cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population

The purpose of this study is to compare three different techniques of EEG recording for extraction of P300 Evoked Related Potentials (ERPs).

Brain Computer Interface (BCI) are used to restore control and communication in patient with severe disabilities such as Locked In Syndrome (LIS) patients.

The aim of this study is to identify the most relevant recording technique for extraction of P300 ERPs in EEG signals. Three different electrodes (needle, standard ,silver) will be simultaneously compared in a prospective design in 10 healthy volunteers, as suggested by principal investigator.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers male or female aging over 18
* Signed informed consent
* Passed the preliminary exam
* Registered in the national database for persons willing to participate in Biomedical research

Exclusion Criteria:

* Visual or hearing problems
* Cognitive problems
* Illiterate persons
* Persons under Guardianship or Trusteeship
* Having Epilepsy
* Pregnant women Not covered by the social security system
A Study of Barzolvolimab in Patients With Prurigo Nodularis

The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis.

The purpose of this study is to assess the efficacy and safety of barzolvolimab (CDX-0159) in adults with prurigo nodularis.

There is a screening period of approximately 28 days, a 24-week double-blind treatment period and a 16-week follow-up period after treatment. Participants will be randomly assigned on a 1:1:1 ratio to receive barzolvolimab (CDX-0159) by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg, 300 mg Q4W after an initial loading dose of 450 mg, or placebo Q4W.

Eligibility Criteria:
Key Inclusion Criteria:

1. Males and females, ≥18 years of age.
2. Diagnosis of Prurigo Nodularis by a dermatologist at least 3 months prior to Screening with:

   1. At least 20 PN nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening.
   2. An Investigators Global Assessment for stage of chronic nodular prurigo (IGA-CNPG-S) score for PN ≥ 3 at screening and Baseline (Day 1).
3. Severe itch, defined as the mean of the daily worst itch NRS (WI-NRS) score of ≥ 7 during the 7-day period immediately prior to initiation of study treatment.
4. Documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable.
5. Willing to apply a topical moisturizer (emollient) once or twice a day throughout the study.
6. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days afterwards after treatment.
7. Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.

Key Exclusion Criteria

1. PN due to neuropathy, psychiatric disorders or medications.
2. Unilateral PN lesions limited to small area on one side of the body (e.g., only one arm affected).
3. Active unstable pruritic skin conditions in addition to PN.
4. Documented atopic dermatitis (moderate to severe) within 6 months before the start of screening.
5. Females who are pregnant or nursing.
6. Known hepatitis B or hepatitis C infection or active COVID-19 infection.
7. Vaccination with a live vaccine within 2 months prior to study drug administration (subjects must agree to avoid vaccination during the study and for four months thereafter). NOTE: Inactivated vaccines are allowed such as seasonal influenza for injection. COVID-19 vaccination is allowed.
8. History of anaphylaxis.
9. Prior receipt of barzolvolimab

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Therapeutic Serious Game and Rehabilitation of Stroke Patient

The growing field of new technologies offers new perspectives for neurorehabilitation. Serious games are a promising solution in the rehabilitation of cognitive impairments, and they may be useful in the rehabilitation of unilateral spatial neglect. The investigators developed a rehabilitation program for visual exploration training with a serious game and investigated its efficiency.

Six patients with unilateral spatial neglect after a right hemispheric stroke were recruited. Three patients assigned to the experimental group received both serious game training and conventional rehabilitation, and three assigned to the control group received only conventional rehabilitation. The investigators compared the two groups after rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral spatial neglect syndrome
* Right cerebral lesion

Exclusion Criteria:

* Epilepsia
* General mental deterioration
* Psychiatric disorder
* No prior history of neurological disease
Sphenopalatine Ganglion Block for Post-Dural Puncture Headache in Orthopedic Patients

The aim of this study is to assess the efficacy, onset and duration of analgesia of sphenopalatine ganglion bock (SPGB) using lidocaine 4% with adrenaline as a treatment of postoperative Post dural puncture headache (PDPH) of orthopedic patients after lower limbs surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to the orthopedic department
* Complaining of criteria of severe post-dural puncture headache within 7 days following subarachnoid block used for lower limbs surgeries.
* American Society of Anesthesiologists (ASA) physical status I and II.

Exclusion Criteria:

* Patient refusal or uncooperative.
* Patients with uncontrollable hypertension.
* Patient with known coagulopathy.
* Patient with nasal septal deviation, polyp, history of nasal bleeding.
* Patient with allergy to local anesthetics
* American Society of Anesthesiologists physical status\>2.
Identification of Cytokine Profiles and T Cell Subsets Among Immunosuppressed Patients at Risk of Developing Active Tuberculosis

The purpose of this study is to identify differences in TB specific immune responses among immunosuppressed patients latently infected with TB and patients with active TB.

Immunosuppressed patients latently infected with TB are at higher risk of developing active TB than patients with normal immune functions. Especially two patient categories are at risk: HIV positives and patients receiving TNF-a blocking medication. Existing methods of diagnosis and surveillance of latent TB infection can not identify who will develop active TB and who can control the infection. There is a need for better understanding of TB specific immune functions,as we believe deficient TB specific immune reactions is a key in reactivation of latent TB infection.

In this study we follow groups of latent TB infected patients with either rheumatoid arthritis or HIV. We follow the patients during treatment with TNF-a blocking medication, HAART treatment or prophylactic TB medication. Results are correlated to patients with active TB, latent TB and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Latent TB infection + rheumatid arthritis
* Latent TB infection + HIV
* Active TB

Exclusion Criteria:

* Age \< 18yrs
* Pregnancy
* Patients not able to understand the given information
Genetic Polymorphisms in UGT1A6 and UGT2B7 in Asian Population: Association With Lung Cancer Phenotype

Primary

1. To determine the presence and frequency of novel and known UGT1A6 and UGT2B7 polymorphisms in healthy Chinese, Malay and Indian subjects.
2. To determine the presence and frequency of novel and known UGT1A6 and UGT2B7 polymorphisms in Chinese lung cancer patients with squamous cell and adenocarcinoma subtype.
3. To analyze the functional variations in UGT1A6 and UGT2B7 polymorphisms.

Secondary

1 To study the correlation of UGT1A6 and UGT2B7 polymorphisms with lung cancer type.

Germline polymorphisms are inherited genetic variation present in all cells of the body. At molecular level, such variations may affect gene transcription, translation, mRNA stability, protein activity, protein expression (1-3). Mounting evidences have emerged showing that genetic polymorphisms in drug metabolizing genes and DNA repaired genes are major determinants of response to drugs and carcinogens with possible predictive or prognostic value for clinical outcome (4-6). However, only a small number of all polymorphisms discovered have functional significance and it is often difficult to predict this base on nucleotide sequence alone. Genome based studies have generated a wealth of data on genetic polymorphisms far exceeds our knowledge on the function of these variants. Hence, there is an urgent need to characterize the functional and expressional impact of genetic polymorphisms in candidate genes so that appropriate target polymorphisms most likely to affect the phenotype can be selected for larger scale association studies. In this study, we will adopt a novel 2-stage approach to identify and characterize new polymorphisms in the UGT1A6 and 2B7 genes in our Asian population. Data from our initial genotyping work will then be used to optimize the study design of the stage II association study for the generation of hypothesis that lung cancer histology (phenotype) is associated with UGT polymorphisms (genotype). This study will help to advance our understanding in the functional significance and diversity of genetic variants that exist in our population. It may also shed light on the role of UGT in carcinogenesis and will provide vital ground work for future studies of risk assessment, treatment and may allow identification of at risk individual for chemoprevention and adjuvant therapy studies.

Eligibility Criteria:
Inclusion criteria for stage I study

* Subjects \>= 18 years old
* Hemoglobin \>= 8g/dL, Total white cell counts \>3.0 x 103/μl
* ECOG =0

Inclusion criteria for stage II study

* Chinese ethnicity
* Patients \>18 years old
* Hemoglobin =\> 8g/dL, Total white cell counts \>3.0 x 103/μl
* Histologically or cytologically confirmed lung cancer for stage II study
* Uncontrolled medical conditions such as diabetes, hypertension and coronary artery disease.

Exclusion criteria

* Histology of small cell lung cancer
* Medical or psychiatric conditions which may impair the patient's ability to provide informed consent.
A Single-Center, Randomized, Double-Masked, Placebo and Active Controlled, Dose-Ranging Evaluation of the Duration of Action of Brimonidine Tartrate Ophthalmic Solution in the Control of Ocular Redness Induced by Conjunctival Allergen Challenge (CAC)

The purpose of this study is to evaluate the safety, efficacy, and dose response of brimonidine tartrate ophthalmic solution as compared to placebo in the prevention of allergen-induced conjunctival redness using a conjunctival allergen challenge (CAC) model.

It is hypothesized that low-dose brimonidine tartrate ophthalmic solution will be more effective than vehicle in the prevention of conjunctival redness induced by conjunctival allergen challenge when instilled prior to the allergen challenge.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* If female, cannot be not pregnant or nursing
* Have a positive skin test reaction to cat hair, cat dander, grasses, ragweed, dog dander, cockroach, dust mite, and/or trees within the past 24 months;
* Have a calculated best corrected visual acuity of 0.6 logMAR or better in each eye as measured using an ETDRS chart;

Exclusion Criteria:

* Have known contraindications or sensitivities to the use of any of the study medications(s) or their components;
* Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety;
* Have a presence of active ocular infection;
* Use specified disallowed medications during the study or appropriate pre-study washout period;
* Have any significant illness;
* Have planned surgery (ocular or systemic) during the trial period or within 30 days after;
* Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study;
* Be a female who is currently pregnant or nursing.
Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents

The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.

The aim of this research is to evaluate the safety and efficacy of the use of the Lap-Band system in the morbidly obese adolescent population in the United States. We also propose to take advantage of the opportunity for liver biopsy and the data collected for the FDA study in adolescents to answer several questions: 1) what is the true incidence of non-alcoholic fatty liver disease (NAFLD) and its variants in morbidly obese adolescents; 2) what is the course of the NAFLD disease in adolescents who have undergone weight loss, including the progression from steatosis to NASH/ fibrosis or the progression of NASH to cirrhosis? 3) What are the factors implicated in this progression and 4) Is there a link between the excess visceral fat, MS and NAFLD as assessed by parallel changes in metabolic syndrome (MS) and NAFLD following weight loss intervention. The LAPBAND may provide obese adolescents with a significantly less morbid and reversible surgical option for weight loss.

Eligibility Criteria:
Inclusion Criteria:

* Ages 14 through 17
* BMI greater than 40
* BMI 35 to 40 and also having an obesity related comorbidity
* Have a history of working in a multidisciplinary weight loss program utilizing nutritional training, behavior modification, and activity training

Exclusion Criteria:

* Subject history of congenital or acquired anomalies fo the gastrointestinal tract
* Severe cardiopulmonary or other serious organic disease
* Severe coagulopathy
* Hepatic insufficiency or cirrhosis
* History of bariatric gastric or esophageal surgery
* History of intestinal obstruction or adhesive peritonitis
* History of esophageal motility disorders
* Type I diabetes
Clinical Study of Oral Endosseous Titanium Implants in Edentulous Subjects

The amendment to Clinical Protocol 86-D-0015, clinical study of Oral Endosseous Titanium Implants in Edentulous subjects, and patients with Ectodermal Dysplasia is to allow the Investigators to determine: (1) If placement of Endosseous Titanium Implants in pre-adolescent patients (age 7 to 10) will influence the growth and development of the craniomandibular complex. (2) The final position of the implant, the ability to fabricate prosthesis. (3) Body image, diet and perceived ease of chewing selected foods.

Selection of patients for participation in the study will be based on the number of congenitally missing teeth associated with Ectodermal Dysplasia. At least 16 permanent teeth must be congenitally missing. A total of 30 patients will be included.

A consent to participate in this study will be obtained from each patient:

18 \& older - consent signed by patient

13-17 years - consent signed by parent, assent signed by patient

7-10 years - consent by parent, assent signed by child if capable of understanding or note on chart describing procedure used to obtain the child's assent to the study

The amendment to Clinical Protocol 86-D-0015, clinical study of Oral Endosseous Titanium Implants in Edentulous subjects, and patients with Ectodermal Dysplasia is to allow the Investigators to determine: (1) if placement of Endosseous Titanium Implants in pre-adolescent patients (age 7 to 10) will influence the growth and development of the craniomandibular complex. (2) The final position of the implant, the ability to fabricate prosthesis. (3) Body image, diet and perceived ease of chewing selected foods.

Selection of patients for participation in the study will be based on the number of congenitally missing teeth associated with Ectodermal Dysplasia. At least 16 permanent teeth must be congenitally missing. A total of 30 patients will be included.

A consent to participate in this study will be obtained from each patient:

18 \& older - consent signed by patient

13-17 years - consent signed by parent, assent signed by patient

7-10 years - consent by parent, assent signed by child if capable of understanding or note on chart describing procedure used to obtain the child's assent to the study

Eligibility Criteria:
Individuals with a need for replacement maxillary and mandibular complete dentures.
Trends in Live Birth Rates Attributable to Assisted Reproductive Technology in British Columbia

Investigators will examine trends in ART use in BC specifically. The use of ART has drastically changed the management of infertility, with worldwide estimates exceeding 1.8 million ART cycles in 2010 alone. Moreover, an excess of six million children have been conceived using ART. Although various countries have published their live birth rates associated with common ART treatment strategies, British Columbia has yet report on its rates. With varying differences in ART practices, whether clinical or laboratory, it is expected live birth rates due to ART to vary depending on region analyzed. Analyzing the live birth rate in BC would not only allow for a benchmark for assessing future improvement, and trends in infertility diagnosis and management, but also allow for comparison to other provinces and countries. The aim of this part of the study is to describe ART cycle contribution to live birth rate in BC from April 2008 to March 2018, which has not been addressed in the literature as of yet. Not only will it give healthcare providers and patients information about this emerging approach to infertility but also provide a impetus for healthy policy makers to adopt a model for partially or fully publicly funded ART, as seen in Ontario and soon Quebec.

Perinatal Services BC maintains a current database on live births, antepartum, intrapartum and postpartum outcomes; including details of ART if used to conceive. Live birth rate, for the purposes of this study, will be defined as the birth of at least one live born baby, with the birth of twins or higher order multiples considered as one live birth. The birth rate for ART will be taken as a proportion for birth rate from ART over total birth rate for given calendar year and the overall period of analysis. Data from April 1 2008 to March 31 2018 on autologous ART treatment cycles and outcomes will be extracted from this database, with approval. Overall proportion of ART contributing to live birth rate will be analyzed as well as sub categorical analysis based on age (younger than 30, 30-34 years, 35-39 years, 40-44 years, and 45 years and older). Only nulliparous women will be included in this study.

Moreover, data will be analyzed by calendar year in which baby from ART delivered to evaluate overall trends in ART outcomes. The total live birth rate for all of BC will serve as the denominator.

Although the data will be reviewed and rules interpreted by the principal investigator of this study, a biostatistician will be hired to carry out the necessary statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women registered in Perinatal Services BC database with live birth between April 2008 and March 2018

Exclusion Criteria:

* multiparous women
* women with missing data in Perinatal Services BC database including gravid, parity, age, date of birth
Training Using Immersive Virtual Reality

In this study, the investigators examine the cognitive load (CL) and performance of a laparoscopic procedure in immersive virtual reality and controlled virtual reality in a randomized, controlled setup. Virtual reality (VR) simulators combined with head mounted displays (HMDs) enable highly immersive virtual reality (IVR) for surgical skills training, potentially bridging the gap between the simulation environment and real-life operating room (OR) conditions. However, the increased complexity of the learning situation in IVR could potentially induce high CL thereby inhibiting performance and learning.


Eligibility Criteria:
Inclusion Criteria:

* First year resident

Exclusion Criteria:

* Previous participation in trials involving laparoscopic training
* Prior experience with laparoscopic surgery (having performed one or more laparoscopic procedures as primary surgeon, including supervised procedures)
* Not speaking Danish on a conversational level
Standardized Procedure for Intracranial Drug-Eluting Stenting in the Treatment of Intracranial Atherosclerotic Stenosis

The primary objective of this trial is to evaluate the Safety, Efficacy, and Standardized Procedural Optimization of the Intracranial Drug-Eluting Stent System in Patients with Symptomatic Intracranial Atherosclerotic Stenosis.

The investigation is a prospective, multi-center clinical study. The trial is expected to enroll 300 subjects. The population for this study is subjects with intracranial atherosclerotic stenosis who are suitable candidates for stent angioplasty. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after they signed the informed consent form. The study consists of ten visits including preoperative screening, procedure date, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years. The primary endpoints are stroke or death within 30 days after enrollment, plus any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females between 18 and 80 years of age
2. Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm
3. Intracranial artery stenosis ( ≥70%) conformed by DSA
4. Those who voluntarily participate in the study and sign informed consent form

Exclusion Criteria:

1. Those who have surgery within previous 30 days or plan to perform major surgery in the next 90 days (surgery grade 3 and above);
2. Subjects of acute hemorrhagic stroke within 3 months;
3. The baseline mRS of disabling stroke is more than 3;
4. The target vessel is severely calcified and closely related to stenosis;
5. Non-atherosclerotic diseases (e.g. arterial dissection, Moya Moya disease, vascular inflammatory lesions caused by infection, autoimmune diseases, post-irradiation, postpartum status; developmental or genetic abnormalities such as fibromuscular dysplasia, sickle cell anemia, suspected vasospasm);
6. It is suspected that the ischemic event is due to embolism or arterial embolism from the extracranial segment (including ipsilateral chest or neck vascular occlusive disease) or potential cardiogenic embolism (e.g. atrial fibrillation, mitral stenosis, patent foramen ovale, left ventricular thrombus, myocardial infarction within 6 weeks, etc.);
7. The presence of a \>50% stenosis in the main blood supply artery of the target vessel. For example, when the lesion is located in the middle cerebral artery, the ipsilateral internal carotid artery stenosis by over 50% should be excluded; when the lesion is located in the basilar artery, the dominant side vertebral artery stenosis \>50% should be excluded;
8. There are intracranial tumors, or intracranial arteriovenous malformations;
9. Those who are allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and stent components;
10. Pregnant and lactating women
11. Those who are unable to complete follow-up because of mental illness, cognitive or emotional disorders;
12. Inapplicable for this study at the investigators' viewpoints.