bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Controlled Study of Comparing Follitrope Versus Gonal-f in Chinese Infertility Women.
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is for evaluating safety and efficacy of Recombinant human follicle-stimulating
      hormone (Follitrope) injection compared with Gonal-F® Pen undergoing controlled ovarian hyper
      stimulation in vitro fertilization - embryo transfer (IVF-ET) in China
    

Detailed description: 
      This is a Phase 3, multicenter, blinded, randomized, controlled, parallel, comparative study
      for the evaluation of safety and efficacy of Recombinant human follicle-stimulating hormone
      injection (Follitrope) compared with Gonal-F® Pen undergoing controlled ovarian hyper
      stimulation in vitro fertilization - embryo transfer (IVF-ET) in China.
    

Intervention name(s): Follitrope PFS; Gonal-f pen
Intervention type(s): Biological; Biological
Intervention description(s): Follitrope PFS; Gonal-f pen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IVF, rhFSH
Impact of Yoga As Complementary Therapy in Patients Undergoing Radical Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The researchers hope to learn if yoga complementary therapy would improve health-related
      quality of life, recovery of urinary continence and erectile function in patients who
      underwent prostate cancer surgery (i.e. radical prostatectomy). We hypothesized that in
      patients undergoing radical prostatectomy, preoperative and postoperative Yoga complementary
      therapy would improve health- related quality of life (HRQOL), recovery of urinary continence
      and erectile function.

      This two-arm, randomized controlled pilot study will compare Yoga intervention to usual care
      group. The aim is to evaluate the efficacy of Yoga complementary therapy on HRQOL in patients
      who underwent radical prostatectomy (RP). Yoga therapy will be given to the intervention
      group three times in a week for 6 weeks prior to surgery and then initiated 3 weeks after the
      surgery for another 6 weeks. The yoga exercise will be tailored to the participant's comfort
      level. As an exploratory analysis, we will evaluate pro-inflammatory and immunological
      markers.
    


Intervention name(s): Yoga therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Prostatectomy; Yoga therapy; Health related quality of life
Transitioning From Cyclosporine to Alefacept in Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to devise a safe and effective method for transitioning patients
      from cyclosporine to alefacept.
    

Detailed description: 
      The purpose of this study is to devise a safe and effective method for transitioning patients
      from cyclosporine to alefacept. Patients in the study are well controlled on cyclosporine and
      desire to switch to alefacept. The study is done in three phases. In Phase 1 (12 week
      duration) the two drugs will be overlapped, with cyclosporine slowly tapering. Both drugs
      will be discontinued after 12 weeks. In Phase 2 (12 weeks duration), patients are off both
      drugs. In Phase 3 (24 weeks long), patients are on a second course of alefacept alone for 12
      weeks and then off for 12 weeks. Topical and UV light treatments are allowed throughout the
      study. Total length of study is one year.
    

Intervention name(s): Transitioning patients from cyclosporine to alefacept
Intervention type(s): Drug
Intervention MeSH terms: Cyclosporine; Alefacept; Cyclosporins
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: psoriasis; cyclosporine; transition; alefacept
Behavioral Economics Incentives for Health Management
Condition: Type 2 Diabetes; Obesity
Study type: Interventional

Summary: 
      Incentives are increasingly being used to motivate health behavior in medical studies. Small
      cash payments conditional on certain health and welfare promoting behaviors have shown
      efficacy in both real world and experimental settings. Furthermore, in incentive studies,
      behavioral economics has been shown to amplify behavior change beyond what is possible with
      simple cash payments, but little is known about how varying incentive payment design may
      impact health behavior. The goal of the present study is to evaluate a new incentive payment
      instrument, lottery insurance, to determine its impact on adherence to the target health
      behavior, attendance at free exercise classes provided by QueensCare Family Clinics, a
      safety-net medical clinic.
    


Intervention name(s): Lottery Insurance; Standard Lottery
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: behavioral economics; incentives; health behavior; exercise
A Relative Bioavailability Study of 60 mg Nifedipine Extended Release Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the relative bioavailability of Nifedipine ER tablets
      60 mg by Abrica Pharmaceuticals LLLP with that of ADALAT® CC Extended Release Tablets 60 mg
      by Bayer Pharmaceuticals Corporation, Bayer HealthCare following a single oral dose (1 x 60
      mg tablet) in healthy adult volunteers under fasting conditions.
    

Detailed description: 
      Study Type: Interventional Study Design: Randomized, single dose, two-way crossover study
      under fasting conditions

      Official Title: A Relative Bioavailability Study of 60 mg Nifedipine Extended Release tablets
      Under Fasting Conditions

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Nifedipine Extended Release tablets 60 mg, single dose; ADALAT® CC Extended Release Tablets 60 mg
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received Abrica Pharmaceuticals LLLP formulated products under fasting conditions; B: Active comparator Subjects received Bayer Pharmaceuticals Corporation, Bayer HealthCare formulated products under fasting conditions
Other intervention name(s): Nifedipine; Nifedipine
Intervention MeSH terms: Nifedipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Nifedipine; Healthy subjects
18F-FDG PET Imaging Analysis of Antiepileptic Drug Response in BECTS
Condition: Benign Epilepsy With Centrotemporal Spikes
MeSH terms: Epilepsy; Epilepsy, Rolandic
Study type: Observational

Summary: 
      This original article is a novel investigation on the metabolic characteristics of different
      patterns of antiepileptic drug (AED) responses in benign epilepsy with centrotemporal spikes
      (BECTS) patients using 18F-FDG PET imaging. In this study, we demonstrated
      remitting-relapsing group showed more widespread hypo-metabolism regions than AED responders.
      Results indicated that metabolic differences had the ability to distinguish the
      remitting-relapsing patients from AED responders. 18F-FDG PET could be used as a marker to
      infer the current seizure activity of BECTS. We think that the established hybrid model based
      on PET and clinical features may be a critical reference for better personalized medication
      in patients with BECTS.
    

Detailed description: 
      Purpose The current drug treatment of benign epilepsy with centrotemporal spikes (BECTS)
      mainly depends on the clinical experience of physicians. This study aimed to investigate
      different patterns of antiepileptic drug (AED) responses in patients with BECTS using
      18F-fluorodeoxyglucose positron emission tomography (18F-FDG PET) imaging for better
      personalized medication.

      Methods A total of 55 patients with BECTS (36 AED responders, 19 remitting-relapsing
      patients) and 23 pseudo-controls who underwent 18F-FDG PET imaging were retrospectively
      included. The group comparison was performed to investigate metabolic differences among AED
      responders, remitting-relapsing patients and pseudo-controls. Three different logistic
      regression models were employed to distinguish remitting-relapsing patients from AED
      responders based on clinical features, 18F-FDG PET images and a hybrid of both. Ten AED
      responders who reduced AED dose and one remitting-relapsing patient who relapsed within one
      month after PET examination were included in the model evaluation.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients with benign epilepsy with centrotemporal spikes
      
Keywords: Benign Epilepsy with Centrotemporal Spikes; glucose metabolism; positron emission tomography; machine learning
Awareness About Breast Cancer Screening
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Breast cancer is the most common cancer in French women, with 52000 new cases each year.

      Shift work and night work is recognized by International Agency for Research on Cancer as a
      potential risk factor. Epidemiological studies find, for most of them, an increased risk of
      breast cancer compared with general population. Physiological hypothesis rely on the
      melatonin role in defense against tumorigenesis.

      According to High Authority of Health clinical good practice guidelines, the risk does not
      justify more screening than the organized screening. We do not have information about
      awareness level of workers in health structures, specially in the Hospices Civils de Lyon.

      Investigators would like to know how employees take part to breast cancer screening,
      specially in night workers.

      This study, as a survey, is a first step to evaluate the need for specific actions to
      increase the participation to breast cancer screening.
    


Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): Questionnaire on the level of awareness of this risk among health sector employees, and more specifically the Lyon Civilian Hospices, and on participation in breast cancer screening for HCL employees, particularly among night shift staff.
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women employees of Hospices Civils de Lyon
Bupivacaine Verus Pethidine for Post Cesarean Section Pain Relief
Condition: Obstetric Pain
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to compare between the effect of wound infiltration with bupivacaine
      or pethidine for post cesarean section pain relief.
    


Intervention name(s): Wound infiltration by Bupivacaine; Wound infiltration by Pethidine
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous and subrectal infiltration with 0.25 % Bupivacaine diluted in 20 ml normal saline before closure of the wound; Subcutaneous and subrectal infiltration with 50 mg pethidine diluted in 20 ml normal saline before closure of the wound
Intervention MeSH terms: Meperidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to local infiltration of cesarean section wound with either bupivacaine or pethidine; with follow up of postoperative pain relief.
Masking: None (Open Label)
Primary purpose: Treatment
Fatigue in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Fatigue
Study type: Observational

Summary: 
      Rheumatoid arthritis (RA) is a disease characterized by autoimmune systemic inflammatory
      polyarthritis, particularly affecting the joints of the hands. In addition to joint findings,
      extra-articular symptoms such as muscle pain, fatigue, fever and malaise are also common.

      Fatigue is characterized by a feeling of extreme tiredness and persistent exhaustion. The
      prevalence of fatigue is between 14% and 15% in healthy adults. Although fatigue is common in
      patients with RA, it may remain in the background in clinical evaluation. The etiology of
      fatigue in RA is related to inflammation, pain, psychosocial factors and sleep disturbance,
      it has not been fully explained.
    

Detailed description: 
      Rheumatoid arthritis (RA) is a disease characterized by autoimmune systemic inflammatory
      polyarthritis, particularly affecting the joints of the hands. In addition to joint findings,
      extra-articular symptoms such as muscle pain, fatigue, fever and malaise are also common.

      Fatigue is characterized by a feeling of extreme tiredness and persistent exhaustion. The
      prevalence of fatigue is between 14% and 15% in healthy adults. Although fatigue is common in
      patients with RA, it may remain in the background in clinical evaluation. The etiology of
      fatigue in RA is related to inflammation, pain, psychosocial factors and sleep disturbance,
      it has not been fully explained.

      There are various studies in the literature examining fatigue and factors associated with
      fatigue in patients with RA. This study aimed to contribute to the literature by determining
      the relationship of fatigue with physical function, pain values at rest and in motion,
      gender, age, pain, disease activity, gender and disease duration in RA patients.
    

Intervention name(s): Determining the relationship of fatigue with some parameters
Intervention type(s): Other
Intervention description(s): Determining the relationship of fatigue with physical function, pain values at rest and in motion, gender, age, pain, disease activity, gender and disease duration in RA patients.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients (38 males, 103 females) over 16 years of age who were diagnosed with RA according
        to the 2002 ACR-EULAR RA criteria.
      
Keywords: fatigue; disease activity; rheumatoid arthritis
A Study to Look at How Insulin NNC0471-0119 Works in the Body in People With Type 1 Diabetes When Injected by Insulin Pump
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is looking at the effect and safety of 3 formulations of the new rapid-acting
      insulin analogue NNC0471-0119, for the treatment of type 1 diabetes when given by insulin
      pump.

      The study will test how 3 different formulations of insulin NNC0471-0119 are tolerated by the
      body, how they are transported in participants bloodstream, how long they stay there and how
      the blood sugar is lowered.

      The 3 formulations of insulin NNC0471-0119 are given as one bolus on top of a constant
      insulin basal rate and compared to Faster Aspart (Fiasp®).

      Participants will get 3 formulations of insulin NNC0471-0119 and Faster Aspart (Fiasp®)
      Insulin NNC0471-0119 is a new rapid-acting insulin designed to be used in an insulin pump.
      Faster Aspart (Fiasp®) is a globally used medication for the treatment of diabetes.

      Participants will have each study medicine administered once via pump at separate study
      visits. This mean that participants will have a total of 4 dosing visits where participants
      will get a study medicine. Which study medicine participants get at what visit will be
      decided by chance.

      The study will last 1-4 months. Participants will have 7 visits at the clinic, 4 of them will
      require an in-house stay of 3 consecutive days each.

      During the in-house visits 2 intravenous (into the vein) cannulas will be inserted for blood
      sampling and infusions.

      Women: Women cannot take part if they are of childbearing potential.
    


Intervention name(s): NNC0471-0119 A; NNC0471-0119 B; NNC0471-0119 D; Faster aspart
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): NNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate.
The study will last 1-4 months; NNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate.
The study will last 1-4 months; NNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate.
The study will last 1-4 months; Faster aspart administered once via an insulin pump as one bolus dose on top of a continuous basal rate.
The study will last 1-4 months
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Non-randomized Safety Study With Bortezomib/Rituximab in Relapsed/Refractory Indolent Lymphoma
Condition: Lymphoma; Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      The promising activity of Bortezomib as single agent in low grade lymphoma patients in small
      studies has led to a number of larger multicenter trials with Bortezomib in combination with
      Rituximab in mantle-cell lymphoma, follicular lymphoma and marginal zone lymphoma.
    

Detailed description: 
      This is a open label, non randomized, phase II , multicenter, prospective trial to evaluate
      the efficacy and safety of the combination of bortezomib and rituximab in patients with
      relapsed or refractory rituximab naïve or sensitive indolent non-follicular and mantle cell
      non-Hodgkin's lymphoma. Despite of the availability of treatment for this disease, this study
      is justified because no known therapies are really curative and it is necessary to look for
      new treatment options to improve the clinical outcome and prognosis of relapsed indolent
      lymphoma. This study is designed for patients not eligible for high-dose chemotherapy and
      autologous stem cells transplantation.
    

Intervention name(s): Rituximab; VELCADE
Intervention type(s): Drug; Drug
Intervention description(s): Rituximab 375 mg/m2 as slow iv infusion day 1-8-15-22.Patients will be treated with six courses of therapy with a thirteen day rest period between them. Courses will be restarted at day 36.; VELCADE 1,6 mg/m2 iv bolus days 1-8-15-22 (Velcade will be administrated prior of Rituximab infusion).Patients will be treated with six courses of therapy with a thirteen day rest period between them. Courses will be restarted at day 36.
Intervention MeSH terms: Rituximab; Bortezomib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapsed/refractory indolent lymphoma; Non-follicular Lymphoma; Mantle cell non-Hodgkin Lymphoma; Patients naïve or sensitive to rituximab; Patients not eligible for high dose chemotherapy with ASCT
Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the absolute (versus placebo) and relative (one
      vaccine compared to the other) efficacies of the live attenuated and inactivated influenza
      vaccines in preventing laboratory confirmed symptomatic influenza caused by circulating
      strains whether similar or dissimilar to strains included in the vaccines.
    


Intervention name(s): Fluzone; Flumist; Physiologic saline
Intervention type(s): Biological; Biological; Other
Intervention description(s): single dose licensed trivalent inactivated influenza vaccine (2007-08); single dose licensed live-attenuated influenza vaccine Flumist (2007-08); single dose placebo administered as an intranasal spray or intramuscular injection
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Live attenuated influenza vaccine; Inactivated influenza vaccine; Vaccine Efficacy
Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
Condition: Growth Hormone Deficiency (GHD)
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      A six month study of ACP-001, a long-acting growth hormone product, versus standard human
      growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone
      (hGH) will be given on a daily basis. The primary aim is to demonstrate safety,
      pharmacokinetics and pharmacodynamics over a period of six months. A secondary objective is
      the comparison of height velocity (HV) of the ACP-001 treated groups to the daily hGH
      treatment group.
    


Intervention name(s): ACP-001; Human Growth Hormone
Intervention type(s): Drug; Drug
Intervention description(s): Once weekly subcutaneous injection; Once daily subcutaneous injection of human Growth Hormone
Other intervention name(s): Somatropin
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human Growth Hormone; rhGH; hGH; GHD
Brain and Mindfulness
Condition: Healthy
Study type: Interventional

Summary: 
      The main aim of this project is to explore the neuro-anatomical and -physiological correlates
      of meditation on attention and emotion-regulation. By investigating this, our scientific goal
      is to more generally identify the mechanisms and biomarkers of health and mental well-being.
      Therefore, the investigators use non-invasive imaging like Magneto-EncephaloGraphy (MEG),
      ElectroEncephaloGraphy (EEG), functional and anatomic Magnetic Resonance Imaging (MRI;
      including Diffusion tensor - DTI). These brain measures will then be linked to behavioral
      measurements. Experimental methods (i.e., simple computer tasks) will be used to measure
      attention, conscious perception and regulation of pain and emotion.
    


Intervention name(s): Magneto-encephalography (MEG); Electro-encephalography (EEG); Functional Magnetic Resonance Imaging (fMRI); Anatomical Magnetic Resonance Imaging (aMRI); Meditation
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Magneto-encephalography; Electro-encephalography; Functional Magnetic Resonance Imaging; Anatomical Magnetic Resonance Imaging; Meditation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science