cyrilzakka/clinical-trials huggingface dataset:
A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD

A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.


Eligibility Criteria:
Inclusion Criteria:

* Active subfoveal choroidal neovascular (CNV) lesion or juxtafoveal lesion secondary to age-related macular AMD
* An ETDRS BCVA score between 60 and 25 (inclusive) letters

Exclusion Criteria:

* Previous treatment for wet AMD or previous treatment for CNV due to other causes in the Study Eye
* Clinically significant ocular disorders which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the Study Eye
* Poorly controlled diabetes mellitus (defined as HbA1c\>7%)
* Any clinically significant cardiovascular, renal or hepatic conditions, recent surgery, or malignancy, that would make the participant unsuitable for the study
Regenerex Tibial Tray Multi-Center Data Collection

The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the Regenerex™ Tibial Tray.

See Protocol

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria will be identical to the indications stated in the FDA approved labeling for the device (cleared in 510(k) K080361. These indications are stated below:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, or arthrodesis.

Patient selection factors to be considered include:

1. Ability and willingness of the patient to follow instructions, including control of weight and activity level
2. A good nutritional state of the patient, and
3. The patient must have reached full skeletal maturity

Exclusion Criteria:

The exclusion criteria will be identical to the contraindications stated in the FDA approved labeling for the device (cleared in 510(k) K080361. These contraindications are stated below:

* Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement.
* Relative contraindications include:

  1. Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
  2. Osteoporosis,
  3. Metabolic disorders which may impair bone formation,
  4. Osteomalacia,
  5. Distant foci of infections which may spread to the implant site,
  6. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
  7. Vascular insufficiency, muscular atrophy, neuromuscular disease,
  8. Incomplete or deficient soft tissue surrounding the knee.
Understanding the Impact of Death Conditions Linked to the COVID-19 Crisis on the Grieving Process in Bereaved Families

This study aims to analyze the grieving process of people who have lost a close first degree relative, understand the impact of death conditions and model a "theory of mourning" in the context of the COVID-19 crisis .

The COVID-19 pandemic has confronted us with an unprecedented health crisis, this had major consequences on mental health . International literature has already shown an increase in psychological and psychiatric distress in patients followed in psychiatry, and in the general population.

For bereaved relatives, certain factors contribute to complicate the mourning process, such as: the absence of communication with the healthcare team, the prohibition of visits, the absence of funeral rites... In the proposed research, we will analyze the grieving process of people who have lost a close first degree relative in children and adolescents population, understand the repercussions conditions of death in bereaved families and model a "theory of mourning" in the context of the current epidemic health crisis.

Eligibility Criteria:
Inclusion Criteria:

* Bereaved person who lost a close relative (child, adolescent, adult) since March 2020
* Age over 15 years old
* First degree relative (husband-wife or equivalent, father-mother, son-daughter, brother-sister)
* A bereaved person who is in at least one of the following conditions:
* Unable to visit the hospital if hospitalized OR
* Unable to travel to the home/EPHAD/hospital OR
* Wish not to travel for personal reasons OR
* Failure to perform funeral rites OR
* Failure to respect the wishes of the deceased and his or her own wishes OR
* Inability to see the deceased OR
* Opportunity to participate in the funeral OR
* Unable to say goodbye OR
* Inability to communicate via telephone and/or smartphone OR
* Unable to repatriate the body to the country or region of origin
* Relative who died (child, adolescent, adult) between March 2020 and March 2021 with Covid-19 or other life-threatening conditions
* Relative who died in an inpatient or outpatient setting (EPHAD, home or other structure)
* French or non-French speaking bereaved person

Exclusion Criteria:

* Presence of a pathology preventing good elocution during the interview:

  * Presence of a neurological pathology (e.g. dementia, Alzheimer's, aphasia, dysphasia)
  * Presence of an unstabilised psychiatric disorder
* Person under guardianship or curatorship
The Burden of Lyme Disease (BOLD) in a Pandemic - Insights From an Online Cross-sectional and Prospective Cohort Survey

A cross-sectional descriptive survey of the BOLD for individuals after having been ill with COVID-19 or have taken the COVID-19 vaccine will be compared with that of individuals who have neither been ill with COVID-19 nor taken the COVID-19 vaccine. Individuals who have both been ill and taken the COVID-19 vaccine will be compared to identify any additive risk factors.

Primary research question:

1. Will the BOLD be worse for individuals who have taken the COVID-19 vaccine?

Secondary research questions:

1. Will the BOLD be worse for individuals who have been ill with COVID-19?
2. What factors affect the BOLD in individuals a) after having been ill with COVID-19, and b) in those who have taken the COVID-19 vaccine? Do they differ?
3. If BOLD risk factors specific to either the COVID-19 vaccine or having been ill with COVID-19 are found, are they additive in people who have experienced both?
4. What is the prevalence of hesitancy in the Lyme disease community to the COVID-19 vaccine?
5. What is the severity of symptoms most likely to predict functional problems in individuals with Lyme disease who have been ill with COVID-19 or taken the COVID-19 vaccine?

Eligibility Criteria:
Inclusion Criteria:

* ≥12 years old
* a self-report of having been diagnosed with Lyme disease.

Exclusion Criteria:

* There are no exclusion criteria.
Twynsta Study With Lifestyle Modifications in Korean Patients With Hypertension

This observational study is designed to evaluate the effects of Twynsta tablets with life style modifications on blood pressure, quality of life, and other risk factors in Korean patients with hypertension in a routine clinical practice setting.

Study Design:

Eligibility Criteria:
Inclusion criteria:

1. Patients with essential hypertension whose blood pressure is not adequately controlled by amlodipine or telmisartan monotherapy (=140/90 mmHg, = 130/80 mmHg for those with diabetes or kidney disease)
2. Age = 19 years at enrollment
3. Male or female patient (or legally acceptable representative) willing and able to provide written informed consent

Exclusion criteria:

1. Patients with previous exposure to Twynsta
2. Patients with hypersensitivity to the active substances, or to dihydropyridine derivatives
3. Female patients at second and third trimesters of pregnancy
4. Female patients with lactation
5. Patients with biliary obstructive disorders
6. Patients with severe hepatic impairment
7. Patients with high grade aortic stenosis
8. Patients with shock
9. Patients with hereditary conditions such as intolerance with excipient of the products
10. Current participation in other clinical trials or observational studies
Genetic Polymorphisms of ABCG2/BCRP on the Transport of Nifedipine to Breast Milk.

This study aims to investigate the influence of the c.421C\>A genetic polymorphism of the ABCG2 / BCRP transporter in the concentration ratio of nifedipine in maternal milk:plasma in hypertensive breastfeeding women attended at the Gynecology and Obstetrics Service of the Medical School of Ribeirão Preto, of the University of São Paulo. Thus, plasma and breast milk samples are being collected from patients in chronic use of the drug (n=30) within 15 to 30 days postnatal.

The breast cancer resistance protein (ABCG2/BCRP) human transporter, encoded by the ABCG2 gene, is highly expressed on the human lactating breast. Nifedipine, a known substrate of ABCG2, is used for the treatment of hypertension in pregnancy and during breastfeeding. ABCG2 plays an important role on secreting drugs and xenobiotics into milk. The aim of the present study was to evaluate the effect of ABCG2 c.421C\>A on nifedipine breast milk/plasma concentration ratio in hypertensive breastfeeding women. Nineteen hypertensive breastfeeding women treated with 20 mg slow-release nifedipine every 12 hours were investigated. Blood and breast milk samples were collected simultaneously 15-30 days after delivery and at least 15 days after drug treatment, in order to reach drug steady state. All patients were genotyped for ABCG2 c.421C\>A using real time-PCR. Nifedipine concentration was determined in plasma and breast milk by high-performance liquid chromatography using UV detection. The comprehension of the variability in the transport of nifedipine to breast milk in hypertensive breastfeeding women will contribute to the evaluation of drug exposure in breast-fed infants to nifedipine and other ABCG2 substrates.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hypertensive breastfeeding women
* Patients being treated with 20 mg slow-release nifedipine every 12 hours for at least 15 days

Exclusion Criteria:

* Patients in use of ABCG2 inhibitors (omeprazole, pantoprazole, ritonavir, saquinavir, imatinib, efavirenz, nicardipine, abacavir, tacrolimus, ciclosporin A, cannabidiol);
* Patients who presented nifedipine adverse drug reactions
* Patients whose blood pressure normalized after delivery
* Patients who interrupted breastfeeding during the study
* Patients who did not return to the hospital for the clinical protocol.
Weight Change With Controlled Ankle Movement (CAM) Walker Boot Use

The purpose of the study is to determine if patients wearing a CAM walker boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional and upper body exercise information.

The study objectives are: (1) Determine if patients wearing a CAM (Controlled Ankle Movement) walker boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional and upper body exercises (gender appropriate) information at the time the CAM boot is dispensed; and (2) Determine, if weight is gained or lost, the average amount gained/lost over the treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Age greater or equal to 18 (male or female)
* Participants prescribed a CAM boot as standard of care from the study investigator's practice
* Participant willing to have weight measured at the clinic site at time of enrollment and final visit
* Participants willing to have blood drawn for Albumin level at beginning and end of study
* Participant is able to provide voluntary, written informed consent
* Participant, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits.
* Fluent in written and spoken English

Exclusion Criteria:

* Participants less than 18 years of age
* Pregnant women
* Cognitive impairment
* Participants with vertigo or other balance issues
* Participants unable to provide informed consent
* Non-English speaking individuals
* Participants who will not be wearing a CAM boot for at least 6 weeks
* Participants unable/unwilling to perform upper body exercises and follow nutrition guidelines
A Clinical Study of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene

This study will compare the safety and effectiveness of normal oral hygiene with two different marketed dentifrices, on longer term dentinal hypersensitivity response following use of potassium oxalate desensitizers.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form
* Complete a confidentiality disclosure agreement
* Be in good general health as determined by the Investigator/designee
* Have at least one tooth with a Schiff sensitivity score of at least 1 in response to the air challenge.

Exclusion Criteria:

* Self-reported pregnancy or nursing
* Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
* Active treatment of periodontitis
* Fixed facial orthodontic appliances
* A history of kidney stones
* Known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate
* Any diseases or conditions that might interfere with the safe completion of the study
* An inability to undergo any study procedures.
Circulating Tumour Cells as Biomarkers to Predict Prostate Cancer Metastasis for Treatment Stratification of Cancer

The goal of this study is to establish the value of Circulating Tumour Cell (CTC) positivity in predicting post-RP treatment failure, including BCR and new lesions detected by cancer imaging. We plan to recruit participants who will undergo Radical Prostatectomy (RP). Participants will have their blood samples taken just before surgery and 3 months after the surgery to test for CTCs. Then participants will be followed-up for cancer progression information at 3 month intervals for the first year then yearly intervals after that. Their PSA will be observed over time.

This is a single site, double-blinded, prospective, paired cohort study. Participating patients and clinicians involved in treatment or management will be blinded to the CTC results, to avoid influencing standard patient treatment, management, and progression outcomes after RP.

Patients will be recruited (months 1-24) at UCLH, where the UK largest urological surgery centre is located and performs robot-assisted RP on PCa patients referred from several regional hospitals. The clinical team at UCLH will identify eligible patients who will be approached by the clinical research fellow (CRF) employed on the research project or the clinical care team for informed consent using the consent forms specifically designed for this project for blood collection and future research. Non-metastatic disease will be based on the current standard diagnostic imaging methods including CT/MRI and PSMA-PET/bone scan. A pre-surgery PSA test will be performed routinely at UCLH.

2 x 10 ml blood samples will be collected (months 1-27) using the lavender cap EDTA tube according to our established method from each consented patient by the CRF or the clinical care team at UCLH during the pre- and post-RP PSA test blood sampling, and taken to the laboratory at Barts Cancer Institute, John Vane Science Centre, Charterhouse Square either by the CRF, a tissue bank acquisition officer (TBAO)(in the absence of the CRF) or the postdoc (anonymise samples transfer in the absence of CRF and TBAO) under the signed material transfer agreement (MTA), at room temperature. The samples will be transported in designated sample carrier using a taxi service. No public transport is to be used for moving samples between sites.

Eligibility Criteria:
Inclusion Criteria:

* High/High intermediate risk non-metastatic risk localised PCa based on the EAU stratification system
* Scheduled for robot-assisted RP
* Informed consent

Exclusion Criteria:

* With other co-occurring cancers
* Neo-adjuvant ADT
* Adjuvant ADT
Place of 68Ga-PSMA-11 PET-CT in the Therapeutic Decision at the End of the Initial Staging for High Risk Prostate Cancer Patients

Several studies have shown a great potential of 68Ga-PSMA PET in high risk prostate cancers patients and a high detection rate than 18F-Choline PET.

The primary aim of this study is to evaluate the difference of management intent, after the inital staging of high risk prostate cancer patients, with 68Ga-PSMA-11 PET-CT results in comparison of 18F-Choline PET-CT results.


Eligibility Criteria:
Inclusion Criteria:

* high risk prostate cancer patients with initial tests : CT, bone scintigraphy and 18F-Choline

Exclusion Criteria:

* contraindication of 68Ga-PSMA PET-CT
Internet-based Behavioral Intervention Following ACS

The aim of this study is to evaluate if an online Cognitive Behavioral Therapy (CBT) protocol customized for patients following Acute Coronary Syndrome (ACS), reduce cardiac anxiety, enhance Quality of Life (QoL), and promote increased physical activity while controlling for caregiver attention, utilizing an active control group receiving internet-based cardiac lifestyle intervention.

ACS is a leading global cause of mortality and health-related losses. Following ACS, many individuals exhibit symptoms of anxiety and depression, recognized risk factors for recurrent cardiovascular events. Specifically, anxiety related to cardiac symptoms and avoidance behavior, known as cardiac anxiety, has been shown to increase the long-term risk of adverse cardiac events.

The purpose of the present interdisciplinary research project is to develop and evaluate an online CBT protocol tailored for ACS patients. This project comprises a series of clinical studies aimed at accumulating knowledge about the most effective ways to treat ACS patients with CBT over the internet.

The aim of this study is to assess whether internet-based CBT, following ACS, reduces cardiac anxiety and improves QoL, while controlling for caregiver attention and expectancy of improvement using an active control group.

Method: A randomized controlled trial is conducted where participants are randomly assigned to either internet-based CBT (N=130) or internet-based cardiac lifestyle intervention (internet-CL) (N=130). The active control group receives internet-CL, focusing on lifestyle modification and health-promoting behaviors. Weekly therapist support through online written communication is provided to participants in both groups. Both treatment are conducted over 8-weeks and are comparable in terms of the number of treatment modules, intensity, and attention from the treating psychologist.

Eligibility Criteria:
Inclusion Criteria:

* ACS ≥ 6 months before assessment (type 1 MI STEMI/NSTEMI or unstable angina \[UA\])
* Age 18 and older
* Clinically significant cardiac anxiety that leads to distress and/or interferes with daily life (Cardiac Anxiety Questionnaire; CAQ: ≥18
* Able to read and write in Swedish

Exclusion Criteria:

* Heart failure New York heart Association class IV or ejection fraction ≤ 30%
* Significant valvular disease
* Planned coronary artery bypass surgery or percutaneous interventions
* Any medical restriction to physical exercise
* Severe medical illness or an acute health threatening disease (e.g., cancer)
* Grade 3 hypertension (i.e., blood pressure ≥ 180 systolic and/or 110 diastolic)
* Severe mental illness requiring urgent psychiatric hospitalization or intervention, or risk of suicide
* Alcohol or substance use disorder that would impede ability to complete study protocol
* Ongoing psychological treatment
Dose and Response of Dietary Nitrate in Healthy and Active Men

It was shown by some researchers that dietary nitrate such as beet root juice can lower oxygen consumption in men and act as a performance enhancing supplement.

It was not shown, what the optimal dosage is and if there is any difference in oxygen consumption comparing beet root juice and inorganic nitrate.

Therefore, the aim of the study is to conduct a study ingesting different sodium nitrate and beet root juice dosages. We would measure nitrate and nitrite concentrations in the blood at different time points and the subjects have to perform an exercise test measuring oxygen consumption 3 hours after the ingestion of nitrate.

1. The subjects have to ingest 7 different dosages of either beetroot juice or sodium nitrate on seven different occasions. Every hour a blood withdrawal is taken to measure nitrate and nitrite concentration in the blood.
2. The subjects have to ingest 7 different dosages of either beetroot juice or sodium nitrate on seven different occasions. Three hours after the intake of the supplement the subjects have to perform an exercise test on a bicycle. They have to cycle 5 min at 50% of maximal oxygen consumption and 8min at 80% of maximal oxygen consumption separated by a 5min break. Oxygen consumption would be measured during the whole exercise test. Blood withdrawal is taken before the ingestion, after 3 hours and after the test.

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 45
* healthy active men
* non-smoking

Exclusion Criteria:

* medication intake during study phase
Pain, Fatigue and Sleep Quality of E-Athletes

E-Sports, which attract great attention in the media and social networks, brings health problems and some risks, depending on the attractiveness of games and the time spent in the digital world. When the investigators examine the literature, although different studies are showing that E-Athletes experience pain and sleep problems, no study examines the factors related to pain and sleep quality together. Therefore, our study was planned to examine the factors associated with pain, fatigue, and sleep quality in E-Athletes.


Eligibility Criteria:
Inclusion Criteria:

* Be over 18 years old
* Take part in professional matches for at least one year
* Have an e-sports license
* Volunteer

Exclusion Criteria:

* Be retired,
* Having any systemic, orthopedic or neurological disease
Effectiveness of Sequential Eustachian Tube Maneuvers in Hyperbaric Oxygen Conditions

Middle ear barotrauma represents the predominant complication associated with hyperbaric oxygen therapy, manifesting symptoms ranging from otalgia to tympanic membrane perforation. Several pressurization protocols have been proposed to reduce the incidence of this trauma, but barotrauma is still the main cause of poor adherence to hyperbaric therapy. Therefore, this study aims to evaluate the effectiveness of serial tubal opening maneuvers to prevent barotrauma in patients undergoing treatment in a hyperbaric chamber.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing the first hyperbaric session.
* Understanding and properly carrying out equalization maneuvers

Exclusion Criteria:

* Patients who did not understand the equalization maneuvers
* Patients with specific contraindications to hyperbaric therapy
* Patients with acute middle ear or tympanic membrane disease