bioihbjkbjnl/mcl2 huggingface dataset:
Specimen Collection Study for H. Pylori Testing
Condition: Helicobacter Infections
MeSH terms: Helicobacter Infections
Study type: Observational

Summary: 
      The objective of this study is to acquire human specimens from subjects undergoing routine
      endoscopy with gastric biopsy for the diagnosis of active H. pylori infection.
    

Detailed description: 
      This is a prospective study designed to acquire and bank human specimens from subjects who
      are scheduled for routine upper endoscopy for symptoms such as dyspepsia. This study will be
      conducted at a minimum of 2 sites in the United States. Investigator sites will enroll
      prospective subjects who meet the inclusion / exclusion criteria. A case report form (CRF)
      provided by the sponsor will be used to capture basic demographic information (DOB, age,
      gender, race/ethnicity), medication history, and related clinical information. The CRFs will
      also record the results of the following tests performed with the gastric biopsy tissue
      specimens: histology and rapid urease test (RUT).
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will consist of subjects scheduled for routine upper endoscopy for
        upper gastrointestinal tract symptoms such as dyspepsia. All prospective subjects must be
        off of proton-pump inhibitors, antibiotics, and bismuth for at least 2 weeks prior to
        submission of the stool specimen and undergoing endoscopy.
      
Biospecimen description: 
      Biospecimen
Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age
Condition: Sedation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of
      dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks
      gestational age, administered as a loading dose followed by a continuous infusion for a
      minimum of 6 hours and up to 24 hours in the neonatal intensive care unit (NICU), cardiac
      intensive care unit (CICU), or pediatric intensive care unit (PICU).
    


Intervention name(s): Midazolam; Fentanyl/Morphine; Dexmedetomidine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion; Per package insert, N-PASS scores and investigator discretion.
Other intervention name(s): Precedex
Intervention MeSH terms: Midazolam; Fentanyl; Dexmedetomidine; Morphine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Initially intubated and mechanically ventilated neonates
Effects of Pranayama Breathing Technique in Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      It will be randomized controlled trial. The research will be conducted at Bahawal Victoria
      hospital Bahawalpur and civil hospital Bahawalpur. We take 60 patients (Epitool), Patients
      will be allocated randomly in two groups. Group A will get conventional medical treatment and
      Group B will get both conventional medical treatment and pranayama breathing exercise. Both
      gender of age group 30 to 55, Patient with diagnosed Chronic obstructive pulmonary disease
      ,Moderate to severe Chronic obstructive pulmonary disease with productive cough, Shortness of
      breathe and no surgical procedure performed will be included in this study. And patients of
      lung surgery, lung cancer, above 70 years age, with open wound, cardiovascular issues, and
      neurological issues will be excluded. Yoga exercise pranayama, 6 min walk test, IPAQ- quality
      of life and VSAQ-exercise capacity will be used as tools. Data will be analyzed on SPSS 21.
    

Detailed description: 
      It will be randomized controlled trial. After approval of synopsis the research will be
      conducted at Bahawal Victoria hospital Bahawalpur and Sadiq abbasi hospital Bahawalpur.
      Written informed consent will be obtained. We take 60 patients (Epitool), Patients will be
      allocated randomly in two groups. Group A and group B. Group A will get conventional medical
      treatment and Group B will get both conventional medical treatment and pranayama breathing
      exercise. Both gender of age group 30 to 55, Patient with diagnosed COPD, Moderate to severe
      COPD with productive cough, SOB and no surgical procedure performed will be included in this
      study. And patients of lung surgery, lung cancer, above 70 years age, with open wound,
      cardiovascular issues, and neurological issues will be excluded. Yoga exercise pranayama, 6
      min walk test, IPAQ- quality of life and VSAQ-exercise capacity will be used as tools. Data
      will be analyzed on SPSS 21.
    

Intervention name(s): Nebulizer; Breathing Technique
Intervention type(s): Other; Other
Intervention description(s): Active Comparator: Nebulization every 3 days with the other medicine to the active comparator.; 15 repeatations of Breathing in morning and evening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pranayama; COPD; Dyspnea; Exercise tolerance
A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given to Healthy Female Volunteers
Condition: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to demonstrate a lack of effect of multiple doses of
      GSK189075 on the PK of an oral contraceptive pill in healthy female subjects. To estimate the
      effects of GSK189075 on hormonal levels and on birth control.
    


Intervention name(s): GSK189075; Brevicon
Intervention type(s): Drug; Drug
Intervention description(s): Given with Brevicon to determine any effects of GSK189075 on Brevicon PK.; Given with GSK189075 to determine if GSK189075 exerts an effect on GSK189075 PK.
Other intervention name(s): GSK189075
Intervention MeSH terms: Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy female,; pharmacokinetics,; pharmacodynamics; drug interaction,
The GLOW Study - The YANG System
Condition: Diabetes Mellitus; Glucose
Study type: Interventional

Summary: 
      This is an open label, interventional, monocentric, prospective early feasibility study,
      designed to evaluate the safety of implant and short-term integration into the tissue of the
      YANG sensor. In addition, the set up will enable data collection which will be used to
      develop the software algorithm to allow real-time, continuous measurement of glucose, ketone
      and lactate levels in the interstitial fluid in adults with diabetes mellitus, in a future
      version of the device.
    


Intervention name(s): The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement
Intervention type(s): Device
Intervention description(s): The YANG SENSOR is an active implantable device, that is intended to be implanted in the subcutaneous abdominal tissue, approximately 10mm below the skin. The SENSOR is battery powered. The battery is wirelessly recharged through the skin by the YANGEXD, using a charging coil ('Donut') applied to the skin with an adhesive patch at the level of the SENSOR. The 'Donut' also receives data from the sensor.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Cranberry Juice for Treatment of Urinary Tract Infections
Condition: Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether daily consumption of cranberry juice
      lessens the symptoms and prevents the recurrence of urinary tract infections (UTIs). This
      study will also determine whether drinking cranberry juice for 6 months selects for less
      virulent bacteria in the rectal, vaginal, and urethral areas.
    

Detailed description: 
      Participants in this study will be randomly assigned to consume either 8 ounces of cranberry
      juice or placebo juice twice a day for 6 months. Participants will have follow-up visits at 3
      and 6 months, and whenever they experience a symptomatic episode. Urine, vaginal and rectal
      specimens will be taken at each visit to test for the presence of bacteria that cause urinary
      tract infections. Participants will complete a questionnaire at study entry, Day 3, Weeks 1
      and 2, and monthly thereafter or whenever there is a recurrence of symptoms.
    

Intervention name(s): Cranberry juice; Placebo cranberry juice
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): TID dosage for UTI treatment; TID placebo dosage to match active comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vaccinium macrocarpon
The Effect of Mannitol on the Serum Potassium During Craniotomy
Condition: Mannitol Adverse Reaction; Hyperkalemia
MeSH terms: Hyperkalemia
Study type: Observational

Summary: 
      This is an observational study designed to research the effect of mannitol on the
      concentration of intraoperative serum potassium in patients undergoing craniotomy, and to
      guide the safe use of mannitol during craniotomy.
    

Detailed description: 
      Patients were assigned to receive 20% mannitol (1g/kg) solution administered intravenously
      15-20 minutes at the time of drilling skull.The serum potassium was measured by arterial
      blood gas analysis before infusion (T0), infusion finished (T1), 15min (T2), 30min (T3),
      60min (T4) and 120min (T5) after infusion.
    

Intervention name(s): Mannitol
Intervention type(s): Other
Intervention description(s): Mannitol was intravenous infused within 15-20 mins when drilling skull
Intervention MeSH terms: Mannitol
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients who are received craniotomy
Indigo Naturalis in Treating Atopic Dermatitis Topically
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      Atopic dermatitis (AD) is a chronic inflammatory skin disorder that most commonly occurs in
      children. The aims of this project are:

        1. To evaluate the efficacy of indigo naturalis ointment in treating AD topically;

        2. To evaluate the safety of indigo naturalis ointment in treating AD topically;

        3. To investigate whether indigo naturalis ointment treatment is associated with a change
           in total IgE, cytokines, eosinophils, and CRP in patients with AD;

        4. To evaluate whether indigo naturalis ointment treatment improves the quality of life in
           patients with AD.
    

Detailed description: 
      Atopic dermatitis (AD) is a chronic inflammatory skin disorder that most commonly occurs in
      children. AD is characterized by itchy and dry skin that affects approximately 5 to 20% of
      children in the world. Currently, corticosteroids are the most widely prescribed medication
      in treating AD; however, there are concerns regarding the side effects such as skin atrophy,
      telangiectasia, striae, folliculitis and adrenocortical suppression that inhibits growth in
      children. Many patients and families seek complementary and alternative medications such as
      traditional Chinese medicine (TCM). In TCM, indigo naturalis has been used to treat various
      infectious and inflammatory skin diseases for hundreds of years. Ancient TCM literature has
      recorded that indigo naturalis is also effective in treating facial eczema (AD) in infants.

      The aims of this project are: (1) To evaluate the efficacy of indigo naturalis ointment in
      treating AD topically; (2) To evaluate the safety of indigo naturalis ointment in treating AD
      topically; (3) To investigate whether indigo naturalis ointment treatment is associated with
      a change in total IgE, cytokines, eosinophils, and CRP in patients with AD; (4) To evaluate
      whether indigo naturalis ointment treatment improves the quality of life in patients with AD.
    

Intervention name(s): Indigo naturalis ointment; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Every 10 x 10 cm area of lesion requires 0.5 g of ointment, applied twice daily (morning and evening, separated by approximately 12±2 hours) for 6 weeks.; Every 10 x 10 cm area of lesion requires 0.5 g of ointment, applied twice daily (morning and evening, separated by approximately 12±2 hours) for 6 weeks.
Other intervention name(s): Lindioil ointment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Indigo Naturalis; Atopic Dermatitis; TCM
Is Theophylline More Effective Than Sumatriptan in the Treatment of Post-dural Puncture Headache
Condition: Post-Dural Puncture Headache
MeSH terms: Post-Dural Puncture Headache; Headache; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Objectives: To compare the safety and efficacy of oral theophylline versus oral sumatriptan
      in the treatment of post-dural puncture headache (PDPH).

      Background: PDPH is the most frequent complication of procedures associated with dural
      puncture for spinal anesthesia or following accidental dural puncture during epidural
      anesthesia. Since invasive treatments have known complications, pharmacologic management may
      be preferable.

      Patients and Methods: This was a prospective, randomized, double-blind, phase four clinical
      trial; carried out on 60 patients presented with PDPH at our hospital. Patients were randomly
      allocated into two equal groups (30 patients each); group T, received oral theophylline, and
      group S, received oral sumatriptan.
    


Intervention name(s): Theophylline Anhydrous Oral Tablet; Sumatriptan Succinate Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Theophylline tablet (150 mg/12h); Sumatriptan tablet (25 mg/12h)
Other intervention name(s): Quibron-T/SR tablets; Sumigran tablets
Intervention MeSH terms: Sumatriptan; Theophylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Post-dural puncture headache; Spinal anesthesia; Sumatriptan; Theophylline
Continuous Femoral Nerve Blockade and Readiness to Discharge Following Total Knee Arthroplasty
Condition: Knee Arthroplasty
Study type: Interventional

Summary: 
      Patients undergoing total knee arthroscopy (knee replacement) surgery usually receive a
      femoral nerve block as part of their anesthetic care. Some centers administer the block with
      a single shot of local anesthetic, which wears off several hours after surgery. Other centers
      administer the block with a single shot followed by continuous infusion of local anesthetic,
      typically for 2 to 5 days after surgery. The latter method, though good for pain control, may
      result in decreased mobility (while the anesthetic is still active), longer hospital stays,
      and greater risk of falls.

      This study will see if using a lower concentration of local anesthetic for the continuous
      femoral nerve block or only the initial single-shot dose will result in increased mobility
      and shorter hospital stays.
    


Intervention name(s): Bolus of 0.2% ropivicaine 20 mls followed by 0.2% ropivicaine at an infusion rate of 5mls/hr until 0600 on postoperative day 2; Bolus of 0.2% ropivicaine 20 mls followed by 0.1% ropivicaine at an infusion rate of 10mls/hr until 0600 on post-operative day 2; Saline control
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Initial bolus of 0.2% ropivicaine 20 mls into the femoral catheter followed by 0.2% ropivicaine at an infusion rate of 5mls/hr with patient controlled boluses of 5ml available every 30 mins, until 0600 on the morning of postoperative day 2; Initial bolus of 0.2% ropivicaine 20 mls into the femoral catheter followed by 0.1% ropivicaine at an infusion rate of 10mls/hr with patient controlled boluses of 10mls available every 30 mins, until 0600 on the morning of postoperative day 2; Bolus of 0.375% ropivicaine 30 mls followed by saline infusion until 0600 on postoperative day 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: continuous femoral nerve blockade; knee arthroplasty; knee replacement; regional anesthesia; readiness to discharge; Femoral nerve blockade for total knee arthroplasty
Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Volume s
Condition: Correction of Nasolabial Folds
Study type: Observational

Summary: 
      To evaluate long-term safety of YVOIRE volume s by incidence of adverse events including
      injection site local reactions and biodegradability.
    


Intervention name(s): YVOIRE volume s
Intervention type(s): Device
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subject who receive hyaluronic acid filler into the nasolabial folds
A Clinical Research About Using Irreversible Electroporation to Treat Locally Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional

Summary: 
      Pancreatic cancers is one the most important malignancies with highest mortality in the
      world. The prognosis of these patients is very poor. Although some patients with
      early-diagnosed disease could receive surgical intervention, a majority (70%to 80%) of
      patients present with locally advanced or metastatic status are inoperable. Patients in this
      late status usually are recommended to receive palliative bypass operation such as
      choledochojejunostomy and/or gastrojejunostomy and palliative radiotherapy for the pancreatic
      cancer. Radiofrequency ablation (RFA) used to be expected an alternative therapy. However,
      the main drawback of RFA is its side effect to damage adjacent structure such as bile duct,
      and the tumors located adjacent to vessels could not be ablated well.
    

Detailed description: 
      Irreversible electroporation (IRE), developed and manufactured by AngioDynamics US Ltd, can
      ablate tumor by fenestrating the cancer cell membrane by electric pulse. The anti-tumor
      effect does not result from thermotherapy, so is also not diminished by adjacent vessels.
      Several pre-clinical and clinical studies have already demonstrated IRE is a safe and
      effective treatment, and the adjacent tissue such as vessels and ductal structures will be
      spared. Recently, IRE had been used to treat pancreatic cancer successfully, and the safety
      is satisfactory. The system has been approved as safe by the European Union (EU) in 2008 and
      received Food and Drug Administration (FDA) approval in 2010. However, there are still few
      experiences in using IRE for tumor ablation in Taiwan. In this study, the investigators will
      perform IRE for inoperable patients with locally advanced pancreatic cancers. They will
      receive IRE during the operation of palliative bypass operation including
      choledochojejunostomy and/or gastrojejunostomy. The investigators will evaluate the potential
      side effect and ablate effect of tumors, and also follow-up the patients for 2 years to
      evaluate the overall survival. The investigators will appraisal the clinical feasibility and
      advantage of the system by this study.
    

Intervention name(s): Irreversible Electroporation (IRE) System
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: irreversible electroporation; pancreatic cancer
Impact Evaluation of Training Civil Servants on Violence Against Women in Medellín, Colombia
Condition: Violence Against Women (VAW)
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the training of civil servants leads to a
      reduction in the violence suffered by women, as well as in their psychological wellbeing and
      attitudes towards violence.
    

Detailed description: 
      The Secretary of Women of Medellin, through the ICONTEC, intends to conduct training to
      officials of the 22 family commissioners in Medellin. The objective of these trainings is to
      standardize procedures in order that women do not feel re-victimized and can forward
      complaints. Since the training will be done in phases in 2014 and there is willingness of
      relevant stakeholders to generate a random order on which commissioners the training is first
      performed, it can be done a cluster randomized trial.

      We will require all 22 commissioners to be randomly assigned into two groups, one treatment
      and one control. To implement it is intended to:

        -  Conduct a baseline survey amongst women who used the services of the commissionaires
           between June and Septmber 2013, completed the process of care and signed informed
           consent.

        -  Training of a randomly chosen set of 11 commissioners will take place between June and
           September 2014.

        -  Conduct an endline survey amongst women who used the services of any of the 22
           commissionaires between June and September 2014, completed the process of care and
           signed informed consent.

      Women will be contacted through the commissioners. Women who have completed the process of
      care will be ask whether they want to participate in the study. If they agree, their contact
      details will transfer to the investigators for the survey to be conducted. This process would
      be conducted twice for baseline information before beginning the training, and for endline,
      once half of the first 11 commissioners have been trained.
    

Intervention name(s): Training civil servants on attention to violence against women
Intervention type(s): Behavioral
Intervention description(s): The Secretary of Women of Medellin, through the ICONTEC, intends to conduct training to officials of the 22 family commissioners in Medellin. The objective of these trainings is to standardize procedures in order that women do not feel re-victimized and can forward complaints.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment