cyrilzakka/clinical-trials huggingface dataset:
A Phase III Study With FE 999169 Versus Niflec for Colon Cleansing

To demonstrate non inferiority of a) "FE 999169 Split Dosing Schedule" (one dose on the day before and the second dose on the day of colonoscopy) and b) "FE 999169 Day Before Dosing Schedule" (two doses on the day before colonoscopy) to " Niflec On the Day Dosing Schedule" in subjects requiring colonoscopy.

This was a phase III, randomized, assessor-blinded, parallel-arm, multicenter, study in Japanese patients. Patients, who signed an informed consent and fulfilled all screening criteria, were randomized in a 1:1:1 ratio to one of the following 3 treatment groups: "FE 999169 Split Dosing Schedule", "FE 999169 Day Before Dosing Schedule" and " Niflec On the Day Dosing Schedule" in subjects requiring colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Japanese patients, age 20 to 80 years inclusive, requiring colonoscopy
* Female patients should be post-menopausal (women ≥45 years with no menstrual period for at least 12 months without an alternative medical cause), or be surgically sterile, or be using medically approved contraception, throughout the trial period.
* Fertile female patients must have a confirmed negative pregnancy test at screening and randomization
* Patients must have had more than or equal to 3 spontaneous bowel movements per week prior to the colonoscopy
* Written informed consent obtained prior to any study-related procedure

Exclusion Criteria:

* Acute surgical abdominal conditions, such as acute intestinal obstruction or intestinal perforation, diverticulitis, appendicitis. If intestinal obstruction and perforation are suspected, perform appropriate diagnostic studies to rule out these conditions
* Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
* Any prior colorectal surgery, excluding appendectomy, haemorrhoid surgery or prior endoscopic procedures
* Colon disease (history of colonic cancer, toxic megacolon, idiopathic pseudo-obstruction, hypomotility syndrome)
* Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)
* Ascites.
* Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
* Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months, Congestive Heart Failure (CHF), or uncontrolled hypertension
* Renal insufficiency (any of the serum creatinine, or serum potassium value exceeding the upper limits of the normal range at screening) or a history of this event
* Participation in any other clinical trial during the past 3 months
* Any clinically significant laboratory value at screening, including pre-existing electrolyte abnormality, based on clinical history that the investigators feel may affect the study evaluation
* Hypersensitivity to active ingredients
* Subject who cannot suspend the prohibited medications
* Subjects not appropriate to participate in the study as deemed by the investigator
Comparison the Topical Anesthesia and Retrobulbar Anesthesia for 27-gauge Vitrectomy for Vitreous Floaters

Routine anesthesia methods for vitrectomy surgery include retrobulbar and peribulbar anesthesia. However, both methods have potential complications that can vary from minor to severe.

Vitrectomy surgery for vitreous floaters is widely considered straighter forward than other vitreoretinal surgeries.

Hence, the investigators compared the effect of topical anesthesia (with eye drops) and retrobulbar anesthesia for 27-gauge par plana vitrectomy for symptomatic vitreous floaters.


Eligibility Criteria:
Inclusion Criteria:

1. patients who is going to undergo vitrectomy surgery for vitreous floaters
2. age\>18 years
3. patients who are willing to participate in this study

Exclusion Criteria:

1. patients who had vitrectomy surgery before
2. patients who had penetrating ocular trauma before
Feasibility Study of Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells in Patients With Multiple Sclerosis

Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once per day for 7 days is a safe and will induce a therapeutic effect in multiple sclerosis (MS) patients.

The proposed study will assess primarily safety and secondary efficacy endpoints of allogeneic umbilical cord mesenchymal stem cells (UC-MSC) administered to 20 patients with MS.

The primary objective of the trial is freedom from treatment associated adverse events at 4,12 and 52 weeks post treatment. Secondary objective will be efficacy as assessed at baseline, week 12 and 52 and will be quantified based on the following: Neurological assessment of the MS functional composite assessment which comprises of Expanded Disability Status Scale (EDSS), the expanded EDSS (Rating Neurologic Impairment in Multiple Sclerosis, the Scripps neurological rating scale (NRS), paced auditory serial addition test (PASAT), the nine-hole peg test, and 25-foot walking time. Short-form 36 (SF-36) quality of life questionnaire and gadolinium enhanced MRI scans of the brain and cervical spinal cord will also be performed at the indicated time points.

Eligibility Criteria:
Inclusion Criteria:

* Patients willing to sign informed consent and capable of understanding the features of this clinical trial.
* Willing to keep a weekly diary and undergo observation for 12 months
* Non-pregnant patients 18-55 years of age with MS according to the revised McDonald criteria and meeting the Poser criteria for clinically defined MS.
* EDSS scores of 2·0 to 5·5 points assessed at least 3 months after the last acute attack of MS.
* Must have proof of health insurance in country of residence.

Exclusion Criteria:

* Patients with evidence of active proliferative retinopathy.
* Patients with poorly controlled diabetes mellitus (glycated hemoglobin: HbA1C \> 8.5%).
* Patients with renal insufficiency (Creatinine\> 2.5) or failure.
* Infection as evidenced by white blood cell (WBC) count of \>15,000 k/cumm and/or temperature \> 38 Celsius.
* History of organ transplant.
* History of previous or active malignancy, except for localised cutaneous basal or squamous cell carcinoma or carcinoma in situ of the cervix
* Exercise limiting angina ( Canadian Cardiovascular Society Class 3
* Congestive heart failure (New York Heart Association class 3
* Unstable angina
* Acute ST elevation myocardial infarction (MI) within 1month
* Transient ischemic heart attack or stroke within 1 month
* Severe valvular heart disease
Laser En Bloc Resection Of Bladder Tumor (HoLERBT) VS. Conventional Transurethral Resection Of Bladder Tumors (cTURBT)

Randomized clinical trial aiming to assess Holmium Laser En Bloc Resection Of Bladder Tumor (HoLERBT) in comparison with Conventional Transurethral Resection Of Bladder Tumors (cTURBT) in tumor histopathological staging quality, detrusor muscle sampling in biopsy, completeness of tumor resection and peri procedure complication.

Urothelial carcinoma of the bladder is the 2nd most common urological malignancy and it makes a growing healthcare problem worldwide.

The vast majority of newly diagnosed are non-muscle bladder cancers (NMIBC) which represents about 75% and can be treated with transurethral resection of bladder tumors (TURBT) so, correct initial staging is critical. The quality of TURBT strongly determines patient prognosis and overall treatment.

Conventional transurethral resection of bladder tumors (cTURBT) causes fragmentation, artifacts, thermal damages and tangential sections that might hamper histopathological evaluation.

The expert meeting at Davos of the European Association of Urology (EAU) section of Uro-Technology (ESUT) and the section of Uro-Oncology (ESOU) identified en bloc resections of bladder tumors (ERBT) using various energy sources or modified resection loops as a promising technique.

Laser therapy for the treatment of non muscle invasive bladder tumor (NMIBC) was first reported in the 1970s. Neodymium:YAG lasers were mainly used for tissue vaporization. Afterward, the introductions of en bloc resection methods have laser treatments for bladder cancer regains its popularity. The most commonly used are holmium (Ho:YAG) and thulium (Tm:YAG).

EBRBT overall complication rate of 0.7%, of which all complications had not been life-threatening. Compared conventional TURBT to HoLERBT, a significant reduction of obturator nerve reflex, related bladder perforations, peri- or postoperative bleeding was rare, reduction in bladder irrigation time in comparison with conventional TURB. Better histopathological results were with laser en bloc resection of bladder cancer by lowering of thermal damage The study will be conducted in a single tertiary centre at Urology and Nephrology Center in Mansoura, Egypt.

Eligible patient presented with papillary bladder tumor will be asked to participate in this study and will be provided with an informed consent form in line with Good Clinical Practise and the Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed at the out-patient cystoscopy with papillary bladder tumour will be legible for inclusion

Exclusion Criteria:

* Tumor criteria

  * Non papillary gross features of the tumor
  * Anteriorly located tumor
* Patients criteria
* Poor performance status
* History of BCG sepsis
* History of bladder irradiation
* Contracted bladder
25-Year Experience With Polytraumatized Patients in a Level 1 Trauma Center

In this study patients who were admitted to our hospital with critical injuries were enrolled retrospectively from January 1992 to December 2019. Patients with an ISS\>16 points, an AIS \>3 in one body region and at least 2 different body regions affected were included. Possible prognostic factors were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* ISS \>16 points
* AIS \>3 in one body region
* at least 2 body regions affected

Exclusion Criteria:

* patients younger than 18 years of age
* isolated traumatic brain injury
* minor injuries (AIS \<3 or ISS \<16 points)
A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate

This trial is conducted in Europe, North America and South America. The aim of this trial is to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared to placebo when administered as weekly repeat subcutaneous (under the skin) injections in to patients with active rheumatoid arthritis (RA) with inadequate responses to methotrexate (MTX) while on a stable background of MTX therapy.


Eligibility Criteria:
Inclusion Criteria: - Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - A documented diagnosis of RA at least 6 months prior to screening visit, according to the American College of Rheumatology (EULAR/ACR 2010 criteria) or by standard criteria (ACR 1987) if diagnosis was made earlier than 2010 - Active RA, characterised by: a. more than 5 tender and more than 5 swollen joints based on a 28 joint count b. C-reactive protein (CRP) above or equal to 1.0 mg/dL (10 mg/L) - Patients can be on methotrexate with or without hydroxychloroquine/chloroquine: a. Methotrexate treatment (above or equal to 15.0 mg/week) for at least 16 weeks, (above or equal to 15.0 mg/week to below or equal to 25 mg/week) for at least 8 weeks prior to screening. Patient can be on MTX as low as 10 mg/week only if due to MTX intolerance b. Hydroxychloroquine (200-400 mg/day per os, oral dosing (p.o.)) or chloroquine (250-500 mg/day p.o.) treatment for at least 8 weeks prior to screening visit Exclusion Criteria: - Patients with arthritis due to other autoimmune diseases than RA - Any active or ongoing bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis) - History of severe, systemic viral or fungal infections within the past 6 months prior to screening visit, unless treated and/or resolved with appropriate therapy - Patients with active malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit - Females of childbearing potential who are pregnant or breast feeding or intend to become pregnant - Any other disease or clinically significant abnormality in laboratory parameters which, according to the Investigator, might compromise the safety of the patient, interfere with participation in the trial or compromise the trial objective
A Wireless Lingual Feedback Device to Reduce Overpressures in Seated Posture: A Feasibility Study

This study evaluates the feasibility of a biofeedback system aimed at reducing overpressures during seated posture. The system consists of (1) a pressure sensors map, (2) a laptop that couples sensors with actuators, (3) a Tongue Display Unit (TDU) consisting of a wireless circuit embedded in a dental retainer with a matrix of electrodes. The principle of this biofeedback system consists in (1) detecting overpressures in people who are seated over long periods of time, (2) estimating a postural change that could reduce these overpressures and (3) communicating this change through directional information transmitted by the TDU.

It is hypothesized that overpressures are diminished after biofeedback.


Eligibility Criteria:
Inclusion Criteria:

* young healthy subjects

Exclusion Criteria:

* motor or sensory disabilities
Clinicopathological Importance of Colorectal Medullary Carcinoma: Retrospective Cohort Study

Medullary carcinoma (MC) is a rare tumor with solid growth pattern without glandular differentiation and constitute less than 1% of colorectal cancer. Lymph node positivity and distant organ metastasis were reported to be lower than other poorly differentiated adenocarcinomas. Therefore, the diagnosis of MC is pathologically important in terms of follow-up and treatment. MC is commonly localized in the right colon, has a large tumor size, and is mostly diagnosed in the T4 stage. As MC most likely have defects in DNA MMR, the correct pathological diagnosis is important for the postoperative treatment and the prognosis of the patients.

427 patients with colorectal cancer who were underwent surgery between January 2011 and December 2017, were evaluated retrospectively into 2 groups as MC (n:13) and non-MC (n:414) in terms of demographic characteristics, pathological data and oncological outcomes.

Eligibility Criteria:
Inclusion Criteria:

* colorectal cancer diagnosis, medullary carcinoma

Exclusion Criteria:

* none
Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa

The purpose of this study is to see whether the ICDs(Impulse Control Disorder) are improved and neuropsychiatric traits related to ICD are changed or not when switching dopamine agonist to levodopa/carbidopa in patients with Parkinson's disease who have been treated with dopaminergic medications.

* PRIMARY OBJECTIVE To evaluate the improvement of mMIDI(modified version of Minnesota Impulsive Disorders Interview,Korean version) score from the baseline to 12 weeks or LOCF(Last Observation Carried Forward)
* SECONDARY OBJECTIVE i) To evaluate the improvement of neuropsychiatric profiles from the baseline to 12 weeks or LOCF ii) To evaluate the improvement of UPDRS(Unified Parkinson's Disease Rating Scale)Score from the baseline to 12 weeks or LOCF

Eligibility Criteria:
Inclusion Criteria:

* Patient with a diagnosis of idiopathic PD according to United Kingdom Parkinson's Disease Brain Bank Criteria
* mMIDI ≥ 3 score with ICD
* Patients must be on an anti-parkinson treatment at least 6 months before screening.
* for this protocol, dopamine agonists should be included in his/her anti-parkinson treatment.
* 30years ≤ patients \< 80years of age, male or female
* patients must give written informed consent before any assessment is performed

Exclusion Criteria:

* Requirement of treatment with serious cognitive disorder, behavioral disorder, or mental illness currently or in the future
* for the patients ≤ 65years: K-MMSE(korean version of Mini-Mental State Exam) ≤24, or for the patients ≥ 66years: K-MMSE ≤ 20, or the patients have dementia(incl. early dementia) even though K-MMSE score is more than 20
* Requirement of treatment more than 6times per day due to the severe motor fluctuation.
* Severe dyskinesia
* DBS(Deep Brain Stimulation)or any other surgical treatment
* History of melanoma or not-diagnostic skin trouble/skin lesions
* narrow angle glaucoma
* clinically serious surgical or medical condition
* malignant tumor
* use of other investigational drugs at the time of enrollment within 4weeks
* pregnant, nursing or lactating women
* women of child-bearing potential
* history of hypersensitivity or allergy to levodopa/carbidopa
* any serious disease according to the investigator's discretion
C11-Sodium Acetate PET/CT Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression

This study will investigate how well Carbon Acetate PET/CT imaging helps to correctly identify recurrent tumor versus post treatment effects (radionecrosis) in patients with previously treated high grade brain gliomas.

The study is designed to investigate the effectiveness of Carbon Acetate PET/CT (AC PET)in terms of its ability to distinguish between radionecrosis/pseudo-progression and viable tumor in patients previously treated with surgery and radiation for high grade glioma brain tumors.

Eligible patients with biopsy proven high grade gliomas (WHO grades 3 and 4) status-post prior cranial irradiation for this tumor; age 18 to 70; ECOG/Zubrod of 0-2, no other contraindications to trial entry, and a post-irradiation cranial MRI or CT demonstrating an enhancing lesion of uncertain etiology (not biopsied) will be treated with at least two weeks of steroidal therapy.

Responders to steroidal therapy will be classified as either pseudo-progression (if asymptomatic) or radionecrosis (if symptomatic). Non-responders (those who do not respond clinically, radiographically, or both) will be referred for an FDG PET/CT and initial AC PET/CT within 3 weeks, and subsequently referred for stereotactic biopsy of their lesion followed by focal laser treatment (in the same operative setting) within 3 weeks of AC PET/CT.

Specific Goals/Questions:

1. What is the yield (sensitivity, accuracy, positive and negative predictive value) of state-of-the-art PET/CT with C-11 Acetate in detecting recurrent disease versus post treatment effects and pseudo-progression in this patient population?
2. How does the performance of PET with C-11 Acetate compare with that of PET using F-18 fluorodeoxyglucose (FDG-PET) and with that of MRI?
3. Evaluate the optimal timing for post injection imaging.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18-70
* Pathologically confirmed World Health Organization (WHO) grade 3 or 4 glioma
* ECOG/Zubrod 0-2
* Prior external beam radiotherapy to 59.4-60 Gray by 1.8-2 Gy fractions
* Post-radiotherapy contrast-enhanced cranial MRI obtained at least 6 weeks after the completion of external beam radiotherapy shows enhancing anomaly (recurrent/progressive tumor versus pseudo-progression versus radionecrosis)
* Patient completed at least a two week course of palliative steroid therapy for this enhancing anomaly
* No prior designated therapy other than steroids for presumed radionecrosis or recurrent tumor
* Patient with no clinical and/or radiological response to steroid therapy
* Patient eligible for stereotactic brain biopsy
* Patient eligible for focal laser therapy

Exclusion Criteria:

* Patients under the age of 18 years
* Claustrophobic patients
Safety and Efficacy of "Immuncell-LC" in TACE Therapy

To evaluate the efficacy and safety of 'Immuncell-LC group' and 'non-treatment group' in the patients undergone Transarterial Chemoembolization for intermediate stage hepatocellular carcinoma

ILC-IIT-05 is randomized, open-label, multi-center phase 2 clinical trial. To confirm clinical efficacy and safety between 'Immuncell-LC group' and 'non-treatment group', primary outcome, recurrence free survival(RFS) will be evaluated.

For secondary outcome, overall survival(OS), changes of Alpha Feto Protein(AFP), correlation of between myeloid-derived suppressor cell change and prognosis, adverse event, ECOG-PS and hematological examination will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have consented to the study by providing signature of self
* Patients who are more than 20 and less than 80 years old
* Child-Pugh Class should be A(score 5-6) or B(score 7-8)
* ECOG Performance Status (ECOG-PS) score is less than 1 or equal to
* Patients who have been diagnosed with BCLC stage B hepatocellular carcinoma by pathological/radiological test(Dynamic contrast-enhanced CT or Dynamic MRI) and tumor removal has been confirmed after TACE (When patients have been diagnosed with recurrence of hepatocellular carcinoma after surgery or local treatment, if conditions are same as above, patients could be included)
* Patients who satisfy the following conditions of the blood test and kidney, liver function test

  * Absolute neutrophil count \> 500/µL
  * Hemoglobin ≥ 8.5 g/dL
  * Platelet count \> 50,000/µL
  * Blood Creatinine ≤ 1.5xupper normal limit
  * Total bilirubin \< 3mg/dL
  * Albumin ≥ 2.8g/dL

Exclusion Criteria:

* Patients who have been confirmed with residual tumor or extrahepatic metastases
* Patients who have lymph node metastases or portal vein, hepatic vein invasion
* Patients who have a history of treatments or are in conditions as below

  * Liver transplantation
  * From Informed consent form sign date, systemic chemotherapy in 4 weeks or ongoing adverse drug reactions from anticancer drug in 6 weeks
  * External beam radiation, immunotherapy, molecular target therapy
  * More than 2 times of systemic chemotherapy
  * Biliary reconstruction or endoscopic biliary treatment
* Patients who have a history of auto-immune diseases (Ex. Rheumatoid Arthritis, Systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-Dependent Diabetes Mellitus, etc.)
* Patients who have a history of malignant tumors in the recent 5 years prior to the study except hepatocellular carcinoma
* Patients who participated in another clinical trial and conducted treatment in 4 weeks or have a plan for administration of another clinical trial treatment since Informed consent form sign date
* Patients who have uncontrollable or serious disease
* Pregnant women or nursing mother
* Patients who intend to get pregnant during the study