cyrilzakka/clinical-trials huggingface dataset:
Treatment of Aphtous Ulcers With Photodynamic Therapy

The search for methods that can shorten the treatment process of aphthous ulcers, the etiology of which is not fully understood, continues. The aim of this study was to determine whether photodynamic therapy (PDT) is a clinically effective alternative in the treatment of oral aphthous ulcers.

After sample size calculation, photodynamic therapy and control groups were formed with 15 patients with aphthous ulcer in each group. Laser therapy with indocyanine green was applied to the photodynamic therapy group on the day they were admitted to the clinic. No treatment was performed in the control group and only follow-up was performed. Lesion diameters, pain intensity and degree of improvement at the end of 1 week were recorded in all patients.

Eligibility Criteria:
Inclusion Criteria:

* ASA-1 patients without any systemic disease,
* With a history of canker sores not exceeding 2 days,
* Not taking any antibiotics or anti-inflammatory drugs.

Exclusion Criteria:

* Laser therapy contraindicated,
* Pregnancy,
* Smoking habbit,
* Poor oral hygiene,
* Patients under 18 years of age
Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine

Clinical trial applying Phenotypic Precision Medicine (PPM) to tacrolimus dosing in liver and/or kidney transplant recipients to show improvement in maintaining drug trough levels within the target range.

The introduction of calcineurin inhibitors like tacrolimus has greatly reduced the incidence of acute rejection, improving graft and patient survival after transplantation. However, tacrolimus, one of the most widely used immunosuppressants and a mainstay of solid organ transplantation, has a narrow therapeutic index and wide pharmacokinetic variability. As such, there is a clear need for precision medicine to address post-transplant immunosuppression.

The study team has developed a powerful platform \[Phenotypic Precision Medicine (PPM)\] that utilizes patient-specific clinical data which represents each patient's response to drug treatment. This platform can efficiently prescribe precise and optimized drug doses despite the frequent changes to patient treatment regimens following transplantation. This potentially can have a profound effect on drug metabolism.

The aim of this project is to use PPM to uncover valuable and previously unknown information pertaining to patient dose requirements and correlate them with patient clinical and other contextual information. This study is also expected to reveal vital patient subpopulation information; and any future discovery of quantitative biomarkers as measures of immunosuppression will serve as a gateway towards even more effective personalized and relevant drug dosing.

Eligibility Criteria:
Inclusion Criteria:

* adults undergoing liver and/or kidney transplantation

Exclusion Criteria:

* transplant patients with contraindications to tacrolimus
Urban Training for COPD Patients

This project plans on a training intervention by using public spaces and urban walkable trails, adapted to each patient needs and capabilities. Primary objective is to assess 12 months effectiveness of the intervention with respect to: (primary outcome): physical activity level, and (secondary outcomes): COPD admissions, exercise capacity, body composition, quality of life, and mental health.


Eligibility Criteria:
Inclusion Criteria:

* age \> 45 years
* COPD diagnosed by pulmonary function tests during clinical stability, with a ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ≤ 0.70
* clinical stability, defined as at least 4 weeks without antibiotics or oral corticosteroids.

Exclusion Criteria:

* living \>6 months/year outside of the included municipalities,
* living to a distance higher than 500 meters to any of the urban trails used for the study,
* mental disability according to the Mini Mental State Examination in its validated Spanish version
* comorbidity that could interfere with study tests (e.g., lower limb amputation)
* severe psychiatric disease or severe comorbidity limiting survival at one year, according to medical history.
Clinical Outcome Of Advanced Renal Cell Carcinoma In Taiwan

The clinical outcome of advanced / metastatic renal cell carcinoma has been changed since targeted therapy being widely applied. This study will retrospectively analyse the clinical outcome of advanced renal cell carcinoma captured in Taiwan National Health Insurance Research Database.

Targeted therapy agents have significantly changed the clinical outcome of advanced / metastatic renal cell carcinoma. However, the dosing pattern varied and might result in impact to duration of treatment. In Taiwan, National Health Insurance system has a coverage more than 90% of population and thus can serve as an appropriate database for further analysis on Taiwanese advanced renal cell carcinoma. This study will retrospectively analyse the clinical outcome of advanced renal cell carcinoma captured in Taiwan National Health Insurance Research Database.

Eligibility Criteria:
Inclusion Criteria:

* advanced/metastatic renal cell carcinoma

Exclusion Criteria:

* N/A
Lovastatin in Reducing Side Effects After Radiation Therapy in Women With Breast Cancer

RATIONALE: Drugs, such as lovastatin, may protect normal cells from the side effects of radiation therapy.

PURPOSE: This phase II trial is studying how well lovastatin works in reducing side effects after radiation therapy in women with breast cancer.

OBJECTIVES:

* To determine the incidence of good/excellent cosmetic outcome, as defined by the Harvard Scale, after radiotherapy in women treated with lovastatin, as compared to historical controls.

OUTLINE: Patients undergo standard external beam whole-breast irradiation and/or accelerated partial breast irradiation. Patients receive oral lovastatin once daily beginning on the first day of radiotherapy and continuing for 12 months in the absence of disease progression or unacceptable toxicity.

Patients complete a questionnaire, the Breast Cancer Treatment Outcome Scale, at baseline and then at 6 months, 12 months, and 3 years after completion of radiotherapy to assess cosmetic and functional outcomes.

After completion of radiotherapy, patients are followed periodically for up to 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of invasive or in situ epithelial cancer of the breast

  * Stage 0, I, or II (Tis, T1, or T2) disease
  * Unifocal disease (single focus that can be encompassed by breast-conserving surgery)
* Has undergone prior surgical resection of the primary lesion (lumpectomy) and axillary nodal evaluation (if invasive disease is present)

  * Negative surgical margins (≥ 1 mm)
* Planning to undergo radiotherapy with either standard external beam radiotherapy or accelerated partial breast irradiation (interstitial or balloon brachytherapy)
* No Paget disease of the nipple
* No evidence of distant metastases
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* Karnofsky performance status 70-100%
* Transaminases \< 3 times upper limit of normal (ULN)
* Creatine kinase \< 5 times ULN
* Creatinine clearance ≥ 30 mL/min
* Negative pregnancy test
* No active liver or muscle disease
* No history of collagen vascular disease (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis)
* History of prior malignancy allowed provided life expectancy is ≥ 4 years
* No major medical or psychiatric illness that, in the investigator's opinion, would prevent completion of study treatment or interfere with follow-up
* No contraindication to an HMG-coA-reductase inhibitor

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior radiotherapy to the breast, lung, or mediastinum

  * Prior radiotherapy to the contralateral breast allowed
* No chemotherapy for ≥ 2 weeks prior to, during, and for ≥ 2 weeks after completion of radiotherapy
* No concurrent cytochrome P450 3A4 inhibitors
* Concurrent HMG-coA-reductase inhibitor allowed provided patient is able to switch to 20 mg of lovastatin per day
* Concurrent tamoxifen or an aromatase inhibitor allowed
Vigorous Exercise for Depressed Smokers

In this project the investigators will develop and pilot test a supervised, vigorous intensity exercise intervention for depressed female smokers. If the pilot intervention is successful the investigators will have a blueprint for a large randomized controlled trial. The long term objective is to develop interventions for depressed women that will ultimately reduce their risk of tobacco-caused disease and mortality.

This project will be the first to evaluate supervised vigorous exercise for depressed smokers

Eligibility Criteria:
INclusion Criteria:

1. depressed (CES-D) score 16 or above
2. 18 years of age
3. female gender
4. sedentary
5. current cigarette smoker

Exclusion Criteria:

1. smoking cessation medication
2. Not able to exercise medically
Medical Abortion Via Telemedicine for Women and Adolescents in Moldova

This study evaluates the safety, feasibility, and acceptability of a novel medical abortion via telemedicine service in the Republic of Moldova.

Women and girls in Moldova, especially those in rural areas, must travel to regional medical centers to obtain an abortion from a certified gynecologist. This creates barriers to accessing safe abortion that disproportionately affect poor women and girls, through wage loss due to missed work and accrued costs due to transportation. This innovation is a novel service delivery model that allows self-management of medical abortion (MA) with remote guidance from a provider. After confirming their pregnancy, women seeking MA will receive counseling from a gynecologist via videoconference and will subsequently obtain the necessary medication via mail or at at participating pharmacy with prescription. Follow-up will occur 1 weeks later via phone/videoconference (with referral to a doctor if necessary) to confirm MA success and assess the patient's and provider's satisfaction with the service. We hope to demonstrate the feasibility, effectiveness and acceptability of telemedicine MA services in Moldova so that it can thus be integrated into the national public healthcare system. As a result, this project will serve as a model that could be adapted and implemented in nearby countries within the Eastern Europe and Central Asia region.

Eligibility Criteria:
Inclusion Criteria:

* 16 years or older
* Has an unwanted pregnancy
* Confirmed the pregnancy using a test or via ultrasound
* Gestational age of 9 weeks or less
* Has personally decided to end the pregnancy
* Has a device (phone, tablet, or computer) with internet connection, a webcam, and a microphone.
* Has immediate access to emergency services
* Reports no contraindication to medical abortion

Exclusion Criteria:

* Under 16 years of age
* Does not have an unwanted pregnancy
* Did not confirm pregnancy
* Gestational age greater than 9 weeks
* Does not have a device (phone, tablet, or computer) with internet connection, a webcam, and a microphone
* Does not have immediate access to emergency services
* Has an intrauterine device
* Is allergic to abortion medications (mifepristone or misoprostol)
* Has severe anemia or acute porphyria
* Has a condition that affects the ability of blood to clot normally
* Has hepatic failure or chronic renal disease
* Has an ectopic pregnancy
* Has heart disease or other cardiovascular problem
* Has a condition that requires hormone treatment
Cardiometabolic Response to a Sodium-bicarbonated Mineral Water

The effects of consuming a sodium-bicarbonated mineral water rich in bicarbonate, sodium, chloride, lithium and silicon are studied in humans. The aim of this assay was to determine whether the consumption of this water as part of the usual diet, reduces cardiometabolic risk factors in adult men and women.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults, men and women \>18 and ≤ 45 years
* Total-cholesterol \> 200 mg/dL and \< 300 mg/dL

Exclusion Criteria:

* Age \<18 and \> 45 years
* Total-cholesterol ≥300 mg/dL
* Triglycerides \> 250 mg/dL
* Total-cholesterol / HDL-cholesterol \> 6
* Being a usual consumer of carbonic mineral water
* BMI \< 20 and \>30 kg/m2
* Diabetes
* Hypertension or digestive, liver or renal disease
* Eating disorders
* Being under medication that could affect lipid metabolism
* Consumption of functional foods that could affect lipid metabolism (food containing n-3 fatty acids or phytosterols)
Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis; Weight Loss

This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counseling, after which. Patients will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle.

This substudy aims to investigate any changes in MRI associated with the initial 8-week weight loss intervention, and the value of CT scans in predicting the effect of weight loss.


Eligibility Criteria:
Inclusion Criteria:

* Same as parent trial (NCT02905864)

Further Exclusion Criteria

* Same as parent trial (NCT02905864)
* Usual exclusion criteria for MRI (i.e. pacemakers etc.)
A Research Study Looking at Long-term Blood Sugar Control in People With Type 2 Diabetes Being Treated With Xultophy® in a Real-world Setting in Italy

The purpose of the study is to collect information on how Xultophy® works in patients like them with type 2 diabetes. Participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 18 months. Participants will be asked questions about their health and diabetes treatment as part of the normal study doctor's appointment.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study-related activities (study-related activities include any procedure related to recording of data according to the protocol).
* Male or female, age greater than or equal to 18 years at the time of signing informed consent.
* Patient diagnosed with T2D greater than or equal to 12 months prior to signing informed consent.
* The decision to initiate treatment with commercially available Xultophy® has been made by the patient and the treating physician before and independently from the decision to participate in this study.
* Treated with basal insulin with or without use of oral antidiabetics (OADs), with or without use of bolus insulin prior to initiating Xultophy®.
* For patients transferring from a regimen including bolus insulin, upon initiation of Xultophy® the bolus insulin component of the treatment regimen was stopped.
* The patient initiated Xultophy® treatment for at least 2 months, but no more than 3 months prior to signing informed consent.
* Available and documented HbA1c measurement no more than 3 months prior to Xultophy® initiation.

Exclusion Criteria:

* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
* Diagnosed with type 1 diabetes mellitus, maturity-onset diabetes of the young, latent autoimmune diabetes in adults, gestational diabetes or any hyperglycaemic state other than T2D.
* Women known to be pregnant or breastfeeding, or women planning to become pregnant during the conduct of the study.
* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Participation in another T2D clinical study that involves any clinical intervention or administration of an investigational drug within 3 months prior to enrolment into the study.
* Any contraindications for Xultophy®, including hypersensitivity to the active substances or any of the excipients as specified in the Xultophy® local label.
Multimodal Analgesia for Cholecystectomy

It is important to decrease the postoperative pain in patients undergoing laparoscopic cholecystectomy. We will compare the pharmacologic analgesia with the parmacologic and surgical analgesia in patients undergoing laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective laparoscopic cholecystectomy

Exclusion Criteria:

1. Recent gastric ulcer disease
2. Hepatic or renal insufficiency
3. Opioid dependency
4. Coagulopathy
5. Pre-existing neurologic or anatomic deficits in the lower extremities
6. Severe psychiatric illness
7. pregnancy
Study of STIM1 Membrane Expression

The aim of this study is to determine the expression of STIM1 in the plasma membrane of lymphocytes from patients suffering from different autoimmune diseases in order to identify new pathologies of interest presenting an over-expression of STIM1PM.

This would allow to initiate, following this study, research and development programs on the use of anti-STIM1 antibodies in these identified autoimmune diseases of interest.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of one of the autoimmune diseases

Exclusion Criteria:

* Treatment with rituximab in the previous 12 months
Food Collection From Type 1 Diabetic Patients Practicing Insulin Functional Therapy

a food collection will be performed in this study with type 1 diabetic patients trained to carbohydrate counting, to collect data on the meals consumed daily and their quantities for a period of 1 month.


Eligibility Criteria:
Inclusion criteria:

* type 1 diabetic patients
* Using carbohydrate counting and functional insulin therapy
* Patient with Social security or beneficiary
* Patient able to read and understand the procedure, and able to express consent for the study protocol

Exclusion criteria:

* Patient abusing substances
* person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure -- Patient having a psychological conditions making him unable to follow and understand study protocol
A Randomized, Double-Blind, Trial Comparing Epinephrine Versus Phenylephrine as a Vasoconstrictor in Regional Anesthesia for Upper Extremity Surgery

The study involves research, the purpose of which is to compare three different drug mixtures (Epinephrine, Phenylephrine 25 µg, or Phenylephrine 50 µg). Specifically, how long each medicine lasts will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Shoulder surgery with regional anesthesia

Exclusion Criteria:

* Shoulder surgery with general anesthesia unhealthy
Caudal Block & Hip Fracture Surgery in Anticoagulated Patient

Hip fractures are common in elderly patients, and require surgery. Many elderly patients take anticoagulants for vasculopathy treatment. Anticoagulation precludes the use of neuraxial anesthesia because of the risk of epidural bleeding. Caudal anesthesia may be a safe and effective technique in anticoagulated emergency surgical patients.

Quantitative analysis of prospective clinical data. Evaluation of caudal anesthesia efficacy for hip fracture surgery. Analysis of perioperative outcome, and postoperative course.

Hip or femoral neck fractures are common in elderly patients. These fractures require surgical repair. Many elderly patients take regular anticoagulant therapy for vasculopathy. Anticoagulation precludes the use of spinal or epidural anesthesia because of the risk of epidural bleeding. Caudal anesthesia is another form of neuraxial anesthesia that may be safe and effective for hip fracture surgery in anticoagulated elderly patients.

Quantitative analysis of prospective clinical data. It is an evaluation of caudal anesthesia efficacy for hip fracture surgery. This is an analysis of intraoperative analgesia, perioperative outcome, postoperative course, and complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients with fractured hip or femoral neck who undergo surgical repair

Exclusion Criteria:

* Patients who refuse surgical repair
Three-Dimensional Assessment of Dentoskeletal Changes Associated With a Modified Twin Block Appliance

The aim of the current study is to evaluate the skeletal, dental, soft tissue, TMJ, and upper airway size changes associated with a new design of twin block compared to the conventional twin block appliance. Additionally, patients' satisfaction with the two designs will be assessed.

Twin block appliance is the gold standard for the treatment of skeletal class II patients with deficient mandible. Yet, it has some drawbacks as proclination of the mandibular incisors, development of posterior open bite and the unesthetic appearance. Many modifications in twin block A new design were made to overcome the previous problems, as adding incisor capping, Clasps, sagittal blocks, and esthetic twin block appliances. In the current trial A new design of esthetic twin block appliance with sagittal blocks is investigated and the post treatment skeletal, dental, and soft tissue, TMJ, and upper airway size will be assessed and compared to the changes associated with the conventional design of twin block. Moreover, patient satisfaction with the appliance will be assessed with both appliances.

Eligibility Criteria:
Inclusion Criteria:

* skeletal class II deficient mandible
* Class II molar and canine relation
* male growing patients CVM 2,3 age range 10-14
* normal vertical growth pattern
* ANB \> 4
* mild to moderate crowding

Exclusion Criteria:

* Previous orthodontic treatment.
* Craniofacial syndrome.
* Periodontal disease.
* Extracted first permanent molars.