cyrilzakka/clinical-trials huggingface dataset:
OCTA (Optical Coherence Angiography Tomography) Versus Structural OCT(Optical Coherence Tomography) in Neovascular AMD (Age Macular Degeneration)

The objective is to find if there is a relationship between the Fractal Dimension, the gap, vascular density (VD), the surface, the span ratio and the status of the choroidal neovessels to adjust the interval between 2 intravitreal injections nor on the qualitative aspect of Optical Coherence Structural Tomography but also on quantified quantitative and objective values.

This quantification is based on the analysis of fractal dimension (FD, without unit), lacunarity (Lac, without unit), vascular density (VD,%) and surface area of choroidal neovascular ( CNV, mm2).

The fractal dimension of a vascular structure corresponds to its degree of complexity. Fractals are models found in nature and biological systems that show self-similarity at different magnifications. It is obtained from the "box counting" method calculating the number of vascular segments contained in squares of varied size. Normal retinal vessels have a known and quantified complexity (FD = 1.7).

A neovascular tumor treated with anti-angiogenics will reduce vascular density, losing its random architecture; the investigators observe a return to a model standardized. NVCs have a random organization. The lower the FD, the more random the vascular architecture.

Lacunarity represents the texture or the homogeneity of a lesion, this one is heterogeneous when it is little vascularized and homogeneous if the vascularization is very dense. The lower the lake, the more homogeneous the lesion.

FD and Lac are obtained in Angiography Optical Coherence Tomography (OCTA) by the analysis of the hypersignal detected on the cut of the external retina.

The image is automatically binarised and skeletonized. NVC delineation is automatic and associated with automatic background noise processing. This software is fully automatic whose inter and intra grader reproducibility will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Man / woman over 50,
* Showing type 1 or type 2 CNV (choroidal neovessel) related to AMD during the second year of follow-up.
* Acceptance to participate in the protocol
* Affiliated to a social security scheme

Exclusion Criteria:

* Type III CNV related to AMD,
* Other cause of CNV
* Signal less than 80 decibel and detachment of pigment epithelium (PED) greater than 250 μm on structural OCT B.
* Protected Majors (Guardianship, Curator, Safeguard of Justice)
* Participation in another interventional research.
* Refusal to participate in the study
Clinical Evaluation of a Wheelchair Mounted Robotic Arm

The primary purpose of this project, is to evaluate the effect of a wheelchair mounted robotic arm (WMRA) to improve the functional independence of veterans with SCI.

The study will determine if the ability to perform marker tasks within the following four categories is improved after the 4 week training period using the robotic arm:

1. activities of daily living, 2. vocational tasks, 3. advanced tasks, and subject-specific tasks.

The primary purpose of this project, is to evaluate the effect of a wheelchair mounted robotic arm (WMRA) to improve the functional independence of veterans with SCI.

The study will determine if the ability to perform marker tasks within the following four categories is improved after the 4 week training period using the robotic arm:

1. activities of daily living, 2. vocational tasks, 3. advanced tasks, and subject-specific tasks.

The secondary purposes of this project are the following: 1.Does quality of life (life satisfaction and health status) improve after a 4 week period of using the WMRA? 2. What are the perceived advantages of the WMRA to the veteran with SCI? Additionally, the study will evaluate the following: 1) ease of installation and usefulness of instructional manuals; 2) training requirements (time, tasks); 3) safety features; 4) reliability of the device; 5) home, community, and vocational applications; 6) user acceptability; 7) maintenance/ service; 8) portability; and possible modifications.

Eligibility Criteria:
Patients with spinal cord injuries
A Bioequivalence Study Comparing Clopidogrel/Aspirin Combination Tablet With Coadministration of Clopidogrel and Aspirin

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of clopidogrel and aspirin in free combination as HCP0911.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 55
* Signed informed consent

Exclusion Criteria:

* Has a history of hypersensitivity to IP ingredients
* Hypotension or hypertension
* Has a history of acute infection within 14days of screening
Outcomes of Transanal Tran-section and Single-stapled (TTSS) Ileal Pouch-Anal Anastomosis

This study aims to compare the functional and surgical outcomes of Ulcerative Colitis (UC) patients undergoing Transanal Transection and Singl-Stapled (TTSS) versus Double-stapled Ileal Pouch-Anal Anastomosis (IPAA)

Ileal Pouch-Anal Anastomosis (IPAAI in Ulcerative Colitis (UC) patients is usually performed by double-stapling technique after rectal transection with a linear stapler. Double-stapling is increasingly criticized for the uneven longer cuffs and potential weak points. The Transanal Transection and Single-Stapled (TTSS) approach may potentially overcome the limitations of double-stapling. A single-stapled anastomosis may be accomplished through a transanal rectal transection followed by bottom-up dissection (transanal-ileal pouch-anal anastomosis) or through an abdominal, rectal dissection and subsequent transanal transection and single-stapled anastomosis. TTSS-IPAA approach was shown to provide reduced rectal cuff length and reduced rate of urgency at six months after stoma closure. However, the retrospective and single-center features of these findings may prevent a robust conclusion about the superiority of TTSS-IPAA. The purpose of this study is to compare short-term and functional outcomes of double-stapling versus TTSS techniques for IPAA in UC patients in a prospective multicentric cohort study.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years old) patients diagnosed with drug-refractory and/or steroid-dependent UC scheduled for elective restorative proctectomy.
* Patients scheduled for robotic or laparoscopic surgery

Exclusion Criteria:

* Planned open surgery.
* Concomitant colorectal cancer or dysplasia. Patients with an incidental intraoperative diagnosis of colorectal cancer will be withdrawn from the study.
Interest of Intravenous Ondansetron in the Prevention of Spinal Anaesthesia-induced Hypotension in Caesarean Section

The intravenous injection of 8mg of ondansetron (a serotonin type 3 receptor antagonist) before spinal anaesthesia for caesarean section, leads to a smaller reduction in systolic arterial pressure (SAP).

The expected results are a decrease in the frequency and severity of hypotension, thus leading to improved comfort for the mother and decreased maternal and foetal morbidity. Indeed, episodes of hypotension are responsible for impaired foeto-placental circulation, with sometimes severe consequences for neonates.

It has been established that episodes of hypotension alter foetal pH. Investigators therefore hope to see a smaller reduction in SAP in the ondansetron group, and show a benefit for the infant.

One of the objectives of this study is also to observe a decrease in the quantity of vasopressors used and thus to avoid the adverse effects of their use in high doses.

The expected results are thus an improvement in haemodynamic stability during spinal anaesthesia for caesarean section.

The originality of this project lies in the use of a CNAP monitor (Continuous Non-invasive Arterial Pressure) as the collection of haemodynamic data will allow greater precision with the continuous measurement of AP, as well as a study of maternal cardiac output.


Eligibility Criteria:
Inclusion Criteria:

* Persons who have provided written informed consent
* Persons with national health insurance cover
* Patients aged over 18 years, ASA I or II
* About to undergo scheduled or non-scheduled caesarean section under spinal anaesthesia

Exclusion Criteria:

* Adults under guardianship
* Contra indication for spinal anaesthesia (SA) (refusal, haemodynamic instability, innate or acquired coagulation disorder)
* History of hypersensitivity to Zophren or local anaesthetics
* Heart and/or kidney failure
* Treatment with angiotensin converting enzyme (ACE) inhibitor, Beta Blockers, or angiotensin II receptor antagonist (ARA II), Zophren, atropine, Selective Serotonin Reuptake Inhibitors, Triptans
* Caesarean in a context of extreme emergency, with a time to foetal extraction incompatible with SA and the injection of Zophren, (up to 30 minutes) and requiring consent in an emergency.
* Pregnancy-related arterial hypertension (AHT)
* Pre-eclampsia
* Gestational diabetes
Long-Term Follow-up Study of Early Stage Breast Cancer Patients Included in GEICAM Studies

This is a multicenter, cohorts study to collect information from patients diagnosed with early-stage invasive breast cancer who have been previously included in a neoadjuvant or adjuvant clinical trial of the GEICAM group.

Patients will be included in this study from the moment of completion of the follow-up of the studies of origin and will be followed for approximately 30 years

One consequence of the improvement in survival rates of certain tumors such as breast cancer is the increase in the number of patients available for long-term follow-up in randomized controlled clinical trials. This long follow-up allows an additional long-term evaluation of the efficacy, as well as of the sequelae related to the treatments that may occur beyond the time of the primary analysis.

The target population of the study are all patients who were included in neoadjuvant and adjuvant clinical trials of GEICAM performed by the goup since 1998 in the medical oncology units of the participating sites, ensuring a follow-up of patients of approximately 30 years. This will allow to describe the long-term evolution of the patients with invasive breast cancer in early stages.

The information obtained will be very useful to professionals involved in the diagnosis, treatment and monitoring of breast cancer, hospital managers, patients with this condition and society in general. This study provides data of great interest for the estimation of long-term disease requirements.

Eligibility Criteria:
Inclusion Criteria:

* Patients included in neoadjuvant and adjuvant clinical trials with GEICAM's participation. If any of these patients had taken part or is participating in another clinical trial, she/he is eligible for this trial and her/his information will also be collected.
* Patients whose death or contact loss has not been previously collected in the databases of the original studies.

Exclusion Criteria:

* Patient who were not included in the analyses of the original studies due to non-compliance of the eligibility criteria or the original study informed consent withdrawal.
Evaluation of a Non-Invasive Electrocardiogram-Assisted Blood Pressure Monitor

Approximately one billion people suffer from hypertension worldwide. At least 10% of this population, that is, 100 million people, also suffers from associated chronic conditions namely, atrial fibrillation (AF), obesity, arterial stiffness (AS), and heart failure (HF). Personal interaction with medical practitioners (doctors) and review of published clinical research confirms that current non-invasive automatic blood pressure (BP) monitors that rely on BP pulse analysis alone cannot provide accurate measurement due to the unpredictable/weak nature of BP pulses in the above-mentioned chronic conditions. Lack of accuracy in BP estimation can lead to wrong diagnoses and hence to complications such as stokes and heart attacks.

The Sponsor is developing a novel non-invasive BP monitor that is similar to existing automatic monitors yet is capable of acquiring and analyzing electrocardiogram (ECG) data in conjunction with BP pulse data to provide better and more accurate measurements in the above chronic conditions.

The objective of this clinical trial is to evaluate the performance of this ECG-assisted BP monitor against invasive BP measurements in a small group of patients who suffer from the above conditions.


Eligibility Criteria:
Inclusion:

1. Patients undergoing an angiography in the catheterization lab who also suffer from at least one of the following chronic conditions:

   * Established diagnosis of AF.
   * Obesity characterized by a BMI \> 40 (extremely high, Class III).
   * Established diagnosis of AS.
   * Established diagnosis of HF.
2. Age ≥ 18 years.

Exclusion:

1. Patients unwilling or unable to comply with study requirements.
2. Failure to sign the informed consent form.
3. Age \< 18 years.
Survival Study of the Genutech® Total Knee Arthroplasty

Prospective cohort sudy of patients undergoing a Genutech® total knee arthroplasty

A prospective cohort study will be performed collecting patient's data before and after the total knee arthroplasty surgical procedure at one, five and ten years. The main goal of this work is to prospectively study the results obtained with the implantation of the knee prosthesis currently used in the Orthopaedic Service of Sant Rafael Hospital of Barcelona (Genutech®). The main outcome of the study is the survival of the implant, that is, having no revision surgeries in the follow-up. The secondary objective is the clinical and radiological evaluation of the implants measured by outcome measueres: Oxford Knee Score (OKS), SF12 questionnaire and WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionaire. OKS and SF12 scores are higher with good results and lower with bad results. WOMAC expresses results the other way around.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years with knee osteoarthritis that had not responded to conservative treatment
* capable of providing informed consent
* patients who receive a Genutech® total knee prosthesis at the investigators' Institution.

Exclusion Criteria:

* having received a prior total knee arthroplasty in the same joint
* inability to provide informed consent
* not willing to participate in the study
A Study to Evaluate Safety, Pharmacokinetics and Anti-Tumor Activity of RO7300490, as Single Agent or in Combination With Atezolizumab in Participants With Advanced Solid Tumors

A study to evaluate the safety, pharmacokinetics and anti-tumor activity of RO7300490 as a single agent or in combination with atezolizumab. The study will consist of 3 parts: \[Part 1\] Dose-Escalation of RO7300490 as a single agent; \[Part 2\] Dose-Escalation of RO7300490 in combination with atezolizumab and \[Part 3\] Dose-Expansion of RO7300490 in combination with atezolizumab in selected cancer types.


Eligibility Criteria:
Inclusion Criteria:

* Life expectancy of \>= 12 weeks.
* Histologically confirmed diagnosis of locally advanced and/or metastatic solid tumors that are not amenable to standard therapy.
* Radiologically measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Agreement to provide protocol-specific biopsy material.
* Adverse Events (AEs) from prior anti-cancer therapy resolved to Grade =\<1.
* Adequate performance status and cardiovascular, hematological, liver, renal and coagulation function.
* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating eggs.
* For male participants: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm.

Exclusion Criteria:

* Known central nervous system (CNS) primary tumors or metastases, including leptomeningeal metastases, unless protocol-specific conditions are met.
* Active second invasive malignancy within two years prior to screening.
* Significant cardiovascular/cerebrovascular disease within 6 months prior to study treatment start.
* Any other diseases, metabolic dysfunction, physical examination finding or clinical laboratory finding that gives reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug.
* Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
* Active or history of autoimmune disease.
* Known hypersensitivity to any of the components of RO7300490 formulation or to components of atezolizumab formulation.
* Pregnancy, lactation or breastfeeding.
* Dementia or altered mental status that would prohibit informed consent.
* Major surgery or significant traumatic injury within 28 days prior to the first study drug administration (excluding biopsies) or anticipation of the need for major surgery during study treatment.
* Treatment with radiotherapy, chemotherapy, hormonal therapy, targeted therapy, immunotherapy or investigational drug concurrent or within 28 days or 5 half-lives of the drug (whichever is shorter) before the first study drug administration.
The Detection of Heat Stress by Assessing Individual Body Responses to Heat (Heat Strain) in Young and Healthy Non-athlete Participants

• This study investigates and compares the within and in-between variances of the body responses to different heat stressors in a controlled lab-setting. The participants will be exposed to different heat sources while a variety of physiological heat strain reactions such as heartrate, sweat rate, and core body temperature are recorded using on- and in-body devices. For the participant monitoring during the study, medical grade devices such as a certified ECG and a swallowable sensor-pill to continuously monitor the core body temperature will be applied. A one-for-all wearable device is additionally applied for physiological validation. Further, sweat will be collected to assess (i) the local sweat rate and (ii) the appearance of different heat stress associated molecular markers in this non-invasively collectable biofluid. As a secondary aim, a model will be developed that will enable to predict the different heat stress sources out of the heat strain measurements.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participant, able to give consent
* Age 18-40 years
* Non-athlete (\<4h sport/week)
* BMI\<30 (non-obese)
* German speaking, or fluent in German

Exclusion Criteria:

* Pregnancy (urine pregnancy test), and breastfeeding
* Regular medication intake (excluding birth control pill)
* Intake of drugs and/or daily alcohol consumption
* Fever or symptoms of an acute infection (cough, shortness of breath, sore throat, taste loss)
* Active smoking or history of smoking \<9 months ago
* Mobility impairment
* Traveled (\<1 month ago) to a warm/hot temperature zone and stayed for \>6 days
* Any chronic conditions such as: high blood pressure, diabetes mellitus, immuno-deficiencies, sweat disorders such as anhidrosis
* Color blindness (STROOP test)
* Weight \<40 kg (e-Celsius pill)
* Diverticulum or obstructions of the gastrointestinal tract (including motility disorders, swallowing disorders) as well as major abdominal surgery (e-Celsius pill)
* Need of exposure to strong electromagnetic fields during study participation, above all MRI examinations (e-Celsius pill)
Pilot Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin (Boca HBVIg) Used in Combination With Lamivudine for Patients With Hepatitis B Virus (HBV) Associated Liver Disease Undergoing Liver Transplantation

The purpose of this study is to find the best monthly dose schedule for the new Hepatitis Immune Globulin (Boca HBVIg, a study drug) when used in combination with an antiviral agent Lamivudine after liver transplantation. Boca HBVIg will be given along with Lamivudine to prevent hepatitis B reinfection following liver transplantation in patients with end stage liver failure due to hepatitis B infection.


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years old or greater, either male or female, of any ethnic background.
* Be positive for HBsAg. Patients may be either positive or negative for anti-HDV, HBeAg, and HBV DNA (non-PCR assay).
* Be diagnosed with HBV-induced liver disease including either:
* HBsAg positive cirrhosis, or
* HBsAg positive and presence of hepatocellular carcinoma (HCC) with no evidence of vascular invasion or extrahepatic spread, and either:
* a single tumor no larger than 5 cm in diameter, or
* no more than three tumors, the largest of which is no greater than 3 cm in diameter.
* Have received at least one dose of Lamivudine 100 mgs po qd prior to transplantation.
* Fulfill UNOS minimal listing criteria.
* Have received approval for liver transplantation at the respective participating center and are listed as Status 2 or 3 and felt to be within three months of liver transplantation.
* If requiring retransplantation for primary graft nonfunction or hepatic artery thrombosis, retransplantation must take place within the first four weeks of the initial transplant with no evidence of recurrent hepatitis B.
* Be able and willing to give written informed consent. In patients with Grade 3 or 4 hepatic encephalopathy, a legal guardian must be available to provide consent. In the case of a minor, a parent or guardian must provide consent.
* If a woman of childbearing potential, have a negative serum beta HCG pregnancy test within 14 days prior to starting Lamivudine therapy and within 14 days prior to transplant and agree to practice contraception during the study (a total of 36 weeks).

Exclusion Criteria:

* Eligible patients must not:
* Require retransplantation for recurrent hepatitis B.
* Have chronic hepatitis B liver disease with a history of breakthrough infection on Lamivudine
* Have other causes of liver disease including chronic hepatitis C.
* Have HCC and do not meet Inclusion Criterion #3, or who require systemic chemotherapy.
* Be seropositive for HIV infection.
* Be using experimental devices or receiving experimental drugs.
* Be participating in any other clinical treatment trial with an investigational drug within 30 days prior to liver transplantation or plan to receive another investigational drug during this study.
An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males

To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and its primary metabolite LX1033.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 30 to 65 years of age.
* Male subjects and their partners must agree to use an adequate method of contraception
* Historically able to produce a minimum of 1 bowel movement every day on most days

Exclusion Criteria:

* Female subjects
* Use of any medication or supplement within 5 days prior to Dosing
* Radiation exposure exceeding 5 millisieverts (mSv) in the last 12 months or 10 mSv in the last 5 years
* Current smokers or the use of cigarettes within 90 days prior to Screening
* History or renal disease or abnormal kidney function
* History of hepatic disease
* Acute diarrhea or constipation within 7 days of dosing
* Positive urine glucose at Screening