cyrilzakka/clinical-trials huggingface dataset:
Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks

The purpose of this study is to compare urinary and bowel side effects of hypofractionated radiotherapy in 20 treatments (4 weeks) to ultra-hypofractionated radiotherapy in 5 treatments (2 weeks) for prostate cancer that has returned after prostatectomy. The investigators are also interested in looking at time to progression and the quality of life (health scores).

The standard treatment for most patients with biochemical recurrence after radical prostatectomy is salvage radiotherapy. Salvage radiotherapy delays the need for chronic, non-curative treatment, such as long-term androgen suppression, and is the only potentially curative treatment of some biochemical recurrences after prostatectomy.

Patients are recommended to undergo salvage radiotherapy to eradicate biochemical disease delivered in approximately 40 treatments over the course of 8 weeks, representing a high burden of therapy, which may be related to lower utilization of salvage radiotherapy. Modern radiotherapy for prostate cancer has been afforded many advantages including advanced image-guided radiotherapy allowing for larger dose delivery in fewer treatments and smaller margins with hypofractionated (20 treatments) and ultra-hypofractionated (5 treatments) radiotherapy.

In patients that need salvage radiotherapy, the potential advantages of hypofractionated and ultra-hypofractionated radiotherapy delivered over 20 or 5 treatments are: 1) increased convenience to patients because of fewer treatment days, 2) reduced costs to patients because of reduced travel expenses and copays, 3) improved resource utilization for physicians because of the fewer number of treatments per patient and consequently 4) reduced cost to society. In prostate cancer specifically, hypofractionated and ultra-hypofractionated radiotherapy has the added potential of not increasing toxicity with shorter treatment times.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 and older with histologically confirmed prostate cancer after prostatectomy with detectable PSA. PSA does not need to be detectable for men with pathologically node positive disease.
* KPS \>=70
* Patient with no evidence of distant metastatic disease on PET/CT/MRI or bone scan \< 9 months prior to enrollment. Patients with positive pelvic lymph nodes are eligible.
* Ability to receive MRI-guided radiotherapy.
* Equivocal evidence of metastatic disease outside the pelvis on standard imaging requires documented negative biopsy.
* Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.

Exclusion Criteria:

* Prior history of receiving pelvic radiotherapy.
* Patient with inflammatory bowel disease.
* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of ultra-hypofractionated radiotherapy.
* History of bladder neck or urethral stricture.
Construction of a Risky Sexual Behaviour Intervention Programme for College Students Based on BCW Theory

Using the intervention functions of Behavior Change Wheel (BCW) and BCTs, we constructed an intervention program for college students' risky sexual behaviors by combining literature analysis, qualitative research, Delphi's expert correspondence, and pre-experiment (20 students in the test group and 20 students in the control group). Before the intervention (T0) and at the end of the intervention (12 weeks, T1), we measured students' psychosexual health, social support, and sexual self-efficacy using relevant scales to ensure the effectiveness of the intervention. By clarifying the influencing factors of college students' risky sexual behaviors, the proposed intervention program for college students' risky sexual behaviors can effectively reduce the incidence of college students' risky sexual behaviors, improve the level of college students' psychosexual health, increase the level of social support, improve the sense of sexual self-efficacy, improve the level of risk perception, enhance the ability of risky decision-making, reduce the risky behaviors, and reduce the occurrence of adverse outcomes, thus providing a reference and reference for the prevention and control of college students' risky sexual behaviors. This will provide reference for the prevention and control of risky sexual behaviors among college students.


Eligibility Criteria:
Inclusion Criteria:

1. aged ≥16 years;
2. full-time undergraduate college students;
3. engaged in risky sexual behaviors (including multiple sexual partners, unprotected sex, and casual sex, and one of them is considered to have engaged in risky sexual behaviors) during their college years;
4. able to clearly recall and describe the incident;
5. signed an informed consent form

Exclusion Criteria:

1. not wanting to be asked sex-related questions;
2. being screened at the beginning of the semester using the Mental Health Survey and diagnosed by a psychiatrist as having a mental illness (schizophrenia, major depressive disorder, bipolar disorder)
Comparison of eBX and Mohs Surgery for Treatment of Early-stage Non-melanoma Skin Cancer a Matched Pair Cohort Study.

This is a retrospective-prospective study design. Patients who completed treatment approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be identified and any existing data in the patient's record will be collected in addition to conducting office visits for long-term follow-up.

This is a retrospective-prospective study design. Patients who completed treatment approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be identified and any existing data in the patient's record will be collected in addition to conducting office visits for long-term follow-up. The study will include 2 parts:

1. Retrospective chart review: Collect data from patient records who completed treatment a minimum of 2 years prior to study onset and determine the feasibility of doing a matched pair cohort study comparison of eBx versus Mohs surgery. The history, demographic and treatment data will be retrospectively collected from up to 320 subjects previously treated with eBx for the treatment of NMSC and up to 320 subjects previously treated with Mohs surgery for the treatment of NMSC.
2. Prospective Follow-up: Patients will return for long-term follow-up visits for the investigators to assess the lesion site, document absence of recurrence/ absence of recurrence, toxicities, and collect patient reported outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System or Mohs surgery;
2. Provides informed Consent;
3. Greater than 40 years of age;
4. Pathological diagnosis confirmed to be squamous cell or basal cell carcinoma prior to treatment;
5. Cancer Staging included in this study:

   * Stage 0: Tis, N0, M0
   * Stage 1: T1, N0, M0
   * Stage 2: T2, N0, M0 and ≤ 4cm in diameter

Exclusion Criteria:

1. Target area is adjacent to a burn scar
2. Any prior definitive surgical resection of the cancer, prior to Radiation Treatment
3. Known perineural invasion
4. Actinic Keratosis
5. Known spread to regional lymph nodes
6. Known metastatic disease
Parent Behavioral Training for Disruptive Behaviors in Tourette Syndrome

This is a randomized controlled trial to assess the efficacy of a parent training program to control disruptive behaviors in children with Tourette Syndrome.

Disruptive behaviors occur in 80% of children with Tourette Syndrome, and can be more disabling than the tics themselves.

The aim of this study is to assess the efficacy of a parent training program to control disruptive behaviors in children with Tourette Syndrome. In addition, social cognition will be examined in all the participants to analyze its relationship with the severity of disruptive behavior and the treatment response.

42 children with Tourette Syndrome and moderate disruptive behaviors will be randomly assigned to a 10-week Parent Training Program or a 10-week Supportive Therapy. Clinical response will be evaluated after the intervention period, and three and six months later.

Eligibility Criteria:
Inclusion Criteria:

* Fulfill DSM-5 diagnostic criteria for Tourette's Disorder
* Moderate disruptive behaviors (Home Situations Questionnaire score \>3)

Exclusion Criteria:

* Lifetime history of global learning disability, autism spectrum disorder, psychosis, bipolar disorder or organic brain disorder.
* Previous parent training with qualified therapist within the last 12 months prior to assessment
* Simultaneous individual treatment for disruptive behaviors.
* Initiation or adjustment of any psychotropic medication within the last 6 weeks prior to assessment
Triceps Surae Trigger Point Size and Muscle Extensibility

The purpose of this study is to determine the effectiveness of dry needling in improving ankle range of motion and functional outcomes. There have been an increasing number of studies on dry needling as an intervention for pain but none thus far that have studied functional outcome measures of the ankle. The study will include healthy male subjects between the ages of 18-30 years old randomized in to 3 intervention groups of: dry needling of the triceps surae, triceps surae stretching only, dry needling and stretching. The subjects who receive dry needling as an intervention will have the trigger point identified and dry needling performed while under musculoskeletal ultrasound visualization. The subjects will undergo pre and post intervention testing including Lower Quarter Y-Balance test, passive ankle dorsiflexion, closed chain half kneeling dorsiflexion, standing dorsiflexion, deep squat, multisegmental flexion as well as Marx Activity Level Scale. There will be 3 days between the initial testing/intervention and follow up. These outcomes will be the primary variables of interest. Ultrasound, Y balance testing, self stretching, and range of motion measurements are safe and pose no risk to the subject. Dry Needling has been found to be very safe and effective in the hands of physical therapists with a calculated risk of adverse events to be less than 0.04%.


Eligibility Criteria:
Inclusion Criteria:

* Male
* 18-30 Years Old
* No history of ankle surgery
* No current ankle injuries

Exclusion Criteria:

* hypothyroidism
* fibromyalgia
* connective tissue disorders
* chronic pain
* bleeding disorders including use of anti-coagulants
* vitamin D and B12 deficiencies
* active sites of cancer
* local or systemic infections
* local skin lesions, local lymphedema
* peripheral vascular disease including varicose veins
* compromised immune system
* needle phobia
Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration

Objective: to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes

In this prospective clinical trail, 43 patients with plantar ulcer grade 1 or 2 (wagner scale) were randomized to one of two off-loading modalities: total contact cast or custom-made temporary footwear.outcomes assessed were wound surface area reduction (square cm.)and time to wound healing (days0 at 2,4,8 and 16 weeks. to evaluate safety, possible side effects were recorded at each follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diabetes
* neuropathic ulcer grade 1/2 (wagner scale)
* confirmed sensory neuropathy

Exclusion Criteria:

* osteomyelitis patients unable to walk
* life threatening co-morbidity ankle/brachial index , 0.4
The Use of HIV Self-tests to Promote Partner and Couples Testing: a Randomized Trial

This randomized controlled trial will explore whether the provision of oral HIV self-test kits to women can increase HIV testing among their male partners. The study will recruit adult women from antenatal care and post-partum clinics in Kisumu. Each participant will be randomized to either receive two HIV self-tests or to receive counseling referring their partner to HIV testing (standard of care). Over a 3 month period, we will obtain information from study participants on how many sexual partners they offered the tests to, the receptivity of their sexual partners to using self-tests, and the incidence of any adverse events. We will compare partner testing rates in intervention and control groups.

This randomized controlled trial will enroll women, ages 18-39, attending antenatal care (ANC) and post-partum care (PPC) at 3 sites in Kisumu, Kenya. The study's purpose is to investigate whether offering multiple HIV self-tests to women can increase the likelihood that either partner or couples HIV testing takes place.

Women who are randomized to the intervention group will be provided with multiple oral self-tests as well as information about how to use the tests and where to seek care if necessary. These women will be encouraged to give the self-tests to their sexual partners and encourage those partners to take a self-test. Women who are randomized to the control group will be offered the standard counseling to refer their partners for clinic-based HIV counseling and testing. Our hypothesis is that the intervention group will have higher uptake of HIV testing by women's partners within 3 months of enrollment in the study than the control group. Participants in the study will complete a baseline interview and a follow-up interview at 3 months post-enrollment. Qualitative in-depth interviews will be conducted with a subset of participants in the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* Primarily resides in or near Kisumu
* Reports having a current, primary partner (someone that the woman has been in a relationship with for at least 6 months and is identified as her primary partner)
* Reports that primary partner has not tested for HIV in past 6 months
* Have undergone the opt-out HIV testing at the ANC or PPC clinic
* Intends to continue living in or around Kisumu for the next 3 months (follow-up period).

Exclusion Criteria:

* Believes that her partner will hurt her if she gives him an HIV self-test and encourages him to use it
* Reports having an HIV+ partner
* Intends to relocate from Kisumu area within the next 3 months
Prediction of NODAT After Renal Transplantation

A statistical analysis of the predictive value of OGTT and FPG testing executed as part of standard clinical practice after renal transplantation for the diagosis of new-onset diabetes mellitus after transplantation.

All patients transplanted in our department receive a formal oral glucose tolerance test (and thus also fasting plasma glucose concentration) in the first week after renal transplantation. This testing for DM or Impaired Glucose Tolerance (IGT) is part of our standard clinical protocol and data are collected prospectively in all these patients in an electronic patient medical file. The development of diabetes mellitus in all transplant patients is documented, including DM therapy.

Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary single kidney transplantation
* Age older than 18 years

Exclusion Criteria:

* Pre-existing DM or documented impaired glucose metabolism
* Combined organ transplantation
Concentration of Plant Sterols in Serum and Aortic Valve Cusps

This study investigates the effect of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations of plant sterols. We assume that consumption of margarine supplemented with plant sterol esters increases serum and cardiovascular tissue concentrations of plant sterols (sitosterol; campesterol).

The role of plant sterols in cardiovascular diseases is controversially debated. There is an increasing body of evidence that indicates that increased plant sterol serum concentrations are correlated with an increased cardiovascular risk. Functional foods such as margarines supplemented with plant sterol esters are advertised to patients with hypercholesterolemia. Numerous studies show that margarines supplemented with plant sterol esters reduce serum cholesterol concentrations significantly. However, there are no studies available investigating relevant clinical endpoints. Nor are there any studies availabe investigating the effect of the consumption of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations. This study is done to investigate the effect of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations.

Eligibility Criteria:
Inclusion Criteria: aortic valve stenosis -

Exclusion Criteria:familial hypercholesterolemia.

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Testing Self-Directed Care in Florida

This study tests a psychosocial intervention called mental health self-directed care by assessing its impact on recovery, mental health status, rehabilitation outcomes, and service costs in the state of Florida.

With additional funding from the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR), a new cohort of 40 study subjects will be recruited in the state of Florida to test mental health self-directed care (SDC). SDC is a self-directed model of service delivery in which participants manage a personal budget from which they purchase goods and services, including specific types of mental health care, social supports, and items that allow them to recover their health and emotional wellness and live independently. Investigators are studying the impact of SDC on recovery, mental health status, rehabilitation outcomes, and service costs. Working with Lutheran Services Florida, a public managing entity coordinating mental health care management in northeastern and central Florida, adults with mental health conditions will be recruited into the study and randomly assigned to receive SDC for one year or continue receiving services as usual. Assessments will occur at baseline, 6- and 12-month followup.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Serious mental illness
* Receiving services coordinated by behavioral health managing entity

Exclusion Criteria:

* Cognitive impairment preventing informed consent
* Enrollment in Medicaid/Medicare
* Representative payeeship
* Court-mandated treatment
* Recent substance disorder crisis
* In residential treatment
* History of violent behavior in the past 10 years
Free-living Monitoring of Parkinson's Disease Using Smart Objects

Parkinson's disease, one of the most common neurodegenerative diseases of the central nervous system, presents motor symptoms, including tremor, rigidity, bradykinesia, and postural instability. Assessments of patients with Parkinson's disease are typically performed using clinical scales, compiled by the healthcare staff or by the patient. Although commonly used in clinical practice, they have some limitations, including the low temporal resolution of the scales, the low granularity of the scores and the possible low inter- and intra-operator reliability. The recent development of digital technologies has led to the creation of IoT (Internet of Things) devices capable of providing quantitative indicators, potentially useful for an accurate differential diagnosis, as well as for monitoring the effects of therapeutic interventions. The peculiarity of these systems is the ability to provide indicators not only during periodic visits to the clinic, but also the ability to remotely monitor the patient's daily life activities. In this scenario, this study wants to test the hypothesis that the IoT devices like smart-ink pens and insoles are usable options for monitoring patients with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Adult individuls
* Cognitive impairments
* Ability to independently sign the written informed consent

Exclusion Criteria:

* Unstable pharmacological treatment for Parkinson's Disease during the study
* Previous history of major neurological, vascular, musculoskeletal disorders
Prognostic Values of Inflammation-based Indices in Gastric Cancer

This study aims to evaluate the prognostic values of preoperative inflammation-based indices in patients undergoing potentially curative resection of gastric cancer.

Gastric cancer is one of the most common and deadly cancers worldwide. Based on GLOBOCAN 2018 data, it is the fifth most common malignancy and the third leading cause of cancer deaths, with an estimated 783,000 deaths in 2018. Despite advances in diagnosis and management strategies, outcomes for patients diagnosed with gastric cancer still remain poor and the five-year survival is approximately %20. In addition, there is marked heterogeneity in the duration of survival among patients. Hence, there are increasing research efforts towards the identification of possible predictive clinical, pathological, or biologic factors to determine more accurate patient stratification, which will improve clinical decision-making and possibly contribute to more rational study design and analysis. Systemic inflammation is known to play a crucial role in the pathogenesis, development, and progression of cancer. Preoperative inflammation-based indices, such as the Glasgow prognostic score (GPS), modified Glasgow prognostic score (mGPS), neutrophil-lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR), prognostic index (PI), prognostic nutritional index (PNI), CRP/albumin ratio, systemic inflammation score (SIS), modified systemic inflammation score (mSIS), have been found to have potential prognostic values in various cancer. Previous studies have suggested that several of these scoring systems may have a role in predicting survival in patients with upper gastrointestinal cancer. These scores are all derived from blood tests that are already routinely performed in clinical practice and thus have the potential to offer valuable additional information that may help to guide patient management. This study aims to evaluate the prognostic values of preoperative inflammation-based indices in patients undergoing potentially curative resection of gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 who underwent a surgical procedure for gastric cancer

Exclusion Criteria:

* Patients \< 18 years of age
* Patients with no routine blood examination before surgery or incomplete medical records
* Patients followed up less than 3 months
* Patients with additional malignancy
* Patients having tumors that invading adjacent organs
* Patients with adjacent or distant metastasis
* Patients receiving neoadjuvant therapy (chemo- or radiotherapy)
* Patients with previous malignancy history
* Patients with a clinical evidence of infection
* Patients with a history of preoperative use of anti-inflammatory drugs or immunosuppressive treatment
* Patients with a history of chronic inflammatory disease or autoimmune disease
* Patients who underwent emergency surgical resection
* Patients who have undergone R1/R2 resection or those with positive peripheral margins
* Patients with missing data on follow-up