cyrilzakka/clinical-trials huggingface dataset:
The Relationship Between Structure and Visual Function in Myopia Foveoschisis

Macular foveoschisis (MF) is a common complication of pathological myopia, which is characterized by choroid-retinal degeneration and vision impairment. Although pars plana vitrectomy (PPV) is the primary method for MF treatment, there is still a large proportion of recurrent MF due to the extremely long global axial length and posterior staphyloma. Macular buckling (MB) surgery aims at counteracting the traction exerted by the posterior staphyloma, and has been proven an effective method for treating MF. Optical Coherence Tomography (OCT) is widely used for the structural analysis of MF. Multifocol electroretinogram (mfERG) is an objective examination for visual evaluation. To our knowledge, there is a lack of data on the comprehensive visual function evaluations of MF patients associated with OCT findings. Our clinical trial aims to provide the structural and functional relationship in MF patients undergoing MB surgery, and find out potential factors to determine the visual prognosis.


Eligibility Criteria:
Inclusion Criteria:

1. axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter;
2. macular foveoschisis that requires surgical intervention.

Exclusion Criteria:

1. ocular trauma or surgery history;
2. glaucoma, diabetic retinopathy;
3. intraocular active hemorrhage or inflammation;
4. unable to coordinate the OCT, mfERG, or other ophthalmological examinations.
OxIGen: Oxford Imagery Generation: Investigating the Effects of an Internet Based Computer Program in Depression

This research study is designed to investigate the effects of an online computer program, called OxIGen (Oxford Imagery Generation), on thinking style and mood in depression. The OxIGen program will be delivered online over four weeks and with follow-up at one, three and six months. This will inform potential future development of this computerized task into an online intervention to modify negative thinking styles in depression.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give consent to the study
* Male or Female, aged between 18 and 65 years
* Current Major Depressive Episode (assessed by semi-structured clinical interview)
* Access to internet in order to complete the online program
* Able to travel to research centre for assessment appointments
* Fluent in written and spoken English

Exclusion Criteria:

* Meets criteria for current psychotic disorder
* History of mania or hypomania as assessed by semi-structured clinical interview, or has elsewhere received a diagnosis of Bipolar disorder
* Antidepressant medication begun or changed in dosage during last month
* Meets criteria for current substance abuse disorder
* Involved in other current treatment trials
* Currently receiving psychological therapy
Safety and Tolerability Study of REGN846 (SAR302352) in Healthy Volunteers

This study is being conducted to assess the safety and tolerability of a single ascending intravenous (IV) dose of REGN846 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile
* Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, inclusive
* Normal vital signs after resting in a sitting position for 5 minutes:
* Normal standard 12-lead ECG
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed informed consent
* Able to understand and complete study-related questionnaires

Exclusion Criteria:

* Current or prior history of smoking
* Any illness or condition that would adversely affect the subject's participation in this study
* Hospitalization within 60 days of the screening visit
* Any clinically significant abnormalities observed during the screening visit
* History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
* History of positive blood test for hepatitis B/hepatitis C or positive hepatitis screen result at the screening visit
* History of positive drug screen result for drug or alcohol abuse within a year prior to the screening visit
* Known sensitivity to any of the components of the Investigational Product formulation
* Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit
* Any condition that would place the subject at risk, interfere with participation in the study
* History of a parasitic infection or recent (within the previous 6 months) travel to a parasitic endemic area
* Live/attenuated vaccinations within 12 weeks of screening or during the study
* Any subjects with planned elective surgery
* Sexually active men who are unwilling to utilize adequate contraception
CD147 Targeting Nanobody Probe for PET Imaging in Solid Tumors

The objective of the study is to construct a noninvasive approach using 68Ga-NOTA-MAL-NB147 PET/CT to detect the CD147 expression of tumor lesions in patients with Solid tumors and to identify patients benefiting from CD147 targeting treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Histopathologically or cytologically confirmed malignant melanoma, hepatocellular carcinoma, colorectal cancer, pancreatic cancer, breast cancer, gastric cancer, and lung cancer.
2. Aged ≥18 and ≤75 years, with no gender restrictions.
3. ECOG score of 0 or 1.
4. Expected survival time ≥6 months.
5. At least one easily accessible lesion that can be biopsied within one month before or after the PET scan. The patient consents to using archived or fresh biopsy tissue samples for relevant analysis.
6. Blood routine and liver/kidney function must meet the following criteria: Blood routine: WBC ≥ 4.0×10⁹/L or neutrophils ≥ 1.5×10⁹/L, PLT ≥ 100×10⁹/L, Hb ≥ 90 g/L; PT or APTT ≤ 1.5 ULN; Liver/kidney function: T-Bil ≤ 1.5×ULN (upper limit of normal), ALT/AST ≤ 2.5×ULN or 5×ULN (for subjects with liver metastases), ALP ≤ 2.5×ULN (if bone or liver metastases exist, ALP ≤ 4.5×ULN); BUN ≤ 1.5×ULN; SCr ≤ 1.5×ULN; At least one measurable target lesion according to RECIST 1.1 criteria.
7. Women must use contraceptive measures during the study or for six months after the study ends (effective contraceptive methods include sterilization, hormonal intrauterine devices, condoms, contraceptive pills/devices, abstinence, or partner tubal ligation, etc.). Men must agree to use contraceptive measures during the study or for six months after the study ends.
8. Able to understand and voluntarily sign the informed consent form, with good compliance.

Exclusion Criteria:

1. Pregnant or breastfeeding women, or women planning to become pregnant during the study or within three months after administration, as well as individuals donating sperm or oocytes.
2. Individuals known or suspected to be allergic to the investigational drug or any of its components.
3. Individuals with significantly abnormal liver or kidney function: serum total bilirubin (TBIL) \> 1.5 × 20 µmol/L, or aspartate aminotransferase (AST) \> 2.5 × 45 µmol/L, or alanine aminotransferase (ALT) \> 2.5 × 40 µmol/L, or serum creatinine \> 1.5 × 130 µmol/L.
4. Unable to cooperate in completing the PET scan, or suffering from claustrophobia or other conditions that prevent cooperation during the PET scan.
5. Other situations deemed inappropriate for participation in the trial by the investigator. Female patients who are pregnant or breastfeeding.
Evaluating Patient Reported Outcomes in Radiation Therapy, the PRO-RT Study

This study explores the use of the Hugo platform to involve study participants in their healthcare and treatments. The Hugo platform may allow researchers to collect better and more accurate real-time health data, from other clinics/hospitals, pharmacies and other electronic devices. The purpose of this research is to see if the use of the Hugo platform is consistent, accurate, cost effective, and time efficient, as it collects and transmits important real-time health information from other clinics/hospitals, pharmacies, and other electronic devices.

PRIMARY OBJECTIVES:

I. Evaluate the data aggregation from a patient centered platform over a follow up period for completeness and quality, including externally linked electronic health record (EHR) information, toxicity completion, and the patient reported outcomes (PRO) response rates for study patients, compared with historical pre-coronavirus disease (COVID) cohort of registry patients.

II. To explore biometric information obtained from wearables as it pertains to the toxicity of treatment for patients using a wearable device.

III. To estimate app-based survey completion rates using Hugo-based survey incentive completion (gift cards).

IV. To explore the cost data available on the platform.

OUTLINE:

Patients complete surveys via the Hugo Platform at baseline (before treatment), after treatment, and at 3 and 6 months after treatment. Patients' medical records and Fitbit information are also collected into the Hugo Platform.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* English speaking
* Consented for Outcomes Registry Study (15-000136)
* Undergoing radiotherapy for cancer treatment with curative intent
* Willing to and able to give consent and participate in study
* Willing to complete all surveys
* Able to access a device (computer, smartphone, or tablet) with web access every day to complete study surveys
* Willing to connect to a device (i.e., a smartphone, Fitbit, or tablet) that can regularly link to Hugo for data transfer
* Willing to share personal information to Tremendous to be able to obtain the Visa e-cards for time and effort put into this study
* Willing to use the Hugo health data sharing platform
* Willing to create a Mayo Clinic Patient Portal (if not already created)

Exclusion Criteria:

* Unable to give consent and enroll prior to administration of baseline survey
* Partial breast radiation therapy (RT) (3 fraction), due to overlap in cadence used for all disease sites
* Stereotactic body radiation therapy (SBRT) to the lung, due to overlap in cadence used for all disease sites
* Co-enrollment on another PRO related study (soft rule)

  * Coordinator would need to get source data from Adam via Hugo
  * Response data will only be accessible by select people
Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS)

The aim to evaluate whether activation of the hypothalamic-pituitary-gonadal axis in PCOS is associated with transient microstructural and metabolic changes in the female hypothalamus using MRI approaches to assess water diffusion and measure proton magnetic resonance spectra.


Eligibility Criteria:
Inclusion Criteria:

For all subjects

* Aged from 19 to 30 years
* Body mass index : 18-25
* Informed consent before inclusion
* Do not smoke the 3 days before the MRI

For Healthy volunteers subjects :

* Regular cycles (between 25 and 35 days) AND ovulatory.
* No signs of hyperandrogenism.
* Subjects desirous of taking oral contraceptives (estrogen/progestin combination).
* For the realization of the 2nd MRI: to be during the 3rd month of a treatment well followed by oestro-progestative monophasic minidose to 0,02mg of Ethinyl-oestradiol / 0,1mg Levonorgestrel.

PCOS women:

* PCOS defined by Rotterdam criteria
* Needing a treatment with cyproterone acetate
* To carry out the 2nd MRI: to be in progress during the 3rd month of a treatment well followed by 50 mg of Cyproterone acetate in association with 2mg / day of natural estradiol.

Exclusion Criteria:

* Hormone treatment within 3 months prior to inclusion (including birth control pill )
* On-going pregnancy (determined before each MRI scan visit)
* Claustrophobia
* Any metal or foreign implants (e.g., aneurysm clips, ear implants, heart pacemakers or defibrillators)
* Diabetes or known dysthyroidism.
* Current substance abuse (including smoking more than 5 cigarettes/day; determined using drug screening at the screening visit)
* Pregnancy or breastfeeding the last 3 months.
* Practice of intense physical exercise (ex jogging\> 10km) the day before the MRI.
* Person incapable of consenting, or enjoying legal protection (guardianship / curatorship).
* Unability to understand the treatment protocol
NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT

The current study is a single center randomized control trial that will examine the effect of closed incision negative pressure wound therapy (ciNPT) versus conventional dressing on abdominal incision in a deep inferior epigastric perforator (DIEP) flap based reconstruction. Patients will be followed by 30 days post-operatively to compare outcomes including the rate of surgical site infection, seroma, and the scar quality.

The current study will examine the effect of closed incision negative pressure wound therapy on DIEP flap donor site. A total of 520 patients who are candidates for DIEP flap-based breast reconstruction will be included in this study, and randomly divided into the two groups. Those with contraindications to ciNPT will be excluded. The surgical consultation and procedure will be conducted same for both groups. Patients will be followed by 30 days post-operatively. Outcome measures will include incidence of surgical site infection, wound dehiscence, seroma, hematoma, delayed wound healing, and surgical scar quality.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are undergoing either immediate, or delayed reconstruction of the breast following mastectomy
* Patients going either unilateral or bilateral reconstruction

Exclusion Criteria:

* Patients who are not candidates for DIEP flap based breast reconstruction, such as those with insufficient abdominal tissue, or unfit for the surgery will be excluded from this study. -
* Patients who have contraindications to the ciNPT
* Patients who have pre-existing conditions that may confound results such as bleeding disorder or therapeutic anticoagulation will be excluded from the study.
* Patients who do not want to carry an additional canister from the ciNPT during the initial recovery phase will be excluded from the study.
Saint Luc Valve Registry

The "Cliniques Universitaires Saint Luc" are one of the high specialized center in valvular heart diseases and valvular heart surgery. Aortic stenosis, mitral and aortic regurgitation are the three valve pathology that are mainly frequent and studied.

International guidelines in the management of valvular heart diseases are based on few limited old studies, mainly retrospective. And, a matter of concern is staying, about the timing of surgery for asymptomatic patients.

A prospective registry will help us to better understand the pathologies and try to better define guidelines criteria for surgery.

With this prospective registry, all patients with aortic stenosis, mitral and aortic regurgitation will be followed. The investigators will find followed patients not yet operated or until surgery, but also patient after surgery according to the presence or abscence of guidelines criteria.

It will permit to compare different kind of management of patients with valvular heart disease and to better define guidelines criteria for surgery.

Eligibility Criteria:
Inclusion Criteria:

* Presence of aortic stenosis, mitral or aortic regurgitation at the time of an echocardiography at the "Cliniques Universitaires Saint Luc".

Exclusion Criteria:

-
Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers

The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of multiple rising doses of BI 113608 in healthy male volunteers


Eligibility Criteria:
Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
Internet for Anesthesia Information : a Patient Questionaire

Patients need information for perioperative period and internet may be an interesting alternative.This study analysed by questionaire what does patient look on internet: information of perioperative period and specifically for anesthesia. Questionaire (8 questions) are distributed to the patient before surgery and after they were prepared by surgeon. Population : adult (\> 18 y), no emergency procedure.The mean question is the use of internet for anesthesia information.

This is a prospective study with 23 centers ( France, Suisse, Belgium, Canada) including before surgery: adult (\> 18y), no emergency procedure. Questionaires (8 questions) are distributed to the patient before surgery and after they were prepared by surgeon. After collecting all questionaires, questionaires are analysed by an independant center. The mean question is the use of internet for anesthesia information. More than 8000 patients have to be enrolled during the study period over 23 centers.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\> 18 yr)
* surgery
* private or public hospital

Exclusion Criteria:

* refusal,
* emergency surgery
* epidural analgesia for pregnant patient
Exploration the Mechanism of Ba-Duan-Jin Therapy in the Management of Fibromyalgia

Fibromyalgia (FM) is a chronic debilitating musculoskeletal pain syndrome. "Central sensitization" is an important mechanism of the disease. Recent studies have shown that "microbiome-gut-brain axis" imbalance may be one of the important mechanisms of "central sensitization". The purpose of this study was to investigate the therapeutic mechanism of Ba-Duan-Jin therapy in the treatment of fibromyalgia by improving intestinal microecology. The mechanism was evaluated by comparing the results of brain functional MRI (fMRI) and microbacterial analysis of the patients' stool pre and post treatment .


Eligibility Criteria:
Inclusion Criteria:

* meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia and 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria;
* be between the ages of 18 to 70 years;
* not taking medication for FM for at least 4 weeks;
* no special eating habits.

Exclusion Criteria:

* had practiced Ba-Duan-Jin, Tai Chi, yoga or other forms of Qigong exercise within 12 months of their recruitment to the study;
* be less than 40mm of pain VAS score;
* had renal failure, severe depression or anxiety;
* had any poorly-controlled comorbid medical conditions, such as dementia, cancer, thyroid disease, inflammatory arthritis;
* pregnancy or planned pregnancy within the study period;
* patients residing more than 70 miles from the research site;
* patients with a history of head trauma;
* a smoker or drinker;
* contraindications for MRI,including metal implants, cardiac pacemaker,false tooth, surgical artery clips, metal tattoos or claustrophobia;
* patients with cerebral infarction or cerebral hemorrhage.
Validation of Swedish Short PROM för Venous Insufficiency

Validation of a new short Swedish patient reported outcome measure for superficial venous insufficiency. Analysis of its capacity to measure quality of life and its responsiveness to change caused by treatment.


Eligibility Criteria:
Inclusion Criteria:

* agrees to participate, diagnosed with superficial venous insufficiency C2-C6

Exclusion Criteria:

* does not want to participate, less than C2, does not submit the answered questionnaires
The Technical Operations And Standard Clinical Application Protocol of CBBCT in Diagnostic Process of Breast Cancer

This study intends to recruit about 800 volunteers with 400 malignant cases and 400 benign cases (negative results included). The information acquired from those cases mainly includes: image acquirement parameters, physical examination data of patients, scanning positions, radiological images and diagnosis reports of CBBCT, mammography, breast ultrasound, MRI (if any), pathologic reports, follow-up reports and the like. The image quality comprehensive evaluation and multi-observer, multi-case diagnostic comparing experiment will be processed. With the pathologic report as gold standard, diagnostic comparing experiment between CBBCT and mammography, breast ultrasound, MRI will be designed to determine the differences between various lesions' presentation on CBBCT and on other approaches with diverse breast conditions (size, density).

The problems to be solved in this study include:

1. Standardize the scanning positons, equipment parameter settings and other technical essentials based on the comprehensive analysis of image data acquisition, image quality and diverse patients' conditions, so as to guarantee image quality stability.
2. Summarize the breast anatomic features, typical and atypical lesions' characteristics on CBBCT image based on the analysis of 3D-CBBCT data and pathologic results as well as the comparing of CBBCT with other approaches, so as to establish the radiological diagnostic standard of CBBCT.
3. Standardize the application consensus of CBBCT based on the image features, data acquisition process and patients' conditions.


Eligibility Criteria:
Inclusion Criteria:

* Female, older than 35 years. Already have mammography, or other standard exams (ultrasound, MRI, etc). Could participate this trial within 2 weeks after mammography. Have the ability of consent inform.

Exclusion Criteria:

* During pregnancy or lactation period. Patients that may not be capable of prone position, such as patients with scapulohumeral periarthritis, cardiac pacemaker or have recent cardiac surgery.

Lymphoma patients that under therapy. Severe scoliosis.
Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance

Obesity is an epidemic in Western society and is the biggest risk factor for insulin resistance and type 2 diabetes. The investigators have preliminary evidence showing that hyperbaric oxygen therapy rapidly increases insulin sensitivity in humans. This requires confirmation in a larger population, and with this study the investigators will also test for mechanisms how this occurs. The investigators suspect that modulation of hypoxia and stress response proteins following changes in tissue oxygenation may contribute to these improvements. This study has the potential to yield new and important insights into the insulin resistance in obesity.


Eligibility Criteria:
Inclusion Criteria:

* Obese men with and without type 2 diabetes aged 45-70
* Lean men without type 2 diabetes aged 45-70

Exclusion Criteria:

* smokers
* claustrophobic
* sleep apnoea
* blood donor
* exercise more than 2 times per week
* under certain medications eg: bleomycin,corticosteroid