bioihbjkbjnl/mcl2 huggingface dataset:
High Risk Prostate Cancer Prevention Study
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to study the molecular effects of the chemopreventative agent,
      finasteride, in combination with dietary soy supplementation in patients at high risk for the
      development of prostate cancer. Also, the investigators intend to create a large database
      with health information from men who are at high risk of developing prostate cancer, along
      with serum and tissue samples from those patients who are willing to provide tissue and serum
      samples.
    

Detailed description: 
      Over 180,000 new cases of prostate cancer are diagnosed in the United States each year,
      making prostate cancer the most frequently diagnosed cancer in men. With an estimated 28,660
      deaths occurring in 2008, prostate cancer is the second leading cause of cancer death in men.
      In Kansas, prostate cancer is also the most frequent cancer among men and ranked third (253
      deaths in 2006) behind lung cancer (884 deaths in 2006) and colorectal cancer (273 deaths in
      2006) in cancer related mortality. Despite the significant morbidity and mortality related to
      this disease, screening and treatment approaches remain controversial and there is
      significant morbidity related to the treatment of early stage disease. Preventative
      strategies and strategies which identify patients at highest risk are needed desperately.

      The goal of this proposal is to study the molecular effects of the chemopreventative agent,
      finasteride in combination with dietary soy supplementation in patients at high risk for the
      development prostate cancer.
    

Intervention name(s): finasteride
Intervention type(s): Drug
Intervention description(s): Finasteride 5 mg once daily
Soy 4 capsules twice daily (160 mg total)
Other intervention name(s): Proscar; Propecia; isolavone
Intervention MeSH terms: Finasteride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prostate cancer
Sensorimotor Affect Relationship-based Therapy (SMART) for Children With Autism Spectrum Disorders Ages 2-12
Condition: Autism Spectrum Disorder; Autistic Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The SMART Program at Nationwide Children's Hospital is an interdisciplinary social skills
      group that teaches children with autism spectrum disorders (ASD) ages 2-12 the fundamental
      social skills necessary to build and maintain relationships. The manualized curriculum
      addresses skills such as joint attention, eye contact, play, and peer engagement. Currently
      individual goals are set for each child who participates and this is documented in the daily
      treatment note. In order to research group outcomes, the investigators will use parent
      questionnaires (an addition to current clinical practices) to measure changes in behavior
      after each 12 week session for up to one year of treatment. The investigators hypothesize
      that maladaptive behaviors will decrease and adaptive behaviors will increase in children
      with ASD after participation in the SMART program.
    


Intervention name(s): Sensorimotor Affect Relationship-based Therapy (SMART)
Intervention type(s): Behavioral
Intervention description(s): The SMART Program is an interdisciplinary program that teaches children ages 2-12.5 the fundamental skills necessary to build and maintain relationships. Sessions last for 12 weeks at a time and address skills such as: tolerance for sitting and structure, joint attention, eye contact, transitions between activities, participation in group activities, communication skills, and play skills.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Double Blind Clinical Trial of DCS for Food Anxiety
Condition: Anorexia and Bulimia Nervosa
MeSH terms: Anorexia; Bulimia; Bulimia Nervosa
Study type: Interventional

Summary: 
      This is a pilot study investigating if cycloserine (DCS; a learning enhancement medication)
      augments exposure therapy for food anxiety in patients with anorexia and bulimia nervosa. The
      investigators expect that (a) exposure therapy will reduce anxiety (b) anxiety will be
      reduced more in the DCS relative to placebo condition (c) participants in the DCS condition
      will have a greater increase in Body Mass Index.
    

Detailed description: 
      This study investigated if DCS vs placebo augmented food exposure in individuals with eating
      disorders.
    

Intervention name(s): Placebo vs Setraline; Setraline
Intervention type(s): Drug; Drug
Intervention description(s): Placebo; 250mg DCS
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anorexia, Bulimia, Anxiety, Exposure
New Treatment for Patients With Temporal Hollowing After Lateral Wall Decompression
Condition: Thyroid-Associated Ophthalmopathy
MeSH terms: Eye Diseases; Graves Ophthalmopathy
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether injection of autologous fat or
      hyaluronic-acid injections in temporal region are effective in the treatment of temporal
      hollowing after lateral wall decompression in patients with thyroid eye disease.
    

Detailed description: 
      Grave's disease is one of the most common autoimmune diseases. Thyroid eye disease is
      affecting nearly 50% of patients with Grave's disease. Surgical treatment may address several
      of the manifestations, including the increased volume of the orbital contents. Decompression
      of the orbit can be achieved by removing the lateral orbital walls; "lateral wall
      decompression".

      In a retrospective study at the Department of Ophthalmology, Haukeland University Hospital,
      about half of the patients had a disfiguring hollowing in the temporal region after lateral
      wall decompression. The patient reported outcome of the procedure is clearly an indication
      for further esthetic treatment. However, until now the treatment option for these patients
      have been limited, or simply neglected. The investigators have contacted over 40 patients
      with this complication that want treatment.

      In this project the investigators will treat bilateral hollowing with injection of autologous
      fat in one temporal region and hyaluronic-acid injections on the opposite side. Participants
      with unilateral hollowing will be randomized to one of the treatment options. Outcomes will
      be evaluated by clinical examination, photographs and ultrasound volume measurement at 6, 12,
      18 and 24 months postoperatively. The participants will be retreated at these follow up
      intervals if necessary.

      The project will be an interventional, prospective follow-up study and is approved by the
      regional ethics committee. The study will be the first of its kind to date as the
      investigators will be able to prospectively evaluate the effect of autologous fat injections
      to hyaluronic-acid injections in the same patient for the same condition.
    

Intervention name(s): Autologous fat injection; Hyaluronic acid injection
Intervention type(s): Procedure; Procedure
Intervention description(s): Injection in one side with autologous fat and the other side with hyaluronic acid.; Injection in one side with autologous fat and the other side with hyaluronic acid.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Temporal hollowing; Lateral orbital wall decompression; Thyroid eye disease
Is the Neosquamous Epithelium "Normal" Following Endoscopic Ablation of Dysplastic Barrett's Esophagus?
Condition: Barrett's Esophagus; Intestinal Metaplasia; Gastroesophageal Reflux Disease (GERD)
MeSH terms: Barrett Esophagus; Gastroesophageal Reflux; Metaplasia
Study type: Observational

Summary: 
      The investigators propose a study comparing the morphological and functional aspects of the
      neosquamous epithelium (NSE) after ablative therapy for dysplastic Barrett's esophagus (BE)
      to that of native squamous epithelium in normal controls as well as gastroesophageal reflux
      disease (GERD), non-Barrett's Esophagus (BE) subjects.
    

Detailed description: 
      Purpose: We propose a study comparing the morphological and functional aspects of the
      neosquamous epithelium (NSE) after ablative therapy for dysplastic Barrett's esophagus (BE)
      to that of native squamous epithelium in normal controls as well as gastroesophageal reflux
      disease (GERD), non-BE subjects.

      Participants: Eligible subjects will be women and men between the ages of 18-80, with one of
      the following:

        1. Two or greater cm of dysplastic BE, who will undergo or have undergone radiofrequency
           ablation for BE at UNC, or

        2. Diagnosed with GERD per a gastrointestinal (GI) physician undergoing upper endoscopy for
           other indications at UNC, or

        3. Non-GERD controls per a GI physician with normal esophageal mucosa undergoing upper
           endoscopy for other indications at UNC.

      Procedures (methods): Esophageal biopsies will be obtained specifically for research purposes
      before ablation therapy or, in subjects not receiving ablative therapy, after completion of
      the clinically indicated procedure and before withdrawal of the endoscope. Information from
      the medical record or from patient interview will be obtained regarding diagnosis (Barrett's
      esophagus, GERD, etc), and a questionnaire administered regarding the duration and frequency
      of reflux symptoms and complications of reflux disease. Subjects who are enrolled in the
      pre-ablation group will have additional biopsies and questionnaires administered during
      scheduled follow-up visits. On the last follow-up visit, this group will also undergo
      impedance-pH testing using standard methods, to assess for degree of control of esophageal
      acid exposure, and for number, duration and symptom correlation of non-acid reflux events.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Potential subjects will be identified by their gastrointestinal (GI) physician and
        approached by a study coordinator, nurse, or their GI physician regarding this study on the
        day of their scheduled procedure at UNC hospitals/GI clinic.
      
Biospecimen description: 
      esophageal biopsies
    
Keywords: Barrett's Esophagus; Intestinal metaplasia; Gastroesophageal reflux disease (GERD); Neosquamous epithelium; Radiofrequency ablation (RFA)
Upper Extremity Rehabilitation With the BURT Robotic Arm
Condition: Stroke; Hemiparesis
MeSH terms: Paresis
Study type: Interventional

Summary: 
      The overall objective of the proposed study is to carry out usability and design-evaluation
      assessments of the BURT robotic device for delivering long-term intervention in stroke
      survivors. The BURT is an upper extremity robotic device that enables the user to see and
      feel engaging games that encourage intensive therapy. The investigators intend to recruit up
      to 10 stroke survivors over the course of the study. Participants will train their arm with
      the BURT for 18 sessions over approximately 6 weeks then participate in a question/answer
      formatted discussion with research staff to discuss the usability of the device. The
      investigators will also assess participant's arm function at baseline and after the training
      sessions.
    


Intervention name(s): Arm motor function retraining with BURT
Intervention type(s): Device
Intervention description(s): Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions
Intervention model: Single Group Assignment
Intervention model description: All participants will receive the same intervention
Masking: None (Open Label)
Primary purpose: Other
Keywords: stroke; hemiparesis; Robotic
ALX-0061 Phase I Bioavailability Study in Healthy Volunteers
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall aims of the study are:

        -  To assess the bioavailability of single doses of ALX-0061, administered s.c. at three
           dose levels, using 2 corresponding single i.v. dose levels as reference.

        -  To provide additional information on pharmacokinetics and pharmacodynamics of ALX-0061.

        -  To further determine the safety and tolerability of ALX-0061.

        -  To further evaluate the systemic (serum) immunogenicity of ALX-0061.
    


Intervention name(s): ALX-0061; ALX-0061
Intervention type(s): Biological; Biological
Intervention description(s): single dose, intravenous; single dose, subcutaneous
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Single Dose Crossover Study In Healthy Subjects To Evaluate Different Formulations Of PF-06882961
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This open label study will evaluate the pharmacokinetics (PK) following single oral doses of
      different formulations of PF-06882961, including controlled release (CR) tablets at 2 release
      rates (long and short duration), an immediate release (IR) oral solution, and IR tablets, in
      healthy adult subjects.
    


Intervention name(s): PF-06882961 Immediate Release Tablet; PF-06882961 Controlled Release Tablet (long); PF-06882961 Controlled Release Tablet (short); PF-06882961 Immediate Release Solution
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Immediate Release Tablet; Controlled Release tablet (long); Controlled Release tablet (short); PF-06882961 Immediate Release solution
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Natural History of Small Airways Physiology in Diseased and Healthy States
Condition: Asthma; COPD; Interstitial Lung Disease; Cystic Fibrosis; Patients Requiring Lung Transplant
MeSH terms: Cystic Fibrosis; Asthma; Lung Diseases; Lung Diseases, Interstitial
Study type: Observational

Summary: 
      Spirometry is a useful clinical tool for the assessment and monitoring of lung disease,
      however, it does not provide information on peripheral airways resistance. On the contrary,
      impulse oscillometry (IOS) may provide information not only on airway resistance (Rrs) but
      also on the elastic properties of the lung (Xrs). In addition, multiple breath nitrogen
      washout (MBNW) utilizes the exhalation of nitrogen gas from the airways to determine changes
      in lung ventilation and derive small airways indices (that tells us about small airways
      calibre). This method, like IOS, allows a precise assessment of small airways function.

      Even though patients with asthma may show some reduction of the caliber of the small airways
      these changes are more a feature of patients with COPD. The study team hypothesize that IOS
      and MBNW measurements may detect these differences and provide different resistance profiles
      for asthma and COPD. Furthermore, the study team would like to investigate the relationship
      between airway inflammation and small airway disease by measuring exhaled nitric oxide (NO)
      at multiple exhalation flow rates. This technique allows the partitioning of NO produced in
      the central airways from that generated more peripherally in the lung, providing valuable
      information on the activity of inflammation in different parts of the respiratory system. The
      study team hope that the combined use of IOS, MBNW and NO will identify a possible
      correlation between inflammation and small airway dysfunction.
    

Detailed description: 
      Background

      The main objective of this study is to measure the damage of the small airways in lung
      disease exploring the "silent zone" with methods that have not been used before together in
      the same patients. Furthermore, because this is a 4 year longitudinal study, the study team
      will investigate the time related changes of small airway function in lung disease and normal
      healthy subjects.

      The study will also investigate the relationship between small airway resistance and
      inflammation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients will be recruited from outpatient clinics
      
Keywords: resistance; reactance; inflammation; lung function; respiratory function
ROTEM Versus aPTT/PT in Pediatric Surgery
Condition: Coagulation Defect; Bleeding
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Observational

Summary: 
      Hemocoagulation management in perioperative bleeding is nowadays based on standard
      coagulation testing: activated partial thromboplastin time (aPTT), prothrombin time (PT),
      fibrinogen, D-dimers, platelets. An interest about viscoelastic coagulation testing methods
      is rising - use of rotational thromboelastometry (ROTEM) is mentioned in the newest European
      guidelines for hemostasis management. ROTEM has more advantages then standard tests. However,
      both tests have only grade 1C recommendation, and most of trials have been done on adults.
      The goal of the study is to compare a relationship between standard tests and ROTEM in
      pediatric patients in perioperative period to find out which test has better correlation with
      clinical status, to compare therapeutic strategies and time necessary for gain both of tests
      and to compare the difference in blood loss and blood products consumption in group treated
      by ROTEM versus standard tests. Reduced blood loss and amount of blood products transfusion
      is expected to be found in ROTEM group, representing lowering risk for the patient, all due
      to early evaluation of hemocoagulation and targeted therapy guided by ROTEM.
    

Detailed description: 
      Pediatric patients who underwent spine surgery (under 18 years old) will be recruited in our
      study.

      Retrospective data will be analysed from these patient who underwent scoliosis surgery before
      ROTEM implementation to daily practice and after ROTEM implementation do daily practice in
      our department.

      Time to available results of ROTEM versus aPTT/PT tests will be compared. Blood loss and
      blood products used in these both groups will be analysed and compared between 2 groups.
    

Intervention name(s): Comparison of two approaches to bleeding management
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        pediatric patients who underwent surgical scoliosis correction
      
Keywords: ROTEM, PT, aPTT
Exercise Response on Dose Curve Among Class I Obese Young Adult Population
Condition: Obesity
Study type: Interventional

Summary: 
      The study is aimed to determine impact of dynamic resistance exercise training on Body Fat
      percentage of class-I Obese population and to quantify the dose of exercise program using a
      probit regression curve
    

Detailed description: 
      Methodology

      A sample size of 34 participants 17 male and 17 female of aged between 20-40 years with
      class-I obesity were selected and recruited in this study. All the participants were
      initially screened using a physical activity and readiness questionnaire to determine if they
      are fit to perform exercises afterwards intervention based on dynamic exercises were given to
      the patient for 12 weeks based on the guidelines of American College of Sports Medicine and
      the quantification of exercises was done using a Frequency, Intensity, Time and Type (FITT)
      protocol. The training session was based on Warm up 5 to 10 minutes followed by conditioning
      phase of 20 minutes and a cool down phase of 5 to 10 minutes. The detailed description of
      each of the phase is as under:

      Warm up Phase Dynamic light aerobic warm up exercises were performed by the participants for
      5 to 10 minutes before the start of the conditioning. Two different exercises that were
      performed included i) High Knee in which the knees will be lifted as high as possible in such
      a manner that both feet should be at one time be above the ground ii) Jumping Jack Exercise
      in which a simultaneous movement of upper and lower limb will be performed in a manner that
      every time during a jump the arms were thrusted over the head while the foot moved out to the
      side and than returning back to the original position 10 repetitions of both the exercises
      were performed.

      Dynamic Resistance Exercise Modified Wingate protocol that incorporates 20 minutes of
      training on a cycle ergometer; included one minute of cycling with resistance to be performed
      at 85% to 90% of Maximal Heart Rate (MHR) followed by one minute of cycling with no
      resistance. The protocol will be performed for 10 times for a duration of 20 minute of
      workout.

      Cool Down The process of cool down last for 5-10 minutes. During this low intensity, long
      hold stretching were performed of lower limb and upper limb that included shoulder, calf and
      hamstring stretch
    

Intervention name(s): Dynamic Resistance Exercises
Intervention type(s): Behavioral
Intervention description(s): Modified Wingate protocol that incorprates 20 minutes of training on a cycle ergometer; included one minute of cycling with resistance to be performed at 85% to 90% of Maximal Heart Rate (MHR) followed by one minute of cycling with no resistance. The protocol will be performed for 10 times for a duration of 20 minute of workout.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1910 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled study designed to evaluate
      the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of
      single ascending doses (SADs) of ALXN1910 subcutaneous (SC) and SAD of ALXN1910 intravenous
      (IV).
    


Intervention name(s): ALXN1910; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort.; Participants will receive Placebo IV or Placebo SC according to their assigned cohort.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: ALXN1910; Safety; Pharmacokinetics; Pharmacodynamics; Japanese Descent