cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities

The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratoses on the upper arms and hands


Eligibility Criteria:
Inclusion Criteria:

* Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on one upper extremity

Exclusion Criteria:

* Pregnancy
* grade 3 and/or atypical \>1cm AKs within Treatment Area
* history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
* lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
* skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
* Subject is immunosuppressed
* unsuccessful outcome from previous ALA-PDT therapy
* currently enrolled in an investigational drug or device study
* has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment
* known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)
* use of the following topical preparations on the extremity to be treated:

  * Keratolytics including urea (greater than 5%), alpha hydroxyacids \[e.g.glycolic acid, lactic acid, etc. greater than 5%\], salicylic acid (greater than 2%) within 2 days of initiation of treatment.
  * Cryotherapy within 2 weeks of initiation of treatment
  * Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks of initiation of treatment.
  * Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment.
* use of systemic retinoid therapy within 6 months of initiation of treatment.
High Resolution Wavefront-guided vs. Wavefront Optimized LASIK

The investigators are comparing outcomes of LASIK surgery using a high definition wavefront-guided laser to a wavefront-optimized laser in patients with nearsightedness with and without astigmatism.

The patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the patient from the study, then the investigators will inform the patient and make an appropriate referral. if the patient is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. The patient will undergo bilateral simultaneous eye surgery. Which eye is treated with the CustomVue and which eye is treated with Wavelight will be randomized so there is a 50% chance for either eye to receive one treatment. The patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. The patient will receive topical antibiotics in each eye for one week following the procedure. The patient will receive pred forte 1% ophthalmic drops for one week after treatment. The patient will also receive vigamox ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK surgery.

Eligibility Criteria:
Inclusion criteria.

* Subjects age 21 and older with healthy eyes.
* Nearsightedness between -0.25 diopters and -11.00 diopters with or without astigmatism of up to 5.00 diopters.

Exclusion criteria.

* Subjects under the age of 21.
* Patients with excessively thin corneas.
* Patients with topographic evidence of keratoconus.
* Patients with ectatic eye disorders.
* Patients with autoimmune diseases.
* Patients who are pregnant or nursing.
* Patients must have similar levels of nearsightedness and farsightedness in each eye. They can not be more than 1.5 diopter of difference between eyes.
* Patients must have similar levels of astigmatism in each eye. They can not have more than 1.5 diopter of difference between eyes.
Pain After PRP Revascularization and Endodontic Treatment of Non-vital Mandibular Molars With Apical Periodontitis

randomized clinical trial which Evaluate thr Post-operative Pain Following Platelet Rich Plasma (PRP) Revascularization versus Conventional Endodontic Treatment of Non-vital Mature Mandibular Molars with Chronic Peri-apical Periodontitis

it will be done in 2 visits where in the firist visit, i will finish cleaning and shaping of the canals and inject double antibiotic paste as intracanal medication.

in the second visit, removal of intracanal medication then obturaton of the canals in the control group. while in the intervention group,over instrumentation of the canals beyond the working length using k-file size 20-35 to establish bleeding in the canals.then blood sample is collected for PRP preparation then injected into the canal.the patient will record post operative pain 6,12,24,48 hours then 3,4,5 days later.then they will do CBCT at 6, 12 months after the treatment to assess peri-apical healing

Eligibility Criteria:
Inclusion Criteria:

* Medically free patients, between 18-40 years
* Patients with necrotic pulp in mandibular molar permanent teeth with closed apex

Exclusion Criteria:

* Illiterate patient
* Patients with systemic diseases
* Pregnant women
* Patients that have allergy to ciprofloxacin or metronidazole
* Teeth that:

  * Have vertical root fracture, coronal perforation, and calcification.
  * re-treatment cases
  * Non restorable
* Patients that have T.M.J. disorder
Antiviral Pharmacology and Adherence in Drug Users

Approximately one half of all Americans living with Hepatitis C virus (HCV) are drug users, yet they are the least likely to receive HCV treatment. Drug users are presumed non-adherent and therefore denied potentially life-saving therapy. This assumption can only be confirmed or dispelled through prospective pharmacologic and adherence studies in this population. Such studies would be greatly enhanced by an objective, quantitative measure of adherence which does not currently exist in the HCV field. Through the work proposed in this application, sixty HIV/HCV co-infected drug users will be treated with direct acting antiviral agents (DAA) and randomized to receive directly observed DAA therapy (DOT) vs. no directly observed therapy (no-DOT). Patients randomized to no-DOT will have wirelessly observed therapy (WOT) which involves use of a portable medication dispenser that sends a signal to a server with the date and time when the dispenser is opened. In Aim 1, DAA concentrations will be compared in those randomized to DOT vs. no-DOT. DAA pharmacokinetics will also be defined accounting for clinical factors like degree of hepatic impairment and use of concomitant recreational and antiretroviral drugs. The goal is to quantify adherence in this population and the effect of variable adherence on drug concentrations. In Aim 2, DAA concentrations (plasma, cellular, hair) will be linked with adherence patterns identified using WOT and DOT. The goal is to identify a drug concentration biomarker that predicts adherence in this population. In Aim 3, the relationship between DAA adherence (as measured by WOT and DOT and drug concentrations) and rate of cure will be established. The goal is to define the degree of adherence needed for HCV cure.


Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent
* HIV-infected men and women
* Chronic HCV infection as documented by quantifiable HCV RNA
* HCV genotype 1, 4, 5, 6
* 18-70 years of age
* Willingness and ability to comply with study procedures, including DOT, WOT, and biweekly clinic visits
* Considered an active drug user by HCV provider and self-reported drug use within the past month

Exclusion Criteria:

* Glomerular filtration rate \< 30 mL/min/1.73 m2
* Receipt of prior HCV treatment and radiographic, histologic, or clinical evidence of cirrhosis
* Decompensated liver disease (i.e., ascites, history of esophageal variceal bleeding, hepatic encephalopathy)
* Medications not recommended per the SOF/LDV prescribing information (e.g., tipranavir and other P-gp inducers, tenofovir disoproxil fumarate plus cobicistat, rosuvastatin, amiodarone)
* Any medical condition that in the opinion of the investigators will make it challenging to adhere to the study protocol, such as unstable heart disease or cancer
* Chronic Hepatitis B virus Infection
* For females, active pregnancy or any intent to become pregnant
* For both sexes, an unwillingness to use contraception during the study period
* On parole or impending sentencing
Prospective Randomized Study of SILS Versus CLS for Rectal Cancer

Background: Single-port laparoscopic surgery is emerging as a method to improve morbidity and cosmetic benefits of conventional laparoscopic surgery and minimize the surgical trauma. However, the feasibility of this procedure in rectal surgery has not been determined yet. The aim of this study is to evaluate our initial experience using single port access in laparoscopic rectal surgery.

Design: randomized, prospective clinical study Patients: 40 patients


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age.
* ASA I-III.
* Tumor-location: maximum 15 cm from the anal verge.
* No involvement of neighbouring organs.
* No distant metastasis.

Exclusion Criteria:

* Linguistic, physical or psychological barriers precluding oral and written consent.
* History of intestinal surgery (excl. appendectomy).
New Prognostic Index for Neoadjuvant Chemotherapy Outcome in Patients With Advanced High-grade Serous Ovarian Cancer

A validated prognostic index for the outcome of advanced high-grade serous ovarian cancer (HGSOC) patients undergoing neoadjuvant chemotherapy (NACT) is still lacking. To address this need, we developed an ovarian neoadjuvant chemotherapy prognostic index (ONCPI) to improve predictive accuracy. We analyzed the clinicopathological characteristics of advanced HGSOC patients receiving platinum-based NACT. Blood inflammatory composite markers were calculated and binary-transformed using optimal cutoffs. Omental hematoxylin and eosin (H\&E) stained slides were selected for the assessment of chemotherapy response score (CRS). Logistic regression analysis and Cox proportional hazards regression model were utilized to develop a prognostic index.

1. The clinicopathological data of patients newly diagnosed with high-grade serous ovarian cancer in Sun Yat-sen Memorial Hospital were collected and screened.
2. Statistical analysis of hematological indicators that may be related to inflammation before platinum-based therapy in patients who met the inclusion criteria, including but not limited to: Absolute white blood cell count, absolute neutrophil count, absolute lymphocyte count, absolute monocyte count, platelet count, hemoglobin and fibrinogen were calculated. NLR, MLR, PLR, FLR and SII were calculated, and the correlation between the above indicators and tumor grade, stage, platinum-based drug sensitivity and prognosis was analyzed.
3. CRS scoring was performed using H\&E sections of omentum obtained during IDS surgery.
4. logistic regression and Cox regression were used to analyze the independent risk factors affecting the sensitivity of neoadjuvant platinum-based chemotherapy and the prognosis of patients.
5. K-M analysis and ROC curve were used to analyze the predictive value of NLR combined with CRS ONCPI index for the response of high-grade serous ovarian cancer to platinum therapy.

Eligibility Criteria:
Inclusion Criteria:

1. confirmed diagnosis of HGSOC by two experienced pathologists;
2. clinical stage III-IV according to the 2018 International Federation of Gynecology and Obstetrics (FIGO) guideline;
3. Eastern Cooperative Oncology Group (ECGO) performance status of 0 to 1;
4. no prior anti-cancer therapy;
5. received ≥ 3 cycles of platinum-based NACT followed by IDS;
6. complete pretreatment blood test results and clinical and imaging data.

Exclusion Criteria:

1. other pathological types;
2. without NACT or IDS;
3. incomplete pretreatment data;
4. lost to follow-up.
Influence of Wrist Taping on Handgrip Strength in Crossfit Athletes

The idea that the use of a wristband can increase the grip strength is old, but without systematic scientific evidence. Most Crossfit practitioners wear wrist bands during training because it is believed that the wristband increases the grip strength of the hand. The aim of this study is to to analyze the influence of the use of the wristband on the maximum force value and on the dynamic resistance of hand hold. A simple blind randomized cross-over trial will be performed.


Eligibility Criteria:
Inclusion Criteria:

* be an amateur practitioner of the Crossfit modality with at least 6 months of regular sports practice (at least 4 times a week)
* between 18-40 years old
* agree to participate in the study and sign the informed consent form (ICF).

Exclusion Criteria:

* active wrist/ arm injury or pain on the day of the test (pain score greater than 3 in 10 for both shoulder, forearm, wrist and / or hand on the VAS pain scale)
* history of wrist injury (especially fracture or ligament injury)
* previous wrist surgery
Erector Spinae Versus Intercostal Nerve Blocks With Liposomal Bupivacaine for Analgesia in Thoracic Surgery

This clinical trial compares efficacy in postoperative pain management in thoracic surgery between erector spinae block versus liposomal bupivacaine injections.


Eligibility Criteria:
Inclusion Criteria:

* Video assisted pulmonary resection, pleurodesis or decortication

Exclusion Criteria:

* Allergy to local anesthetics
* Patient undergoing bilateral surgery
* Surgery is emergent as deemed by the principal investigator
Safety and Tolerability of WVE-210201 in Patients With Duchenne Muscular Dystrophy

This is a Phase 1, double-blind, placebo-controlled, single ascending dose cohort study to evaluate the safety, tolerability, and plasma concentrations of WVE-210201 in ambulatory and non-ambulatory male pediatric patients with DMD amenable to exon 51 skipping intervention.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Duchenne muscular dystrophy (DMD) based on clinical phenotype with increased serum creatine kinase
* Documented mutation in the Dystrophin gene associated with DMD that is amenable to exon 51 skipping
* Ambulatory or non-ambulatory male patients aged ≥5 - ≤18 years
* Stable pulmonary and cardiac function as measured by:

  1. Reproducible percent predicted forced vital capacity (FVC) ≥50%
  2. Left ventricular ejection fraction (LVEF) \>55% in patients \<10 years of age and \>45% in patients ≥10 years of age, as measured (and documented) by echocardiogram within one year prior to enrollment into the study.

Exclusion Criteria:

* Severe cardiomyopathy; cardiomyopathy that is managed by angiotensin-converting enzyme (ACE) inhibitors or beta blockers is acceptable provided the patient meets the LVEF inclusion criteria.
* Need for mechanical or non-invasive ventilation OR anticipated need for mechanical or non-invasive ventilation within the next year, in the opinion of the Investigator.
* Changes in nutritional or herbal supplements or concomitant medications within 1 month prior to Screening visit or plans to modify dose or regimen during the study.
* Currently on anticoagulants or antithrombotics.
* Received treatment with eteplirsen or ataluren within the past 14 weeks.
* Received prior treatment with drisapersen.
* Received any investigational drug within the past 3 months or 5 half-lives, whichever is longer.
Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial

The goal of this clinical is to assess the efficacy of natural enzymes mouthwash in the treatment of xerostomia (dry mouth). The main questions it aims to answer are: (1) the efficacy of natural enzymes mouthwash in the symptomatic treatment of xerostomia; and (2) the response of xerostomia patients towards natural enzymes mouthwash. Participants were given a mouthwash to be used. Intervention group received natural enzymes moisturising mouthwash, while control group received benzydamine mouthwash. Mouthwashes were repacked, labelled with specific code and were given to participants by third-party. Subjects were instructed to rinse with the mouthwash 4 times per day at a specific period, for 2 weeks. Data were compared within each arm before and after using the mouthwashes; and between both arms after using the mouthwashes.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old and above,
* complained of dry mouth (xerostomia), and
* taking nutrition orally

Exclusion Criteria:

* patients who had been using mouthwash for xerostomia in the past 1 week,
* unable to provide saliva samples,
* unable to chew paraffin wax for stimulated saliva,
* patients with oral motor function deficits, and
* those with severe cognitive deterioration.
Second-generation Drug-eluting Stents in Diabetes

This is an investigator initiated randomized trial, performed under the auspices of the Spanish Society of Cardiology.

It is a multicenter, international, parallel, randomized 1:1 (amphilimus-eluting stents vs zotarolimus-eluting stents) clinical trial performed exclusively in patients with diabetes mellitus. The study has an "all-comers diabetics" design.

The primary-endpoint is target lesion failure at 1-year follow-up (non-inferiority design) and the co-primary end-point is target lesion failure at 2-years follow-up (superiority-design).


Eligibility Criteria:
Inclusion Criteria(must meet all):

* Patients ≥18 years who understands the nature of the study and provides written informed consent.
* Diagnosis of diabetes according to the American Diabetes Association diagnostic criteria (\*)
* Documented silent ischemia, stable angina, unstable angina, or myocardial infarction (with or without ST elevation).
* At least one de novo coronary lesion with stenosis of more than 50% in a vessel with a reference vessel diameter of 2.25 to 4.5 mm by visual estimation. Coronary anatomy is suitable for PCI (patients with potential CABG indication should be eligible for PCI after a multidisciplinary evaluation in a Heart Team).

Exclusion Criteria:

* Cardiogenic shock or resuscitation
* Comorbidity with anticipated life expectancy to 24 months
* Inability to consent due to mechanical ventilation
* Pregnant female patient
* Conditions that could preclude a minimal of 1 month of DAPT (such as, but not limited to: severe liver failure, platelet count \<100,000 cells/mm3, recent gastrointestinal bleeding or history of bleeding diathesis or coagulopathy)
* Contraindication or known allergy to aspirin, heparin, P2Y12 inhibitors, cobalt and/or chromium metal alloys, sirolimus or derivates, polyurethane, or contrast media (for contrast-media allergy, patients that might be safely and adequately pre-medicated should be allowed to enter the study).
* Currently enrolled in another clinical trial.
A Validation Study of Selfie Technology for Assessment of Vital Signs

The aim of this study is to compare accuracy of DocMe, a video technology developed by DocMe Health Technologies, with previously validated medical devices used for measurements of heart rate, heart rate variability, respiratory rate and blood pressure in adults.

Photoplethysmography (PPG) makes uses of low-intensity infrared (IR) light. When light travels through biological tissues, it is absorbed by bones, skin pigments and both venous and arterial blood. However, as light is more strongly absorbed by blood than the surrounding tissues, the changes in blood flow can be detected by PPG sensors as changes in the intensity of light.

The signal from PPG is proportional to the quantity of blood flowing through the blood vessels and even small changes in blood volume can be detected using this method. Analysis of the waveform can provide information on a range of physiological measurements affecting the cardiovascular and respiratory systems. PPG is widely used in medicine in the form of pulse oximeters using sensors applied to peripheral digits.

Recently, it has been shown that PPG data can be obtained using images acquired from videos taken using the camera on smartphones and there is now a significant and growing body of published literature to support this.

DocMe Health Technologies has developed a system of obtaining these data using a video selfie.

At this time, the technology has been shown to be reasonably accurate when compared to home devices in healthy subjects. However, to make the technology more widely useful, the results obtained by video selfies need to be formally validated.

The aim of the study therefore is to compare measurements obtained from video selfies with measurements taken using already validated machines in the same patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 - 100 years old). Participants must be willing and able to give informed consent for participation in the study, and considered fit for the study by the nurse.

Exclusion Criteria:

* None
Rectosigmoid Resection vs Seromuscular Tumor Shaving in Ovarian Cancer Surgery

Ovarian cancer is the most common cause of death in gynecological cancer. Approximately 75% of epithelial ovarian cancers are detected at an advanced stage. Metastasis and spread are mostly through transperitoneal planting and neighborhood by shedding from the ovarian surface. Metastasis mostly occurs in the peritoneum, omentum, and intestines. The rectosigmoid colon is the main part of the intestine affected by metastasis due to its neighborhood.

Treatment in ovarian cancer consists of a combination of cytoreduction surgery and platinum-based chemotherapy. Surgery is the basis of the treatment, and the main goal is to achieve no residual visible tumor (complete cytoreduction: R0). The residual tumor is one of the main factors affecting survival and reflects the possibilities of the surgical center and the team. Multiple surgical procedures (total hysterectomy, bilateral salpingo-oophorectomy, total omentectomy, peritonectomy, retroperitoneal lymphadenectomies such as pelvic and paraaortic, bowel resections, splenectomy, distal pancreatectomy, various resections related to the bladder, liver, stomach, and diaphragm) may be required to achieve complete or optimal cytoreduction.

In the involvement of the rectosigmoid colon, primarily the serosa, then the muscular layer and finally the mucosa are infiltrated due to the nature of the spread, and therefore most of the involvement is observed in the seromuscular layer. In seromuscular infiltration, resection of the rectosigmoid colon or shaving of tumoral implants without resection can be performed. There are advantages and disadvantages of each method in terms of morbidity. Although there are retrospective studies evaluating recurrence and survival between both methods, as far as investigators know, no randomized prospective studies have been conducted comparing these two methods. The investigators designed this study to compare these two methods successfully applied in our clinic in a prospective randomized study.


Eligibility Criteria:
Inclusion Criteria:

* Epithelial ovarian cancer
* Negative colonoscopy ( no mucosal involvement)
* Intraoperative confirmed serosal or seromuscular rectosigmoid infiltration
* ECOG \<3
* ASA \<3

Exclusion Criteria:

* Nonepithelial ovarian cancers
* Rectosigmoid mucosal infiltration
* Total or subtotal colectomy necessitating large bowel infiltrations
* ECOG \>2
* ASA \>2