cyrilzakka/clinical-trials huggingface dataset:
Prospective Single-center Long-term Follow-up Study of a Series of Cases Previously Included in the QUALVIDON Study

Dry eye affects millions of people around the world. Some dry eye patients complain of neuropathic eye pain that can affect their quality of life.

From August 2016 to June 2017, the QUALVIDON study (NCT03296111), conducted at the Adolphe de Rothschild Foundation Hospital, assessed pain and its impact on quality of life using self-administered questionnaires in a series of dry eye patients. This 2nd study, entitled QUALVIDON2, focuses on the outcome of patients previously included in QUALVIDON.


Eligibility Criteria:
Inclusion Criteria:

* Patients previously included in the QUALVIDON study with the following characteristics:
* With characteristics of idiopathic neuropathic eye pain associated with dry eye
* Give informed consent
* Affiliated or beneficiary of the french social security

Exclusion Criteria:

* Pregnant or nursing woman
* Patient under legal protection
Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®)

The trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial.

IDA is highly prevalent in subjects with cancer and gastrointestinal diseases such as inflammatory bowel diseases, menstruating or pregnant women, and subjects who have undergone bariatric procedure. IDA can have a substantial medical and quality of life (QoL) burden on the subjects, and treatment of these subjects includes controlling the bleeding and replenishing lost iron.

Eligibility Criteria:
Inclusion Criteria:

1. Japanese man or woman ≥ 20 years, \< 65 years of age
2. Hb of ≥ 9.0 g/dL, \< 12.0 g/dL for women and \< 13.0 g/dL for men
3. Serum ferritin \< 25 ng/mL
4. TIBC ≥ 360 μg/dL
5. Body weight ≥ 50 kg
6. Willingness to participate and signing the informed consent form

Exclusion criteria include:

1. Anemia caused by conditions other than iron deficiency
2. Cancer
3. IV or oral iron treatment, or blood transfusion 4 weeks prior to screening
4. Erythropoiesis stimulating agent (ESA) treatment prior to screening
5. Imminent expectation of blood transfusion on part of treating physician
6. Iron overload or disturbances (e.g. hemochromatosis and hemo-siderosis)
7. Known hypersensitivity reaction to iv iron preparations
8. Decompensated liver cirrhosis or active hepatitis
9. Active acute or chronic infections
10. Pregnant or nursing women.
11. Planned elective surgery during the trial
Diabetic Retinopathy and Diabetic Macular Edema Screening by Non-Physicians With Limited Training

The purpose is to assess accuracy of digital retinal image interpretation by technicians and direct ophthalmoscopy by nurses for the determination of diabetic retinopathy severity and the presence of diabetic macular edema for the identification of referrals to ophthalmologists. The results of both screening methods were compared with comprehensive eye examination by ophthalmologists.

Diabetic visual disabilities have increasingly become a global concern since a number of diabetic patients are expected to surge dramatically in the coming decade. Essential means to minimize this problem are detecting vision-threatening diabetic retinopathy early in the course of disease and timely interventions by ophthalmologists.

The American Diabetes Association had issued a guideline for the detection and recommended regular comprehensive eye examination as a preferred method. However, it is not likely that there will be ophthalmologists enough to comprehensively examine the surging number of diabetic patients. Other practical screening methods, such as an interpretation of digital retinal images or direct ophthalmoscopy employed by other health care providers, for identifying the retinopathy for referral to ophthalmologists, should minimize this problem.

Eligibility Criteria:
Inclusion Criteria:

* diabetic patients defined by WHO criteria
* lived in the geographic area of participated hospitals

Exclusion Criteria:

* have contraindications for receiving mydriatic medications
* have ocular media not clear enough for making diagnosis by any of the screening equipment
* have other retina diseases precluded the diagnosis of diabetic retinopathy
Endocan Levels at Polycystic Ovary Syndrome and Periodontal Inflammation

Periodontal diseases are chronic inflammatory disease occurred by the interaction between pathogenic microorganism and the host defense. Polycystic ovary syndrome (PCOS) is a reproductive and metabolic disease associated with increased risk of cardiovascular events. Endocan is a proteoglycan secreted mainly by endothelial cells under the control of inflammatory cytokines.

Periodontal diseases, including gingivitis, are common chronic infectious diseases caused by predominantly pathogenic microorganisms that colonize the subgingival area and cause local and systemic elevations of proinflammatory cytokines such as Interleukin-6 (IL-6).

Several lines of evidence established the association between periodontal and systemic diseases, including metabolic syndrome, diabetes, and cardiovascular disease.

Because of the fact that both periodontal disease and PCOS are associated with systemic inflammation and insulin resistance, these two disorders may be linked through a common pathophysiologic pathway.

A number of studies have indicated a possible relationship between PCOS and periodontal inflammation. Despite common risk factors, including oxidative stress, the relationship between chronic periodontitis (CP) and PCOS remains unclear.

The aims of the study were to determine serum and saliva Endocan and IL-6 levels and to evaluate the correlation between these two biomarker in women with periodontal disease and PCOS.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed PCOS patients
* Never smokers
* Had no history of systemic disease
* BMI\<25 kg/m2
* Participants had ≥20 teeth present.

Exclusion Criteria:

* Pregnancy
* Lactation
* Hemoglobin A1c (HbA1c) ≥ 6.5%
* 2-h oral glucose tolerance test (OGTT-2h) ≥200
* Cushing syndrome, non-classic congenital adrenal hyperplasia, hyperprolactinemia, thyroid dysfunction, and androgen-secreting tumors
* Using antibiotics and antiinflammatory within the past 6 months
* Periodontal treatment within the past 6 months
Treatment of Severe Male Infertility - Predictive Factors (Imaging)

Testes of men with non-obstructive azoospermia (NOA) are imaged using MRI to find potential differences depending on the outcome, ie. sperm recovery in consequent microdissection testicular sperm extraction (MD-TESE).

Sperm recovery rate in non-obstructive azoospermia (NOA) men is 43% in Turku University Hospital, depending on the diagnosis leading to NOA. To date, there are no known parameters known to differentiate between successful and unsuccessful sperm recovery.

MRI is performed on men prior to the operation, and the objective is to compare the functional parameters assessed by magnetic resonance imaging between the group of men with positive and the men with negative sperm recovery in testicular microdissection sperm extraction (MD-TESE).

Eligibility Criteria:
Inclusion Criteria:

* non obstructive azospermia

Exclusion Criteria:

* malignancy
* contraindication for fertility treatment
Mesh Fixation With Intraperitoneal Tisseel

The purpose of this study is to determine whether mesh fixation in laparoscopic umbilical hernia repair with fibrin glue is superior to tacks in terms of postoperative pain and recovery.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-85 years and Danish speaking
* Umbilical hernia Ø 1.5 - 5 cm at preoperative clinical examination
* ASA group I-III

Exclusion Criteria:

* Former laparoscopic umbilical herniotomy
* Incarceration
* Drug/alcohol abuse/ongoing use of strong analgesic
* Bad compliance
* Liver disease Child-Pugh stage B/C
* Immunodeficiency (ex. steroid use)
* Pregnancy
* Other hernias recognized perop. and operated on at the same operation
* Lack of consent
Burden of Obstructive Sleep Apnea in Stroke (BOSAST)

There are two purposes of this study. The first purpose is to define the frequency of obstructive sleep apnea in stroke survivors as well as its association with fatigue and quality of life. The second purpose is to determine if continuous positive airways pressure (CPAP) treatment can have a beneficial effect on these patients' fatigue and quality of life.

Stroke survivors frequently complain of fatigue, depressive symptoms, and decreased cognitive functioning. These burdens complicate the recovery and rehabilitation from stroke. While there may be many contributing factors to these burdens, one factor in particular may be both terribly common and yet readily susceptible to intervention. Consistent reports from around the world demonstrate that \>50% of stroke patients have obstructive sleep apnea (OSA), a disorder that is also associated with fatigue, depressive symptoms, and decreased cognitive functioning. OSA is also associated with increases in inflammatory products which themselves are associated with the same array of burdens.

This study will examine inpatients at a stroke rehabilitation center. Patients' sleep will be studied. Patients with OSA will be randomized to 10 days treatment double blind with either continuous positive airways pressure (CPAP) treatment or to sub-therapeutic CPAP treatment. After 10 days of treatment, the OSA patients and the stroke patient without OSA will be restudied.

The study will shed light on the impact of OSA on stroke patients' burdens.

Eligibility Criteria:
Inclusion Criteria:

* stroke survivor in stroke rehabilitation unit
* age 45-85
* able to consent
* no prior treatment with CPAP

Exclusion Criteria:

* complex apnea
* known inflammatory disease
* neurological disease precluding patient's ability to consent and cooperate
A Phase I Study of LXS196 in Patients With Metastatic Uveal Melanoma.

This study was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of LXS196 as a single agent and in combination with HDM201 in patients with metastatic uveal melanoma.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female patients ≥18 years of age
* Diagnosis of uveal melanoma with histological or cytological confirmed metastatic disease. Disease must be treatment naive or have progressed (radiologically or clinically) on most recent therapy.
* Willingness to provide newly obtained tumor tissue at baseline and on treatment unless contraindicated by medical risk in the opinion of the treating physician.
* Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \>10 mm with CT scan.
* ECOG performance status ≤ 1

Key Exclusion Criteria:

* Malignant disease other than that being treated in this study.
* Symptomatic or untreated CNS metastases or spinal cord compression. Brain metastasis must be stable with verification by imaging .
* Impaired cardiac function or clinically significant cardiac diseases
* History of thromboembolic or cerebrovascular events within the last 6 months, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism (applicable to combination part only).
* Patients who are receiving treatment with medications that cannot be discontinued prior to study entry and that are considered to be any of the following:
* known and possible risk for QT prolongation
* known to be strong inducers or inhibitors of CYP3A4/5 (for single agent part); known to be moderate to strong inducers or inhibitors of CYP3A4/5 (for combination part)
* known to be inducers or inhibitors of P-gp
* known to be substrates of CYP3A4/5 and P-gp with a narrow therapeutic index
* Patients with abnormal laboratory values, defined as any of the following:
* AST or ALT \> 3 times ULN, AST or ALT \> 5 times ULN for patients with liver metastases.
* Total bilirubin \> 1.5 x ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin \> 3.0 x ULN or direct bilirubin \> 1.5 x ULN.
* Absolute neutrophil count (ANC) ≤ 1.5 x109/L.
* Platelets ≤ 100 x 109/L.
* Hemoglobin (Hgb) ≤ 90 g/L (9 g/dL).
* Creatinine \> 1.5 x ULN
* Patients receiving live vaccines due to the expected bone marrow toxicity (applicable to combination part only).
* Patients treated with growth factors targeting the myeloid lineage (e.g. G-CSF, GM-CSF and M-CSF) within 2 weeks of starting study treatment. (applicable to combination part only).
The Curative Effect of Extended Thymectomy Performed Through Subxiphoid-right VATS Approach With Elevation of Sternum

Extended thymectomy is the main treatment for thymoma and other anterior mediastinal diseases. Video-assisted thoracic surgery(VATS) plays an important role in the surgery of extended thymectomy. Now, VATS thymectomy through intercostal approach has been the commonly used minimally invasive surgical procedure for thymus surgery and is applied worldwide. But the intercostal approach may cause residue of thymus tissue and chronic pain. In 2013, doctor Marcin Zielin´ski form Poland reported a new technique of minimally invasive extended thymectomy performed through the VATS approach with double elevation of the sternum. And their early results proved this technique is probably the least invasive and the most complete technique of VATS thymectomy with excellent cosmetic results. Until now, doctor Jiang Fan form Shanghai Pulmonary Hospital has performed 50 cases extended thymectomy through the subxiphoid approach with double elevation of the sternum by VATS. This study is designed to compare the curative effect between this new method and traditional intercostal VATS.

This study is a prospective multicentre cohort study.The main study content is comparative study of the curative effect of extended thymectomy performed through the subxiphoid-right video-thoracoscopic approach with double elevation of the sternum versus intercostal video-thoracoscopic approach, divided into subxiphoid and intercostal groups. Communicating with the surgeon and patients who meet the inclusion criteria, decide whether to enter the subxiphoid or intercostal group. Subxiphoid group with subxiphoid-right video-thoracoscopic approach under double elevation of the sternum in extended thymectomy , intercostal group with traditional intercostal video-assisted thoracoscopic surgery in extended thymectomy. By collecting personal information of two groups of patients and the corresponding observation indicators to analyze whether the subxiphoid-right VATS approach with double elevation of the sternum is the least invasive and the most complete technique of VATS thymectomy.

Eligibility Criteria:
Inclusion Criteria:

1. MG with thymic hyperplasia, thymoma or other anterior mediastinum disease
2. Masaoka stagingⅠ-Ⅱ
3. Patients with normal cardio-pulmonary function before operation, BMI\<30

Exclusion Criteria:

1. Unable to tolerate surgery
2. Masaoka staging Ⅲ-Ⅳ
3. Patients who have undergone previous surgery or radiotherapy
4. Myasthenia crisis
5. Chronic pain or using opioid analgesics before surgery
6. Preoperative mental disorders such as excessive anxiety
7. Patients who underwent previous mediastinal surgery or cardiac surgery
8. Patients with thoracic deformity
The Danish National Survey of Diet and Physical Activity 2021-2024

The Danish National Survey of Diet and Physical Activity (DANSDA) 2021-23 is a nationally representative, cross-sectional survey of dietary and physical activity habits of 4-80 year-old Danes, and is carried out at the National Food Institute, Technical University of Denmark (DTU Food). DANSDA provides high quality, nationally representative data on diet, physical activity, smoking, alcohol and weight status in Denmark.

The principal objective of DANSDA is to monitor dietary intake and physical activity in a representative sample of the Danish population aged 4-80 years, and provide data for surveillance of the food and nutrient intake and physical activity of the general population.

The survey is a nationally representative cross-sectional survey, which includes face-to-face interviews, anthropometric measurements, blood pressure measurement, blood sampling, 7-day web-based food diaries, and pedometer-determined physical activity which is recorded in 7-day web-based step diaries. In the interview socio-demographic details as well as lifestyle and health attitudes are recorded. Web-based food and step diaries are collected in the entire survey population of 4000 individuals, blood pressure is measured in 15-80 year-olds, and biological samples (blood) are collected in a subpopulation of approximately 1000 individuals aged 40-70 years. Biomarker of metabolic health are measured in a blood sample drawn after an overnight fast. The blood-based biomarkers (cholesterol, triglycerides, glucose), anthropometric data and blood pressure measurements are used to assess the prevalence of the metabolic syndrome (WHO definition) in 40-70 year-old Danes. Surplus blood samples are stored in a biobank for 30 years.

The data from the survey provide the evidence base to support work by the authorities to facilitate the adoption of healthier eating and physical activity behavior and reduce lifestyle-related diseases. Another objective is to provide detailed data on food consumption at the individual level, which enables food chemical exposure assessment and forms an essential part of food safety risk assessment. Furthermore, the data will be used to assess the environmental impact of the diet.

Eligibility Criteria:
Inclusion Criteria:

* Danish Citizen
* 4-80 years old
* Sufficient Danish language proficiency

Exclusion Criteria:

* Care home resident
Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients

Tramadol is widely used as analgesic in trauma patients. However, it causes side effects, most notably nausea and vomiting. This study aim to determine the role of prophylactic metoclopramide in preventing tramadol induced nausea and vomiting.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older on day of presentation to ETD SGH
* Sustained from traumatic injuries of extremities (Fracture of hand \& wrist, radius, ulna, humerus, femur, tibia, fibula and/or foot \& ankle; laceration wounds of extremities; soft tissue injury)
* Patient who is able to give consent

Exclusion Criteria:

* Known allergy to metoclopramide
* Concurrently taking medication with anti-emetic effect, including antihistamines, phenothiazines and dopamine antagonists.
* A history of vomiting since time of injury
* Patients who had already received tramadol or metoclopramide in the previous 8 hours prior to arrival at ETD
* Below age of 18 on day of presentation, or patients who could not consent to the study
* Any alteration in level of consciousness
* Hemodynamic instability or primary diagnosis requiring time critical intervention
* Pregnancy or lactation
* History or known case of vertiginous disorder
* Currently undergoing chemotherapy or radiotherapy
Metformin for the Treatment of MCRC Patients Undergoing FOLFIRI Plus Target Therapy

To investigate progression-free survival (PFS) in patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin

Objectives:

1. Main purpose

   • To investigate progression-free survival (PFS) in patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin
2. Secondary purpose (1) To investigate the survival (OS) of patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin (2) To investigate the disease control rate (DCR) of patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 20 and 90 years old
2. Patients diagnosed with metastatic colorectal cancer who is going to receive FOLFIRI chemotherapy
3. Female must not be planning to become pregnant or breastfeeding, and not pregnant at any point during treatment. (Contraception is required to participate in this trial)
4. Those without major physiological diseases (example of major cardiovascular disease is acute myocardial infarction; example of major cerebrovascular disease is acute stroke, malignant hypertension, acute kidney failure, acute liver failure)
5. Those who are not allergic to the relevant drugs required for the test
6. Those who can follow the doctor's order to take the medicine
7. Subjects must be willing to sign the consent form
8. Blood sugar level above 80 mg/dL

Exclusion Criteria:

Subjects who meet any of the following exclusion conditions are not allowed to join the trial

1. Patients other than the above-mentioned main inclusion criteria.
2. Non-native speakers
3. Known allergy to metformin or any of its components.
4. Severe instability in diabetes (ketoacidosis).
5. Blood sugar level lower than 80 mg/dL
6. Heart failure, respiratory insufficiency.
7. inadequate hematopoietic function defined as below:

   * hemoglobin \< 9 g/dL;
   * absolute neutrophil count (ANC) \< 1,500/mm3;
   * platelet count \< 100,000/mm3;
8. inadequate organ functions defined as below:

   * total bilirubin \> 2 times upper limit of normal (ULN);
   * hepatic transaminases (ALT and AST) \> 2.5 x ULN;
   * creatinine \> 1.5 x ULN;