bioihbjkbjnl/mcl2 huggingface dataset:
Pergoveris FD and Liquid China BE Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the bioequivalence (BE) of the fixed combination
      of follitropin alfa and lutropin alfa in Pergoveris freeze-dried (FD) (Test 1) or in
      Pergoveris Liquid (Test 2) versus the co-administration of Gonal-f and Luveris (Reference),
      administered subcutaneously (SC) in pituitary suppressed, healthy premenopausal Chinese
      female participants, at the doses of 900 international unit (IU) of follitropin alfa and 450
      IU lutropin alfa.
    


Intervention name(s): Pergoveris FD; Pergoveris Liquid; Gonal-f; Luveris
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will be administered with 900 IU of recombinant human follicle-stimulating hormone (r-hFSH) and 450 IU of recombinant human luteinizing hormone (r-hLH) freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in investigation period 1 or investigation period 2 or investigation period 3. There will be a washout period of 6 days between investigation period 1 and investigation period 2 and 17 days between investigation period 2 and investigation period 3.; Participants will be administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Pergoveris Liquid) as subcutaneous injection using disposable pen-injector on Day 1 in investigation period 1 or investigation period 2 or investigation period 3. There will be a washout period of 6 days between investigation period 1 and investigation period 2 and 17 days between investigation period 2 and investigation period 3.; Participants will be administered with 900 IU of folitropin alfa (Gonal-f) as subcutaneous injection on Day 1 in investigation period 1 or investigation period 2 or investigation period 3. There will be a washout period of 6 days between investigation period 1 and investigation period 2 and 17 days between investigation period 2 and investigation period 3.; Participants will be administered with 450 IU of lutropin alfa (Luveris) as subcutaneous injection on Day 1 in investigation period 1 or investigation period 2 or investigation period 3. There will be a washout period of 6 days between investigation period 1 and investigation period 2 and 17 days between investigation period 2 and investigation period 3.
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy; Pergoveris; Bioequivalence; Infertility
Exercise Study in Subjects With NAFLD
Condition: Non-Alcoholic Fatty Liver Disease; Gastrointestinal Microbiome; Exercise
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Non-Alcoholic Fatty Liver Disease is the most common cause of chronic liver diseases. The
      benign non-alcoholic fatty liver, characterized by excessive fat accumulation, can evolve
      into non-alcoholic steatohepatitis and liver cancer.

      The recommendation nowadays is a lifestyle change with physical exercise and diet to reduce
      liver fat and improve inflammation. Besides this, a leaky gut and dysbiosis have an impact on
      the liver, and exercise ameliorates the diversity of gut microbiota and permeability of the
      intestine.

      The aim of this study is to find out a link between exercise and the gut-liver axis regarding
      the stage of liver adiposity and define exercise-responsive gut microbiome in NAFLD patients
    

Detailed description: 
      For this 12-week randomised controlled intervention 60 subjects between 18 and 70 years old,
      diagnosed with NAFLD and body mass index under 35 kg/m2 will be recruited. They will be
      randomly assigned in a high-intensity aerobic interval training (n=30) and a control group
      with a sedentary lifestyle (n=30). The intervention group follows a supervised high-intensity
      aerobic interval training two times per week and additionally, an individualised home workout
      program to have 3 hours of aerobic training per week. Blood samples, adipose tissue biopsy,
      24h-urine and faecal samples will be collected at the baseline, midway (only stool) and at
      the end of the study. Dietary intake will be analysed at weeks 0, 6, 12.
    

Intervention name(s): high-intensity aerobic interval training
Intervention type(s): Behavioral
Intervention description(s): The intervention group will follow a high-intensity interval training protocol on a cycle ergometer for 2 times per week and 1 time an individualised home workout program to have a total exercise amount of 3 hours.
Leisure time physical activity at baseline as well as during the intervention period will be assessed by Polar Active devices.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study contains two arms. One arm is the control group without any changes in their lifestyle (sedentary lifestyle) and the other arm is the intervention group with a high-intensity interval training. Both groups have no changes in their diets.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: NAFLD; Gut microbiota; high-intensity training
A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With Dercum's Disease Lipomas
Condition: Dercum's Disease
MeSH terms: Adiposis Dolorosa
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 study will be an open-label and randomized study to assess the efficacy and
      safety of CBL-514 in participants with Dercum's Disease lipomas.
    

Detailed description: 
      This is a Phase 2a study to evaluate the efficacy and safety of CBL-514 injections in
      participants with Dercum's disease. It will employ an open-label, randomized study design.

      Eligible participants will have at least 4 painful lipomas of appropriate size and up to 8
      lipomas will be treated per subject. Eligible participants will be enrolled and randomized to
      2 dose groups, with 6 participants per group. Each enrolled participant will receive up to 2
      courses of their allocated dose of CBL-514 administered into selected lipomas, which the
      injection volume per lipoma will be based on the lipoma size, determined by ultrasound.
    

Intervention name(s): 10 mg CBL-514 per injection; 15 mg CBL-514 per injection
Intervention type(s): Drug; Drug
Intervention description(s): The total injection volume per lipoma will be based on the lipoma size, as determined by ultrasound. Dosing sceme is presented as below:
Lipoma diameter of ≥1.0cm and ≤2.0cm - 1 injection (2 mL each); total of 10 mg CBL-514.
Lipoma diameter of >2.0cm and ≤3.5cm - 2 injections (2 mL each); total of 20 mg CBL-514.
Lipoma diameter of >3.5cm and ≤5.0cm - 3 injections (2 mL each); total of 30 mg CBL-514.
Lipoma diameter of >5.0cm and ≤6.0cm - 5 injections (2 mL each); total of 50 mg CBL-514.; The total injection volume per lipoma will be based on the lipoma size, as determined by ultrasound. Dosing sceme is presented as below:
Lipoma diameter of ≥1.0cm and ≤2.0cm - 1 injection (3 mL each); total of 15 mg CBL-514.
Lipoma diameter of >2.0cm and ≤3.5cm - 2 injections (3 mL each); total of 30 mg CBL-514.
Lipoma diameter of >3.5cm and ≤5.0cm - 3 injections (3 mL each); total of 45 mg CBL-514.
Lipoma diameter of >5.0cm and ≤6.0cm - 5 injections (3 mL each); total of 75 mg CBL-514.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adiposis Dolorosa; Lipedema; Lipomatosis; Skin Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Connective Tissue Diseases
Target Volume Delineation After NACT in LA-NPCarcinoma Patients Treated With NACT+ CCRT
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The gross tumor volumes of the primary site and the neck nodes (GTVnx and GTVnd) could be
      delineated according to the post-NACT tumor position and receive radical radiation dose,
      while the tumor disappear after NACT could be encompassed in the first clinical target volume
      (CTV1) and receive high preventive radiation dose. Through this method,it is more likely to
      achieve the ultimate goal that maximize the chance of cure while minimize the injury of
      surrounding normal tissues, maintaining organ function and life quality. Therefore, this
      stage II clinical trial was designed to study the prognosis and locoregional failure patterns
      of this target volume delineation method in LA-NPC treated with NACT plus CCRT.
    


Intervention name(s): Target Volume Delineation after NACT
Intervention type(s): Radiation
Intervention description(s): The gross tumor volumes of the primary site and the neck nodes (GTVnx and GTVnd) were delineated in accordance with the head and neck magnetic resonance imaging (MRI) and endoscopy, which obtained two weeks after the last cycle of NACT. The first clinical target volume (CTV1) was defined as the GTVnx plus a 5-10mm margin (2 to 3mm margin posteriorly) to encompass the high-risk sites of microscopic extension, the whole nasopharynx, and the location and extent of the primary tumor before NACT. The second clinical target volume (CTV2) was defined as the CTV1 plus a 5-10mm margin (2 to 3mm margin posteriorly) to encompass the low-risk sites of microscopic extension, the level of the lymph node located before NACT, and the elective neck area. The prescribed dose to GTVnx, GTVnd, CTV1 and CTV2 were 68Gy/30f, 62-66Gy/30f, 60Gy/30f and 54Gy/30f, respectively.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neoadjuvant Chemotherapy; Intensity-modulated Radiation Therapy; Target Volume Delineation; Locoregional Failure Pattern; Nasopharyngeal Carcinoma
Personalized Translational Platform for Biomarker Discovery in Brain Tumors
Condition: High Grade Glioma
MeSH terms: Brain Neoplasms
Study type: Observational

Summary: 
      The central hypothesis for this proposal is that multimodal (clinical, imaging, tissue)
      biomarkers will better predict early brain tumor response to treatments and will be more
      reliable prognostic markers in patients with malignant brain tumors.
    


Intervention name(s): FLT-PET/CT: (3'deoxy-3'-[(18)F] fluorothymidine) PET/CT
Intervention type(s): Drug
Intervention description(s): Each patient will have 0-3 or more FLT-PET brain scans.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting to BWH/DFCI emergency department (ED), inpatient, or neurology/
        neurosurgery/ radiation oncology clinics with newly diagnosed brain masses (suspected high
        grade gliomas) will be consented and enrolled in this study after adequate explanation of
        the risks and benefits of the study.
      
Keywords: Glioblastoma multiforme; FLT; PET
Does a Home-based Exercise Programme Affect Physical Capacity and Quality of Life in Patients With Pulmonary Embolism?
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Study type: Interventional

Summary: 
      In a randomised design the study aims to investigate whether an intervention of 8 weeks
      home-based exercise in addition to usual care can positively influence the physical capacity,
      quality of life, sick leave and use of psychoactive drugs in patients medically treated for
      pulmonary embolism.
    

Detailed description: 
      Background: The existing knowledge regarding pulmonary embolism is primarily focused on the
      diagnostic methods and medical treatment of the condition, and furthermore on the short term
      prognosis in terms of mortality and complications. Very few studies investigate how every day
      life is affected in patients struck by a pulmonary embolism, although many patients display
      worries and concerns about their physical, emotional and social well-being after discharge.
      For the time being, no rehabilitation options are available for these patients in Denmark.

      Methods and materials: 140 patients medically treated for pulmonary embolism will be
      recruited from 6 different hospitals. After inclusion the patients will be randomly allocated
      to either the control group, receiving usual care, or the intervention group, receiving an
      8-week home-based exercise programme in addition to usual care. At the time of inclusion,
      after 2 months and after 6 months, the patients' physical capacity is measured using the
      Incremental Shuttle Walk test.

      Furthermore the patients' complete a questionnaire on quality of life (EQ-5D and Pulmonary
      Embolism Quality of Life Questionnaire), self-reported sick leave and use of psychoactive
      drugs. All follow-up measurements and visits take place at the hospital from which the
      patient was discharged.

      Expected outcome and perspective: The investigators expect that the home-based exercise
      programme will improve the overall treatment outcome for the patients in the intervention
      group. The study will furthermore contribute significantly to the limited knowledge about the
      optimal rehabilitation for this group of patients, and may thereby form the basis of future
      recommendations in this field.
    

Intervention name(s): 8-week home-based exercise programme
Intervention type(s): Other
Intervention description(s): 8-week home-based exercise programme is assigned to patients in exercise group following discharge. This includes 3 follow-up telephone calls by physiotherapist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rehabilitation; physical capacity; quality of life
A Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty
Condition: Subjects Requesting and Requiring an Open Rhinoplasty
Study type: Interventional
Phase: Phase 2

Summary: 
      Rhinoplasty (nasal reconstruction i.e. "a nose job") is a surgical procedure performed on the
      nose to correct a medical problem or change the appearance of the nose. During the healing
      process, swelling and/or bruising is likely to occur. A drug called ARTISS Fibrin Sealant may
      or may not lessen these effects. This study is looking to see the effects of ARTISS on
      adhering tissue and improving wound healing in an external rhinoplasty. The purpose of this
      study is to evaluate the safety and effectiveness of rhinoplasty using ARTISS compared to
      rhinoplasty without using ARTISS in patients undergoing rhinoplasty performed through an
      external approach.
    


Intervention name(s): ARTISS human fibrin sealant
Intervention type(s): Biological
Intervention MeSH terms: Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rhinoplasty; external rhinoplasty; open rhinoplasty; nose job
A Wireless Lingual Feedback Device to Reduce Overpressures in Seated Posture: A Feasibility Study
Condition: Postural Behaviour; Overpressures Reductions
Study type: Observational

Summary: 
      This study evaluates the feasibility of a biofeedback system aimed at reducing overpressures
      during seated posture. The system consists of (1) a pressure sensors map, (2) a laptop that
      couples sensors with actuators, (3) a Tongue Display Unit (TDU) consisting of a wireless
      circuit embedded in a dental retainer with a matrix of electrodes. The principle of this
      biofeedback system consists in (1) detecting overpressures in people who are seated over long
      periods of time, (2) estimating a postural change that could reduce these overpressures and
      (3) communicating this change through directional information transmitted by the TDU.

      It is hypothesized that overpressures are diminished after biofeedback.
    


Intervention name(s): recordings with device equipped; Control
Intervention type(s): Device; Device
Intervention description(s): Recording without device equipped
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Young healthy subjects
Homeless Youth Study - Stepping Stone Project
Condition: Mental Health
Study type: Interventional

Summary: 
      Homelessness is associated with a multitude of negative consequences including an increased
      risk for mental health problems. Once homeless, these individuals face significant barriers
      to mental health care and are therefore less likely to receive the treatment they need.
      Mobile technology may offer a novel platform for increasing access to mental health care in
      this population. Thus, the primary goals of this pilot study are to (1) establish the
      feasibility and acceptability of delivering a brief cognitive-behavioral intervention to
      homeless youth via smartphone technology, (2) examine the extent to which brief
      cognitive-behavioral interventions delivered via mobile technology improve mental health and
      trauma-related psychological symptoms in homeless youth, and (3) establish smartphone usage
      patterns among homeless youth to inform future interventions.
    


Intervention name(s): Coaching sessions; Mobile applications
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants receive three 30-minute phone sessions with a doctorate-level therapist over the course of one month. These sessions are skills-based and focus on improving participants' problem solving through cognitive-behavioral techniques. Participants are allowed to text the therapist between sessions for information and support.; Participants will have access to 3 mobile apps for the duration of the study, and after it ends. One app will push participants a daily, self-reflective survey to complete, and a daily motivational or instructional tip to rate. Other apps will provide education and exercises on various aspects of mental health and wellness, such as sleep and relaxation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The purpose of this study is to test a new computerized training program as well as to find
      out whether the computer training might help people who have schizophrenia. The investigators
      will study the effects of the computer training on how people with schizophrenia think about
      social interaction and on their social skills. At completion of training, TARA subjects will
      show improvement on measures of social cognition compared to their baseline performance.
    

Detailed description: 
      This study employs two computerized programs: TARA (the treatment program), and a set of
      ordinary computer games (the active control program). Participants will be asked to use their
      assigned program (treatment or active control) for one hour per session, for four-five
      sessions per week, over 8-10 weeks (40 total sessions). Several elements of flexibility are
      allowed in the schedule to accommodate the challenges that people with ASD can face.
    

Intervention name(s): TARA computer-based exercises
Intervention type(s): Behavioral
Other intervention name(s): Targeted Affective Remediation Approach; TARA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: social cognition; cognitive deficits; prodromal schizophrenia; recent-onset schizophrenia; remediation; computer training; cognitive training exercises
Fatty Acid Oxidation Disorders & Body Weight Regulation Grant
Condition: Trifunctional Protein Deficiency
MeSH terms: Protein Deficiency; Body Weight
Study type: Observational

Summary: 
      Several hormones involved in body weight regulation increase the subject's ability to burn
      fat for energy. The purpose of this study is to investigate how burning fat for energy may
      affect those hormones and body weight in children. The study will also determine if eating a
      diet higher in protein alters the amount of fat you burn and how these hormones control body
      weight.
    

Detailed description: 
      A role for mitochondrial fatty acid oxidation in the peripheral signaling cascade of leptin,
      adiponectin and insulin has recently been proposed from animal studies but has not been
      investigated in humans. Children with trifunctional protein (TFP, including deficiency of
      long-chain hydroxyacyl-CoA dehydrogenase) and very long-chain acyl-CoA dehydrogenase (VLCAD)
      deficiency, inherited disorders of long-chain fatty acid ß-oxidation, lack an ability to
      oxidize fatty acids for energy. They have increased levels of body fat and circulating leptin
      and a high incidence of obesity. Current therapy for children with these disorders is based
      on frequent meals and consuming a low fat, very high carbohydrate diet. Despite treatment,
      exercise induced rhabdomyolysis is a common complication of TFP and VLCAD deficiency that
      frequently leads to exercise avoidance. The effects of these genetic defects on body
      composition and weight regulation have not been investigated. The contribution of fatty-acid
      oxidation during moderate intensity exercise in children has also not been reported.

      Two groups of subjects were recruited: one group of subjects had a long-chain fatty acid
      oxidation disorder (n=13). The other group is a group of controls (n=16). We studied
      peripheral signals of body weight regulation, glucose tolerance, body composition, and
      exercise metabolism in subjects with a long-chain fatty acid oxidation disorder compared to
      normal controls.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects were patients with a diagnosis of mitochondrial trifunctional protein, long-chain
        3-hydroxyacylCoA dehydrogenase, very long-chain acylCoA dehydrogenase or carnitine
        palmitoyltransferase 2 deficency. They were recruited through advertisements on the FAO
        support website, or physician referral. Control subjects were from the greater Portland
        area. They were recruited via adverstisements at OHSU.
      
Biospecimen description: 
      Blood and urine samples. Body composition and energy expenditure data. MRI/MRS images.
    
Keywords: trifunctional; protein; deficiency; TFP; weight; regulation