cyrilzakka/clinical-trials huggingface dataset:
Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD

The primary objective of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Eculizumab in Chinese Adults with Neuromyelitis Optica Spectrum Disorders (NMOSD).


Eligibility Criteria:
Inclusion Criteria:

* Participants with diagnosis of NMOSD as defined by the 2015 international consensus diagnostic criteria
* Anti-AQP4 antibody positive
* At least 1 attack or relapse in the last 12 months prior to the Screening Period
* EDSS score ≤ 7
* If a participant enters the study receiving IST(s) for relapse prevention, the participant must be on a stable maintenance dose of IST(s) as follows, prior to screening and must remain on that dose for the duration of the study, unless the participant experiences a relapse
* Female participants of childbearing potential must have a negative pregnancy test (serum HCG at screening
* Male participants are eligible to participate if they agree to the following during the study intervention Treatment Period and for at least 5 months after the last dose of study intervention:

  * Refrain from donating fresh unwashed semen. PLUS, either,
  * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR
  * Must agree to use barrier as detailed below:

    * Agree to use a male condom when having sexual intercourse with a WOCBP who is not currently pregnant.

Exclusion Criteria:

* Pregnant, breastfeeding, or intending to conceive during the course of the study
* Prior history of N meningitidis infection or unresolved meningococcal disease
* Any systemic bacterial or other infection which is clinically significant in the opinion of the Investigator and has not been treated with appropriate antibiotics
* Presence of fever ≥ 38 C within 7 days prior to study intervention administration on Day 1
* Hypersensitivity to murine proteins or to one of the excipients of study intervention
* Use of rituximab, inebilizumab, or other B cell-depleting therapy within 6 months prior to Day 1 and during the study
* Use of mitoxantrone or satralizumab within 3 months prior to screening and during the study
* Use of IVIg within 3 weeks prior to screening
* If a participant enters the study receiving oral corticosteroid(s) with or without other ISTs, the daily corticosteroid dose must be no more than prednisone 20 mg/day (or equivalent) prior to screening and the participant must remain on that dose for the duration of the study or until the participant experiences a relapse (specific medications listed in Section 6.9.1 may be allowed)
* Has previously received treatment with C5 inhibitors
* Participation in any other investigational drug study or exposure to an investigational drug or device within 5 half-lives of treatment (if known) or 30 days, which is longer, before the first dose administration
More Intensive Cardiac Rehabilitation Programs in Less Time

To determine if an intensive cardiac rehabilitation program with periodic reinforcements improve the compliance/adherence to secondary preventive measures (physical exercise, mediterranean diet, tobacco abstinence, pharmacological treatment) after an acute coronary syndrome with or without ST segment elevation versus an standard cardiac rehabilitation program


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Equal or older 18 years old
* Acute coronary syndrome with or without ST elevation within last two months
* Being able to do physical exercise
* Being able to understand the educative sessions
* Being able to understand patient information in the consent form

Exclusion Criteria:

* Hemodynamic instability
* Left ventricular ejection fraction (LVEF) \< or = 35%
* Heart failure class III -IV (New York Heart Association (NYHA) Functional Classification)
* Refractory angina
* Any pathology for which physical exercise is not indicated
Chronic Neuropathic Pain After Nerve Repair Hand Surgery

This study intends to compare the patients with pain with those who underwent same procedure without developing pain. The patients with pain and without pain will be further analyzed in respect to clinical differences, biomarkers and genetical differences.

Chronic pain is a well-known complication after surgery, but the prevalence of persistent pain after upper extremity surgery or other trauma affecting the radial, ulnar or the medial nerve, or branches of these nerves such as digital nerves is unknown. The reason that some patients develop persistent neuropathic pain after surgery, while others, who have been through the exact same procedure or trauma, are pain free is still unknown. The underlying mechanisms are still largely unknown. This can lead to different responses to treatment. Whenever possible, it is important to identify and address the underlying pain mechanisms in the individual patient in order to design an optimal treatment.

The aim of this study was to determine the prevalence and the factors implicated in the development of persistent pain after nerve suture surgery investigating Clinical symptoms, standardized clinical examination for neuropathic pain, 92 biomarkers special developed for neuropathic pain, genetics.

Conditioned pain modulation and Cold pressor test is intend to be performed in all the patients.

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Eligibility Criteria:
Exclusion Criteria:

* Other condition that may confound assessment of pain attributed to posttraumatic upper limb pain, as judged by the investigator
* Any condition/disease that could interfere with the study measurements, e.g. peripheral vascular disease, diabetes mellitus, polyneuropathy etc as judged by the investigator

Inclusion Criteria:

* • Female or male subjects \> 18 years of age

  * Provision of written informed consent
  * Be able to understand and comply with the requirements of the study
  * Patients with a history of persistent spontaneous and/or evoked pain (by e.g. touch, movement) interfering with daily activities of at least 3 months duration, associated with upper extremity surgery or other trauma affecting the radial, ulnar, medial or digital nerve
  * Spontaneous or evoked pain upon standardized test (mechanical, movement)\> 50 on a 100 mm VAS scale in the group with pain after nerve repair surgery and a group of patients with no pain
Vascular Graft Storage Solution Preserves Endothelial Function

Since Saline is still the most widely used storage and flushing solution in cardiovascular procedures despite knowing evidence of its influence on the human endothelial cell function the main aim of this study was to assess the effect of DuraGraft©, an intraoperative graft treatment solution, on human saphenous vein segments 8 Remnants from the operation after trimming the bypass length), rat aortic segments and human umbilical vein endothelial cells (HUVECs) in comparison to saline.

Saline is still the most widely used storage and flushing solution in cardiovascular procedures despite knowing evidence of its influence on the human endothelial cell function. Aim of this study was to assess the effect of DuraGraft©, an intraoperative graft treatment solution, on human saphenous vein segments, rat aortic segments and human umbilical vein endothelial cells (HUVECs) in comparison to saline. According to literature saline could have detrimental effects on the endothelium but data shows conflicting evidence. Duragraft a so called endothelial preservation solution should protect the human endothelium. Intent of this observational study was to study the effects of both solutions and compare them.

Within 12 patients undergoing aortocoronary bypass surgery, left overs from saphenous vein graft segments were randomized to DuraGraft© (n=12/6) or saline (n=12/6) solution before intraoperative storage. These segments as well as rat aortic segments underwent assessment of vascular function in a multichamber isometric myograph system in comparison to Krebs-Henseleit solution (KHS), a physiologic organ buffer solution. Additionally, human umbilical vein endothelial cells (HUVECs) were used for cell viability tests.

Eligibility Criteria:
Inclusion Criteria:

* Patient is undergoing isolated CABG procedure or CABG plus aortic or mitral valve surgery with at least one saphenous vein or radial artery grafts
* Patient is ≥18 years of age
* Patient (or a legally authorized representative) is willing and able to provide consent
* DuraGraft® is being used for the CABG procedure

Exclusion Criteria:

* Participation in a device study or receiving active drug product in an investigational study within one month (30 days) prior to enrollment.
X-82 to Treat Age-related Macular Degeneration

The purpose of this study is to evaluate the safety and efficacy of X-82 in the treatment of vision loss due to wet AMD.

Subjects will be randomized in a 1:1:1:1 ratio to the following dose groups:

* X-82 50 mg plus ivt anti-VEGF prn
* X-82 100 mg plus ivt anti-VEGF prn
* X-82 200 mg plus ivt anti-VEGF prn
* Placebo plus ivt anti-VEGF prn

Subjects will be treated for a total of 52 weeks with one of three doses of X-82 or placebo.

Primary Efficacy Outcome:

The primary efficacy outcome is the change in visual acuity score from Day -1 to 52 Weeks after randomization.

Safety Outcomes:

Systemic and ocular safety will be evaluate by assessing ECG, laboratory analyses, adverse events and serious adverse events.

Approximately 132 subjects will be randomized into one of the four arms (33 subjects per dose group).

Eligibility Criteria:
Inclusion Criteria:

* Participants mush have wet AMD which has been diagnosed and treated with anti-VEGF in one or both eyes for at least 6 months prior to joining the study and has required at least two prior injections of intravitreal (ivt) anti-VEGF at intervals of not greater than 6 weeks for the past two injections in the eye that is selected to be the study eye.
* Must have demonstrated a reduction in macular fluid or macular thickness in the study eye 14 days following an anti-VEGF injection at Screening Visit 1
* Early Treatment Diabetic Retinopathy (ETDRS) Best Corrected Visual Acuity (BCVA) of 25 letters (20/320) or better in both eyes

Exclusion Criteria:

* Previous vitrectomy to the study eye within 30 days of Screening Visit 1
* Choroidal neovascularization (CNV) due to causes other than AMD
* Proliferative diabetic retinopathy in either eye
Polysomnography and Heart Rate Indexes in Obstructive Sleep Apnea

The purpose of this study is to evaluate the diagnostic accuracy of polysomnography indexes for diagnosis of sleep apnea in human subjects obstructive sleep apnea (OSA). This includes evaluation of polysomnography indexes (AHI; AI, arousal index; ODI, oxygen desaturation index) and heart rate variability (HRV) indexes.

This is a cross-sectional study collecting data from patients from the Sleep Institute of Itaperuna, Rio de Janeiro, Brazil. Polysomnography (PSG) monitoring and diagnosis was in accordance with American Society of Sleep Medicine (ASSM) standards. Standard baseline polysomnography is performed using a computerised system. The following extracted signals are measured: 2 electroencephalogram channels (O1-A2, O2-A1, C3-A2, C4-A1), 2 electrooculogram channels, electromyography (EMG, bilateral anterior tibialis), pulse oximetry (arterial oxygen saturation), nasal-oral airflow (thermistors), and electrocardiogram (ECG derivation DII). The polysomnograms are scored according to the criteria of Rechtschaffen and Kales.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of obstructive sleep apnea with an apnea-hypopnea index (AHI) \> 5.

Exclusion Criteria:

* Subjects with a history or clinical examination suggestive of neuromuscular disease, hypertension or any surgical treatment were not considered in the study.
Smoking Cessation for Young Adult Pacific Islanders: Motivating Pacifika Against Cigarettes and Tobacco

The current study aimed to test a culturally tailored program designed to help Pacific Islanders (PIs) between the ages of 18 and 30 quit smoking cigarettes by using a randomized controlled trial design with one intervention group and one control group.

This randomized control trial (RCT) consisted of a baseline assessment (Wave 0) and three follow-up assessments (Waves 1-3). Follow-up assessments were conducted at 2 months, 5 months, and 8 months after the baseline assessment. The objective of the study was to test a culturally-tailored online program designed to help PI young adults quit smoking cigarettes. The online program contained (1) personalized, automated text messages, (2) interactive, online educational modules, and (3) an online forum.

Hypotheses for this study include:

1. Participants in the intervention program tailored to PIs would have significantly higher rates of abstinence, lower rates of relapse, and lower smoking frequency and intensity at each follow-up time point than those in the standard intervention program.
2. Participants with impaired affective decision capacity (low scores on Iowa Gambling Task (IGT)) would benefit more from the tailored intervention program than participants with normal affective decision capacity (high IGT scores).
3. Effects from the tailored intervention program would be more pronounced among participants with particular dispositional phenotypes (depression, hostility, impulsivity) and baseline severity of tobacco addiction (nicotine dependence).
4. High-intensity users of the tailored intervention program would be more successful than low intensity users in reducing the frequency and intensity of cigarettes smoked.
5. The tailored intervention program would have greater success at engaging and retaining participants than the standard intervention program.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified as Native Hawaiian or Pacific Islander
* Between the ages 18 and 30
* Lived in Southern California
* Would be living in Southern California for the next year
* Owned a cell phone with a text messaging plan
* Had access to a computer with internet for at least 2 hours per week
* Smoked daily or most days of the week (\>3 days)
* Smoked at least 100 cigarettes in lifetime

Exclusion Criteria:

• Was currently using another smoking cessation method
An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD

The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for the treatment of adult participants with NMOSD.


Eligibility Criteria:
Inclusion Criteria:

1. Anti-aquaporin-4 antibody-positive and a diagnosis of NMOSD as defined by the 2015 international consensus diagnostic criteria.
2. At least 1 attack or relapse in the last 12 months prior to the Screening Period.
3. Expanded Disability Status Scale score ≤7.
4. Participants who enter the study receiving supportive immunosuppressive therapy must be on a stable dosing regimen of adequate duration prior to Screening.
5. Body weight ≥40 kilograms.
6. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

1. History of Neisseria meningitidis infection.
2. Human immunodeficiency virus (HIV) infection (evidenced by HIV-1 or HIV-2 antibody titer).
3. Previously or currently treated with a complement inhibitor.
4. Use of rituximab or mitoxantrone within 3 months prior to Screening.
5. Use of IV immunoglobulin within 3 weeks prior to Screening.
AGN-199201 for the Treatment of Erythema With Rosacea

This study will evaluate the safety and efficacy of 3 doses of AGN-199201 once and twice daily compared to vehicle for the treatment of moderate to severe facial erythema associated with rosacea.


Eligibility Criteria:
Inclusion Criteria:

* Redness of the skin caused by rosacea

Exclusion Criteria:

* ≥3 inflammatory lesions
* Laser light-source or other energy based therapy in the last 6 months
* Any prescription or over the counter product for the treatment of acne or rosacea in the last 14 days
A Study Following Males With Haemophilia A on Prophylaxis With Esperoct®

This study will collect information on side effects and how well Esperoct® (turoctocog alfa pegol (N8-GP)) works during long-term treatment (prophylaxis) in males with haemophilia A. Participants in this study will get the same treatment as they would normally get, if they were not participating in the study. All visits at the clinic are done in the same way as participants are used to, when visiting their doctor. During visits at the clinic participants might be asked for some relevant tests if considered useful by the study doctor. During the visits the study doctor might ask if participants had any side effects since the last study visit. Participants will be asked to note down in their own diary the number of bleeds and how these were treated, as well as their regular prophylaxis. Participation in the study will last for about 5-7 years, depending on when participants join the study. Participants are free to leave the study at any time and for any reason. This will not affect their current and future medical care.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* The decision to initiate treatment with commercially available Esperoct® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
* Male patients of all ages, according to local label, are allowed in this study
* Diagnosis of severe or moderate Haemophilia A

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Known or suspected hypersensitivity to N8-GP or related products
* Mental incapacity, unwillingness or language barriers precluding adequate understanding and cooperation
* Clinical suspicion or presence of FVIII inhibitors at time of inclusion
PKU Carriers Trial (Pilot Study): Impact on Cognition, Mental Health, Blood Pressure and Metabolism

This is a clinical intervention pilot/feasibility study of PKU carriers (cases) and non-carriers (controls). Upon completing the informed consent process, participants will complete baseline measures of chronic mental health prior to the intervention (PHQ-9, GAD-7, BIS-Brief). Participants will attend the Human Nutraceutical Research Unit (HNRU) at the University of Guelph, fasted, and first undergo baseline measures of cognition and acute mental health (mood) and provide samples or saliva, urine and dried blood spots to evaluate phenylalanine (Phe), tyrosine (Tyr) and their metabolites (PAH pathway functioning). Participants will also complete a brief questionnaire which will include age, sex, ethnicity, income, weight and height (measured using a stadiometer and calibrated weigh scale), and confirmation that participants arrived to the lab fasted (i.e. have only had water to drink and no other foods/beverages prior to analyses). Blood pressure will also be measured at baseline. Following baseline tests, participants will consume a pure L-Phe supplement dosed at 100 mg/kg mixed into 250 mL water with 1 tsp white sugar. Blood pressure will be repeated at 1-hour post-L-Phe consumption. Two-hours postprandial, participants will repeat the cognitive tests and acute mental health (mood) assessment, blood pressure measurement and provide follow-up saliva, urine and dried blood spot samples. Participants will also be asked to report any side effects they experienced with the L-Phe consumption.


Eligibility Criteria:
Inclusion Criteria:

* Known carrier or non-carrier of PKU
* At least 18 years of age
* Comfortable fasting the morning of the study (no food or drink other than water)

Exclusion Criteria:

* Diagnosed with: PKU, severe neurodegenerative conditions affecting cognition (e.g. Alzheimer's, Parkinson's, dementia), melanoma, hypertension, liver disease and/or kidney disease
* Taking a Monoamine Oxidase Inhibitor anti-depressant
* Pregnant or breastfeeding
Bevacizumab for Primary Pterygium Treatment

The aim of this study was to investigate the efficacy and safety of subconjunctival bevacizumab application as an adjuvant therapy for primary pterygium.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary pterygium

Exclusion Criteria:

* Patients with diabetes mellitus
* collagenopathies,
* previous ocular surgeries,
* pregnant or lactating patients
Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer

Phase III multicentric, open-label, randomized study

The main objective is to assess the efficacy on time to disease recurrence (TTR) of treating minimal residual disease diagnosed by the presence of ctDNA after full treatment (surgery + chemotherapy) in stage III or high-risk stage II colon or upper rectum adenocarcinoma


Eligibility Criteria:
Inclusion Criteria:

* Fully resected stage III or high-risk stage II colon or upper rectum adenocarcinoma previously treated by standard adjuvant chemotherapy or peri-operative chemotherapy (FOLFOX or CAPOX) for either 3 or 6 months based on local multidisciplinary meeting, and on TNCD recommendations
* Positive ctDNA screening (methylation) and confirmation (NGS) on samples collected at the 3- or 6 months follow-up visit post-adjuvant chemotherapy
* Patients ≥ 18 years and ≤ 80 years (provided the score of the G8 geriatric questionnaire is \>14 for patients 70 years or older)
* Subjects with WHO performance status \< 2
* No documented disease using TAP CT-scanner and liver MRI in the case of contra-indication to dye contrast (or TEP-scanner may be also used in addition depending on physicians' choice and local availabilities).
* Adequate haematological function: with neutrophils ≥ 1,500 /mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL (5,6 mmol/l)

Total bilirubin ≤ 1.5 x ULN (upper limit of normal) ASAT and ALAT ≤ 2.5 x ULN Alkaline phosphatase ≤ 2.5 x ULN Creatinine clearance ≥50 ml/min according MDRD (Modification of Diet in Renal Disease)

* Available tumor sample for NGS analysis
* Signed written informed consent obtained prior to any study specific procedures
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Patients already treated with trifluridine tipiracil or irinotecan in the past 5 years
* Uncontrolled intercurrent illness
* Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 3 years
* Pregnant or breastfeeding women, women of childbearing age not having had a negative pregnancy test
* Any known specific contraindication or allergy to the treatments used in the study†
* Total or partial dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia \> 16ng/ml)
* Known Gilbert's disease (UGT1A1\*28 genotype)
* In case of concomitant use with St John's Wort related to irinotecan
* In case of bowel obstruction according related to irinotecan
* In case of recent concomitant treatment with brivudine, related to fluorouracil.
* Participation to another interventional study for postoperative therapy
* Persons deprived of liberty or under guardianship or incapable of giving consent
* Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.