bioihbjkbjnl/mcl2 huggingface dataset:
Resect and Discard Strategy in Clinical Practice
Condition: Endoscopic Assessment; Colonic Polyps; Endoscopic Surveillance; NBI
MeSH terms: Colonic Polyps
Study type: Observational

Summary: 
      Nowadays, post-polypectomy surveillance intervals are determined by combining endoscopic and
      pathologic data. Real-time imaging technologies, have shown promising results in
      discriminating adenomatous from non-adenomatous polyps.

      The "resect and discard strategy" for small polyps (based on real-time assessment of the
      histology and on the endoscopic resection without pathological examination) has been shown to
      be cost-effective in simulation models. No data exist about the impact of this strategy in
      clinical practice.

      The aim of present study was to assess whether the systematic use, in the everyday clinical
      practice, of the "resect and discard strategy" allows to correctly manage patients with small
      colonic polyps.
    


Intervention name(s): endoscopic assessment of colonic polyps
Intervention type(s): Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive adult outpatients undergoing colonoscopy for routine clinical indications
Fecal Transplantation in Patients With IBS
Condition: IBS - Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The study will characterize the biology of FMT in the context of IBS prior to wider clinical
      application of the method. Given the ethical concerns of unknown and long-term adverse
      effects of FMT therapy, the study will include patients only with moderate to severe
      symptoms. IBS is a heterogenous disorder and it is important to characterize the patients,
      and study as homogeneous patient populations as possible. Therefore the study will only
      include post-infectious IBS patients after the Giardia outbreak.
    

Detailed description: 
      Primary aims:

      Detailed characterisation of donor and recipient microbial community composition (by means of
      16S rRNA profiling) and determination of the kinetics of changes following FMT

      Secondary aims:

        -  Determination of interactions of importance to persisting recipient gut microbiota.

        -  Evaluate safety of FMT in an IBS population

        -  To evaluate the efficacy of FMT in relieving symptoms in selected patients with IBS in
           an open pilot trial in order to have the possibility to calculate number of patients
           needed when planning future controlled studies.
    

Intervention name(s): fecal suspension
Intervention type(s): Dietary Supplement
Intervention description(s): helathy donor fecal suspension administered by duodenal scope
Intervention model: Single Group Assignment
Intervention model description: Open pilot study
Masking: None (Open Label)
Primary purpose: Treatment
Non-invasive Measures of Distal Lung Disease in Asthmatics
Condition: Asthma
MeSH terms: Lung Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4, single center study conducted in mild-to moderate asthmatics.
    

Detailed description: 
      The study consists of 3 phases. There are 7 study visits.
    

Intervention name(s): QVAR; Advair; Servent Diskus
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 480 mcg; 250/50 mcg; 50 mcg
Other intervention name(s): beclomethasone dipropionate HFA; Advair Diskus
Intervention MeSH terms: Beclomethasone; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts
Condition: Warts; Warts Hand; Verruca
MeSH terms: Warts
Study type: Interventional

Summary: 
      This prospective, multicenter, single-blinded, randomized comparison study is designed to
      compare the safety and effectiveness of the CellFX System to Cryosurgery for the clearance of
      cutaneous non-genital common warts on all areas of the body excluding the scalp, nose, within
      the orbital region of the face, plantar or periungual area in healthy adult subjects.
    

Detailed description: 
      The study will enroll healthy adult subjects with a minimum of two cutaneous non-genital
      warts, excluding the face, with each wart lesion not exceeding 10 x 10mm. Macrophotography of
      all study warts will be captured along with a blinded site Investigator to characterize wart
      healing, wart clearance and wart reduction. All subjects will be followed at 7, 30, 60, and
      90-days following the last CellFX or Cryosurgical Procedure. All wart lesions are eligible
      for up to a total of 3 treatments over the course of the study. Adverse events will be
      documented.
    

Intervention name(s): CellFX System Device; Cryosurgery Liquid Nitrogen Sprayer
Intervention type(s): Device; Device
Intervention description(s): The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.; Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: CellFX; Nano-Pulse Stimulation; NPS; Clearance; Wart Reduction
Graston vs Manual Myofascial Release Technique in Piriformis Syndrome.
Condition: Piriformis Syndrome
MeSH terms: Piriformis Muscle Syndrome; Syndrome
Study type: Interventional

Summary: 
      The objective of our study is to compare the effects of Graston and manual myofascial release
      technique on pain, muscle length and functional status in patients with Piriformis syndrome.
    

Detailed description: 
      In 2019, a study was conducted to conclude the effectiveness of Passive stretching v/s
      Myofascial release in improving Piriformis flexibility in females. They reported that
      myofascial release was more valuable than passive stretching exercises in enhancing
      piriformis flexibility in patients with piriformis tightness.

      According to another study in 2018, after a single treatment, compressive myofascial release
      showed more improvement in ankle dorsiflexion than Graston technique, in participants with
      decrease dorsiflexion range.

      In 2016, a study reported the effects of the Graston technique and general exercise in
      patients with chronic low back pain. Graston group showed greater improvement in pain and
      range of motion in patients with chronic low back pain.

      According to a study conducted in 2014, self-myofascial release was more effective than
      Graston technique in improving knee joint flexibility, hamstring, and quadriceps strength.

      In 2011, a study evaluated the effectiveness of deep soft tissue mobilization techniques and
      stretching exercises in piriformis syndrome and found that the deep soft tissue mobilization
      techniques along with stretching exercises significantly improved the piriformis syndrome.
    

Intervention name(s): Graston; Manual myofascial release
Intervention type(s): Other; Other
Intervention description(s): Ultrasound for 10 mins/1 set/ (3 sessions/week), Graston for 5 mins/1 set/ (3 sessions/week), Piriformis stretching exercises/ 10 reps with 30 sec hold/ 1 set/(3 sessions/week), Hip abductor strengthening/10 reps/1 set/(3 weeks), Hip extensor strengthening/10 reps/1 set/(3 weeks),
A total of 9 sessions for 3 weeks (3 sessions/week) were given each consisting of 20 mins.; Ultrasound for 10 mins/1 set/ (3 sessions/week), Manual myofascial release for 5 mins/1 set/ (3 sessions/week), Piriformis stretching exercises/ 10 reps with 30 sec hold/ 1 set/(3 sessions/week), Hip abductor strengthening/10 reps/1 set/(3 weeks), Hip extensor strengthening/10 reps/1 set/(3 weeks),
A total of 9 sessions for 3 weeks (3 sessions/week) were given each consisting of 20 mins.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Both groups were treated simultaneously with their specified treatment techniques within given duration.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Graston technique; Myofascial release; Lower extremity functional scale; Piriformis syndrome
EUS-guided Biliary Drainage vs. ERCP Assisted Transpapillary Drainage for Malignant Biliary Obstruction
Condition: Malignant Biliary Obstruction
Study type: Interventional

Summary: 
      Purpose of the study: To compare efficacy, stent patency, re-intervention rate, cost, quality
      of life, survival time, and adverse events between EUS-guide biliary drainage (EUS-BD) and
      ERCP assisted trans-papillary drainage for malignant biliary obstruction.

      Subjects of the study: Patients who have malignant biliary obstruction.

      Methods of the study:

        -  Prospective randomized controlled study

        -  Patients were randomly divided into two groups, EUS-BD group or ERCP group

        -  Patients will get assigned procedure (EUS-BD or ERCP assisted trans-papillary
           drainage)for decompression of malignant biliary obstruction

        -  After the procedure, regular follow up, blood test, and imaging test will be done to
           check sufficient biliary decompression, stent patency, re-intervention rate, cost,
           quality of life, survival time, and adverse events rate.

      Statistical methods: SPSS 23.0 statistical software was used. The measurement data was
      expressed as x± s, and t-test or non-parametric test was used. Chi-square test was used for
      count data.
    

Detailed description: 
      ERCP is a well-established procedure for the management of malignant biliary obstruction.
      However, even in expert hands, ERCP fails in 3%-5% of cases, especially in patients with
      surgically altered anatomy or difficult biliary cannulation. In these cases, more invasive
      options are usually considered, which including percutaneous trans-hepatic biliary drainage
      and surgical intervention, but they all have been associated with a higher risk of
      complications and prolonged hospital stay. EUS-guide biliary drainage using a metal stent,
      particularly a lumen-apposing metal stent, is a promising technique for biliary decompression
      in patients with failed ERCP. There has been growing global experience with EUS-BD in recent
      years, and data from expert centers support the feasibility and efficacy of EUS-BD. However,
      few researches compared the efficacy and complication rates between EUS-BD and ERCP for
      malignant biliary obstruction. The investigators herein aim to conduct a randomized
      controlled clinical trial to compare the efficacy and complication rates between EUS-BD and
      ERCP for malignant biliary obstruction.
    

Intervention name(s): ERCP assisted trans-papillary drainage for malignant biliary obstruction; EUS-guide biliary drainage for malignant biliary obstruction
Intervention type(s): Procedure; Procedure
Intervention description(s): ERCP assisted trans-papillary drainage for malignant biliary obstruction; EUS-guide biliary drainage for malignant biliary obstruction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Personalized Dietary Advice on Health Status of Diabetes Type 2 Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study addresses the challenge of increasing compliance with dietary recommendations and
      guidelines among diabetes type 2 patients by introducing professional dietary advice based on
      individual requirements.

      The objective of this study is to assess the effect of the Personalized Dietary Advice
      Services (PDAS) after a three month intervention on established markers of nutritional and
      health status in diabetes type 2 patients (HbA1c, glucose, insulin). Besides, the effect of
      the PDAS on perceived health status of diabetes type 2 patients will be assessed.
    

Detailed description: 
      This study will be a randomized control trial studying the effect of personalized dietary
      advice services on established markers of nutrition and health status of diabetes type 2
      patients. This dietary advice will be based on individual genetic, blood and food intake
      profiles, which will be measured at the start of the study.

      The dietitian will provide this personalized dietary advice, during the regular patient
      visits. In the control group, the dietitian will give the regular dietary advice.

      The study will start with a run-in period of two weeks, during which baseline measures will
      be done. After the run-in period, the three-month study will start with a first dietary
      consult during which the dietitian will use the personalized dietary advice services for
      providing dietary advice in the experimental group.
    

Intervention name(s): Personalized Dietary Advice Services; Regular care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This Personalized Dietary Advice is based on markers for nutrition status and SNPs (single nucleotide polymorphisms).
This advice is given via Personalized Dietary Advice Services, in which health data of the client can be entered and will be translated into advice on intake of specific nutrients or food categories.; The control group will receive usual advice for diabetes type 2 from the dietician. However, after the end of the study participants in the control group will be offered the opportunity to receive the Personalized Dietary Advice from their dietician, as based on the parameters measured during the study.
Other intervention name(s): Algorithms for personalized dietary advice; Food4Me algorithms; Dietary advice based on individual health status
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dietary services; personalized advice; biological markers
Maintenance After Induction Chemotherapy in Elderly Patients With Advanced Non-small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer (Squamous or Non Squamous)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      For elderly patient, the treatment of Non Small Cell Lung Cancer was based on monotherapy but
      IFCT-0501 trial begun in 2006, demonstrated that a bitherapy (carboplatin and paclitaxel) is
      better than monotherapy in term of overall survival and progression free survival. The
      current recommendations are now to administer a carboplatin based bitherapy (4 or 6 cycles).
      After the treatment is stopped until progression and initiation of a second line treatment.
      The risk of this strategy is to be confronted to a rapid disease progression during the free
      interval. Indeed, about 1/3 of the patients whose disease was controlled after the
      chemotherapy do not receive 2nd line. The concept of maintenance is based on a continuous
      therapeutic pressure in order to preserve the therapeutic profit obtained by the treatment of
      1st line (induction chemotherapy).

      There is two types of maintenance :

        -  continuous maintenance therapy which consists in continuing the treatment initially
           associated with platinum until disease progression.

        -  switch maintenance which consists in introducing a new treatment after the end of
           induction chemotherapy The two types are validated by several trials. The marketing
           authorization of pemetrexed was enlarged to maintenance for non squamous carcinoma.

      Gemcitabine has a good tolerance profile which make possible the use in a maintenance
      strategy. Several trials evaluated maintenance with this product and some show benefits in
      term of progression free survival.

      The objective of this trial is to evaluate the switch maintenance in elderly patient with a
      controlled disease after 4 cycles of chemotherapy carboplatin-paclitaxel.
    


Intervention name(s): Pemetrexed; Gemcitabine; Induction chemotherapy
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 4 cycles of carboplatin-paclitaxel
Intervention MeSH terms: Gemcitabine; Pemetrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Elderly; lung cancer; switch; maintenance; Elderly patients (between 70 and 89 years); NSCLC; IFCT
Efficacy of Peroperative Suction Drain Usage in Arthroscopic Knee Surgery
Condition: Chondropathy; Knee Effusion; Knee Hemarthrosis
MeSH terms: Hemarthrosis
Study type: Interventional

Summary: 
      The study was designed to investigate efficacy of suction drains in arthroscopic knee
      surgery, rather than anterior cruciate ligament (ACL) reconstruction. two groups were
      randomised, and suction drain was applied to one group, and the other group as the control
      group without a suction drain.
    

Detailed description: 
      The groups were compared in terms of patellar shock, knee effusion, knee scoring systems,
      range of motion, loss of labour, hospitalization time. Also different arthroscopic procedures
      such as meniscectomy, meniscus repair, synovectomy and microfracture were evaluated in terms
      of need for a suction drain. The controls was at 1st and 15th day, 6th week and 3rd month.
    

Intervention name(s): Suction drain; No suction drain
Intervention type(s): Device; Device
Intervention description(s): A suction drain is used to remove excess fluid from tissues after surgery.; A suction drain is used to remove excess fluid from tissues after surgery.
Other intervention name(s): Hemovac drain
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: suction drain; knee arthroscopy; knee pain
Wear Experience With Daily Toric Contact Lenses Over a Long Day
Condition: Contact Lens; Astigmatism of Both Eyes
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      This study is evaluating the wear experience of a daily toric contact lens after 10, 12, 14,
      and 16 hours of lens wear.
    


Intervention name(s): Precision1® Daily Disposable Toric Contact Lens
Intervention type(s): Device
Intervention description(s): Soft, toric contact lens used to correct distance vision and astigmatism.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Toric Contact Lens; Daily Contact Lens
Offering Free Fruits and Vegetables to Men at Risk of Poverty
Condition: Dietary Habits
Study type: Interventional

Summary: 
      The study aims to investigate whether the provision of free fresh fruits and vegetables to
      middle-aged men at risk of poverty increases their fruit and vegetable intake over a period
      of 4 weeks.
    

Detailed description: 
      A total of 100 men (> 30 years, living alone) with a low SES will be randomly assigned to a
      control or intervention group while controlling for food bank use. The intervention group
      will receive free fresh fruits and vegetables consisting of 2 daily portions of their
      favorite variety over a period of 4 weeks which will be provided to them once per week.

      All participants will be asked to fill out a demographic questionnaire as well as a Food
      Frequency Questionnaire (FFQ), a questionnaire on variety of fruits and vegetables consumed
      and a 24-h-food-recall questionnaire. All questionnaires will be administered by trained
      interviewers. During the study period, the 24h-food recall questionnaire will be administered
      four more times; two times before the 4-week intervention period and two times after the
      intervention period. After the 4-week intervention period, interviewers will administered the
      FFQ and the questionnaire on variety.

      Participants assigned to the control group will receive a fruit and vegetable basket after 4
      weeks after baseline.

      All participants will receive gift certificates for local supermarkets in the amount of 35,00
      €.
    

Intervention name(s): Intervention Group
Intervention type(s): Behavioral
Intervention description(s): The intervention consists of providing free fruits and vegetables of the participants' liking for a period of 4 weeks. Each week, a total of 2 portions of either fruits and/or vegetables per day will be provided.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: fruit, vegetables
Topical Betaxolol for the Prevention of Retinopathy of Prematurity
Condition: Development of Side Effects From Betaxolol
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Interventional
Phase: Phase 1

Summary: 
      We hypothesize that topical betaxolol will reduce the development of severe retinopathy of
      prematurity.
    

Detailed description: 
      The drug is administered twice a day between 32 and 35 weeks gestational age, at a t ime when
      ROP is most likely to arise.
    

Intervention name(s): Betaxolol; topical betaxolol
Intervention type(s): Drug; Drug
Intervention description(s): given topically
Intervention MeSH terms: Betaxolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: betaxolol/ retinopathy of prematurity
Pelvital Stress Urinary Incontinence Training Device: P-SUIT
Condition: Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      The purpose of this investigation is to compare the clinical benefits of using the Pelvital
      product, in comparison to a sham procedure as a noninvasive treatment for female incontinence
    

Detailed description: 
      120 subjects with SUI will be recruited into a randomized, double-blind, sham-controlled
      crossover trial. Subjects will be allocated in a 1:1 ratio (60 per arm) to either the control
      arm (PFMT) or the treatment arm (PFMT in conjunction with the Pelvital therapy). Subjects
      will conduct their respective therapy five minutes a day over the course of six weeks. At
      weeks two, four and six, the subjects will conduct bi-weekly check-ups. After six weeks, all
      patients in the control arm will have the option to cross over into the treatment arm if no
      improvement in symptoms has been shown.
    

Intervention name(s): Pelvital probe; Placebo Probe
Intervention type(s): Device; Device
Intervention description(s): Pelvital probe; Placebo Probe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Incontinence