cyrilzakka/clinical-trials huggingface dataset:
Interferon Alfa in Treating Patients With Recurrent Unresectable Meningiomas and Malignant Meningiomas

RATIONALE: Interferon alfa may interfere with the growth of cancer cells.

PURPOSE: Phase II trial to study the effectiveness of interferon alfa in treating patients with recurrent unresectable meningiomas and malignant meningiomas.

OBJECTIVES:

* Evaluate the efficacy of recombinant interferon alpha (IFN alpha) as a single agent in the treatment of recurrent unresectable meningiomas and malignant meningiomas.
* Determine the nature and extent of central nervous system (CNS) toxicities associated with the use of alpha interferon in current doses and schedules.

OUTLINE: This is a two arm, randomized study. The first arm includes all histologically benign meningiomas. The second arm includes all other pathologies.

All patients receive INF alpha as a subcutaneous injection Monday through Friday for 8 weeks. Treatment continues without interruption as long as there is no tumor recurrence or progression and toxicity is acceptable.

Treatment continues without dose adjustment for the first 8 weeks as long as there are no toxic effects of grade III or greater. Dosage for subsequent courses is one dose level below the dose that produced toxicity of grade III or greater.

PROJECTED ACCRUAL: 20 patients will be entered per year into each arm.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven tumors:

  * Unresectable meningioma
  * Atypical meningioma
  * Malignant meningioma
  * Angioblastic meningioma
  * Hemangiopericytoma
* Recurrent or progressive, unresectable tumor after failing radiation therapy or refused radiation therapy following 2 surgeries

PATIENT CHARACTERISTICS:

Age:

* 16 and over

Performance status:

* Karnofsky at least 60%

Life expectancy:

* At least 3 months

Hematopoietic:

* AGC at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* SGPT less than 2.0 times normal
* Alkaline phosphatase less than 2.0 times normal
* Bilirubin less than 1.5 mg/dL

Renal:

* BUN less than 1.5 times normal OR
* Creatinine less than 1.5 times normal

Other:

* No active infection
* No diseases that obscure toxicity or dangerously alter drug metabolism
* No serious intercurrent medical illness
* Not pregnant
* Fertile patients must use adequate contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent biologic therapy

Chemotherapy:

* Prior chemotherapy allowed and recovered from all myelotoxicity secondary to the therapy

Endocrine therapy:

* Prior hormonal therapy allowed
* No concurrent hormonal therapy

Radiotherapy:

* Prior radiotherapy allowed

Surgery:

* Not specified
Advancing Nursing Practices in Hospital Oncology Care

The purpose of this study is to find out if a new training program for nurses called PACT (Partnership, Assessment, Care, and Transition) will be effective and relevant in helping nurses gain the skills needed to provide high-quality family-centered care. Family-centered care skills include engaging family caregivers as partners in patient care, and strengthening their capacity for caregiving by assessing family support needs and facilitating access to resources when needed. The study will also look at whether the quality of nurses' family-centered care skills is associated with improved outcomes for family caregivers. Both nurses and family caregivers will be enrolled in this study. Participants will be nurses/caregivers who care for advanced GI cancer patients admitted to Memorial Sloan Kettering.


Eligibility Criteria:
Inclusion Criteria:

Nurses:

* MSKCC day-shift nurses and/or night-shift nurses (Clinical Nurse I to IV) assigned to the GI inpatient unit (M16) at the time of study, all of whom provide initial and ongoing assessment of patients' physical, psychosocial, cultural and informational needs
* Nurse is comfortable speaking and reading English as per self report

Family caregivers (FC) - Phases 1b, 2, 4:

* Adult (≥18 yrs) family caregiver (family caregiver is defined here as any informal caregiver who is a relative, friend or legal representative) who self-identifies and/or is identified by the nursing staff as involved in the care of an MSK cancer patient who either:

  * is currently admitted to the M16 unity for at least 12 hours OR
  * has been discharged from the M16 unit within the last 2 weeks
* English-speaking as per self-report
* Only one FC per patient case will be invited to participate.

M16 Patients (chart review only):

* Adult (≥18 yrs) cancer patient who is currently admitted in the M16 unit at Memorial Hospital for at least 12 hours o English speaking as per self-report

Exclusion Criteria:

Nurses:

* Nurse plans to leave MSK or the GI unit within 3 months as per self-report
* \[Phases 2-4\] Nurse refuses observation of consultations as per self-report

Family caregivers (FC) - Phases 1b, 2, 4:

* FC participated in an earlier study phase
* FC's patient is deceased at time of consent
S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Pulsed Dye Laser (PDL) Therapy in Adults

Pulsed dye laser (PDL) on the face is painful. For this reason, local anesthesia is commonly used to eliminate or minimize the pain. S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) is a eutectic formulation of lidocaine and tetracaine. The purpose of this study is to evaluate the efficacy of S-Caine Peel for induction of local dermal anesthesia for PDL therapy in adults.

This was a multi-center (5 centers), double-blind, placebo-controlled, parallel study that included 80 adults who met all the eligibility criteria and who were undergoing PDL therapy for the treatment of vascular lesions on the face.

During the screening visit, the study, including potential risks and benefits, was clearly explained to each patient, and written informed consent was obtained from each patient. The screening visit also included: evaluating eligibility criteria, obtaining a medical history (including skin type, demographic data, and concomitant medications), a brief physical examination, and a urine pregnancy test (for women of childbearing potential). The screening visit could be completed on the same day as the procedure visit.

At the procedure visit, eligible patients were assigned the next available sequential patient number. By having a patient number assigned to them, patients were randomized to receive S-Caine Peel or placebo on the facial treatment area.

The surface area of the intended treatment area was determined (up to 200 cm2). A thin layer (approximately 1 mm or the thickness of a dime) of the study drug was applied evenly across the area to be treated. The study drug was applied for 20 minutes (±2 minutes).

Immediately following removal of the study drug, the investigator performed an evaluation of skin reactions, assessing the treatment area for erythema, edema and blanching or any other adverse skin reaction.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years of age or older
* Patient elects to undergo PDL therapy for the treatment of vascular lesions on the face

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient has participated in a clinical trial of an unapproved drug within the previous 30 days
* Patient has participated in any clinical trial involving S-Caine Peel
To a Sustainable Quality Policy

The investigators need stronger feedback loops and a quality monitoring and management system to improve the quality of care in sustainable way. The Chair Sint-Trudo "To a sustainable quality policy" was established to scientifically develop prerequisites for a sustainable quality of care. In this study protocol, a monocentric mixed-method quasi-experimental study will be used to assess the impact of a rapid-cycle quality indicator feedback mechanism on both patients and professionals.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in the hospital for more than one night

Exclusion Criteria:

* Patients admitted in the hospital for less than one night
An Evaluation of an Injectable Material for Correction of Wrinkles

The objective of this study is to determine the effectiveness of a filler in improving wrinkles.

The primary objective of this study is to determine whether focal injection of calcium hydroxylapatite (Radiesse®), an injectable biodegradable filler, into jowl-induced chin notches can result in safe, aesthetically pleasing, and long-lasting correction of these.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-65
* Have wrinkles
* The subjects are in good health.
* The subject has willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

Exclusion Criteria:

* Subjects who have received within the past 3 months or are planning to receive in the next 6 months, botulinum toxin injections for correction of wrinkles.
* Subjects who have received within the past one year any soft tissue augmentation material into the chin and experimental area (defined as any area on the face below the lower lip vermilion, excluding the lateral lip marionette line up to 1 cm below this level).
* Subjects with prior history of nodule formation or hypersensitivity reactions to lidocaine or medium-term augmentation materials, including hyaluronic acid derivatives, poly-L-lactic acid, and calcium hydroxylapatite.
* Subjects who are currently using anticoagulation therapy.
* Subjects who have a history of bleeding disorders.
* Subjects who are unable to understand the protocol or to give informed consent.
* Subjects with mental illness.
Safety and Tolerability of LEO 138559 in Healthy Subjects and Subjects With Atopic Dermatitis

The primary objective of this trial is to investigate the safety and tolerability of LEO 138559 in healthy subjects and subjects with moderate to severe atopic dermatitis.

The secondary objective of this trial is to study the pharmacokinetics and pharmacodynamics following administration of LEO 138559 to healthy subjects and subjects with moderate to severe atopic dermatitis.

Healthy subjects will be exposed to 7 different dose regimens of LEO 138559 (one dose regimen per subject).

Subjects with moderate to severe atopic dermatitis will be exposed to 2 different dose regimens of LEO 138559 (one dose regimen per subject).


Eligibility Criteria:
Inclusion Criteria:

For healthy subjects and subjects with atopic dermatitis:

* Males and females without childbearing potential.
* Age between 18 and 55, inclusive.
* Body mass index between 18 and 32 kg/m2, inclusive.
* Healthy apart from atopic dermatitis for the subjects presenting the disease.

For subjects with atopic dermatitis only:

* History of atopic dermatitis for more than 6 months.
* Female subjects with childbearing potential and male subjects with female partners with childbearing potential using highly effective contraception from start of the trial and until a period after the last administered dose of trial drug.

Exclusion Criteria:

For healthy subjects and subjects with atopic dermatitis:

* Any significant disease detected prior to enrolment.
* Subjects who are still participating in a clinical trial or who have participated in a clinical trial within 3 months prior to enrolment or within 5 times of the half-life of the experimental therapy, whichever is longer.
* Skin diseases that may interfere with the diagnosis of atopic dermatitis or assessment of the treatment.
* Use of tanning beds or phototherapy within 6 weeks prior to enrolment.
* Subjects with atopic dermatitis requiring more than 3 bleach baths from 4 weeks prior to screening until end of trial.
* Blood pressure or pulse rate outside of the normal range.

For subjects with atopic dermatitis only:

* Initiation of treatment of atopic dermatitis with prescription emollients during the screening period.
Comparison of the Effect of Neck Collar, Act-as-Usual, and Active Mobilisation Early After a Whiplash Injury

Background: Long-lasting pain and disability, known as chronic whiplash-associated disorder (WAD), may develop after forced flexion-extension trauma to the cervical spine. Mechanisms behind WAD are virtually unknown, as are the possible effects of early intervention. This trial was undertaken to compare the effect of three early intervention strategies for the prevention of developing chronic WAD following acute whiplash injury.

Methods: 458 participants were randomised to one of 1) stiff neck collar, 2) advice to act-as-usual, or 3) an active mobilisation regime. Participants were followed for one year and treatment effects were compared in terms of lasting neck pain, headache, disability and sick-leave.


Eligibility Criteria:
Inclusion Criteria:

* Been exposed to rear-end or frontal car collision
* Experienced symptoms within 72 hours
* 18 - 70 years

Exclusion Criteria:

* Could not be enrolled within 10 days of the collision
* Fractures or dislocations of the cervical spine
* Amnesia for the accident
* Unconsciousness in relation to the accident
* Injuries other than the whiplash injury
* Average neck pain during the preceding 6 months exceeding 2 on a box scale 0-10, where 0= no pain and 10= worst possible pain
* Significant pre-existing somatic or psychiatric disease
* Alcohol or drug abuse
* Does not read or understand Danish.
Impact of Omega-3 Fatty Acids on Lactate

Pre- and intra-operative nutritional support in patient undergoing major surgery results in decreased morbidity and mortality. Studies investigating the role of omega-3 fatty acids in these patients are increasing. Some are focused on perfusion at the cellular level. This study was undertaken to address the effect of postoperative administration of omega-3 fatty acids on cellular hypoperfusion associated with major gastric surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing major gastric cancer surgery

Exclusion Criteria:

* None
Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes

Initially, 4 teams of investigators conducted randomized controlled trials (RCT) at their own site to evaluate the effectiveness of bariatric surgery compared to medical/lifestyle management of type 2 diabetes. Each study followed subjects for a duration of about 1 - 3 years. Following this, a consortium was created to pool data and continue to follow study participants. This early collaboration of the 4 groups of investigators was supported by Industry sponsors (Ethicon, Inc and Medtronic-MITG). Now, the investigators have successfully received a grant from the NIH, as the sole supporter of continued observational follow-up of study participants.

The continuing aim of this study is to combine data from the 4 studies and follow the original randomized subjects for an additional 5 years of follow-up. The purpose of the study is to determine the longer term durability and effectiveness of bariatric surgery compared to medical/lifestyle intervention on the treatment of type 2 diabetes.

The four investigative groups initiated their individual RCT's at their respective sites to evaluate the effectiveness of bariatric surgery compared to multidisciplinary medical and lifestyle management of diabetes and body weight. The original trials were each designed to assess feasibility over a relatively short duration of follow-up (1-3 years). Individually, each trial lacked the sample size and duration of follow-up to meaningfully inform clinical decision making. Together, with the funding provided by the NIH for longer follow-up, the Consortium trial can provide a unique national resource to address timely and unanswered clinical questions related to the durability of these alternative management approaches in patients with T2D and obesity. Together, participants from these studies represent the largest cohort with diabetes (one third having a BMI \<35 kg/m2) ever to undergo randomized assignment to bariatric surgical procedure vs. medical/lifestyle intervention.

Eligibility Criteria:
Inclusion Criteria:

* Original inclusion criteria for participation in the RCTs at all sites included:

  * Candidate for general anesthesia or unsupervised exercise.
  * Age ≥20 and ≤65 years.
  * Body mass index \>27 and ≤45 kg/m2.
  * Diagnosis of type 2 diabetes confirmed by either requiring diabetes medication and/or having elevated glycemia based on HbA1c, fasting plasma glucose, and/or oral glucose tolerance test (OGTT) results, according to American Diabetes Association criteria.
  * Ability and willingness to participate in the study and agree to any of the research arms.
  * Able to understand the options and to comply with the requirements of each program.
  * Negative urine pregnancy test at screening and baseline visits (prior to surgery) for women of childbearing potential (i.e., biologically capable of becoming pregnant).

Exclusion Criteria:

* Subjects who were randomized in one of the four RCTs but never initiated intervention / did not receive randomized treatment
* Refusal to sign informed consent
FE in Anterior Teeth

The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in maxillary anterior teeth with apical periodontitis.

Foraminal enlargement (FE) is an intentional procedure that enlarges the cement canal. However, some RCTs indicate that enlarging the FE causes postoperative pain, flare-up, and destroy the apical constriction, whilst some RCTs pointed out there is no difference in terms of pain when a FE has been performed in maxillary anterior teeth with apical periodontitis. We will assess the risk of postoperative pain as risk ratio (RR). The binary (dichotomous) data: 0-44 mm: Mild or no pain; 45-100 mm: Moderate to severe pain.

Eligibility Criteria:
Inclusion Criteria:

Mature permenent maxillary anterior teeth having pulpal necrosis and apical periodontitis.

Exclusion Criteria:

Systemic disorders, diabetes, pregnancy, less than 18 years of age, immunocompromised, patients who had taken antibiotics in the past 1 month, patients who had a positive history of analgesic use within the past 3 days, previously accessed teeth.
Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer

The study aims include:

* Exploring potential predictive molecular profiles to immunotherapy/chemotherapy
* Investigating the role of circulating tumor DNA as a dynamic biomarker during immunotherapy/chemotherapy
* Identifying possible resistance mechanisms to immunotherapy/chemotherapy

Materials and methods:

Approximately 150 patients diagnosed with metastatic NSCLC assigned for immunotherapy or chemotherapy will be candidates for inclusion during a 1-2 years period.

A comprehensive molecular profiling will be made from the diagnostic biopsy. Before every treatment-cycle a blood sample will be taken to quantify ctDNA. At time of progressive disease during/after first line treatment, patients will be asked to participate in a new biopsy and a comprehensive molecular profiling will be performed.

The tissue and blood samples collected will be stored in a biobank. Clinical data will be collected to perform a comprehensive database.

Analysis:

Potentially predictive molecular profiles for immunotherapy/chemotherapy will be found by comparison of treatment outcome for patients with specific molecular characteristics.

Through quantification of ctDNA during treatment and upon progression, the role of ctDNA as a dynamic biomarker will be further strengthened.

Differences in molecular profiles pre- and post-treatment may reveal resistance mechanisms to treatment. Molecular profiling on progression can be valuable in second-line treatment guidance.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Able to understand and read Danish
* WHO Performance status 0-2
* Acceptable organ function (liver/kidney/heart) for treatment
* The disease has to be:

evaluable or measurable according to RECIST/iRECIST accessible for biopsy metastatic or not suitable for curative intended treatment

Exclusion Criteria:

* Other active cancers
* Contraindications for systemic therapy
* ALK-positive, ROS-1 or EGFR mutations
Whole Body Vibration and Virtual Reailtry on Quadriceps Strength and Activity of Daily Living in Children With Burn

Burns are injuries that can have both local and systemic effects and are brought on by biological, chemical, electrical, and physical factors. Mobility is a significant problem for burn patients in terms of their quality of life since the burn injury affects their capacity to participate in activities of daily living. The immobility of the patient has a major impact on their physical health. The aim of current study was to compare between the effect of virtual reality and whole body vibration as two methods of proprioceptive stimulation on quadriceps strength and activity of daily living in children with burn.

The current study is pre-post experimental study which was carried out from January 2024 to June 2024. A stratified and convenience sampling technique was used to select the study participants taking into consideration the inclusion criteria. Forty children with lower limb thermal burn were selected from Ahlah Misr Burn Hospital to participate in this study. They were selected according to the following inclusion criteria: a) Both sexes were included, b) Children with unilateral front thigh thermal burn of deep partial thickness of dermis (second degree) burns, c) Their ages ranged from 6 to 12 years, d) They can assume standing position. A child who had one or more of the following criteria was excluded from the study: a) 1st, 3rd and 4th degrees of burn, b) Other types of burn rather than thermal, c) Neurological or neuromuscular disorders, d) Dermatological disorders, e) Visual or hearing disorder, f) Child with contractures or lower limbs on fixed deformities. Subjects who met the previous mentioned criteria were randomly assigned into two study groups of equal numbers Study I \& study II using sealed envelope. Study group I were treated by a conventional physical therapy program directed towards improving the condition of the patient function in addition to whole body vibration therapy. Study group II were treated by a Wii-fit therapy program in a form of virtual reality treatment program in addition to the same conventional physical therapy program given to patients in the study group I.

Eligibility Criteria:
Inclusion Criteria:

1. Both sexes were included
2. Children with unilateral front thigh thermal burn of deep partial thickness of dermis (second degree) burns
3. Their ages ranged from 6 to 12 years, d) They can assume standing position

Exclusion Criteria:

1. 1st, 3rd and 4th degrees of burn
2. Other types of burn rather than thermal
3. Neurological or neuromuscular disorders
4. Dermatological disorders
5. Visual or hearing disorder
6. Child with contractures or lower limbs on fixed deformities.
NF2 Natural History Consortium

OBJECTIVES:

I. Define the growth rates and clinical course of NF2-related tumors in patients with neurofibromatosis type 2. Associate growth rate with physical function.

PROTOCOL OUTLINE: Data on the clinical course and growth rate of NF2-related tumors in patients with neurofibromatosis 2. Patients are evaluated each year on a cranial and a spinal MRI, eye tests, hearing tests, quality of life, neurological tests, and physical functioning.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosed with neurofibromatosis 2 on or after 01/01/93
* Must meet one of the following conditions:

Bilateral vestibular schwannoma OR Family history of neurofibromatosis 2 (first degree family relative) AND Unilateral vestibular schwannoma at under 30 years OR Any 2 of the following: Meningioma Glioma Schwannoma Juvenile posterior subcapsular lenticular opacity/juvenile cortical cataract

* No plans to treat vestibular schwannoma in next 12 months

--Prior/Concurrent Therapy--

* Not specified

--Patient Characteristics--

* Age: 5 and over