bioihbjkbjnl/mcl2 huggingface dataset:
The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity
Condition: Obesity; Sarcopenic Obesity; Sarcopenia; Aging; Sedentary Lifestyle
MeSH terms: Sarcopenia; Obesity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Obesity is highly prevalent in older adults and is a major cause of sarcopenia and disability
      in older adults. Although exercise can counteract the effects of obesity and sarcopenia, many
      have difficulty adhering to an exercise program and the benefits of exercise are variable.
      Therefore, there is an urgent need to test novel pharmacologic interventions to prevent
      disability and loss of independence. Oxytocin is a pituitary hormone released during
      parturition and lactation that is also known to suppress appetite in rodents and humans; and,
      recent small studies have found that intranasal oxytocin reduces body weight in adults. We
      propose a pilot study of intranasal oxytocin as a novel approach to promote weight loss and
      increase muscle mass in older subjects with sarcopenic obesity.
    

Detailed description: 
      The pilot study will be conducted at 3 sites in 9 visits over a period of 12+ weeks. Older
      sedentary subjects will be screened for sarcopenic obesity using a modified consensus
      definition and evaluated at baseline for safety labs, glucose tolerance, body composition,
      cognition and physical performance, as well as systemic inflammatory markers in blood and
      muscle tissue.

      Eligible subjects self-administer 24 IU intranasal oxytocin four times a day for 8 weeks.

      The study will examine whether the intervention will promote weight loss and preserve muscle
      mass, thereby preserving and/or improving physical function in older subjects with sarcopenic
      obesity.

      Generalized linear mixed effects model will be used to evaluate the effect of oxytocin on the
      change of each continuous measure. The effect of oxytocin will be assessed by whether the
      time by oxytocin interaction is significantly different from 0 with a 2-sided p-value<0.05.
    

Intervention name(s): Oxytocin nasal spray; Placebo nasal spray
Intervention type(s): Drug; Drug
Intervention description(s): Self administered Oxytocin nasal spray q.i.d. for 8 weeks versus placebo (normal saline nasal spray); Self administered Placebo nasal spray q.i.d. for 8 weeks (normal saline nasal spray)
Other intervention name(s): Intranasal oxytocin; Syntocinon nasal spray; Saline nasal spray
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Achieving Hybrid Monovision By Paring Monofocal And EDOF Lens Technology
Condition: Cataract Senile
MeSH terms: Cataract
Study type: Observational

Summary: 
      Modern day cataract surgery isn't just a rehabilitative procedure anymore but rather aims at
      improving a patient's quality of life by reducing the need for spectacles in everyday life to
      a minimum. One way of achieving this goal is by using different lens technologies, such as a
      monofocal lens paired a lens with EDOF technology, as EDOF lenses provide an enhanced depth
      of focus by creating a single elongated focal point. As this "mix-and-match" is well
      established, the aim of this study is to compare the monofocal lens cohort to the EDOF lens
      cohort and evaluate visual acuity and patient satisfaction.
    


Intervention name(s): IOL Implantation:EDOF lens; IOL Implantation: Monofocal lens
Intervention type(s): Procedure; Procedure
Intervention description(s): A EDOF lens is implanted in the dominant eye; A monofocal lens is implanted in the non dominant eye.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        male and female patients with senile cataract undergoing surgery
A Study of Efficacy and Safety With the Transdermal Contraceptive System.
Condition: Contraception; Female Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the contraceptive efficacy, safety, cycle control,
      and compliance with the transdermal contraceptive system.
    

Detailed description: 
      This is an open-label, multicenter, global study to evaluate the contraceptive efficacy,
      cycle control, safety, compliance and subject satisfaction of the transdermal contraceptive
      system. Sixteen hundred healthy women will wear the contraceptive patch for either 6 or 13
      cycles. The first 530 subjects will wear the patch for 13 cycles, and all subsequent subjects
      will wear the patch for 6 cycles. At admission Visit 1, study drug (plus 3 reserve patches)
      and diary cards are dispensed for Cycle 1; first patch application will be on the first day
      of menses. Study drug and diary cards are dispensed on day 28 of Cycle 1 (Visit 2) for Cycles
      2 and 3, on day 28 of Cycle 3 (Visit 3) for Cycles 4 to 6, on day 28 of Cycle 6 (Visit 4) for
      Cycles 7 to 9, and on day 28 of Cycle 9 (Visit 5) for Cycles10 to13. At each of these visits,
      diary cards and empty medication packages are collected. Final study visits are on day 28 of
      Cycles 6 and 13. Diary card information is used to record compliance and bleeding information
      (to assess cycle control). Contraceptive efficacy is assessed by means of the Pearl Index and
      life table analysis (gross cumulative probability of pregnancy). Safety evaluations are based
      on adverse events, which are collected throughout the study, and changes in gynecologic
      examinations, vital signs, and laboratory results from admission to final visit. Each
      transdermal contraceptive patch, containing 6 mg NGM and 0.75 mg EE, and delivering 250 ug
      17-dNGM and 25 ug EE over 24 hours for 7 days, is worn for 1 week and replaced for 3
      consecutive weeks. The fourth week is patch-free. The patch can be worn on: upper arm or
      torso, buttock, or abdomen.
    

Intervention name(s): norelgestromin + ethinyl estradiol
Intervention type(s): Drug
Intervention MeSH terms: Ethinyl Estradiol; Norelgestromin; Estradiol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: contraception; transdermal contraception; hormonal, steroidal contraception; ethinyl estradiol; progesterone
Observational Study of NovoPen Echo® on Safety and Treatment Satisfaction in Children and Adolescents With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1; Delivery Systems
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This study is conducted in Asia, Europe and North America. The aim of this observational
      study is to evaluate the safety of NovoPen Echo® by collecting safety information (incidence
      of technical complaints related to adverse reactions). Study duration: 12-18 weeks.
    


Intervention name(s): NovoPen Echo®
Intervention type(s): Device
Intervention description(s): Prescribed insulin treatment delivered by NovoPen Echo®
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Any child or adolescent with type 1 diabetes who has just started using NovoPen Echo® is
        eligible. The selection of the patients will be at discretion of the individual physician.
Study of XELOX With Cetuximab in Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The combination of capecitabine and oxaliplatin as 'backbone' regimen, adding a newer
      biologic agent, cetuximab, is a reasonable strategy of further chemotherapy development in
      advanced gastric cancer, which is the investigators study rationale.
    

Detailed description: 
      There is presently no chemotherapy regimen considered to be the global standard of care for
      patients with AGC, and there is still a need for new agents and/or regimens to improve the
      efficacy and safety of chemotherapy in advanced stomach cancers.

      The combination of 5-fluorouracil plus cisplatin (FP) has been widely used for the first-line
      treatment of advanced gastric cancer in many countries.

      Randomized phase III trial investigating capecitabine plus cisplatin(XP) versus FP showed XP
      is at least as good as FP with improved patients' preference.

      A Phase II study of capecitabine plus oxaliplatin (XELOX) was conducted in our study group.
    

Intervention name(s): Capecitabine, Oxaliplatin, Cetuximab
Intervention type(s): Drug
Intervention description(s): Xelox(Capecitbine, Oxaliplatin) and Cetuximab every three week; Capecitabine 1,000 mg/m2 was administered twice daily on days 1-14. Oxaliplatin 130 mg/m2 i.v. for 2 h was given on day 1 after cetuximab infusion. Cetuximab at an initial loading dose of 400 mg/m2 i.v. for 2 h and, thereafter, maintenance dose of 250 mg/m2 for 1 h every week.
Other intervention name(s): xeloda, oxalitin, Erbitux
Intervention MeSH terms: Capecitabine; Oxaliplatin; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastric cancer; chemotherapy; cetuximab; capecitabine; oxaliplatin
Video Colposcopy in Women With Dysplasia
Condition: Uterine Cervical Dysplasia
MeSH terms: Uterine Cervical Dysplasia; Hyperplasia
Study type: Interventional

Summary: 
      To assess the effect of live video-colposcopy on women´s anxiety.
    


Intervention name(s): Live Video-Colposcopy; No Live Video-Colposcopy
Intervention type(s): Device; Other
Intervention description(s): The colposcopy will be shown in real time on a flat screen; The TV will be shut off during colposcopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: live video-colposcopy; cervical dysplasia; anxiety; randomized controlled trial; colposcopy
A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined rTMS and BCI Training
Condition: Hemiparesis; Stroke
MeSH terms: Stroke; Paresis
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the combination of low frequency repetitive
      transcranial magnetic stimulation (rTMS) and motor-imagery-based brain computer interface
      (BCI) training is effective for enhancing motor recovery after stroke.

      The PI's hypothesis is that, in comparison with traditional physical therapy alone, subjects
      receiving supplementary rTMS and BCI training will show greater functional improvements in
      hand motor ability over time as well as recovery of normal motor connectivity patterns.
    

Detailed description: 
      The goal of the present study is to develop and evaluate a brain based approach to improve
      motor recovery after stroke, by combining rTMS and BCI training. Treatments will consist of
      low frequency rTMS applied to the contralesional hemisphere, followed by BCI training to
      encourage activity within the lesioned hemisphere. The primary objective of this study is to
      test the main hypothesis above in a stroke patient population. Subjects will also undergo a
      period of BCI only treatments after completion of the combined rTMS and BCI portion.
    

Intervention name(s): rTMS; BCI Training
Intervention type(s): Device; Behavioral
Intervention description(s): Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.; BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hemiparesis; Stroke; Rehabilitation; Transcranial Magnetic Stimulation, Repetitive; Electroencephalography; Functional Neuroimaging; Brain-Computer Interface
Caregiver Burden in Stroke: Robot-Assisted Therapy vs Conventional Rehabilitation
Condition: Stroke Rehabilitation and Caregivers
MeSH terms: Stroke; Caregiver Burden
Study type: Observational

Summary: 
      Caregiver's burden in rehabilitation is important for both patients physical and mental
      health. Therefore researching caregivers burden and treatment of any depression or associated
      any psychological disorders of caregiver is crucial.
    


Intervention name(s): Caregiver's Burden Inventory
Intervention type(s): Other
Intervention description(s): The Caregiver Burden Inventory was developed by Canadian researchers.The authors of the instrument stress the importance of using a multidimensional measurement of burden with separate scores for each dimension in as opposed to global or uni-dimensional scores.
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        18-65 years old stroke patients who are not ambulatuar and dependent to their caregivers.
      
Keywords: Caregivers; Exoskeleton Device; Stroke Rehabilitation
Evaluation of Systemic Bioavailability and Effects on 24-Hour Plasma Cortisol Profile of 6 mg Delivered Once Daily Versus 3 mg Delivered Twice Daily in Healthy Adult Male Volunteers
Condition: Healthy Adult Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-centre, randomized, double-blind, two-period, two-sequence, cross-over 7-day study.

      This study is the first safety/tolerability evaluation of a product -suppository formulation
      containing 6 mg BDP (once daily dosing), a second-generation oral or rectal corticosteroids
      with high topical anti-inflammatory efficacy in the gut and minimal systemic bioavailability
      (BA).

      BDP is marketed in different pharmaceutical formulations, including 3 mg suppositories, and
      approved for ulcerative proctosigmoiditis in the first attack or exacerbation phase at the
      dosage of 3 mg twice a day. For these reasons, a 6 mg suppository (Test - "T" product) is a
      scale-up of the 3 mg formulation (Reference - "R" product).

      For locally-applied-locally acting drug products that result in quantifiable systemic
      availability due to absorption from the administration site, relative systemic BA is
      informative for safety, but also with respect to efficacy. Therefore, safety/tolerability of
      T is evaluated through a comparison to R.
    

Detailed description: 
      Primary objective is the evaluation of systemic safety of T, based on valid surrogate
      outcomes - systemic BA (relative BA) at the start of treatment (first 24 hours) and after 7
      days of continuous treatment; effects on the hypothalamo-pituitary-adrenal axis (HPA)
      assessed based on 24-hour cortisol profile after 7 days of continuous treatment. This
      includes identification of subjects with cortisol levels <10 μg/dL at the last sampling point
      in the 24-hour cortisol profile (08:00 a.m. on Day 8). In such cases, identified subjects
      will undergo ACTH stimulation test in the morning of Day 9.

      Secondary objective is the evaluation of safety/tolerability based on clinical and laboratory
      adverse events.
    

Intervention name(s): Beclomethasone dipropionate
Intervention type(s): Drug
Intervention description(s): BDP 3 mg bid (R product) BDP 6 mg qd (T product)
Other intervention name(s): Beclomethasone 17,21-dipropionate; BDP
Intervention MeSH terms: Beclomethasone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-centre, randomized, double-blind, two-period, two-sequence, cross-over 7-day study.
Masking: Double (Participant, Investigator)
Primary purpose: Other
A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)
Condition: Diabetes Mellitus, Type 2; NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, randomized, placebo-controlled, multi-center study using the oral
      ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM.
    

Detailed description: 
      This is a double-blind, randomized, placebo-controlled, multi-center study using the oral
      ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM. The study will
      consist of a Screening Phase, Placebo Run-in Phase, Treatment Phase and an End-of-Study
      Phase. Approximately 36 subjects will be randomized in a 2:1 ratio to receive either 8 mg
      ORMD-0801, 1 capsule twice a day (once in the morning approximately 30 to 45 minutes prior to
      breakfast and no later than 10 AM, and once at night between 8 PM to Midnight and no sooner
      than 1 hour after dinner) or matching placebo.
    

Intervention name(s): ORMD-0801 (Insulin) capsule 8 mg BD; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 8 mg ORMD-0801, 1 capsule, twice a day, once in the morning and once in the evening.; Matching Placebo
Other intervention name(s): Oral Insulin; Fish oil
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will consist of a Screening Phase, Placebo Run-in Phase, Treatment Phase, and an End-of-Study Phase. Approximately 36 subjects will be randomized in a 2:1 ratio to receive either 8 mg ORMD-0801, 1 capsule twice a day (once in the morning approximately 30 to 45 minutes prior to breakfast and no later than 10 AM, and once at night between 8 PM to Midnight and no sooner than 1 hour after dinner) or matching placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study.
Condition: Venous Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this post-market study is to compare the post-procedure recovery between two
      types of minimally invasive catheter treatments for venous disease in the Great Saphenous
      Vein.
    

Detailed description: 
      Comparison of the post-procedure recovery of radiofrequency (RFA) treatment vs. laser
      treatment.
    

Intervention name(s): Seg. RF Ablation & ClosureFAST catheter; Endovenous Laser
Intervention type(s): Device; Device
Intervention description(s): Seg. RF Ablation & ClosureFAST catheter; laser catheter
Other intervention name(s): VNUS; Commercially approved laser catheter systems.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Varicose veins, venous reflux, GSV disease
A Study of Pregabalin (Lyrica) Augmentation in Serotonin Reuptake Inhibitor-Refractory Obsessive Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will examine the efficacy of pregabalin (Lyrica) added to SRI treatment in OCD for
      individuals who have not responded or only partially responded to an adequate trial of SRI.
      Although SRIs have demonstrated efficacy in OCD in numerous placebo-controlled trials,
      response rates have been as low as 40%. Augmentation strategies would be beneficial to
      maximize treatment response in OCD.

      Pregabalin (Lyrica) is an anticonvulsant medication that appears to have a novel mechanism of
      action. It has been shown to enhance activity at gamma-amino-butyric acid (GABA) receptors as
      well as inhibit glutamate release. These two neurotransmitters systems have been implicated
      in the neurobiology of OCD.

      The study will consist of patients who have not attained full response to an SRI. The
      patients will be randomized in a double-blind fashion to augmentation with pregabalin
      (Lyrica) or placebo. The dose of study medication will be flexible, starting at 75 mg/day and
      increasing in 75 mg increments to a maximum of 600 mg/day, based on efficacy and any side
      effects. Patients' response to treatment will be measured by the Yale-Brown
      Obsessive-Compulsive Scale (Y-BOCS), the Montgomery Asberg Depression Rating Scale (MADRS),
      and the Clinical Global Impression Scale(CGI).
    


Intervention name(s): pregabalin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): pregabalin starting at 75 mg/day (at Study Week 0). Doses will be titrated up in 75 mg increments until a clinical response is achieved, as tolerated in the following manner: to 150 mg/day at the end of Study Week 1, to 225 mg/day at the end of Study Week 2, 300 mg/day at the end of Study Week 4, 450 mg/day at the end of Study Week 6 and to 600 mg/day at the end of Study Week 8. The maximum dose of pregabalin will be 600 mg/day.; Placebo starting at 75 mg/day (at Study Week 0). Doses will be titrated up in 75 mg increments until a clinical response is achieved, as tolerated in the following manner: to 150 mg/day at the end of Study Week 1, to 225 mg/day at the end of Study Week 2, 300 mg/day at the end of Study Week 4, 450 mg/day at the end of Study Week 6 and to 600 mg/day at the end of Study Week 8. The maximum dose of pregabalin/placebo will be 600 mg/day.
Other intervention name(s): Lyrica
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: treatment-resistant; refractory; obsessive compulsive disorder; Lyrica; pregabalin; Serotonin Reuptake Inhibitor-Refractory Obsessive-Compulsive Disorder