cyrilzakka/clinical-trials huggingface dataset:
Research in the Development of a New Type of Digital Dermatoscope for Skin Cancer

This is a multicenter prospective observational clinical investigation with a medical device. The purpose of this study is to develop and validate of a new type of digital dermatoscope with automatic decision support algorithms. By means of this study a better insight can be gained of the current performance and workflow in clinical dermatoscopy. This knowledge will be used to further improve the developed technology.


Eligibility Criteria:
Inclusion Criteria:

* The patient has a lesion that is accessible to the Barco Digital Dermatoscope
* Patient gives informed consent
* Men or women of any ethnic group aged ≥ 18 years

Exclusion Criteria:

* Men or women of any ethnic group aged \< 18 years
* Patients not willing or able to read, understand and sign the study-specific informed consent form
Toripalimab Combined With Concurrent Chemoradiotherapy in Cervical Cancer

To explore the efficacy and tolerance of adding toripalimab simultaneously and subsequently to concurrent platinum-based chemoradiotherapy in patients with locally advanced cervical cancer.

Up to now, there have been several prospective studies exploring the effectiveness of PD-1 inhibitors in patients with recurrent/ metastatic cervical cancer. The results showed that the overall objective response rate (ORR) was between 12.2% and 55.6%, and pembrolizumab was approved by the US Food and Drug Administration for patients with advanced PD-L1-positive cervical cancer who experienced progression during or after chemotherapy. However, the evidence of using PD-1 inhibitors together with concurrent chemotheradiotherapy in patients with locally advanced cervical cancer is rare, so we initiated this single arm prospective phase II clinical study. The purpose is to explore the efficacy and tolerance of adding toripalimab simultaneously and subsequently to concurrent chemoradiotherapy in patients with locally advanced cervical cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75;
* Untreated patients with pathologically proven locally advanced cervical cancer;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Adequate hematological, renal and hepatic functions:

  1. Hemoglobin \> 8.0 g/dl
  2. Neutrophils \> 2000 cells/μl; Leukocytes \> 4 × 109/L
  3. Platelets \> 100 × 109/L

  g. Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL) h. Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL) d. Serum ALT/AST ≤ 2.5× UNL e. Serum Total bilirubin ≤ 1.5× UNL
* Life expectancy \> 6 months
* Eligible for concurrent chemoradiotherapy assessed by principle investigator;
* No obvious active bleeding;
* Written informed consent must be available before study registration

Exclusion Criteria:

* Recurrent or distant metastatic disease;
* Prior malignancies (other than curable non-melanoma skin cancer) within 5 years;
* Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants;
* Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study;
* Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study;
* Previous organ transplantation or HIV patients;
* Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component;
* Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA\> 2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA\> 103 copies/ml.
Assessment Of Peri-papillary Retinal Nerve Fiber Layer Thickness In Patients With Unilateral Branch Retinal Vein Occlusion

Several studies have indicated a relation between the development of RVO and elevated intraocular pressure (IOP) and glaucoma \[9\]. Further investigations into the structural alterations in the fellow eyes of individuals with unilateral RVO have revealed that the pRNFL is thinner than in healthy eyes, suggesting that there may be systemic risk factors for both RVO and glaucoma


Eligibility Criteria:
Inclusion Criteria:

* patients with unilateral BRVO

Exclusion Criteria:

* History of retinal and/or optic nerve diseases involving glaucomatous optic disc, ischemic optic neuropathy, or optic neuritis.
* History of trauma, intravitreal injections, vitreoretinal surgeries, and retinal or macular lasers.
* A significant media opacity that makes it difficult to capture clear images.
* No history of diabetes and/or hypertension in those recruited as the control group
Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis

The purpose of this study is to determine whether a limited duration of treatment (two weeks of low molecular weight treatment) is a safe and effective treatment for distal deep vein thrombosis of the lower limb.

Approximately 50% of symptomatic episodes of deep vein thrombosis (DVT) will be confined to the calf veins (distal DVT). The proportion of distal DVT that propagate to the proximal veins, increasing the risk of pulmonary embolism, is not known. The best treatment of isolated distal DVT is therefore controversial and options include no treatment, follow-up scanning and treatment of only those patients with thrombus propagating to proximal veins, and full anticoagulation for periods ranging from 2 weeks to 3 months.

There is good evidence that the 3-month thromboembolic risk in patients with a negative CUS that is limited to the proximal veins is low, in the order of 1%. Previous studies have demonstrated that patients treated with a short period of anticoagulation (4-6 weeks) have a low risk of developing recurrent DVT or PE. In addition, the specificity of CUS for distal DVT is lower than that for proximal DVT, increasing the proportion of false positive findings, making it likely that a proportion of patients diagnosed with distal DVT are treated unnecessarily, with the attendant risks of major and fatal haemorrhage.

The need for anticoagulation of patients with distal DVT to prevent recurrent DVT is therefore uncertain, however a survey of current practice suggested that most patients with this condition currently receive antithrombotic therapy. The impact of anticoagulation on initial patient symptoms, and the subsequent risk of the post-thrombotic syndrome are also unclear, and may be a possible alternative justification for antithrombotic therapy.

In this proposed multicentre, prospective, cohort study, we plan to determine if a shorter duration of anticoagulation (minimum 2 weeks) is a safe and effective treatment for isolated distal vein thrombosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older with acute symptomatic provoked or unprovoked distal vein thrombosis (axial or muscular veins but not involving trifurcation or distal popliteal vein)
* Absence of symptomatic pulmonary embolism

Exclusion Criteria:

* DVT involving trifurcation or more proximal leg veins on imaging
* Prior DVT
* Active malignancy ie present at time of diagnosis, or on treatment, or treatment completed within 3 months
* Ongoing risk factors for propagation e.g. immobility (\>50% of day in bed or ≥72 hours), plaster cast or non-weight bearing
* Other indication for therapeutic anticoagulation (e.g. AF)
* Active gastro-oesophageal ulceration or bleeding
* Other high risk for bleeding (e.g. recent neurosurgery, vascular retinopathy, coagulopathy)
* Platelet count \<80 x 109/L
* Renal impairment (CrCl \<30ml/min) • Pregnancy or lactation
Bisantrene for Relapsed /Refractory AML

Induction of response in patients with AML that are either primary resistant (failed induction and or salvage therapy) or relapsed including post allogeneic stem cell transplantation and failed salvage therapy or cannot receive additional anthracycline .


Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet all of the following inclusion criteria to be eligible to enroll in this study.

Disease-related:

1. Patients with Rel/Ref/AML
2. Adequate birth control in fertile patients.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Demographic:

1. Age ≥ 18 years and willing and able to comply with the protocol requirements
2. Life expectancy ≥ 3 months Ethical/Other
3. Written informed consent in accordance with federal, local, and institutional guidelines.
4. Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception.
5. Male subjects must agree to practice contraception

Exclusion Criteria:

* Disease-related

  1. Patients with other type of basic disease other than Rel/Ref AML.
  2. Patients with respiratory failure (DLCO \< 30%).
  3. Patients with active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention.
  4. Patients with \> grade II liver renal toxicity.
  5. Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
  6. Bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit
  7. Creatinine \> 2.0 mg/dl
  8. ECOG-Performance status \> 2
  9. CNS disease involvement
  10. Severe pleural effusion and ascites. Concurrent Conditions

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  1. Pregnant or lactating females
  2. Known human immunodeficiency virus infection
  3. Active hepatitis B or C infection
  4. Non hematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
  5. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
  6. Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
  7. Patients with relapse or disease progression \>3 months post HSCT are allowed into the study unless they have severe (grade III-IV) GVHD.

Patients with grade III-IV GVHD will be excluded from the study.
Assessing the Effects of Air-cooling on Capillary Malformations

The purpose of this observational study is to ascertain the effects of cutaneous air cooling on vessel diameter within Capillary Malformations (CM).

Capillary malformation (CM) is the most common vascular malformation occurring in approximately 0.3% of all newborn. The standard treatment for facial or aesthetically sensitive CM's is flashlamp Pulsed Dye Laser. Skin cooling prior to laser treatment of CMs is standard practice within our department. The effects of skin cooling on the vasculature within CMs are poorly understood. Previous studies by our department have shown that raising ambient temperature increases CM vessel size. It has been postulated that by increasing CM vessel size, it may also increase the effectiveness of treatment. We hypothesize that cooling the skin during laser treatment may cause vasconstriction of the superficial vessels within the CM. This may have an impact on treatment success.

Eligibility Criteria:
Inclusion Criteria:

* Adult more than 16 years of age
* Patient diagnosed with Capillary Malformation

Exclusion Criteria:

* Patients less than 16 years of age
Expiratory Muscle Strength Training in Improving Bulbar Function and Quality of Life in Patients With Head and Neck Cancer

This randomized clinical trial studies how well expiratory muscle strength training works in improving bulbar function and quality of life in patients with head and neck cancer. Expiratory muscle strength training may help to strengthen the muscles involved in breathing and swallowing and may allow improved breathing, airway safety, swallow function, and quality of life in patients with head and neck cancer.

PRIMARY OBJECTIVES:

I. Investigate the impact of a prophylactic targeted exercise program, expiratory muscle strength training (EMST), on swallowing function and well-being of individuals on head and neck cancer (HNC).

II. Determine the impact of EMST on objective respiratory measures of individuals with HNC.

III. Determine the relationship between mean dose across the swallowing muscles (oral tongue and supra-hyoids, base of tongue, superior, middle and inferior pharyngeal constrictors, proximal esophagus)/dose on each muscle and the swallowing functional outcomes from aim 1.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care comprising of written patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus. Patients participate in a therapy session conducted by a speech pathologist over 30 minutes once per week for 6 weeks during chemoradiation therapy. Patients also perform prescribed exercises at home daily for 3 sets of 10 repetitions.

ARM II: Patients receive standard of care comprising of written patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus. Patients participate in a therapy session conducted by a speech pathologist over 30 minutes once per week for 6 weeks during chemoradiation therapy. Patients perform prescribed exercises at home daily for 3 sets of 10 repetitions. Patients also participate in an EMST session over 30 minutes comprising of 5 sets of 5 repetitions daily for 5 days per week for 6 weeks during chemoradiation therapy.

After completion of study, patients are followed up at 1, 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a definitive, curative treatment plan consisting of chemoradiation for head \& neck cancer

  * Surgery, if required, must be limited to: diagnostic biopsy

Exclusion Criteria:

* Participants enrolled in a radiation de-intensification protocol
* Current or previous neurological disease, which may adversely affect swallowing
* History of oropharyngeal swallowing disorder prior to cancer diagnosis
* Previous neurosurgery on the brain
* Severe chronic obstructive pulmonary disease (COPD) requiring oxygen dependence, as this is a contraindication of EMST
Project Affinity: Excess Cancer Blood Testing

Study investigating cancer blood samples on an iterative measurement systme


Eligibility Criteria:
Inclusion Criteria:

* Undergoing SACT
* Routine blood tests

Exclusion Criteria:

* Not had first cycle of SACT
Combined Role of Position Emission Tomography (PET) and Magnetoencephalography (MEG) in Nonlesional Epilepsy

The first aim of this study are to evaluate the lobar concordance of FDG-PET and MEG with intracranial electrographic study in children with intractable partial epilepsy. The second aim is to determine if the combined role of FDG-PET and MEG improve detection of epileptogenic zone as defined by invasive intracranial recordings.

Children with poorly controlled epilepsy are extensively investigated with various tools including MR brain, electroencephalography (EEG), magnetoencephalography (MEG) or position emission tomography (PET) scans. When MR brain does not show an abnormality, the patient is said to have nonlesional epilepsy. In these cases, it is even more crucial to be able to identify the epileptogenic zone, depending on availability of investigative tool.

Recognizing that individual modalities have limitations, the aim of this study is to determine if combining non-invasive investigations with MEG and PET, which respectively evaluate the electrical and metabolic activity of the brain, could improve the children with intractable nonlesional epilepsy with MEG and PET and compared this with invasive intracranial monitoring. The endpoint of the study being agreement on localizations of epileptogenic zone using PET and MEG individually and in combination and comparing this with invasive intracranial monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages 0-18 years with (1) nonlesional intractable focal epilepsy and (2) those with discordant clinical and EEG findings, who are potential surgical candidates

Exclusion Criteria:

* Patients who are pregnant
Teletherapy for Upper Extremity Fracture Rehabilitation (TELE-REHAB Study)

Following upper limb surgeries, patients could receive occupational therapy either in-person or remotely (teletherapy). The investigators currently do not know which occupational therapy delivery is better in terms of clinical outcomes and patient recovery. The proposed study is a pilot randomized controlled trial (RCT) testing the feasibility of comparing in-person occupational therapy to teletherapy following operative fixation of upper extremity fracture. It is a single site, parallel-arm, randomized controlled trial to compare teletherapy versus in-person occupational therapy. Patients who are eligible will be randomized similar to a flip of a coin (1:1) to occupational therapy in-person or through a telemedicine platform. Patients would also complete surveys at each follow-up visit to measure clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have had operative fixation of upper extremity fracture located between the humeral shaft and distal radius (inclusive) who are indicated for outpatient occupational therapy.
* Participants at least 18 years (≥ 18 years of age).
* English-speaking participants

Exclusion Criteria:

* Participants unable to consent
* Vulnerable populations including prisoners and marginally housed patients
* Additional traumatic conditions that may affect the ultimate-use pattern of the injured limb including traumatic brain injury, spinal cord injury, peripheral nerve injury, or associated soft tissue injury requiring specific postoperative activity modifications.
* Contralateral upper extremity injury that prevents participating in the standardized exercises.
* Initiation of occupational therapy (OT) during an inpatient hospital stay
* Pre-existing comorbidities that may interfere with communication or that may limit the use of standard telecommunications tools (sight/hearing impaired, speech impaired)
* Patients without a smart-phone or internet access.
Green Coffee Extract and Metabolic Syndrome

Metabolic syndrome (Mets) is an assemblage of risk factors which can increase the risk of developing type 2 diabetes mellitus and cardiovascular disease. Green coffee extract (GCE) is derived from unroasted coffee beans and has substantial amounts of polyphenols primarily chlorogenic acids (CGA). It has been shown that GCE and CGA can exert a positive influence over Mets components including blood pressure, blood glucose, inflammation, oxidative stress, insulin resistance and blood lipids. Up to our knowledge no study has been conducted on humans in the field of GCA influences on Mets patients. Therefore, this study is planned to evaluate GCA supplementation effects on anthropometric measurements, glycemic control, blood pressure, lipid profile in patients with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Waist circumference\>102 cm in men and \>88 cm in women
* Fasting blood glucose\>100 mg/dL (5.6 mmol /L)
* Systolic blood pressure\>130 mmHg or diastolic blood pressure\>85mmHg
* Triglycerides\> 150 mg/dL (1.7 mmol/L)

Exclusion Criteria:

* Insulin administration
* Pregnancy and breastfeeding
* regular consumption of coffee and green tea
Perioperative Glucose and Insulin Changes in Major Urologic Surgeries

Urological surgery patients will have their blood glucose measured before, during, and after surgery. Blood glucose will be measured using a continuous glucose monitor (CGM) device. We hypothesize the presence of a hyperglycemic state towards the end of surgery due to increased metabolic demand.

Surgical stress causes acute insulin resistance, increased circulating free-fatty acids, and reduced blood glucose uptake resulting in hyperglycemia. Intraoperative and postoperative glucose levels are typically only monitored in the diabetic or cardiac surgical patient. There is a lack of data on perioperative glucose levels in most prolonged surgeries and thus a barrier in determining the best glycemic management strategy to prevent or resolve acute insulin resistance and hyperglycemia. Obtaining blood glucose by CGM is less invasive and will avert disruption of current surgical pathways and standards of care while also producing reliable glucose measurements.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years) undergoing a major urologic surgery (proposed case duration \>4 hours) at The University of Kansas Medical Center (KUMC)
* English speaking

Exclusion Criteria:

* Diagnosis of Type 1 or Type 2 diabetes mellitus or an A1C \> 6.5%
* Pregnant or lactating
* Known allergy to milk, soy, egg, wheat, peanuts, or tree nuts
* Swallowing difficulties
A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers

A multicenter randomized clinical trial aiming to assess the efficacy of hydroxychloroquine associated to Zinc compared to hydroxychloroquine, in the prevention of Military Health Professionals Exposed to SARS CoV2 in Tunisia

Detailed Description: The study is a multicenter randomized controlled double blind clinical trial, including up to 660 military health professionals working in Tunisia and exposed to SARS CoV2 at different levels (2 levels of exposure).

The trial will assess the efficacy of hydroxychloroquine associated to Zinc compared to hydrxyochloroquine. Randomization will be performed by IWRS (Interactive Web Response System) by random double blocs of 9 and 6.

Collected data are managed by the electronic data capture system (DACIMA Clinical Suite),according to the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the EU GDPR (European General Data Protection Regulation), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation)

Eligibility Criteria:
Inclusion Criteria:

* No self-medication with chloroquine, hydroxychloroquine or antivirals
* COVID-19 negative diagnosis confirmed by "rapid test" and "PCR test" (Polymerase Chain Reaction test)
* No clinical symptoms suggestive of COVID-19
* Having given written consent for their participation in the study

Exclusion Criteria:

* Participation in other clinical trials for the treatment or prevention of SARS-COV-2 infection within 30 days before inclusion
* Hypersensitivity to any of the drugs or to any of its excipients.
* ECG showing rhythm disturbances, QT interval\> 500 ms, conduction disturbances.
* Severe hepatic impairment.
* Concomitant treatments : colchicin, ergot of rye, pimozide, mizolastin, simvastatin, lomitapide, alfuzosin, dapoxetin, avanafil, ivabradin, eplerenone, dronedaron, quetiapine, ticagrelor, cisapride, astemizole, astemizol.
* Retinal pathology.
* Epilepsy.
* Myasthenia.
* Psoriasis.
* Methemoglobinemia.
* Porphyria.
* Pregnant or lactating women
* Contraindication to the study products