cyrilzakka/clinical-trials huggingface dataset:
Adherence Assessment With Travalert Dosing Aid

The purpose of the study is to compare adherence in patients on a fixed combination of travoprost 0.004%/timolol 0.5% and patients on a concomitant combination of travoprost 0.004% and timolol 0.5% using the Travalert® device.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open-angle glaucoma or ocular hypertension;
* Inadequate control with beta-blocker or prostaglandin monotherapy and starting therapy with travoprost 0.004% and timolol 0.05%;
* Intraocular pressure (IOP) at the screening visit in at least one eye ≥ 19 mmHg but not exceeding 36 mmHg in either eye;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Females of childbearing potential currently pregnant, breastfeeding, or not taking control measures to prevent pregnancy;
* Not currently receiving treatment for lowering IOP with beta-blockers or prostaglandin analogs;
* Currently on therapy or was in therapy with another investigational agent within 30 days prior to the baseline visit;
* History of chronic or recurrent severe inflammatory eye disease, or history of ocular trauma within the past six (6) months, or history of ocular infection or ocular inflammation within the past three (3) months in either eye;
* History of clinically significant or progressive retinal disease or history of any other severe ocular pathology in either eye that would preclude the administration of a topical prostaglandin analogue;
* History of severe or serious hypersensitivity to prostaglandin drugs or their analogues, to topical or systemic beta-blockers, or to any components of the study medication;
* Intraocular surgery within the past six (6) months or ocular laser surgery within the past three (3) months as determined by patient history and/or examination in either eye;
* Any abnormality preventing reliable applanation tonometry of either eye;
* Best-corrected visual acuity worse than 20/30 Snellen in either eye;
* Use of any additional topical or systemic ocular hyposensitive medication during the study;
* Other protocol-defined exclusion criteria may apply.
Investigating the Effects of Orienting Skin Grafts Parallel to Skin Tension Lines on Quality of Life in Head and Neck Located Basal Cell Carcinoma

The goal of this observational study is to learn about the effect of orienting graft for treatment of skin cancer in patients who undergo skin cancer excision and grafting for their skin cancer. The main question to answer is

Does orienting the grafts parallel with skin tension lines have any effect on quality of life or cosmetic results?

Participants who already underwent or planned to undergo an excision and grafting procedure will answer a qaulity of life tool and cosmetic results will be evaluated by two seperate dermatologist.


Eligibility Criteria:
Inclusion Criteria:

* Patients with nodular basal cell carcinomas with a tumor size equal or less than 12 millimeters
* A history of surgical excision and grafting

Exclusion Criteria:

* Immunosuppressed patients
* Recurrent tumors
* Patients with BCC's that arose from the previously irradiated area
* Gorlin's Syndrome diagnosis
* Illiterate individuals
* İmpaired cognitive functions
Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions

This trial investigates the effects of FE 200440 compared to placebo on implantation rate in women undergoing IVF/ICSI treatment


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-37 years
* Women who have undergone 2-4 previous fresh in vitro fertilization (IVF) or intracytoplasmatic sperm injection (ICSI) cycles that all resulted in a negative βhCG test, despite transfer of at least one embryo/blastocyst of good quality
* Women who have in the current controlled ovarian stimulation cycle for IVF/ICSI followed the long Gonadotrophin Releasing Hormone (GnRH) agonist or GnRH antagonist protocol, received hCG for triggering of final follicular maturation and have undergone oocyte retrieval for IVF/ICSI with the purpose of fresh transfer
* Retrieval of at least 6 oocytes in the current controlled ovarian stimulation cycle
* Subjects should have at least one embryo of good quality available for transfer on day 3, or at least one good quality blastocyst available for transfer on day 5

Exclusion Criteria:

* A total of 6 or more controlled ovarian stimulation cycles for IVF/ICSI
* Abnormal karyotype
* Uterine pathology or hydrosalpinx
* Diagnosed with acquired or congenital thrombophilia disease
Brain Dynamics in Response to Jugular Vein Compression

Clinical trials have suggested that this device is effective in mitigating changes in brain structure and function in athlete populations. The purpose of the current study is to better understand the underlying mechanistic response of the brain hemodynamics to mild jugular vein compression

Significant morbidity, mortality, and related costs are caused by traumatic brain injury (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the field, designed to mitigate TBI resulting from blast trauma or concussive events, would save lives, and the huge costs currently being experienced for life-treatment of surviving victims. An externally-worn medical device (the Device) that applies mild jugular vein compression according to the principle of the Queckenstedt Maneuver, is being developed by Q30 Sports Science, LLC (Q30). Preliminary research suggests that the Device has the potential to reduce the likelihood of TBI. The currently developed collar (Smith 2009, Smith and Fisher 2011, Smith and Fisher 2011, Smith 2012) has been approved for studies in humans (IRB 2013-2240) and the results indicate safety for use during high demand and maximal exertion activities. Regarding safety, the externally worn collar is meticulously designed to mimic the body's own omohyoid muscle actions upon the jugular veins that will provide similar pressure and volume increases not to surpass that of a yawn or the mere act of just lying down. Initial safety testing and early clinical trials indicate that the collar application is both safe and efficacious to prevent brain microstructure and neurophysiological changes in response to head impacts.

Eligibility Criteria:
Inclusion Criteria:

* Normal healthy volunteer aged 7-40
* Able to provide written consent
* Able to tolerate hypercapnia for 1-2 minutes

Exclusion Criteria:

* Unable to provide written consent
* History of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-season screening:
* Medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)
* Glaucoma (Narrow Angle or Normal Tension)
* Hydrocephalus
* Recent penetrating brain trauma (within 6 months)
* Known carotid hypersensitivity
* Known increased intracranial pressure
* Central vein thrombosis
* Any known airway obstruction
* Any known seizure disorder
Action Medical Research

Learning disability affects 3% of the population. Severe types of learning disability are more likely to have an underlying genetic cause but diagnosis is difficult because many different genetic abnormalities may be involved. Obtaining a diagnosis is important so that patients can be managed appropriately and their families can be given accurate information.

We aim to use new types of genetic testing which will make it possible to screen for several different genetic abnormalities which cause learning disability at the same time, so improving the accuracy and speed of diagnosis in the group of patients with severe learning disability. We will focus particularly on patients where seizures and behavioural problems are also present.This will enable more patients to be diagnosed accurately, reduce the number of hospital appointments needed and ultimately be more cost- effective.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with severe learning disability associated with either seizures, movement or behaviour problems who had previously undergone routine investigation but where no cause had been identified for their problems

Exclusion Criteria:

* Individuals with SLD where the cause is already known
* Individuals where informed consent cannot be obtained for participation
Management of Cytomegalovirus (CMV) Infection in Lung Transplant Recipients (LTR)

Background: Lung transplant recipients (LTR) have the highest risk of CMV infection. CMV pneumonitis, lymphocytic bronchitis, and detection of CMV DNA in bronchoalveolar lavage fluid are independent risk factors for the development of chronic lung allograft dysfunction (CLAD). However, to demonstrate the clinical impact of the indirect effects of CMV, it is necessary to conduct studies with a very large sample size.

Hypothesis: The different current preventive strategies for CMV infection in LTR and their clinical application on a daily basis impact on the development of direct and indirect effects of CMV in this population.

Objectives: To study the effect of CMV infection on LTR in relation to current preventive strategies in terms of:

* The incidence of acute and chronic rejection
* The incidence of other opportunistic infections
* The incidence of neoplastic disease, especially, post-transplant lymphoproliferative disease
* Patient and graft survival Methods: Multicenter, retrospective, cohort study. Consecutive inclusion of all adult lung transplant recipients from 2013 to 2017 with 2 years of follow-up. The investigators will collect and analyze the main clinical and microbiological variables in order to respond to the objectives of the study.

Relevance: Knowing in detail the current epidemiology of CMV infection in LTR and its subsequent influence on both mortality and the presence of different complications, could allow improving the management of these patients in the future.


Eligibility Criteria:
Inclusion Criteria:

· Survival \> 1 month post-transplant

• High to moderate risk patients to develop CMV disease by means of pre-transplant CMV serology:

* Donor positive to recipient negative
* Recipient positive independently of donor serology

Exclusion Criteria:

* Survival \< 1 month after procedure
* Low risk serology to develop CMV disease: both donor and recipient seronegative
68Ga PSMA-11 PET/CT in Recurrent Prostate Cancer

The goal of this research is to examine the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to detect sites of recurrent prostate cancer in patients with biochemical recurrence previously treated with radical prostatectomy (RP) or external beam radiation (EBRT) and to assess treatment response to subsequent salvage therapy.

In developed countries, prostate cancer is the most common malignancy in men and the third leading cause of death in men. Following primary therapy for prostate cancer, a substantial number of patients will recur either locally in the pelvis or in extra pelvic locations. Approximately 20-30% of patients' status post RP will recur and up to 60% patients treated with EBRT will recur, as detected by rising serum levels of prostate specific antigen (PSA) after original therapy. This phenomenon is referred to as biochemical recurrence (BCR), as the elevated PSA usually occurs in advance of obvious clinical or radiologic evidence.

This study is designed to evaluate the performance of 68Ga PSMA-11 PET/CT in detecting the location (localized versus extra pelvic) of BCR and advanced metastatic prostate cancer compared to conventional imaging. In addition, we will evaluate its performance in assessing interim and post salvage therapy response compared to conventional imaging, including pelvic magnetic resonance imaging (MRI), computed tomography (CT), and bone scintigraphy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected BCR of prostate cancer following initial treatment with either prostatectomy or definitive EBRT of the prostate or patients with known metastatic prostate cancer who have failed systemic therapy.
* Patients being considered for salvage therapy.
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
* Patients must be medically stable as judged by the patient's physician.
* Patients must be able to lie still for 20-40 minutes for the PET/CT scans.
* Ability to understand and the willingness to sign a written informed consent.
* Patients with BCR and no known lesions should not be on antiandrogen therapy at the time of scans. Patients with known metastases who are currently being treated with anti-androgen therapy may remain on this medication.

Exclusion Criteria:

* Patients who have or have had a biopsy proven concurrent other malignancy, excluding skin cancers.
* Patients may not weigh more than the maximum weight limit for the PET /CT scanner table (\> 200 kg or 440 pounds).
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11. Furosemide will not be administered to patients with known allergy.
* Patients must not be claustrophobic.
Lactoferrin Infant Feeding Trial - LIFT_Canada

This is a multicentre, phase III, 2-arm, masked randomized controlled trial. The primary hypothesis is that oral bovine lactoferrin (bLF), through its antimicrobial, antioxidant and anti-inflammatory properties, will reduce the rate of mortality or major morbidity in very low birth weight (VLBW) preterm infants.

Almost 3,000 very low birth weight (VLBW), \<1500g preterm infants are born and treated in Canada annually. About 1,200 either die or survive with severe brain or lung injury, retinopathy, late-onset sepsis or necrotizing enterocolitis (NEC), each of which is associated with substantial risk of childhood disability.

Lactoferrin is an antimicrobial, antioxidant, anti-inflammatory iron-carrying, bifidogenic glycoprotein found in all vertebrates and in mammalian milk, leukocytes and exocrine secretions. However, most VLBW infants receive insufficient human lactoferrin (hLF) from human breast milk in the first months of life, resulting in suboptimal protection. Because hLF is expensive, bovine lactoferrin (bLF) has been considered as an alternate supplement to improve this suboptimal protection.

LIFT is one of several ongoing trials using higher doses of bovine bLF in the VLBW population (120-200 mg/kg/d). If LIFT confirms a 19% reduction in the relative risk of its primary outcome, bLF will have a major impact, translating into thousands more intact survivors without major morbidity in Australia, New Zealand, Canada, Europe and worldwide each year. As \>90% of very preterm survivors at hospital discharge reach adulthood, this represents more than 19,000 life-years gained in Canada alone each year, one of the largest gains in intact survival in any specialty since neonatal surfactant and antenatal steroids

Eligibility Criteria:
An infant will be able to participate once a parent or guardian has provided a written informed consent and the infants must meet all of the following inclusion criteria:

* \<1500 g at birth
* 2-7 days old and not moribund
* infant is considered to be stable by the clinical care team
* has initiated feeds

Any infant meeting any of the following exclusion criteria will be excluded from participation in this study

* severe congenital anomalies which are likely to cause death or known to contribute to an adverse neurodevelopmental outcome
* major congenital gastrointestinal anomalies which will prevent an early approach to feeding
* parents unable to provide informed consent
Prevention and Treatment of Chronic Low Back Pain Through an Adapted Exercise Program

Objective: The purpose of this study is to investigate the effects of a adapted exercise program and general exercise recommendations compared with only general exercise recommendations for the management of chronic back pain among the workers of BSH (Bosch Siemens Hausgeräte), a manufacturing company.

Design: Randomized controlled trial. Participants: Subjects (N_40 volunteers) experimental group (n_20) control group (n_20). All of the participants needs to be diagnosed with chronic back pain by a physician. Participants are going to be randomly assigned to two groups: a control group (CG), and experimental group (EG).

Intervention: The experimental group is going to follow a home-exercise program designed specifically to compensate the overloads and strength necessities of the workplace, the patient enter the description of the workplace in a mobile application (APP) and the APP shows specific exercises that the patient needs to practice. The exercise program includes muscle strengthening, flexibility, and endurance training, during 2 months, 3 times/week and generla recommendations. The control group is going to receive only general recommendation (ACSM recommendations) with the same kind of mobile application to control the amount of exercise that each patient performs during the week.

Data on pain intensity (BPI short form, Brief Pain Inventory), disability (Oswestry Low Back Pain Disability Questionnaire), functional assessment of the lumbar spine (EMG Flexion-relaxation test), amount of weekly physical activity (IPAQ), and number of sick leaves are going to be measured immediately before and after intervention and 3 months after the end of the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* BSH industry workers.
* Spine pain diagnosed by a doctor, that has caused a previously sick-leave. The pain does not incapacitate to the patient to perform his job.
* In possession of a next-generation mobile.

Exclusion Criteria:

* Lumbar injury that does not let the patient performs his work or an exercise program.
Neck Surgery in Treating Patients With Early-Stage Oral Cancer

RATIONALE: Surgery may be an effective treatment for oral cancer. It is not yet known whether surgery to remove the tumor and lymph nodes in the neck is more effective than surgery to remove the tumor alone in treating patients with early-stage oral cancer.

PURPOSE: This randomized clinical trial is comparing two types of neck surgery to see how well they work in treating patients with early stage oral cancer.

OBJECTIVES:

* To determine whether the use of a selective neck dissection (SEND) used electively on all patients presenting with stage I-II oral cavity squamous cell carcinoma (SCC) improves survival, disease-free survival, and loco-regional disease control rates.
* To determine how SEND and complex reconstruction affect quality of life and mental health.
* To determine whether the use of SEND on all patients presenting with stage I-II oral cavity SCC represents a cost-effective use of resources.

OUTLINE: This is a multicenter study. Patients are stratified by age (\< 40 vs 40-64 vs ≥ 65 years of age), tumor stage (T1 vs T2), and surgeon.

* Arm I: Patients undergo resection of the primary tumor with neck dissection.
* Arm II: Patients undergo resection of the primary tumor alone. Patients complete the EORTC QLQ-C30, EORTC QLQ - H\&N35, and the Hospital Anxiety and Depression Scale (HADS) before surgery and at 6, 12, and 24 months after surgery. Patients also complete the EQ-5D questionnaire at baseline, 6 months, 12 months, and 24 months. Additionally, a self-completion Health Service Use questionnaire is completed every 2 months, during the first 24 months after treatment, to enable costs to the NHS to be monitored.

After surgery, patients are followed periodically for up to 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patients with oral squamous cell carcinoma measuring 1 to 3 cm at the primary site
* No clinical or preoperative imaging evidence of nodal involvement in the neck (N0)
* Surgery is the primary mode of treatment

  * Dose not need reconstruction that necessitates opening the neck, as assessed by the surgeon
* No cancer of the lip
* No prior head and neck tumor

PATIENT CHARACTERISTICS:

* No technical, medical, or anaesthetic difficulties that preclude patients being entered into one of the trial arms
* Not considered to be medically, socially, or psychiatrically unfit for surgery as first-line treatment by the multidisciplinary team
* No other synchronous tumor
* No preference for non-surgical treatment

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy

Assessing the effects of noninvasive spinal cord neuromodulation on improving function in individuals with cerebral palsy


Eligibility Criteria:
Inclusion Criteria:

* 1) individuals above the age of 2 years of age and 2) diagnosed with cerebral palsy (CP). The exclusion criteria included 1) children with selective dorsal root rhizotomy, 2) intramuscular Botox injection in the preceding 12 months, 3) current antispastic medications 4) unhealed fractures or contractures that would prevent them from performing functional tasks and 5) tendon lengthening surgeries.

Exclusion Criteria:

* Intramuscular Botox injection in the past 12 months
A Study for Dynamic Prediction Model of Breast Cancer Bone Metastases

The purpose of this study is to identify the risk factors of bone metastasis in breast cancer patients so as to develop a dynamic prediction model using real world clinical data. The multicenter data will be retrospectively collected, and the clinical characteristics related to bone metastasis will be analyzed.

Breast cancer is the most common malignant tumor in women worldwide and bones are the most common sites of metastases in breast cancer patients(\~70%). Bone metastasis often leads to skeletal-related events (SREs) ,which may not only reduce the quality of life in patients, but also affect the long-term survival. Therefore, early detection and early intervention of bone metastasis are particularly important for breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with breast cancer by histopathology;
2. Age between 20 and 70 years old;
3. The first diagnosis time is between 2010 and 2020;
4. Complete diagnosis and treatment information, including basic information, breast cancer diagnosis, surgery, recurrence diagnosis data (including the diagnosis of the metastasis sites), anti-tumor treatment data, bone health and bone metastasis-related diagnosis and treatment data, etc.;
5. Sufficient available follow-up information.

Exclusion Criteria:

1. Missing important basic information (including initial and recurrent pathology, stage, pathological grade and time, surgery time, and drug treatment);
2. With distant metastasis at the initial diagnosis;
3. Patients with autoimmune diseases or aggressive viral infections (such as HIV or hepatitis);
4. Other malignant tumors;
5. Unclear information about distant metastasis.