cyrilzakka/clinical-trials huggingface dataset:
Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using triptorelin and flutamide may fight cancer by reducing the production of androgens. It is not yet known whether giving hormone therapy for 4 months is more effective than giving therapy for 8 months prior to radiation therapy for prostate cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of combination hormone therapy for 4 or 8 months followed by radiation therapy in treating patients with prostate cancer.

OBJECTIVES: I. Compare the efficacy of 4 months vs 8 months of luteinizing hormone-releasing hormone (LHRH) agonist therapy combined with antiandrogen therapy prior to radiotherapy, in terms of disease-free survival and overall survival, in patients with stage I-IV localized invasive prostate cancer.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. All patients receive triptorelin IM once a month and oral flutamide three times daily with meals. Patients randomized to arm I receive this therapy regimen for 4 months. Patients randomized to arm II receive this therapy regimen for 8 months. All patients then undergo radiotherapy 5 days a week for 7 weeks within 2 months of the last injection of triptorelin and within 1 month of the last oral flutamide tablet. Patients are followed every 3 months after radiotherapy.

PROJECTED ACCRUAL: A total of 276 patients (138 per treatment arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed invasive adenocarcinoma of the prostate Stage I or II (PSA greater than 20 or Gleason score at least 7) OR Stage III or IV (any PSA, any Gleason) Histologically confirmed benign nodal status No distant metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior malignancy except nonmelanoma skin cancer No other uncontrolled illness that would prevent compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No prior or other concurrent hormonal therapy Radiotherapy: Not specified Surgery: No prior treatment other than transurethral prostatectomy No prior orchiectomy
Does Biological Sex Influence the Cardiac Output Response to Sprint Interval Exercise Training in Humans?

Sprint interval exercise training refers to brief repeated bouts of vigorous effort that are separated by short periods of recovery. Cardiac output refers to the amount of blood that is pumped out of the heart each minute. Research has shown that sprint interval exercise training can increase peak cardiac output - or the highest cardiac output that is achieved during strenuous exercise - but this response may be influenced by biological sex. The primary goal of this study is to determine whether the peak cardiac output response to 12 weeks of sprint interval exercise training differs between males and females. Cardiac output will be estimated using a non-invasive technique that involves breathing in a mixture of standardized gases. This research will help to determine whether biological sex influences the response of the heart to brief vigorous cycle exercise training.

The primary purpose of this study is to determine whether biological sex influences the peak cardiac output response to 12 weeks of sprint interval exercise training. Peak cardiac output will be determined non-invasively using an inert gas rebreathing technique. Each session of sprint interval exercise training will involve a 10-minute period of cycling on a stationary ergometer. The protocol will consist of a two-minute warm-up; three, 20-second 'all out' efforts that are separated by two minutes of recovery; and a three-minute cool down. Three sessions of training will be performed each week for a total of 12 weeks. Groups of male and female participants will be recruited and tested using best practice guidelines for sex-based comparisons of exercise responses. The study will advance knowledge regarding the potential for biological sex to influence the cardiovascular response to brief vigorous cycle exercise training.

Eligibility Criteria:
Inclusion Criteria:

* Being untrained based on a self-report of engaging in \< 1 h of weekly moderate to vigorous physical activity based on the Canadian Society for Exercise Physiology Get Active Questionnaire.
* Having an estimated cardiorespiratory fitness in the lower 50% of adults in the specified age range based on the online fitness calculator available at: www.worldfitnesslevel.org.
* Females who are naturally cycling (i.e., not using any form of hormonal contraceptive) or are using a 2nd generation oral contraceptive.

Exclusion Criteria:

* Experiencing a condition that might preclude safe participation in physical activity and exercise, as determined by answering "Yes" to any question on Page 1 of the Canadian Society for Exercise Physiology Get Active Questionnaire.
* Females with a positive pregnancy test.
Propranolol in Capillary Hemangiomas

The investigators observed that Propranolol, a beta-blocker commonly used in children was efficient to control the growth of alarming hemangiomas of the face.

The primary objective of this study is to determine the efficiency of 1 month-early treatment of propranolol in infants aged less than 4 months affected by an hemangioma without any consequences on vital or functional structure and not justifying corticosteroids.

The secondary objectives are:

* the kinetic of the hemangioma evolution in infants treated by propranolol
* Observance
* Safety

Infantile hemangiomas are frequent vascular tumors (4 à 10 % of the neonates) and correspond to 100 new cases per year in dermatology consultation of the CHU of Bordeaux. Hemangiomas have a characteristic clinical course marked by early proliferation during 3 to 12 months followed by slow and spontaneous involution from 3 to 7 years. Occasionally, as well as esthetical damages, hemangiomas may impair vital structures, ulcerate, bleed, or cause high-output cardiac failure or significant structural abnormalities. Standard treatments (corticotherapy, interferon, vincristine...) lead to a stagnation of hemangiomas in some cases, but with frequent side effects.

We observed that Propranolol, a beta-blocker usually used in neonates could lead to a decreased in volume of serious haemangiomas of the face (article published in New England Journal of Medicine).

In this study, we proposed to determine the efficiency of 1 month-early treatment of propranolol in neonates aged less than 4 months affected by non alarming hemangioma and not justifying corticotherapy. This is a double blind randomized placebo controlled study of propranolol.

Infants will be recruited from the dermatology consultation of CHU Bordeaux. After verification of eligibility criteria and informed consent of legal surrogates, infants will be randomized to receive either propranolol or either placebo. The infants will be observed during 1 month according to the following visits.

Eligibility Criteria:
Inclusion Criteria:

* Infant aged less than 4 months
* Infant with one or more hemangiomas sized more than 1 cm diameter
* Infant not threatening for vital or functional structure and for which no treatment would be proposed
* Informed consent
* Patient with social insurance.

Exclusion Criteria:

* Alarming hemangioma (s) (complicated forms or localization at risk)
* Cardiac pathology (cardiac malformation, heart failure, cardiac arrhythmias, pulmonary hypertension)
* Asthma
* Bronchopulmonary dysplasia
* Bronchiolitis
* Raynaud syndrome
* Phéochromocytoma
* Development of serious form of hemangioma (bleeding, necrosis, ulceration, infection, respiratory distress) requiring standard treatment
Technology-enabled Patient Support System for Self-management of CF

This project will test a technology-enabled patient support system (PSS) as a self-management tool for children with CF and their family caregivers.

The goal of this study is to refine and test a technology-enabled patient support system (PSS) as a tool for self-management of pediatric CF. The PSS includes two components: 1) patient-facing: an app with customizable dashboards for tracking patient-generated outcome measures and providing personally relevant decision-making support; and 2) clinic-based: clinical patient management and technical support. Using a one-group pretest-posttest design, we will evaluate the effect of the adapted technology-assisted PSS on patient-reported outcomes (PROs). Study hypothesis: Among pediatric CF patients treated at the UAB CF Center, the use of technology-aided PSS over 6 months will improve health-related quality of life (primary outcome) as well as patient satisfaction, patient activation, and shared decision-making (secondary outcomes).

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of Cystic Fibrosis -

Exclusion Criteria:

None

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A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)

This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle Lotion.

This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123 Vehicle Lotion. To be eligible for the study subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe acne.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female at least 9 years of age and older;
2. Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit);
3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the baseline visit;
4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;
5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;
6. Subjects with two or fewer nodules

Exclusion Criteria:

1. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;
2. Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, eczema;
3. Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive;
4. Subjects with a facial beard or mustache that could interfere with the study assessments;
5. Subjects with more than two (2) facial nodules;
6. Evidence or history of cosmetic-related acne
Salivary Cytokine Profile as a Biomarker for Dental Pain

always reliable.Pain is an important diagnostic tool in dentistry. The type of treatment, extent of treatment and, sometimes, even the decision on whether to treat or not is dependent on the pain history obtained from the patient.The absence of an accurate description of dental pain is a factor that severely limits dental treatment planning in children with CP. The aim of this study is to study to evaluate the salivary cytokine profile of children with CP who have severe dental problems and to compare this to verbal children who have a similar dental profile.

The sample with CP will be selected from individuals attending the dental clinics of the Prince Sultan bin Abdulaziz Humanitarian city (SBAHC). The control patients will be selected from the dental clinics of the Riyadh Colleges of Dentistry and Pharmacy and be matched to the CP patients for age, gender and extent of dental problems. The sample will comprise of 20 patients with CP and 20 verbal controls.The oral health of all children will be recorded using WHO examination criteria .The teeth will be examined using WHO category II criteria - clinical examination with lighting and without radiographs.aliva will be collected from the children using the passive drool method and stored in sterile plastics collection tubes. The collected sample will be stored at -600C until they can be analyzed. The cytokine profile of the saliva sample will be analyzed using an ELISA kit for total cytokine profile (Luminex Performance Human Cytokine Panel A, LUH000, R\&D systems) to measure cytokines IL-1 alpha, IL-1 beta, IL-8, and TNF-alpha. The pain perception of the verbal control group will be recorded using the validated Arabic version of the short form of the McGill Pain Questionnaire. The children will also indicate the extent of the pain using the Wong Baker Faces ™ pain perception scale.Normality of the total cytokine levels will be tested using the Shapiro-Wilkes Test. The Mann Whiney U test will be used to compare the cytokine profile the CP and control group. The spearman correlation will be used to explore the relationship between the reported pain and cytokine profile levels. If found to be significant an initial cytokine-pain map will be proposed.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral Palsy
* At least one tooth with pulpal involvement
* Aged between 8-12 years
* No neurological illness (for Control Group)
* Ability to verbalize pain (for Control Group)
* One dental tooth with pulpal involvement matching the condition of the test group (for Control Group)

Exclusion Criteria:

* confounding neurological disorders
* History of orofacial pain syndromes
* Absence of consent or assent
Project Dulce for Arab Americans With Type 2 Diabetes

Arab Americans (AA) face many challenges in diabetes self-management due to the limited educational resources and support available for them. The cultural and linguistic barriers between patients and health care providers lead to poor diabetes management and outcomes. This study (Project Dulce Arabic) is adapted from the Project Dulce, an American Diabetes Association (ADA)-recognized Diabetes Self-Management Education Support (DSMES) program. Project Dulce Arabic comprises both peer-led diabetes education in Arabic and a 3-month text messaging program (Dulce Digital). The main aim of the study is to examine the effectiveness of a more culturally and linguistically appropriate diabetes education program in improving diabetes knowledge, beliefs, and self-management as well as hemoglobin A1C.

Although the Arab American (AA) population is at a higher risk of pre-diabetes and type 2 diabetes (T2D) compared to the white non-Hispanic population, there are hardly any culturally appropriate diabetes self-management resources available for Arab Americans.

Project Dulce Arabic is a pilot study addressing both the linguistic and cultural barriers faced by the AA community in diabetes self-management while exploring the genetic background of type 2 diabetes in Arab Americans. To overcome the linguistic barriers, we adapt educational materials from the Project Dulce diabetes self-management study of Mexican Americans (A. Philis-Tsimikas et al., 2011). This 5-week peer-led educational program in Arabic aims to enhance type 2 diabetes knowledge, beliefs, and self-management behaviors as well as improving diabetes management measured by hemoglobin A1C after 3 months and 6 months in the study.

Project Dulce Arabic is incorporating genetic education as a part of its curriculum to raise the community awareness of the role of genetics in T2D development as well as the importance of early genetic risk detection for T2D prevention. We are also asking our Project Dulce Arabic participants to participate in the Scripps Bio-Repository (https://www.scripps.org/research/bio-repository). The specimens obtained from our study cohort will be used for genetic sequencing. Obtaining this genetic information will enable us to gain more insights into the genetic basis of type 2 diabetes in Arab Americans. Comparing the genetic risk of T2D, available from different biobanks, in other ethnic groups with that in Arab Americans would highlight the disease risk faced by the community and draw more attention towards the importance of early disease detection and prevention through tailored screening recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Are a participant of Metro Caring
* Self-identified Arab
* Diagnosed with type 2 diabetes mellitus (T2DM)
* HbA1c ≥7.5% in the last 30 days
* Able to speak, read, write, and comprehend in English and Arabic
* Have access to a cell phone that can receive/send text messages throughout the study

Exclusion Criteria:

* Pregnant
* Are currently participating in another diabetes-related study
SPI Value Relevance in Clinical Practice

Primary endpoint: Defining The optimal target range for Surgical Pleth index. Surgical Pleth Index (SPI, formerly used SSI = Surgical Stress Index) is a novel multivariate index, which is based on the sum of the normalized pulse beat interval (PBI) and the photoplethysmography. SPI indicates the balance between intensity of surgical stimulation and the level of anti-nociception (opioid analgesia and neural blockade). This study is a Spin off from a larger Adequacy of Anaesthesia study and aims on finding the most appropriate target range for SPI in order to avoid signs of inadequate anaesthesia. Patients are treated without monitoring adequacy of anaesthesia thus the values are collected blinded and analyzed afterwards in accordance of signs for inadequate anaesthesia. The study population will be 150 patients.

Signs of non-adequate anaesthesia are motor and/or autonomic nervous system arousals during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent

  * Age 18-80 years of age
  * Surgery that is expected to last at least 2 hours under general anesthesia with endotracheal tube

Exclusion Criteria:

* Any subject that meets the definition of vulnerable subject as defined in ISO 14155:2011o Per ISO 14155:2011, a vulnerable subject is defined as an individual whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate

  * Any subject with a cardiac pacemaker
  * Any subject with atrial fibrillation at the time of obtaining the baseline values
  * Any subject with more than 5 ventricular extra systoles/minute at the time of obtaining the baseline values
  * Any subject who needs invasive blood pressure measurement
  * Any subject who show hemodynamics that would have qualified for being considered as a sign of inadequate anesthesia already at baseline:

    o Mean blood pressure below 60 mmHg or above 100 mmHg o HR below 45 /min or above 100/min
  * Any subject with epidural anesthesia or analgesia during the surgery. Epidural catheter may be placed pre-operatively, and used in the PACU, but not during the surgery
  * Any subject having surgery that requires prone position
* Any subject with very high body mass index (\>35) because of incompatibility with the target controlled anesthesia models used

  * Any subject with known allergies to the specific anesthetic agents/ analgesic drugs intended for use in their surgeries
  * Any subject with laryngeal mask airway
  * Any subject who requires neuromuscular blocking agent infusion
  * Any subject who is going to have major surgery with a high risk of extensive blood loss
  * Any subject with known chronic use of opioids
Home Examinations Researching and Understanding Submucosal Evaluations

To demonstrate that imaging via home ultrasound can identify submucosal fibroids. The image quality and submucosal fibroid detection specificity of the home imaging has already been demonstrated; the aim of this study is to generate further data for sensitivity. This will be a single visit study, with participants scanning themselves at home with healthcare professional (HCP) supervision. Targeted population is women with previously diagnosed submucosal fibroids that have not been removed. The study will be single-blinded to the image raters.


Eligibility Criteria:
Inclusion Criteria:

* Women with one or more submucosal fibroid, with appropriate attestation (see more detail below)
* Women between the ages of 18 and 49 inclusive (women 38 and younger can also receive their antral follicle count, or AFC; 39 and older will participate in uterine scanning only)
* Women with BMI up to 40
* Women located in states where the PI or sub-PI licensure is valid
* Women able to freely give consent electronically, given COVID. For the purposes of this study, this is defined as women who speak native or fluent English; and have a high school degree or equivalent, and who are otherwise, in the professional judgement of the PI, able to give informed consent

Exclusion Criteria:

* Women with expert ultrasound experience, e.g., ultrasound technologists, radiologists, OB/GYNs, Reproductive Endocrinologists
* Women with BMI over 40
* Women who do not speak English natively or fluently
* Women who have recently given birth, and have had fewer than 3 postpartum menstrual cycles
* Women who have recently had a stillbirth or abortion more than 20 weeks (subject to the 3 postpartum menstrual cycles above). Miscarriages or abortions less than 20 weeks are subject to two wait cycles
* Women who are currently pregnant or may be pregnant
* Any woman the PI believes is not capable of giving independent, informed consent
* Turtle Health employees