillful
      echocardiographers will evaluate peripheral artery plaque characteristics by
      ultrasound.Ultrasound parameters of peripheral artery will be compared among patients with
      different coronary culprit lesion characteristics, such as plaque rupture and plaque erosion.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ACS patients
The Effectiveness of Laser Acupuncture and Standard Medication Therapy on Mandibular Post-Odontectomy Patients
Condition: Laser Acupuncture; Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      Acute toothache is a problem that often occurs in the oral cavity. Toothache can be caused by
      an impacted tooth, in which the tooth cannot or will not erupt into its normal position. The
      American Association of Oral and Maxillofacial Surgeons (AAOMFS) states that 9 out of 10
      people have at least one impacted tooth, and impacted mandibular third molars have the
      greatest prevalence. Laser acupuncture is an acupuncture modality that has the benefit of
      reducing pain after third molar extraction. The goal of this randomized controlled trial is
      to evaluate the group that received a combination of laser acupuncture and standard
      medication compared to the group that received the combination of sham laser acupuncture and
      standard medication alone, in management of post-mandibular odontectomy patients. The main
      objective of this study is to analyze the combination of laser acupuncture and medication
      significantly improving the patient's pain intensity, interincisal distance and
      post-odontectomy swelling compared to the combination group of sham laser acupuncture and
      medication.
    

Detailed description: 
      This is a clinical trial study to evaluate the group that received a combination of laser
      acupuncture and standard medication compared to the group that received the combination of
      sham laser acupuncture and standard medication alone, in management of post-mandibular
      odontectomy patients. The required sample was 57 mandibular third molars in male/female
      subjects post-odontectomy and randomized into 2 groups: (1) combination of laser acupuncture
      with standard medication and (2) combination of sham laser acupuncture with standard
      medication. The subjects will receive two times treatment, on day-1 (baseline) and day-3
      after odontectomy. The outcome will be assessed on day-1 (baseline), day-3 and day-7
      post-odontectomy. Patients and outcome assessors will be blinded to the group allocation.
    

Intervention name(s): Laser Acupuncture and Standard Medication; Sham Laser Acupuncture and Standard Medication
Intervention type(s): Device; Device
Intervention description(s): Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. Dose 4 Joule at the acupuncture body points and 1 Joule at the ear points; Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. The laser is turned on but not activated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment