cyrilzakka/clinical-trials huggingface dataset:
Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency

The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film.


Eligibility Criteria:
Inclusion Criteria:

* Non-contact lens wearer;
* Symptomatology as defined by the Ocular Surface Disease Index (OSDI) questionnaire;
* Lipid deficiency;
* Best visual acuity of 6/9 or better in each eye;
* Willingness to adhere to the instructions set in the clinical protocol;
* Signature of the subject informed consent form;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Use of systemic medication which might produce dry eye side effects;
* Systemic disease which might produce dry eye side effects;
* Active or recent ocular inflammation or infection;
* Use of ocular medication;
* Significant ocular anomaly;
* Previous ocular surgery;
* Previous use of Restasis;
* Any medical condition that might be prejudicial to the study;
* Pregnant or lactating;
* Other protocol-defined exclusion criteria may apply.
Progression-free Survival After MWA Plus Durvalumab and Tremelimumab for Unresectable Locally Advanced Pancreatic Cancer

This phase-2 monocenter non-randomized prospective clinical trial evaluates the effectiveness of minimally invasive microwave ablation plus immunotherapy for unresectable non-metastatic locally advanced pancreatic cancer.

Research Hypothesis Does MIS-MWA combined with durvalumab (MEDI4736) plus tremelimumab and gemcitabine prolong progression-free survival in patients with unresectable non-metastatic adenocarcinoma of the pancreas?

Investigational Product(s) and Reference Therapy:

Combination of Durvalumab (fixed dose of 1500 mg) and Tremelimumab (fixed dose of 75 mg) will be given 2 weeks before surgery.

Minimally invasive surgical microwave ablation (MIS-MWA) of the pancreatic tumor will be performed two weeks after the first dose of Durvalumab and Tremelimumab After 4 doses of Durvalumab and Tremelimumab, only Durvalumab 1500mg is provided q4w until disease progression.

Systemic gemcitabine will be started 6 weeks after MIS-MWA. Gemcitabine will be given at a dose of 1000 mg /m² body surface, once a week for 3 weeks, followed with a week of rest.

Objectives:

Primary Objectives:

Progression-free survival (PFS)

Secondary Objectives:

* Safety: clinical and hematological toxicity (NCI CTCAE v. 5.0) of chemotherapy and immunotherapy
* Safety: number and type of postoperative complications of the MIS-MWA procedure
* Length of hospital stay

Tertiary Objectives Overall survival (OS)

Eligibility Criteria:
Inclusion Criteria:

* Patients with unresectable non-metastatic Locally Advanced Pancreatic Cancer (LAPC) defined according to NCCN guidelines Version 2.2017
* Histologically proven adenocarcinoma of the pancreas located in the head, body or tail
* LAPC tumor greatest diameter maximum 5 cm
* Male or female, age 18 years and older, ECOG PS 0-1
* Life expectancy of at least 12 weeks
* Only patients who did not receive chemotherapy for their PC are allowed
* Patients without distant organ metastases on conventional diagnostic imaging
* Pre-operative biliary drainage for obstructive jaundice is allowed, but the type of biliary stent is standardized in all jaundiced patients
* Patients fit for MIS-MWA
* Able to receive Durvalumab and Tremelimumab.
* Patients with good liver and renal function and with good hematology
* Effective contraception for both male and female patients if applicable. Women of childbearing potential must have negative blood pregnancy test at screening visit.
* Written informed consent (+ optional for TR) must be given according to ICH/GCP and national/European regulations

Exclusion Criteria:

* Pregnancy
* Metastatic PC on conventional diagnostic imaging or staging laparoscopy
* LAPC tumor greatest diameter is larger than 5 cm
* Borderline or resectable PC defined according to the NCCN guidelines version 2.2017
* Systemic chemo(radio)therapy is not allowed before MIS-MWA
* Major surgical procedure within 28 days prior to the first dose of investigational products
* Classic contraindications for PDL and CTLA antibodies
Optimization of Selenoprotein P in Chinese Subjects

The purpose of this study is to determine the amount of selenium as selenomethionine that is required to optimize selenoprotein P in selenium-deficient Chinese subjects

Selenium is an essential nutrient. The Recommended Dietary Allowance (RDA) for selenium is considered to be the amount required to optimize plasma selenoproteins. There are two selenoproteins present in the plasma: selenoprotein P (Se-P) and glutathione peroxidase 3 (GPX-3). Although the amount of selenium required to optimize GPX-3 has been determined, the amount required to optimize Se-P in the plasma remains unknown. We aim to determine this amount by supplementing selenium deficient subjects with varying amounts of selenium as selenomethionine.

The study will take place in Mianning County, China, where selenium status is low. Approximately 150 people will be screened for eligibility to participate in this study. 98 subjects will be enrolled. Background information obtained from each participant will be: age, height, weight and smoking status.

Subjects will be randomized to a selenium supplement group. The selenium supplement will contain either 0, 20, 40, 60, 80, 100, or 120 µg of selenium as selenomethionine. A CDC worker will visit each participant daily to give them their selenium supplement. The CDC worker will watch them take their supplement and will ask if they have any unanticipated problems. Blood samples of 20 ml will be obtained at weeks 0, 4, 8, 12, 16, 20, 24, 32, and 40. Hair samples and 24-hr urine collections will be obtained at 0, 20 and 40 weeks. The total study duration is 40 weeks.

Eligibility Criteria:
Inclusion Criteria:

* aged 17 years or older
* healthy
* resident of Mianning County for at least 1 year
* hematocrit (PCV) of 30 or greater

Exclusion Criteria:

* subject has taken selenium supplements within the year prior to study
* subject plans to relocate during study
Preparation and Feasibility of Exams for Expected Studies

Feasibility study: the examinations carried out as part of this protocol aim to carry out all the acquisitions and simulations of use, necessary for the development of the clinical research protocols to come to Clinatec (in particular, configuration of the equipment, dimension of the examination time and the size of the cohorts etc ...)

To ensure the feasibility of a clinical trial, it is necessary to test the parameters as well as the sequence of the different examination times offered to participants.

The expected results of this protocol are mainly the dimension of experimental paradigms and the optimization of the clinical management of subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age ⩾ 18 years
* Affiliated to a social security scheme
* Free and informed consent signed

Exclusion Criteria:

* Subject in a period of exclusion from another study.
* Subject deprived of liberty by a judicial or administrative decision, or major subject subject to a legal protection measure (guardianship, curatorship and safeguarding of justice) referred to in Articles 1121-6 to 1121-8 of the Public Health Code.
* Subject who would receive more than 4500 euros in compensation because of his participation in other research involving the human person in the 12 months preceding this study.
* Pregnant woman, parturient, nursing mother (Article 1121-5 of the Public Health Code)
* Subject not reachable urgently.
The Effect of a Self-Management Lymphedema Education Program on Lymphedema, Symptoms, Compliance, Daily Living Activities, and Patient Activation in Breast Cancer-Related Lymphedema: A Quasi-Experimental Study

The aim of this pre-test post-test quasi-experimental study is to evaluate the effects of a self-management lymphedema (SML) education program on patient adherence, daily life activities, and patient activation in individuals with breast cancer-related lymphedema (BCRL). This study involves 44 patients diagnosed with BCRL and is conducted at Hacettepe University Oncology Hospital Lymphedema Diagnosis and Treatment Application and Research Center. Upper extremity lymphedema assessments are performed at the beginning of the study, followed by the implementation of a structured SML education program. Participants are monitored for a total of 12 months. Data collection tools include the Personal Information Form, Upper Extremity Lymphedema Diagnosis Form, Adaptation to Chronic Illness Scale, KATZ Daily Living Activities Index, Disability of Arm, Shoulder, and Hand Questionnaire, and Patient Activation Measure.

This study focuses on evaluating the potential benefits of a structured self-management lymphedema education program in patients with breast cancer-related lymphedema. It aims to improve patient adherence, activation, and daily life activity levels through a comprehensive education-based intervention.The study was conducted as a master's thesis and has been completed.

Eligibility Criteria:
Inclusion Criteria:

* Being female,
* Aged 18 years or older,
* Having undergone axillary lymph node dissection,
* Having undergone breast cancer surgery,
* Diagnosed with lymphedema (stage 1-2),
* Individuals with no surgical plans during the study period.

Exclusion Criteria:

* Not diagnosed with lymphedema,
* Having a medical condition that prevents exercise,
* Having advanced-stage heart or kidney failure,
* Patients who refused to participate in the study.
Survival After Emergency Laparotomy in Octogenarians

In this single-center retrospective study we wanted to investigate mortality and postoperative complications after emergency laparotomy performed in patients aged 80 years or above.

Methods:

During 2015-2016 106 patients aged 80 years or above underwent emergency laparotomy at Haukeland University Hospital.

Primary outcome was mortality at 30 days. Secondary outcomes were mortality at 90 days, 1 year, postoperative complications and level of care at discharge.

The Medical records were reviewed in detail and mortality and postoperative morbidity were registered. Post-operative complications were defined according to the European Perioperative Clinical Outcome (EPCO) definitions and included if they were Clavien Dindo grade 2 or above.

Eligibility Criteria:
Inclusion Criteria:

* emergency laparotomy in patients 80 years or above

Exclusion Criteria:

* palliative surgery
* abdominal surgery other than gastrointestinal
* abdominal surgery without midline incision
An Evaluation of a Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds

Patients who meet the inclusion criteria will be provided with fibrillar collagen powder dressing. The powder dressing will be used in accordance with its label. After cleansing the wound by the clinical site staff, the powder is placed directly on the wound, and then the wound will be covered with an appropriate moisture retentive secondary dressing. Patients will visit the clinic twice a week to have the powder re-applied. Wound evaluations will take place once a week at the outpatient clinic, with the intervention lasting up to twelve weeks. Concurrent standard of care, such as compression for venous ulcers, will be provided.


Eligibility Criteria:
Inclusion Criteria:

* Has one of the following types of wounds below the knee: diabetic ulcers, pressure ulcers, venous ulcers, ulcers of mixed-vascular origin, traumatic wounds, or post-surgical wounds
* Wound has been present for at least four weeks
* Wound is free of necrotic tissue or debridement practices will take place prior to initial visit in order to remove necrotic tissue
* Wound has failed at least one wound care treatment
* Wound size is between 1 and 100 square centimeters
* Patient has adequate circulation as demonstrated by biphasic or triphasic Doppler waveform, measured within three months prior to study enrollment. If monophasic on exam, then non-invasive tests must display Ankle Brachial Index greater than 0.8 and no worse than mild disease on segmental pressures.
* Wound is confirmed as being free of infection and absence of osteomyelitis

Exclusion Criteria:

* Pregnant, planning to become pregnant during the study timeframe, or breast feeding
* Unable or unwilling to receive porcine collagen
* Wound is infected or presence of osteomyelitis
* Allergy or sensitivity to collagen
* Inability, in the opinion of the Investigator to follow protocol requirements, attend follow up visits in a timely manner, or otherwise comply with the requirements of the protocol
Biobehavioral Predictors of Coronary Angioplasty Outcome

To examine some of the psychosocial predictors of poor outcome among revascularized coronary artery disease patients.

BACKGROUND:

Percutaneous coronary revascularization procedures are increasingly used in the treatment of coronary artery disease, with approximately 300,000 interventions performed each year. Despite new developments in cardiology such as intra-coronary stents and anticoagulant pharmacological treatments, a major problem remains the frequent occurrence of coronary restenosis and new cardiac events within six months after the intervention. These adverse outcomes occur in one out of four patients and have substantial impact on the costs of medical care and patients' quality of life. Research indicated that hemostatic factors (e.g., fibrinogen, von Willebrand factor, and plasminogen activator inhibitor) promote the formation of blood clots and that these factors predict coronary restenosis. Moreover, prior longitudinal studies have also demonstrated that the psychosocial traits of hostility and depression affect clinical progression of coronary disease. These psychosocial factors significantly predict adverse long-term outcome after revascularization and both hostility and depression are known to affect blood clotting factors. In addition, acute mental and physical stress are reported to affect blood clotting factors (coagulation and fibrinolysis) and responses to stress are reported to be more pronounced in hostile individuals. However, previous research on predictors of adverse clinical outcome after percutaneous coronary revascularization has not examined stress-induced changes in hemostatic factors and the consequences of these responses for progression of coronary artery disease. Therefore, the study investigates whether psychosocial factors and responses to acute mental stress affect measures of the blood clotting process that are involved in progression of coronary disease, thereby increasing the risk of an adverse prognosis following percutaneous coronary revascularization. This study may improve the identification of patients at risk for recurrent cardiac events and provide further understanding of the pathophysiological mechanisms involved in the progression of coronary artery disease.

DESIGN NARRATIVE:

The study investigated whether psychosocial factors and responses to acute mental stress affected measures of the blood clotting process that are involved in progression of coronary disease, thereby increasing the risk of an adverse prognosis following percutaneous coronary revascularization. This study helped to improve the identification of patients at risk for recurrent cardiac events and provided further understanding of the pathophysiological mechanisms involved in the progression of coronary artery disease.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
The Effects of Video Based Cervical and Thoracal Posture Exercises on Office Workers

Aim of this study was investigate the effects of video-based cervical and thoracic postural exercises on muscle strength and endurance, hand grip strength, head-neck posture, quality of life and patient satisfaction in office workers.

60 office workers between the ages of 25-65 were included in the study. Participants were randomly divided into Exercise group (EG, n=30) and Control group (KG, n=30). The video-based postural exercises were uploaded to the computers of the EG participants. They were asked to perform the exercises simultaneously with the video, 3 days a week for a total of 6 weeks. The control group was given one session of training on postural exercises. Cervical and scapular muscle strength and endurance, grip strength, craniovertebral angle, muscle endurance and strength, grip strength and head-neck posture measurements were made before the study and at the end of the 6th week. In addition, quality of life and satisfaction were evaluated with questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* To be an office worker for at least 3 years
* To be literate

Exclusion Criteria:

* History of cervical, thoracic or shoulder surgeries
* Exercising regularly for the last 6 months
Urological Complications and Management After Gynecological Operations

OBJECTIVE: In the study, investigators aimed to evaluate the urological complications of gynecologic operations in a tertiary academic center and to evaluate the treatment methods of these complications.

METHODS: The files of all patients who underwent gynecological surgery between January 2016 and January 2019 were retrospectively reviewed. The age of patients with urological complications, American Anesthesia Society score, menopausal status, body mass index (BMI), preoperative hemoglobin level, postoperative hemoglobin level and hospitalization duration and number of previous surgeries were recorded. In addition, the patients with urological complications were evaluated in terms of the indications for surgery, type of surgery, type of urological complication and the way of treatment of the complication.

In women, the anatomical localization of urinary and genital tracts is very close to each other. This proximity can lead to injuries during pelvic operations. Advances in gynecologic operation techniques and the growing experience of gynecologists may suggest a decrease in urological injuries. However, according to the literature, gynecologists face approximately 0.2% to 1% urinary tract injuries during pelvic surgeries. The increase in the number of recurrent surgeries and adverse situations encountered during the operations such as adhesions and anatomical variations factor into the persistence of urologic complications. Investigators aimed to evaluate the urological complications of gynecologic operations in a tertiary academic center and to evaluate the treatment methods of these complications.

The files of all patients who underwent gynecological surgery between January 2016 and January 2019 were retrospectively reviewed. The age of patients with urological complications, American Anesthesia Society score, menopausal status, body mass index (BMI), preoperative hemoglobin level, postoperative hemoglobin level and hospitalization duration and number of previous surgeries were recorded. In addition, the patients with urological complications were evaluated in terms of the indications for surgery, type of surgery, type of urological complication and the way of treatment of the complication.

Eligibility Criteria:
Inclusion Criteria:

-Gynecologic operations with urologic complications

Exclusion Criteria:

* Patients with incomplete data and patients who underwent obstetric operations
* patients aged under 18
* patients who were operated under emergency conditions
Magnetic Resonance Imaging Evaluation of Lateral Ankle Instability

Lateral ankle instability may be acute or chronic. Acute instability usually occurs due to extreme rear foot supination with planter-flexion trauma leads to injury of lateral collateral ligament complex especially the anterior talofibular ligament. Most ankle ligamentous injuries are treated conservatively. However, 20% to 40% of patients complain of chronic instability and persistent discomfort. Structural instability, loss of proprioceptive capabilities, and the weakness of peroneal muscles seem to induce chronic instability


Eligibility Criteria:
Inclusion Criteria:

- Patients with any sex, age, complaining of chronic lateral ankle pain.

Exclusion Criteria:

1. Tumors at ankle region.
2. Postoperative status around the ankle.
3. Rheumatoid arthritis.
4. Comminuted fracture at the ankle.
5. Congenital anomalies of the ankle.
COVID Feel Good-An Easy Self-Help Virtual Reality Protocol to Overcome the Psychological Burden of Coronavirus

This pragmatic trial aims to evaluate whether a weekly self-help virtual reality protocol can help overcome the psychological burden of the COVID-19 pandemic. The protocol is based on 'The Secret Garden' 360° VR video available online (www.covidfeelgood.com) which simulates a natural environment to promote relaxation and self-reflection. The VR experience is combined with daily cognitive and social exercises designed to facilitate critical examination of personal identity, relationships, and coping strategies. The study assesses whether this intervention can reduce anxiety, depression, perceived stress, and hopelessness while improving well-being and social connectedness during pandemic-related restrictions.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants (≥18 years)
* Native speakers of the country where they will be enrolled
* Have experienced at least two months of quarantine or isolation related to the coronavirus pandemic
* Provide full, written, informed consent
* Have the availability of a smartphone and a cardboard VR headset
* Availability and agreement of a partner for conducting the self-help component of the treatment

Exclusion Criteria:

* Visual or hearing impairments that can limit the participation in the protocol
* Participants reporting vestibular and/or balance disorders
Ampicillin for DYT-1 Dystonia Motor Symptoms

The purpose of this study is to evaluate if the antibiotic Ampicillin is safe and tolerated in patients that have generalized dystonia caused by the DYT-1 gene mutation, as compared to patients treated with a placebo. A placebo is a pill that looks and tastes the same as the real drug, but without the active ingredient. The second objective of this study is to determine if dystonia symptoms improve while on the study drug.

This is a double-blinded and randomized drug study: neither the patient nor the investigator know if patients are taking study drug (Ampicillin) or placebo.

Three study visits will include neurological exams, review of medical history, genetic test results and video-taped BFM-DRS motor scales. Patients will receive medication during baseline visit, consisting of either Ampicillin drug or placebo, which will be consumed twice daily for 28 days. Following a washout period (no drugs) of 7 days, patient will return to clinic for second study visit and receive second set of medication (placebo -vs- Ampicillin). Medication will be consumed twice daily for 28 days, with patient returning to clinic after a washout period of 7 days for final study visit in clinic.

Eligibility Criteria:
Inclusion Criteria:

* DYT-1 dystonia, confirmed by genetic testing
* Between ages of 7 and 80 years
* BFM-DRS score greater than 6

Exclusion Criteria:

* Negative DYT-1 dystonia gene test
* Allergy to penicillins or cephalosporins
* Concurrent bacterial, viral or fungal infection at time of enrollment
* Pregnancy
* Inability to follow study protocol
* Lactose intolerance (placebo contains lactose powder)
Do Home Monitors Improve Blood Pressure Control?

The purpose of this study is to determine if home blood pressure monitors can help decrease blood pressure in patients with diabetes at a low income clinic.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years old,
* diabetes as defined by HgA1C over 6.5%,
* uncontrolled blood pressure (SBP \> 130 and or DBP \> 80)

Exclusion Criteria:

* pregnancy,
* transplanted organ,
* MI/CHF/CVA within 3 months,
* dialysis,
* arrhythmia,
* metastatic cancer,
* dementia,
* visual or hearing difficulties