bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With a Mild Infection of a Foot Ulcer
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the gentamicin-collagen sponge when
      combined with standard of daily wound care is safe and effective in treating mildly infected
      skin ulcers compared to treatment with an oral antibiotic (levofloxacin) and standard daily
      wound care.
    

Detailed description: 
      Infected skin ulcers in patients with diabetes can be very debilitating because they are
      difficult to heal. Diabetic ulcers are responsible for frequent health care visits, and are a
      major predictor of amputation. Diabetic ulcers can be caused by a patient's inability to
      sense pain or warmth as well as peripheral vascular disease, which causes diminished blood
      flow to the foot. Early aggressive treatment is necessary to treat infection and prevent the
      need for amputation.

      Gentamicin is an antibiotic that is effective in treating certain kinds of infection.
      Collagen is a protein that is found in all mammals. The gentamicin-collagen sponge is a thin
      flat sponge made out of collagen that comes from cow tendons and containing gentamicin. When
      applied to an open ulcer, the collagen breaks down and the gentamicin is released into the
      ulcer, but very little is absorbed into the blood stream. The high levels of gentamicin in
      the open infected ulcer may help treat the infection.

      In this study, all subjects will be given the necessary supplies and taught how to take care
      of their foot ulcer. Subjects who are randomly assigned to the gentamicin-collagen sponge
      treatment group will place a gentamicin-collagen sponge on their ulcer during daily wound
      care. Subjects who are randomly assigned to the oral levofloxacin treatment group will also
      perform daily wound care, but they will not be given the gentamicin-collagen sponge. Instead
      they will be given the antibiotic, levofloxacin to take by mouth during the treatment period.
    

Intervention name(s): gentamicin-collagen sponge; Levofloxacin
Intervention type(s): Drug; Drug
Intervention description(s): Inserted daily into open ulcer; 750mg oral levofloxacin daily
Intervention MeSH terms: Levofloxacin; Gentamicins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetic Foot Ulcer
Nasal Provocation Test With Lysine-Acetylsalicylate (ASA) in Patients With Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Hypersensitivity
Condition: Aspirin Hypersensitivity; NSAIDs Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      This study aims to compare the efficacy of nasal provocation test with
      Lysine-Acetylsalicylate in patients with history of NSAIDs hypersensitivity between
      mucocutaneous symptoms and respiratory symptoms and laboratory outcomes.
    


Intervention name(s): Lysine-ASA Nasal ProvocationTest
Intervention type(s): Procedure
Intervention description(s): Lysine-ASA 80 µl (16 mg of aspirin) will be installed in both nostrils with pipette
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer
Condition: Colorectal Neoplasms; Liver Neoplasms
MeSH terms: Neoplasms; Colorectal Neoplasms; Liver Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver
      metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen,
      compared to 5-FU/FA alone.
    


Intervention name(s): Irinotecan + 5 FU + folinic acid; Folinic Acid + 5 FU
Intervention type(s): Drug; Drug
Intervention description(s): irinotecan 180 mg/m2 folinic acid 400 mg/m2 (DL) followed by 5 FU bolus 400 mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks; folinic acid 400 mg/m2(DL) followed by bolus 5 FU 400mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks
Intervention MeSH terms: Leucovorin; Folic Acid; Irinotecan; Fluorouracil; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma
Condition: Disease, Hodgkin
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety profile of brentuximab vedotin in
      combination with multi-agent chemotherapy in treatment-naive Stage IIa or IIb-IV Hodgkin
      lymphoma. It is a phase 1, two-arm, open-label dose escalation study designed to define the
      maximum tolerated dose, pharmacokinetics, immunogenicity and anti-tumor activity of
      brentuximab vedotin in combination with frontline therapy.
    


Intervention name(s): brentuximab vedotin; doxorubicin; vinblastine; dacarbazine; bleomycin; brentuximab vedotin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.6-1.2 mg/kg IV every 2 weeks; 25 mg/m2 IV every 2 weeks; 6 mg/m2 IV every 2 weeks; 375 mg/m2 IV every 2 weeks; 10 units/m2 IV every 2 weeks; 0.9-1.2 mg/kg IV every 2 weeks
Other intervention name(s): SGN-35; SGN-35
Intervention MeSH terms: Doxorubicin; Bleomycin; Brentuximab Vedotin; Dacarbazine; Vinblastine; Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antibodies, Monoclonal; Antibody-Drug Conjugate; Antigens, CD30; Disease, Hodgkin; Hematologic Diseases; Immunotherapy; Lymphoma; monomethyl auristatin E
Low Carbohydrate and Conventional Diets Associated to Resistance Training on Muscle Fitness and Health Markers
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study was to compare the effects of two different diets (low carbohydrate
      - LCD and conventional - CONV) on body composition, strength performance, muscle mass and
      biomarkers of health in overweight adults submitted to resistance training (RT). It has been
      hypothesized that LCD would produce higher rates of weight loss and that both diets would be
      useful to maintain muscle mass and strength and biomarkers of health.
    

Detailed description: 
      Overweight and obesity prevalence has increased worldwide. Current guidelines recommend
      health behavior modifications, including better eating habits and regular physical activity
      (including resistance training - RT) as a strategy to control and prevent the problem.
      Traditionally, diets poor in energy and fat (conventional diets - CONV) have been recommended
      to promote losses in body and fat masses; however, there has been recently a growing interest
      in the academic community to investigate the effects of low carbohydrate diet (LCD) on health
      outcomes, since this kind of diet appears to be more effective for reducing body mass as
      compared to CONV. Nevertheless, evidences are scarce regarding the effects of LCD associated
      to RT on body composition, strength performance, blood lipids, endothelium function and other
      markers of health, demanding the development of clinical trials aiming to determine the
      combined health effects of these interventions.
    

Intervention name(s): macronutrient and energy manipulation
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: resistance exercise; body mass index; hypertrophy; endothelial function; blood lipids
Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Bioequivalence between oral nicotine replacement products and Nicorette® gum.
    

Detailed description: 
      This study compares a new oral Nicotine Replacement Therapy (NRT) product containing 2 and 4
      mg nicotine with Nicorette® gum 2 mg and 4 mg, after 12 hours of nicotine abstinence, with
      respect to nicotine pharmacokinetics, during 10 hours after start of administration. Single
      doses of each treatment are given once in the morning during four separate treatment visits
      scheduled in a crossover setting with randomized treatment sequences. The study will include
      88 healthy smokers between 18-50 years, who have been smoking at least 10 cigarettes daily
      during at least one year preceding inclusion. Subjects and study personnel will be aware of
      which treatment is administered at a given visit.
    

Intervention name(s): Nicotine; Nicorette® (Nicotine Gum)
Intervention type(s): Drug; Drug
Intervention description(s): Single-dose of a new Nicotine Replacement Therapy (NRT) product 2 mg and 4 mg; Single-dose of marketed nicotine gum 2 mg or 4 mg
Other intervention name(s): Not yet marketed; Nicorette®
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking Cessation; Nicotine pharmacokinetics
Effects of Home Exercise Intervention on Bone Density, Muscle Functions, QoL, and Curve Progression in Girls With AIS
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      Studies with exercise intervention aimed to improve the bone health and muscle functions in
      patients with AIS were lacking. Evidence suggested that low bone mass and low muscle mass
      were associated with curve severity and occurrence of AIS. Weight-bearing exercise that aimed
      to improve musculoskeletal and metabolic health could enhance bone health and muscle mass,
      and could provide a feasible alternative conservative treatment to prevent curve progression
      as well as the quality of life in AIS girls. This is a pilot feasibility study for future
      large randomized controlled trial (RCT) aiming at determining the effects of home based
      exercise program on improving bone mineral density (BMD), muscle mass and functions, quality
      of life (QoL), and prevent curve progression in skeletally immature girls with adolescent
      idiopathic scoliosis (AIS).
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): 7-min High Intensity Interval Training with 12 different exercises (each exercise 30 seconds continuously with 10 seconds rest interval)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Observational

Summary: 
      A prospective observational study of the incidence of treatment-requiring ROP (TR-ROP), at a
      national level, in Greece.
    

Detailed description: 
      The purpose of this observational study is to prospectively collect data on ROP cases
      necessitating treatment at a national level. Each and every ROP screening unit in Greece
      (collaborating centers) report their new TR-ROP cases, their demographics and treatment
      characteristics, monthly, for a 12-month period. A reminder email is sent to avoid
      under-reporting due to neglect. Data are collected by the Responsible Party and will be
      analyzed together with national registry data on all preterm births in the same 12-month
      period.
    

Intervention name(s): Other: observational study
Intervention type(s): Other
Intervention description(s): Observational study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All preterm infants who underwent treatment for ROP in a public or private hospital in
        Greece during the 12-month study period.
      
Keywords: Retinopathy of prematurity; ROP; Treatment
Auriculotherapy as a Coping Strategy in Professional Nursing
Condition: Stress, Psychological; Coping Behavior
MeSH terms: Stress, Psychological
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This randomized clinical trial aimed at evaluating the auriculotherapy as coping strategies
      in 75 nursing professionals in a University Hospital.
    

Detailed description: 
      There is consensus that psychological and social factors can lead to physical health problems
      of individuals and coping strategies in stressful situations may be crucial for the mental,
      physical and social development of people. Taking care of professionals who provide health
      services is a key strategy, since good results depend on the service, especially in work
      teams healthy and, therefore, able to promote the humanization of service.
    

Intervention name(s): auriculotherapy by needles; auriculotherapy by seeds
Intervention type(s): Other; Other
Intervention description(s): The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.; We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day.
Other intervention name(s): auricular acupuncture; auricular acupuncture by seeds
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: stress psychological; coping behavior
Trial of SK-1404 for Nocturia Due to Nocturnal Polyuria in Japanese Subjects
Condition: Nocturia Due to Nocturnal Polyuria
MeSH terms: Polyuria; Nocturia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to demonstrate efficacy of SK-1404 against placebo for the
      treatment of subjects with nocturia due to nocturnal polyuria, during 4 weeks of treatment.
    


Intervention name(s): SK-1404; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4 weeks of repeated administration of SK-1404 to the patients of nocturia; 4 weeks of repeated administration of Placebo to the patients of nocturia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Trial of Somatostatin With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding
Condition: Acute Bleeding Esophageal Varices; Portal Hypertension; Cirrhosis
MeSH terms: Hypertension, Portal; Esophageal and Gastric Varices; Hemorrhage
Study type: Interventional

Summary: 
      Background: Efficacy of endoscopic variceal sclerotherapy in achieving initial control of
      acute variceal bleeding and five-day haemostasis has been shown to significantly improve when
      vasoactive drug is added. However, there is limited data whether addition of somatostatin, to
      endoscopic variceal ligation (EVL) improves the efficacy of EVL.

      Aim: To compare EVL plus somatostatin versus EVL plus placebo in control of acute variceal
      bleeding.

      Patients and methods: Consecutive cirrhotic patients with acute variceal bleeding from
      esophageal varices were enrolled in the trial. After emergency EVL, patients were randomized
      to receive either somatostatin (250 mcg/hr) or placebo infusion. Primary endpoint was
      treatment failure within 5 days. Treatment failure was defined as fresh hematemesis ≥2 hour
      after start of therapy or death.
    


Intervention name(s): Somatostatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days; Emergency EVL plus placebo infusion for 5 days
Other intervention name(s): Somatosan; Somastin
Intervention MeSH terms: Somatostatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Variceal bleeding; Endoscopic therapy; Band ligation; Somatostatin; Vasoactive drugs; Octreotide
Usefulness of Cephalometry in the Second and Third Trimester of Pregnancy in the Diagnosis of Fetal Microretrognathia
Condition: Pierre Robin Sequence
MeSH terms: Pierre Robin Syndrome
Study type: Observational

Summary: 
      Congenital retrognathia, with or without Pierre Robin Sequence (PRS), is a rare anomaly which
      can be associated with chromosomal abnormalities. Respiratory and feeding consequences can be
      present at birth. After birth, the diagnosis of retrognathia is based on the clinical
      examination. Cephalometry can be used to complete the diagnosis. Several authors have
      proposed the use of objective quantitative ultrasound parameters for the antenatal screening
      of PRS. In our study, the investigators evaluated fetal cephalometry.

      The aim First, the investigators studied the inter- and intra-observer reproducibility of
      cephalometry. Second, the investigators established reference values for antenatal
      cephalometry in normal fetuses. Third, the investigators compared the diagnostic performance
      of cephalometry and the other angles described in the literature for the diagnosis of
      retrognathia.
    


Intervention name(s): Fetal cephalometry
Intervention type(s): Other
Intervention description(s): Fetal cephalometry
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All pregnant patients with one or more fetuses suffering from a microretrognathia,
        diagnosed prenatally and integrated into a Pierre Robin Sequence
      
Keywords: with one or more fetuses suffering from a microretrognathia; Cephalometry; Prenatal Diagnosis; Facial angles; Fetal echography; Microretrognathia; diagnosed prenatally
Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse
Condition: Rectal Prolapse
MeSH terms: Rectal Prolapse; Prolapse
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and feasibility of endoluminal rectal
      prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum
      with sutures to the abdominal wall under needlescopic control. Further, investigators will
      evaluate the short and long-term clinical outcomes after this novel approach to treating
      rectal prolapse.
    

Detailed description: 
      .Aims/Objective The purpose of this study is to evaluate the safety and feasibility of
      endoluminal rectal prolapse repair under sedation and local anesthesia using CO2 colonoscopy
      to fix the rectum with sutures to the abdominal wall under needlescopic control. Further, we
      will evaluate the short and long-term clinical outcomes after this new procedure.

      Primary Outcomes

        1. Feasibility: successful completion of endoluminal rectal prolapse repair with
           needlescopic assistance

        2. Safety: measured by the incidence of the Intraoperative complications (bowel
           perforation, organ injury and bleeding requiring blood transfusion)

        3. Sedation and local anesthesia feasibility: surgery completed without patient intubation

        4. Clinical Outcomes: rectal prolapse recurrence within 30 days, length of hospital stay
           and postsurgical complications

        5. Long Term Clinical Outcomes: Rectal Prolapse Recurrence

      Methods Design: A prospective pilot study with 10 patients who will be undergoing Combined
      Needlescopic and Endoluminal (Colonoscopic) Surgery under sedation and local anesthesia for
      Rectal Prolapse Repair with the Colon and Rectal Surgeons at WCMC. Data will be collected
      prospectively before, during, and after surgery.

      Settings: Colon and Rectal Surgery at WCMC-NYPH Population: Patients male and female above 75
      years of age, with rectal prolapse will be invited to participate in the study after surgery
      is deemed necessary for standard treatment of their medical conditions.
    

Intervention name(s): endoluminal rectal prolapse repair under sedation
Intervention type(s): Procedure
Intervention description(s): endoluminal rectal prolapse repair under sedation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia; Hyperplasia
Study type: Observational

Summary: 
      Urinary ascorbyl peroxide level in the first week of life will be a good predictor of
      Bronchopulmonary dysplasia (BPD) in preterm infants less than 33 weeks of gestation.
    

Detailed description: 
      This study uses ascorbyl peroxide as representative of oxidative stress in premature infants
      on parenteral nutrition and aims to test the correlation of this metabolite and the different
      major neonatal outcomes 'mainly bronchopulmonary dysplasia).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm infants less than 33 weeks of getation
      
Biospecimen description: 
      Urine sample (650 µl) Blood sample (500 µl)
    
Keywords: Ascorbyl peroxide; Bronchopulmonary dysplasia; Redox status; Necrotising entercolitis; Retinopathy of prematurity; Patent ductus arteriosus; Intraventricular hemorrhage; Periventricular leucomalacia
Follow-up Study of the Effectiveness of Virtual Reality Therapy in MS Patients
Condition: Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis, Primary Progressive
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional

Summary: 
      Different therapies can improve clinical and motor symptoms of multiple sclerosis (MS)
      similarly, but studies comparing the effects of different exercise therapies on clinical and
      motor outcomes are scant. We compared the effects of exergaming (EXE), balance (BAL), cycling
      (CYC), proprioceptive neuromuscular facilitation (PNF), and a standard care wait-listed
      control group (CON) on clinical and motor symptoms and quality of life (QoL) in people with
      MS (PwMS).

      Methods: PwMS (n = 68, 90% female; age, 47.0 yr; Expanded Disability Status Scale score 5-6)
      were randomized into five groups. Before and after the interventions (five times a week for 5
      wk), PwMS were tested for MS-related clinical and motor symptoms (Multiple Sclerosis Impact
      Scale-29 (MSIS-29), primary outcome), QoL (EuroQol Five Dimensions Questionnaire), symptoms
      of depression, gait and balance ability (Tinetti Assessment Tool), static and dynamic balance
      and fall risk (Berg Balance Scale), walking capacity (6-min walk test), and standing
      posturography on a force platform.

      Patients were followed up for 2 years after 5 weeks of intensive care. Tests are performed
      every six months.
    


Intervention name(s): Training groupe; PNF; Spinning grp; Balance
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Using virtual training; PNF technique was used; They only worked with spinning bikes.; Balance development was done
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: multiple sclerosis; posture; neurorehabilitation; balance