cyrilzakka/clinical-trials huggingface dataset:
Regenerative Endodontic Procedure of Immature Permanent Teeth With L-PRF: a Pilot Controlled, Clinical Trial

This study evaluates the impact of autologous 'leucocyte and platelet rich fibrin' (L-PRF) on the periapical bone healing and further root development of infected immature permanent teeth. In the test group regenerative endodontic procedure (REP) is performed with L-PRF as scaffold, in the control group REP without L-PRF is performed .

Regenerative endodontic procedures are biologically based procedures designed to restore function of a damaged and nonfunctioning pulp by stimulation of existing stem and progenitor cells present in the root canal and/or the introduction and stimulation of new stem and dental pulp progenitor cells into the root canal under conditions that are favorable to their differentiation and reestablishment of function. L-PRF has the potential advantage of creating a bioactive construct that stimulates the local environment for differentiation and proliferation of these stem and progenitor cells. We have designed this confirmatory study to test the hypothesis that the use of L-PRF in REP of infected permanent immature teeth will accelerate periapical bone healing and stimulate the root maturation.

Eligibility Criteria:
Inclusion Criteria:

* Provision of Informed Consent
* Permanent immature teeth with weak root canal walls (hopeless prognosis)
* Patients younger than 25 years

Exclusion Criteria:

* - Unlikely to be able to comply with the study procedures, as judged by the investigator.
* Patients older than 25 years
* Deciduous teeth
* Permanent (immature) teeth that can be treated by a "regular" root canal treatment/ apexification
* Known or suspected current malignancy
* History of chemotherapy within 5 years prior to study
* History of radiation in the head and neck region
* History of other metabolic bone diseases
* A medical history that makes REP unfavorable
* Involvement in the planning and conduct of the study
* Previous enrolment in the present study
Effect of Body Position and Probe Position on the Localization of Breast Mass

The purpose of this study is to demonstrate that BVN G-1000 can precisely and consistently measure the position of female breast lesions regardless of patient rotation and probe angle during ultrasound examination.

The proposed research consists of quantitatively detecting and reporting the effect of body rotation and ultrasound probe position on the breast on the position of breast lesions relative to the breast nipple and body orientation planes, required for positional annotations, in female subjects at one study visit. Measurements will be manually and automatically recorded by two ultrasound operators with each image and will be compared among these conditions to detect effects of probe position and probe orientation and patient's body position relative to the exam table. The manual and automated measurements will be compared to determine the differences between the data obtained using the two different methods.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. 21-70 years of age
3. Known palpable or non-palpable benign or probably benign breast mass or masses, less than 2 cm in maximum diameter and at least 4 cm away from the nipple, from a previous ultrasound examination

Exclusion Criteria:

1. Women with cardiac pacemaker or portable defibrillator
2. Women with known breast cancer or suspicious lesions
3. Pregnant and lactating women
4. Women who have breast implant(s)
5. Women who have had prior breast surgical intervention not including breast needle biopsy, in the same breast with the qualifying target mass.
6. Women with the target finding to be mapped within a distance of 4 cm from patient's nipple.
7. Women with multiple similar qualifying targets in close proximity (less than 4 cm between targets).
8. Women with history of allergy to medical-grade adhesive tape or ultrasound gel
9. Women whose weight is over 250 pounds
Ultrasound Confirmation of Fluoroscopically Guided Piriformis Muscle Injections

Subjects will have failed conservative treatment, including, but not limited to oral medications, physical therapy, manual manipulation, and/or alternative medicine. They will be evaluated by a spine specialist in the Spine Division of the Department of Orthopaedics and will be scheduled for a piriformis muscle (PM) corticosteroid injection.


Eligibility Criteria:
Inclusion Criteria:

* Subject Scheduled to receive piriformis injection for buttock pain
* Baseline pain visual analogue scale (VAS) value of at least 4 on a scale of 0-10 points
* Subjective complaint of pain in the buttocks with radiation down the thigh and/or leg
* Objective clinical diagnosis of piriformis syndrome
* Reproduction of pain with maneuvers that stretch or contract the piriformis muscle over the sciatic nerve

Exclusion Criteria:

* Litigation
* Those receiving long-term (\>6 months) remuneration for their pain or seeking new or increased long-term remuneration
* Those unable to read English and complete the assessment instruments
* Diagnosis of systemic inflammatory arthritis (e.g. rheumatoid, lupus)
* Addictive behavior, severe clinical depression or psychotic features. The subjects will be identified at the sole discretion of the PI who per the current standard of care will consent the potential subjects to the study
* Possible pregnancy or other reason that precludes the use of fluoroscopy. Fluoroscopy is the current standard of care for piriformis injections. Its use in this study is no different than the standard of care and will be no different if the subjects are enrolling in the study or not
* Contra-indication to corticosteroid, including known allergies or sensitivities
A New Active Vitamin D, ED-71 for Osteoporosis

A prospective, randomized, double-blind study to compare the effect of ED-71 with that of alfacalcidol on fracture incidence


Eligibility Criteria:
Inclusion Criteria:

* Osteoporotic patients who meet any of the following condition:

  1. with at least one fragility fracture,
  2. above 70 year-old with bone mineral density below 70% young adult mean,
  3. with bone mineral density below 60% young adult mean
* Women three years or more after menopause or men

Exclusion Criteria:

* Current disorders such as primary hyperparathyroidism, Cushing's syndrome,gonadal insufficiency, poorly controlled diabetes mellitus or other causes of secondary osteoporosis
* A history or suspicion of active urolithiasis at any time
* Use of bisphosphonates in the past 12 months
* Use of medications known to affect bone in the past 2 months
* Abnormal serum calcium, urinary calcium, serum creatinine or liver function tests
Delivra-Celecoxib 8% Cream and Osteoarthritis

The observation of the clinical use of the Delivra Celecoxib cream (8%) in the treatment of osteoarthritis of the knee. Observations will be made over 12 weeks of treatment. Evaluations include: pain, functionality and patients global assessment of disease. Patients will self administer treatment as prescribed.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Patients with primary osteoarthritis (with radiological evidence) of the knees who have been prescribed Del-Cel.
* On stable pain therapy with an oral or topical NSAID or acetaminophen.
* Able to read and understand English to answer pain assessment questions independently.
* Willing and able to fulfill the requirements of the study, including complete scheduled follow-up phone visits.

Exclusion Criteria:

* Inability to adequately read and understand English as required to complete study assessments and comply with the protocol.
* Current recreational or medicinal use of cannabis within 4 weeks of study initiation.
* Participants with a lifetime history of cannabis use disorder or other substance use disorders (except tobacco use disorder) will be excluded.
* Participants with a lifetime history of daily cannabis use will be excluded.
* Dose changes of concomitant medication will not be permitted during the study period.
* Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months), or women who are planning on becoming pregnant.
* Diagnosis of any of the following mental disorders as defined by the DSM-5: a lifetime history of schizophrenia or any other psychosis, organic medical disorders, bipolar disorder. Entry of patients with obsessive compulsive disorder or post- traumatic stress disorder will be permitted if the anxiety disorder is judged to be the predominant disorder, in order to increase accrual of a clinically relevant sample.
* Major depression will be allowed if not severe (Montgomery Åsberg Depression Rating Scale-MADRS27≥ 25). Patients with significant suicidal ideation (MADRS item 10 score \> 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
* Participants with a family history of schizophrenia spectrum or bipolar disorder will be excluded.
* Participants who have a history of adverse reactions to cannabis will be excluded.
* Known allergy to any of the ingredients in the Delivra base.
* Use of Rimonabant (SR141716) within three weeks of enrollment and/or planned use for the duration of the study participation\[27\].
* Use of 5-HT1A receptor antagonists (SSRI inhibitors) within three weeks of enrollment and/or planned use for the duration of the study participation, e.g.: Pindolol, Lecozotan, Brexpiprazole, etc.
Effectiveness of a Multicomponent Intervention to Promote Physical Activity Levels During the School Day (MOVESCHOOL)

Study based a multicomponent school-based intervention during the school-day (i.e., Physically active learning, active breaks, and active recess) on Physical Activity, health, educational, and cognition outcomes in adolescents.

MOVESCHOOLS is a quasi-experimental study coordinated by fully qualified researchers in physical activity and sport sciences from two universities \[University of Cadiz (UCA) and University of Extremadura (UEX), Spain\]. This study is aimed at year 1 to year 3 from Secondary Education students (11-16 years old), belonging to 10 schools in Spain (5 schools in Cadiz and 5 schools in Caceres). The schools will be assigned to a control group (n = 5 schools and 400 students) and an intervention group (n = 5 schools and 400 students). The intervention will last 6 months, and will consist of three components:

1. Inclusion of a physically active classes per week.
2. Development of two daily active breaks of 5 minutes duration.
3. Implementation of daily active recesses.

Before and after the intervention, Physical Activity and sedentary time will be assessed by accelerometry, health-related fitness levels by field tests, body composition parameters by anthropometry, academic performance by school grades, positive health (quality of life and self-perception of health) by questionnaire, and cognitive parameters (executive functions and mathematical fluency) by specific cognition tests. In weeks 8 and 16, Physical Activity and sedentary time will also be evaluated as intermediate measures.

At the end of the intervention the researchers will determine the changes of the main outcome variables. Likewise, the main hypotheses raised will be:

1. Students belonging to the experimental group will improve physical activity and will decrease sedentary time during the school-day when comparing to the students belonging to the control group.
2. Students belonging to the experimental group will result in improved in physical and psychological health markers when comparing to the students belonging to the control group.
3. Students belonging to the experimental group will result in improved academic indicators and cognitive markers when comparing to the students belonging to the control group.
4. Students belonging to the experimental group will improve school climate and motivational variables in academic classes compared to students belonging to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents in 1st, 2nd and 3rd year of ESO.
* Adolescents with informed consent signed by the family/guardian.
* Schools with at least 80 students enrolled in 1st, 2nd and 3rd ESO.
* Schools belonging to the regions of Cáceres and Cádiz.

Exclusion Criteria:

* Adolescents with any physical disability or health condition that may limit physical activity levels.
* Schools participating in any other physical activity or health promotion program.
Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following ACL Reconstruction With Bone Patellar Tendon Bone Autograft:

A randomized, single-blind, single-center study measuring the effects of adductor canal block combined with IPACK infiltration compared to adductor canal block alone on post-operative pain and opioid consumption in patients undergoing ACL reconstruction with Bone Patellar Tendon Bone Autograft

The protocol will determine if the addition of an IPACK block to the standard adductor canal block is superior to an isolated adductor canal block in controlling post-operative pain and decreasing postoperative opioid consumption in patients undergoing ACLR with Bone Patellar Tendon Bone Autograft

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 75 years of age
* Patients undergoing primary ACL reconstruction with BPTB Autograft
* ASA I or II

Exclusion Criteria:

* Patients younger than 18 and older than 75.
* Patients with multi-ligament injury
* Patients undergoing concomitant cartilage procedure or osteotomy.
* Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer.
* Patients who are allergic to oxycodone;
* Patients with diagnosed or self-reported cognitive dysfunction;
* Patients with a history of neurologic disorder that can interfere with pain sensation;
* Patients with a history of drug or recorded alcohol abuse;
* Patients who are unable to understand or follow instructions;
* Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
* Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
* Patients with a BMI over 45;
* Any patient that the investigators feel cannot comply with all study related procedures;
* Any pregnant patient; assessed via urine pregnancy test in the preoperative area as part of standard preoperative surgical protocol;
Prognostic Value of the Marker P63 in Adenocarcinoma of Lung, Breast, and Pancreas

The p63 gene is a recently discovered member of the p53 family located at chromosome 3q27Many studies have reported that overexpression of p63 can mimic p53 activities by binding DNA, activating transcription, and inducing apoptosis.

Various studies proved p63 as a marker of basal cells in normal salivary glands, breast, prostate, respiratory and squamous epithelia, and of tumor cells from various malignancies. Still, p63 has been the subject of relatively few studies in lung adenocarcinoma, and breast carcinoma, and no study has described the correlation of p63 with pancreatic ductal adenocarcinoma.

In the current study, we aim to evaluate the prognostic value of the expression of p63 in the lung adenocarcinoma, breast adenocarcinoma, and pancreatic ductal adenocarcinoma. We will achieve this aim by collecting clinical data retrospectively from the patients' medical records as well as assessing the histological sections and performing immunohistochemical staining for p63.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were treated at our institution for lung adenocarcinoma, breast adenocarcinoma, or pancreatic ductal adenocarcinoma.
* Available histopathological diagnosis of the malignancy.

Exclusion Criteria:

* Patients with inoperable tumors.
* Patients with second primary tumor.
* Patients with pathological blocks not enough for future slicing.
Radiotherapy With Hyperthermia in Recurrent and Radiation-Induced Sarcomas

After a screening, which consists of biopsy, physical examination, initial diffusion-weighted magnetic resonance imaging (DWI-MRI) or body computed tomography (CT) scan, blood tests and case analysis on Multidisciplinary Team (MDT) meeting, a patient with radiation-induced or in-field recurrent sarcoma will receive the hypofractionated radiotherapy with deep hyperthermia (twice a week) within three weeks. The response analysis in CT or DWI-MRI and toxicity assessment will be performed after 6 weeks. In resectable tumors, a patient will be referred to surgery. In the case of unresectability, the patient will followed-up.

Due to the rarity of radiation-induced (RIS) or previously irradiated recurrent (PIRS) sarcomas, no guidelines nor randomized prospective clinical trials on this topic exist. Thus the management of RIS and PIR is challenging. The only curable modality in non-metastatic RIS/PIRS is radical resection with wide negative margins. The role of secondary radiotherapy in locally advanced RIS/PIRS is unclear, mostly due to the concerns about possible severe side effects after re-irradiation.

The addition of deep hyperthermia to irradiation and in the prolonged gap between the end of moderately hypofractionated radiotherapy (with or without integrated boost) and surgery may allow obtaining the long-term local control with the maintenance of a good treatment tolerance Hyperthermia is a method of increasing the temperature in the tumor to damage cancer cells with minimum injury to the normal cells. It should be combined with another treatment modality (radio- or chemotherapy) rather than used alone. Its efficacy was proven in clinical trials. Treatment tolerance is usually very good.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* Eastern Cooperative Oncology Group performance status 0 - 2
* Age ≥18 years old
* Histologically-proven diagnosis of radiation-induced or recurrent soft tissue sarcoma
* Previous radiotherapy within the planned target volume

Exclusion Criteria:

* Histologic diagnosis of rhabdomyosarcoma (except spindle cell and pleomorphic subtype), osteogenic sarcoma, Ewing's sarcoma/PNET, aggressive fibromatosis
* Contraindications to radiotherapy or hyperthermia
* Predicted unacceptable high risk of reirradiation-related toxicity, in the Investigator's judgment
* Unresectable metastases
Follow-up of Breast Cancer and Multiple Myeloma Patients Previously Enrolled in NIH Gene Therapy Studies

This study will provide follow-up evaluations of breast cancer or multiple myeloma patients who received gene therapy (gene transfer) as part of their participation in an NIH protocol. Gene therapy is a new technology, which may involve a permanent change in the patient s genetic code. Therefore, although the risk of long-term harmful effects of this therapy is very small, the Food and Drug Administration requires prolonged monitoring of patients health status.

Patients previously enrolled in NIH protocols 96-C-0007, 93-C-0208, 92-C-0161, or 92-H-0057 will be followed under the current protocol. No further gene therapy will be provided in this study.

Patients health status will be evaluated for an indefinite period of time, or as long as they are willing to be monitored. They will provide a blood sample once a year and will be interviewed about their health status twice a year for the first 5 years after gene therapy and once a year thereafter. These procedures are done to look for the development of any diseases such as cancer, neurological disorders, autoimmune or blood disorders that may be related to side effects of the gene transfer.

This Protocol aims to provide long-term follow-up of breast cancer and multiple myeloma subjects previously receiving autologous primitive marrow and blood hematopoietic cells exposed to gene transfer retroviral vectors on the following protocols: MB 294 (92-C-0161; T-92-0018), MB 310 (93-C-0208; T-92-0192), MB 361 (96-C-0007; T-95-0096) or (92-H-0057; T-92-0139) at the National Cancer Institute and the National Heart, Lung, and Blood Institute. Subjects will undergo an annual health history and annual complete blood counts will be performed. Blood samples will also be collected annually (either locally or off-site by the subjects' personal physicians) for testing for presence of the gene transfer vector and vector integration sites.

Eligibility Criteria:
* INCLUSION CRITERIA:

Subjects who received gene transfer products on the following protocols: MB 361, 96-C-0007, T-95-0096; MB 294, 92-C-0161, T-92-0018; MB 310, 93-C 0208, T-92-0192; or 92-H-0057, T-92-0139.

EXCLUSION CRITERIA:

Patients unwilling to participate.
A Window of Opportunity Trial of Intratumoral Injection of Copaxone® in Patients With Percutaneously Accessible Tumors

The investigator believes that injecting Copaxone into tumors will help participants immune system fight cancer. This has been studied in mice and has shown encouraging results. Copaxone is a safe medication currently used to treat Multiple Sclerosis (MS) and has very few side effects. To be considered for this trial a tumor must be easy to be injected and must be at least the size of a pea. Participants will be closely monitored for any side effects. Tissue from before surgery will be compared to tissue after the treatment and surgery to be checked for immune response and anti-tumor effects.


Eligibility Criteria:
Inclusion Criteria:

* Ability of participant or Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent.
* Have confirmed diagnosis of squamous cell cancer or cutaneous squamous cell cancer or basal cell carcinoma.
* Have one or more tumors measuring at least 5 mm in diameter.
* No prior therapy for this malignancy.
* Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation until the end of study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately.
* Men of child-bearing potential must not father a child or donate sperm while on this study until the end of study treatment.
* Physician feels the patient is medically fit for the trial.

Exclusion Criteria:

* Current or anticipated use of other investigational agents while participating in this study.
* Pregnant or breast feeding. There is a potential for congenital abnormalities and for this regimen to harm breast feeding infants (if applicable) Planned treatment with chemotherapy and/or radiation therapy prior to standard of care surgery. Concurrent treatment with anti-cancer therapy is not allowed.
* Hypersensitivity to Copaxone® or glatiramer acetate, mannitol, or any component of the formulation.
* A known condition that leads to immunosuppression such as Acquired Immunodeficiency Syndrome (AIDS) or concurrent use of immunosuppressive therapy.