bioihbjkbjnl/mcl2 huggingface dataset:
Community-Based Cervical Cancer Prevention and Education Among Women Living With HIV
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The long-term goal is to build a sustainable, community-based outreach program to promote
      cervical cancer screening among women living with HIV (WLH), thereby reducing related
      morbidity and mortality. The strategy for achieving this goal is to develop an intervention
      incorporating health literacy approaches and principles of community-based participatory
      research. Health literacy is a relatively new concept that has been applied mainly toward
      identifying high-risk individuals rather than toward changing health behaviors and outcomes.
      The proposed intervention is the first to integrate health literacy into educating WLH to
      promote cervical cancer screening. Community Health Workers (CHW) support has also rarely
      been incorporated into cancer screening interventions targeting WLH, making the proposed
      intervention a uniquely comprehensive approach. Building on recent successful testing by the
      investigators of a health literacy-focused intervention to promote cervical cancer screening
      in recent immigrant women, the investigators will test whether health literacy-focused
      interventions delivered by trained CHWs will be effective in promoting health literacy and
      increasing Pap test rates in a new population, WLH. The investigators hypothesize that,
      compared to WLH in the control group, WLH who receive the health literacy-focused CHW
      intervention will demonstrate: (1) higher rates of Pap test, (2) greater levels of health
      literacy, (3) higher levels of cervical cancer knowledge, and (4) higher self-efficacy.
    


Intervention name(s): Health-Literacy Focused Education Session
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study Determining Safety and Efficacy of Avena Sativa (Oat) Skincare Products for Treating Skin Dryness and Itching in Cancer Patients
Condition: Ichthyosis; Pruritus
MeSH terms: Ichthyosis; Pruritus
Study type: Interventional

Summary: 
      This study will test the safety and efficacy of three topical agents containing oat kernel
      flour to determine how well they relieve skin dryness and itching related to cancer
      therapies. Participants will receive a body wash, a body cream, and an anti-itch balm to use
      at home for 4-6 weeks.
    

Detailed description: 
      Many patients undergoing cancer therapies experience skin reactions like dry skin, rash,
      redness, itchiness, and hyperpigmentation. Dry skin and itching are especially common for
      those undergoing chemotherapy and targeted treatments.

      Skincare products containing Avena sativa (oat) kernel flour have a long history of tolerance
      and efficacy in treating various skin conditions involving pruritus (itching) and xerosis
      (dry skin), as Avena sativa (oat) kernel flour is known for its skin protectant properties
      and soothing effects on skin. This study will evaluate the safety and efficacy of a regimen
      of three topical agents containing Avena sativa (oat) kernel flour for cancer patients
      experiencing mild to moderate pruritus and/or xerosis.

      Participants will received the products at Baseline (Visit 1) and return to the clinical site
      at Week 5 +/- 1 week for Visit 2. In addition, questionnaires will be completed remotely
      between Baseline and Visit 2.
    

Intervention name(s): Avena Sativa Skincare Regimen
Intervention type(s): Other
Intervention description(s): Regimen consisting of 3 topical agents containing Avena Sativa (oat) kernel flour: a body wash (type = cosmetic), a body cream (type = cosmetic), and an anti-itch balm (type = OTC monograph drug with 0.5% Pramoxine HCl)
Intervention model: Single Group Assignment
Intervention model description: All participants will receive the same study regimen consisting of 3 products: a body wash, a body cream, and an anti-itch balm.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pruritis; Itching; Dryness; Xerosis
Clinical Study of hUC-MSCs Treating Decompensated Liver Cirrhosis With HBV
Condition: HBV
MeSH terms: Liver Cirrhosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study was to observe the safety ,tolerability ,Efficacy dose of human
      umbilical cord mesenchymal stem cells in patients of decompensated liver cirrhosis with HBV.
    

Detailed description: 
      Investigators plan to recruit 24 voluntary patients of decompensate liver cirrhosis with HBV,
      dividing them into 3 group：1) low-dose group: 100mL with 2.5×10^7 cells；2) medium-dose group:
      100mL with 5.0×10^7 cells；3) high-dose group: 100mL with 1.0×10^8 cells. Each group contains
      8 patients. Investigators treat the participants with human umbilical cord mesenchymal stem
      cells via venous transfusion. First investigators arrange a whole test for participants, such
      as vital sign examination, laboratory test, ECG, CT, MRI, ultrasound etc. Investigators
      screen these patients with a complete eligibility criteria. Then investigators proceed the
      therapy in the 1st, 8th and 15th day. There are 8 times of follow-up visit for these
      patients, 4 times of those are proceeded during the hospitalization, while other 4 times
      happens after the discharge. The follow-up visit includes vital sign examination, laboratory
      test, ECG, CT, MRI, ultrasound, Child-Pugh grade, MELD grade, SF-36 test. These follow-up
      visit last 24 weeks since the first treatment. After that, investigators also arrange a
      survival visit through phone or clinic each 6 months, lasting another 1.5 years. The main
      object of this research is investigating the survival rate, promotion of the liver function,
      improvement of health, safety of hUC-MSCs, tolerability of patients, for exploring a new way
      for the therapy of decompensated liver cirrhosis with HBV.
    

Intervention name(s): hUCMSCs
Intervention type(s): Biological
Intervention description(s): Human umbilical cord mesenchymal stem cell preparation, 100ml/ bag, containing 2.5×107 cells, 5.0×107 cells, 1.0 x 108 cells
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: We allocate 24 participants into 3 group, low-dose, medium-dose and high-dose group. It is going to proceeded sequential from low-dose group to high-dose group. Next group is allowed to be started only the last group has been finished.
Low-dose group: 100mL human umbilical cord mesenchymal stem cell preparation, containing 2.5×10^7 cells;
medium-dose group: 100mL human umbilical cord mesenchymal stem cell preparation, containing 5.0×10^7 cells;
High-dose group: 100mL human umbilical cord mesenchymal stem cell preparation, containing 1.0×10^8 cells
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Study of Optimized CT-guided Pulmonary Nodule Microcoil Localization Technique
Condition: Pulmonary Nodule, Solitary
MeSH terms: Multiple Pulmonary Nodules; Solitary Pulmonary Nodule
Study type: Interventional

Summary: 
      In the early stage of the study, the CT-guided micro-coil locating method for pulmonary small
      nodules was optimized. This study will use a single set of target values non-randomized
      controlled trials to evaluate the safety and effectiveness of the optimized pre-loaded
      micro-coil locating method in pulmonary small nodules.
    

Detailed description: 
      A series of optimization and improvement measures were tried for the complications of the
      CT-guided micro-coil locating method. After discussion, the method of micro-coil pre-loaded
      in the puncture needle and sealed first, and then for subsequent locating has more
      advantageous. The method avoids the direct penetration of the puncture needle into the
      atmosphere during operation, and the operation is simpler. In vitro tests of isolated lung
      specimens and pre-tests of 9 clinical patients were carried out. The results showed that this
      method not only reduced the number of operators on site, but also had the tendency to shorten
      the operation time, reduce the incidence of pneumothorax, and improve the success rate.
      However, there is currently no rigorous scientific research to provide objective evidence for
      its safety and effectiveness.

      Therefore, this study intends to use a single set of target values non-randomized controlled
      trials to evaluate the safety and effectiveness of the optimized pre-loaded micro-coil
      locating method in pulmonary small nodules.
    

Intervention name(s): Optimized Localization Technique
Intervention type(s): Procedure
Intervention description(s): The small pulmonary nodules of the subjects will be located using an optimized pre-loaded microcoil puncture locating method.
Intervention model: Single Group Assignment
Intervention model description: This study intends to use a single set of target values for non-randomized controlled trials, and enrolled 120 subjects who met the inclusion criteria. The small pulmonary nodules were located using an optimized pre-loaded microcoil puncture positioning method. Observe the clinical indicators such as pneumothorax incidence rate, positioning success rate, other complication rate, operation time, and number of operators, and evaluate the safety and effectiveness of the optimized CT-guided pulmonary nodule microcoil localization technique.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Micro-coil; CT-guided locate
Clinical Trial of Anusol Ointment for Symptom Relief in Patients With Haemorrhoids
Condition: Hemorrhoids
MeSH terms: Hemorrhoids
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of Anusol topical ointment for
      the relief of internal and external haemorrhoid symptoms in people with Grades I-III
      haemorrhoids compared to a placebo (the study medication without the active ingredients) and
      a benchmark product.
    

Detailed description: 
      Adult patients with haemorrhoids meeting all the eligibility criteria will be allocated in
      three study arms: test, placebo and benchmark. Approximately twenty-two subjects per group
      will be enrolled to assure that approximately 20 subjects in each group complete the study.
      The study will be conducted in Armenia.The study will last approximately 2 weeks for each
      subject and will consist of 3 visits. The first subject first visit is planned for June 2021,
      and the study will continue until the target sample size is reached.
    

Intervention name(s): Anusol; Relief [Name]; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Daily at night and in the morning and after each bowel movement for two weeks; Daily at night and in the morning and after each bowel movement for two weeks; Daily at night and in the morning and after each bowel movement for two weeks
Other intervention name(s): Anusol Ointment (Zinc oxide, Bismuth subgallate, Balsam peru), Bismuth oxide); RELIEF rectal ointment (phenylephrine hydrochloride); Placebo ointment (Anusol ointment without active ingredients)
Intervention MeSH terms: Bismuth subgallate; Phenylephrine; Oxymetazoline; Zinc Oxide; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Determine the Effect of Food on the Pharmacokinetics of PCI-32765
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the effect of food and two modified fasting regimens
      on the pharmacokinetics (study of what the body does to a drug) of PCI-32765 in healthy adult
      participants.
    

Detailed description: 
      This is a randomized (individuals will be assigned by chance to study treatments), open-label
      (identity of assigned study drug will be known), 4-way crossover study to compare the effect
      of food and two fasting regimens on the pharmacokinetics of PCI-32765 in healthy adults.
      There will be approximately 52 (at least 25% women) participants (11 in each sequence in the
      4-way crossover and 8 in an optional cohort). A screening phase will be followed by an
      open-label treatment phase consisting of 4 single-dose treatment periods of 420 mg PCI-32765
      administered with or without food. Doses in successive open-label treatment periods will be
      separated by a washout period of 7 days. Participants will be confined to the study center
      from Day -1 of each treatment period (at least 10 hours before each study drug
      administration) until completion of the 72 hour pharmacokinetic blood sample collection on
      Day 4 of Period 4. Blood samples for pharmacokinetic analysis of PCI-32765 and metabolite
      PCI-45227 will be collected before dosing and over 72 hours after dosing in each treatment
      period. A follow-up visit approximately 10 days after the last dose will be made to measure
      lymphocyte count and to capture any additional adverse events. After completion of the 4-way
      crossover portion of the study, and in absence of significant safety observations at the 420
      mg PCI-32765 dose, an additional separate cohort of 8 participants may be enrolled to
      participate in one treatment period and receive a dose of 840 mg in combination with a
      high-fat breakfast. Safety will be assessed throughout the study. The total study duration is
      a maximum of 85 days.
    

Intervention name(s): Sequence 1: PCI-32765; Sequence 2: PCI-32765; Sequence 3: PCI-32765; Sequence 4: PCI-32765; Sequence 5: PCI-32765
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Period 1 = Treatment D, Period 2 = Treatment C, Period 3 = Treatment A, Period 4 = Treatment B; Period 1 = Treatment A, Period 2 = Treatment D, Period 3 = Treatment B, Period 4 = Treatment C; Period 1 = Treatment B, Period 2 = Treatment A, Period 3 = Treatment C, Period 4 = Treatment D; Period 1 = Treatment C, Period 2 = Treatment B, Period 3 = Treatment D, Period 4 = Treatment A; After completion of the 4-way crossover, an additional separate cohort of 8 subjects were enrolled. These subjects participated in 1 treatment period to document safety and PK
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteers; PCI-32765; PCI-45227; Pharmacokinetics
Safety and Causal Prophylactic Efficacy of KAF156 in a Controlled Human Malaria Challenge Model
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to investigate the safety and causal prophylactic efficacy of KAF156
      in healthy subjects using a controlled human malaria infection model.
    


Intervention name(s): KAF156; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg tablet, 20 mg tablet, 50 mg tablet; 100 mg tablet, 20 mg tablet, 50 mg tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Malaria; KAF156; P. falciparum
Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method
Condition: Common Bile Duct Stone; Malignant Hepatobiliary Neoplasm; Biliary Stricture; Pancreatic Diseases; Sphincter of Oddi Dysfunction
MeSH terms: Pancreatic Diseases; Sphincter of Oddi Dysfunction
Study type: Interventional

Summary: 
      The aim of this study are to evaluate the feasibility of needle knife fistulotomy (NKF) as an
      initial procedure for biliary access in patients with biliary disease who are at increased
      risk for post-endoscopic retrograde endoscopic retrograde cholangiopancreatography (PEP) and
      to assess the incidence rate of complications including PEP between NKF and conventional
      cannulation methods.
    

Detailed description: 
      Endoscopic retrograde endoscopic retrograde cholangiopancreatography (ERCP) is widely used
      for the diagnosis and treatment of pancreatic and biliary tract disease. However, post-ERCP
      pancreatitis (PEP) is the most common adverse event following the procedure, ranging from 2%
      to 10% in nonselective cases, and it can cause substantial morbidity, mortality, or high
      medical costs. Recent advances in cannulation technique and accessories for biliary
      cannulation have contributed to reduce the incidence of PEP, but biliary cannulation can fail
      in 5% to 20% of cases of ERCP. Suprapapillary needle-knife fistulotomy (NKF), with or without
      large-diameter balloon dilation, has been used as a rescue method in cases of difficult
      biliary cannulation, and NKF was recommended as an initial approach to selective biliary
      cannulation in cases of repetitive unintentional pancreatic cannulation.9 Moreover, difficult
      biliary cannulation is known to be a risk factor for PEP, and it has been reported that NKF
      is associated with a low risk of PEP. Thus, we hypothesized that NKF may reduce the risk of
      PEP in patients who are at increased risk for PEP.
    

Intervention name(s): cannulation of ampulla of Vater
Intervention type(s): Device
Intervention description(s): Cannulation of ampulla of Vater is a procedure that a guide-wire is passed through ampulla using interventional devices
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Dose Response Study of Levalbuterol in the Prevention of Exercise Induced Bronchoconstriction Compared to Racemic Albuterol in Pediatric Subjects
Condition: Asthma; Bronchoconstriction
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate, using an exercise challenge approach, the dose
      response of levalbuterol HFA MDI in pediatric subjects with asthma
    

Detailed description: 
      A randomized, double-blind, active controlled, multicenter, parallel treatment, 3x3 dose
      level crossover study evaluating the dose response of levalbuterol in pediatric subjects
      between the ages of 6 and 11, inclusive with exercise induced bronchoconstriction. This study
      was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by
      Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion
      Pharmaceuticals Inc.
    

Intervention name(s): Levalbuterol HFA MDI; Racemic Albuterol
Intervention type(s): Drug; Drug
Intervention description(s): levalbuterol 45 µg (1 actuation of 45 µg); (b) levalbuterol 90 µg (2 actuation of 45 µg) and (c) levalbuterol 180 µg (4 actuations of 45 µg each).
Arm #A
Xopenex HFA MDI; racemic albuterol 90 µg (1 actuation of 90 µg); (b) racemic albuterol 180 µg (2 actuations of 90 µg) and (c) racemic albuterol 360 µg (4 actuations of 90 µg).
Arm #B
Proventil HFA MDI
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Exercised induced bronchoconstriction
Task Oriented Activities Based on NDT Therapy Principles
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Cerebral palsy (CP) is one of the primary causes of disability effecting majority of
      pediatric population. Cerebral Palsy is considered a neurological disorder caused by a
      non-progressive brain injury or malformation that occurs while the child's brain is under
      development. The worldwide incidence of cerebral palsy is it affects three to four
      individuals out of 1000 individuals in the general population. Cerebral palsy has different
      types depending upon the severity of disease or the area of the body it is affecting. Amongst
      the different types of CP, spastic diplegia is the most common type which mainly affects the
      lower extremities and lesser extent to upper extremities. It mainly affects functional
      performance and gait.
    

Detailed description: 
      This study will be conducted on 20 subjects which would be equally divided into experimental
      and control groups. Trunk control measurement scale (TCMS) and quality of upper extremity
      skills test (QUEST) will be the tools used in this study. Pre and post values of the effects
      of intervention will be evaluated. The significance of this study is that it will help us how
      to improve trunk control and upper extremity function in spastic dipegic children. Data will
      be analyzed using SPSS 22.0. Mean and standard deviation will be calculated. Appropriate
      statistical test will be used after checking normality of data.
    

Intervention name(s): Neurodevelopmental therapy treatment; conventional physiotherapy
Intervention type(s): Other; Other
Intervention description(s): The group will receive NDT therapy; conventional physiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It is a randomized control trial, used to compare conventional physiotherapt and neurodevelopmental therapy approaches on trunk control and upper extremity function in spastic diplegic cerebral palsy patients. subjects with spastic diplegic cerebral palsy meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: CP, NDT therapy, task-oriented training, trunk control
Impact of Left Atrial Function on Postoperative Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      We aimed to demonstrate the impact of left atrial functions which were evaluated by three
      different echocardiographic modalities , on postoperative atrial fibrillation.
    

Detailed description: 
      Postoperative atrial fibrillation after coronary artery bypass greft operation (CABG) is
      major complication with a prevalence of 10-50%. Although the men mechanism is not known, in
      recent studies, age and left atrial function have been demonstrated as the most responsible
      factors. Velocity vector imaging (VVI) is a new modality which may give accurate and detailed
      information on both left atrial segmental and global function. In this study, our aim was to
      assess preoperative left atrial function by using three different echocardiographic
      modalities, VVI, tissue Doppler imaging and conventional echocardiography and evaluate the
      relation between the left atrial functions and the development of post-operative atrial
      fibrillation after CABG.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Tertiary care clinic
      
Keywords: atrial fibrillation, left atrium, velocity vector imaging