cyrilzakka/clinical-trials huggingface dataset:
Targeting Drug Memories with Methylphenidate

This study aims to identify the neural, behavioral, and pharmacological mechanisms promoting diminished expression of drug-related memories in human drug addiction. In this fMRI study with a within-subjects placebo-controlled double-blind cross-over design, oral methylphenidate (20 mg) or placebo will be administered to individuals with cocaine use disorders (CUD) to peak during the retrieval of a drug-cue memory before extinction; in addition to fMRI activations, skin conductance responses (SCR, acquired simultaneously) will serve as the psychophysiological indicators of memory modification. Assessments of interference with the return of drug-cue memories via SCR and craving will be conducted the day following MRI. This pharmocologically-enhanced behavioral approach to decreasing drug memories and craving in iCUD could ultimately be used to develop effective cue-exposure therapies for drug addiction. Procedures include MRI, blood draw, questionnaires and interviews, skin conductance response measures, and behavioral tasks.

Cue-exposure therapy has not proven efficacious in reducing relapse in drug addiction, illuminating the need for alternative strategies. Here researchers will test the neural correlates of two strategies, encompassing behavioral and pharmacological approaches, aimed to interfere with the return of drug memories in individuals with cocaine use disorders. Results may pave the way towards enhancing the efficacy of cue-exposure therapy in reducing cue-induced craving and relapse in drug addiction (generalizable across drugs of abuse/behavioral addictions).

Eligibility Criteria:
Inclusion criteria:

* Ability to understand and give informed consent
* Males and females, 18-65 years of age
* DSM-V diagnosis for CUD or otherwise problematic cocaine use as clinically determined

Exclusion criteria:

* DSM-5 diagnosis for schizophrenia or developmental disorder (e.g., autism)
* Head trauma with loss of consciousness
* History of neurological disease of central origin including seizures
* Cardiovascular disease including high blood pressure and/or other medical conditions, including metabolic, endocrinological, oncological or autoimmune diseases, and infectious diseases including Hepatitis B and C or HIV/AIDS
* Metal implants or other MR contraindications
Sleep Apnea in Pregnancy Screening Study

Obstructive sleep apnea is known to be a significant source of morbidity in the general population. It has been proposed to be associated with the development of preeclampsia and fetal growth restriction. As these are conditions that have long term maternal and neonatal implications, further information may help improve maternal/fetal outcome. One reason why women and in particular pregnant women are under diagnosed is the lack of an effective, reliable screening tool. Validated questionnaires used in the general population may not be effective in screening pregnant women. The investigators hypothesize that sleep apnea will have 20% prevalence in the obese pregnant population and that it is associated with increased maternal and neonatal morbidity. The investigators will recruit obese pregnant women in their prenatal care clinics and they will be screened for OSA using validated sleep questionnaires including the Epworth sleepiness scale, the Fatigue Scale and the Berlin Questionnaire. The subjects will then perform overnight apnea monitoring utilizing a portable sleep apnea detection device. Women who meet clinical criteria for OSA will be referred for overnight polysomnogram and management by the Pulmonary and Critical Care Division of the Internal Medicine Department. For all enrolled patients the remainder of prenatal care will be per routine. Data will be collected regarding the pregnancy course and outcomes.

The primary outcome of interest is the prevalence of sleep apnea in obese women and the associated maternal and neonatal morbidity. The secondary outcome measures will be molecular measures of systemic inflammation, oxidative stress and angiogenesis associated with sleep apnea.


Eligibility Criteria:
Inclusion Criteria:

* Prepregnancy BMI of 30kg/m2 or greater
* Singleton pregnancy
* 18 years or older

Exclusion Criteria:

* Chronic use of narcotics or other CNS drugs
* Inability to sleep beyond 2 hours
* 3 or more missed prenatal visits
SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery

To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal surgery when using the Boston Scientific WaveWriter SCS Systems.


Eligibility Criteria:
Key Inclusion Criteria:

* Chronic low back pain, with or without leg pain, for at least 6 months
* Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy)
* If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at Screening
* Subject signed a valid, IRB-approved informed consent form (ICF) provided in English

Key Exclusion Criteria:

* Primary pain complaint of vascular origin (e.g. peripheral vascular disease)
* Require implantation of lead(s) in the cervical epidural space
* Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to assess pain intensity
* Previous failed spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration

This is a multicenter, active-controlled, double masked study assessing the safety, efficacy and durability of four monthly intravitreal (IVT) injections of RBM-007 monotherapy, and four monthly RBM-007 injections in combination with Eylea® dosed at every other month, compared to Eylea® monotherapy dosed at every other month in approximately eighty-one subjects with exudative age-related macular degeneration (AMD).

RBM-007 is a novel oligonucleotide-based aptamer having potent anti-FGF2 activity and anti-VEGF-expression activity

Eligibility Criteria:
Inclusion Criteria:

1. Provide signed written informed consent.
2. Male or female 55 years of age or older on the date of signing the consent and able and willing to comply with all treatment and study procedures.
3. Diagnosis of exudative age-related macular degeneration in the study eye, for which previous standard treatment with intravitreal anti-vascular endothelial growth factor agents (at least 4 injections over the past 8 months) has demonstrated incomplete resolution of exudation, as assessed by spectral domain optical coherence tomography.
4. Presence of macular edema or subretinal fluid.
5. Absence of central atrophy or retinal epithelial tear in the fovea or any condition preventing visual acuity improvement in the study eye.
6. Visual acuity of 78 to 24 letters (20/32 to 20/320) in the study eye.
7. Visual acuity of 24 letters (20/320) or better in the fellow eye.
8. Reasonably clear media and some fixation in the study eye to allow for good quality tomography and fundus photography

Exclusion Criteria:

* Ocular:

  1. Use of any of the following treatments or anticipated use of any of the following treatments to the study eye:

     1. Any intravitreal treatment within 4 weeks prior to Baseline (Visit 1).
     2. Intravitreal or periocular corticosteroid, within 90 days prior to Visit 1 (Day 1) and throughout the study.
     3. Fluocinolone acetonide intravitreal implant, within 12 months prior to Visit 1 (Day 1) and throughout the study.
     4. Visudyne® photodynamic therapy, within 90 days prior to Visit 1 (Day 1) and throughout the study.
  2. Uncontrolled or advanced glaucoma, evidenced by an intraocular pressure of \> 21 mmHg or cup/disc ratio \> 0.8 while on medical therapy, or chronic hypotony (\< 6 mmHg) in the study eye.
  3. Evidence of any other ocular disease other than wet age-related macular degeneration in the study eye that may confound the outcome of the study
  4. History of vitrectomy in the study eye.
  5. Need for ocular surgery in the study eye during the course of the study.
  6. YAG laser capsulotomy within 30 days prior to Visit 1 (Day 1) in the study eye.
  7. Intraocular surgery, including lens removal or laser, within 90 days prior to Visit 1 (Day 1) in the study eye.
Diagnosis and Allergen Identification of Perioperative Anaphylaxis

Perioperative anaphylaxis may lead to fatal respiratory and/or circulatory events, yet both clinical diagnosis and management are challenging. Serum tryptase is an indicator that can provide important retrospective diagnostic value for anaphylaxis. Another key point in perioperative anaphylaxis management is to identify the allergens, and thus avoid re-exposure during later perioperative management. Skin testing is an important way to identify allergens.

Perioperative anaphylaxis are rare, but may be fatal. The combined use of anesthetic drugs and other medications, and the additional effects of surgical procedures, make the diagnosis and differential diagnosis rather complicated. Subsequent allergy investigations and allergen identification are often difficult.

The change of tryptase levels is an important biomarker in differentiating anaphylaxis from other causes. It is recommended that, in case of any suspicion of perioperative anaphylaxis, serum samples for tryptase detection should be collected as soon as possible after the onset of symptoms and then repeated 24 h later. Skin testing including skin prick tests (SPT) and intradermal tests (IDT) is universally used in identifying allergens. Skin testing will be performed 4-6 weeks after the onset of perioperative anaphylaxis.

This prospective cohort study is designed to clarify the rate of perioperative anaphylaxis with testing serum tryptase level and to identify the underlying allergens by conducting skin testing in surgical patients with suspected perioperative anaphylaxis.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or over;
* Suspected anaphylaxis in the operating rooms, or history of suspected anaphylaxis in the operating room.

Exclusion Criteria:

* Refuse to participate;
* Other conditions that are considered unsuitable for study participation.
Interrupting Self-Harm Study

My study will employ a convergent mixed methods two-arm parallel randomized controlled design. The qualitative strand will primarily rely on semi-structured interview procedures to answer the following questions: (1) How do adolescents perceive and experience the phenomenon of nonsuicidal self-injury (NSSI)? (2) What do adolescents believe needs to be done to address NSSI? The quantitative strand will primarily rely on clinical interview data, self-report measures, and an experimental task protocol to answer the following question: What is the impact of a brief mindfulness induction (versus a control condition) on self-injury attentional bias among self-injuring adolescents?


Eligibility Criteria:
Inclusion Criteria:

* To be included in the study, a participant must be: 1) at least 12 years old and no more than 18 years old, 2) able to understand and communicate in English, 3) willing and able to participate in all study procedures, and 4) currently engaging in nonsuicidal self-injury OR have a history of nonsuicidal self-injury.

Exclusion Criteria:

* Individuals will be excluded from the study if they are experiencing a suicidal crisis at the time of the study procedures (e.g., they endorse suicidal ideation, planning, and intent as determined by the Mini International Neuropsychiatric Interview 7.0) and require crisis intervention or hospitalization.
A Real-World Study on Distal Aortic Remodeling for Stanford Type B Aortic Dissection With Fabulous Thoracic Aortic Stent System

To evaluate aortic remodeling of Fabulous thoracic aortic stent system in the treatment of acute and subacute Stanford type B aortic dissection (the changes of aortic diameter, cross-sectional area,and volume of true lumen, false lumen and total aorta in different aoritc levels, and false lumen thrombosis in different aoritc levels), and splanchnic artery perfusion.

Fabulous Thoracic Aortic Stent System is specially designed for aortic dissection based on PETTICOAT technique.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old, regardless of gender;
2. Fabulous thoracic aortic stent System is suitable for the treatment of acute or subacute Stanford type B dissection, and the lesions meet one of the following criteria:

   1. It is necessary to treat distal lesions due to the presence of distal tears;
   2. The dissection involved a wide range, and there was collapse of the distal true cavity;
   3. Dissection combined with poor perfusion of distal branch vessels.
3. With appropriate arterial access and suitable for endovascular aortic repair;
4. Subjects could understand the purpose of the trial, volunteered to participate in the study, signed the informed consent form by themselves or their legal representatives, and were willing to complete the follow-up as required by the protocol.

Exclusion Criteria:

1. Patients have participated in clinical trials of other drugs or medical devices related to target lesion treatment or have participated in clinical trials of other drugs or medical devices and have not reached the primary endpoint;
2. Patients were unable or unwilling to participate in the study;
3. Patients were judged by the investigator to be ineligible for participation in the trial.
Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients

Patients with severe refractory ulcerative colitis (UC) or those who received placebo in study F506-CL-1107 will receive tacrolimus for a maximum of 12 weeks. Safety and efficacy will be evaluated.

Patients with severe refractory ulcerative colitis (UC) or those who received placebo in study F506-CL-1107 study can participate in this study. Patients will receive tacrolimus for a maximum of 12 weeks in an open-label study manner. Improvement of Disease Activity Index (DAI) score and other efficacy scores will be evaluated during the drug administration period.

Eligibility Criteria:
Inclusion Criteria:

* Severe refractory UC patients who meets the following criteria

  * Disease activity: more than 6 times of stool a day, bloody stool, moderate to severe endoscopic finding
  * Steroid resistant or dependent

OR

* Moderate to severe refractory UC patients who participated and received placebo in F506-CL-1107 study

Exclusion Criteria:

* Mild or fulminant type
* Renal failure patients, hepatic failure patients
* Patients taking 6-mercaptopurine, cyclosporin or other immunosuppressants within 12 weeks prior to entry
* Patients who received LCAP or GCAP within 2 weeks prior to entry
* Patients who changed the dose of steroid or started steroid within 2 weeks prior to entry
* Patients who changed the dose of steroid or started steroid within 1 week prior to entry in case they received more than 40 mg/ day or 1mg/kg/day of steroid just before the study
Combined Cumulative Irritation Potential and Repeat Insult Patch Test of LEO 90100

The purpose of this study is to determine the skin irritation potential and sensitisation potential of LEO 90100 and the vehicle after repeated applications on the skin of healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* 1. Following verbal and written information about the trial, subject must provide signed and dated informed consent before any study related activities are carried out.
* 2. Healthy male or female subjects, 18 to 65 years of age inclusive at screening.

Exclusion Criteria:

* 1. Female subjects who are pregnant, of childbearing potential and who wish to become pregnant during the study, or who are breast feeding
* 2. Subjects with any systemic or cutaneous disorder that might interfere with the evaluation of the test site reactions (e.g. atopic dermatitis, contact eczema, psoriasis) 3. Subjects with scars, moles or other abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the study results (skin type V and VI on the Fitzpatrick scale)
Post Market Study to Collect Data for Software Recognizing the Anatomical Structures During Bronchoscopy.

The primary aim is to develop a software algorithm that has the capacity to detect the normal 18 anatomical structures of the lung by using the position of the scope during the bronchoscopy procedure and using existing bronchoscopy technology.

2.000 subjects, preferable 150-200 number of patients per site. The 2.000 videos will be divided into an 80%/20% split (training and testing). It is a wish to obtain a spread of videos coming from across Europe, preferable from Germany, France and Denmark, with up to 800 videos coming from Denmark

The patient population indicated are patients indicated for full airway bronchoscopy. Of this group it is the aim to enrol the following:

1. Patients with obstructing tumors (when tumor blocks the view of the camera) - no more than 5% (120 patients) of studies
2. Bronchoscopies on indication of haemoptysis (active bleeding) - no more than 5% (120 patients) of studies
3. Patients with stents or valves - no more than 5% (120 patients) of studies bronchoscopies.
4. Patients with former lung operations, partial or full resections - no more than 2% (48 patients).

Eligibility Criteria:
Inclusion Criteria:

1. Oral and written participant information has been given (NA for Denmark)
2. The subject has signed informed consent (NA for Denmark)
3. Patients indicated for full airway bronchoscopy (identifying all 18 anatomical segments)
4. Patients older than 18

Exclusion Criteria:

1. Subject with serious lung disease which investigator considers not appropriate for this examination.
2. Lack of patient cooperation for bronchoscopy (patient with mental disorders, dysgnosia, psychological disorder...)
3. Subjects unable to give consent (NA for Denmark)
Pilot Study of Treatment for Subclinical AMR (Antibody-mediated Rejection) in Kidney Transplant Recipients

This is a pilot study to determine if extended release Envarsus at an optimal level is just as effective as more invasive standard therapies for subclinical (mild) AMR (antibody mediated rejection) in kidney transplant patients. Subjects will be randomized to either conversion to Envarsus XR (extended release); or, to a standard of care regimen of plasma exchange/IVIG (intravenous immunoglobulin)/rituximab treatments.

There is currently minimal data to guide treatment of mild graft damage in kidney transplant patients. Some of the current therapies used often come with dangerous complications (infections, malignancies, etc.). This is a pilot study to determine if extended release Envarsus at an optimal level is just as effective as more invasive standard therapies for subclinical (mild) AMR (antibody mediated rejection) in kidney transplant patients. The subjects will be randomized to either conversion from their current tacrolimus regimen to Envarsus XR (a once a day, extended release version of tacrolimus); or, to a regimen of 5 plasma exchanges/IVIG (intravenous immunoglobulin) treatments and one treatment with rituximab. Subjects who are within their first year of transplant will visit their doctor monthly for regular tests and checks and then will have a kidney biopsy at 6 months. Subjects who had their transplant over a year prior will see the doctor for tests and checks at 1, 3 and 5 months and then will have a biopsy of the kidney at month 6.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18+ years) recipients of kidney or kidney/pancreas transplants
* Willing to sign an IRB (institutional review board)-approved consent and to comply with study requirements
* DSA (donor specific antibodies) detected by SAB (single antigen beads) screening with MFI ≥ 2000
* Graft biopsy performed within prior 30 days
* Stable renal function defined by serum creatinine increase ≤ 30% over prior 6 months
* Subacute antibody-mediated rejection on biopsy defined by ptc + g + C4d ≥ 2 by Banff 2013 criteria

Exclusion Criteria:

* Kidney/liver or kidney/heart recipient
* Unwilling/unable to undergo screening biopsy
* HIV (human immunodeficiency virus), HCV (hepatitis-C virus), or HBsAg (hepatitis-B surface antigen) positive
* Active/untreated infection
* Acute cellular rejection with Banff grade 1b, 2a, 2b on initial biopsy requiring rATG (rabbit anti-thymocyte globulin) therapy
* Pregnant or nursing females
A Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients

Aim of the study is to compare efficacy and safety of YM177 with placebo and etodolac in patients with postoperative pain.

To verify the superiority to placebo and the noninferiority to etodolac of YM177 in terms of efficacy assessment in patients with postoperative pain. Also, to compare them in terms of safety assessment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with spontaneous pain within 24 hours postoperatively
* The intensity of the pain:

  * 4-categorical assessment: "Moderate pain" or "Severe pain"
  * VAS assessment: 45.0 mm or higher
* Patients whose postoperative pain can be managed using an oral NSAID

Exclusion Criteria:

* A past history of aspirin-induced asthma
* A past of ischemic heart disease, serious arrhythmia, congestive heart failure or cerebrovascular disease
* Patients who undergoes the surgical procedure under general anesthesia
* Patients taking excluded medications