bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Safety and Efficacy of Intravenous Alpha-1 Antitrypsin in Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Alpha 1-Antitrypsin Deficiency; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Alpha-1 Antitrypsin (AAT), trade name (Glassia ®), is being explored in this phase I/II trial
      as a potential disease modifying agent in Type 1 Diabetes Mellitus (T1DM) based on its
      anti-inflammatory properties. AAT is an acute stress reactant protein that increases during
      inflammation. In T1DM inflammation serves a major role in disease progression.
    

Detailed description: 
      AAT is a protein produced by the human liver and secreted into the blood circulation. AAT,
      which belongs to a group of serine protease inhibitors (SERPINS) is an acute stress reactant
      protein that increases during stress conditions, including inflammation. AAT blocks serine
      proteases that enhance pro-inflammatory mediators (i.e. IL-1 alpha, IL-6, IL-8, TNFalpha) as
      well as induces production of anti-inflammatory mediators (i.e. IL-10 and IL-1-receptor
      antagonist).

      In Type 1 Diabetes Mellitus (T1DM) inflammation serves a major role in disease progression.
      The inflammatory signature pattern in these patients appears to have been present years
      before clinical onset.

      Although circulating levels of AAT in T1DM are normal, in majority of cases, the activity of
      AAT is severely compromised by non-enzymatic glycations, supporting the conclusion that serum
      protease inhibitory capacity is reduced in T1DM.

      It has been shown in different studies, including in vivo and in vitro that AAT has a
      protective affect on pancreatic islets. This has been demonstrated in both decrease in
      progression of diabetes in the non-obese diabetic (NOD) mouse as well as during
      transplantation of islets which presented viability and activity (insulin production) in the
      presence of AAT. More specifically, islet cells are protected by human AAT from apoptosis, as
      shown by reduced caspase-3 activity after the addition of human AAT to islet culture media.

      Based on the mentioned anti-inflammatory properties of AAT sided to in vivo and in vitro
      studied indicating that AAT may serve as a disease modifying agent in T1DM, the presented
      study is suggested.
    

Intervention name(s): Alpha-1 Antitrypsin 40mg (AAT, Glassia®); Alpha-1 Antitrypsin 60mg (AAT, Glassia®); Alpha-1 Antitrypsin 80mg (AAT, Glassia®)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Each study group will undergo 3 treatment periods:12 weeks, 8 weeks and 4 weeks.; Each study group will undergo 3 treatment periods:12 weeks, 8 weeks and 4 weeks.; Each study group will undergo 3 treatment periods:12 weeks, 8 weeks and 4 weeks.
Intervention MeSH terms: Alpha 1-Antitrypsin; Protein C Inhibitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validation of a Pediatric Pictorial Version of the QOR-15 Postoperatory Functional Recovery Scale - QoR-15 Pédiatric
Condition: Surgical Intervention; Minor
Study type: Observational

Summary: 
      Consideration from the patient's point of view is an important step in improving
      postoperative functional recovery. The questionnaire Quality-of-recovery 15 (QoR-15) is a
      psychometrically validated questionnaire to measure the quality of postoperative functional
      recovery. it has been recommended in perioperative medecine however, this questionnaire was
      never adapted and validated for a pediatric surgical population.

      The main objective of this protocol is to study the validity, reliability, acceptability and
      feasibility in routine clinical practice of a pediatric pictorial version of the QoR-15
      score.
    


Intervention name(s): Questionnaire Quality-of-recovery 15 (QoR-15)
Intervention type(s): Other
Intervention description(s): Children will use the questionnaire Quality-of-recovery 15 (QoR-15)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Minor patient over 7 years and up to 17 years and 9 months who have a programming surgery
        as part of routine management
      
Keywords: questionnaire Quality-of-recovery 15 (QoR-15)
Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects
Condition: Healthy Subjects; Human Volunteers; Healthy Participants; Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open label, single dose, balanced, two treatment, two sequence, four period,
      fully replicate, cross over bioequivalence study under fasting condition.
    


Intervention name(s): Cortiment; Budesonide
Intervention type(s): Drug; Drug
Intervention description(s): Budesonide 9 mg prolonged release tablets; Experimental (Budesonide 9 mg prolonged release tablets)
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Cross Over
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Budesonide prolonged release tablets 9 mg; Pharmacokinetic; fully replicate
Sarcopenia and Aging
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Observational

Summary: 
      Objective: Evaluate the muscular strength in the ageing process and identify the changes
      between the abdominal muscles, upper and louver edges.

      Method: 48 individuals participated in this study, being divided into four groups according
      to the age: (G1) 11to 18 years old, (G2) 20 to 26 years old, (G3) 45 to 60 years old and (G4)
      66 - 82 years old. The excluding criterion included people who work out more than three times
      a week, severe arthrosin, stroke, significant cognitive deficit , obesity, use of ortheses
      for louver members or any break, with or without metallic implant. The evaluation instruments
      used were: (1) Esfigmomanômetro (EM), (2) Trunk flexor in the supine position,, (3) Jamar
      Dinamômetro and (4) Preston Pinch Gauge Dinamômetro.
    

Detailed description: 
      Forty-eight subjects participated voluntarily in this work and is divided into four groups of
      12 participants with 6 men and 6 women: (G1) 11 to 18 years (G2) 20 to 26 years (G3) from 45
      to 60 and (G4) 66 to 82 years, selected in dependency of Unifran and residences of the city
      of Franca, Sao Paulo - Brazil. To evaluate muscle strength, a BD sphygmomanometer was used to
      analyze the strength of flexors and extensors of the knee. The Jamar Dynamometer was used to
      assess the functional integrity of the upper and Preston Pinch Gauge Dynamometer for
      evaluation of gripper hands.
    

Sampling method: Non-Probability Sample
Study population: 
        48 individuals participated in this study, being divided into four groups according to the
        age: (G1) 11to 18 years old, (G2) 20 to 26 years old, (G3) 45 to 60 years old and (G4) 66 -
        82 years old.
      
Biospecimen description: 
      The evaluation instruments used were: (1) Esfigmomanômetro (EM), (2) Trunk flexor in the
      supine position,, (3) Jamar Dinamômetro and (4) Preston Pinch Gauge Dinamômetro.
    
Keywords: Ageing; Sarcopenia; Muscular contraction
Phase I/II Study of Curdlan Sulfate
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and tolerance of curdlan sulfate, as well as its anti-HIV activity, in
      HIV-infected patients with CD4 T-lymphocytes less than 500 cells/mm3, using first single
      doses and then, after FDA review, daily doses for 7 days.
    

Detailed description: 
      In Phase I of the study, escalating single doses of intravenous curdlan sulfate are tested.
      In Phase II, curdlan sulfate is administered daily for 7 days. (NOTE: Phase I is completed.)
    

Intervention name(s): Curdlan sulfate
Intervention type(s): Drug
Intervention MeSH terms: Curdlan sulfate
Primary purpose: Treatment
Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex; curdlan sulfate
The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a regimen of norethindrone acetate +
      placebo or norethindrone acetate + conjugated estrogens is superior in maintaining skeletal
      health and quality of life in adolescents treated with a GnRH agonist for endometriosis.
    

Detailed description: 
      Endometriosis has become increasingly recognized as a chronic illness which begins during
      adolescence. Untreated endometriosis may lead to chronic pain and infertility. As recognition
      of the need for prompt therapy increases, so does the length of time patients will be exposed
      to treatments. As a result, there exists a pressing need to evaluate adjunctive measures that
      may limit the associated negative health consequences of treatment.

      A gonadotropin-releasing hormone (GnRH) agonist is one medication utilized for patients who
      have failed other treatments. While GnRH-agonists are effective in relieving symptoms, their
      long-term use is problematic. GnRH agonists induce a low-estrogen state, causing deleterious
      effects on bone mineralization. These negative consequences are especially important for our
      pediatric patients. Adolescence is the critical period in a woman's life for bone acquisition
      and attainment of peak bone mass. Anything that interferes with this process puts patients at
      risk for lifelong low bone density and future fracture.

      "Add-back" therapy appears to be a promising adjunct to treatment for prevention of this bone
      loss. Daily therapy with low-doses of hormones preserves bone density in adult patients,
      without altering the efficacy of the GnRH-agonist. However, no data exist on the effect of
      add-back therapy in adolescents.

      The aim of the current study is to evaluate the safety and efficacy of two add-back regimens,
      norethindrone acetate + placebo or norethindrone acetate + conjugated estrogens, for the
      preservation of skeletal health and quality of life in adolescents with endometriosis treated
      with a GnRH-agonist.
    

Intervention name(s): Norethindrone acetate + estrogens; norethindrone acetate + placebo
Intervention type(s): Drug; Drug
Intervention description(s): Norethindrone acetate 5 mg by mouth daily + Conjugated equine estrogens 0.625 mg by mouth daily; norethindrone acetate 5 mg by mouth daily + Placebo capsule 1 pill by mouth daily
Other intervention name(s): Aygestin; Premarin; Aygestin
Intervention MeSH terms: Norethindrone; Norethindrone Acetate; Estrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endometriosis; Adolescents; Bone density; GnRH Agonist; Add-back therapy
Diabetes Group Prenatal Care
Condition: Pregnancy; Gestational Diabetes; Type 2 Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      The investigators primary objective is to conduct a pilot randomized trial to determine the
      effect of group prenatal care on self-care activities in women with diabetes.
    

Detailed description: 
      Long term, the investigators aim to test the central hypothesis that group prenatal care,
      compared to traditional prenatal care, will improve glycemic control and, ultimately,
      maternal and neonatal outcomes in women with type 2 and gestational diabetes. The objective
      of this proposal is to conduct a pilot randomized trial to determine the effect of group
      prenatal care on self-care activities, which have been associated with improved glycemic
      control, in women with diabetes.
    

Intervention name(s): Group prenatal care
Intervention type(s): Behavioral
Intervention description(s): Women will receive their prenatal care in a group rather than in the 1:1 traditional manner.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: group prenatal care; CenteringPregnancy; diabetes
Bladder Cancer Case Control Study of Arsenic in Water
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Observational

Summary: 
      This study is examining the relationship between ingested arsenic and bladder cancer in two
      areas of California where a large percentage of the population was exposed to drinking water
      containing arsenic at low to moderate levels.
    

Detailed description: 
      Water supplies in many parts of the world contain naturally occurring arsenic. Previous
      studies have shown that arsenic at high doses can cause cancer of the bladder. The risk at
      lower doses is unknown. This study is examining the relationship between ingested arsenic and
      bladder cancer in central Nevada and Kings County, California, two areas where a large
      percentage of the population was exposed to drinking water containing arsenic at low to
      moderate levels. Approximately 200 people with bladder cancer and 400 people without bladder
      cancer will be included. Subjects are interviewed by telephone about past residences,
      occupations, diet, drinking water consumption, and other lifestyle factors. Arsenic
      measurements in well water have been collected from the appropriate state agencies and are
      being matched with residences and drinking water consumption rates to estimate lifetime
      arsenic exposures for each subject. People with bladder cancer will then be compared to those
      without to see if people with cancer were more likely to have lived in areas with arsenic in
      their drinking water.
    

Observational model: Case-Control
Time perspective: Retrospective
Keywords: Arsenic; Bladder Cancer; Drinking Water
Heart Inflammation and Mental Stress Study
Condition: Hypertension
MeSH terms: Inflammation; Stress, Psychological
Study type: Interventional

Summary: 
      The aim of the study is to investigate the neural underpinnings of cardiovascular reactivity
      to mental stress as a function of HIV and hypertensive risk.
    

Detailed description: 
      The main objectives of the study are to assess (1) patterns of brain activity/connectivity
      that confers greater cardio-autonomic/emotion regulation, (e.g., heart rate variability,
      blood pressure reactivity, inflammatory-immune activation, etc.), during rest, mental stress,
      and anger-related distress, (2) whether changes in breathing pace mitigate task-based effects
      on cardio-autonomic-immune regulation, and (3) whether these patterns vary as a function of
      HIV or pre-hypertensive (HTN) status-related changes to the brain structures underlying
      cardioautonomic and emotion regulation.
    

Intervention name(s): Paced breathing; Active relaxation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Individuals will be fitted with a respiratory transducer and receive auditory tones with which to pace their rate of inspiration and expiration in the experimental group.; Individuals will be provided with headphones while resting quietly listening to relaxing tones/music.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: High blood pressure; HIV
Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis
Condition: Non-Alcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled study in up to 104 patients with a
      diagnosis of NAFLD and/or NASH. The study will be conducted over a period of up to 22 weeks
      and will include an optional Prescreening, Screening (Days -35 to -7) Phase, a 16-week
      Treatment Phase following randomization on Day 1. Patients will be randomly assigned in a
      ratio of 1:1:1:1 to receive Saroglitazar Magnesium 1mg or 2 mg or 4 mg or matching placebo
      once daily in the morning before breakfast for 16 Weeks. The primary endpoint of the study is
      percentage change from baseline in serum ALT levels at Week 16 in the Saroglitazar Magnesium
      groups as compared to the placebo group.
    


Intervention name(s): Saroglitazar magnesium 1 mg; Saroglitazar magnesium 2 mg; Saroglitazar magnesium 4 mg; Placebos
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.; Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.; Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.; Patients randomly assigned to this group will receive placebo tablet orally once daily for 16 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NASH; NAFLD; Saroglitazar
Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients
Condition: Portal Hypertension; Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This placebo-controlled study will assess the safety and efficacy of a 90-day course of
      treatment with ifetroban for portal hypertension in cirrhotic patients
    


Intervention name(s): Ifetroban; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule; matched placebo delivered as infusion and oral capsule
Intervention MeSH terms: Ifetroban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Risk Factors for Recurrent Urinary Tract Infection in Children
Condition: Urinary Tract Infection; Pyelonephritis; Cystitis
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Cystitis; Pyelonephritis
Study type: Observational

Summary: 
      The purpose of this study is to determine clinical and urodynamic risk factors for recurrent
      urinary tract infection in 5-18 years old children.
    

Detailed description: 
      It is known, that in the group of young children the most common reason of recurrent UTI is
      anatomic abnormalities, such as vesicoureteral reflux, hydronephrosis. However, not all
      recurrent UTI can be explained by anatomic abnormalities. The vast majority of school age
      children with recurrent UTI have anatomically normal urinary tract. Recent studies discuss
      about the role of behavioral and functional abnormalities (inadequate fluid intake, stool
      retention, infrequent voiding, etc.) that can predispose recurrent urinary tract infections.
      Influence of some these abnormalities for recurrent UTI is controversial. Family history,
      behavioral and functional abnormalities which predispose to urinary tract infections in
      children with normal urinary tract are neglected in most protocols of urinary tract
      infection.

      Children in this study receive a careful evaluation including complete history,
      voiding-drinking diary, bowel questionnaire, physical investigation, sonography, voiding
      cystourethrogram.

      Follow up time - 1 year. Urinalysis once a month and during each episode of fever.
    

Observational model: Case-Control
Time perspective: Prospective
Keywords: pyelonephritis; cystitis; risk factor; children; urodynamics
Epirubicin Cisplatin and Fluorouracil (FU) Combined With Endostar in Patients With Advanced or Metastatic Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and tolerability of the ECF regimen
      (epirubicin, cisplatin and FU) combined with endostar-- a inhibitor of angiogenesis, in
      patients with advanced or metastatic gastric cancer (A/MGC).
    

Detailed description: 
      Although there is no standard regimen in the treatment of metastatic gastric cancer, ECF
      regimen (epirubicin, cisplatin and FU) is often considered as a reference regimen. And ECF
      regimen has been suggested as the first line therapy for A/MGC by FDA. According to the
      result of a Chinese phase III clinical trial in metastatic lung cancer, endostar-- a new
      angiogenesis inhibitor prolonged the overall survival, time to progression and improved
      response rate. So we designed this clinical trial to evaluate whether endostar can bring
      survival benefits to patients with advanced and metastatic gastric cancer patients.
    

Intervention name(s): ECF-endostar
Intervention type(s): Drug
Intervention description(s): Epirubicin 50mg/M2 D1, Cisplatin 60mg/M2 D1, FU 500mg/M2 D1-5, endostar 7.5mg/M2 D1-14, treatment cycle repeat every 3 weeks. Treatment should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Other intervention name(s): treatment group
Intervention MeSH terms: Endostar protein
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Time to Progression; Overall survival; Response rate; Quality of Live; Toxicities