cyrilzakka/clinical-trials huggingface dataset:
A Study to Collect Data on the Use of Eylea in Babies Born Too Early Who Have a Condition of the Eye Where Blood Vessels Grow Abnormally in the Retina (Retinopathy of Prematurity)

This is an observational study to collect data from Japanese babies with retinopathy of prematurity (ROP) who will be treated with Eylea. In observational studies, only observations are made without specified advice or interventions.

ROP is a condition that affects the eye and occurs only in babies who are born too early. Most cases of ROP are mild and get better without treatment, but more serious cases need to be treated in time. ROP happens when the blood vessels in the "retina" grow abnormally. The retina is the layer of tissue at the back of the eye that picks up light and sends messages to the brain. In babies with ROP, these abnormal blood vessels can leak. This causes damage to the retina and can sometimes move it out of place causing medical problems such as blindness.

Eylea is received as an injection into the eye. It works by blocking a certain protein (VEGF) that can cause blood vessels in the retina to grow abnormally. Eylea is already available in Japan and is approved for doctors to prescribe to babies with ROP.

The participants in this study are Japanese babies with ROP that their doctors decided to treat with Eylea before the start of this study. Babies with ROP that were already prescribed Eylea by their doctors may also be included.

The main purpose of this study is to collect more data on how safe the treatment with Eylea is in babies with ROP under a real-world setting. Another purpose of this study is to collect more data on how well Eylea works in these participants.

To see how safe Eylea is, the study doctors will collect all medical problems that the participants treated with Eylea have. These medical problems are called adverse events. Doctors keep track of all the adverse events that happen, even if they do not think that they might be related to the treatment.

To see how well Eylea works, the study doctors will check the number of participants:

* with no active ROP after starting treatment
* where ROP came back up to 6 months after start of treatment

In this study, the study doctor will:

* collect past data of the participants from medical records
* interview the participants
* collect treatment-related data during routine visits. The study duration is 6 months with 3 planned visits. One visit will be at start of treatment, one at one month and one at 6 months after start of treatment. All data required for this study will be collected during routine visits. Besides this data collection, no further tests or examinations are planned in this study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ROP requiring treatment
* Patients who have received IVT-AFL treatment according to Japanese approved labeling for AFL in ROP.
* ICF obtained from legal representative.

Exclusion Criteria:

* Patients who have contradictions based on approved label
* Patients who have received IVT-AFL treatment before the treatment for the enrollment Patient.
* Diagnosis of other indication
Studying the Clinical Trial Experiences of Patients With Mesothelioma

Medical research participation percentages haven't always been fully representative of a given demographic.

The goal is to find out which aspects of a clinical study may make it more difficult for patients to take part or see it through.

The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future mesothelioma patients during clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Must have a medical diagnosis of mesothelioma that has been confirmed by a physician.
* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

Exclusion Criteria:

* Pregnant or lactating woman
* Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
* Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results
Feasibility of Endoscopic Pylorotomy in the Treatment of Refractory Gastroparesis, Pilot Study.

Gastroparesis is a common chronic condition, disabling the limited therapeutic resources justifying the exploration of new therapeutic possibilities.

By analogy to the technique of Per Oral Endoscopic Myotomy (POEM), we believe that myotomy pyloric muscle (POP = Per Oral Pyloromyotomy) endoscopically could become a treatment of choice in the refractory gastroparesis with drug treatments by attacking the pyloric obstacle often spastic that counteracts an effective gastric emptying.

Experimental study, prospective, single-center, POP feasibility pilot in the treatment of refractory gastroparesis.

Patients with gastroparesis (significant prolongation of gastric emptying) unimproved by prokinetic treatment and meet all the eligibility criteria will be included after a period of reflection of two weeks minimum.

20 patients will be prospectively included 10 patients with diabetic gastroparesis, 10 patients with non-diabetic gastroparesis (post-surgical, post-Sjogren, idiopathic).

POP will be performed under general anesthesia in intubated-ventilated patients using a carbon dioxide (CO2) inflator. The published standard technique and learned by our team on the pig model will be conducted: submucosal tunnel at the anterior surface of the gastric antrum starting 3-5 cm proximal to the pylorus front section to the fiber by fiber to the muscular pyloric, then closing the inlet tunnel by hemostatic clips.

An evaluation of symptoms by the Gastroparesis Cardinal Symptom Index (ISCC) of the quality of life of the patient Assessment of upper gastrointestinal disorders-Quality Of Life (PAGI-QoL), SF-36 and gastrointestinal Quality of Life Index (GIQLI ) and gastric emptying by a scintigraphic gastric emptying will be carried out at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient with refractory gastroparesis to drug treatment (post-diabetic, post-Sjogren, postsurgical or idiopathic)
* Signed Consent
* Affiliate or beneficiary of a French social security scheme

Exclusion Criteria:

* Contraindications to gastroesophageal gastroduodenal endoscopy,
* Early Unable to follow protocol,
* Contraindications to general anesthesia,
* Can not Stop anticoagulants for the gesture,
* Can not stop antiplatelet agents for the gesture,
* Pregnant or lactating women,
* Gastric resection surgery History of pyloric
* Patients under guardianship, curatorship or safeguard justice,
* Disorders of hemostasis against-indicating the endoscopic procedure.
Relationship of Anthropometric Profile and Fitness Indicators With Sports Performance of Elite Mexican National Team Soccer Players

Relating Anthropometric Profile to Fitness and Sports Performance in Mexican National Team Soccer Players

Previous studies have reported differences in the body composition of Latin American or European youth to elite soccer players based on playing position or age. Furthermore, in youth or sub-elite samples, body composition has been linked to in-match speed, distance, or acceleration. Few studies have been developed with elite samples of soccer players. Elite soccer performance depends on the complex interaction of physical, physiological, tactical, and contextual variables. Therefore, a comprehensive analysis of anthropometric, countermovement jump and in-match performance variables can provide deeper insight into soccer success. Accordingly, this study addresses this knowledge gap by characterizing and analyzing the multidimensional relationships between these variables in elite Mexican soccer players. A descriptive, cross-sectional study will be conducted. According to the International Society for the Advancement of Kinanthropometry (ISAK) standards, sixteen anthropometric variables have been assessed to characterize the athlete's anthropometric profile. The counter-movement jump assessments were conducted using a ForceDecks Max platform. During matches, the players' displacement was monitored using 18 Hz WIMU Pro GPS units. Normality tests of all variables will be performed. A descriptive analysis of anthropometric and body composition characteristics of overall and among playing positions will be performed. The relationship between body composition and anthropometric profile with counter-movement jump and in-match GPS-Derived External Load Metrics will be computed. Multivariate models will be explored to analyze multidimensional relationships between these variables.

Eligibility Criteria:
Inclusion Criteria:

* Athletes who attended the evaluation laboratories.
* Athletes who gave their assent to carry out the evaluations.
* Female or male soccer players.
* Actively competing in national and/or international tournaments.

Exclusion Criteria:

* Not having been called to integrate the Mexican national soccer team during the evaluation dates.
* Injured or ill athletes during the assessments.
* Athletes who do not give their assent to carry out the evaluations.
Nutrition Apps in Occupational Healthcare (Pilot Study of the FOODNUTRI Project)

The aim of this study is to investigate (1) the user experiences and usability of the nutrition apps (the Finnish Nutrition Navigator and the Finnish Nutrition Path) in occupational health care from the perspective of both professionals and customers, (2) the impact on diet, eating behavior, perceived well-being (perceived state of health, quality of life, work and functional ability) and anthropometric indicators compared to treatment as usual, and (3) cost-effectiveness of using the nutrition apps.

For the occupational healthcare customer, the study will include two visits to the occupational healthcare: at baseline and after a 12-week follow-up. First, all volunteer participants enrolled in the study will belong to the control group and they will get the treatment as usual. Their weight, waist circumference, and blood pressure are measured at the visit and they are asked to answer a digital research questionnaire at both baseline and follow-up.

The rest of the volunteer participants enrolled in the study will belong to the intervention group. Before the visit at the occupational healthcare, they are asked to fill in the Finnish Nutrition Navigator and to read the automated feedback about the diet quality. The Finnish Nutrition Path can help in the dietary goal setting and it can be utilized together with the professional or independently. In addition, also weight, waist circumference, and blood pressure are measured at the visit and the participant is asked to answer a digital research questionnaire. The same procedure is done at both baseline and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Employee of the certain employer
* Coming to the medical examination for employees whose work presents a special risk of illnessa OR coming to the dietitian because of dyslipidemia, high blood pressure, weight loss, weight management, type 2 diabetes, cardiovascular disease
* Understands written Finnish

Exclusion Criteria:

* Pregnancy
* Eating disorder
* Severe challenges with diet (e.g., malabsorption, very restrictive diet due to several food allergies or other reasons)
Modification of Pavlovian and Instrumental Learning in Human Addiction

The project aims at investigating modifications of environmental factors (i.e. cues and stress) relevant for learning mechanisms in addictive disorders.

Project C02 aims at investigating modifications of environmental factors (i.e. cues and stress) relevant for learning mechanisms in addictive disorders. The investigators will examine non-treatment seeking subjects with alcohol use disorder (AUD; mild vs. moderate to heavy), and healthy controls with a focus on the impact of Pavlovian conditioned stimuli (context-related cues) on instrumental behavior (so-called Pavlovian-to-Instrumental transfer (PIT)) and whether the PIT effect can be systematically modified by manipulating the approach/ avoidance propensities of Pavlovian cues (work package (WP) 1). Concerning stress as a major modulator of cue reactivity in addiction, the investigators further plan to assess whether acute, active stress reduction modifies such PIT effects (i.e. decreasing transfer effects) as well as goal-directed vs. habitual behavior (i.e. strengthening goal-directed decisionmaking) (WP2). Lastly, this project aims at contributing to the understanding of the underlying neurobiological correlates of manipulation of approach/ avoidance propensities of Pavlovian cues and acute stress reduction by using functional magnetic resonance imaging (WP3) with a focus on amygdala-striatal activity (PIT) and frontostriatal processes (goaldirected decision-making).

Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 16-32 years, 33-49 years, and aged 50-65 years
2. Mild, moderate to heavy alcohol-use disorder (AUD) according to DSM-5 criteria (mild: 2-3 AUD criteria; moderate: 4-5 AUD criteria; heavy: 6 or more AUD criteria); not clinically requiring detoxification (as confirmed by an independent board-certified psychiatrist); AUD patients can have mild to moderate cannabis use disorder as well as tobacco use disorder
3. Ability to provide fully informed consent and to use self-rating scales
4. Willingness to use an android phone
5. Sufficient understanding of the German language

Exclusion Criteria:

1. Lifetime history of DSM-5 bipolar disorder, schizophrenia or schizophrenia spectrum disorder, or substance dependence other than alcohol or nicotine or cannabis dependence. Severe alcohol and cannabis use disorder will be excluded.
2. Current threshold DSM-5 diagnosis of major depressive disorder, or presence of suicidal intention
3. History of severe head trauma or other severe central nervous system disorder (e.g., dementia, Parkinson's disease, multiple sclerosis)
4. Pregnancy or nursing infants
5. Current use of medications or drugs known to interact with the CNS within at least four half-life post last intake
Exploratory Study on Two Different Doses of VML-0001 on the Effects on Vaginal pH in Healthy Post-Menopausal Women

The study is designed to determine the effect on vaginal pH and the duration of action measured on the ability of the base formulation to reduce the vaginal pH


Eligibility Criteria:
Inclusion Criteria:

* be greater than 45 years
* no positive findings on screening gynaecological examination
* negative smear test within the last 5 years

Exclusion Criteria:

* has signs of vaginal infection
* has evidence of alcohol abuse
* has used hormonal replacement therapy in three months prior to study entry
ctDNA in CRC Patients Undergoing Curative-intent Surgery for Liver Metastases

This is a prospective multicenter cohort study, was designed to explore the prognostic value of ctDNA as a biomarker of disease response and recurrence or death in patients undergoing curative-intent surgical resection of Colorectal cancer liver metastasis.

Blood collection times according to specific clinical situations:

* Standard approach
* Combined surgery
* Reverse strategy
* Two-stage hepatectomy

Eligibility Criteria:
Inclusion criteria

The patient will be included if:

1. Has signed informed consent form and is willing to comply with all study procedures and availability for the study duration,
2. Is ≥ 18 years of age,
3. Has histologically confirmed colorectal adenocarcinoma,
4. Has resected primary tumor or is eligible to primary tumor and CRLM (in case of synchronous metastases) resection within 6 months prior to study inclusion,
5. Has isolated CRLM that is deemed resectable or potentially resectable (extrahepatic metastases excluded, except infracentimetric non-specific lung lesions with largest diameter \<1 cm and maximal number of ≤3) as judged by a multidisciplinary team meeting (based on CT scans of chest, abdomen, and pelvis \[or MRI if CT not possible\]),
6. Is eligible to surgical procedure,
7. Is fit for the chemotherapy-surgery combination treatment,
8. Is registered in a national health care system (Protection Universelle Maladie \[PUMa\] included).

Exclusion criteria

The patient will be excluded if:

1. Has definitively unresectable CLRM,
2. Had more than 9 pre-operative cycles of chemotherapy for treatment of metastatic disease planned at inclusion,
3. Has not resected primary rectal tumor (low and middle),
4. Has history of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix,
5. Has no more than two surgical procedures planned for complete resection of primary tumor and/or liver metastases,
6. Has deficient mismatch repair (dMMR)/ microsatellite instability (MSI) tumors treated with immunotherapy,
7. Blood samples cannot be collected if surgical procedure,
8. Is pregnant or breastfeeding,
9. Cannot be followed-up due to geographical, social, or psychic conditions,
10. Has medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol,
11. Is under guardianship, curatorship, or under the protection of justice.
Efficacy and Safety of Transcranial dIrect Current stiMulation (tDCS) in Progressive Supranuclear Palsy (PSP) (STIM-PSP)

This is a double-blind, randomized, sham-controlled clinical trial that aim to verify the safety and the efficacy of anodal transcranial direct current stimulation (tDCS) on cognitive and motor symptoms in Progressive Supranuclear Palsy (PSP) over the left dorsolateral prefrontal cortex (dlPFC).

Progressive Supranuclear Palsy (PSP) is a rapidly progressive neurodegenerative disease characterized by deposition of tau and motor, cognitive and behavioral symptoms. Since no effective treatment is available, non-invasive brain stimulation techniques, such as tDCS, could be a valid complementary therapeutic approach. The tDCS modulates the spontaneous activity of the neural network by applying a direct current flow on the cortical brain areas (anodic or cathodic stimulation). Despite its efficacy in psychiatric disorders, the therapeutic use of tDCS in neurodegenerative diseases requires more systematic studies. The aim of this study is to verify the safety and efficacy of tDCS in PSP on motor, cognitive and behavioral symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PSP according with Movement Disorder Society (MDS) criteria (Hoglinger et al., 2017);
* Age \> 40 and \< 89 years;
* Presence of a caregiver supportive the patient for all study procedure;
* Ability to walk for at least 5 steps either independently or with a minimum support (another patients holding patient's arm or with a walker)

Exclusion Criteria:

* Presence of electrical stimulators (for example, pacemaker, Deep Brain Stimulation, DBS)
* Difficult in understanding Italian language
* Presence of severe sensory deficits (for example, visual or hearing impairments)
* Education level \<5 years
* History of drug abuse
* History of severe psychiatric disorders
* History of transient ischemic attacks
* Cortical or sub-cortical vascular lesions
* Seizures or severe heart problems and previous neurosurgical operations
* Absence of subjective cognitive deficits
* MMSE (Mini-Mental State Examination) score \<20
* Left-handedness
Liposomal Bupivacaine Versus Standard Bupivacaine Plus Dexamethasone in Quadriceps Sparing Femoral Nerve Block and Wound Infiltration for Total Knee Arthroplasty

The purpose of this study is to compare the efficacy and duration of pain relief after total knee arthroplasty provided by a single injection of liposomal bupivacaine (EXPAREL®) versus standard bupivacaine with an adjuvant, dexamethasone when administered as a quadriceps sparing femoral nerve block and periarticular injection. It is hypothesized that liposomal bupivacaine is superior to standard bupivacaine with dexamethasone and will decrease time to discharge readiness.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of American Society of Anesthesiologist (ASA) I-III physical class with a pre-operative diagnosis of primary osteoarthritis scheduled for elective primary total knee arthroplasty.
* Patients must be living independently at home prior to undergoing primary total knee arthroplasty with intention of discharge directly to home after hospitalization

Exclusion Criteria:

* Subjects will not be eligible for this trial if they have a history of allergy to a local anesthetic
* Known peripheral neuropathy
* Known connective tissue or immunological disorders
* Stroke or other known central nervous system disorders
* Renal dysfunction
* Hepatic dysfunction
* Cardiac dysfunction other than hypertension
* Pregnant subjects
* Immunosuppression
* Human immunodeficiency virus (HIV)
* Alcohol or drug abuse
* Chronic pain or opioid dependence
* Coagulopathy or those unable to comply with study requirements.
Documentation of Efficacy of Intralymphatic Allergen Immunotherapy

Investigation of the clinical efficacy of 3 intralymphatic injections with grass pollen extract into inguinal lymph nodes on combined symptom-medication scores during grass pollen season in grass pollen allergic patients compared to placebo

A double-blind, parallel group, placebo controlled multi-site trial of the clinical efficacy of 3 intralymphatic injections with a low dose of grass pollen extract into inguinal lymph nodes in grass pollen allergic subjects.

Primary endpoint is the difference in combined symptom and medication score during grass pollen seasons following treatment compared with patients receiving placebo.

Injections are giving ultrasound-guided with at least 4 weeks intervals.

Eligibility Criteria:
Inclusion Criteria:

* moderate-severe grass pollen allergic rhinoconjunctivitis
* positive skin prick test for grass pollen extract

Exclusion Criteria:

* significant mugwort allergy
* previous AIT for grass pollen allergy
* uncontrolled non-allergic upper airways disease
* uncontrolled asthma
* planned depot steroid injections during season
* uncontrolled autoimmune diseases
* active malignancies
* uncontrolled other severe condition, including psychiatric diseases
Portable Pves Study

A comparative study will be conducted and the patient will undergo a conventional urodynamic study. In order to successfully determine if the Peritron+ is capturing vesical pressure measurements consistent with conventional urodynamics the two sources of Pves will be collected concurrently.


Eligibility Criteria:
Inclusion Criteria:

* Patients normally indicated for urodynamic evaluation

Exclusion Criteria:

* Patients who suffer from bladder infections
* Patients who suffer from strictures in the urethra