bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Trial of Liquid Versus Freeze-Dried Pergoveris® in Pituitary Suppressed Healthy Premenopausal Female Subjects
Condition: Healthy
MeSH terms: Pituitary Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Some women cannot have children because they cannot produce enough follicle stimulating
      hormone (FSH) and luteinising hormone (LH). When this happens the ovaries fail to produce an
      egg during the menstrual cycle - a condition known as anovulation. Anovulation can be treated
      by giving replacement FSH and LH. Pergoveris is a medication that contains both FSH and LH.
      It is used for the treatment of anovulation in women who do not produce enough FSH and LH.

      A new, liquid formulation of Pergoveris is being tested in this study. It will be compared
      with the current freeze-dried marketed formulation to see if the new formulation gets into
      the blood stream as easily as the current formulation.

      This study will involve 38 healthy female subjects and 2 treatment periods and will last for
      approximately 77 days. Each subject will receive a single dose of the new liquid formulation
      and a single dose of the current marketed formulation separated by an interval of two weeks
      in a randomised (by chance) order. Blood samples will be taken at regular intervals over 2
      weeks after each dose to measure levels of FSH and LH.

      To participate female subjects must have normal ovaries on internal ultrasound scan, a normal
      result from a cervical smear test, be taking the combined oral contraceptive (OC) pill.

      Eligible subjects will have their usual OC pill replaced with another called Marvelon
      throughout the study. After 14 days subjects will have their levels of FSH and LH checked and
      if sufficiently reduced will only then proceed to dosing.

      Subjects will then receive one of the formulations. An ultrasound scan of the ovaries will be
      performed 7 days later, and another one 7 days later just before the next dose. Subjects
      whose ovaries show signs of stimulation will not be given the second dose. The ultrasound
      scan will be repeated 7 days after the second dose.
    


Intervention name(s): Liquid pergoveris; Freeze-dried pergoveris
Intervention type(s): Drug; Drug
Intervention description(s): All subjects will be administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.; All subjects will be administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Pergoveris; Bioequivalence; Infertility
Effects of Bitter Melon on Cardiometabolic Health
Condition: PreDiabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The objectives of this study are to assess the effects of a bitter melon product at two
      doses, compared to control, on indicators of cardiometabolic health among men and women with
      prediabetes.
    


Intervention name(s): Low-dose bitter melon; High-dose bitter melon; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Subject will receive 1 Insumate bitter melon capsule/d (300 mg) and 1 placebo capsule/d (300 mg); Subject will receive 2 Insumate bitter melon capsules/d (300 mg each); Subject will receive 2 placebo capsules/d (300 mg each)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Trial Estimating the Efficiency of the Light Therapy in Brain Trauma Sequel Fatigue
Condition: Diffuse Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Diffuse; Fatigue
Study type: Interventional

Summary: 
      After a brain injury (BI) , patients complain in particular about sequel fatigue. This
      symptom affects about 50 % of the patients; it is severe, with a repercussion on quality of
      life, reeducation and occupational reintegration, and persists often at a distance of the
      accident. The investigators' hypothesis is that patients who presented a severe BI could
      benefit from a treatment by withe blue enriched bright light in order to improve fatigue and
      quality of life.
    

Detailed description: 
      After a BI , patients complain in particular about sequel fatigue. This symptom affects about
      50 % of the patients; it is severe, with a repercussion on quality of life, reeducation and
      occupational reintegration, and persists often at a distance of the accident. The
      investigators' hypothesis is that patients who presented a severe BI could benefit from a
      treatment by blue enriched withe bright light in order to improve fatigue and quality of
      life.

      The main objective is to decrease fatigue and the secondary objectives are to improve quality
      of life,decrease daytime sleepiness and increase vigilance.

      This is a randomized clinical trial with 2 groups blue enriched withe bright light versus
      nothing) including 20 patients.The treatment will take 8 weeks with 30 minutes exposition at
      awakening to withe blue enriched bright light (Luminette, Belgium). The investigators willl
      estimate the fatigue severity scale score , the quality of life the score (SF12), the
      sleepiness Epworth score, and the Psychomotor Vigilance Task (PVT) The investigators will
      included patient with severe BI more than six months after the BI.
    

Intervention name(s): placebo; "Luminette",Lucimed Belgium
Intervention type(s): Other; Device
Intervention description(s): THIS GROUP WILL RECEIVE NO BRIGHT LIGHT; THIS GROUP WILL RECEIVE BLEU LIGHT ENRICHIDED IN WITHE BRIGHT LIGHT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: brain injury; blue enriched withe bright light therapy; sequel fatigue
Low-dose Rituximab and High-dose Dexamethasone as First Line Treatment for ITP
Condition: Immune Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the response rate and response duration with the
      combination of low-dose rituximab and high-dose dexamethasone in the treatment of adult
      immune thrombocytopenic purpura.
    

Detailed description: 
      ITP is an autoimmune disorder characterized by formation of autoantibodies against platelet
      antigens leading platelet destruction and bleeding. Corticosteroids increase the platelet
      count in about 80 percent of patients.However, many patients have a relapse when the dose of
      corticosteroid is reduced. Debilitating side effects are common in patients who require
      long-term corticosteroid therapy to maintain the platelet count. Rituximab, a chimeric
      anti-CD20 monoclonal antibody, has been shown to be effectively raise the platelet count in
      some patients with ITP and there is clinical and biological evidence to suggest that, if
      given early, rituximab may prevent ITP relapses. Rituximab 375 mg/m2 weekly for four weeks
      has significant activity in patients with immune thrombocytopenia. Furthermore, using lower
      dose rituximab the level of B-cell depletion and the response rates appear similar to those
      previously observed with standard dosages in a population of ITP.

      The purpose of this study is to determine the response rate and response duration with the
      combination of low-dose rituximab (100mg IV days 1,8, 15 and 22) and high-dose dexamethasone
      (40mg PO days 1,2,3,4) in untreated adult patients immune thrombocytopenic purpura.

      A complete platelet response is defined as an increase in platelet counts to >150×109/L on
      two consecutive occasions. A partial response is defined as an increase in the platelet count
      to between 50 and 150×109/L on two consecutive occasions, 1 week apart. Duration of response
      is considered from the day of the initial infusion to the first time of relapse (platelet
      count <30×109/L)or to time of analysis.
    

Intervention name(s): Rituximab and dexamethasone
Intervention type(s): Drug
Intervention description(s): Rituximab 100mg IV days 1,8,15,22.
Dexamethasone 40mg PO days 1-4 (four days)
Other intervention name(s): Mabthera
Intervention MeSH terms: Dexamethasone; Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rituximab; Dexamethasone; Low-dose; ITP
A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and tolerability of single IV doses of PF-04383119 in Japanese
      patients with moderate to severe pain from OA of the knee (Part I). To evaluate the
      preliminary analgesic efficacy of PF-04383119 in Japanese patients with moderate to severe
      pain from OA of the knee in comparison with placebo (Part I and Part II).
    


Intervention name(s): PF-04383119 (tanezumab); PF-04383119 (tanezumab); PF-04383119 (tanezumab); PF-04383119 (tanezumab); PF-04383119 (tanezumab); PF-04383119 (tanezumab)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single dose of 10 mcg/kg IV; single dose of 100 mcg/kg IV; single dose of 200 mcg/kg IV; single dose of 25 mcg/kg IV; single dose of 50 mcg/kg IV; single dose of Placebo IV
Intervention MeSH terms: Tanezumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: monoclonal antibody
Correlation Between the Amplitude of Ankle Dorsiflexion and Occurrence of Patellofemoral Pain Syndrome
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      The aim of this study was to verify the clinical reliability of ankle dorsiflexion range of
      motion (ADROM) measurement with weight bearing (WB) using an app on the smartphone (iHand)
      and to verify if there is correlation between the limitation of the ADROM and the PFP.
    

Detailed description: 
      The change in lower extremity movement pattern has been previously associated with severe
      knee disorders, including anterior cruciate ligament rupture, patellar tendinopathy,
      iliotibial band syndrome, and patellofemoral pain (PFP). The aim of this study was to verify
      the clinical reliability of ankle dorsiflexion range of motion (ADROM) measurement with
      weight bearing (WB) using an app on the smartphone (iHand) and to verify if there is
      correlation between the limitation of the ADROM and the PFP.
    

Intervention name(s): Ankle dorsiflexion measurement
Intervention type(s): Diagnostic Test
Intervention description(s): It was used the test with WB, called Lunge Test, in which each evaluator marked a point 15 cm distal to the anterior tuberosity of the tibia (TAT) with a felt tip pen. After that the smartphone (app iHand) will be placed at this point. Between each measurement, the mark was removed with alcohol 70% The demarcated point served as a guide for positioning the smartphone. In order to standardize the smartphone positioning, BHome (home button on the iPhone), was aligned with the TAT pen mark. To ensure the same distance from the foot to the test, the distance of the hallux to the wall was measured (tape measure), recorded and reused for each test.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: confiability; ankle; patellofemoral pain syndrome
CHF6467 SAD and MAD in Patients With Diabetic Foot Ulcer
Condition: Diabetic Neuropathic Foot Ulcers
MeSH terms: Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To assess the safety and tolerability of single and multiple days' topical dosing with
      CHF6467 in subjects with diabetic foot ulcer (DFU).
    

Detailed description: 
      This first in human study is designed to investigate the tolerability, safety,
      pharmacokinetics and preliminarily pharmacodynamics following topical administration of
      single and multiple ascending doses of CHF6467 in subjects diagnosed with diabetic foot ulcer
      (DFU).
    

Intervention name(s): CHF6467 active
Intervention type(s): Biological
Intervention description(s): CHF6467, is mutated form of the human Nerve Growth Factor (NGF).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: SAD - Single Ascending Dose & MAD - Multiple Ascending Dose
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: DFU; Diabetic Foot Ulcers; Diabetic Neuropathic Foot Ulcers
PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response
Condition: Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
MeSH terms: Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation
      clinical trial of docetaxel and cisplatin combination chemotherapy with and without
      panitumumab in the first-line treatment of subjects with metastatic or recurrent head and
      neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail
      the chemotherapy only arm. This study will be conducted in the United States. Approximately
      150 subjects with histologically or cytologically confirmed metastatic and/or recurrent
      SCCHN.
    


Intervention name(s): Cisplatin; Panitumumab; Docetaxel; Cisplatin; Docetaxel
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): chemotherapy arm; experimental arm; chemotherapy arm; experimental arm; experimental arm
Intervention MeSH terms: Cisplatin; Docetaxel; Panitumumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SCCHNC; Metastatic; Recurrent
Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses
Condition: Myopia; Refractive Error
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      The purpose of this study is to compare the subjective performance of two daily disposable
      contact lenses with respect to comfort and handling.
    


Intervention name(s): Ultrafilcon B contact lens; Stenfilcon A contact lens
Intervention type(s): Device; Device
Intervention description(s): Silicone hydrogel contact lens CE-marked for daily disposable wear. Private-label versions may be used.; Silicone hydrogel contact lens CE-marked for daily disposable wear. Private-label versions may be used.
Other intervention name(s): Procornea BYO™ Air Daily; MyDay™ Daily Disposable
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: contact lenses; daily disposable contact lenses; silicone hydrogel; contact lens comfort; near-sighted
Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis
Condition: Osteoporosis; Cystic Fibrosis
MeSH terms: Osteoporosis; Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      OBJECTIVES: I. Determine the bioavailability and biologic effect of alendronate on bone
      metabolism in patients with cystic fibrosis.

      II. Assess the safety and efficacy of this treatment regimen in improving osteoporosis in
      this patient population.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind study. Patients will be stratified
      according to sex (male vs female) and osteoporosis disease severity (mild vs severe).
      Patients are randomized to one of two treatment arms.

      Patients undergo bioavailability assessment to confirm the ability to absorb alendronate.

      Arm I: Patients receive calcium and vitamin D supplements with a placebo daily for one month.

      Arm II: Patients receive calcium and vitamin D supplements with oral alendronate daily for
      one month.

      Treatment continues if differences are seen in bone mineral density between the treatment
      arms.

      Patients are followed for biochemical response at week 6, 12, and 52. Bone mineral density is
      measured at 1 year and 2 years.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): alendronate sodium; calcium carbonate; cholecalciferol
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Cholecalciferol; Vitamin D; Alendronate; Calcium Carbonate; Calcium
Primary purpose: Treatment
Keywords: cardiovascular and respiratory diseases; cystic fibrosis; disease-related problem/condition; genetic diseases and dysmorphic syndromes; osteoporosis; rare disease
Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will compare and evaluate the effects of long-term treatment of monotherapy with
      rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of
      glycemic control in patients with recently diagnosed type 2 diabetes mellitus.
    


Intervention name(s): Rosiglitazone; glyburide; metformin
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): glyburide; Rosiglitazone
Intervention MeSH terms: Metformin; Rosiglitazone; Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: type 2 diabetes monotherapy treatment naive
Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a six week, double blind,placebo controlled study for patients with schizophrenia or
      schizoaffective disorder treated with an atypical antipsychotic for at least two months.
      Subjects will be randomized to take armodafinil (Nuvigil) or placebo along with their current
      antipsychotic and tested at baseline and week 6 for differences in memory, attention and
      problem-solving ability. Changes in weight during the six week study will also be tracked.
    


Intervention name(s): armodafinil (Nuvigil); placebo
Intervention type(s): Drug; Drug
Intervention description(s): armodafinil (Nuvigil)150 mg qd; identical in appearance to active comparator
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; cognition
Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized placebo controlled study to test whether a single 14 course of treatment
      with the anti-CD3 monoclonal antibody, hOKT3gamma1(Ala-Ala),Teplizumab will prevent the loss
      of insulin secretory capacity in individuals with Type 1 diabetes of 4 - 12 months duration
      since diagnosis.
    

Detailed description: 
      The study design is a double blind placebo controlled trial that will enroll subjects between
      the ages of 8 - 30 who have had the diagnosis of Type 1 diabetes made 4 - 12 months prior to
      enrollment. A single 14 course of treatment with mAb hOKT3gamma1(Ala-Ala), Teplizumab will be
      given. The primary endpoint is the C-peptide response to a mixed meal at 12 months. A total
      of 60 subjects will be enrolled (30 in the drug treatment and 30 in the placebo groups) at 4
      study sites: Yale University,the University of California at San Francisco, Children's
      Hospital of Philadelphia, and the Barbara Davis Diabetes Center.
    

Intervention name(s): mAb hOKT3gamma1(Ala-Ala), Teplizumab; Placebo Arm
Intervention type(s): Drug; Drug
Intervention description(s): This is a randomized, two-arm, double blind placebo controlled phase II trial in which 60 participants with recent-onset T1DM are randomized at a 1:1 ratio to receive Teplizumab or placebo over a 14 day treatment period. The course of Teplizumab comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2.
Other intervention name(s): mAb hOKT3gamma1(Ala-Ala), MGA031, Teplizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: immune therapy; autoimmunity; insulin secretion; diabetes mellitus
Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to measure the hair growth response to topical NEOSH101 when
      applied twice daily to the balding scalp for 16 weeks. One hundred eighty men with
      Norwood/Hamilton grades III-IV with thinning in the top and center of the scalp will
      participate. Three equally sized treatment groups (60 men each) will receive either topical
      NEOSH101 2.0%, minoxidil 5%, or placebo.
    


Intervention name(s): tetrapeptide aldehyde proteasome inhibitor (NEOSH101)
Intervention type(s): Drug
Intervention description(s): Study preparation (experimental, active comparator, placebo comparator) will be applied twice daily to the scalp for 112 days
Intervention MeSH terms: Proteasome Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: androgenetic alopecia; male pattern hair loss; male pattern baldness; androgenetic alopecia or male pattern hair loss