cyrilzakka/clinical-trials huggingface dataset:
The Effect of Foot Massage With Roles on Cancer Patients

It was aimed to examine the roles in the management of treatment-related peripheral neuropathy in cancer patients receiving taxane-based chemotherapy and the effect of foot massage on neuropathy and quality of life.

Intervention Phase of the Research;

1. Patient information about neuropathy caused by chemotherapy and its management,
2. Teaching the role application to the patient,
3. Application process
4. It will be carried out in 4 steps, including patient monitoring via telemonitoring.

Eligibility Criteria:
Inclusion Criteria:

* Being registered in the medical oncology outpatient clinic of Selçuk University Faculty of Medicine Hospital
* Completed standard taxane-based chemotherapy treatment protocol for breast and ovarian cancer
* Karnofsky Performance Scale being 80 and above (Performance scale of cancer patients)
* Being 18 years or older
* Having received at least 3 cycles of taxane-based treatment
* Presence of grade 2 or higher peripheral neuropathy
* Being conscious and cooperative
* Verbal and written approval to participate in the study after an explanation about the study is made.

Exclusion Criteria:

* Previous skin sensitivity on hands and feet
* Refused to participate in the study after making a statement about the study
* Development of peripheral neuropathy due to reasons other than chemotherapy \[tumor compression, nutritional disorders, infections or major systemic disease (diabetes mellitus, etc.)\]
* Bone, spine metastasis or malignancy
* Having mental and psychic problems that would prevent him from taking part in the research.
Efficacy of Lower Tourniquet Pressure During Total Knee Arthroplasty

This study aims to determine whether the lower tourniquet pressure, which is set by adding 120mmHg (millimeter of mercury) on the systolic blood pressure just before tourniquet inflation, are efficient and safe during total knee arthroplasty, compared with the conventional tourniquet pressure: 150mmHg above the systolic blood pressure before tourniquet inflation.

We will compare the two groups of patients undergoing total knee arthroplasty, which the tourniquet pressure will be set differently: systolic blood pressure plus 120mmHg vs. systolic blood pressure plus 150mmHg, the conventional method, in terms of efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* The patients undergoing total knee arthroplasty

Exclusion Criteria:

* Systolic blood pressure measured at ward \> 200mmHg
* Thigh circumference \> 78cm
* Anesthesia other than spinal anesthesia
* Simultaneous bilateral total knee arthroplasty
* The patients who disagreed the enrollment of this study
Washington State Driving Intervention Research Study

The goal of this clinical trial is to test the effect of hazard perception and attention maintenance training and testing on driving performance. Participants will be randomized into a treatment group receiving hazard perception or attention maintenance training or a control group receiving either vehicle maintenance training or the status quo ZED training. Randomization will occur by location. Researchers will compare the treatment and control groups to see if there are differences in driving behavior and crash rates.

The experiment's purpose is to assess the performance of the investigator's novel Driving Hazard Perception and Attention Maintenance training intervention on improving related driving skills, performance in driving exams, and long-term benefits as assessed by crash statistics and naturalistic driving behavior. A two-group pre-post experimental design will be used to evaluate the effectiveness of the new Driving Hazard Perception Training. Each training (hazard perception and attention maintenance) will be assessed in relation to the status quo (ZED training) and in relation to a placebo that has no training related to hazard perception or attention maintenance (vehicle maintenance training). Participants beginning a driver education program will be recruited. Each participating location will be randomized to one of the four research arms. Baseline hazard perception assessment will be performed first, and then participants will receive one of the four trainings. Lastly, all participants will take a hazard perception exam to assess the participants' performance. All participants will also use a smartphone application to collect driving data during the learner driver period and 12 months of independent driving. Driving behaviors and state-level crash data will be used to assess the impact of the interventions.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in a driver training course through the 911 driving school in Washington State.

Exclusion Criteria:

* Participants must meet the above criteria.
* Additionally, participants will be excluded if either the participant or the participant's parent opts-out.
Effect of Liraglutide on Glucose Profiles and Gastric Emptying in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to determine the effect of NNC 90-1170 (liraglutide) on glucose and hormonal profiles, fasting gluconeogenesis and insulin secretion in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Diet treated and/or subjects in monotherapy with max. 50 % of maximal dose of sulphonylurea (SU). In addition, subjects in treatment with metformin and/or repaglinide could be included
* Body Mass Index (BMI) maximum 35 kg/m\^2
* Fasting plasma glucose 7-15 mmol/l, both inclusive

Exclusion Criteria:

* Impaired liver function
* Impaired renal function
* Anaemia
* Cardiac disease
* Uncontrolled treated/untreated hypertension
* Recurrent major hypoglycaemia as judged by the Investigator
* Known or suspected allergy to trial product or related products
* Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures
* Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness
* Loss of more than 400 ml blood during the three months prior to study start
* Allergy to paracetamol
Protective Effect of PCSK9 Inhibitor Against Negative Inflammatory Response and Organ Dysfunction After Coronary Artery Bypass Grafting (PANDA VIII)

This is a multi-center, randomized controlled study to investigate whether early offering PCSK9 inhibitor can protect against negative inflammatory response and organ dysfunction after coronary artery bypass grafting (CABG). Subjects with myocardial ischaemic syndromes (MIS) will be enrolled in this study after consent information. After randomization, the control group will receive standard therapy, while the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later. Six month after CABG, CRP will be used to evaluate inflammation, and echocardiography and coronary CTA will be used to evaluate cardiovascular function.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age
* Patients with myocardial ischemic syndromes (with any of the following):
* Patients are ready to undergo coronary artery bypass grafting (CABG) with 1 month;
* Participate voluntarily and sign an informed consent

Exclusion Criteria:

i. Pregnant and lactating women ii. During the study period and within 3 months of receiving the last dose of the study drug, women with fertility intentions and men unwilling to use effective contraceptive methods iii. Have used PCSK9 inhibitors within 3 months before enrollment, or have a history of severe allergic reactions to PCSK9 inhibitors iv. Severe infections requiring intravenous antibiotics v. HIV-positive or history of acquired immunodeficiency syndrome (AIDS) vi. With cognitive impairment or psychiatric illnesses
Compare the Effects of Agility and Cycling Exercise Training on Mobility and Balance in PD and Healthy Old Adults

The purpose of the study is to compare the effectiveness and specificity of agility and cycling exercise training on balance and mobility outcomes in PD and age and gender matched healthy controls. The hypothesis is that due to being profoundly deconditioned, agility and cycling will be similarly effective in PD but agility will be more effective then cycling in healthy old adults, in improving mobility and balance.


Eligibility Criteria:
Inclusion Criteria:

* family doctor should be qualified as healthy.
* older adults had to have basic fitness
* weekly movement of at least 3 hours

Exclusion Criteria:

* Severe heart problems
* severe demeanor
* alcoholism
* drug problems
An Open Label Investigational Immuno-therapy Trial of Nivolumab in Cancers That Are Advanced or Have Spread

The purpose of this study is to determine whether nivolumab is an effective treatment for cancer that has advanced or has spread. Various tumor types may be eligible for enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with advanced or metastatic malignancy
* Received standard of care treatment for primary malignancy and standard of care treatment for relapsed cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Prior treatment with an antiPD1, antiPDL1, antiPDL2, antiCD137, or antiCTLA4 antibody, or any other antibody or drug specifically targeting Tcell co-stimulation or checkpoint pathways.
* Subjects previously treated with investigational anticancer therapies less than 6 weeks prior to the first dose of Nivolumab
* Subjects with an active, known, or suspected autoimmune disease

Other protocol-defined inclusion/exclusion criteria apply
Nanogen Pegfilgrastim (Pegcyte) PK/PD Clinical Study in Breast Cancer Patients

Breast cancer patients scheduled to receive myelosuppressive chemotherapy (AC regimen) will be enrolled in this study. Eligible patients receive single SC injection of pegcyte or neulastim 24 hours after administration of chemotherapy (Doxorubicin and Cyclophosphamide) in the first cycle (14 days each cycle). Blood samples are collected to determine the serum concentration of investigational drugs at specific time points in the first cycle. Absolute neutrophil count, CD34+ count, Cmax (maximum serum concentration), AUC0-t (area under the curve of the plasma concentration time) and Tmax (time required to reach Cmax) will be calculated from the serum concentration profile


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged between 18 - 65 years.
* Patients with histological confirmed primary invasive breast cancer; stage I, II or III.
* Patients had no prior chemotherapy treatments.
* Patients scheduled to undergo myelosuppressive Doxorubicin and Cyclophosphamide chemotherapy for 04 cycles, and Paclitaxel chemotherapy for the next 04 cycles; patients were available for 14 days of each cycle for the first 03 chemotherapy cycles.
* Patients with baseline ANC ≥ 1.5 x 109/L, PLT ≥ 100 x 109/L, HgB ≥ 9 g/dL, WBC ≥ 3,000/mL and albumin ≥ 3.0 g/dL.
* Performance status as per ECOG (Eastern Cooperative Oncology Group) score 0, 1 or 2.
* Willing to give written and signed informed consent

Exclusion Criteria:

* Patients with prior exposure of G-CSF or GM-CSF or its pegylated products in clinical development less than 6 months prior to randomization.
* Myelotoxic concomitant treatment such as chloramphenicol, methotrexate, immunomodulating agents, interferons during 10 days before randomization.
* Received systemic antibiotic treatment within 72 hours of chemotherapy.
* Chronic use of corticosteroids, prior bone marrow or stem cell transplant.
* Patients who had an immediate/ concurrent exposure to radiotherapy or surgery (within 4 weeks).
* Severe medical disease: cardiovascular, hepatic, renal, pulmonary...
* Known cases of hematological disease (sickle cell anemia, AML...)
* History of HIV positive, active hepatitis.
* Pregnant and lactating women or patients planning to become pregnant.
* Known allergic reactions to study medications.
* Positive to anti-pegfilgrastim antibody test.
Proximal Femoral Fractures - Patient Population, Risk Factors, Surgical Performance and Outcome

Proximal femoral fractures are a typical pathology in elderly patients after a low-energy trauma.

This study analyses preexisting risk factors for proximal femoral fractures as well as for failing to reach the previous functional level, difference in outcome between patients with femoral neck fracture compared to those with pertrochanteric fracture, surgical performance and its significance for the functional outcome, as well as the impact of proximal femoral fractures on patients' one-year independence.


Eligibility Criteria:
Inclusion Criteria:

* surgery with intramedullary nail type Gamma® Nail or similar in case of pertrochanteric fractures or
* with a partial hip arthroplasty in case of femoral neck fractures

Exclusion Criteria:

* Clinical follow up at another institution
* Documented dissent in study participation
Effect of Oxygen Supplementation During Exercise in Chronic Obstructive Pulmonary Disease Patients

The project will test the hypothesis that lung ventilation during exercise is unaffected by oxygen supplementation. In addition, the acute effect of oxygen supplementation on dyspnoea, heart rate and blood pressure will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Chronic obstructive pulmonary disease

Exclusion Criteria:

* No exacerbation
* No active heart disease
A Real-World Comparison of Safety and Effectiveness of Novel Oral Anti-Coagulant (NOAC) Naïve and Warfarin Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage

The primary purpose of this study is to evaluate the risk of major bleeding and stroke/systemic embolism (SE) among novel oral anti-coagulant (OAC) naïve and warfarin naïve Medicare Advantage patients with non-valvular atrial fibrillation (NVAF) treated with apixaban, dabigatran, rivaroxaban, or warfarin.


Eligibility Criteria:
Inclusion Criteria:

* Had at least 1 pharmacy claim for warfarin, apixaban, dabigatran, or rivaroxaban during the identification period (01-Jan-2013 through 31-Dec-2015)
* Had continuous health plan enrollment with medical and pharmacy benefits for 6 months pre-index date (baseline period)
* Had continuous health plan enrollment with medical and pharmacy benefits for at least 1 month following index date
* Had at least 1 medical claim for atrial fibrillation any time before or on index date

Exclusion Criteria:

* Had medical claims with a diagnosis code for rheumatic mitral valvular heart disease, mitral valve stenosis or heart valve replacement/transplant during the 6-month baseline period
* Had medical claims with a diagnosis code for dialysis, kidney transplant, or end-stage chronic kidney disease during the 6 month baseline period
* Had medical claims indicating a diagnosis of venous thromboembolism during the 6-month baseline period
* Had claims indicating a diagnosis or procedure code of hip or knee replacement surgery within 6 weeks prior to the index date
* Had claims for a diagnosis or procedure code for reversible atrial fibrillation
* Had medical claims indicating pregnancy during the study period
* Had a pharmacy claim for warfarin, apixaban, dabigatran, edoxaban, or rivaroxaban during the 6-month baseline period
* Had \> 1 oral anticoagulant prescription claim on the index date
Evaluation of Using Vibrotactile Coordinated Reset for Management of Parkinson's Disease

This is a study to evaluate peripheral vibrotactile coordinated reset stimulation for Parkinson's disease seeks to explore the safety and efficacy of an experimental non-invasive method to aid in the symptoms of Parkinson's disease. The purpose of the study is to verify the safety and tolerability of non-painful sensory (tactile) vibratory stimulation delivered to the fingertips of patients with Parkinson's disease.

This study aims to evaluate the safety and efficacy of a non-invasive, experimental method to aid in the symptoms of Parkinson's disease. A glove device produces non-painful sensory (tactile) vibratory stimulation to the fingertips of Parkinson's patients. Vibrotactile coordinated reset (vCR) will help investigators compare durability and efficacy of the tactile stimulation to current medical therapy. Participants will receive vCR for a minimum of 3 months and a maximum of 13 and motor ability will be recorded. If the results of this study suggest that vibrotactile CR stimulation is safe and effective for the treatment of Parkinson's disease, this non-invasive treatment approach would have a substantial impact on Parkinson's disease.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and older
2. Diagnosis of idiopathic Parkinson's disease.
3. Levodopa responsiveness as defined by at least a 30% reduction in Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor subscale (excluding tremor scores) in the ON vs off medication state.
4. Willing to participate in the vibrotactile stimulation sessions for 2 consecutive days initially and willing to return for follow-up visits
5. Able to provide informed consent.
6. Appropriate social support

Exclusion Criteria:

1. Hoehn and Yahr stage greater than 3 in the on medication state
2. Presence of other forms of non-idiopathic parkinsonism, including but not limited to atypical parkinsonism, medication induced parkinsonism, vascular Parkinsonism
3. Any illness that in the investigator's opinion precludes participation in the study
4. Subjects unable to communicate with the investigator and staff
A New Risk Score for Predicting 1-year Mortality in Older r Maintenance Hemodialysis Patients.

The goal of this retrospective observational cohort study is to analysis the 1-year mortality in older patients undergoing maintenance hemodialysis. The main question it aims to answer is to explore the risk factors affecting the mortality of older patients undergoing maintenance hemodialysis and establish a risk prediction score.

Data of older patients (age ≥65 years old) undergoing maintenance hemodialysis were collected from 2012-1-December 31, 2014, with data from Beijing Blood Purification Quality Control and Improvement Center (BJHDQCIC). Logistic regression model was used to evaluate the 1-year mortality and the influence of predictive factors. Internal validation of the model was performed using the bootstrap 1000 repeat sampling method. Area under receiver operating characteristic curve (AUC) was used to evaluate the predictive ability of the model.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years.
* More than 6-month history of hemodialysis,the frequency is 3 times a week, and the dialysis time is 4 hours each.
* The dialysate Ca concentration was 1.5 mmol/L and the bicarbonate level was 32 -- 35 mmol/L.

Exclusion Criteria:

* Lack of demographic information, clinical history, or relevant laboratory values (including pre-dialysis serum calcium, phosphorus, iPTH, haemoglobin, albumin, creatinine, total cholesterol, and Kt/v for urea).
Cephalic Version by Acupuncture-Moxibustion for Breech Presentation

For breech presentation, the cesarean section rate is decreased by external cephalic version. This is a painful operation, with some rare but serious complications. The aim of this trial is to evaluate the effectiveness of acupuncture-moxibustion, a non-invasive technique, to correct breech presentation before 37 weeks of gestation.

Monocentric controlled randomized trial in a simple blind fashion, comparing acupuncture-moxibustion versus a placebo in singleton pregnancies with breech presentation between 33+5 to 35+5 weeks of gestation. The intervention arm consists of acupuncture-moxibustion at the BL67 acupuncture point, for six seances of twenty minutes two days apart. In the placebo group, the cold light of an inactivated laser is to be applied in the same point during the same time. When cephalic version fail, a manual external cephalic version is to be proposed. The main outcome measure is cephalic presentation at 37+2 weeks of gestation.

Eligibility Criteria:
Inclusion Criteria:

* breech presentation,
* SINGLETON

Exclusion Criteria:

* maternal age between 18 ans 45,
* multiple gestation,
* fetal or uterine malformation,
* premature rupture of membranes
Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System

The aim of this study is to evaluate the potential improvement in colonoscopy procedure's outcomes when using the Pure-Vu System in hospitalized patients who are indicated for colonoscopy procedure.

This multi-center, prospective, single arm study will include up to 100 patients (20-40 patients per site), aimed at evaluating the performance of the Pure-Vu System in cleansing hospitalized patients' colon who are indicated for standard colonoscopy procedure.

Subjects will be enrolled at up to 4 clinical sites in the United States and Europe. Subjects who meet the eligibility criteria will be prescribed a standard bowel preparation bowel preparation regimen including diet restrictions and oral bowel preparation.

Following the bowel preparation, the patient will undergo colonoscopy with the Pure-Vu system.

In case of inadequate bowel preparation, as per the nurse report and / or BBPS \< 2, in at least one of the colon segments, prior Pure-Vu use, the physician will complete a questionnaire on the patient's management standard of care assuming the absence of Pure-Vu.

Follow-up will be conducted at 48 hours (± 48 hours) post procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized patients who are indicated for a screening, diagnostic, surveillance or therapeutic colonoscopy
2. Patients' age \> 22 years
3. Patient has signed the informed consent

Exclusion Criteria:

1. Patients with known Inflammatory Bowel Disease and / or active Colitis
2. Patients with active diverticulitis
3. Patients with known or detected (during colonoscopy) bowel obstruction
4. Patients with BMI ≤ 18
5. Patients with ascites Child Pugh C
6. Patients who are 30 days post-transplant
7. Patients treated with Peritoneal dialysis
8. Patients under active IV inotropic medications
9. Patients with LVAD
10. Patients who have active anticoagulant medications (excluding aspirin) or dual antiplatelet therapy in their system prior to the procedure. (Note: to avoid exclusion therapy should be discontinued 48 hours or greater prior to the procedure based on discretion of physician)
11. Subjects with known coagulation disorder (INR ≥ 2 or platelets \<50,000)
12. Subjects with hemodynamic instability.
13. Pregnancy (as stated by patient) or breast feeding
14. Subjects with altered mental status/inability to provide informed consent
15. Patients who have participated in another interventional clinical study in the last 2 months
Swallowing Pressure Profiles in Healthy Adults

This study is designed to determine the impact of a pharyngeal High Resolution Manometry catheter on swallowing biomechanics

During pharyngeal High Resolution Manometry (pHRM) a small bore flexible catheter is introduced into the pharynx to detect intrabolus pressure and contact of pharyngeal structures during swallowing. The presence of the catheter through the upper esophageal sphincter (UES) leads to a violation of its natural closed state. It is not clear how this intrusion influences the swallowing biomechanics . Hence, this project's goal is to identify how hyoid movement is altered during swallowing with the presence of a pHRM catheter in place.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults between the ages of 18-45 with no major medical conditions.
* no specific gender or race will be excluded or targeted for participation in this study.

Exclusion Criteria:

* adults who are pregnant
* adults with swallowing impairment, brain injury, deviated septum, G.I. strictures, obstructions, or Zenker's diverticulum, surgeries to nose, neck, or throat, or bleeding disorders will be excluded from this study