bioihbjkbjnl/mcl2 huggingface dataset:
Observational Study With Prospective and/or Retrospective Follow-up, Without Modifying Patient Treatment and Follow-up Practices for the Initial Treatment of Hypothyroidism in France
Condition: Hypothyroidism
MeSH terms: Hypothyroidism
Study type: Observational

Summary: 
      This observational survey with prospective and/or retrospective follow-up is designed to
      study practices for the initial treatment of hypothyroidism in France without modifying
      subject treatment.
    

Detailed description: 
      Thyroid disorder can be central, caused by a deficiency in thyroid stimulating hormone (TSH)
      production; or peripheral, caused by the decrease in the plasma concentration of thyroid
      hormones, more specifically of free thyroxine (free T4). Peripheral hypothyroidism is caused
      by the decrease in the production capacities of the thyroid gland.

      The treatment of hypothyroidism is based on the restoration and maintenance of biological
      (judged on the basis of the standardised TSH and T4 values) and clinical euthyroidism.

      A number of forms of thyroid hormones are available in the French market (Euthyral®,
      Cynomel®, L-thyroxine drops®), of which, Levothyrox® is the most frequently prescribed drug
      in this category.

      The treatment of peripheral hypothyroidism, in particular, is well codified and almost
      consensual. In France, there is no published observational study, based on which one can
      document the manner in which subjects are treated. This observational study is set up to
      document these practices.

      OBJECTIVES The principal objectives of this survey is to to get information on the use of
      Levothyrox in France

        -  Circumstances of diagnosis

        -  Record realised

        -  Terms and conditions of treatment by the general practitioner and/or the endocrinologist

      The secondary objective is to evaluate the inclusion criteria for levothyroxine treatment.

      For each subject the participating doctor will complete a follow up questionnaire form until
      the first control level of TSH after the diagnosis of hypothyroidism.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Independent, hospital and mixed practice endocrinologists and general practitioners
        enrolled 1000 subjects.
      
Biospecimen description: 
      Whole blood
    
Keywords: Hypothyroidism; Thyroid hormones
MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy
Condition: HIV-1-infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label single-center study to determine the safety of MGD014 in
      participants with human immunodeficiency virus (HIV) infection on stable suppressive
      antiretroviral therapy (ART).
    

Detailed description: 
      Eligible participants will be maintained on ART and receive either one infusion (Part 1) or
      multiple infusions of MGD014 (Part 2). Part 1 is a single ascending dose study with a 1+3
      design for the first 2 dose cohorts, and a 3+3 design with staggered accrual for the 6 higher
      dose cohorts, with an aim of determining the safety, pharmacokinetics (PK), and
      pharmacodynamics (PD) of ascending doses up to either the Optimal Biologic Dose (OBD) or the
      maximum administered dose (MAD).

      Part 2 is a multi-dose expansion cohort with MGD014 administered at the OBD, as determined in
      Part 1. In Part 2, additional assessments on the effects of MGD014 on HIV latent infection
      parameters will be evaluated.
    

Intervention name(s): MGD014
Intervention type(s): Biological
Intervention description(s): HIV-1 x CD3 bispecific DART molecule
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Open-label dose-escalation study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV, Latent HIV-1 infection, HIV therapy, antibody-based therapy
Non-invasive Mechanical Ventilation as a Rescue Therapy to Relieve Dyspnea in Patients With Stable Severe COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether non-invasive mechanical ventilation(NIV),
      playing the role as a rescue therapy , are effective in relieving exertional dyspnea in
      stable severe COPD patients.
    

Detailed description: 
      Chronic obstructive pulmonary disease(COPD) is a preventable and treatable illness, which is
      clinically characterized by persistent airflow limitation that is usually progressive. It's
      well known that airflow limitation lead to air trapping particularly during exercise,
      resulting in increased dyspnea and limitation of exercise capacity. Thus, COPD patients often
      unconsciously adopt a sedentary lifestyle, probably due to distressing exertional dyspnea.
      The sedentarism results in physical deconditioning and alterations of the peripheral muscles,
      and the latter one causes more exertional dyspnea and fatigue, which in turn leads to much
      more sedentarism, forming the vicious cycle of sedentarism, dyspnea/fatigue and more
      sedentarism. Thereby, measures should be taken to interrupt this vicious cycle. Some previous
      studies suggested that niv acting as an add-on therapy could help unloading the inspiratory
      muscle, reducing the dynamic compression of the airway, diminishing the dynamic
      hyperinflation,to some extent, relieved dyspnea during exercise in COPD patients.
      However,those measures were taken during exercise, acting as an add-on therapy. Whether NIV
      can play a role as a rescue therapy to relieve exertional dyspnea while the patients are
      already undergoing optimal treatment with bronchodilator and anti-inflammatory medication is
      still not quite clear. Therefore, we hypothesize that niv as a rescue-therapy has the same
      effect on relieving dyspnea in stable severe COPD patients just like the add-on therapy.
    

Intervention name(s): niv plus oxygen therapy; oxygen therapy
Intervention type(s): Device; Device
Intervention description(s): NIV given on Philips Respironics BiPAP Vision apparatus.
Other intervention name(s): Philips Respironics BiPAP Vision
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; dyspnea; exercise; Noninvasive Ventilation
Multi-Center, Randomized, Open-Label, Parallel Group Study of a Vaginal Micronized Progesterone Tablet (Endometrin®) Compared to Crinone 8% Vaginal Gel in Female Patients Undergoing In-Vitro Fertilization (IVF)
Condition: Fertility
Study type: Interventional
Phase: Phase 3

Summary: 
      This multicenter, randomized, open-label study will be performed in approximately 990 healthy
      females undergoing IVF. Each study center will follow their study center standard practice
      for IVF unless otherwise noted in this protocol. The study centers will be provided with the
      medications for down regulation, stimulation and ovulation induction. The subjects will be
      randomized to study medication on the day of oocyte retrieval or the day following and will
      continue treatment for up to 10 weeks. The subjects with a confirmed pregnancy will be
      required to return to the clinic several times during the course of the 10 week treatment
      period for serum pregnancy tests and transvaginal ultrasounds to monitor the pregnancy.
    

Detailed description: 
      This multicenter, randomized, open-label study will be performed in approximately 990 healthy
      females undergoing IVF. Each study center will follow their study center standard practice
      for IVF unless otherwise noted in this protocol. The study centers will be provided with the
      medications for down regulation, stimulation and ovulation induction. The subjects will be
      randomized to study medication on the day of oocyte retrieval or the day following and will
      continue treatment for up to 10 weeks. The subjects with a confirmed pregnancy will be
      required to return to the clinic several times during the course of the 10 week treatment
      period for serum pregnancy tests and transvaginal ultrasounds to monitor the pregnancy.
    

Intervention name(s): Endometrin; Endometrin; Crinone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Endometrin 100mg BID x 10weeks; Endometrin 100mg TID x 10weeks; Crinone QD x 10weeks
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Polycystic Ovary Syndrome and BETATROPHIN
Condition: Polycystic Ovary; Obesity
MeSH terms: Polycystic Ovary Syndrome
Study type: Observational

Summary: 
      This is an original study giving an information about the association body mass index,
      polycystic ovary syndrome and betatrophin.
    

Detailed description: 
      Introduction: Betatrophin is a protein hormone which has a significant role in glucose
      homeostasis and lipid metabolism. The aim of this study is to compare the levels of serum
      betatrophin in overweight and normal weight women with PCOS.

      Material and Method: Thirty-five patients normal weight women with PCOS (BMI<25) and 38 obese
      women with PCOS (BMI≥25) were included in this prospective, cross-sectional study. Patients
      were selected according to Rotterdam criteria. Serum betatrophin levels were studied by ELISA
      method and then compared between these two groups besides the following additional parameters
      as waist circumference/hip circumference ratio, fasting blood glucose, 75 g OGTT (oral
      glucose tolerance test) results and HOMA-IR levels.
    

Intervention name(s): serum marker levels
Intervention type(s): Diagnostic Test
Intervention description(s): two groups comparisons
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Comparison of the Betatrohin serum marker of insulin resistance in normal weight and
        overweight women with polycystic ovary syndrome cases.
      
Keywords: Betatrophin; PCOS; obesity; insulin resistance
18613 - Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor 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 Number - R84-087)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of Sertraline in Young Children With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a control trial of sertraline (Zoloft) in children aged 2 to 5 years old
      inclusive with Autism Spectrum Disorder. The trial is six months long, and each participant
      will receive a series of tests at both the beginning and end of the study. The researchers
      hope to show improvements in language and social deficits.
    

Detailed description: 
      This is a single center study and the UC Davis MIND Institute for Autism Spectrum Disorder
      (ASD) patients aged between 2 years and 5 years old inclusive funded by the Health Resources
      and Services Administration (HRSA). It is a double-blind control trial of sertraline
      (Zoloft), an anti-depressant typically used in the treatment of depression,
      obsessive-compulsive disorder, panic disorder, and other conditions. The researchers are
      investigating the use of this selective serotonin reuptake inhibitor (SSRI) in ASD because a
      retrospective study has shown significant improvements in language and social deficits. There
      is also emerging evidence regarding the stimulation of brain-derived neurotrophic factor
      (BDNF) and the stimulation of neurogenesis when an SSRI is given early on in the development
      of animal models of Down syndrome. The researchers hope to see improvements in language
      stimulation, social gaze and social reciprocity, spatial attention, and a decrease in
      autistic behaviors.

      The aim of this study is to carry out a double-blind placebo controlled trial of sertraline
      in children with ASD who are between the ages of 2 years and 5 years old inclusive. At
      baseline, the researchers will assess behavioral and cognitive development. Each participant
      will be involved in this trial for a period of six months. This will include three visits to
      the UC Davis MIND Institute and eight phone calls. The researchers will also assess the side
      effects of the sertraline treatment throughout the study.
    

Intervention name(s): Sertraline Liquid Placebo; Sertraline
Intervention type(s): Drug; Drug
Intervention description(s): Liquid placebo given in parallel to active medication; Active medication
Other intervention name(s): Placebo; Zoloft
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; Behavior; sertraline; treatment
Study of Celecoxib Bioavailability in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the bioavailability of celecoxib administered as capsule contents sprinkled onto
      applesauce relative to intact capsule
    


Intervention name(s): Celecoxib
Intervention type(s): Drug
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mindfulness Based Stress Reduction for Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Mindfulness based stress reduction offered to couples where one has metabolic syndrome to see
      if their stress is reduced as measured by bio markers and surveys
    

Detailed description: 
      This is a pilot study being designed to pilot a MBSR program for the purposes of future
      research.The investigators will be using two cohorts. One who will get the intervention and
      the other who will be wait listed and receive the intervention at a later date. Eight week
      mindfulness class offered to couples, who also attend an orientation session and a half day
      retreat with other couples to learn how to control stress through mindfulness meditation
      practices. Participants will come for lab work before intervention, eight weeks after initial
      class and at the end of entire program. Bio- markers to be measured are waist circumference,
      FBS and cholesterol.
    

Intervention name(s): MBSR
Intervention type(s): Behavioral
Intervention description(s): Eight week class on MBSR in addition to an orientation class and a half day retreat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Metformin Suspension and Insulin Sensitivity
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance; Hypersensitivity; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Metformin is an insulin sensitizing drug routinely used for the treatment of anovulatory
      patients with polycystic ovary syndrome (PCOS). To date, the metabolic effects of the
      long-term metformin administration are know but no data are available on the effects after
      its suspension.

      The purpose of this study is to evaluate the effects of metformin suspension on insulin
      sensitivity in PCOS patients.
    

Detailed description: 
      Thirty young normal-weight anovulatory PCOS women will be enrolled. The diagnosis of PCOS
      will be based on the presence of clinical [Ferriman-Gallwey score ≥ 8] or biochemical
      hyperandrogenism (serum testosterone levels (>2 SD above our reference mean values) and
      chronic anovulation [serum luteal progesterone (P) below 2 ng/mL)].

      Patients will be randomly allocated into two groups (metformin and placebo group) using a
      computer-software. Fifteen PCOS patients will be treated with metformin at a dosage of 1700
      mg daily (one tablet of 850 mg twice daily; metformin group), whereas other 15 PCOS will be
      treated with placebo tables (one tablet twice daily; placebo group). The duration of the
      treatment will be 12 months. Patients will be instructed to follow their usual diet and
      physical activity, and to use barrier contraception throughout the study. The length and the
      frequency of the menstrual cycles, and the adverse experiences (AEs) will be reported on a
      daily diary.

      Each subject will undergo follow-up visits under (at six and 12 months from treatment
      starting) and after treatment (at six and 12 months from treatment withdrawal). At each
      follow-up visit, in all subjects the same operator will perform clinical, hormonal,
      metabolic, and insulin sensitivity assessments by euglycemic hyperinsulinemic clamp.
    

Intervention name(s): Metformin cloridrate
Intervention type(s): Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Insulin sensitivity; Insulin-sensitizing drug; Metformin; PCOS; Treatment
Study to Assess the Effect of ONS Nutridrink® 200 ml on the Recovery of Patients With COVID-19 and Respiratory Support
Condition: COVID-19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The goal of this low-interventional study was to learn about the effect a nutritional
      supplement in patients with COVID-19 and respiratory support. The main questions it aimed to
      answer were:

        -  if additional nutrition support has an effect on recovery of physical health in patients
           with COVID-19;

        -  to examine the effect of additional nutrition support on quality of life of patients
           with COVID-19;

        -  to examine the effect of the additional nutrition support on hospitalization period of
           patients with COVID-19.

      Participants were split into two groups. One group had the common hospital diet, another
      group in addition to the common diet was given with NutriDrink® 200 ml X 2 daily. During the
      observation period participants were asked to measure hand strength measured by hand grip
      tester and fill out the quality of life standard questionnaire SF-36. In addition, several
      routine blood tests were performed.
    


Intervention name(s): Nutridrink ONS 200 ml
Intervention type(s): Dietary Supplement
Intervention description(s): Nutridrink is a high-protein, high-calorie formula for the specialized nutrition of patients with or at risk of malnutrition. The product can be used as an additional or sole source of nutrition
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        185 patients infected with a new coronavirus infection COVID-19 and getting respiratory
        support were enrolled to the study in accordance with the inclusion/exclusion criteria.
        Patients were randomly devided into two groups.
      
Keywords: covid-19; ICU; respiratory support; quality of life; physical recovery
Evaluation of Effect of Combination With Telmisartan and Hydrochlorothiazide in Hypertensives Uncontrolled on Amlodipine
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare depressor effect and safety between combination
      therapy with telmisartan plus low-dose hydrochlorothiazide and amlodipine in hypertensive
      patients.
    

Detailed description: 
      In hypertensive patients whose blood pressure (BP) does not reach less than 140/90 mmHg with
      5mg/day of amlodipine are divided the following two groups and BP response, laboratory data,
      and adverse effects are compared. Group 1: 12 week combination therapy with telmisartan plus
      low-dose hydrochlorothiazide. Group 2: Amlodipine is continuously administered.
    

Intervention name(s): telmisartan plus hydrochlorothiazide; Amlodipine
Intervention type(s): Drug; Device
Intervention description(s): Combination therapy with telmisartan (40 mg/day) plus hydrochlorothiazide (12.5 mg/day): If blood pressure is not reach to lower than 140/90 mmHg, dose of telmisartan can be increased to 80 mg/day
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Telmisartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies
Condition: Pancreatectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate if a lidocaine infusion will provide benefit to
      pancreatectomy patients in regards to analgesia and return of bowel function.
    


Intervention name(s): Lidocaine; Placebo D5W
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Detection of Reductions in Cystic Fibrosis Airway Inflammation While Using Aztreonam Lysine Solution
Condition: Cystic Fibrosis in Adults, Chronic Colonization With Pseudomonas Aeruginosa
MeSH terms: Cystic Fibrosis; Fibrosis; Inflammation
Study type: Observational

Summary: 
      In cystic fibrosis, there is a critical need for better predictors of treatment response. The
      investigators have identified a panel of white blood cell biomarkers which can be directly
      measured as a blood test in subjects with cystic fibrosis. These biomarkers predict reduction
      of airway inflammation and infection more accurately than lung function testing, in patients
      receiving intravenous antibiotic therapy. In the current study, we hypothesize that this
      panel of gene biomarkers which can be readily measured from peripheral blood will sensitively
      predict changes in inflammation when patients receive inhaled antibiotic therapy,
      specifically Cayston (or inhaled aztreonam lysine). Patients enrolled in the study will have
      blood drawn before and after a month of inhaled Cayston, in order to test whether genes
      predict response to Cayston therapy more robustly than do standard measures such as lung
      function tests.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Enrolled subjects will include adults with cystic fibrosis, over the age of 18 years, who
        are at baseline health and colonized with Pseudomonas aeruginosa, and who are newly
        prescribed Cayston (aztreonam lysine) for inhalation, or who are resuming use of this drug
        after 28 days off of inhaled antimicrobial agents with activity against Pseudomonas
        aeruginosa.