bioihbjkbjnl/mcl2 huggingface dataset:
A fMRI Study of Compressive Spinal Cord
Condition: Orthopedic Disorder of Spine; Neurologic Disorder
MeSH terms: Musculoskeletal Diseases; Spinal Diseases; Nervous System Diseases
Study type: Observational

Summary: 
      Cervical myelopathy (CM), a chronically compressive spinal cord lesion, is the most common
      cause of non-traumatic paraparesis/quadriparesis among the elderly. Hong Kong is facing a
      heavy social economic burden from CM with the rapidly aging population. Surgical
      decompression is considered as the mainstay of the treatment for CM patients to relieve their
      symptoms and signs. Yet the surgical outcome is not always satisfactory. There is a pressing
      need for understanding the exact mechanism of surgical decompression on the recovery of
      myelopathic cord in order to improve the prognosis of CM patients in near future.This project
      will evaluate neuronal activities and axon regeneration by longitudinally monitoring at time
      zero, 3 and 6 month after the surgery in CM patients using UTE, BOLD-fMRI and DTI, and to
      investigate the relationship of preoperative neuronal activities of myelopathic cord with
      axon regeneration.
    

Detailed description: 
      This study aims to monitor the structural and functional changes of chronically compressed
      spinal cords longitudinally after surgical decompression in vivo. Three kinds of MRI
      techniques will be used in this study. These are (1) axial T1-weighted (T1WI) and T2-weighted
      imaging (T2WI), UTE MRI, (2) BOLD-based fMRI, and (3) diffusion tensor imaging (DTI). To
      quantitatively investigate the structural deficits, T1/T2 MRIs will delineate the gross
      morphology of the spinal cord, CSF, and surrounding anatomical structures, while DTI will
      quantify the fiber orientation and integrity within the spinal cord. BOLD-based functional
      MRIs will assess the local hemodynamic changes and neuron activities in response to the motor
      or sensory stimulation along the C3 to C8 spinal nerve levels. The MRI evaluations will be
      applied to the same cervical myelopathy (CM) patient before surgery and 3 and 6 months
      post-surgery, when clinical recovery reaches a plateau9. Clinical examination will include
      neurological evaluation, Japanese Orthopaedic Association (JOA) scoring assessment, and
      clinical electrophysiological evaluation.
    

Intervention name(s): MRI examination
Intervention type(s): Diagnostic Test
Intervention description(s): Three kinds of MRI techniques will be used in this study. These are (1) axial T1-weighted (T1WI) and T2-weighted imaging (T2WI), UTE MRI, (2) BOLD-based fMRI, and (3) diffusion tensor imaging (DTI).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 50 CM patients requiring surgical decompression will be recruited.
      
Keywords: cervical spondylotic myelopathy; diffusion tensor imaging; functional magnetic resonance imaging
Study to Evaluate the Long Term Safety and Efficacy of DWP16001 Compared to Placebo in the Treatment of T2DM.
Condition: T2DM (Type 2 Diabetes Mellitus)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is evaluate the long term safety and efficacy of DWP16001 compared
      to placebo in the treatment of type 2 diabetes mellitus.
    


Intervention name(s): DWP16001 Amg
Intervention type(s): Drug
Intervention description(s): DWP16001 Amg, Tablets, Orally, Once daily
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Evaluate the Effect of Moisturizing Creams on Skin Barrier Function
Condition: Dry Skin; Skin Care
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the impact of twice-daily topical application of two
      different moisturizing creams on skin barrier function for 4 weeks.
    

Detailed description: 
      This study will be a randomized, evaluator-blind, single-center, two-treatment regimen,
      controlled, parallel-group, with a treatment period of 4 weeks. The study will assess the
      skin barrier function of the two-treatment regimen in healthy participants with dry,
      sensitive skin on the face and lower legs. All participants will be centrally randomized to
      one of the 2 treatment groups using an Interactive Response Technology (IRT).
    

Intervention name(s): Developmental moisturizing cream 1; Developmental moisturizing cream 2; Standard cleanser soap
Intervention type(s): Drug; Drug; Other
Intervention description(s): Participants will topically apply developmental moisturizing cream 1; Participants will topically apply developmental moisturizing cream 2; Participants will cleanse the entire face and both lower legs (between the knees and the ankles)with simple pure soap
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Skin care, Moisturizing Cream
Physiological Factors That Influence Maintenance of Lifestyle Changes and Weight Loss - a Longitudinal Study
Condition: Obesity; Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      In Denmark and the western world, there is an increasing prevalence of obesity probably due
      to a combination of inadequate daily physical activity and a high energy intake. One approach
      to achieve weight loss and change life style is to participate in an intensive supervised
      prolonged life style modification course. The immediate effect is often positive, but over
      time the overall effect is limited as the majority will not maintain weight loss and a
      changed life style.

      The purpose of this study is therefore to characterize the physiological factors that
      determine/influence the capacity to maintain weight loss and a healthy lifestyle after a
      prolonged lifestyle intervention.

      We have the following research questions:

        1. Are there physiological traits and characteristics that mediate better adherence to
           lifestyle changes and weight loss?

        2. Does the adaptation in muscle oxidative capacity after lifestyle intervention predict
           success in maintaining weight loss and lifestyle changes 3, 12 and 39 months after
           intervention?

        3. How does gender and age influence the capacity to maintain the lifestyle induced
           adaptation in muscle and adipose tissue and maintaining weight loss?

      The study design is a longitudinal intervention and will be based on a lifestyle
      intervention, as it is practiced in a real life setting at Ubberup folk high school.
    


Intervention name(s): Intensive Lifestyle Intervention
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Lifestyle intervention; Body weight; Body composition; Weight loss maintenance; Physical activity
Diamel in the Treatment of Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy of Diamel administration in the treatment
      of Polycystic Ovary Syndrome. The duration of this double-blind placebo controlled phase 3
      clinical trial will be 24 weeks.
    


Intervention name(s): Diamel; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.; Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dietary supplement; Diamel; Polycystic Ovary Syndrome; Female Infertility
Effect of Prevnar 13 on Ear Infections in Children
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Observational

Summary: 
      Prevnar (7 valent pneumococcal conjugate vaccine [7vPnC]) has been shown to be effective
      against ear infections in children. Prevnar 13 is a new vaccine that is similar to Prevnar.
      It is expected that the effectiveness of Prevnar 13 against ear infections in children will
      be similar to that observed following Prevnar. Pfizer has committed to conduct a
      postmarketing study of the impact of Prevnar 13 in reducing ear infections among children.
    

Detailed description: 
      Infants who have completed the Prevnar 13 infant vaccination series who provide consent and
      fit the study inclusion criteria to participate in the study will be recruited.
    

Intervention name(s): Tympanocentesis; Nose/throat swab; Observational
Intervention type(s): Procedure; Procedure; Biological
Intervention description(s): To be performed as needed on children presenting with acute otitis media; To be performed at every study visit; Observational Study Only
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy children aged approximately 6 to 36 months of age.
      
Biospecimen description: 
      Middle Ear Fluid for microbiologic analysis Nose and throat swab for microbiologic analysis
    
Keywords: Acute otitis media; Prevnar 13; Streptococcus pneumoniae; nasopharyngeal colonization.
Efficacy of Manual Toothbrushes in Removing Dental Plaque
Condition: Dental Plaque; Oral Hygiene
MeSH terms: Dental Plaque
Study type: Interventional

Summary: 
      This clinical methodology development study will evaluate the plaque removal efficacy of four
      marketed manual toothbrushes, with differing bristle types and brush head designs, in healthy
      dentate participants. Changes in supra-gingival plaque accumulation will be assessed after
      first use and following 1-and 4-weeks treatment (twice-daily brushing), using two different
      clinical measures of dental plaque. Study participants will abstain from oral hygiene for a
      period of 12-18 hours prior to each assessment visit. Data generated will inform the design
      of future clinical studies investigating the plaque removal efficacy of manual toothbrushes.
    

Detailed description: 
      This will be a single center, 4-week, randomized, controlled, examiner-blind, four-treatment
      arm, parallel design, clinical methodology development study to investigate the plaque
      removal efficacy of marketed manual toothbrushes in healthy, dentate participants. Changes in
      plaque level will be evaluated after first brushing, after two further single brushing events
      (Days 7 and 28) and following 7 and 28 days usage (twice daily brushing with assigned
      toothbrush treatment).

      Supra-gingival plaque levels will be assessed using two established clinical measures: the
      Rustogi Modified Navy Plaque Index (RPI) and the 6-site Turesky Modified Quigley and Hein
      Plaque Index (TPI). Participants will abstain from oral hygiene for a period of 12-18 hours
      prior to each assessment visit. Participants with Day 0 pre-brushing mean RPI overall ≥ 0.6
      will be stratified by their Day 0 pre-brushing RPI score (lower: mean RPI overall ≥ 0.6 to ≤
      0.8; higher: mean RPI overall; 0.8 to 1.0) and randomized to study treatment (Visit 2).

      To standardize oral hygiene practice, eligible participants will complete a lead-in period
      (minimum 5 days) prior to Visit 2 during which they will brush with the toothbrush and
      regular fluoride toothpaste provided.

      The safety and oral tolerability of each study toothbrush will be monitored after first use
      and over the 28-day usage period by review of reported treatment emergent adverse events
      (TEAEs).
    

Intervention name(s): Oral B Indicator 123; Dr Best Original; Dr Best Multi Expert; parodontax Interdental
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Manual toothbrush (medium bristle stiffness; compact head, UK market).; Manual toothbrush (medium bristle stiffness; regular head, German market); Manual toothbrush (medium bristle stiffness; compact head, German market); Manual toothbrush (soft bristle stiffness; compact head, German market)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Oral Hygiene
Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy
Condition: Myoma;Uterus
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 3

Summary: 
      Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20
      mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal
      myomectomy
    

Detailed description: 
      Background; Myomectomy is a curative interventional option for many kinds of uterine
      fibroids, but considerable intraoperative haemorrhage and the necessities for transfusions of
      blood are still the main challenge for abdomen myomectomy.

      Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20
      mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal
      myomectomy Subjects and methods; This was a prospective randomized double-blind controlled
      study that included 90 patients complaining of uterine myoma and indicated for myomectomy
      selected from the outpatient clinic at Beni-suef university hospital
    

Intervention name(s): Dinoprostone; Misoprostol
Intervention type(s): Drug; Drug
Intervention description(s): prostaglandin (PG) E2 analog; prostaglandin (PG) E1 analog
Other intervention name(s): Dinoglandin; Cytotec
Intervention MeSH terms: Misoprostol; Dinoprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Uterine leiomyoma; misoprostol; dinoprostone
Prevention of Oxaliplatin-induced Neuropathic Pain by a Specific Diet
Condition: Neuropathy; Digestive Cancer System
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 3

Summary: 
      Use lay language. Oxaliplatin is a reference anticancer drug in the treatment of colorectal
      cancer. However, its use is hampered by a specific neurotoxicity, which is characterized by
      acute thermal hypersensitivity, notably to cold temperatures, and by chronic neuropathy
      appearing with the repetition of chemotherapy cycles.

      To this date there is no effective therapy able to prevent and/or to treat these adverse drug
      reactions. So oncologists are sometimes strained to decrease anticancer doses or to stop
      chemotherapy; Previously, a polyamine deficient diet has been able to prevent acute
      oxaliplatin-induced hypersensitivity in animals.

      So we hypothesizes that a specific nutritional therapy, a polyamine deprived diet, may
      prevent acute oxaliplatin-induced hypersensitivity in patients.
    

Detailed description: 
      This is a prospective, single-center, controlled and interventional study with two parallel
      groups randomized in single-blind.

      After obtaining informed consent, all included patients will be randomized, either:

        -  in the group with a polyamines depleted diet : 2-4 cans per day of Polydol® (oral
           alimentation without polyamines), associated to predefined menus low in polyamines,
           according to the chemotherapy cycle and for 107 days

        -  in the control group with a normal polyamines containing diet: 1 can per day of Polydol®
           associated with predefined menus with normal average in polyamines and for 107 days.

      Randomization will be performed by considering stratification on the tumor presence or not,
      because it is one of the polyamines source (Linsalata and Russo, 2008) and could influence
      the results in the study.

      In addition, patient compliance will be collected in the case report form all along the
      study, and included in the statistical analysis of the study.
    

Intervention name(s): Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Anticancer drug;; Oxaliplatin;; Digestive cancer system; Acute oxaliplatin-induced hypersensitivity; Hyperalgesia;; Allodynia;; Dysesthesia; Polyamines depleted diet
The Impact of Contraception on Postpartum Weight Loss
Condition: Weight
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      This is a prospective mixed methods study to assess weight changes in women randomized to
      receive Implanon ® or Depo Provera® (DMPA) immediately postpartum compared to women who
      choose non-hormonal contraception or no contraception immediately postpartum. After
      enrollment, subjects return for a visit at 3, 6 and 12 months postpartum to be asked a series
      of questions, take a pregnancy test, and be weighed. Total length of participation for each
      subject is 1 year or until pregnancy.
    


Intervention name(s): DMPA immediately postpartum; Implanon immediately postpartum
Intervention type(s): Drug; Drug
Intervention description(s): DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.; Implanon ® is a subdermal implant that contains 68mg of etonogestrel.
Other intervention name(s): DepoProvera, depot medroxyprogesterone acetate (DMPA); etonogestrel implant
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone; Etonogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Maintenance Treatment vs. Stepwise Drug Discontinuation in First-Episode Schizophrenia
Condition: Schizophrenia; Psychoses
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      After one year neuroleptic maintenance treatment in patients with first episode
      schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized
      design) over a period of 1 year. Under both conditions prodrome based early intervention take
      place.
    

Detailed description: 
      After one year neuroleptic maintenance treatment in patients with first episode
      schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized
      design) over a period of 1 year. Under both conditions pharmacologic early intervention
      strategies in case of early sign of relapse will be applied.
    

Intervention name(s): maintained antipsychotic treatment vs. stepwise drug discontinuation
Intervention type(s): Other
Intervention description(s): maintained antipsychotic treatment (in low dose) vs. stepwise drug discontinuation; both supplemented by prodrome-based early intervention; 1 year
Intervention MeSH terms: Antipsychotic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; first episode; neuroleptic maintenance treatment; drug discontinuation; prodrome based early intervention
An Efficacy and Safety Study of Prucalopride in Participants With Chronic Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of prucalopride to placebo
      (an inactive substance that is compared with a drug to test whether the drug has a real
      effect in a clinical trial) in treatment of participants with chronic (very serious, life
      threatening) constipation (decreased number of or difficulty making bowel [the intestine]
      movements).
    

Detailed description: 
      This is a randomized (study drug is assigned by chance), double-blind (neither physician nor
      participant knows the treatment that the participants receives), placebo-controlled,
      multi-center (when more than 1 hospital or medical school team work on a medical research
      study) study with a parallel-group design (a medical research study comparing the response in
      2 or more groups of participants receiving different treatments) study of prucalopride. This
      study consist of 3 phases: a 2 weeks drug-free screening or run in phase, a 12-week treatment
      phase and follow-up (post-treatment) phase performed 7 days following the last dose of study
      drug. The total duration of study will be approximately 15 to 20 weeks, including the run-in
      and post-treatment phases. During the run-in phase, participants will receive laxative
      (bisacodyl) as a rescue medication throughout the study, if they will not have bowel movement
      (BM) for 3 or more consecutive days. If participants will not be able to tolerate bisacodyl,
      an enema may be used in place of the bisacodyl. During the double-blind treatment phase,
      participants will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups to receive
      either 2 milligram (mg) prucalopride or matching placebo prucalopride for 12 weeks, orally
      once daily. Participants will be primarily assessed for spontaneous complete bowel movements
      (SCBMs) per week. Participant's safety and quality of life will be monitored throughout the
      study.
    

Intervention name(s): Prucalopride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg tablet, orally once daily, for 12 weeks; 1 tablet, orally once dailyfor 12 weeks
Other intervention name(s): Resolor
Intervention MeSH terms: Prucalopride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Constipation; Prucalopride; Resolor
Pancreatic Islet Transplantation Into the Gastric Submucosa
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall objective of this pilot project is to evaluate the safety and efficacy of the
      gastric submucosal space as a novel site for clinical islet transplantation. The site has
      several physiologic attributes that may improve the outcomes of islet transplantation
      compared with the conventional intraportal transplant site.
    

Detailed description: 
      The overall objective of this pilot project is to evaluate the safety and efficacy of the
      gastric submucosal space as a novel site for clinical islet transplantation. Safety will be
      evaluated by the monitoring of side effects such as post procedural GI complications,
      frequency of hypo and hyperglycemic events, and immunosuppression side effects. Efficacy will
      be determined by accepted measures including insulin independence, long term glucose control,
      and reduction/elimination of hypoglycemic events.

      The site has several physiologic attributes that may improve the outcomes of islet
      transplantation compared with the conventional intraportal transplant site.
    

Intervention name(s): Isolated Human Pancreatic Islets
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin Dependent