cyrilzakka/clinical-trials huggingface dataset:
Prospective Follow-up of Outcomes in Patients Receiving Photodynamic Therapy for Neoplastic Diseases

From 1996-present, we have used photodynamic therapy (PDT) to treat a number of neoplastic diseases both on prospective research protocols (for head and neck cancer, pleural malignancies, peritoneal carcinomatosis or sarcomatosis and prostate cancer) as well as for FDA approved and off label or compassionate exemption indications (neoplasms of the skin, bronchus, esophagus, head and neck and pleura). The goal of this treatment is to maximize quality of life and organ function while minimizing the chance of tumor recurrence. As such, we would like to retrospectively review the treatment parameters of all patients who undergo/underwent PDT (including operative notes and photodynamic therapy records) and treatment outcomes (including all organ functions, performance status, tumor recurrence, laboratory values and any other data present in the routinely documented follow up visits). For patients who have died or were lost to follow-up prior to initiation of this study, a retrospective review of available data will be performed. For patients who are still being actively followed after PDT or who receive PDT after the initiation of this study, informed consent will be obtained for obtaining continued follow-up data prospectively and any previous data will be collected retrospectively.. These subjects will continue to receive care from their current physicians according to standard medical practice and no attempt will be made to alter the types of follow-up, radiologic or other diagnostic studies or medical treatment as a result of enrollment in this study. All data will be de-identified and added to our already existing PDT treatment outcome databases for outcomes analysis, quality improvement and reporting of results in abstract and manuscript forms.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be age 18 or greater
* Subjects will have undergone PDT for a diagnosis of neoplastic disease under the direction of a Penn physician.

Exclusion Criteria:

* None
MPA Pharmacokinetics in Renal Transplantation

Adequate exposure to mycophenolic acid (MPA) is associated with better outcomes in kidney transplantation. This study evaluated repeated, MPA pharmacokinetics (MPA-PK) according to post-transplant time-points and concomitant CNIs. Fifty-two patients, 33 allocated to tacrolimus (TCL) and 19 to CyA (all with mycophenolate mofetil (MMF) and steroids), had the full MPA area under the time-concentration curve (AUC0-12hrs) repeatedly evaluated at days 7, 14, 30, 60 and 180 post-transplant. MMF daily dose was lower in TCL group as per protocol. Dose-adjusted MPA-AUC0-12hrs progressively increased throughout the study period in both groups but profiles were different according to the CNI regimen and time. The majority of patients were underexposed to MPA on day 7 for both groups what reinforces the need of a higher dose in the first week. Dose-adjusted MPA-AUC0-12hrs was higher in TCL group, after day 7, due to both a diminished MPA clearance (for both groups) and higher AUC4-12hrs in the TCL group. There was a progressive overexposure to MPA in order that at day 180, 21-30% of the patients were overexposed to MPA what indicates a time for MPA monitoring and dose correction for long-term follow-up. These PK data suggest that changes in MPA profile occur according to time and CNIs used and suggests that MPA monitoring may be mandatory at specific time-points.


Eligibility Criteria:
Male and female patients aged 18-65 years, recipients of a non-HLA identical kidney allograft who presented a PRA \< 50% were eligible for the MoDIFY trial. Subjects were excluded if they received a non-renal organ, had current history of alcohol or illicit drug abuse, had liver enzymes more than two times the upper normal limit or received induction with anti-lymphocyte preparations.
Socket Shield Technique and Guided Bone Regeneration

Among the individuals who applied to the Department of Periodontology, Faculty of Dentistry, Health Sciences University between 2019 and 2021, patients with an unrestorable tooth in the maxillary esthetic region and required implant placement were included in this randomized clinical trial. Before implant surgery, patients were randomized into socket shield technique and guided bone regeneration groups. While the buccal gap was untreated in the socket shield group, a xenograft, and membrane were applied in the regeneration group. Peri-implant pocket depth, modified plaque index, modified bleeding index, keratinized mucosa width, and mucosal thickness were recorded at the permanent restoration and the postoperative first year. Horizontal bone level and vertical bone level were assessed with cone beam computed tomography images taken before the surgery and one year after prosthesis insertion. The pink esthetic score was evaluated with intraoral photographs taken before the surgical procedure and first-year follow-up.

This study aimed to compare the non-grafted socket shield technique with simultaneously guided bone regeneration in immediate implant placement in terms of clinical, esthetic, and radiographic parameters. Within the scope, immediate implant placement was applied to randomized groups (socket shield technique and guided bone regeneration). Immediate implant placement was performed following shield preparation in the shield group, and guided bone regeneration was applied in the regeneration group. A temporary non-functional immediate prosthesis was inserted at the same visit. After four months, permanent restorations were applied. Clinical, radiographic, and esthetic parameters were compared between two groups at baseline and first-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the health status of American Society of Anesthesiologists class I or II,
* Nonsmokers,
* Unrestorable single-rooted tooth in the maxillary esthetic region,
* Periodontally healthy, non-mobile teeth,
* Single implant placement,
* Minimum 3-5 mm available vertical bone apical to the apex,
* Intact socket wall after extraction.

Exclusion Criteria:

* Medically compromised patients, especially uncontrolled diabetes,
* Psychiatric problems,
* Pregnancy, lactation, or suspicion of pregnancy,
* A history of radiation therapy to the head and neck region or immunosuppressive therapy,
* Metabolic bone disorder or the presence of drugs known to affect bone metabolism,
* Poor plaque control,
* Vertical root fracture on the buccal surface or a horizontal fracture below the bone level,
* External or internal resorption affecting the buccal part of the root,
* Acute infection in the area intended for implant placement,
* Refusal to attend follow-up appointments.
Pneumocystis Jerovici Pneumonia in Infants and Steroids

This is a double-blind randomized controlled trial assessing the efficacy of adjuvant corticosteroids in clinically diagnosed Pneumocystis jiroveci pneumonia in infants.

The study aims to determine whether the early administration of adjuvant corticosteroids in addition to high dose oral Co-trimoxazole reduces mortality amongst infants aged 2-6 months with vertically acquired HIV and clinically diagnosed Pneumocystis jiroveci pneumonia. Infants will be randomized to receive either a steroid regime of oral prednisolone at 2 mg/kg for 7 days, then 1 mg/kg for 7 days, then 0.5mg/kg for 7 days for a total of 21 days or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive infants with HIV and clinical features of Pneumocystis jiroveci pneumonia who require oxygen (oxygen saturations in air \< 90%).
* Clinical diagnosis of Pneumocystis jiroveci pneumonia will be made by one of the study investigators. All infants must be HIV ELISA positive or exposed, have an oxygen requirement (saturations on air \< 90%) and have severe respiratory distress and cough. They may also have a low grade fever, clear chest or diffuse signs on auscultation and features suggestive of Pneumocystis jiroveci infection on chest radiography.

Exclusion Criteria:

* Previous known allergy or hypersensitivity or other contraindication to corticosteroids or co-trimoxazole.
* Previous treatment for suspected Pneumocystis jiroveci pneumonia or a delay starting steroids for greater than 24 hours after starting high dose co-trimoxazole.
* Patients who are not exposed to HIV.
* Infants with known preexisting active pulmonary or cardiac disease.
* Patients who do not live within the Blantyre district and who are unable to attend follow up at QECH.
* Infants whose parents or guardians refuse consent.
The Effect of Self-care Emphasizing on Balloon-Blowing Exercise Program on Severity of Sleep Apnea and Respiratory Muscle Strength Among School Age Children With Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) is a common condition in school-age children, often leading to sleep disturbances and associated health issues. Non-invasive interventions, such as respiratory muscle training, have shown promise in mitigating the severity of OSA. This study explores the effects of a self-care-focused balloon-blowing exercise program on improving respiratory muscle strength and reducing OSA severity in children.

This research aimed to study the effects of a self-care emphasizing on balloon-blowing exercises program on severity of sleep apnea and respiratory muscle strength in school-aged children diagnosed with mild to moderate obstructive sleep apnea (OSA), receiving treatment at the outpatient ENT department at Siriraj Hospital.

Thirty children participated, divided into two groups: 15 children received the self-care emphasizing on balloon-blowing exercises program for five weeks based on Orem's self-care theory (2001), and 15 children received regular nursing care. The research instruments included a severity assessment scale for apnea and a self-care behavior assessment scale for children with OSA. Both instruments had content validity indexes of 0.95 and 0.80, and their reliability, Cronbach's alpha, were 0.83 and 0.76, respectively. Respiratory muscle strength was measured using a Respiratory Pressure Meter. Data were analyzed using statistical t-tests.

Eligibility Criteria:
Inclusion Criteria:

* School-age children aged 6-12 years diagnosed with obstructive sleep apnea (OSA) of mild to moderate severity (AHI 1-9 events/hour).
* Children receiving a consistent medication dosage with no planned adjustments to increase the dosage.
* Fully conscious, with no hearing problems, and able to understand the Thai language.
* Children voluntarily agree to participate in the study, and their parents consent to provide care during the research period.
* Have a smartphone or tablet capable of using the LINE application, with the ability to operate the application under parental supervision.
* Agree to allow the researcher to communicate via LINE and phone calls.

Exclusion Criteria:

* Children with severe comorbidities or chronic illnesses requiring ongoing treatment.
* Children undergoing treatment with continuous positive airway pressure (CPAP) therapy.
* Children who have engaged in exercise sessions lasting more than 20 minutes per session, at least 3 times per week, within the 6 months prior to the start of data collection.
China Rural Hypertension Control Project

China Rural Hypertension Control (CRHC) Project is a cluster randomized trial that will test the effectiveness of a village doctor-led multifaceted intensive blood pressure intervention on hypertension control in 18 months (Phase 1), cardiovascular disease risk in 36 months (Phase 2), and all-cause dementia in 48 months (Phase 3) among patients with hypertension in rural China.

The overall objective of the CRHC Project is to develop an effective, adoptable, and sustainable implementation strategy to achieve more intensive blood pressure (BP) control among rural residents in China. Moreover, this effectiveness-implementation trial will test the effectiveness of a lower BP target (\<130/80 mmHg) on cardiovascular disease (CVD) and all-cause dementia. Specifically, we will test the effectiveness of a village doctor-led multifaceted intervention, compared with usual care, on BP control, CVD, and dementia among rural residents with hypertension in China. This cluster randomized trial is conducted in 326 villages from three provinces in mainland China. A total of 163 villages was randomly assigned to a village doctor-led multifaceted intervention and 163 villages to usual care, stratified by provinces, counties, and townships. A total of 33,995 individuals aged ≥40 years with uncontrolled hypertension were recruited into the study. The village doctor-led multifaceted intervention is designed to overcome barriers at the healthcare system, provider, patient, and community levels. Study participants are followed every 6 months for BP, CVD, and other study outcomes. The primary outcome is BP control (\<130/80 mm Hg) at 18 months in phase 1, CVD events over 36 months in phase 2, and all-cause dementia at 48 months in phase 3.

Eligibility Criteria:
Eligibility criteria for study villages:

* The village has a regular village doctor who is willing to participate in the hypertension control project
* The village does not plan to merge with other villages within 3 years
* The village is at least 2 kilometers away from other participating villages
* The village participates in the China New Rural Cooperative Medical Scheme

Eligibility criteria of study participants:

* Men or women aged ≥40 years
* Mean untreated systolic BP ≥140 mm Hg and/or diastolic BP ≥90 mm Hg or mean treated systolic BP ≥130 mm Hg and/or diastolic BP ≥80 mm Hg for individuals without a history of clinical CVD; or mean treated/untreated systolic BP ≥130 mm Hg and/or diastolic BP ≥80 mm Hg for individuals with a history of clinical coronary heart disease, heart failure, stroke, diabetes, or chronic kidney disease
* Have lived in a participating village for at least 6 months
* No intention to migrate within next 3 years
* Taking part in the New Rural Cooperative Medical Scheme
* Not pregnant or planning to become pregnant
* No malignant tumors and life expectancy ≥3 years
* Willing to participate and able to sign informed consent
A Comparison of the Littler Flap With the Bipedicled Nerve Flap

A retrospective study is conducted with 59 patients who has a combination of soft tissue and digital nerve defects following trauma treated using the Littler flap or bipedicle nerve flap.Patients are divided into two groups. The group reconstructed with the Litter flap includes 26 patients and the group reconstructed with the bipedicle nerve flap includes 33 patients.Discriminatory sensation, pain and cold intolerance of the reconstructed finger, and patient satisfaction were evaluated.

At final follow-up, we measured the sensation of the pulp of the reconstructed finger and the flap using the static two-point discrimination (2PD) test and Semmes-Weinstein monofilament (SWM) examination. The test points were at the centers of the radial and ulnar portions of the finger pulp and the flap. Cold intolerance of the injured and donor fingers was assessed using the self-administered Cold Intolerance Severity Score questionnaire. The maximum score was 100; scores were grouped as mild (0 to 25), moderate (26 to 50), severe (51 to 75), and extremely severe (76 to 100). Pain was given subjectively by the patient using a grading system that included grade 1, none; grade 2, mild, no interference with daily activities; grade 3, moderate, patient works but has some limitation in use of the hand because of pain; and grade 4, severe, cannot work or use hand. The Tinel sign on the donor and recipient sites was graded as follows: grade 1, none; grade 2, mild, slight tingle; grade 3, moderate, very uncomfortable; and grade 4, severe, patient unable to use hand because of any stimulation of the neuroma. Finally, patients reported their satisfaction with functional recovery of the injured finger according to the Michigan Hand Outcomes Questionnaire that was based on a 5-point response scale. All tests were performed by an independent senior hand surgeon.

Eligibility Criteria:
Inclusion Criteria:

* the defect in a region where sensory return is considered important
* soft tissue defect with exposed bone or tendon in only one digit
* associated single or double digital nerve defects with 1 to 4 cm in length7
* a soft tissue defect greater than 1.5 cm and less than 4 cm in length
* necessity to preserve digit length
* a patient between 15 and 60 years of age.

Exclusion Criteria:

* injury to the course of donor arterial pedicle or donor nerve
* nerve defect less than 1 cm or larger than 4 cm
* a soft tissue defect≤1.5 cm or ≥4 cm in length
* multiple-digit soft tissue defects
* extremely contaminated wounds
* the defect in a region the flap is unable to reach, such as thumb fingertip
Design and Validation of a New Assessment Tool for Lichen Planopilaris

The study's Primary Objective is to design and validate a grading system for objective and accurate assessment of lichen planopilaris.

Secondary Objectives:

* To assess change in symptoms such as pain and itch using a Numeric Rating Scale(NRS) scores and quality of life using the Dermatology Life Quality Index (DLQI) scores
* To correlate this grading system with patient skin biopsies evaluating disease activity on a microscopic level
* To correlate this grading system with digital global photography and trichoscopy


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects in general good health between the ages of 18 and 80 years old
2. Clinical and histologic diagnosis of lichen planopilaris
3. Subject is able to understand and sign informed consent
4. Subject is able to complete the study and comply with study procedures
5. Subject has no known allergy to non-toxic ink
6. Subjects should be managed by an Massachusetts General Hospital dermatologist for their lichen planopilaris for the duration of the study

Exclusion Criteria:

Eligible subjects will be excluded from participation if they meet any of the following criteria:

1. Presence of dermatoses that might interfere with LPP diagnosis and/or evaluation such as seborrheic dermatitis or psoriasis
2. Other selected concomitant causes of hair loss, including discoid lupus erythematosus, central centrifugal cicatricial alopecia (CCCA), telogen effluvium
3. Abnormal TSH laboratory value \>1 standard deviation above normal within last year
4. Any significant medical condition that may prevent the patient from participating in the study according to the investigator's assessment
5. Any known allergy to non-toxic ink Related to Biopsy
6. History of poor wound healing or blood-clotting abnormality
7. History of keloid formation or hypertrophic scarring
8. Regular intake of high doses of aspirin or anti-coagulant medications
9. Hypersensitivity to local anesthetics
10. History of poorly controlled diabetes mellitus
11. Pregnant, nursing or planning a pregnancy
Mastery Learning Versus Time-based Education: Skill Acquisition and Retention of Basic Life Support in Laypeople

Background:

In cardiac arrest survival rates dramatically increase when bystanders are present and initiate Basic Life Support (BLS). However, even though serious efforts have been made, skill retention after a traditional time-based BLS course for laypeople remains suboptimal. In contrast, a mastery learning-based educational approach was shown to be efficacious and might be promising even for laypersons. Therefore the investigators aim to evaluate the impact of a mastery learning-based BLS course on skills retention of BLS in laypeople.

Methods:

Forty laypeople without previous BLS experiences will be randomized into the traditional time-based BLS course group (Control - TB group) or mastery learning-based group (Intervention - ML group).

Both groups will receive BLS training consisting of 6 successive stations including diagnosis of cardiac arrest, chest compression, ventilation, one-rescuer BLS, two-rescuer BLS and AED use. In the ML group, subjects will deliberately practice and receive feedback at each station until a pre-set target level is reached. Subjects will be allowed to proceed to the next station only when they achieve the required target level of performance. In contrast, participants of the TB group will be taught the same 6 stations in two hours, according to standard American Heart Association BLS criteria. All subjects will have an assessment of knowledge and skills immediately after teaching (immediate post-test) and at four months (retention post-test).

Implications:

Previous research has shown that mastery learning-based education improves learners' procedural skill performance. The investigators study will determine the impact of a mastery learning-based BLS course on skill retention in laypeople.


Eligibility Criteria:
Inclusion Criteria:

* University students in Ottawa

Exclusion Criteria:

* Students of the Faculty of Medicine
* Previous Basic Life Support Training Certificate
Stepwise Approach Versus Linear Ablation in Patients With Recurrence of Persistent Atrial Fibrillation

Catheter ablation of persistent atrial fibrillation (AF) remains a challenging procedure. Even in experienced centres, repeat interventions are necessary in up to 70 of patients to achieve sinus rhythm at a long-term follow-up.

While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for the ablation of paroxysmal and persistent AF ablation, different additional ablation strategies are used to achieve a modification of the substrate that perpetuates the arrhythmia: linear lesions (anterior and roof lines) or ablation of complex fractionated atrial electrograms (CFAE). In the stepwise approach PVI, CFAE ablation and/or LL are combined according to the presenting arrhythmia during procedure.

The aim of the study is to determine whether there is a difference in terms of freedom from arrhythmia between a stepwise approach and a linear ablation for repeat procedure in patient with recurrence of persistent atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrence of symptomatic persistent atrial fibrillation after at least one ablation procedure,
* with the last ablation procedure at least 3 months ago.
* at least one unsuccessful attempt of antiarrhythmic drug
* oral anticoagulation for at least 4 weeks prior to ablation

Exclusion Criteria:

* LA thrombus