bioihbjkbjnl/mcl2 huggingface dataset:
Combined Modality Treatment for Resectable Non-Small Cell Superior Sulcus Tumors
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      1. To determine the outcome of patients with potentially resectable superior sulcus tumors
           of non-small cell histology treated by surgery followed by accelerated radiation therapy
           and chemotherapy.

        2. To evaluate toxicity, the initial local-regional control rate, sites of and time to
           local and distant failures.
    

Detailed description: 
      Eligible (surgically resectable and medically operable) patients will have surgery followed
      by radiation therapy, given twice daily, for 5 weeks if margins are negative and for 5-1/2
      weeks for positive margins. Grossly positive margins can be treated by brachytherapy followed
      by external radiotherapy.

      Concomitant chemotherapy consisting of cisplatin given intravenously on days 1 and 8, and
      etoposide taken by mouth 30-60 minutes prior to each radiotherapy treatment x the first 10
      days. The cycle will be repeated start day 29.

      If the patients are considered to have no evidence of disease in one month after completion
      of chemotherapy, optional prophylactic radiotherapy to the brain will be give in 10 fractions
      once daily for 2 weeks.
    

Intervention name(s): Surgery; Chest Irradiation; Cisplatin; Etoposide; Prophylactic Cranial Irradiation
Intervention type(s): Procedure; Radiation; Drug; Drug; Radiation
Intervention description(s): Segmentectomy or lobectomy with en bloc resection of the involved chest.; Radiation therapy consists of 60 Gy in 50 fractions for negative margins, or 64.8 Gy in 54 fractions for positive margins, at 1.2 Gy per fraction, 2 fractions per day, 5 days per week.; 50 mg/M^2 given intravenously on days 1 and 8; the cycle will be repeated beginning on day 29.; given by mouth 30-60 minutes prior to each administration of radiotherapy, on days 1-5 and days 8-12; the cycle will be repeated beginning day 29.; 25 Gy in 10 fractions of 2.5 Gy, 1 fraction per day, will be given at the completion of chest irradiation, and is optional.
Other intervention name(s): Radiotherapy; Platinol; CDDP; VePesid; VP-16; PCI
Intervention MeSH terms: Etoposide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Superior Sulcus Tumor; Lung Cancer; Non-Small Cell; Multimodality Treatment; Surgery; Segmentectomy; Lobectomy; Cisplatin; CDDP; Etoposide; VP-16; VePesid; Radiation Therapy; Radiotherapy; Chest Irradiation; Prophylactic Cranial Irradiation; PCI
Patient Response to Spinal Manipulation - Pilot Study
Condition: Low Back Pain
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research
      will conduct a pilot study for the purposes of testing equipment, finalizing data collection
      protocol, and training study personnel before conducting the full-scale trial.
    

Detailed description: 
      In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research
      will conduct a pilot study for the purposes of testing equipment, finalizing the data
      collection protocol, and training study personnel before conducting the full-scale trial.
      Only feasibility data will be collected and reported for this pilot study.

      The full-scale trial, titled as "Patient response to spinal manipulation" (Trial
      registration: NCT01670292 on clinicaltrials.gov), is the Project 1 of the Developmental
      Center for Clinical and Translational Science in Chiropractic (Award No. U19AT004663).

      In the current pilot study, we test how research clinicians can treat patients under study
      measurement conditions and with equipment resulting in modified treatment procedures. This
      pilot study will also test spinal stiffness using 3 different methods on 2 study visits. We
      will also assess the function of low back muscles during standing and while bending forward
      on 2 visits. These measurements include placing sensors on the back with tape and measuring
      the electrical activity of low back muscles. Participants with low back pain are treated with
      side-lying high-velocity low-amplitude spinal manipulation by experienced research clinicians
      who are doctors of chiropractic. Specifically, we will recruit 6 participants who are 21 - 64
      years old and have had low back pain for at least 3 months. Each participant will attend 1
      baseline visit, 1 enrollment visit, and 4 treatment visits over a period of approximately 4
      weeks. Following the baseline visit, participant eligibility will be determined. The
      enrollment visit will be scheduled on the same day as the first treatment visit. The
      following feasibility data will be collected:

        -  # of participants recruited

        -  # of participants consented

        -  # of participants enrolled

        -  # of participants who completed the study

        -  Total duration of the study from launch data to the final study visit
    

Intervention name(s): HVLA-SM
Intervention type(s): Other
Intervention description(s): High velocity, low amplitude spinal manipulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of the Hologic Genius Digital Diagnostics System With the ThinPrep Imaging System
Condition: Cervical Cancer Screening
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      Quality assurance of the laboratory examinations. Retrospective non-interventional study with
      ThinPrep slides collected as part of the German Co-Screening Program for routine diagnostic.
      These slides will retrospectively be used to validate the Hologic Genius Digital Cytology
      (DC) system vs. the ThinPrep Imaging system (TIS).
    

Detailed description: 
      The cause of cervical cancer is a persistent infection with high-risk types of human
      papillomavirus (HPV). Cytology has been the gold standard for cervical screening since the
      introduction of routine screening with the Pap test in the 1950s due to its effect on
      mortality in regions with screening programs. Since that time, there have been several
      technological advances (LBC, Imaging) to improve and automate cervical cytology, resulting in
      increased disease detection and efficiency. The Hologic's Genius Digital Diagnostics System
      is a CE-IVD (CE-marked in vitro diagnostic device) marked digital cytology platform. For
      quality assurance and to retrospectively validate the Hologic Genius Digital Cytology (DC)
      system selected slides earlier measured with TIS will be additionally reviewed with the
      Genius Digital Diagnostic System in order to demonstrate clinical performance and efficiency.

      Hologic's Digital Image Analysis Algorithm uses AI to identify diagnostically relevant
      objects of interest.Only anonymized results will be evaluated.
    

Intervention name(s): Hologic's Genius Digital Diagnostics System
Intervention type(s): Diagnostic Test
Intervention description(s): Genius Digital Diagnostics is a digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced volumetric imaging technology to help cytotechnologists and pathologists identify pre-cancerous lesions and cancer cells in women.
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        As part of the German National Cancer Plan, women over the age of 35 years will be given a
        cotest comprising a Pap smear and an HPV test, every three years.
Plyometric and Strength Training of Quadriceps and Hamstrings in Football Players
Condition: Football Players
Study type: Interventional

Summary: 
      Football is a trendy sport in the world. A typical footballer runs more than 10 kilometers in
      an average game of 90 minutes. FIFA regulates the sport of football and the world cup is
      conducted every 4 years. Plyometric exercise training uses speed and different forced
      movements to build muscle power. Plyometrics training improves physical performance and the
      ability to do different activities. Strengthening exercises are designed to increase the
      strength of specific groups of muscles. Strengthening exercises overload the muscle until the
      point of muscle fatigue. By conducting the study, it will help us to make a better
      understanding that whether plyometrics or strength training is more effective so that we can
      cooperate it into the regular exercise of the football player so that their sports
      performance can be enhanced.
    

Detailed description: 
      It will be a randomized clinical trial. It will be conducted at the Pakistan sports board and
      coaching center, Lahore. A sample of 40 athletes will be taken using convenient sampling.
      Athletes will be randomly allocated into two groups. Group A was given plyometrics and group
      B was given strengthening exercises. Athletes will be assessed using a 20m sprint test and an
      Illinois agility test before the initiation of the exercise regimen. Athletes will perform
      plyometrics 5 days a week and strength training twice a week for 6 weeks. Athletes will be
      reassessed after 6 weeks. Statistical analysis will be used to determine their effects with
      the help of the software SPSS 25.
    

Intervention name(s): plyometric exercises; strenghtening of quadriceps and hamstring
Intervention type(s): Other; Other
Intervention description(s): st week Wall touches 3x30 s Split squat jumps 2x40 Lateral cone jumps 2x30 Cone hops with 180 turn 4conesx10
nd week Wall touches 4x30 s Split squat jumps 2x40 Lateral cone jumps 2x30 Cone hops with 180 turn 4 cones x 30
rd week Wall touches 5x30 s Split squat jumps 2x60 Lateral cone jumps 2x50 Cone hops with 180 turn 4 cones x 30
th week Wall touches 5x30 s Split squat jumps 2x60 Lateral cone jumps 2x50 Cone hops with 180 turn 4 cones x 30 Drop jump 45.72 cm 45.72 cm (20)
th week Wall touches 5x30 s Split squat jumps 2x60 Lateral cone jumps 2x50 Cone hops with 180 turn 4 cones x 30 Drop jump 45.72 cm 45.72 cm (30)
th week Wall touches 6x30 s Split squat jumps 2x70 Lateral cone jumps 2x60 Cone hops with 180 turn 4 cones x 40 Drop jump 45.72 cm (40); 1st to 3rd week l 4th to 6th week Squat 2x12 3x8 l 3x10 4x6 Knee extension 3x12 3x8 l 2x10 2x6 Nordic hamstring 3x3 3x3 l 3x4 3x4
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Prophylactic Fluconazole Therapy in Preterm and Very Low Birth Weight Neonates in Preventing Invasive Fungal Infection.
Condition: Invasive Candidiases
MeSH terms: Candidiasis; Mycoses; Invasive Fungal Infections; Candidiasis, Invasive; Birth Weight
Study type: Interventional
Phase: Phase 3

Summary: 
      Invasive fungal infection is detecting candida species in blood, cerebrospinal fluid, or
      urine. Clinical signs of invasive candidiasis may include lethargy, temperature instability,
      feeding intolerance, apnea, hypotension, respiratory distress, abdominal distension, and
      thrombocytopenia. Fungal infection has been associated with an increased risk of retinopathy
      of prematurity and chronic lung disease. Preterm and low birth weight infants have an
      immature immune system that predisposes them to infections with bacteria, viruses, and fungi.
      These infants usually require prolonged admission in the neonatal unit and there is often a
      need for the administration of broad-spectrum antibiotics which predisposes them to
      colonization with fungi that may invade to cause systemic disease8. Other risk factors for
      the development of invasive fungal infection include endotracheal intubation, abdominal
      surgery, the presence of a central venous catheter, administration of H2 antagonists, and
      steroids. Infection with Candida species is the third most common cause of bloodstream
      infection in premature infants. Mortality in preterm infants due to invasive candidiasis is
      around 20% and can be as high as 50% in infants weighing <1500g at birth. Invasive
      candidiasis is the second most common infectious cause of death in extremely preterm infants.
      The present study was conducted to determine the incidence of invasive candidiasis among
      preterm and very low birth weight infants in our neonatal unit and to evaluate the efficacy
      of prophylactic fluconazole in preventing invasive fungal infection. Based on the results of
      the present study institutional guidelines may be designed in our neonatal unit relating to
      antifungal prophylaxis in preterm and very low birth weight infants.
    


Intervention name(s): Fluconazole; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Fluconazole will be given for prevention of invasive candidiasis in preterm and very low birthweight babies.; 0.9% Saline 2cc intravenous will be given to preterm babies in placebo group.
Intervention MeSH terms: Fluconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Uterine Artery Doppler and 11-14 / 20-22 Weeks of Gestation Pregnancy
Condition: Pregnancy Related
Study type: Observational

Summary: 
      Uterine artery doppler measurements will be made at 11-14 weeks and 20-22 weeks of gestation,
      and the classification of these measurements according to type of delivery; and to
      investigate the change in the effect of delivery type on uterine artery flows on obstetric
      outcomes (maternal, fetal, neonatal outcomes).
    

Detailed description: 
      The first and second trimester perinatal examination results performed by the same operator
      from pregnant women who have applied to the clinic since the first trimester are removed from
      the ViewPoint 6.0 server and database and their uterine artery doppler values (uterine artery
      PI and RI values, presence of uterine artery notch), placental location, gestational week of
      measurement, blood pressures, PAPP-A and hCG MoM values, obstetric results (type of birth,
      week, weight, ante-postpartum complications), data to be generated from other hospital
      records will be saved to the base
    

Intervention name(s): uterine artery doppler measurement
Intervention type(s): Other
Intervention description(s): The effect of delivery type on changes in uterine blood flow will be investigated.
Doppler results groups will be defined according to the effect of deviations in uterine blood flow on neonatal and perinatal results.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who had uterine artery doppler measurements and delivered at 11-14 weeks and 20-22
        weeks of pregnancy will be the study group. these patients; Doppler results will be
        classified according to pregnancy results, and the classification of these measurements
        according to type of delivery; and the effect of delivery on uterine artery flows on
        obstetric outcomes (maternal, fetal, neonatal outcomes) will be examined.
      
Keywords: Uterine artery doppler; type of delivery; obstetric outcomes
Randomized Study of Positron Emission Tomography - Computed Tomography (PET/CT) in Pre-Operative Staging of Lung Cancer
Condition: Non-Small Cell Lung Cancer; Thoracotomy
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      Patients with possible operable non-small cell lung cancer are randomised to conventional
      staging, or conventional staging and PET/CT. According to, patients with operable tumor will
      be referred to surgery, and the number of thoracotomies and futile thoracotomies wil be
      compared with the two groups in order to asses the possible benefit of PET/CT.
    

Detailed description: 
      Patients with possible operable NSCLC after staging with CT are randomised to PET-CT with FDG
      or not, prior to mediastinoscopy. All patients are referred to mediastinoscopy unless a
      positive FDG uptake results in a positive biopsy suggesting stage IV disease.

      Biopsies are performed according to the following criteria:

        1. Lymph nodes are numbered according the Mountain classification, and abnormal lesions
           must be confirmed histologically, by mediastinoscopy or thoracotomy.

        2. PET-positive lesions in the liver must be biopsied unless ultrasound or MRI
           unequivocally indicate the lesions are benign cysts or haemangioma.

        3. PET-negative adrenal lesions are accepted without biopsy if CT scan indicate the lesion
           is a benign adenoma.

        4. PET-positive bone lesions must be evaluated by plain x-ray, CT, MRI, or bone
           scintigraphy. In case of equivocal findings a biopsy must be performed.

        5. PET-positive brain lesions must be confirmed by CT or MRI.

      Number of patients:

      Patients with clinically operable NSCLC after CT-staging are included. All patients must have
      mediastinoscopy performed.

      All patients referred to mediastinoscopy can be randomised after informed consent. A total of
      430 consecutive, non-selected patients are planned. It is anticipated that approximately 60%
      of the referred patients with clinical stage I-IIIa NSCLC will undergo thoracotomy, and a
      risk of type I and II error of 5% and 10%, respectively, is accepted. Thus a total of 215
      patients are randomised in each arm in order to observe an absolute difference of 15% in the
      number of thoracotomies. This number seems to be sufficient to evaluate differences in the
      secondary endpoints.

      After inclusion of a total of 220 patients, corresponding to 110 PET-scans, an interim
      analyses are performed. In case of a highly significant difference in the number of
      thoracotomies (p < 0,001) the study will be closed.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with non-small cell lung cancer
      
Keywords: NSCLC; PET/CT; Surgery; FDG; staging
Safety and Effects of Ramipril Combined With Candesartan
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      we hypothesized that combination therapy has additive beneficial effects to improve
      endothelial dysfunction and adipocytokine profiles in patients with hypertension.
    

Detailed description: 
      Forty patients will be given ramipril 10 mg and placebo, ramipril 10 mg and candesartan 16
      mg, or candesartan 16 mg and placebo daily in a randomized, double-blind, placebo-controlled
      cross-over trial with three treatment arms and two washout periods (each 2 months).
    

Intervention name(s): ramipril, candesartan
Intervention type(s): Drug
Intervention MeSH terms: Candesartan; Candesartan cilexetil; Ramipril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: endothelial function, insulin resistance, adipocytokines
Pomegranate Extract Biomarker Study in Osteopenic Women
Condition: Osteopenic Women
Study type: Interventional
Phase: Phase 1

Summary: 
      Treatment of post-menopausal subjects (with decreased bone mineral density) with pomegranate
      extract capsules will produce statistically significant changes in biomarkers for bone
      resorption and formation when compared to subjects receiving placebo.
    


Intervention name(s): 2 POMx Capsules; 2 placebo Capsules
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 POMx Capsules daily; 2 placebo Capsules daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: POMx; Osteopenia; postmenopausal women; Pomegranate
The Usefulness of Patients Receiving Their Own Letter After an Outpatient Attendance
Condition: Heart Diseases; Lung Diseases
MeSH terms: Lung Diseases; Heart Diseases
Study type: Interventional

Summary: 
      As part of the NHS plan it has been proposed to extend some consultants' usual practices and
      to send all patients copies of the letters sent to their general practitioners (GPs)
      following outpatient consultations. The current Secretary of State for Health has further
      extended this proposal and suggested that patients should have a specific letter to
      themselves after a hospital consultation.

      The aim of this study is to send patients both a copy of the letter sent to their GPs and a
      specific letter to themselves and to assess the usefulness and comprehensibility of each.
    

Detailed description: 
      As part of the NHS plan it has been proposed to extend some consultants' usual practices and
      to send all patients copies of the letters sent to their general practitioners following
      outpatient consultations. The current Secretary of State for Health has further extended this
      proposal and suggested that patients should have a specific letter to themselves after a
      hospital consultation.

      The aim of this study is to send patients both a copy of the letter sent to their GPs and a
      specific letter to themselves and to assess the usefulness and comprehensibility of each.
      This study will assess the two styles of letter in Cardiology and Respiratory Outpatient
      Clinics staffed by 7 consultants and will involve a group of 15-20 patients from each of the
      clinics, total number approximately 150 patients.

      All patients attending the clinics will be given a sheet outlining the study before their
      consultations. If they are interested in the study, patients will be given a Patient
      Information Sheet and asked consent to take part. The length of each of the two dictated
      letters will be recorded. To avoid costs to the NHS, the direct to patient letters will be
      typed at the study investigators' cost. Two copies of each letter, a short explanatory letter
      and a questionnaire will be sent to the patient and the patient will be asked to circle
      points in each of the letters which are unclear and return them to the department. At the end
      of the study the general practitioners will be contacted and asked their views about the two
      letters.
    

Intervention name(s): Additional specific letter written to patient
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: post consultation letter
Single Rising Dose Trial of BI 655130 for Healthy Japanese Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the safety and tolerability of BI
      655130 following administration of single rising intravenous doses and single subcutaneous
      dose in healthy Japanese male volunteers.

      Secondary objective is the exploration of the pharmacokinetics including dose proportionality
      of BI 655130 in healthy Japanese male volunteers.
    


Intervention name(s): BI 655130; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single dose; single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment