cyrilzakka/clinical-trials huggingface dataset:
Phototherapy for the Management of Oral Ulcers in Bone Marrow Recipients

Study hypothesis: light therapy may prevent oral ulcers in bone marrow recipients.

Methods: patients will be treated with either active light-emitting device or inactive light-emitting device. Daily treatment with light therapy will start at the beginning of the conditioning regimen and will last until day 21 post-transplant. Each daily treatment last about 5 minutes. Patients will be evaluated for oral mucositis and oral pain level on a weekly basis.

Primary endpoint:

o Assessment of effectiveness of treatment with QRay1 in preventing oral mucositis in patients undergoing hematopoietic stem cell transplantation (HSCT).

Secondary endpoint:

* Assessment of mucositis associated- pain relief.
* Assessment of safety of treatment with QRay1 (oral adverse events).
* Assessment of the patients' acceptance of the device.

Study design:

Double-blind, randomized, placebo-controlled, 2 groups (randomization ratio 1:1).

Duration of treatment:

Daily treatment. Study-treatment administration began at the initiation of conditioning regimen (visit 1) and continued to day 28 or at least until day 21 if the patient had no mucositis (WHO or OMAS = "0")

Light radiation dose:

60-70mW/cm2 (administered over 3 treatment areas), starting with 45 seconds per surface, increasing each day in intervals of 15 seconds, up to a maximum of 90 seconds per surface.

Evaluation plan:

Evaluation began before the conditioning regimen was initiated (visit 1) and continued weekly until day 28 or until day 21 if the patient had no mucositis. A follow-up evaluation was performed a month after discharge the patient. Unusual clinical presentation was addressed whenever observed.

Criteria for evaluation:

Primary efficacy variable:

o Rate of absent of mucositis at any of the visits using WHO scale for mucositis and OMAS.

Secondary efficacy variables:

* Severity of oral mucositis at any of the visits using WHO scale for mucositis and OMAS.
* Severity of oral pain at any of the visits using WHO scale for mucositis and OMAS.
* Safety (oral adverse events)
* Patients' acceptance of the study drug on an 11-step ladder. Others
* Compliance with standard oral care (chlorhexidine rinse, nystatin readymix, saline mouthwash)

Eligibility Criteria:
Inclusion Criteria:

* No oral ulceration at baseline
* At risk for oral mucositis due to the conditioning regimen to HSCT
* Age above 18 years old
* Karnofsky score \>60
* Agree to participate in the study (signed an informed consent)

Exclusion Criteria:

* Pregnant woman
* Well-founded doubt about the patient's jurisprudence
* Children
* Sensitivity to light or treated with drugs which are sensitizers to light
* Treatment with other experimental topical drug during the study period
Regulatory AVAMYS Nasal Spray PMS

Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of AVAMYS nasal spray administered in Korean patients according to the prescribing information.

AVAMYS is a registered trademark of the GSK group of companies.


Eligibility Criteria:
All subjects must satisfy the following criteria.

1. Subject who is treated with AVAMYS nasal spray for the first time.
2. Subject who is treated due to symptoms of seasonal and perennial allergic rhinitis in adults and children ≥2 years.
3. Subject who is considered to follow the PMS protocol by an investigator.
4. Subject who is contactable via telephone.
5. Subject who is treated with AVAMYS nasal spray according to its prescribing information.

As considering the characteristic of the observational post marketing surveillance, the exclusion criteria is not strict. All investigators should prescribe AVAMYS nasal spray according to prescribing information which approved in Korea.

All subjects must not satisfy the following criteria.

1. Subject who has hypersensitivity to its ingredients.
2. As corticosteroids can slow the healing of wounds, if a subject who has surgery on his/her nose recently, or has a sore in his/her nose, or if his/her nose has been injured, the subject does not use AVAMYS nasal spray until his/her nose has healed.
Prognosis and Treatment of COPD in Primary Care-use of Biomarkers

This is an observational study in primary care aiming to validate biomarkers for chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* 40 years old or more,
* diagnosis of COPD in primary care

Exclusion Criteria:

* Major psychiatric illness,
* inability to visit primary care doctor,
* inability to understand danish language,
A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs

To evaluate the efficacy of Saquinavir-SGC combination with Zidovudine and Lamivudine in the treatment of HIV-1 infected patients with no previous anti-retroviral drug therapy.

All enrolled patients will receive the following 3 drug combination: Saquinavir, Zidovudine and Lamivudine. Efficacy and duration of anti-viral response will be evaluated by monitoring of HIV-1 RNA levels. Patients below the detectable limit of 200 copies/ml will be analyzed using the Ultra-direct method with a detection limit of 20 copies/ml. CD4 and CD8 cell counts will also be analyzed.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Plasma HIV-1 RNA titers \> 10,000 copies/ml.
* CD4 cell count \> 100 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following conditions will be excluded:

* Any prior anti-retroviral drug therapy.

Prior Medication:

Excluded:

Previous anti-retroviral drug therapy.
Efficacy of Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy on a Virtual Reality Simulator

Virtual reality devices are widely accepted tools to familiarize surgical novices with the principles of laparoscopy. Free Virtual reality training will be tested against basic training and efficacy assessed in a randomized controlled trial of surgical novices.

Virtual reality simulators are widely accepted tools to familiarize surgical novices with the principles of laparoscopy without jeopardizing patient safety. However, access to a Virtual reality simulator and initial instruction alone followed by free training of the surgical novice may not be sufficient to achieve the training goals efficiently. The aims of this study are to determine if proficiency based laparoscopic training on the Simbionx LAP Mentor™ with external formative assessment using peer group derived benchmarks is superior to free training with self-assessment using the simulated laparoscopic cholecystectomy procedure with different endpoints (time to extract the gallbladder, serious complications, safe cautery and instrument pathways) as outcome parameters.

Eligibility Criteria:
Inclusion Criteria:

* Surgical novices (trainees / residents)
* Performed less than five laparoscopic procedures
* No previous simulator experience

Exclusion Criteria:

* Specialist surgeons
* Performed more than five laparoscopic procedures
* Previous experience with a simulator
Amblyopia and Strabismus Detection Using Retinal Birefringence Imaging

The purpose of this project is to compare the accuracy of two products at detecting amblyopia and strabismus in children. The devices will be Rebiscan's "blinq" (Pediatric Vision Scanner; PVS) and Rebiscan's RBI (Retinal Birefringence Imager).

Rebiscan is proposing a two-cohort study. The first cohort will include a population enriched for pathology in amblyopia to best assess device sensitivity, while a second cohort will be based in a primary care setting to best assess device specificity. The study will be conducted in busy, ethnically and economically diverse cites affiliated with the Retina Foundation of the Southwest (RFSW) in greater Dallas, TX area. Each child will be screened with Rebiscan's RBI device and it's PVS device in sequence, with results compared to the PVS as well as a comprehensive ophthalmic examination performed by a certified pediatric ophthalmologist in a statistically appropriate subset of screened subjects. Testing times will be assessed to compare the efficiency of the PVS and the RBI screening experiences. The percentage of children successfully completing the screening process will also be measured.

The RBI is expected to identify children with amblyopia and strabismus, without referring children who will not benefit from early treatment

Eligibility Criteria:
Inclusion Criteria:

* Children who present to the participating clinics
* Provide assent
* Guardian provides informed consent

Exclusion Criteria:

- Developmental delay or cognitive deficit
Cognitive, Morphological and Neurobiological Progressive Aspects in Bipolar Disorders in the Elderly: Toward to a Neurodegenerescence Detection?

The purpose of this study is to identify association between cerebrospinal fluid Alzheimer's Disease's neurodegenerescence biomarkers (tau, ptau, Aß40 and Aß1-42) and occurrence of cognitive deficits in older patients with bipolar disorders.


Eligibility Criteria:
Inclusion Criteria:

* male or female subject aged between 60 and 80 years old
* in patient or out-patient at one of the centers participating in the study
* Mini-mental state examination (MMSE) score \> 20 at baseline
* patient with diagnostic of amnestic-Mild Cognitive Impairment
* patients suffering of bipolar disorders type I or II
* in remitted (euthymic) state at baseline

Exclusion Criteria:

* pre-existing history of dementia
* history of neurologic disorder
* lifetime history of a severe psychiatric disorder other than bipolar disorders
* current medical problems
* patients treated with electroconvulsive therapy within the past six months
* patients with substance abuse or dependence within the past 12 months
* patients hospitalized without consent
A Follow-Up Survey of Oral Hygiene and Health Outcomes for Women Previously Enrolled in "OHMOM"

The objective of this study is to assess oral health, oral hygiene knowledge, and daily oral hygiene practices of women who participated in a randomized controlled trial (2011001) at University of Alabama Birmingham during the period 2012-2014. Additional objectives of the research include evaluation of possible cultural, biological or other mechanisms for outcomes observed in the OHMOM clinical trial, and oral health screening of children born to mothers during the study for the purposes of understanding possible multigenerational effects of oral hygiene education.


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age
* sign an informed consent form and be given a copy
* be a former subject in study 2011001 at University of Alabama Birmingham with a live birth outcome from that study.

Exclusion Criteria:

* any medical condition requiring pre-medication prior to dental procedures
* any diseases or conditions that might interfere with the subject safely completing the study
* inability to undergo study procedures
Evaluation of a Balance-recovery Specific Falls Prevention Exercise Program

This study aims to investigate the potential to train compensatory stepping and grasping reactions for the prevention of falls.

Physical activity and exercise have been shown to prevent falling in older adults, although the exact mechanisms by which exercise prevents falls is unclear. Compensatory stepping and grasping reactions are frequently used to prevent a fall to the ground following a loss of balance. Age-related impairment in these reactions may be related to an increased risk of falling. Therefore, the purpose of this study is to investigate means for reversing age-related impairment in compensatory stepping and grasping reactions. A training program involving perturbation-evoked reactions will be evaluated.

Comparison(s): Balance recovery ability before and after a 6-week training program will be assessed. Performance of the training group will be compared to a control group not receiving stepping and grasping training.

Eligibility Criteria:
Inclusion Criteria:

* Community dwelling
* History of falls (at least 1 fall in the past 12 months) or poor balance
* Functional mobility (no dependence on mobility aids)

Exclusion Criteria:

* Neurological or musculoskeletal disorder
* Cognitive disorder (e.g. dementia)
* Osteoporosis
The Impact of Indocyanine Green-enhanced Fluorescence Imaging on Bowel Transection in Left-sided Colorectal Resection

The aim of this study was to evaluate the impact of fluorescence imaging on the location of colorectal transection lines based on evaluation of perfusion with indocyanine green, how it's going to affect surgical planning and its possible benefits in reducing anastomotic leakage.

During surgery, the line of intended bowel transection would be determined by the surgeon. Then the anesthesiologist will administer a bolus of 5mg ICG intravenously (2.5mg/ml, 2ml), followed by 10ml normal saline flush. The perfusion of colon will be assessed via fluorescence angiography. The actual bowel transection, after ICG fluorescence study, would be compared with the intended bowel transection site. The difference in terms of distance and either more proximal or distal is recorded. Then bowel anastomosis is completed in the usual manner.

Eligibility Criteria:
Inclusion Criteria:

* All left-sided colorectal resection involving division of inferior mesenteric artery

Exclusion Criteria:

* Patients with a history of adverse reaction or known allergy to ICG, iodine, or iodine dyes. Pregnant and/or lactating patients.
Endothelial Dysfunction Induced by Postprandial Lipemia

Postprandial lipemia and exercise oppose each other in terms of cardiovascular risk, however the mechanism of their interaction is not well understood.

Therefore we want to study vascular function, as assessed by brachial artery (BA) flow mediated dilation (FMD), in healthy men before and after a high fat meal (HFM) preceded (16-18 hrs) by rest, a single bout of continuous moderate intensity exercise (CME), and high intensity interval exercise (HIIE).


Eligibility Criteria:
Inclusion Criteria:

* male, 20-40years, BMI between 25 and 30, resident in Trondheim.

Exclusion Criteria:

* unstable angina, CHD, heart failure,
Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children

The purpose of this study is planned to investigate whether small doses of methylprednisolone pulse macrolide therapy can relieve symptoms,chest X-rays faster than macrolide alone therapy for refractory mycoplasma pneumoniae pneumonia(MPP) .

Corticosteroid has been used in adulthood refractory MPP with satisfactory efficacy. But there were few studies about the use of corticosteroid in children with refractory MPP. Lee KY et al indicated oral prednisolone of 1 mg/kg/ day for 1 week be useful for children with severe MPP. Akihiro T et al demonstrated that intravenously administered methylprednisolone at a dose of 30 mg/kg once daily for 3 consecutive days had an efficacious treatment for children with refractory MPP.But the methods of corticosteroid use, such as the dosage, administration route, duration of treatment have not been well understood. So in this study, we planned to investigate whether small doses of methylprednisolone pulse macrolide therapy can relieve symptoms,chest X-rays faster than macrolide alone therapy for refractory mycoplasma pneumoniae pneumonia in a prospective, open-label fashion.

PMID: 11096025 PMID: 18033831 PMID: 10434547 PMID: 16437541 PMID: 18656264

Eligibility Criteria:
Inclusion Criteria:

* mycoplasma pneumoniae pneumonia
* prolonged fever and deterioration of radiological findings despite macrolides treatment for 7 days or more.

Exclusion Criteria:

* chronic cardiac and pulmonary disease
* immunodeficiency
* requiring mechanical ventilation
* with other pathogens detected during pneumonia.
Quantification and Characterization of Foot Postoperative Edema

In foot surgery, postoperative edema is a complication making the postoperative outcome quite uncertain as to the rehabilitation of the patient. The evolution of this edema is unknown ... The means of "mastering" this edema are empirical, with little study other than cryotherapy and restraint. This study aims to study postoperative edema in a cohort of patients undergoing forefoot surgery. The follow-up will be prospective with measurement of the volume of the foot using an optical technique, during the various follow-up consultations between Day 8 and Month 6 postoperative.


Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Patient operated on forefoot surgery
* Patient having given informed consent
* For female patients of childbearing age, not to be pregnant or likely to be during the study, not to be breastfeeding

Exclusion Criteria:

* Minor patient
* Patient deprived of his liberty or under guardianship
* Patient operated on for surgery of the forefoot other than hallux and lateral toes
* Patient unable to undergo protocol monitoring for psychological, social, family, geographic or linguistic reasons
* Patient with an underlying or concomitant pathology incompatible with inclusion in the trial, whether psychiatric or somatic
* Vulnerable people according to article L1121-6 of the CSP
Non-Interventional Study In Patients With Peripheral Or Central Neuropathic Pain Treated With Lyrica

The purpose of this study is to obtain more data about efficacy and safety of the study drug Lyrica.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of peripheral or central neuropathic pain

Exclusion Criteria:

* None. Patients recruited by physician decision. Patient's personal data are not collected.
Study Watch AF Detection At Home

This is a multi-center, prospective, non-randomized study to evaluate the performance of the study watch PPG algorithm in detecting irregular rhythms suggestive of atrial fibrillation (AF) in subjects at risk of having an event of AF in the free living (home) environment.


Eligibility Criteria:
Inclusion Criteria:

* At least 22 years old
* Able to read and speak English
* Able and willing to sign written Informed Consent
* Interest in participating in the study
* At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF (PAF) and meeting one of the following: (a) scheduled or to be scheduled to undergo AF ablation, (b) with implantable loop recorder (ILR), implantable cardioverter defibrillator (ICD), permanent pacemaker (PPM), holter monitor, or adhesive monitoring patch with documented AF burden of ≥25% in the 3 months prior to consent date, (c) CHA2DS2VASc ≥3, (d) Left atrial diameter ≥4.4 cm
* Without significant limitation in ability to participate in the study, in the opinion of the investigator

Exclusion Criteria:

* Currently in a paced rhythm
* Currently on class Ic or class III antiarrhythmic medication that has been successful in eliminating AF (no documented AF of more than 30 seconds since the initiation of the medication)
* Had successful AF ablation (no documented AF of more than 30 seconds post procedure)
* Known severe allergy to nickel or metal jewelry
* Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies
* Are diagnosed with persistent AF
* Use of implantable neuro-stimulator
* Open injury or rash where the study device or comparator will be worn
Prediction of Acute Kidney Injury After Operation of Acute Type A Aortic Dissection Based on Multimodal Model

Acute kidney injury is one of the most common postoperative complications of acute type A aortic dissection, which is closely related to early postoperative death. Early prevention, early diagnosis and early treatment are the key to improve the prognosis of such patients. It has been a hot topic in clinical research for a long time. Previous reports revealed a series of risk factors for acute kidney injury after aortic dissection, but limited by research design and single modal data, high quality studies were rare. The purpose of this study is to further clarify the risk factors by studying the relationship between preoperative CT renal perfusion imaging indexes and postoperative acute kidney injury; establish and externally verify the multimodal radiomics prediction model for acute kidney injury after operation of aortic dissection combining with preoperative CT renal perfusion imaging and CT angiography information by analysis methods of information fusion, feature engineering and radiomics, so as to guide the follow-up clinical practice, improve the prognosis of such patients and save medical resources.


Eligibility Criteria:
Inclusion Criteria:

1. 18-70 years old
2. Acute type A aortic dissection diagnosed by CT angiography
3. Sign informed consent

Exclusion Criteria:

1. History of chronic kidney disease
2. History of cardiovascular operation
3. Acute kidney injury has occurred before operation
4. Pregnancy status
Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects

This is a prospective pilot study to evaluate the safety, tolerability and efficacy of utilizing precise computer controlled gas challenge in healthy subjects for identification of coronary artery disease.

This study will establish the safe and tolerable level of high PC02 and low P02 for future studies as potential stressors for coronary artery disease assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥ 45 years of age
2. No known cardiac disease

Exclusion Criteria:

1. Low blood pressure (systolic blood pressure \< 100 mmHg)
2. Inability to voluntarily increase their breathing rate if prompted to do so
3. Persons with the inability to lie supine for 30-40 minutes
4. Persons who are pregnant, nursing, or implanted with intrauterine devices (IUD's)
5. Persons with significant neurological, pulmonary, renal or hepatic disease
6. Persons who have an abnormal cardiac rhythm or resting heart rate \>100/min
7. Inability or unwillingness to provide informed consent
High Doses Vitamin C and Tissular Repair in Surgical Patients

This is a prospective, randomize, double-blind, and placebo-controlled study to evaluate in patients with clinical criteria for any of the following open surgical procedure: (1) cesarean section; (2) aesthetic surgery like abdominoplasty; (3) orthopedic surgery; and (4) abdominal open surgery \[excluding laparoscopic procedures\] will be invited to receive either a high dose of vitamin C (12.5 g) three times (48 h pre-surgery, immediately before surgery and 48 h post-surgery) or its placebo, to evaluate the tissue repair process using an international validated instrument named Patient and Observer Scar Assessment Scale.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years.
* Susceptible for any of the following surgical procedures: (1) cesarean section; (2) aesthetic abdominal plastic surgery; (3) orthopedic prosthetic replacement surgery
* Voluntary consent to participate

Exclusion Criteria:

* Known allergy to the vitamin C
* Known problems with wounds healing
* Kidney disease (including lithiasis) or gout