bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Trial of Home Versus Clinic-Based STD Testing
Condition: Chlamydia; Gonorrhea
MeSH terms: Gonorrhea
Study type: Interventional

Summary: 
      This study randomizes St. Louis men to home-based STD screening or clinic-based STD
      screening. Home-based screening will be completed through the mail and clinic-based screening
      in a local clinical setting. We hypothesize that men randomized to home-based screening will
      be more likely to complete screening.
    


Intervention name(s): Home Screening; Clinic Screening
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Home-based STD screening using self-obtained urine samples and study paid postal return of samples.; Clinic-based STD screening using self-obtained urine samples in a local university clinical setting.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
A Trial Comparing a Prophylactic With a Therapeutic Platelet Transfusion Strategy in Two Groups
Condition: Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to show that a therapeutic platelet transfusion strategy (i.e.
      platelet transfusion only in case of bleeding) needs minimally a quarter less of transfusions
      compared to the standard prophylactic transfusion strategy (i.e. platelet transfusion without
      any sign of bleeding when the platelet count is below 10.000/µL). With the experimental
      transfusion strategy transfusions could be safely reduced when the study hypothesis can be
      proven. This is the first prospective randomized study on this topic.
    


Intervention name(s): Prophylactic platelet transfusion; Therapeutic platelet transfusion
Intervention type(s): Biological; Biological
Intervention description(s): In the PP arm platelet transfusion has to be performed when platelet count is below 10.000/µL in any case and when bleeding (more than petechial) occurs.; In the TP arm platelet transfusion is only required if bleeding occurs (more than petechial)or in case of pulmonary infections with or without sepsis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: proof of safety and cost effectiveness of the new therapeutic platelet transfusion strategy
Safety and Efficacy Study of Bosentan for Intermittent Claudication in Peripheral Arterial Disease
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
Study type: Interventional

Summary: 
      A prospective study, proof-of concept, randomized, controlled, parallel groups, simple blind
      was performed in 30 male patients (50-60 years old) with Intermittent Claudication
      (Rutherford category 1-2) recently diagnosed and clinical manifestations not exceeding 6
      months with hypertension and/or dyslipidemia as unique co-morbility disorders. After a period
      of stabilization of the claudication distance in the Stress test (12.5%, 3.2 km/h) during 2
      weeks, were randomized 1:1 to the experimental arm (Bosentan 62.5 mg twice daily/four weeks
      and 125 mg twice daily/eight weeks) or control group.
    


Intervention name(s): Bosentan; Antiaggregant therapy; Statins; Antihypertensive therapy
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Bosentan 62.5 mg/12 hours (first four weeks) and 125 mg/12 hours (eight weeks); AAS 100mg/d or Clopidogrel 75mg/d
Other intervention name(s): Tracleer
Intervention MeSH terms: Antihypertensive Agents; Bosentan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Bosentan; Peripheral Arterial Disease
Glutathione and Health With Post-Polio Syndrome
Condition: Post-polio Syndrome; Physical Activity; Depression; Pain; Sleep Disorders
MeSH terms: Poliomyelitis; Postpoliomyelitis Syndrome; Sleep Wake Disorders; Syndrome
Study type: Interventional

Summary: 
      In this study, people who have symptoms of post polio will take oral glutathione supplements
      for three months. Their levels of fatigue, physical activity and sleep efficiency will be
      assessed.
    

Detailed description: 
      Subjects will take a glutathione supplement by mouth for three months after an initial
      medical visit, blood draw and physical exam. There are four timepoints during the three
      months when subjects will fill out surveys and record food intake and sleep times in diaries
      for seven days. They will also wear a small device for seven days, a Sensewear monitor that
      records physical activity, body temperature and other measures.

      After the fourth timepoint they will return to the medical center for another physical exam
      and blood draw. Physicians trained in physical medicine and rehabilitation will be monitoring
      the study.
    

Intervention name(s): Glutathione
Intervention type(s): Dietary Supplement
Intervention description(s): glutathione is a dietary supplement and an antioxidant. Subjects will take 1000 mg per day for three month. Each capsule contains 500 mg glutathione.
Other intervention name(s): 500 Ultrathoine, GSH and l-glutathione.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: disability; polio; rehabilitation; wellness
Scar-Improvement Efficacy and Safety of a Single Intradermal Injection of Avotermin (Juvista) Administered Following Full-Thickness Skin Incisions
Condition: Cicatrix
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was undertaken to investigate the scar-improvement efficacy and safety of a single
      dose of avotermin (Juvista) injection into skin incisions.
    


Intervention name(s): Avotermin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.; Matched to avotermin dosage strength
Other intervention name(s): Juvista, RN1001, transforming growth factor beta 3; None applicable
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: scarring, Juvista, avotermin, transforming growth factor beta 3, TGFB3
Effects of COVID-19 Forced Isolation Context on Adolescents With and Without Somatic Symptom Disorder
Condition: Somatic Symptom Disorder
MeSH terms: Medically Unexplained Symptoms
Study type: Observational

Summary: 
      The purpose of this study is to evaluate whether a forced isolation context (such provided by
      the ongoing Covid-19 pandemic restrictive measures) could reduce the burden of somatic
      symptoms among a group of patients with Somatic Symptom Disorder (SSD). Secondary objective
      is to assess if a reduction in terms of depression tendency and anxiety occurs in this
      specific population and which are the effect of such a context among a group of adolescents
      without SSD. We want to compare these results with data obtained at the end of the pandemic.
    

Detailed description: 
      This study aims to evaluate whether the forced isolation context provided by the ongoing
      Covid-19 pandemic is providing an advantage in terms of reduction of somatic symptoms burden
      among an Italian group of adolescents with SSD, assessed by the Patient Health Questionnaire
      (PhQ15) administered during and at the end of the pandemic.

      Secondary objectives of the study are:

        -  To investigate the difference in anxiety and depression scores assessed by the
           Multidimensional Anxiety Scale for Children (MASC2) and Child Development Inventory
           (CDI-2) questionnaires among a group of SSD adolescents, during and after the pandemic
           isolation context.

        -  To investigate the difference in anxiety and depression scores assessed by the
           Multidimensional Anxiety Scale for Children (MASC2) and Child Development Inventory
           (CDI-2) questionnaires among a group of adolescents without SSD, during and after the
           pandemic isolation context.

        -  To compare the difference in anxiety and depression scores time modification between the
           two groups of adolescents.

        -  To explore through tailored questions which adolescents' coping strategies are during a
           pandemic isolation context among SSD patients and a group of controls without SSD.
    

Intervention name(s): Forced isolation context
Intervention type(s): Other
Intervention description(s): Exposure to the forced isolation context provided by the ongoing Covid-19 pandemic restrictive measures
Other intervention name(s): COVID-19 lockdown
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        -  SSD group: Adolescents who received a diagnosis of SSD at the Institute for maternal
             and child health "Burlo Garofolo"

          -  Without SSD group: Adolescents who accessed the Emergency Department for traumatic
             injuries or the Pediatric Clinic/Day Hospital Service for oral immunotherapy because
             of food allergies.
      
Keywords: SSD; adolescents; coping strategies; social media
Prenatal Test for Fetal Aneuploidy Detection
Condition: Aneuploidy; Trisomy 21
MeSH terms: Down Syndrome; Aneuploidy; Trisomy
Study type: Observational

Summary: 
      The purpose of this study is to develop and evaluate a blood test for pregnant women for
      detection of fetal aneuploidy.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women planning to undergo chorionic villus sampling or amniocentesis for fetal
        genetic evaluation
Is Routine Use of Histopathological Examination Necessary After Cholecystectomy ?
Condition: Cholelithiasis
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones
Study type: Observational

Summary: 
      Cholecystectomy has been made with benign conditions usually. The aim of this study is to
      compare the macroscopic evaluations of the cholecystectomy specimens with it's
      histopathological examinations.
    

Detailed description: 
      Cholecystectomy is one of the most frequently performed surgery in the world and often made
      with benign conditions. Routinely cholecystectomy specimens sent for histopathologic
      examination. The histopathologic examination of the cholecystectomy specimens are benign in
      most of the cases and the incidental malignancy of the gallbladder is 2-2.9% in the
      literature. The histopathologic evaluations of the gallbladder come with additional workload
      for pathology and surgery departments. Also there is additional cost for the patients.
      Because of that the idea of selective histopathologic examination has been raised.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        1000 patients who is operated with non inflamated cholelithiasis will be included to this
        study.
      
Biospecimen description: 
      cholecystectomy specimens
    
Keywords: histopathology; gallbladder; specimen
A Study Evaluating the Pharmacokinetics of Ceftobiprole When Taken by Obese Patients
Condition: Obesity; Staphylococcal Skin Infections; Streptococcal Infections
MeSH terms: Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Streptococcal Infections; Staphylococcal Skin Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to compare the pharmacokinetics (how drugs are
      absorbed in the body, how they are distributed within the body and how they are removed from
      the body over time) of ceftobiprole in morbidly obese patients and non-obese patients. The
      secondary objectives are to assess the pharmacodynamics (the study of the action or effects a
      drug has on the body) and to assess safety and tolerability of ceftobiprole in order to
      support dosing recommendations in the morbidly obese population.
    

Detailed description: 
      This is an open-label (all people involved know the identity of the intervention),
      parallel-group, Phase 1 study in morbidly obese and non-obese men and women. A total of 25
      patients (12 morbidly obese and 13 non-obese) patients will be enrolled in the study.
      Morbidly obese and nonobese patients are matched individually 1:1 by age (±10 years), sex,
      and renal function (as defined by creatinine levels in the urine). There are 4 phases in the
      clinical study: the pretreatment (screening/baseline) phase of up to 21 days; the 2-day
      open-label treatment phase when each patients receives a single 2-hour intravenous (directly
      into the vein) infusion of ceftobiprole 500 mg followed by multiple (up to 15) blood and
      urine samples drawn over the 24 hours following study drug administration; and the follow-up
      phase of approximately 1 week after the last blood sample when each patient will be monitored
      by telephone for development of new adverse events and assessment of ongoing adverse events.
      Each patient receives a single 2-hour infusion (directly into the vein) of ceftobiprole 500
      mg
    

Intervention name(s): Ceftobiprole
Intervention type(s): Drug
Intervention description(s): Ceftobiprole, 500 mg as single iv infusion over 2 hours
Intervention MeSH terms: Ceftobiprole; Ceftobiprole medocaril
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Obesity, Ceftobiprole; Skin Infections; Staphylococcal Skin Infections; Bacterial Skin Infections; Streptococcal Infection
IMPACT: Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee.
Condition: Foreign-Body Reaction; Inflammation; Effusion (L) Knee; Knee Pain Swelling
MeSH terms: Inflammation; Foreign-Body Reaction; Foreign Bodies
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Articular cartilage defects in the knee have a poor intrinsic healing capacity and may lead
      to functional disability and osteoarthritis. Cartilage cell therapy using autologous
      chondrocyte implantation (ACI) has been established as the first advanced treatment therapy
      medicinal product. Although this technique has achieved good mid-term results, it is a costly
      and extensive two-stage procedure which is limited by the number of chondrocytes obtained by
      biopsy and the dedifferentiation resulting from the expansion phase. Therefore, there is a
      need for improvement. A new cartilage repair technique should aim at decreasing surgical
      trauma, lowering complexity, improving logistics and cost-effectiveness while retaining or
      improving clinical outcome. Direct contact between mesenchymal stromal cells (MSCs) and
      dedifferentiated articular chondrocytes in vitro showed improvement of the chondrogenic
      phenotype of dedifferentiated articular chondrocytes. In addition, preserving the
      pericellular matrix of chondrocytes improves cartilage formation. These chondrons
      (chondrocytes with their pericellular matrix) have shown improved cartilage formation when
      combined with allogeneic MSCs in extensive preclinical studies. The cells are mixed with
      fibrin cell carrier and applied to the cartilage lesion within one surgical procedure. This
      will reduce patient morbidity and improve patient care through immediate transplantation of a
      potent cell-based cartilage product. This is a phase I/II prospective monocenter study to
      evaluate the safety and feasibility of the IMPACT for treatment of focal articular cartilage
      lesions of the knee.
    


Intervention name(s): Cartilage repair surgery
Intervention type(s): Other
Intervention description(s): Single-stage surgery, After debridement, the cartilage defect is filled with the fibrin glue carrier containing autologous chondrons and allogeneic MSCs
Other intervention name(s): Single-stage; Cartilage repair; IMPACT
Intervention model: Single Group Assignment
Intervention model description: First in man surgery: autologous chondrons are mixed with allogeneic MSCs and implanted in a fibrin glue carrier in a one-stage surgical procedure.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IMPACT; Chondrons; Mesenchymal stem cells; Allogeneic MSCs; single-stage; Cartilage repair; Safety; Efficacy
A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate if treatment with AZD9668 for 28 days is
      effective in treating Bronchiectasis (Brx) and if so how it compares to placebo (a substance
      which does not have any action).
    


Intervention name(s): AZD9668; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 x 30 mg, oral tablet, twice daily for 28 days; 2 x Matched placebo, oral tablet, twice daily for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: bronchiectasis; Phase II
Various Serving Sizes of Lentils on Blood Glucose and Insulin
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of consuming either 1/2 or 1/4 cup
      servings of lentils on post-prandial blood glucose and insulin as compared to 4 types of
      starchy foods (corn, macaroni, white potato, white rice).
    

Detailed description: 
      Eligible participants will undergo a total of 6 study visits. During each visit, a fasted
      blood sample will be taken by fingerprick, and approximately 500 µL of blood will be dripped
      into a collection tube. The participant will then consume a meal of either: two types of
      lentils, corn, macaroni, white rice, or white potato. All study days will be randomized. Each
      meal will be served in either 1/4 or 1/2 cup servings depending on the study block. Six more
      blood samples will be taken by fingerprick at 15, 30, 45, 60, 90 and 120 minutes after the
      beginning of the meal.
    

Intervention name(s): 1/4 cup- Small red lentil; 1/4 cup- Small green lentil; 1/4 cup- corn; 1/4 cup- macaroni; 1/4 cup- white potato; 1/4 cup- white rice; 1/2 cup- small red lentil; 1/2 cup- small green lentil; 1/2 cup- corn; 1/2 cup- macaroni; 1/2 cup- white potato; 1/2 cup- white rice
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: lentils; diabetes; glycemia; insulin; glucose
A Study to Test the Safety, Tolerability, and Pharmacokinetics of UCB0599 in Healthy Study Participants and Patients With Parkinson's Disease (PD)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability after administration of
      multiple doses and the pharmacokinetics (PK) of single and multiple doses of UCB0599 in
      healthy study participants and participants with Parkinson's Disease (PD).
    


Intervention name(s): UCB0599; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive an assigned dosage regimen of UCB0599 during the Treatment Period.; Participants will receive an assigned dosage regimen of Placebo during the Treatment Period to maintain the blinding.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: UCB0599; Parkinson's Disease; Phase 1 study; Healthy participants; Patients
Dose-Ranging, Pharmacokinetic (PK), Glucodynamic (GD), Safety and Tolerability Study of Subcutaneously (SC) Administered Humulin R and Humalog With or Without rHuPH20
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, Phase I, open-label, single-blind (subjects blinded to the contents
      of each injection), 4 stage study designed to determine the PK, GD, safety, tolerability, and
      optimal ratio of rHuPH20 administered with fixed Humulin R or Humalog doses in healthy
      subjects.
    

Detailed description: 
      Subjects will be enrolled in one of four sequential study stages. In each stage, a euglycemic
      clamp procedure will be used to control plasma glucose levels. Blood samples will be
      collected over an 8-hour time period after insulin administration (either Humulin R or
      Humalog) to analyze insulin and glucose levels using fully validated methods. Glucose
      infusion rates (GIR) will be recorded throughout the study period. The study is single-blind,
      with study subjects blinded as to the contents of each injection.

      Determine the pharmacokinetics (PK) and optimum ratio of rHuPH20:insulin when a range of
      rHuPH20 dose ratios are administered subcutaneously (SC) with fixed doses of Humulin R, by
      determining Tmax, Cmax, AUCs, and relative bioavailability based on serum insulin
      concentrations collected at specified time points (Stage 1).

      Determine if different concentrations of Humulin R impact the PK and minimal rHuPH20 dose
      necessary to achieve full insulin PK effect over a representative range of typical prandial
      SC Humulin R doses using the rHuPH20:insulin ratio identified in Stage 1 (Stage 2).

      Determine the PK and optimum ratio of rHuPH20:insulin when a range of rHuPH20 dose ratios are
      administered SC with fixed doses of Humalog, by determining Tmax, Cmax, AUCs, and relative
      bioavailability based on serum insulin concentrations collected at specified time points
      (Stage 3).

      Determine if different concentrations of Humalog impact the PK and minimal rHuPH20 dose
      necessary to achieve full insulin PK effect over a representative range of typical prandial
      SC Humalog doses using the rHuPH20:insulin ratio identified in Stage 3 (Stage 4).

      Evaluate the safety and local tolerability of the SC injection at various rHuPH20, Humulin R,
      and Humalog doses (Stages 1 - 4).

      Assess the glucodynamics (GD) of the SC injection of various rHuPH20, Humulin R, and Humalog
      doses (Stages 1 - 4).
    

Intervention name(s): rHuPH20; Insulin Human Injection; Insulin Lispro Injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): recombinant human hyaluronidase PH20; injection; injection
Other intervention name(s): Humulin® R; Humalog®
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Humalog; Humulin R; rHuPH20; Hylenex