cyrilzakka/clinical-trials huggingface dataset:
Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer

A pilot study testing the effect of an in-visit English and Spanish language decision aid for Hispanic-Latino men using best practices of cultural tailoring to be used in urology practice. Subjects will be followed for approximately 1 year during standard care in-clinic office visits. Study results and subject surveys will be analyzed to determine clinical utility of the tool.

The objective of this research is to determine the effect of a culturally tailored decision aid tool on the cancer treatment decisions of Hispanic-Latino patients.

The specific aims are:

i. To develop and pilot test in an uncontrolled fashion an in-visit English and Spanish language decision aid for Hispanic-Latino men using best practices of cultural tailoring to be used in urology practice ii. To pilot and test the impact of a culturally tailored, English and Spanish language version of the Prostate Choice in-visit decision aid on decision quality, knowledge, and quality of life in low-income Hispanic/Latino patients diagnosed with localized prostate cancer iii. To assess the barriers and facilitators of decision aid use including the relative contribution of language-concordance on 1-year practice implementation parameters.

Eligibility Criteria:
Inclusion Criteria:

* Subjects utilize English or Spanish as their primary spoken or written language and identify with a Latino ethnicity and/or culture
* Men with a new histologic diagnosis of localized prostate cancer
* PSA level of 0.1 - 50 ng/dl
* Gleason score of 6 - 10
* Cancer stage: T1 - 4N x M0

Exclusion Criteria:

* Metastatic disease, including lymph nodes or distant metastasis
* PSA \> 50 ng/dl
* Individuals with a medical condition that necessitates a specific prostate cancer treatment plan
* Individuals that are unwilling or unable to attend study visits or are planning to move out of a study site coverage area during the subject's anticipated participation in the study
Effects of Oral Motor Therapy in Children With Cerebral Palsy

: CP is a neurodevelopmental condition. A set of irreversible impairments of movement and posture development, resulting in activity limitation. Acquired CP can be the outcome of a variety of issues that arise after the first 28 days of a baby's existence. A CP diagnosis can now be made as early as 16 weeks. speech-language pathologists (SLPs) began collaborating with OTs and PTs for Infants and toddlers who also struggle with speech impediments, feeding and swallowing disorder. Oral motor exercises (OMEs), also known as "mouth exercises," "non-speech oral motor training," and "oral motor treatment" were designed for their treatment. The objective of this study was to assess the effects of oral motor exercises in children with cerebral palsy having feeding and swallowing difficulties.

Over 17 million people throughout the world are living with cerebral palsy (CP), making it the most common physical disability among children. CP is a neurodevelopmental condition\[1\]. Cerebral palsy is a fitting classification of the condition and its associated deficits because the word cerebral means "pertaining to the brain" and palsy means "loss of muscle control." A set of irreversible impairments of movement and posture development, resulting in activity limitation, that are linked to non-progressive disruptions that occurred in the developing foetus or infant brain, was chosen as the official definition of CP in 2005 by the International Consensus \[2\]. It's important to keep in mind that the phrase "cerebral palsy" refers to a spectrum of conditions, each of which has its own unique appearance, set of symptoms, and prevalence rate within the general population. In addition to the musculoskeletal and neurological symptoms of CP, epilepsy and other sensory and cognitive impairments are also common

Eligibility Criteria:
Inclusion Criteria:

1. CP children already diagnosed with feeding and swallowing difficulties.
2. Age range: 4 to13 years

Exclusion Criteria:

1. Patients with any co morbid conditions like uncontrolled epilepsy.
2. Patients on NG or feeding tube.
Effect of Motor Cognitive Interference on Cognition and Quality of Life on Patients with Multiple Sclerosis

Is there an effect of Cognitive Motor Interference on Cognition and quality of life on Multiple Sclerosis patients.

we will assess the effectiveness of Cognitive Motor interference on Cognition and quality of life on Multiple Sclerosis patients

Eligibility Criteria:
Inclusion Criteria:

1. M S patients complain of Mild Cognitive impairment according to Modified Mini Mental State (MMSE).
2. Patients with remission and relapse, primary and secondary progression types of MS.
3. Age between 25 and 45 years.
4. Patients from both gender.

Exclusion Criteria:

1. patients have visual disorders
2. patients have auditory disturbance
3. Non educational patients.
4. Patients with psychiatric disorders.
5. Patients with mod to severe cognitive impairment according to MMSE
A Clinical Trial to Evaluate the Safety and Efficacy of ALLO-ASC-DFU for Second Deep Degree Burn Injury Subjects

This clinical trial is a Phase II controlled, parallel, open-label trial, designed to test the efficacy and safety of ALLO-ASC-DFU and conventional therapy in Deep Second-degree burn wound subjects.

ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating Deep Second-degree burn wounds.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years of age and older.
2. Subjects who have deep second-degree burn wound ≥100cm\^2.
3. TBSA(Total burn surface area) ≤ 30%
4. Negative for Urine beta-HCG for women of childbearing age.
5. Subject is able to give written informed consent prior to study start and comply with the study requirements.

Exclusion Criteria:

1. Subject who have been enrolled in another clinical study within 30 days of screening.
2. Subjects who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue.
3. Subjects who are receiving steroids, immunosuppressive, or anticoagulant for long term
4. Subjects with active infection.
5. Subjects with hemorrhagic and hemocoagulative disease.
6. Subjects who are unwilling to use an "effective" method of contraception during the study.
7. Subjects who have a history of malignant tumor within the last five years, or is currently undergoing.
8. Subjects who are pregnant or breast-feeding.
9. Subjects who are considered to have a significant disease which can impact the wound healing by the investigator
10. Burn wound is present on any part of the face.
11. Subjects who are considered not suitable for the study by the investigator.
12. Subjects who are not able to understand the objective of this study or to comply with the study requirements
Facial Type Determination Through Cephalometry, Anthropometry and Facial Analysis

Introduction:

Human face with its bony and muscular structures has singular and peculiar characteristics. It may be classified in three types, associated with the variation of shape and craniofacial configuration, both in vertical and horizontal planes, directly affecting dental occlusion, face harmony, orofacial musculature and oral functions. Aim: to correlate cephalometric with anthropometric and facial analysis findings on determining the facial type.

Method:

105 leukoderm adults were involved, 34 male and 71 female aging between 20 and 40 years old. Data were collected in December 2006 in an orthodontic clinic located at Belo Horizonte- MG, Brazil. Cephalometric findings to determinate facial types were compared to seven anthropometric facial measurements, three anthropometric facial proportions and three anthropometric facial indices, in addition to facial type identification through clinical facial analysis of photographs.


Eligibility Criteria:
Inclusion Criteria:

* to have Ricketts cephalometric analysis

Exclusion Criteria:

* to have been submitted on orthognathic surgery
* black or asian people
Study of BEST1 Vitelliform Macular Dystrophy

The purpose of this study is to establish the natural history of of participants with BESTROPHIN 1 Vitelliform Macular Dystrophy.

The blinding disorder Best Vitelliform Macular Dystrophy (VMD) is caused by any one of more than 250 different mutations in the BEST1 gene.

As new treatments are developed, a clear understanding of the natural history of disease progression of BEST1 VMD is necessary. The goals of this natural history study are to:

1. Report the natural history of retinal degeneration in participants with a clinical diagnosis of VMD with molecular confirmation of a pathogenic BEST1 mutation(s).
2. Identify sensitive structural and functional outcome measures to use for future multicenter clinical trials for the treatment of BESTROPHIN 1 VMD.
3. Compare progression of the identified structural and functional measures between the two eyes to judge the suitability of the second untreated eye as a control for a future clinical trial involving unilateral treatment
4. Identify well-defined patient populations for future clinical trials of investigative treatments for BEST1 VMD.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Diagnosis of BEST1-associated VMD by study physician, who are trained retinal specialists in the university clinic Must be able to commit to 4 follow-up study visits (3 years)

Exclusion Criteria:

* Systemic condition that prevents the participant from undergoing the exams
Music Therapy in Sickle Cell Transition Study

The purpose of this study is to investigate the effects of the BEATS Music Therapy Program on the self-efficacy, trust, knowledge, and adherence of young adult patients with sickle cell disease during transition.

Primary Hypotheses:

Compared to baseline, young adult patients with sickle cell disease who receive the music therapy interventions will report:

1. Higher sickle cell self-efficacy as measured by the Sickle Cell Self Efficacy Scale (SCSES),
2. Higher trust in health care providers as measured by the Wake Forest Trust in the Medical Profession Scale, and
3. Higher sickle cell disease knowledge as measured by the Seidman Sickle Cell Knowledge Quiz.

Secondary Hypotheses

1. Compared to the one year prior to the study period, young adults with sickle cell disease who receive the music therapy interventions will have a higher rate of adherence to clinic appointments during the one-year study period.

Additional Questions

1. Do music therapy interventions influence attendance to scheduled blood transfusions?
2. Do music therapy interventions influence the rate of hospital utilization as measured by Emergency Department visits, Acute Care Clinic visits, and admissions during the study period compared to the previous year?
3. Do music therapy interventions influence adherence to hydroxyurea therapy for patients receiving hydroxyurea as measured by change in mean corpuscular volume (MCV) during the study period?
4. Do music therapy interventions influence adherence to iron chelation therapy for patients receiving iron chelation therapy as measured by ferritin count during the study period?


Eligibility Criteria:
Inclusion Criteria:

* Subject is between 18 and 23 years of age
* Subject is diagnosed with sickle cell disease
* Subject is able to speak and understand English
* Subject is currently scheduled for quarterly appointments in the Bridge Clinic

Exclusion Criteria:

* Subject has significant hearing impairment that has not been corrected
* Subject has significant visual impairment that has not been corrected
The Effect of Losartan in Bicuspid Aortic Valve Patients

The specific aims of this study are to:

* Establish baseline levels of circulating MMP-2 and -9 , TIMP-1and- 2 and TGFB levels in individuals with bicuspid aortic valve and ascending aortic or aortic sinus measurements \>40mm.
* Assess the effect on MMP levels during treatment with losartan, an angiotensin II receptor blocking agent.
* In the setting of losartan therapy for one year, evaluate the response of MMP levels in these patients, and clinical outcomes including effects on aortic growth rate


Eligibility Criteria:
Inclusion Criteria:

* Adults \>age 18 years and \< 65 years old
* Able to give informed consent
* Presence of a bicuspid aortic valve (functional or true bicommisural)and ascending aorta or sinus of Valsalva \>4.0cm
* No contraindications to treatment with Losartan, an Angiotensin II receptor blocker
* Able to safely participate in a 4 week drug washout period if currently taking an angiotensin II receptor blocker or ACE inhibitor.

Exclusion Criteria:

* Unable to safely take losartan due to one or more of the following:

  * Hypersensitivity to losartan or other angiotensin receptor blockers
  * Pregnancy
  * Nursing mothers
  * History of angioedema
  * Hypotension - chronically volume depleted patients
  * Hepatic or renal impairment (Cr\>1.5mg/dL)
  * Hyperkalemia (K+\>4.8)
  * Renal artery stenosis
  * Severe congestive heart failure (class III-IV)
  * Currently taking potassium supplements or salt substitutes containing potassium
  * Currently taking lithium
* Prior surgical intervention to aorta or aortic valve
* Unable or unwilling to give informed consent and follow up with study activities
* Currently taking an angiotensin receptor blocker or ACE inhibitor specifically for hypertension and are therefore unable to or are unwilling to participate in a 4 week drug washout period.
* Females of child bearing who are unwilling to practice adequate birth control throughout the study.
Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate Cancer

The goal of this clinical study is to determine impact of carbon ion radiotherapy (CIRT) treatment in combination with systemic therapy for oligo-metastatic prostate cancer. The primary objective: to determine disease biochemical progression-free survival in man with oligo-metastatic (M1a/b) prostate cancer undergoing systemic therapy with definitive radiotherapy of the primary tumor. The secondary objective: to determine local control, overall survival and quality of life in men with oligo-metastatic prostate cancer undergoing carbon ion radiotherapy


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed adenocarcinoma of the prostate
2. Age ≥ 20 and \< 80 years of age
3. ECOG PS 0 or 1
4. Life-expectancy ≥1 year
5. Stage T1-4,N0-1,M1a/b disease on imaging, with a combined maximum of 3 synchronous lesions.
6. Ability to understand and willingness to sign informed consent

Exclusion Criteria:

1. No pathologically confirmed adenocarcinoma of the prostate
2. visceral metastasis
3. Previous pelvic radiotherapy or prostatectomy
4. Severe systemic disorders
Airway Clearance by Fiberoptic Bronchoscopy in Bronchiectasis Followed by Gentamicin and Dexamethason Injection

Fiberoptic Bronchoscopic Removal of Secretions and Antibiotic Injection

fiberoptic bronchoscopic injection of dexamethason and gentamicin after airway clearance

Eligibility Criteria:
Inclusion Criteria:

1- Adult subjects. 2- Male and female subjects are enrolled. 3- patients with NCFB confirmed by chest high-resolution computed tomography (HRCT) 4- patients needing antibiotic treatment at the hospital due to exacerbation 5- Patients who underwent AC by bronchoscopy at the hospital.

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Exclusion Criteria:

1- Uncooperative subjects. 2- Unwilling to participate. 3- Inability to lie on the back with raised arms over the head for HRCT. 4- Presence of cystic pulmonary fibrosis; 5- Patients with active pulmonary tuberculosis; 6- Those awaiting surgery; 7- Patients who underwent interventional therapy for hemoptysis; those with allergic bronchopulmonary aspergillosis (ABPA); 8- Patients who did not undergo bronchoscopy for different reasons or combined with lung cancer.

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Use of Parent Connectors in First Episode Psychosis (FEP)

This study proposes to adapt an evidence based peer parent navigator (PPN) intervention, called Parent Connectors, in which trained and supervised PPNs deliver weekly telephone-based support for six to nine months to parents or caregivers of all newly enrolled youth or young adults (Y/YA) in FEP services. This PPN model will be used to enhance the delivery of Coordinated Specialty Care (CSC) for Y/YA in New York's state program for FEP, called OnTrackNY (OTNY). This research project has potential to add value to the CSC model through the inclusion of a feasible, low burden intervention that may improve family participation in services and Y/YA outcomes. Using random assignment, this study will examine the feasibility and preliminary impact of an accelerator strategy-the inclusion of peer parent navigators or PPNs-in CSC teams.


Eligibility Criteria:
Inclusion Criteria:

* Parents or caregivers of all newlyenrolled youth or young adults (Y/YA) in FEP services

Exclusion Criteria:

* NA
The Effect of Thoracal Paravertebral Block on Seroma Reduction in Breast Surgery

Thoracal paravertebral block (TPVB) is a commonly prefferred regional anesthesia technique to provide postoperative analgesia. In addition, the successful use of TPVB is reported for some seroma related pain cases. Postoperative analgesia in breast surgery is a difficult and overworked issue due to etensive surgery and complex innervation of the breast and in addition to this complex mechanisms, seroma accumulation has a negative effect for patients postoperatively. With this study, the investigators aimed to study the effect of TPVB on seroma reduction for breast cancer surgery.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years of agge
* ASA I-II
* Undergoing elective breast cancer surgery

Exclusion Criteria:

* obesity (body mass index \>35 kg/m2)
* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* coagulopathy
An Investigation of Ball Rolling Effects on Trigger Points

The current study aims to examine the potential effects of rolling a Myostorm ball on the trigger points in the upper back muscles.

The investigators will ask the participants to attend the laboratory in two sessions. They will seek the tender spots on the trapezius muscle. Then the participants will be asked to roll a Myostorm ball ( a small hard ball made of plastic with a layer of soft material cover) on their affected muscles. They will be tested for pain-pressure threshold (PPT), shoulder range of motion, electromyography (EMG), and force before and after the manipulation.

Eligibility Criteria:
Inclusion Criteria:

* trigger points on the trapezius muscle

Exclusion Criteria:

* back injury
Patient Decision Aid for Antidepressant Use in Pregnancy

The proposed study is a pilot randomized controlled trial (RCT) of an electronic patient decision aid (PDA) for antidepressant use in pregnancy. The overall aim of this pilot RCT is to establish the feasibility of future large international RCT of the PDA's effectiveness.

Depression in pregnancy is common, affecting up to 10% of women and represents serious risk to mother and infant. Unfortunately, antidepressant medication, a first-line treatment for depression in pregnancy, also comes with risks, making this a complex decision. Clinical care appears to be insufficient for ensuring that women make decisions that are consistent with their own values and with which they feel satisfied. Patient decision support tools can address such barriers. Canadian colleagues have created a patient decision aid (PDA) that has the potential to improve the decision-making process for women regarding antidepressant use in pregnancy in conjunction with clinical care. This study is a pilot RCT of the above PDA in London, to be conducted in parallel with a pilot RCT in Toronto.The overall objective of this project is to inform the development of a larger, international RCT to assess the efficacy of this PDA for antidepressant use in pregnancy. To achieve this objective, the investigators will assess the feasibility of the trial protocol to evaluate the PDA and determine the preliminary effect size for a larger multisite efficacy study. The primary outcome for this pilot study is the feasibility of conducting a large randomized controlled trial to evaluate the efficacy of the PDA. This includes feasibility (how well the trial protocol can be implemented), acceptability (usability and tolerability of the intervention) and adherence (the degree to which the trial protocol is followed). It is hypothesized that the protocol will be feasible, that the PDA will have a high degree of acceptability, and that adherence to the protocol will be high.

Eligibility Criteria:
INCLUSION CRITERIA: Women who meet all of the following criteria:

* Are aged over 18
* Are planning a pregnancy or are \<30 weeks pregnant at enrolment
* Have been offered to start or continue an antidepressant as treatment for depression by their clinician a
* Have moderate-to-high decisional conflict (score of \>25 on the Decisional Conflict Scale)

EXCLUSION CRITERIA: Women who meet any of the following criteria:

* Have had alcohol or drug abuse or dependence in the previous 12 months
* Have active suicidal ideation or psychosis
* Are incapable of consenting to participation
* Have any major obstetric complications or foetal cardiac anomaly in the current or in a past pregnancy,
* Are visually impaired
* Do not have sufficient English language proficiency to use the PDA.
Sarcopenia After Bariatric Surgery in Older Patients: a Cohort Study

The retrospective cohort study will compare the prevalence of sarcopenia and associated factors between older patients who have undergone bariatric surgery and older patients with obesity without previous bariatric surgery.

The aim of the study is to compare the prevalence of sarcopenia and nutritional status between adults older than 65 years who have previously undergone bariatric surgery and patients with obesity but without previous bariatric surgery. Current sarcopenia will be assessed during a cross-sectional assessment after surgery using the criteria from the European Working Group on Sarcopenia in Older People (EWGSOP).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age 65 years or older
* Cohort 1 (exposed): Previous bariatric surgery for obesity at least 1 one year ago
* Cohort 2 (unexposed): No previous weight loss surgery

Exclusion Criteria:

* Current diagnosis of cancer
* Advanced organ failure, including chronic kidney disease Stage 5, liver cirrhosis Stage 3, intestinal failure, heart failure stage D, or chronic obstructive pulmonary disease stage 4.
* Immobility
* Neuromuscular degenerative conditions