cyrilzakka/clinical-trials huggingface dataset:
Older Adults Virtual Reality

In the older adult population, over the years, progressive changes are generated on the different functions and systems of the human body. The musculoskeletal system is not exempt from this process, with the loss of muscle associated with aging being one of the main problems for the older adult population. These alterations bring with them a decrease in muscle strength, along with a loss of functional capacity. Among all the consequences that these deficits can generate, there are: alterations in gait, difficulties in daily transfers, alterations in balance, among others. These changes develop as a consequence an increased risk of falling, these being one of the main causes of morbidity and mortality in the elderly.

As technological development advances, new devices are being created that allow new forms of training our senses and abilities. Since its conception, in the late 1980s, virtual reality has been an area of growing possibilities. Butler and Willet define virtual reality as a technology that allows the user to interact directly with a computer-simulated environment. This tool is gaining more and more interest in the motor rehabilitation of multiple pathologies and also as an option for stability training in older patients. The aim of this study is to evaluate changes in stability after a 2 weeks protocol of virtual reality

This is a quasi-experimental study with a sample of 35 volunteers. Patients of both genders and over 60 years old will be potential candidates for participating in the study. Volunteers will be invited to participate in the study through social networks and e-mail.

The study will be conducted in 6 experimental sessions on different days and 2 assessment days. During assessment sessions several measurements will be performed, including: balance (will be assessed using a balance tracking system balance plate) function (will be assessed by using the Short Physical Performance Battery) and cybersikness (will be assessed using the Sickness Simulator Questionnaire).

The experimental sessions consist in virtual reality immersion for about 1 minute 6 times per session. During the first and the second session, subjects will experiment virtual reality while sited. Moreover, during the third and the fourth session subjects will be standing with a side by side stand. During the last two experimental sessions subjects will be standing with a semi tandem stand.

The one-tailed a priori sample size calculation used the effect size calculated to detect 2.39 cm2 of difference in the displacement area parameter. The sample size for the study was calculated as α set at 5% and the expected power (1-β) at 95%. The analysis returned a minimal sample of 35 participants. With an actual power of 0.95. The G-Power (v. 3.1.9.7, Franz Faul, University Kiel, Germany).

Eligibility Criteria:
Inclusion Criteria:

To have signed the informed consent.

Exclusion Criteria:

* Surgical history of the lower extremities
* Uncontrolled neurological, metabolic, cardiac or respiratory disease
Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)

Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).


Eligibility Criteria:
Inclusion Criteria:

Cases:

* Aged at least 18 years
* Newly diagnosed primary tumor, histologically confirmed squamous cell carcinoma of the oropharynx (stages I-IV)
* Has not received treatment (surgery, chemotherapy, radiation, or immunotherapy) within the previous four weeks
* Provided written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is identified and enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center
* Aged at least 35 years
* Have no previous diagnosis of HNC or HPV-related cancer
* Fully understands study procedures
* Voluntarily agrees to participate by giving written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center

Exclusion Criteria:

* Not meeting all of the above inclusion criteria for either the case or control group
Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi

Left ventricular (LV) thrombus is a common problem that is encountered in patients who survived from a large myocardial infarction, and distal systemic embolization is the main issue in these patients due to its major clinical consequences especially cerebrovascular stroke.

Novel oral anticoagulants (NOACs) are now used safely in nonvalvular atrial fibrillation, these agents were shown to be at least as effective as Vitamin K antagonists (VKA) such as warfarin in prevention of systemic embolism, while having an improved safety profile with less bleeding risk. However, the data about their usage for LV thrombi instead of the commonly used VKA are still lacking except for case reports and small case series.

The proposed aim of this randomized observational clinical trial is to assess the efficacy of the conventional anticoagulation in the form of warfarin and NOACs in the form of rivaroxaban in the treatment of LV thrombus.

The proposed aim of this randomized observational clinical trial is to assess the efficacy of the conventional anticoagulation in the form of warfarin and NOACs in the form of rivaroxaban in the treatment of LV thrombus.

So patients with actual LV thrombus will be divided into 2 groups, one will receive the traditional therapy which is warfarin with follow up of the INR in order to reach the desired level of 2-3 then follow up every two weeks to determine the time in therapeutic range until the end of the study follow up. The other group will receive oral rivaroxaban 20 mg per day with follow up for the persistence or the disappearance of the LV thrombus one month, three months and 6 months later.

As a secondary and safety end point, any major bleeding will be recorded as well as any thrombo-embolic events

Eligibility Criteria:
Inclusion Criteria:

* Evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE).

Exclusion Criteria:

* Creatinine clearance less than 50 ml/min.
Safety and Efficiency of γδ T Cell Against Liver Cancer

In this study, effects of γδT cells on human Liver Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated.

A liver tumor will be removed using tumor reducing surgery such as cryosurgery.PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and DC-CIK, they will be infused to the patients as an immunotherapy treatment.

NOTE: Originally, our designed proposal was to use autologous PBMCs from cancer patients to ex vivo expand Vγ9Vδ2-T cells, and then perform adoptive transfer therapy. However, PBMCs of majority of cancer patients could not be effectively expanded, including cell number, cell purity and cell function could not meet the requirements of reinfusion. Meanwhile, those patients could not tolerate 100ml of blood drawing for culture every 2 \~ 3 weeks.

Therefore, we submitted new clinical study application to the ethical committee of the Fuda Hospital affiliated with Jinan University (Guangzhou, PR. China) by changing the autologous protocol with the allogeneic protocol. After the allogeneic protocol was approved, we adapted allogeneic cells instead of autologous in our subsequentially clinical study.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-75
2. Karnofsky performance status \>50
3. Diagnosis with Liver Cancer based on histology or the current accepted radiological measures
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive cryosurgery, IRE, gd T cells
6. Life expectancy: Greater than 3 months
7. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other kinds of cancer
2. History of coagulation disorders or anemia
3. Patients with heart disease
Cangrelor in ST-Elevation Myocardial Infarction to Decrease Infarct Size

This study evaluates differences in the extent of myocardial necrosis noted by cardiac MRI in patients with ST-elevation myocardial infarction randomized to receive cangrelor during their percutaneous coronary intervention and compares them to patients randomized to not receive cangrelor.

Cangrelor is a direct-acting and reversible intravenously administered platelet inhibitor approved as an adjunct to percutaneous intervention (PCI) for reducing the risk of periprocedural myocardial infarction, repeat coronary revascularization, and stent thrombosis. As it has a quick onset of action (2 minutes) compared to traditional oral platelet inhibitors, cangrelor is emerging as an important new option for use in patients undergoing percutaneous intervention who have not been treated with oral platelet inhibitors.

Furthermore, multiple studies have demonstrated that patients with ST-elevation myocardial infarction (STEMI) who undergo emergent PCI do not have optimal platelet inhibition even after administration of a loading dose of traditional oral platelet inhibitors. However, the clinical significance of complete platelet inhibition around the time of PCI is not fully understood.

The primary objective is to characterize the utility of immediate platelet inhibition with intravenous cangrelor in patients presenting with an acute STEMI by assessing the extent of infarct size (either enzymatically or by imaging). If the findings are favorable, this may suggest that immediate platelet inhibition is an important part of care in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an acute STEMI with the University of Kentucky as the institution of presentation with plans for PCI
* English-speaking

Exclusion Criteria:

* Pregnant patients
* Prisoners
* Patients who are unable to provide his/her own consent
* Patients with a prior history of myocardial infarction
* Patients who have received thrombolytics
* Patients on systemic anticoagulation
* Patients who are hemodynamically unstable with evidence of shock
* Patients who are mechanically intubated
* Patients with devices not MRI compatible
* Patients with chronic kidney disease, glomerular filtration rate less than 30
* Patients who are already on dual antiplatelet therapy
The Influence of Hormone Replacement Therapy and Supervised Exercise Training on Body Composition, Cardiovascular Risk and Insulin Sensitivity in Postmenopausal Women

This trial investigates whether supervised training in combination with hormonal substitution therapy has an impact on body composition, cardiovascular risk, risk for dementia, osteoporosis and insulin sensitivity in postmenopausal women.

270 postmenopausal women will be included. Each woman will perform a 12 to 24 weeks sports program with supervised training exercises.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* Good general health
* BMI: 20-30 kg/m2
* Only the use of cholesterol-, blood pressure- or/and thyroid-regulating medication is permitted

Exclusion Criteria:

* Women who are not yet in the menopause
* BMI \<20- and \>30 kg/m2
* Use of any other medication than cholesterol-, blood pressure- and thyroid-regulating medication
Decision-making Preferences and Its Related Factors on Parents With Children Having Cancer

A cross-sectional correlational study was conducted in the pediatric hematology-oncology ward and outpatient clinic of a medical center in southern Taiwan. Participants included fathers or mothers of children diagnosed with cancer aged between 20 and 65 years. Structured questionnaires were used, including FACES IV, JCS, and CPS-P. This study aims to explore the current status of family cohesion, coping behaviors, and decision making preferences among parents of children with cancer, and to identify factors influencing decision making preferences.


Eligibility Criteria:
Inclusion Criteria:

1. Parents aged between 20 and 65 years whose child has been diagnosed with pediatric cancer by a physician.
2. Individuals who understand Mandarin or Taiwanese Hokkien and are able to complete the questionnaire.
3. Individuals who consent to participate in the study after being informed of the research purpose.

Exclusion Criteria:

(1)Individuals diagnosed with a mental illness by a physician.
Exercise Therapy in Head and Neck Squamous Cell Carcinoma (HNSCC)

The goals of this clinical trial are to learn 1. Determine the feasibility of a home-based exercise analog therapy using Transcutaneous Electrical Nerve Stimulation (TENS), 2. Determine the effects of exercise analog therapy on muscle mass, strength, and clinical outcomes, and 3. Determine the effects of exercise analog therapy on immune phenotype and inflammation response in patients undergoing radiation for head and neck squamous cell carcinoma (HNSCC).

The main question it aims to answer are:

Does an exercise regimen using an analog TENS unit during the course of cancer treatment for those with HNSCC improve muscle mass, strength, clinical outcomes and immune response compared to those that do not perform the exercise regimen during their cancer treatment?

Researchers will compare outcomes of patients undergoing cancer treatment + TENS unit exercise to those being treated for their cancer with no exercise TENS unit.

In the exercise arm, subjects will use the TENS unit for 30 minutes of exercise a day, 3 times a week for the extent of their cancer treatments.

Weekly check-ins by phone or less frequently at scheduled in person visits.

Participants will keep a log of their exercise sessions to make sure that the exercise occurs 3 times a week for 30 minutes each and note any reasons why a session may have been missed or time shortened.

Both arms will have a blood draw at the beginning of their cancer treatment and approximately 4 weeks after the last cancer treatment (\~40mL). These samples will be tested for molecules that signal a higher or lower immune response with the addition of the exercise in one group compared to the cancer therapy only group.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years or older)
* Diagnosed with head and neck squamous cell carcinoma
* HPV negative
* Undergoing treatment at OLOL H\&N Center

Exclusion Criteria:

* Any subject less than 18 years of age.
* Subjects who have HPV positive HNSCC
* Subjects who have a pacemaker or electronic implant
Pharmacokinetic Properties of Lorcaserin in Subjects With Renal Impairment

The purpose of this study is to evaluate the PK properties of lorcaserin in subjects with end stage renal disease (ESRD) who require dialysis and will be studied under dialysis and non-dialysis conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged between 18 and 79 years (inclusive)
2. Able to give signed informed consent
3. Renal function will fall into one of the following categories (ideal body weight will be used for the calculation):

   * One-fifth of subjects will have normal renal function, defined as creatinine clearance \> 80 mL/min calculated using the Cockroft-Gault equation
   * One-fifth of subjects will have creatinine clearance 51-80 mL/min
   * One-fifth of subjects will have creatinine clearance 31-50 mL/min
   * One-fifth of subjects will have creatinine clearance 5-30 mL/min, but not require dialysis
   * One-fifth of subjects will have chronic end stage renal disease, require regularly scheduled hemodialysis, and be on a stable hemodialysis regimen for at least 3 months prior to dosing
4. Subjects in the renally impaired groups will have stable renal disease as per Investigator's assessment, with no clinically meaningful changes for 1 month prior to randomization.
5. Subjects in all groups will have a BMI of 27-45 kg/m2.
6. Considered to be in stable health in the opinion of the Investigator.
7. Eligible male and female subjects must agree not to participate in a conception process.

Exclusion Criteria:

1. Prior participation in any study of lorcaserin.
2. Clinically significant new illness in the 1 month before screening
3. Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol
4. History of any of the following cardiovascular conditions:

   * Myocardial infarction (diagnosed by cardiac enzyme\[s\] and/or diagnostic ECG), CVA, TIA or RIND within 3 months of screening
   * Cardiac arrhythmia requiring initiation of a new medical or surgical treatment within 3 months of screening (pacemaker and/or defibrillator implanted \> 3 months prior to screening is acceptable)
   * Unstable angina
   * History of pulmonary artery hypertension
5. Positive result of HIV, hepatitis B or hepatitis C screens.
6. Malignancy within 2 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins)
7. Use of SSRI's, SNRI's, and other medications must meet washout period.
8. Recent history (within 3 months prior to the screening visit) of alcohol or drug/solvent abuse or a positive screen for drugs of abuse at screening.
9. Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to dosing
10. Unwilling, or whose partner is unwilling, to use an adequate means of contraception during and for 1 month following completion/withdrawal of the study
3D Versus 2D Laparoscopic Total Gastrectomy With Splenic Hilum Lymph Nodes Dissection

The investigators will perform a prospective randomized comparison between 3D and 2D laparoscopic total gastrectomy with splenic hilum lymph nodes dissection.

A prospective randomized comparison of 3D and 2D laparoscopic surgery for advanced gastric cancer with spleen-preserving splenic hilum lymph nodes dissection will be performed, to evaluate the safety and feasibility for the extensive application of the novel 3D laparoscopic technique. The evaluation parameters are number of group No.10 lymph nodes harvested, perioperative clinical efficacy, postoperative life quality and 3-year survival and recurrence rates.

Eligibility Criteria:
Inclusion Criteria:

1. Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy;
2. cT2-4aN0-3M0 at preoperative evaluation according to AJCC Cancer Staging Manual, 7th Edition.
3. Eastern Cooperative Oncology Group (ECOG): 0 or 1;
4. American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ;
5. Written informed consent.

Exclusion Criteria:

1. Pregnant or breast-feeding women;
2. Severe mental disorder;
3. Previous upper abdominal surgery (except laparoscopic cholecystectomy);
4. Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection;
5. Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging;
6. Other malignant disease within the past 5 years;
7. Previous neoadjuvant chemotherapy or radiotherapy;
8. Contraindication to general anesthesia (severe cardiac and/or pulmonary disease);
9. Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer.
Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation

This study evaluates the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally (active) compared with the same device applied extranasally (control) relating to symptoms of dry eye exacerbated by the Controlled Adverse Environment model.

Participants will be randomized to a single application sequence, either sequence "A" (intranasal application followed by control application) or sequence "B" (control application followed by intranasal application) using the device. Upon entering the CAE, participants will complete dry eye questionnaires every five minutes and will administer the device either intranasally or extranasally in randomized sequence when a certain level of ocular discomfort has been reached.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe dry eye disease
* Normal lid/lash anatomy, blinking function and closure as determined by the Investigator
* Literate, able to speak English, and able to complete questionnaires independently

Exclusion Criteria:

* Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the Investigator, may lead to risk of clinically significant increased bleeding
* Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
* Implanted metallic or electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator
* Corneal transplant in either or both eyes
* A woman who is pregnant, nursing an infant, or planning a pregnancy at the Screening Visit
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening Visit
Clinical Comparison of Two Soft Contact Lenses

This study was designed to gather short-term clinical performance data for 2 soft contact lenses.

The purpose of this participant-masked, non-randomized, crossover controlled, non-dispensing, study was to compare the short-term performance of 2 daily disposable contact lenses after 15 minutes of daily wear each. The lenses were identical in all aspects except for diameter. Participants attended for 1 visit only which lasted for approximately 2 hours.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will only be eligible for the study if:

  1. They were of legal age (18) and capacity to volunteer.
  2. They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent.
  3. They were willing and able to follow the protocol.
  4. They were wearing soft contact lenses, or had done so within the past two years.
  5. They were able to be fitted with the study lenses within the power range available.

Exclusion Criteria:

* Subjects will not be eligible if:

  1. They had an ocular disorder which would normally contra-indicate contact lens wear.
  2. They had a systemic disorder which would normally contra-indicate contact lens wear.
  3. They were using any topical medication such as eye drops or ointment.
  4. They were aphakic.
  5. They had had corneal refractive surgery.
  6. They had any corneal distortion resulting from previous hard or rigid lens wear or had keratoconus.
  7. They were pregnant or lactating.
  8. They had an eye or health condition including an immunosuppressive or infectious disease which could, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
  9. They had taken part in any contact lens or care system clinical research within two weeks prior to starting this study.