cyrilzakka/clinical-trials huggingface dataset:
A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate

This study will compare blood collection from the forearm using an investigational device, TAP20-C to blood collection from the finger tip. The blood collected from the forearm and from the fingertip will then be analyzed for glucose, hemoglobin and hemoglobin A1c.


Eligibility Criteria:
Inclusion Criteria:

Healthy Subject Group

1. Male and female volunteers 18 years of age or older.
2. Voluntary written consent to participate in this study.

Diabetic Subject Group

1. Male and female volunteers 18 years of age or older.
2. Have been diagnosed with Type 1 or Type 2 diabetes mellitus by self-report.
3. Voluntary written consent to participate in this study.

Exclusion Criteria:

1. Subjects who are pregnant or nursing mothers by self-report.
2. Subjects who have eaten or consumed sugar-containing drinks in the 2 hours before blood sample collection begins.
3. Subjects with a history of skin disorders or who present with abnormal skin integrity or atypical skin health within the areas to be tested.
4. Subjects with a missing index or middle finger on either hand or a missing forearm
5. Subjects who have known allergies to titanium.
Efficacy of Plasmapheresis in Patients of Drug-Induced Liver Injury (DILI) With Underlying Chronic Liver Disease

DILI is an underdiagnosed and under appreciated causal or contributing factor to liver injury. DILI can mimics features of the entire spectrum of acute and chronic liver disease.

Asia-Pacifc region is characterized by two unique features; the high prevalence of tuberculosis (TB) in the population and the ubiquitous use of traditional and complimentary medicines.Current definition of Hy's law presents significant difficulties when dealing with patients with preexisting CLD in clinical trials. Hallmark of the hepatic manifestation in these patients is hyperbilirubinemia and coagulopathy rather than ALT elevation.

Study Design Single-center, non-blinded, parallel group, randomized controlled trial. Allocation ratio between two groups: 1:1.

Study population: Adults aged 18-75 years with previously known or unknown underlying CLD Diagnosis of DILI-based causality of assessment by RECAM. Severe DILI with bilirubin \> 12mg/dl or INR\>2, S.Bili \>5 mg/dl Consent to participate in the study (based on biopsy, imaging or clinical criteria).

Study design: RCT Study period: 1 year Sample size: 96 Intervention: Patients after screening for all exclusion criteria will be randomized into either the standard treatment group or the plasma exchange group.

Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization they will receive either steroid or plasma exchange followed by steroid.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18-75 years with previously known or unknown underlying CLD.
2. Diagnosis of DILI based causality of assessment by RECAM.
3. Severe DILI with bilirubin \> 12mg/dl or INR\>2, S.Bili \>5 mg/dl.
4. Consent to participate in the study (based on biopsy/imaging/or clinical criteria).

Exclusion Criteria:

1. Active infection
2. Contraindications to plasmapheresis (e.g., severe coagulopathy, hemodynamic instability, patients with sepsis, shock, poor P/F ratio).
3. Pregnant or breastfeeding women.
4. HCC or any malignancy
5. UGI bleed, uncontrolled HE
6. Option LTx being considered
7. S. Creatinine \> 2mg/dL
8. DILI ALF
9. Alcoholic Hepatitis
Evaluation of Perioperative Management of Curative Anticoagulants in the Geriatric Perioperative Unit in Patient Hospitalized for Femoral Neck Fracture.

Pilot study to evaluate the management of curative anticoagulant prescriptions pre- and postoperatively in elderly patients hospitalized for femoral neck fracture.


Eligibility Criteria:
Inclusion Criteria:

* Patient 75 years or older
* Hospitalized in the geriatric perioperative unit for a femoral neck fracture between 18/11/2019 and 30/06/2021
* Treated with a curative anticoagulant at entry
* Patient enrolled in or receiving a social security plan

Exclusion Criteria:

* Orthopedic patient housed in the geriatric perioperative unit
* Patient who objected to the use of their data
The Application of Rapid Fresh Digital Pathology on the Diagnosis and Biomarker Testing of Lung Cancer

Through this project, the rapid staining process will be optimized for ex-vivo human lung specimens and integrate advanced ex-vivo mesoscale nonlinear optical gigascope. Initially, this will provide rapid digital pathological diagnosis during lung cancer surgeries. This will help achieve the dual goals of precise and efficient complete resection of lung cancer tissues while preserving tissue functionality. The application of this technology aims to provide higher-quality medical services for patients suffered from lung cancers.

Frozen section can provide rapid diagnosis during the operation, and its information is very important for surgeons to make decisions for the operative methods, especially for patients whose clinical conditions or lesions sites are inappropriate for biopsy. The frozen section procedure requires a pathological laboratory, a skilled technician, and an experienced pathologist. Not all pathological laboratories can perform the frozen section procedure. The frozen section can also cause frozen artifacts and tissue loss especially for small biopsy samples. In this study rapid fresh digital pathology combining the rapid whole-mount hematoxylin-eosin (H\&E) tissue staining (the-RTS) method and optical imaging via mesoscale nonlinear optical gigascope (mNLOG) will be used to obtain digital images with ultra-high resolution of resected lung specimens. These images will be analyzed by experienced pathologists and compared with H\&E-stained slides from traditional frozen section procedures to see if the rapid fresh digital pathology can be used as an alternative method for intraoperative frozen section procedure.

Moreover, the potential to use rapid fresh digital pathology in the detection of lung cancer biomarkers (including low-grade or high-grade patterns, invasive or in situ lesions, and STAS) and three-dimensional pathology will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* (1) Adults aged 20 and above.
* (2) Patients diagnosed with lung cancer or lung tumors, scheduled for surgical resection.

A total of 300 patients are expected to be included.

Exclusion Criteria:

* (1) Patients unable to provide consent. (e.g., inability to speak, inability to communicate in Chinese, etc.).
* (2) Patients for whom a definitive pathological diagnosis cannot be established.
* (3) Patients suitable only for biopsy and not for surgical resection.
* (4) Exclude specimens that are too small or lesions that are too small to retain extra tissue.
Chromoendoscopy for Dysplasia Detection in Chronic Inflammatory Bowel Disease

Patients with longstanding ulcerative colitis or crohn's disease in the large bowel have an increased risk of developing cancer. The purpose of this study is to determine if visualizing of the mucosa in details using a dye spray (indigo-carmine) will result in detection of more abnormalities than conventional colonoscopy without dye spray.

Background: Patients with ulcerative colitis and Crohn's colitis are at increased risk of colon cancer. The usefulness of chromoendoscopy is debated. Previous studies are either based on magnifying endoscopy or on non-randomized trials. Some guidelines recommend chromoendoscopy with targeted biopsies and some normal colonoscopy with up to 40 random biopsies.

Chromoendoscopy has the ability to identify subtle lesions that are otherwise missed by standard endoscopy. Whether chromoendoscopy with targeted biopsies can replace standard colonoscopy with random biopsies in the surveillance of patients with chronic colitis is unknown.

Aim: In a RCT in surveillance colonoscopies in patients with ulcerative colitis or Crohn's colitis, we will determine if chromoendoscopy using a dilute solution of Indigo-carmine will improve dysplasia detection rate compared with colonoscopy without chromoendoscopy.

Methods: After informed consent patients undergoing surveillance colonoscopy will be randomized to be examined by the study or control method. The study method will employ a 0.2-0.5% Indigo-Carmine solution sprayed over the colonic and rectal mucosa. The control method will be colonoscopy without Indigo-Carmine chromoendoscopy. In both the study arm and the control arm all subjects will have 32 random biopsies taken (4 from each of 8 defined segments of the colon) and biopsies from suspicious mucosa.

Eligibility Criteria:
Inclusion Criteria:

Patients with ulcerative colitis or Crohn's colitis satisfying criteria for surveillance colonoscopy:

* Ulcerative colitis, extensive \> 8 years OR Crohn's colitis involving ≥ 1/3 of colon/rectum
* history of PSC or
* history of previous dysplasia on colon biopsies or
* family history of colon cancer in first degree relative

Exclusion Criteria:

* Patients who decline to participate
* Unable to give informed consent
* Increased risk of bleeding (i.e. Warfarin, bleeding disorders, Clopidogrel)
Effect of Diode Laser on Post-operative Pain After Endodontic Treatment in Teeth With Apical Periodontitis

Aim: This study aims to assess the effect of root canal disinfection with a 980 µm diode laser following chemomechanical root canal preparation on the severity of pain after root canal treatment (RCT).

Materials and Methods: In present study, asymptomatic, single-rooted teeth with periapical index (PAI) score 3 or 4 were included. All patients were treated with two visits of root canal treatment including dressing with calcium hydroxide. Patients were randomly divided into two groups (n: 28). 'Control (no laser)': The final irrigation was performed using 5ml 2.5% NaOCI, followed by 5 ml 17% EDTA and 5 ml distilled water. 'Laser Disinfection (LD)': Root canals were irradiated with 980 µm diode laser after final irrigation at both visits. The pain levels were evaluated using visual analog scale (VAS) after 8, 24, 48 hours and 7 days. In addition, analgesic intake and time intervals were recorded by patients. The collected data were statistically analyzed with the Chi-square and Mann-Whitney U test (p\<0.05).


Eligibility Criteria:
Inclusion Criteria:

* Healthy patients
* Patients that had asymptomatic, single-rooted teeth with PAI score 3 or 4

Exclusion Criteria:

* antibiotic use with in the last month,
* anti-inflammatory analgesic use within the last five days,
* systemic disorder, pregnancy or lactation,
* traumatic occlusion,
* presence of other teeth requiring RCT,
* teeth with root canal fillings,
* calcified canals,
* root resorption,
* periodontal diseases,
* sinus tracts
* severe crown destruction preventing rubber-dam application
Local and Widespread Hypoalgesic Effects of Neurodynamic Mobilization in Healthy Controls

Background \& Significance Pain is the primary reason many patients seek care from healthcare professionals who utilize various manual therapy techniques. Gaining further understanding of the hypoalgesic properties of such techniques can enable practitioners to more skillfully integrate them in managing patients presenting with pain. Previous research has revealed that various manual techniques result in both local and widespread hypoalgesic changes in asymptomatic controls and patients in pain. Much of this previous research has investigated thrust manipulation; however, there is a paucity of similar research investigating these effects in neurodynamic mobilization.

Specific Aims Aim: To assess for immediate local and widespread hypoalgesic effects of neurodynamic mobilization applied to the upper extremity.

Hypotheses:

* Subjects who receive neurodynamic mobilizations will exhibit greater positive changes in local and widespread Qualitative Sensory Testing (QST) measures compared to those who receive a sham mobilization.
* Subjects who receive neurodynamic mobilizations will exhibit greater positive changes in elbow ROM and reported sensation intensity with upper limb neurodyndamic testing as compared to those who receive a sham mobilization.

Aim: To assess for differences in immediate local and widespread hypoalgesic effects of sliding vs tensioning neurodynamic mobilization techniques applied to the upper extremity

Hypotheses:

* Subjects who receive sliding neurodynamic mobilizations will exhibit greater positive changes in local and widespread QST measures compared to those who receive tensioning neurodynamic mobilization
* Subjects who receive sliding neurodynamic mobilizations will exhibit greater positive changes in elbow range of motion (ROM) and reported sensation intensity with upper limb neurodynamic testing testing compared to those who receive a tensioning neurodynamic mobilization

See protocol uploaded in documents section

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65
* Ability to speak and comprehend English.

Exclusion Criteria:

* Current neck or upper extremity symptoms
* Disorders that could result in impaired sensation - such as diabetes.
* Current use of prescription pain medication or other medications that could result in altered pain perception - such as anti-anxiety medications or anti-depressants.
* History of any chronic painful condition
* Diagnosis of any major psychiatric disorder
* Current pregnancy
* Any painful condition within the past 3 months for which care was sought
Reliabılıty,Validity Of The Turkish Version Of The Back Pain Function Scale

This study, we performed the Turkish version validity and reliability of the Back Pain Function Scale.

Low back pain is defined as the pain that can occur in the region between the lower border of the scapula and the hip, sometimes spreading to the lower extremities, which causes activity limitation and is one of the most common health problems in the society. Appropriate use of assessment questionnaires is one of the most important steps in the evaluation of the functional level of the patient and in deciding on an effective treatment protocol. The purpose of our study is to determine the Turkish version, validity and reliability of Back Pain Function Scale. 180 patients with chronic low back pain were included in the study. Test-retest and internal consistency analysis were conducted to determine the reliability of the questionnaire. Test-retest results were evaluated using the Intraclass Correlation Coefficient method. Intraclass Correlation Coefficient results vary between 0.857 and 0.951, and the total Intraclass Correlation Coefficient value is found to be 0.961. These results indicate that the test-retest responses have a high degree of correlation. For internal consistency analysis, the Cronbach Alpha score was fou nd to be 0.910, indicating that the survey has high internal consistency. The total score obtained from the Back Pain Function Scale was assessed using the Pearson correlation analysis with the total scores obtained from the Roland Morris Disability Scale , Oswestry Disability Scale. Pearson's correlation coefficient was -0.840 with Oswestry Disability Scale of Back Pain Function Scale, Pearson's correlation coefficient was -0.803 with Roland Morris Disability Scale. The results show that the Back Pain Function Scale correlates perfectly with the Oswestry Disability Scale and the Roland Morris Disability Scale. In conclusion, Turkish version of Bac Pain Function Scale is valid and reliable.

Eligibility Criteria:
Inclusion Criteria:

Having a low back pain Literate

Exclusion Criteria:

pregnant canser trauma
Motion Syros: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness

A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in subjects affected by motion sickness during travel


Eligibility Criteria:
Inclusion Criteria:

* History of motion sickness
* Age 18-75

Exclusion Criteria:

* Nausea-inducing disorder other than motion sickness
* BMI\>40
* History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists
Validation Of Quantitative Flow Ratio (QFR) - Derived Virtual Angioplasty

Prospective intervention study to assess the accuracy of the predicted QFR-derived virtual angioplasty compared to hyperaemic and non-hyperaemic pressure-wire derived indexes after PCI, as well as with QFR post-PCI.


Eligibility Criteria:
Inclusion Criteria:

* Patients submitted to a coronary angiogram with at least one non-left main stable coronary stenosis with PCI indication.

Exclusion Criteria:

* Severe stenosis of the left main coronary artery.
* Patients admitted with ST-elevation myocardial infarction.
* Culprit lesions in Non-ST-Elevation Acute Coronary Syndromes (NSTEACS) patients.
* Unability to identify the culprit lesion in NSTE-ACS patients.
Treatment Off Gingival Recession Defects Using a Xenogenic Acellular Dermal Matrix Compared to Connective Tissue Graft.

Limitation of donor site and significant postoperative morbidity are often described in connective tissue graft harvesting. We want to show if mucoderm used in tunnel technique to recover miller class I and II recessions defects could be an alternative to connective tissue graft.

Connective tissue graft harvested from the palate does not always have sufficient size to cover multiple recession defects. Moreover, connective tissue graft shows significant postoperative morbidity to treat generalized multiple gingival recessions. The goal of this study is to show if Mucoderm could be considered has a substitute of connective tissue graft in the coverage of gingival recession defects.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 45 years, postmenopausal women (ie with amenorrhea for more than a year).
* Subject with bilateral Miller class I or II recessions defects
* non smoking patients
* patients having read and understood the information note on the study and signed the informed consent form.
* patients affiliated to the social security system.

Exclusion Criteria:

* Patient with absolute contra-indication for dental surgery: valvular heart disease at risk of infectious endocarditis, recent myocardal (≤ 12 months), organ transplants, recent placement of a coronary stent (≤ 12 months), transient ischemic attacks recurrent, cardiovascular instability, uncontrolled epilepsy, rheumatic fever.
* Patient with metabolic bone disease (Paget's disease, osteomalacia, osteogenesis imperfecta)
* Patient with an ASA score ≥ 3.
* Patient with absolute contra-indication to dental surgery
* Patient with severe hematologic disease
* Patient with I or type II diabetes
* Patients with previous or current acute illness or severe chronic cardiovascular, renal, hepatic, gastrointestinal, allergic, endocrine, neuro-psychiatric, considered by the investigator to be incompatible with the conduct of the study.
* Patients treated with retinoids, oral bisphosphonates, oral anticoagulants or anticonvulsants.
* Patient have or have had cancer of the upper aerodigestive tract treated by radiotherapy.
* Patient taking a steroidal or non-steroidal anti-inflammatory, anti-cancer or immunosuppressive chemotherapy in the last 6 months.
* Patient monitoring considered difficult by the investigator.
* Patient with poor oral hygiene incompatible with oral surgery.
* Patients with periodontal disease unstabilized
* Patient with oral dermatitis or adverse occlusion.
* Patient with an acute or chronic infection of the surgical site (osteomyelitis).
* Patient with a known allergy to collagen
* Patient with autoimmune disease
* Patient with a linguistic or mental incapacity to understand information
* Patient younger than 45 years old
* Patient trust under curatorship or judicial protection
* Patients aged over 45 premenopausal.
* Patient participating in another clinical study.
Hemostatic Profile of Post COVID-19/Long COVID-19 Patients

The present study aims at assessing long-term hemostatic profile of patients recovered from COVID-19 acute infection that remain asymptomatic (POST-COVID) versus patients with residual symptoms (LONG-COVID) through the employment of a commercially available new generation point-of-care viscoelastic device. The primary endpoint is based upon the hypothesis that patients with residual symptoms maintain an abnormal coagulation profile even after recovery from COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years;
* recovery from acute COVID-19 infection;
* COVID-19 pneumonia that required hospitalization in our Institution;
* discharge from the hospital minimum 3 months before the day of the visit;
* written consent to participate to the study.

Exclusion Criteria:

* none.
A Study of Adaptive Radiation Therapy for Pelvic Genitourinary Cancer

Radical radiation therapy for prostate cancer is a common treatment that has shown to improve clinical outcomes in a post-operative setting. However, radiation therapy after surgery poses a greater risk for bladder and rectum injury for patients with prostate or bladder cancer. For prostate cancer patients, the risk is further amplified when pelvic nodes are part of the target irradiated volume. For bladder cancer patients, the risk of injury increases when more of the bladder is part of the target volume. Using an adaptive radiation therapy approach allows for correcting any shifts in the target volume. ART approach uses images from treatment to adapt the treatment plan. This study will use Adaptive Radiation Therapy for patients who receive pelvic nodal radiotherapy for either prostate or bladder cancer. Their treatment plans will adapted using MRI scans and CBCT scans taken during their first week of radiotherapy to account for any shifts in the target volume. The purpose of this study is to evaluate the feasibility of ART approach and its and on treatment plan quality metrics for pelvic radiotherapy. Acute and late toxicities will also be evaluated. 40 participants (minimum of 10 bladder cancer patients) will be enrolled. The participants will be followed for a period of 5 years post radiation therapy, during which they will have PSA as per standard practice, along with follow-up questionnaires (EPIC for prostate cancer patients and BUSS for bladder cancer patients).


Eligibility Criteria:
Inclusion Criteria:

1. Histologic diagnosis of adenocarcinoma of the prostate after radical prostatectomy:

   * Clinical stage pT3, pT4, or pT2 with positive margin; OR,
   * any p-stage with persistently elevated post-operative PSA \> 0.05ng/mL; OR,
   * a delayed rise in PSA post-operative
2. Histologic diagnosis of transitional cell carcinoma of the bladder with intact bladder and:

   * Clinical stage cT2, cT3, cT4, and N0 or N1

Exclusion Criteria:

1. Inflammatory bowel disease or other contraindications to radiotherapy.
2. Prior pelvic radiotherapy
3. Previous cytotoxic chemotherapy
4. Evidence of systemic metastases on imaging
Gene Therapy for X-linked Retinitis Pigmentosa (XLRP) - Retinitis Pigmentosa GTPase Regulator (RPGR)

Phase 1 of the study is a dose escalation of the subretinal administration of AAV5-hRKp.RPGR vector to assess the safety of this vector in participants with XLRP caused by mutations in RPGR. Participants enrolled in Phase 1 were assigned to a dose group based on when they enrolled (i.e., sequential assignment).

Phase 2 of the study is a cohort expansion of the subretinal administration of AAV5-hRKp.RPGR vector to assess the safety and efficacy of this vector in participants with XLRP caused by mutations in RPGR. Participants enrolled in Phase 2 were randomized to immediate or deferred treatment.

This is an open-label phase 1/2 dose-escalation and cohort expansion trial to determine the safety and efficacy of subretinal administration of AAV5-hRKp.RPGR vector in participants with XLRP caused by mutations in RPGR.

Eligibility Criteria:
Key inclusion Criteria:

* Males aged 5 years or older
* Have X-linked retinitis pigmentosa confirmed by a retinal specialist (CI or PI)

Key exclusion Criteria:

• Have participated in another research study involving an investigational medicinal therapy for ocular disease within the last 6 months