bioihbjkbjnl/mcl2 huggingface dataset:
Autoimmunity in Sisters of Lupus Patients
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Observational [Patient Registry]

Summary: 
      This study enrolled over 400 unaffected sisters of young women diagnosed with SLE. These
      unaffected sisters are being followed with an annual health questionnaire (CSQ) and blood
      sample.
    

Detailed description: 
      Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease that causes inflammation
      and is accompanied by the development of autoantibodies. The inflammation caused by SLE may
      affect the skin, joints, lungs, blood, kidneys and nervous system. The cause of SLE is
      unknown, but research has indicated that it is caused by a combination of genetic and
      environmental factors.

      Autoimmune diseases often run in families. Close relatives of people with these diseases are
      at greater risk of developing the same or another autoimmune disease. The study is designed
      to determine several things: If sisters of people with SLE make the same antibodies that are
      present in people with SLE, whether or not environmental factors affect the chances of
      developing these antibodies and if so what these environmental factors may be, if the
      presence of these antibodies in healthy people leads to increased risk for the development of
      SLE.

      This study enrolled over 400 unaffected sisters of young women diagnosed with SLE. These
      unaffected sisters are being followed with an annual health questionnaire (CSQ) and blood
      sample.

      Participation is voluntary and participants can stop participating at any time.
    

Observational model: Family-Based
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Sisters: One sister must be diagnosed with Systemic Lupus Erythematous ( SLE ) by and
        including age 40 who has a sister(s) or half sister(s) not affected with SLE currently
        between the ages of 10 and 45 are being recruited nation wide through community and
        physician referrals.
      
Biospecimen description: 
      We will use your DNA blood sample to study the function of genes and biomarkers and gain
      understanding of their role in protection against disease or the role they play in increasing
      the risk factors of developing lupus. No, you will not get test results since the information
      we gather is only useful for research and is not diagnostic. Participation in this study is
      not a substitute for regular medical care.

      The information and blood sample that is collected for research will be analyzed for many
      years and it is not possible to know how long this analysis and follow-up will take.
      Therefore, participation allows the information and banking of your blood sample to be
      indefinite.
    
Keywords: SLE; sister; autoimmune disease
Pharmacokinetics of Caspofungin in Burn Patients
Condition: Thermal Injury
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Drug pharmacokinetics of antimicrobial agents is significantly altered in the burn patients.
      Additionally, burn patient population exhibits a wide inter- and intrapatient variation in
      drug handling. Several investigations carried out in burn patients treated with e.g.
      fluconazole showed the requirement to increase daily dose in comparison with healthy
      volunteers. However, no pharmacokinetic data are available of caspofungin in the burn
      population. The aim of this investigation is to investigate pharmacokinetics of caspofungin
      in burn patients after a single usual dose (70 mg i.v.), in order to determine the optimal
      dose in this population.
    

Detailed description: 
      The aim of this investigation is to investigate pharmacokinetics of caspofungin in burn
      patients after a single usual dose (70 mg i.v.). Blood samples are drawn just before
      administration and 0.25, 0.5,1 1.5, 3, 6, 12, 24, 48, 72, 96 and 120 hours after
      administration. Caspofungin plasma concentrations are measured by liquid-chromatography
      spectrometry mass tandem.The primary end-points are :

        -  area under the curve of caspofungin plasma concentrations over 24 hours

        -  mean peak level and trough concentration (24 hours after dosing)

      The secondary end-points are :

        -  mean total clearance

        -  mean distribution volume These parameters will be compared to those usually observed in
           non burn patients. The optimal dose in burn patients is the dose achieving an exposure
           similar to that in non burn patients.
    

Intervention name(s): Caspofungin (drug)
Intervention type(s): Drug
Intervention description(s): pharmacokinetics of caspofungin in burn patients after a single usual dose (70 mg i.v.), in order to determine the optimal dose in this population
Other intervention name(s): pharmacokinetics of caspofungin in burn patients
Intervention MeSH terms: Caspofungin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Caspofungin,; burn patients,; pharmacokinetics,; optimal dose,; antifungal treatment
Motivational Enhancement Therapy to Improve Treatment Utilization in Pregnant Substance Users - 1
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare Motivational Enhancement Therapy (MET) with standard
      drug abuse treatment among pregnant women.
    


Intervention name(s): Behavior Therapy
Intervention type(s): Behavioral
Primary purpose: Treatment
Keywords: behavioral intervention
Influence of Central Obesity on the Esophageal Epithelial Barrier
Condition: Gastroesophageal Reflux; GERD
MeSH terms: Gastroesophageal Reflux; Obesity, Abdominal
Study type: Interventional

Summary: 
      This study is being done to help understand why some people with an increased amount of
      central obesity, without gastroesophageal reflux, develop changes to the lining of their
      esophagus that can potentially lead to esophageal adenocarcinoma (cancer).
    


Intervention name(s): Confocal endomicroscopy; Mucosal impedance; Research biopsies; Bravo ambulatory pH monitor
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Confocal endomicroscopy will be performed during clinically indicated endoscopy.; Mucosal impedance will be performed at the time of clinically indicated endoscopy.; Research biopsies will be obtained during clinically indicated endoscopy.; Bravo ambulatory pH capsule will be placed during clinically indicated endoscopy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Gastroesophageal reflux disease; GERD; Barrett's Esophagus; Esophageal adenocarcinoma
Effect of Steroids on Cerebral Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement
Condition: Aortic Stenosis
MeSH terms: Aortic Valve Stenosis; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to investigate if methylprednisolone is effective in reducing
      the cerebral inflammatory response after open heart surgery with cardiopulmonary bypass.
    

Detailed description: 
      In a previous study we found that patients undergoing aortic valve surgery had elevated
      cerebrospinal inflammatory markers. In this study we aim to investigate if this inflammatory
      response can be reduced after treatment with steroids.

      30 patients will be randomized to intraoperative treatment with either placebo or
      methylprednisolone 15mg/kg. CSF and blood will be collected the day before and the day after
      surgery, analyzed for markers of inflammation (IL-6, IL-8), neuronal damage (S-100) and blood
      brain barrier function (alb).
    

Intervention name(s): Methylprednisolone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Methylprednisolone 15mg/kg; Placebo
Other intervention name(s): Solu-Medrol; Sodium Chloride
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cerebrospinal fluid; inflammatory markers; heart surgery; neuronal damage; blood brain barrier
Nutritional Status and Hidradenitis Suppurativa (Acne Inversa)
Condition: Hidradenitis Suppurativa; Mediterranean Diet; Body Composition; Vitamin D Deficiency; Trimethylamine N-oxide (TMAO)
MeSH terms: Hidradenitis Suppurativa; Hidradenitis; Vitamin D Deficiency
Study type: Observational

Summary: 
      Hidradenitis suppurativa (HS) is a chronic inflammatory, debilitating skin disorder. The
      exacerbating factors of HS include nutrition and adiposity. The objective of this study was
      to investigate the relationships between body composition and the adherence to the
      Mediterranean diet (MD) with the severity of HS in a sample of naïve-treatment patients with
      HS. In the wake of this evidence, in the study to investigate the relationships between
      nutritional status, the adherence to the MD, body composition, and the severity of HS in a
      sample of naïve-treatment patients with HS compared to control group matched for sex, age,
      and body weight.
    


Intervention name(s): Mediterranean Diet
Intervention type(s): Dietary Supplement
Intervention description(s): We aim to determine the effects of the traditional Mediterranean Diet on Hidradenitis suppurativa
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Study population consisted of 82 participants, 41 patients with HS and 41 healthy subjects
        as control group.
A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will identify the optimum concentrations of AGN-199201 and AGN-190584 when dosed
      in combination once a day for the improvement of uncorrected near visual acuity in
      participants with presbyopia (inability to focus on items close-up).
    


Intervention name(s): AGN-199201 ophthalmic solution; AGN-190584 ophthalmic solution; AGN-190584 vehicle; AGN-199201 + AGN-190584 Combination; AGN-199201 vehicle
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.; 1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye.; Vehicle to AGN-190584; 1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.; Vehicle to AGN-199201
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, pharmacokinetics, HCV RNA kinetics, and
      other viral characteristics after administration of two arms of MP-424 in combination with
      Peginterferon Alfa 2b (PEG-IFN-a-2b) and Ribavirin (RBV) to patients with chronic hepatitis
      C.
    


Intervention name(s): MP-424(H), PEG-IFN-a-2b, RBV; MP-424 (L), PEG-IFN-a-2b, RBV
Intervention type(s): Drug; Drug
Intervention description(s): MP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks; MP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks
Other intervention name(s): Telaprevir; Telaprevir
Intervention MeSH terms: Interferon-alpha; Interferon alpha-2; Interferon-alfa-1b; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Chronic Hepatitis C; Protease Inhibitor; Telaprevir
A Study to Evaluate the Efficacy and Safety of Toripalimab or Placebo Combined With Chemotherapy in Treatment-naive Advanced NSCLC
Condition: Treatment-naive Advanced Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      This is one randomized, double-blind, placebo-controlled, multi-center, phase III clinical
      study to evaluate the efficacy and safety of Toripalimab injection (JS001) or placebo
      combined with standard 1st-line chemotherapy in treatment-naïve advanced non-small cell lung
      cancer (NSCLC); and evaluate the population with the best predictive biomarkers, i.e.,
      positive diagnosis population.

      About 450 subjects with advanced non-small cell lung cancer without activated EGFR mutation
      (exon 19 deletion, or exon 21 L858R, exon 21 L861Q, exon 18 G719X or exon 20 S768I mutations)
      and ALK fusion will be 2:1 randomized into two groups, JS001 combined with the standard
      1st-line chemotherapy will be given in the study group whereas placebo combined with standard
      1st-line chemotherapy will be given in the control group. The stratification will be based on
      the following factors:

      PD-L1 expression (TC≥1% vs TC<1%); Smoking state (often smoking vs no smoking or infrequent
      smoking); Pathological type (squamous cell carcinoma vs non-squamous cell carcinoma).
    


Intervention name(s): TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy
Intervention type(s): Drug
Intervention description(s): TORIPALIMAB INJECTION(JS001 ) or Placebo ,240mg/6ml/vial, Q3W,up to 2 years of treatment.
Other intervention name(s): JS001, TAB001
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A First Time in Human Study in Healthy Volunteers and Patients
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      A multi-part study to investigate the safety, tolerability and local and systemic
      pharmacokinetics of V565
    


Intervention name(s): V565; V565; Placebo; V565; V565
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): single ascending dose of V565; Multiple dose; Single and multiple dose; Open-label single dose; Open-label single ascending dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Behavior Brain Responses
Condition: Alcohol Drinking; Drinking Behavior; Physiological Effects of Drugs; Central Nervous System Depression
MeSH terms: Alcohol Drinking; Drinking Behavior
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To compare responses to acute oral doses of ethanol in healthy young adults who experience
      mainly stimulant subjective effects from the drug or mainly sedative effects.
    


Intervention name(s): Ethanol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The 0.8 g/kg body weight dose of gelatin alcohol will be divided into an average of 10 servings of 0.08 g/kg each. The 0.8 g/kg dose is equivalent to 4 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol.
The 0.4 g/kg body weight dose of gelatin alcohol will be divided into an average of 5 servings of 0.08 g/kg each. The 0.4 g/kg dose is equivalent to 2 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol.; The placebo comparator will be individual servings of back cheery sugar-free jello.
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study of Dapivirine Vaginal Ring (VR) in Adolescents
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring in
      HIV-uninfected adolescent females, when inserted once every 4 weeks during 24-week of study
      product use.
    

Detailed description: 
      MTN-023/IPM 030 is a Phase 2a, two-arm, placebo-controlled, double-blinded, multi-site,
      randomized trial of dapivirine vaginal ring (VR) versus placebo VR. The clinical trial is
      designed to assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring
      (primary objective) and evaluate the acceptability of the dapivirine or placebo VR in
      sexually experienced, HIV-uninfected adolescent females, when inserted once every 4 weeks
      during 24-weeks of study product use.

      Approximately 96 participants will be randomized in a 3:1 ratio to receive either a silicone
      elastomer vaginal ring containing 25 mg of dapivirine or a placebo VR. The ring will be
      replaced every 4 weeks during the 24 week study product use period.

      Use of a VR to provide sustained delivery of microbicides is a novel investigational method
      for prevention of heterosexual transmission of HIV in women. This drug delivery method may
      circumvent potential difficulties related to adherence to daily or coitally-dependent uses of
      microbicide regimens.
    

Intervention name(s): placebo ring; dapivirine ring
Intervention type(s): Combination Product; Combination Product
Intervention description(s): intravaginal ring silicone elastomer intravaginal ring containing no drug product; intravaginal ring silicone elastomer intravaginal ring containing 25 mg dapivirine
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Human Immunodeficiency Virus
Safety and Efficacy of Seroquel in First Episode Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the safety, tolerability and efficacy of Seroquel and risperidone in first episode
      schizophrenia
    


Intervention name(s): Seroquel and Risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Schizophrenia
Quality Assessment of Orotracheal Intubation Without Neuromuscular Blocking Agents in Obese Patients
Condition: Obesity; Bariatric Surgery Candidate; Intubation Complication
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess the condition of orotracheal intubation in obese patients undergoing
      an elective bariatric surgery without the use of neuromuscular blocking agents.

      During the induction of general anesthesia, Propofol - Remifentanil combination will be used.

      The patients will be randomized in 2 groups with different doses of Remifentanil.
    

Detailed description: 
      The prevalence of obesity increases steadily. For anesthesiologists, the airway management of
      obese patients is known to be difficult and at risk. Tracheal intubation needs to be
      successful quickly. Neuromuscular blocking agents allow this option but with a risk of
      anaphylaxis and respiratory complications. In fact, for many surgical procedures those drugs
      are not necessary.

      Numerous studies in non-obese patients with the combination of Remifentanil and Propofol have
      shown adequate conditions for tracheal intubation without neuromuscular blocking drugs. This
      combination has never been studied in obese patient.

      After randomization, induction of general anesthesia will be performed with 2,5 mg/kg of
      Propofol in association with either 3 µg/kg of Ideal Body Weight of Remifentanil, or 3 µg/kg
      + 30% of Ideal Body Weight of Remifentanil.

      Minutes after the induction, orotracheal intubation will be performed, and the Intubation
      Difficulty Scale recorded.

      Other data on hemodynamic, respiratory and airway management will be are collected during the
      surgery.

      In the Post Anaesthetic Care Unit (PACU),Any symptoms of traumatic airway management or
      aspiration are collected.

      Those data will be again looked for and collected on the day of the patient's discharge.
    

Intervention name(s): Remifentanil Injection; Remifentanil Injection plus 30%
Intervention type(s): Drug; Drug
Intervention description(s): Injection of 3 μg/kg (Ideal Body Weight) of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery; Injection of 3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery
Other intervention name(s): orotracheal intubation; anesthesia; bariatric surgery; orotracheal intubation; anesthesia; bariatric surgery
Intervention MeSH terms: Remifentanil; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, controlled, double blinded and monocentric Pilot Study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tracheal intubation; obese patient; neuromuscular blocking agent; remifentanil