cyrilzakka/clinical-trials huggingface dataset:
A Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)

This study evaluates the efficacy and safety of the experimental drug, BLS-ILB-E710c, in patients with Cervical Intraepithelial Neoplasia 2/3 (CIN2/3). 2/3 of participants will receive the experimental drug, while 1/3 of participants will receive placebo.

Primary Outcome Measure:

Complete histopathological regression from baseline \[Time Frame: Baseline through Week 16\]

Secondary Outcome Measures:

* Change from baseline of CIN classification \[Time Frame: Baseline through Week 16\]
* Change from baseline of RCI \[Time Frame: Baseline through Week 16 and Week 32\]
* Change from baseline of cytopathological classification based on bethesda system \[Time Frame: Baseline through Week 16 and Week 32\]
* Change from baseline as compared to placebo in the expression rate of P16/Ki-67 \[Time Frame: Baseline through Week 16\]
* Change from baseline as compared to placebo of the number of CD8 positive cells in the cervical tissue \[Time Frame: Baseline through Week 16\]
* Change from baseline as compared to placebo in HPV 16 clearance rate
* Change of RCI based on the histopathological regression at Week 16 \[Time Frame: Week 16 through Week 32\]

Eligibility Criteria:
Inclusion Criteria:

* Fertile female aged between 20 and 49
* Subjects who are infected with HPV 16 type only or with HPV 16 type and any other types listed below

  1) low risk type of HPV, 2) HPV 16-related type
* Subjects who are diagnosed as Cervical interaepithelial neoplasia 2/3 (CIN2/3) by colposcopic biopsy within 6 weeks before enrollment
* All lesions must be observable by colposcopy and CIN2 or higher lesion must be less than 1/2 in the transformation zone area
* Willing to use adequate contraception methods during the study period
* Eligible based on screening test results
* Normal electrocardiogram
* Voluntarily signed informed consent form

Exclusion Criteria:

* Subjects who are diagnosed with Carcinoma In Situ with microinvasion or suspicious invation
* Presence of adenocarcinoma or glandular lesion in the cervix
* Subjects who are infected with HPV type 18-related type
* Subjects with autoimmune disease
* Current or prior treatment past 2 months with immunosuppressant therapies
* Hypersensitive to the investigational drug
* Subjects who currently have acute diseases that require medical attention
* Participation in other studies involving investigational drug(s) or investigational device(s) within 3 months
* Currently having chronic pancreatitis or diagnosed with acute pancreatitis
* Currently having underlying diseases including inflammatory intestinal diseases and tumors, ulcer, bleeding or puncture in the gastrointestinal tract
* Pregnant or breastfeeding
* Subjects with active or inactive hepatitis, or infectious disease
* History of HIV infection
* History of therapeutic HPV vaccination
* Subjects who require continuous use of antibiotics
* Administration of blood product within 3 months before signing informed consent form
* History of vaccination within 2 months before signing informed consent form (4 months in case of live vaccine)
Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity

This trial is conducted globally. The aim of this trial is to investigate the effect of liraglutide for weight management in pubertal adolescent subjects with obesity.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male or female, age 12 to less than 18 years at the time of signing informed consent and less than 18 years at date of randomisation
* BMI corresponding to equal to or above 30 kg/m\^2 for adults by international cut-off points and equal or above the 95th percentile for age and sex (for diagnosis of obesity)
* Stable body weight during the previous 90 days before screening V2 (below 5 kg self-reported weight change)
* History of failing to lose sufficient weight with lifestyle modification as judged by the investigator and documented in subject's medical record

Exclusion Criteria:

* Pre-pubertal subjects (Tanner stage 1) at screening V2
* Type 1 diabetes mellitus (T1DM)
* Family or personal history of multiple endocrine neoplasia type 2 (MEN2)
* Medullary thyroid carcinoma (MTC)
* History of pancreatitis (acute or chronic)
* Subjects with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine causes)
* Treatment with medications within 90 days before screening V2 that, based on the investigator's judgement, may cause significant weight change. This should also include treatment with any of the following medications: pramlintide, orlistat, zonisamide, topiramate, lorcaserin, phenteremine, bupropion, naltrexone, glucagon-like peptide-1 (GLP-1) receptor agonists, or metformin (used as treatment for obesity)
* Anti-diabetic treatment other than metformin
* History of major depressive disorder within 2 years before screening V2
Evaluating the Pharmacokinetic Interaction Between AD-2071 and AD-2072

The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2071 and AD-2072 in healthy male volunteers.

To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the administration of AD-2071 and AD-2072.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male between 19 and 50 years of age at the time of screening
* Weight between 50 kg and 90 kg and body mass index (BMI) between 18.0 kg/m2 and 27.0 kg/m2

Exclusion Criteria:

* Clinically significant disease or history of clinically significant disease such as liver, kidney, nervous system, respiratory, endocrine\*hematologic, cardiovascular, urinary, psychiatric
* Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery
* HDL values less than 35 mg/dL
* AST, ALT values over than 1.5 times of ULN at screening
* A person who has a history of drug abuse or who has positive result for an abuse drug in a urine screening test
Emotion Regulation Therapy for Clinical Worry and Rumination

The present project aims to broaden our understanding of neural mechanisms which may underlie change in symptoms occurring over the course of Emotion Regulation Therapy. Specifically, we aim to examine neural changes as a result of either an 8-session or 16-session version of the treatment.

This study aims to examine the utility of Emotion Regulation Training (ERT) in reducing symptoms of anxiety and/or depression in young adults aged 18 to 29 years old. Additionally, we are interested in assessing neural, cardiac, and immunological changes associated with psychological symptom reduction in these individuals. Lastly, we are interested in examining whether an abbreviated 8-session version of ERT produces similar results to a longer (16-session) version of ERT.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-29 years during the time of participation
* Meets diagnostic criteria for an anxiety and/or depressive disorder
* Endorses significant worry and/or rumination

Exclusion Criteria:

* Active suicidal intent
* Current substance dependence disorder (within the past year)
* Current or past psychotic disorder, bipolar-I disorder, or dementia
* Not currently received any other form of psychosocial treatment
* Not being on a stabilized dose of medication (less than 3 months) during enrollment
* Pregnancy or plans to become pregnant during active participation
* Irremovable metal objects in the body
* Neurological disorder, traumatic brain injury, or loss of consciousness
* Tattoos if/when posing risks for involvement in the MRI component of the study
A Follow-up Study to Assess Resistance to ABT-072 in HCV-infected Subjects Administered ABT-072 in Prior ABT-072 Studies

This is a follow-up study with no treatment and only samples being collected.

The purpose of this study is to evaluate the development of specific viral mutations in response to treatment with ABT-072.

Eligibility Criteria:
Inclusion Criteria:

- Main Selection Criteria: A subject that has received either ABT-072 or placebo in a prior study involving ABT-072.

Exclusion Criteria:

- The investigator considers the subject unsuitable for the study for any reasons inclusive of, but not limited to, failure to comply with study procedures in a prior ABT-072 clinical study.
Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease

Efficacy study of ecabet ophthalmic solution in dry eye disease


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with dry eye disease

Exclusion Criteria:

* Dry eye disease secondary to surgery
Multi-modality MRI Study on Prediction for Mild Cognitive Impairment Conversion

The purpose of this study is to find the characteristics of mild cognitive impairment (MCI) using technology of Multi-Modality MRI , including structural MRI, functional MRI and diffusion tensor imaging(DTI). Then analyze the difference between progressive MCI (MCIp) and stable MCI (MCIs) and further construct the predictable classifier from MCI to Alzheimer's disease (AD) based on Multi-Modality MRI characteristics of MCI patients.

The cognition of MCI is between normal healthy and AD, which is thought the transitional stage of AD. Patients with MCI have heavy risk to convert to AD, so in this study, the investigators focus on the exploration of the characteristics of mild cognitive impairment (MCI) using technology of Multi-Modality MRI, including structural MRI, functional MRI and DTI. Then the investigators further study the patients who convert to AD and explore their MRI characteristics on baseline, in order to construct the predictable classifier from MCI to AD. The investigators want to achieve the early diagnosis of AD and help clinicians interfere with the progress of this disease.

Eligibility Criteria:
Inclusion Criteria:

* Age is between 55 to 75 years old
* Memory loss complaint and confirmed by an informant
* Cognitive impairment in single or multiple domains, adjusted for age and education
* Normal or near-normal performance on general cognitive function and no or minimum impairment of daily life activities
* A Clinical Dementia Rating (CDR) score is 0.5 and consistent with the boundary of neuropsychological scale
* Failure to meet the criteria for dementia
* Must be able to accept examination of MRI, sight and hearing allow to complete test
* Right handedness

Exclusion Criteria:

* Other diseases that cause cognitive impairment, such as thyroid disease, stroke and so on
* People who have severe visual and hearing impairment
Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

The study investigates the long term persistence the Japanese encephalitis vaccine IC51 and the need of a booster dose

This is an open label, non-randomized multi-center phase 3 follow-up study. All volunteers having completed trial IC51-304 (NCT00595790) will be enrolled into this trial at 2 sites

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Written informed consent obtained prior to study entry
* Subjects correctly included in and having completed study IC51-304 according to the protocol.

Exclusion Criteria:

* Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period
* Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
* Pregnancy, lactation or unreliable contraception in female subjects
Neurokinin (NK) 1 Antagonist for Pathological Aggression for Harmful, Impulsive, and Self-/Aggressive Behaviour

Neurokinin (NK) -1 antagonist will be administered to study patients in a double-blind placebo trial. Patients receive assessments including Anger Disorder Scale (ADS) and Modified Overt Aggression Scale (MOAS) and perform computerized study tasks during MRI before the trial begins. Patients receive either one week of the drug or one week of placebo and perform the same tasks and assessments. Then patients receive another week of the alternate pill, followed by another round of tasks during MRI and assessments.


Eligibility Criteria:
Inclusion Criteria:

* are outpatients between 18 and 65 years old inclusive
* meet diagnostic criteria for either Intermittent Explosive Disorder or the adult-modified criteria for Disruptive Mood Dysregulation Disorder (Appendix A)
* have maintained a stable regimen of psychotropic medications (antidepressants, antipsychotics, anticonvulsants, and anxiolytics) for at least 4 weeks prior to study enrolment and throughout the duration of the treatment phase of the study
* If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
* Have capacity with respect to medical decision-making and consent to participate
* pass the TMS Assessment Safety Survey (TASS) MRI safety questionnaire

Exclusion Criteria:

* have a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or other primary psychotic disorder
* meet criteria for a current manic episode or hypomanic episode
* have a diagnosis of dementia or other neurodegenerative illness affecting the central nervous system
* have a history of substance dependence or abuse within the last 3 months
* are pregnant or currently nursing\*

  * \*Patients will be tested before and after the study with a urine pregnancy test.
* are taking contraindicated or interacting medications from product monograph of aprepitant
* have an implanted intracranial device or pacemaker
* have a diagnosis of severe hepatic insufficiency
A Comparison of Nivolumab-based Treatments in a Real-world PD-L1 Positive Metastatic Melanoma Population in the US

The goal of this study is to describe patient characteristics, treatment outcomes and adverse events for patients with metastatic melanoma testing positive for PD-L1 expression treated first line (1L) with either nivolumab and ipilimumab in combination (NIVO + IPI) or nivolumab (NIVO) monotherapy


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years or older
* First advanced of diagnosis of metastatic/Stage IV) melanoma
* Tested for PD-L1 expression with a tumor proportion score (TPS) greater than or equal to 1% (Phase 1 data collection)
* Initiating a first line of therapy during the index period between October 1, 2015 through July 1, 2017
* Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period)

Exclusion Criteria:

* Patients enrolled in a cancer treatment-related clinical trial prior to first line therapy initiation for metastatic/Stage IV) melanoma

Other protocol defined inclusion/exclusion criteria could apply
Microvascular Invasion for Guiding Treatment of Barcelona Clinic Liver Cancer Stage B Hepatocellular Carcinoma

The goal of this observational study is to explore the role of prediction of microvascular invasion by radiomics based on pre-treatment magnetic resonance imaging for guiding treatment of Barcelona Clinic Liver Cancer stage B hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years;
2. BCLC stage B HCC;
3. Received no previous anti-cancer treatment;
4. At least 1 measurable intrahepatic lesion based on the Response Evaluation Criteria in Solid Tumors criteria (RECIST) 1.1;
5. Adequate hematological, liver, renal function:

   1. absolute neutrophil count ≥ 1.5×109/L;
   2. platelet count ≥ 100×109/L;
   3. hemoglobin concentration ≥ 90 g/L;
   4. albumin ≥ 28 g/L;
   5. total bilirubin \< 1.5 times the upper limit of normal;
   6. alanine aminotransferase and aspartate aminotransferase \< 5 times the upper limit of normal;
   7. blood urea nitrogen and serum creatinine concentration \< 1.5 times the upper limit of the normal range or less and creatinine clearance rate ≥ 45 mL/min;
6. Life expectancy of at least 3 months.

Exclusion Criteria:

1. Acute or chronic active hepatitis B (HBV) or C (HCV) infection with HBV-DNA \> 2000 IU/ml or 104 copies/ml; hepatitis C virus RNA \> 103 copies/ml; HBsAg and anti-HCV antibody positive at the same time. Those who are below the above criteria after nucleoside based antiviral therapy may be enrolled;
2. Life-threatening bleeding event within the past 3 months, including the need for blood transfusion, surgical or local treatment, or continuous medication;
3. History of previous arterial or venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary artery embolism, deep vein thrombosis, or any other serious thromboembolism;
4. Use of aspirin (\>325 mg/day) or other drugs known to inhibit platelet function such as dipyridamole or clopidogrel for 10 consecutive days within 2 weeks prior to enrollment;
5. Uncontrolled hypertension, systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy;
6. Symptomatic congestive heart failure (New York Heart Association class II-IV); Symptomatic or poorly controlled arrhythmias; History of congenital long QT syndrome or corrected QT (QTc) \> 500 ms at screening;
7. Diagnosis of other malignant tumors within 5 years prior to enrollment;
8. Pregnant or lactating women or subjects planning to have a baby during the study period;
9. Accompanied with other uncontrolled co-morbidities;
10. Co-infection with HIV, known syphilis infection requiring treatment.
Assessment of Dental Caries Among a Group of Institutionalized Orphan Children Compared to Parented School Children

Children from two orphanages will be examined for dental caries experience, in comparison to parented school children.

A total of 156 children were included in this study, they were, residing in governmental orphanage, non-governmental orphanage and parented children attending primary school. Written informed consent was obtained prior to the start of the study, form legal guardians or child's parent. Dental examination was carried out on an ordinary chair beside a window on day light. DMF and def indices were used to assess dental caries for primary and permanent teeth. Also, unmet treatment need index, care index and significant caries index were calculated.

Eligibility Criteria:
Inclusion Criteria:

* apparently healthy children aged from six to12 years old

Exclusion Criteria:

-
Efficacy and Safety of MgSO4 as Tocolytics Compared to Ritodrine in Preterm Labor

Ritodrine is the conventional and the only approved tocolytics in Korea(by KFDA), although it was withdrawn from the US market more than 10 years ago. As already known well, ritodrine has many side effects such as tachycardia, hyperglycemia, pulmonary edema and so on. When such complications of ritodrine appears, clinicians consider of using MgSO4 as substitute, but its use is off-the-label yet in Korea. Facing this discrepancy, the investigators want to compare the efficacy and safety of MgSO4 with ritodrine and prove that MgSO4 is not inferior to ritodrine as tocolytics. For the singleton and twin pregnancies between 24+0weeks and 34 completed weeks whose uterine contraction is more than 4 during 20 minutes period with their cervical ripening is more than 25%, the investigators randomise them in Ritodrine group or MgSO4 group. Then, the investigators will check the change of their interval of uterine contraction, degree of pain and the appearance of any side effects or treatment failure sign.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age of 24+0 to 34+6weeks
* singleton and twin pregnancies
* preterm labor with more than 4 times of uterine contraction for 20 minutes or more than 8 times for 1 hour on external tocography
* cervical dilatation of 0 to 3cm and cervical ripening more than 25%, or cervical length in sonography below 2cm

Exclusion Criteria:

* triplet etc
* preterm premature rupture of membrane
* cervical dilatation more than 3cm
* history of cerclage operation during this pregnancy
* placenta previa
* severe hypertensive diseases in pregnancy
* history of administration of any tocolytics 12 hours before enrollment
* fever more than 38.0'c
Improvement of Women's Health After Allogeneic Stem Cell Transplantation

The aim of this prospective research project is to better understand vulvovaginal cGVHD to improve care of allografted women. The expected outcomes include better knowledge of the incidence and manifestations of vulvovaginal cGVHD, risk factors, response to treatments and impact on sexual health of allotransplanted female patients. The knowledge acquired will allow transplant clinicians to make more precise recommendations for gynecological management of future allografted women.

The invetigators plan to recruit 100 women who will be evaluated 9 times over a period of 2 years (before allograft, at + 3 months, +6 months, +9 months, +12 months, +15 months, +18 months, +21 months, and +24 months +/- 14 days). If a new diagnosis of cGVHD is made between 2 visits, an additional gynecological examination will be performed.

Visits by the Hôpital Maisonneuve-Rosemont Hospital transplant team will include a physical examination to assess for the presence of cGVHD using the NIH criteria. The FACT-BMT quality of life questionnaire will also be completed before the allograft, at 3 months and 6 months after transplant. If cGVHD is diagnosed, the participants will also have to complete two questionnaires specific to cGVHD (Lee Scale for cGVHD, Patient self-assessment of cGVHD) at diagnosis and then at + 6, +12, +18 and +24 months from day 0 of allograft.

Assessments by CHUM gynecologists will take place before the allograft, then at +3, +6, +12, +18 and +24 months from day 0 of the allograft and will include: a vulvar/vaginal examination, a sample for HPV testing and sexual health questionnaires to be completed (Personal assessment of intimacy within relationships - PAIR, Female Sexual Function Index - FSFI , Female Sexual Distress Scale-Revised - FSDS-R).

Eligibility Criteria:
Inclusion Criteria:

* All women aged 18 and over who will receive a first allogeneic HSCT (bone marrow, peripheral blood stem cells from a related, unrelated (including cord blood) or haploidentical donor) at the CIUSSS-EMTL. Recruitment will begin when the project receives ethical approval. Recruitment period will be of 2 to 3 years.

Exclusion Criteria:

1. Those who receive a second HSCT allograft.
2. Those who receive an autologous transplant.
3. Inability to give informed consent.
4. Unable to communicate in French or English.
5. Any other reason which, according to the investigators, makes it preferable for a patient not to participate.
Study to Compare Two Formulations of Lamotrigine in Healthy Subjects

This study intends to compare the pharmacokinetic characteristics, safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers


Eligibility Criteria:
Inclusion Criteria:

* Body weight \>50 kg (males) or \>45 kg (females) and BMI within the range 19 to 30 kg/m2 inclusive.

Exclusion Criteria:

* Female subjects of childbearing potential will not be eligible to participate if they are unwilling or unable to use an appropriate method of contraception at least 30 days prior to the first study drug through 30 days.
* Female subject is pregnant (positive serum human chorionic gonadotrophin (hCG) test at Screening and pre-dose to the study) or lactating.
* Female subjects using hormonal contraceptive precautions including progesterone-coated intra-uterine device (IUD).
* Female subjects using hormonal replacement therapy.
* History of regular alcohol consumption
* Current smokers of 10 or more cigarettes per day