cyrilzakka/clinical-trials huggingface dataset:
Relationship Between Prosthesis Adaptation and Functional Mobility

This study investigates the relationships between locomotor skills, timed performance, gait parameters, balance, fear of falling, and prosthesis satisfaction in individuals who underwent amputation due to an earthquake. Conducted at Ankara Bilkent City Hospital, it included participants aged 18 years and older who were in the prosthetic rehabilitation phase and classified at or above the K1 functional level.

Lower limb amputation significantly affects an individual's mobility, balance, and overall quality of life. The impact is even more pronounced in individuals who have undergone amputation due to traumatic events such as earthquakes. Understanding the factors influencing locomotor performance, balance, and prosthesis satisfaction in this specific population is crucial for optimizing rehabilitation strategies and improving functional outcomes.

This study was conducted at Ankara Bilkent City Hospital and included participants aged 18 years and older, who were in the prosthetic rehabilitation phase and classified at or above the K1 functional level. Participants underwent a series of assessments related to gait, balance, locomotor skills, timed performance, and prosthesis satisfaction. Data were analyzed using correlation analyses, taking into account normality distribution.

The study contributes to the existing literature by highlighting the importance of comprehensive rehabilitation programs that address both physical and psychological aspects of prosthesis adaptation. Future research should focus on larger sample sizes, longer follow-up periods, and the influence of psychosocial factors and rehabilitation approaches on prosthesis satisfaction and functional outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Having a lower extremity amputation
* Being in the prosthetic period
* Being at K1 functional level or above
* Agreeing to participate in the study voluntarily
Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy

This study will be comparing the treatment of varicose vein tributaries using either foam sclerotherapy or ambulatory phlebectomies. Patients will be randomised to having either ambulatory phlebectomy (group A) or foam sclerotherapy (group B) following treatment of their saphenous vein.

The re-intervention rates, safety, patient experience as well as the cost effectiveness of each intervention will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years of age
* Symptomatic GSV or SSV vein reflux \> 0.5 seconds on colour Duplex
* Varicose vein tributary requiring treatment

Exclusion Criteria:

* Current DVT
* Recurrent varicose veins
* Arterial disease (ABPI\<0.8)
* Vein diameter \< 3mm
* Preference for one of the treatment options
* Patient who are unwilling to participate
* Inability or unwillingness to complete questionnaires
* Inability to attend follow-up appointments
* Patient currently included in a study of varicose vein treatment
Lean Diabetes Study

Systematic assessment of perinatal, behavioral and genetic risk factors will be evaluated in an underserved population with lean diabetes (LDM) as compared to a control population with obese type 2 diabetes (ODM).

Background:

The prevalence of lean (BMI \<25, non-type 1) diabetes (LDM) is not rare; however, the reason why these individuals develop diabetes without traditional risk factors is often not investigated. Since this subset of individuals with diabetes are not overweight, they represent an ideal population to examine the causes of diabetes development without the confounding effect of obesity. Understanding critical risk factors for non-autoimmune causes of beta cell underdevelopment, injury and failure can impact prevention, early detection and even treatment in this population of lean individuals. Guidelines for diabetes management currently mainly targets either type 1 or overweight/obese type 2 diabetes (ODM) with a lack of guidance on how best to personalize work-up and treatment in LDM.

Objective:

Systematic assessment of perinatal, behavioral and genetic risk factors will be evaluated in an underserved population with LDM as compared to a control population with ODM. Understanding why certain lean individuals develop diabetes will potentially elucidate mechanisms that could be masked when obesity is also present.

Study Hypothesis:

LDM patients have more impaired beta cell function than classic ODM. The potential pathogenic drivers for the beta-cell impairment in LDM may involve in-utero/childhood malnutrition, lifestyle insults to beta-cells like alcohol and smoking and specific genetic traits that impair beta cell function.

Eligibility Criteria:
Inclusion Criteria:

Cases: BMI \<25 with diabetes, not having exclusion criteria Controls: BMI \>29 with diabetes, not having exclusion criteria

Exclusion Criteria:

individuals \<20 years of age, currently pregnant or undergoing chemotherapy, those on glucocorticoid therapy; history of bariatric surgery or pancreatitis; known positive antipancreatic antibodies; individuals with a BMI between 25.0-29.9, A1c \>10%
A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal Cancer

This study was designed to investigate the safety and tolerance of three doses (100µg, 200µg, 500µg) of G17DT for the treatment of patients with colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or over with histologically verified adenocarcinoma of colon or rectum.
* Recurrent of metastatic disease not amenable to curative surgery and/or radiotherapy.
* Life expectancy greater than 3 months.
* Karnofsky Index Score greater than or equal to 50%.
* Written informed consent obtained.

Exclusion Criteria:

* Neoplastic lesions other than colorectal cancer (except treated basal cell carcinoma of the skin or cancer of the uterine cervix, through Stage I.
* Acute intercurrent illness.
* Patient considered to be a medical risk because of non-malignant systemic disease or grossly abnormal laboratory results.
* Patients who had received any other anticancer therapy within 3 months.
* Factor liable to alter the serum gastrin concentration or affect intra-gastric acidity, for instance concomitant therapy with H2 receptor antagonist drugs, proton pump inhibitors, or previous gastric surgery.
* Patients immunologically compromised including those on corticosteroid therapy.
* Women of child-bearing age.
* Positive immediate hypersensitivity reaction to skin testing with study medication.
* Patients unable to complete the diary book
* Haematogical Status Haemoglobin count less than 10g/dL White Blood Cell count less than 4.0 x 10\^9/L Platelet count less than 100 x 10\^9/L
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell IV Infusion for Systemic Sclerosis

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Systemic Sclerosis

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Systemic Sclerosis. Patients with Systemic Sclerosis will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Systemic Sclerosis
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur
Collaborate2Lose: Involving Support Persons in Weight Management

This study involves an evaluation of whether social support from a cohabitating adult improves Veteran weight loss in a weight management program.

Dyads comprising a Veteran with obesity and a cohabitating adult will be randomized to participate in a weight management program by the Veteran alone or with their support person. The program will be delivered by research staff using a secure video platform. Outcomes will be assessed remotely at baseline and weeks 24, 48, and 72, with 72 weeks as the primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

Patient inclusion criteria

* aged 18 years or older
* BMI \>= 30 kg/m2
* at least one visit with a VA primary care provider within the past year
* weight \<=420 lb due to study scale limits
* have been cohabitating and have daily contact over the past 6 months with an adult who can provide support (e.g., spouse/domestic partner, sibling, adult child, friend, family member) for the next 18 months
* desire to lose weight
* able to stand for weight measurements without assistance
* \< 2 errors on a validated 6-item cognitive screener
* ability to speak English
* agrees to attend visits per protocol
* individual email-address
* access to hardware and internet connection to enable participation with approved virtual platform Partner inclusion criteria
* aged 18 years or older
* willing to participate
* \< 2 errors on a validated 6-item cognitive screener
* ability to speak English
* individual email address

Exclusion Criteria:

Patient exclusion criteria

* active dementia or substance abuse
* history of bariatric surgery or planning to have bariatric surgery in the next 18 months
* pregnancy or planning to become pregnant in the next 18 months, or breastfeeding
* weight loss \>= 10 lb in the month prior to screening
* living in a facility such as a nursing home, skilled nursing facility, or assisted living facility
* unable to control what food is purchased and / or served
* impaired hearing
* current use of weight loss medications
* chronic or unstable illness that would limit ability to participate (e.g., recent hospitalization)
* participation in VA MOVE! weight management program in the past 6 months
* current participation in a research or clinical program focusing on lifestyle change
* vomits once or more per week Partner exclusion criteria
* BMI \< 18.5 kg/m2
* active dementia or substance abuse
* impaired hearing
* chronic or unstable illness that would impair their ability to provide support
* living in a facility such as a nursing home, skilled nursing facility, or assisted living facility
COVID-19 in Polish Ice Swimmers.

Ice swimming is an increasingly common phenomenon in Poland. It has been confirmed that it has a beneficial effect on health by increasing the natural non-specific immunity to infections. In the face of the current Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic causing Coronavirus Disease 2019 (COVID-19), researchers decided to use a survey to check the incidence of COVID-19 among Polish ice swimmers, as well as recent ailments. Then, the researchers will compare the obtained results with epidemiological data for Poland.Researchers will also investigate the relationship between susceptibility to SARS-CoV-2 infection and the blood group and Rh factor among ice swimmers.

The research tool is an original questionnaire compiled by a team of experts conducting the study. The survey includes questions about sociodemographic data, such as age and gender and blood type in AB0 system with Rh factor, and questions about the frequency of ice swimming, the duration of a single session, and since when respondents have been ice swimming. There was also a question about the respondents' compliance with the restrictions and recommendations related to the pandemic and contacts with people with confirmed SARS-CoV-2 infection. In the survey, researchers ask about the infectious symptoms experienced during the pandemic and about being diagnosed with COVID-19 or its exclusion. People who have been ill are asked about the place of treatment.

The questionnaires are collected in traditional form, on the Internet and as scans of documents. Each survey was completely anonymous. The obtained statistical data will be compared with official data on new COVID-19 cases and recoveries at the same time. Official data are published by the Ministry of Health and earlier also by Sanitary and Epidemiological Stations. The main aim of the study was to determine whether ice swimming also increases resistance to SARS-CoV-2 and COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* ice swimmers

Exclusion Criteria:

* not active ice swimmers
Effect of HCO1100 on Cardiovascular Function

The purpose of this study is to determine whether high porous membranes are effective in the treatment of cardiovascular events in chronic dialysis patients.

Cardiovascular events are the leading cause of the increased mortality rate of chronic dialysis patients. It is believed that increased micro-inflammation plays an important role in the pathophysiological process of cardiovascular disease. High porous dialysis membranes can better eliminate inflammatory mediators as compared to standard dialysis membranes. In this study, the high porous dialysis membrane HCO1100 is investigated for its potential capability to improve the cardiovascular status of chronic dialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Dialysis dependent chronic renal failure (CKD 5) in a stable condition
* Serum albumin at randomisation equal to or above the median of the normal range (pre- dialysis value)

Exclusion Criteria:

* Diabetes mellitus as the disease underlined end stage renal failure
* Haemodynamic instability that precludes unsupported dialysis
* planned surgical interventions \<= 4 months at time of inclusion
* known allergy against dialysis membranes
* Significant cardiac disease (atrial fibrillation, myocardial infarction within 6 months; unstable angina pectoris; LV-EF \< 30%, clinically significant pericardial disease; cardiac amyloidosis)
* pulmonary disease with chronic hypoxia
* Advanced disease or significant co-morbidity with poor short term prognosis, necessitating palliation and not subject to active or disease specific treatment
* Clinically significant liver dysfunction (bilirubin \> 1.8mg/dl (30µmol/L))
* Prior fistula surgery on both arms or other operations or paralysis on both arms
* Known HIV, HCV infection
* Alcoholism
* Active uncontrolled infection
* Pregnancy or lactation
* Inability to give informed consent to participate in the study
Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea

The purpose of this study is to collect safety information following routine vaccination with Synflorix™ among infants in Korea.

Rationale for the protocol amendment: The therapeutic indication for Synflorix in Korea has been updated. The protocol is being amended to reflect this update.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representatives can and will comply with the requirements of the protocol.
* Korean male or female subjects whose age while receiving the first vaccination with Synflorix is 6 weeks - 5 years.
* Written, signed or thumb-printed informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the child. Where parent(s)/Legally acceptable representatives are illiterate, the consent form will be countersigned by a witness.

Exclusion Criteria:

* At the time of Post Marketing Surveillance entry, the contraindications and precautions of use indicated in the local Prescribing Information should be checked and the infant must not be included in the Post Marketing Surveillance if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.
* Subjects who receive any investigational or non-registered pneumococcal vaccine 30 days prior to the study start will not be enrolled. Subjects who had previous administration of a pneumococcal vaccine other than Synforix will not be enrolled into the study.
* A male or female children \>= 5 years of age at study entry.
Multiple Firings in Double-stapled Colorectal Anastomosis

Multiple linear stapler firings during double stapling technique (DST) is associated with anastomotic leakage (AL) after laparoscopic low anterior resection (LAR). We aim to investigate the risk factors and then to develop a deep learning model to predict the usage of ≥3 linear stapler cartridges during DST anastomosis.


Eligibility Criteria:
Inclusion Criteria:

* 1) carcinoma of rectum confirmed by histopathological evaluation;
* 2) tumor located in the mid-low rectum (less than 10cm from the anal verge);
* 3) performance of DST anastomosis;
* 4) pelvic MRI obtained within 14 days before surgery.

Exclusion Criteria:

* 1) other anastomotic techniques (e.g., trans-anal rectal excision);
* 2) Hartmann's operation or other procedures without anastomosis;
* 3) the number of linear stapler cartridges was not traceable in the operative report.
Combining PET/CT and EBV DNA to Evaluate the Hazard of Progression in the Follow-up of Locally Advanced NPC

PET/CT and EBV DNA are important in diagnosis of NPC. We consider that combining post-treament PET/CT and plasma EBV DNA may be effective in evaluating the hazard of progression in the follow-up of Locally Advanced Nasopharyngeal Carcinoma. Hence we establish this prospective cohort study.

Newly-diagnosed patients with stage III or IV non-metastatic Nasopharyngeal Carcinoma (AJCC 7th) will be recruited. All subjects receiving chemoradiotherapy will undergo a baseline integrated \[18F\]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) scan or traditional follow-up examination and plasma EBV DNA test before the start of chemoradiotherapy.

Patients receiving IMRT treatment will receive a dedicated FDG PET/CT protocol 12 weeks after the end of chemoradiotherapy (primary endpoint).Plasma EBV DNA test will be performed 4, 12, 24 weeks after the end of IMRT treatment. In patients with negative PET/CT results, 2 follow-up visits are required to complement nasopharyngoscope examination and plasma EBV DNA test in the frist year. All patients will undergo annual PET/CT or traditional follow-up examination and plasma EBV DNA test 1 year after completing chemoradiation unless recurrent/residual disease is histopathologically-confirmed.

Patients with a PET/CT result suspecting for residual/recurrent/metastatic tumor must have pathological and/or clinical evidence of tumor existence before salvage therapy is started.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be informed of the investigational nature of this study and given written informed consent.
* Aged between 18-65, male/female.
* Staged III or IV (AJCC 7th) NPC patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, WHO II and III).
* Received induction chemotherapy and/or concurrent chemoradiotherapy.
* ECOG scale 0-1.
* Fertile women should practice contraception during the study period.
* HGB ≥90g/L ,WBC ≥4\*109/L , PLT ≥100\*109/L,
* With normal liver function test (ALT and AST ≤2.5\*ULN, TBil ≤2.0\*ULN)
* With normal renal function test (serum creatinine ≤1.5\*ULN)

Exclusion Criteria:

* Women in pregnancy or lactation
* Prior malignancy except adequately treated basal cell, squamous cell skin cancer, or cervical cancer in situ.
* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
* Already involved in other clinical trial.
* Mental disorder, civil disability, limited capacity for civil conduct.
Biomarker Study to Diagnose Alzheimer's Disease

The purpose of our study is to investigate CSF and blood biomarkers among the subjects with mild cognitive impairment (MCI) and Alzheimer's disease (AD) as well as normal controls.

Alzheimer's disease is the most prevalent cause of dementia. A biomarker is a variable that are measured in vivo and indicate specific features of disease related molecular mechanisms and pathologic changes, including amyloid processing and aggregation, tau hyperphosphorylation, accumulation of neurofibrillary tangles, synaptic dysfunction, neurodegeneration, and loss of brain tissue.

We examine serum oligomeric beta-amyloid 42 and CSF monomeric beta-amyloid 42, total tau and phosphorylated tau, as well as PiB-PET, FDG-PET and brain MRI in 90 participants (30 normal controls, 30 patients with mild cognitive impairment, 30 patients with Alzheimer's disease).

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated written informed consent obtained from the subject or the subject's legally acceptable representative ( if applicable) in accordance with the local regularities.
2. Both male and female, aged \> 50 and \<90, if women, must have no childbearing potential
3. Controls did not have subjective memory complaints or any of 28 diseases and did not have a history suggestive of a decrease in cognitive function (stroke or transient ischemic attack, seizures, Parkinson's disease, multiple sclerosis, cerebral palsy, Huntington's disease, encephalitis, meningitis, brain surgery, vascular surgery of the brain, diabetes requiring insulin control, improperly managed hypertension, cancer diagnosed within the past 3 years excluding skin cancer, shortness of breath while sitting still, use of home oxygen, heart attack with changes in memory, walking, or solving problems lasting at least 24 hours afterwards, kidney dialysis, liver disease, hospitalization for mental or emotional problems in the past 5 years, current use of medications for mental or emotional problems, alcohol consumption greater than 3 drinks each day, drug abuse in the past 5 years, treatment for alcohol abuse in the past 5 years, unconsciousness for more than one hour other than during surgery, overnight hospitalization due to head injury, illness causing a permanent decrease in memory or other mental functions, trouble with vision that prevents reading ordinary print even with glasses, or difficulty understanding conversations because of hearing even with a hearing aid)
4. The controls also had scores that were at least one standard deviation above the mean scores of the respective age- and education-matched population on the K-MMSE and an average score of 0.42 or less on the Korean Instrumental Activities of Daily Living (K-IADL)

Exclusion Criteria:

-