cyrilzakka/clinical-trials huggingface dataset:
Inspiring Seniors Towards Exercise Promotion to Protect Cognition

The goal of this clinical trial is to test the benefits of beat-accented music stimulation (BMS) for behavioral changes of physical activity (PA) in older adults with subjective memory complaints. Specific Aims are to determine (1) whether BMS beneficially influences PA behaviors and psychological responses to PA in older adults for 6 months, and (2) whether exercising with BMS differently influences physical and cognitive functioning as well as quality of life in older adults.To test the effects of BMS on PA, participants will be randomly assigned to an exercise intervention that either includes BMS or does not include BMS. Participants will attend a supervised group strength training (ST) (30 min/day) and and aerobic exercise (AE) (30-50 min/day) session for 3 days/week for the first 2 months, 1 day/week for the next 2 months (while encouraging participants to independently perform both AE and ST on other days), and independently for the final 2 months (always with a goal of performing \>150min/week AE and 3 days/week of ST for 30 min/day).


Eligibility Criteria:
Inclusion Criteria:

* Adults at least 65 years old.
* Ambulatory/capable of walking for 6 minutes without pain or aid such as a walker/cane.
* Able to speak and read English.
* Healthy enough to exercise at moderate intensity with or without medical clearance by a primary care physician.
* Living in the community for the duration of the study (6 months).
* Having a reliable means of transportation.
* Having a safe place (at least 6 feet by 6 feet of open space) at home for unsupervised exercise training.
* Having self-perceived memory complaints.
* Having no symptoms of suicidal ideation and not meeting criteria for depressive disorder.
* Physically low-active by doing \< 60 min/week of moderate-intensity aerobic exercise and no strength training for the last 3 months.

Exclusion Criteria:

* Diagnosis of neurological disorder or spinal cord disorder.
* Known exercise contraindications.
* Current cancer treatment.
* Stroke or neural impairment in the past 6 months.
* Hip/knee/spinal fracture or surgery in the past 6 month.
* Unable or unwilling to attend intervention classes 3x/week in Months 1-2 and 1x/week in Months 3-4.
* Currently participating in any other physical activity or fitness-related research study.
* Use of medication for Alzheimer's disease. Change in dosage of medications prescribed for anxiety or depression within the previous 6 months.
* Regularly drink \> 14 alcoholic beverages a week or current illicit drug use.
* Meet the threshold for cognitive impairment.
* Meet the threshold for clinical depression.
* Uncorrected hearing or visual impairments.
* Unable to understand the study procedures.
* One of the household members is participating in this study.
Urinary Protein to Creatinine Ratio in Term Pregnant Women

This study will determine the incidence of elevated U Pr/Cr in normal term pregnant women. In addition we will determine if a "clean catch" urine has an effect on the U Pr/Cr.

Clean catch urine should be used due to possible vaginal secretion contamination with falsely elevated U Pr/Cr ratio. However, no supporting reference was found in the article and no control group with random urine collection for comparison to clean catch specimen U Pr/Cr was included in their study. The original studies that validated spot Pr/Cr urine as a predictor of 24 -hour total urine protein used random non-clean catch random urines . They had an r value of .93-.99 in estimating total protein excreted in 24 hours. At our institution we use Siemens-base test to determine U Pr/Cr. In the product insert the company states that no special patient preparation is necessary.

Thus, this study will determine the incidence of elevated U Pr/Cr in normal term pregnant women. In addition we will determine if a "clean catch" urine has an effect on the U Pr/Cr.

Eligibility Criteria:
Inclusion Criteria:

* women of 37 weeks gestation or greater

Exclusion Criteria:

* Urinary tract infections
* Hypertension
* Pre-eclampsia
* Renal dysfunction
Patients Overexposed for a Prostate Adenocarcinoma

Background:

Between 2000 and 2006, 433 patients were overexposed (8% to 10%) during a course of conformal radiotherapy for a prostate adenocarcinoma in Jean MONNET hospital, Epinal, France. Among them, twenty four patients received an additional mean dose about 20%, due to an inappropriate use of the treatment planning system. Severe adverse events (proctitis, cystitis, and tissue necrosis) have occurred among most of these overexposed patients. We propose to develop several research programs in order to increase the scientific knowledge on iatrogenic effects related to overexposure of ionizing radiation, by studying their relationship with dosimetric, clinical, biologic and genetic characteristics.

Aim of the study:

To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data.

Primary study endpoint:

Incidence and severity of adverse events related to radiotherapy (according to SOMA - LENT and CTCAE scales).

Secondary study endpoint:

* Correlation between adverse events and radiation doses with biologic, phenotypic and genetic data.
* Evaluation of T-lymphocyte apoptosis to predict radiation-induced late toxicity
* Gene associations with risks for adverse events related to radiotherapy
* Levels of circulating microparticles and bystander effect after irradiation

Inclusion criteria:

Consecutive patients treated for a prostate adenocarcinoma in the radiation department of the Jean MONNET Hospital between 2000 and 2006.

Potential. Better identification of patients at high risk of adverse events related to radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* provision of informed consent
* patient treated for prostate adenocarcinoma and overexposed during radiotherapy in a prostate adenocarcinoma in the radiation department of the a prostate adenocarcinoma in the radiation department of the Jean MONNET hospital/ service de radiotherapies between 2000 and 2006

Exclusion Criteria:

* No provision of informed consent
* Patient with disease worsening and in incapacity to move about to CHJM
Characterization of Vietnamese Patients With Obesity at Outpatient Clinics

In the past three decades, obesity has emerged insurmountably, not only in affluent nations but also in many low- and middle-income countries worldwide. It has been linked to various non-communicable diseases, including hypertension, coronary heart disease, diabetes mellitus, dyslipidemia, stroke, colorectal cancer, and many other chronic conditions, such as musculoskeletal disorders, putting tremendous pressure on healthcare systems and the socio-economy. The Asia and Pacific region harbors the highest absolute number of people with overweight and obese, amounting to approximately 1 billion. In Southeast Asia, the prevalence of overweight and obesity increased by almost 40% between 1990 and 2013. Although Vietnam has the lowest percentage of obese adults in the region (about 3.6%), we experienced a 38% increase in the number of obese people between 2010-2014, much higher than that in the University Kingdom and the United States (10% and 8% correspondingly). However, the problem is underestimated by not only healthcare professionals but also patients with obesity. These alarms underscore the necessity of implementing a comprehensive assessment and more focused and practical strategies for addressing obesity in Vietnam, where data has been limited. Therefore, our research has two arms: (1) characterization of patients with obesity to identify those at the highest risks for obesity complications, and (2) understating the attitudes and perceptions of people living with obesity to gain insights into the psychological factors associated with obesity. This research will be a foundation for further research on obesity in Vietnam and Southeast Asia.

All Vietnamese, aged 18-65, diagnosed with obesity defined by BMI ≥ 25 kg/m2 as per Asia-Pacific Guidelines for Obesity, present at University Medical Center Ho Chi Minh City and My Duc General Hospital outpatient clinics, will be enrolled to the study. The patients will have:

* Standard anthropometric data will be done, using a professional medical HM200P Portable Height Stadiometer and a standardised ISO (International Organization for Standardization) 9001:2015 weight scale, by professional and experienced physicians according to standard study protocol: Weight, height, waist and hip circumference, waist to hip ratio, BMI calculated, followed by World Health Organization guidelines for Asian people.
* Blood pressure measure.
* Fat mass measured by the Tanita MC-780 MA (Serial: 17050004).
* Blood tests: fasting plasma glucose, cholesterol, HDL-C, LDL-C, and triglyceride.
* Mood disorder screening by answering a Patient Health Questionnaire-9.

Eligibility Criteria:
Inclusion Criteria:

* Subject is diagnosed with obesity defined by BMI ≥ 25 kg/m2

Exclusion Criteria:

* Inability to cooperate with height measurement.
* Inability to answer questionnaire.
Application of Computer-assisted Navigation in Total Knee Arthroplasty: A Randomized Pair-matched Double-blind Trial

Objective:

The purpose of this study is to evaluate the application of computer-assisted navigation in Total Knee Arthroplasty (TKA ) by comparing it with conventional TKA.

Methods:

Gemini MK II implants (Link, Germany) were used. VectorVisionâ CT-free navigation system (BrainLab, Germany) was employed for the TKA. For each subject, computer-navigation TKA and the conventional TKA were separately performed on two knee joints. The operative method and order of the operations were decided on a randomized basis. All the patients and doctors conducting follow-up study and performing imaging measurement were blind to selection of the operation. Student t test was used for statistical analysis.

hypothesis: computer-assisted navigation system can significantly improve the accuracy of tibial and femoral cuts on coronal and sagittal planes.


Eligibility Criteria:
Inclusion Criteria:

* plan for simultaneous bilateral TKA.

Exclusion Criteria:

* plan for unilateral TKA.
Enhancing Reading Recovery in Aphasia with TDCS and Phonomotor Therapy

This study is designed for individuals with aphasia, a language disorder that affects many stroke survivors, making it difficult to read, speak, and understand language. Up to 70% of people with aphasia struggle with reading, which impacts their ability to communicate, work, and engage in daily life.

The study aims to test a new approach to reading rehabilitation by combining Phono-Motor Treatment (PMT), a language therapy adapted to improve reading, with transcranial direct current stimulation (tDCS), a safe and painless brain stimulation technique. tDCS delivers a mild electrical current to the brain, which may enhance learning. This study will assess whether adding tDCS to PMT improves reading therapy outcomes.

This study aims to improve reading rehabilitation for individuals with aphasia, a language disorder that affects many stroke survivors. The goal is to determine whether adding transcranial direct current stimulation (tDCS), a safe and painless brain stimulation technique, to Phono-Motor Treatment (PMT), a language therapy adapted for reading, enhances treatment effectiveness.

Participants will be randomly assigned to one of three treatment groups, each receiving different combinations of PMT and tDCS over six weeks. Some will receive active tDCS at different points in therapy, while others will receive a placebo (sham) version. By comparing how the timing of tDCS affects reading improvement, this study aims to optimize treatment strategies for individuals with aphasia.

Reading and language skills will be assessed before, during, and after treatment using standardized tests to measure progress. The study will take place at two sites: Kessler Foundation and the Medical College of Wisconsin (MCW), where participants will complete therapy sessions.

Findings from this research may help develop more effective and accessible treatments for stroke survivors with aphasia, improving their ability to read and communicate.

Eligibility Criteria:
Inclusion Criteria:

* Chronic (\>6 months) left-hemisphere stroke
* Aphasia diagnosis.
* Deficits in reading aloud.

Exclusion Criteria:

* Eye condition not correctable with lenses and interfering with reading (e.g., blindness)
* Severe apraxia of speech or cognitive deficits preventing participation.
* Participation in one-on-one aphasia rehabilitation during the study period.
* Brain disorders other than stroke (such as Alzheimer's Disease or Dementia, Parkinson's Disease, etc)
* Contraindications of tDCS or MRI

  * Skin condition affecting the scull (e.g., psoriasis) or open wounds at the stimulation site.
  * Presence of metallic implants (e.g., cardiac stimulators or pacemakers, cochlear implants)
  * History of ongoing/unmanaged seizers
  * Pregnancy
  * Claustrophobia
  * Inability to lie flat on the back
PRECISE: A Prospective, Multi-Center Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor

The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements (YSI glucose analyzer). The investigation will also evaluate safety of the Senseonics CGM System usage, while in the clinic and during home use.


Eligibility Criteria:
Inclusion Criteria:

Subjects meeting all of the following inclusion criteria will be included in this study:

1. Males and females ≥18 years of age
2. Clinically confirmed diagnosis of diabetes mellitus for a duration of 1 year and uses insulin therapy for their diabetes management (including subjects on insulin pump therapy)
3. Subject has signed an informed consent document and is willing to comply with protocol requirements

Exclusion Criteria:

Subjects meeting any of the following exclusion criteria will be excluded from this study:

1. History of severe hypoglycemia in the last 6 months prior to study start, defined as hypoglycemia resulting in loss of consciousness or seizure
2. Diabetic ketoacidosis in the past 6 months
3. Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition.
4. Any medical condition or illness that in the judgment of the investigator might interfere with the procedures, results or compliance during the course of this investigation, or increase the risk of induced hypoglycemia or repeated blood testing including significantly impaired hepatic function and renal failure
5. Known microvascular (diabetic) complications, including active proliferative diabetic retinopathy or macular edema, active non-proliferative retinopathy, diabetic nephropathy including active retinopathy
6. Hematocrit \>50% or \<30%
7. Females lactating or pregnant or intending to become pregnant during the course of the investigation
8. A condition requiring or likely to require magnetic resonance imaging
Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients

This early phase I is to find out how common vitamin D insufficiency is among African American patients with a history of prostate cancer that has not spread to other parts of the body (localized) or has spread to other places in the body (metastatic) and how vitamin D insufficiency affects the immune system. This study also aims to find out if replacing vitamin D results in normalization of the immune function. Information from this study may benefit prostate cancer patients by identifying vitamin D insufficiency which in several studies had been found to contribute to more aggressive prostate cancers.

PRIMARY OBJECTIVES:

I. Determine the prevalence of vitamin D insufficiency among black / African American (AA) prostate cancer patients.

II. Determine the changes in circulating immunological cell function among patients with vitamin D insufficiency and the effects of vitamin D replacement on those changes.

III. Determine the acceptability of cholecalciferol (vitamin D) replacement therapy among black / AA prostate cancer patients and potential impact on health-related quality of life.

IV. Determine if there are differences in the peripheral blood immunological cell function in black / AA patients with metastatic or locally recurrent prostate cancer compared to those with localized prostate cancer.

V. Determine if vitamin D replacement is associated with improvement in progression free survival (PFS) of black/AA patients with prostate cancer with detectable changes in immune response compared to those with no detectable changes in immune response and compared to stage matched historical controls.

OUTLINE:

Patients with low vitamin D3 levels receive cholecalciferol orally (PO) daily for 8 weeks in the absence of unacceptable toxicity. Patients undergo blood sample collection throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* African American males, age \>= 18 years
* Patients with a previous history of localized or metastatic or locally recurrent prostate cancer
* Patients with Vitamin D levels below 30 ng/mL

Exclusion Criteria:

* Known hypersensitivity to vitamin D
* End stage renal failure on dialysis
* Liver cirrhosis
* Currently taking a vitamin D or multivitamin supplement, that has more than 400 IU/10mcg of vitamin D daily for the past month
* Legal inability or restricted legal ability. Medical or psychological conditions not allowing proper study completion or informed consent signature
* Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection
* History of hypercalcemia
Pre-emptive Pregabalin on Attenuating Maternal Anxiety And Stress Response To Intubation During Caesarean Section

There is exaggerated neuroendocrine stress response to laryngoscopy and endotracheal intubation during the Induction to anesthesia-delivery (I-D) period under light anesthesia. Mechanical stimulation of laryngeal proprioceptors elicits increased secretion of cortisol and catecholamine with subsequent elevation of blood pressure from 40 to 50 % and heart rate up to 20 % during direct laryngoscopy and endotracheal intubation

The sample size was calculated using OPEN EPI program assuming that the mean visual analogue scale anxiety score was 49.3±14.1 among oral pregabalin group and was 58.6± 14.4 among Placebo group (8) so at power of study 80% confidence interval 95%, the sample size was calculated to be 74 cases (37in each group

Eligibility Criteria:
Inclusion Criteria:

* Age: 21-38 years old.
* Pregnant Female with a singleton fetus of at least 36 weeks of gestation.
* American Society of Anesthesiologist Physical status: 1\& II.
* Body Mass Index (BMI) (25-30kg/m²).
* Type of operations: elective caesarean section under general anesthesia.
* Written informed consent from the parturient.

Exclusion Criteria:

* Altered mental state.
* Women with known history of allergy to pregabalin.
* Women with uncontrolled diabetes mellitus, bleeding, coagulation disorders, Hepatic, renal, Cardiovascular, respiratory disease and neuropsychiatric disorders.
* Patients receiving anticonvulsants, antidepressants.
* Pregnancy induced hypertension, intrauterine growth restriction or fetal compromise
G-Tech Feasibility Study for Early Detection of a Post-op Ileus

This feasibility study is for the purpose of determining if the G-Tech Device can differentiate between normal return of GI activity post-operatively and the myoelectric activity in patients who develop a POI.

While preventing the development of a POI is most important, POIs still occur; therefore, it is important to definitively diagnose a POI as early as possible during the post-operative course for treatment to prevent patient discomfort, complications, and extended hospital stay. The purpose of the G-Tech study is to determine if the G-Tech Device can detect a difference in the myoelectric signals from patients who develop a POI compared to those patients who do not develop a POI. It is anticipated that up to 20% of patients enrolled in this study and consented preoperatively, excluding screen failures, will show evidence of a post-operative ileus as detected by the G-Tech GutCheck Device and differentiate the myoelectric signals from the patients who do not develop a POI. Patients who are known to have developed a POI may also be selected for the study.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide informed consent;
2. Eighteen (18) years of age or older;
3. Subject is willing and able to follow all study requirements;
4. Subject who will undergo or has undergone open or laparoscopic gastrointestinal surgery or surgery not involving the abdominal cavity.

Exclusion Criteria:

1. Subject is pregnant or suspects pregnancy;
2. Known allergy to medical grade adhesive;
3. Weight \> 350 lbs (159 Kg);
Questionnaire and Laboratory Data on Vitiligo Vulgaris

Vitiligo vulgaris is an autoimmune disorder that causes loss of pigmentation over the skin, hair and mucous membranes (e.g. lips, nose, genitals). While genes have been identified that are thought to be required for development of vitiligo, only 5-10% of relatives develop disease. The triggers for disease onset have not yet been identified. The intent of this study is to research trends in laboratory data, social and medical history that may be contributory to vitiligo onset, location of disease, course of illness and response to therapy.

Patients who participate in this study will be asked to complete a survey and have blood/ laboratory testing performed that relates or may relate to the diagnosis of vitiligo.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Vitiligo Vulgaris
* Ability to sign consent

Exclusion Criteria:

* Pregnant
* Inability to sign consent
* Inability to complete questionnaire