cyrilzakka/clinical-trials huggingface dataset:
Prospective PuraPly™ AM Case Series Study

The PuraPly AM case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylene biguanide hydrochloride (PHMB) and is intended for the management of wounds; no experimental intervention is involved.

The purpose of the case series is to assess the ability of PuraPly AM to meet wound specific treatment goals including management of bioburden, support of granulation tissue formation, and support of wound closure. Patients will undergo clinical assessments and receive the standard of care as determined by the treating physician.

The case series is being undertaken to better understand PuraPly AM utilization and subsequent healing outcomes as well as to evaluate the effects of concomitant wound therapy on healing. Patient's participation may involve follow-up for up to 12 weeks following application of PuraPly AM.

Eligibility Criteria:
Inclusion Criteria:

1. Participant is at least 18 years of age
2. Participant has read, understood and signed and Institutional Review Board (IRB) approved Informed Consent Form (ICF).
3. Participant has at least 1 wound appropriate for receiving PuraPly AM, including

   * Partial and full-thickness wounds
   * Pressure ulcers
   * Venous ulcers
   * Diabetic ulcers
   * Chronic vascular ulcers
   * Tunneled/undermined wounds
   * Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)
   * Trauma wounds (abrasions, lacerations, second-degree burns, skin tears)
   * Draining wounds

Exclusion Criteria:

1. Participant has a known sensitivity to porcine materials
2. Participant has a third-degree burn
3. Participant has a known sensitivity to polyhexamethylene biguanide hydrochloride (PHMB)
4. Participants receiving concurrent treatment with other topical antimicrobials or skin substitute products
Low Back Pain and Motor Control Dysfunction After Pregnancy- the Possible Role of Abdominal Rectus Muscle Diastasis

The aim of this study was to compare participants with increased symptoms after index pregnancy with those reporting no change in back pain or subjective movement control and analyzed their inter rectus distance (IRD). This study is a case-control study of a cohort of women who had delivered a year earlier. We recruited participants with increased symptoms (n=14) after index pregnancy and controls (n=41) and recorded their inter rectus distance with ultrasound. A questionnaire was filled, and an ultrasound was performed two times for the study groups.

A case control study was conducted in Helsinki University Hospital during 1.1.2018-31.3.2021.

Participants were enrolled in pregnancy screening unit. Exclusion criteria was pregnancy during the second questionnaire and body mass index over 28kg/m2. The first questionnaire was filled and the baseline width of linea alba was measured by abdominal ultrasound (US) in connection of the first early pregnancy screening during 1.1.2018-8.3.2019. The second electronic questionnaire was sent a year after the expected delivery timing. Two screening questions were used to grade the participants. Altogether 36 individuals scored at least five points reflecting to substantial increase in symptoms in screening questions in the second questionnaire after pregnancy out of which fourteen participants were randomly recruited. Another 94 individuals scored the lowest possible two points implicating no change in ones bodily experience. Three controls per case were recruited, altogether 42 controls and with one dropout the total number of controls was 41. All participants had at least 12 months from the last delivery.

Two physiotherapists conducted motor control tests and the width of linea alba was measured with a high-end ultrasound. The physiotherapists were blinded with group allocation and the previous IRD measurement. Participants did not know their own exposure status or their IRD when answering the questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years

Exclusion Criteria:

* Body mass index (BMI) over 28 kg/m2 ( weight and height combined to report BMI in kg/m\^2
* Ongoing pregnancy during the second questionnaire, a year after the index pregnancy
Guanfacine to Improve Substance Use Outcomes in Women

Hypothesis: Guanfacine (GUA) (3mg/day) will reduce drug craving, improve cognitive flexibility and result in associated lower drug use in women with substance use disorder (SUD) in an outpatient clinical setting.

This study proposes to extend previous Phase I experimental work to address the following specific aims: (1) assess GUA's target engagement of drug craving and cognitive flexibility in a laboratory challenge session and in a 10-week outpatient clinical study, (2) demonstrate target validation by showing that reduced drug craving and improved cognitive flexibility will predict lower drug use outcomes during the 10-week clinical trial in SUD women, and finally, (3) evaluate data replication and scalability of GUA target effects across two clinical sites (Yale and SUNY-Stony Brook).

Eligibility Criteria:
Inclusion Criteria:

* 100 treatment seeking women
* Ages 18-70 years
* Body mass index (BMI) of 18-35
* Meet current DSM-V criteria for co-occurring SUDs, with primary DSM-V cocaine or primary DSM-V opioid use disorder AND co-occurring cannabis or alcohol or nicotine use disorders;
* Positive drug urine toxicology screens for primary addictive disorder during a 2-week intake assessment period
* Good health as verified by screening examination
* Able to read English and complete study evaluations
* Able to provide informed written and verbal consent

Exclusion Criteria:

* Meet criteria for physiological dependence on alcohol requiring medical detoxification
* Regular use of anti-hypertensives, anti-arrythmics, antiretroviral medications, and medications that would interact with Guanfacine and be contraindicated as per study physician;
* Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania)
* Significant underlying medical conditions which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study; Specifically hepatic and renal impairment as per liver enzymes at 3X the normal limit, or BUN\>50mg or BUN:Cr \> 10:1.
* Hypotensive women with sitting blood pressure below 100/50 mmHG
* Women who are pregnant, nursing or refuse to use a reliable form of birth control
* EKG evidence at baseline screening of any clinically significant conduction abnormalities, including a Bazlett's QT c\>470 msec for women.
Deep Brain Stimulation of NAc/ALIC to Prevent Treatment-Refractory Obsessive Compulsive Disorder

Nucleus accumbens/anterior limb of internal capsule play important roles in the process of treatment-refractory obsessive compulsive disorder, deep brain stimulation of nucleus accumbens/anterior limb of internal capsule will inhibit its activity and thus to effectively prevent the disorder.

Obsessive-compulsive disorder (OCD) is characterized by obsessions (persistent thoughts) and compulsions (repetitive ritualistic behaviour). Core symptoms of OCD cause remarkable distress and often perceived as inappropriate. The prevalence of OCD in the general population is estimated between 1% and 3%. It is a psychiatric illness that can lead to chronic functional impairment. Treatment options for OCD include cognitive behavioural therapy (CBT) and/or pharmacotherapy. Even when the best treatment options are used, approximately 10% of these patients remain severely affected and are considered therapy-refractory resulting in marked suffering and impairment in self-care, work and social life. More recently, deep brain stimulation (DBS) has been investigated as a therapy for refractory OCD, and the procedure was granted a limited humanitarian device exemption by the FDA in 2009. For these patients, deep brain stimulation (DBS), a neurosurgical treatment that involves stereotactic implantation of electrodes in specific deep-seated brain regions, has emerged as a new treatment option.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD;
2. Duration of illness: min. 5 year;
3. 18 years old \<Age \<60 years old;
4. Severe form of OCD, as evidenced by: a score≥25 on the Y-BOCS, a score \> 4 on the CGI scale, a score≤40 on the GAF ("global assessment of functioning).
5. All patients were lack of response to drug therapy after adequate administration (defined as more than 12 weeks at the maximum tolerated dose) of at least four different medications, lack of response to CBT (Cognitive Behaviour Therapy)over the course of 1 year of therapy or after 20 sessions.
6. Normal cognitive status and ability to understand and comply with instructions for multiple therapies.
7. Good overall health.

Exclusion Criteria:

1. Present or past history of psychotic symptoms.
2. Severe personality disorders;
3. Any clinically significant neurological disorder or medical illnesses affect ;
4. brain function, other than motor tics or Gilles de la Tourette syndrome;
5. Patient currently treated with anticoagulant or antiplatelet drug;
6. Patient with contraindication for surgery or anesthesia;
7. Inability to undergo awaked operation;
8. Infection, coagulopathy, significant cardiac or other medical risk factors for surgery;
9. Patient with contraindication for MRI scanning (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), abnormal brain MRI or serious inter current disease
Streamlined Localization Using SCOUT® at Biopsy (STREAMLoc )

This registry is intended to demonstrate the utility of SCOUT® in the Canadian public and US healthcare systems with fixed resources and a conservative approach to patient and clinician exposure to harm. The efficacy and safety of this system will be further assessed, as well as the acceptance of clinicians and patients.

This registry is intended to demonstrate the utility of SCOUT® in the Canadian public and US healthcare systems with fixed resources and a conservative approach to patient and clinician exposure to harm (i.e., radiation, COVID-19 exposure, patient emotional trauma). By assessing the utility of reflector insertion at the time of biopsy, this study will be able to measure the impact on patient visits to the breast center for invasive procedures between biopsy and surgery, and quantify this value to the public healthcare system. The efficacy and safety of this system will be further assessed, as well as the acceptance of clinicians and patients.

Eligibility Criteria:
Inclusion Criteria:

1. Woman \>18 years and \< 80 years of age;
2. Classified as Breast Imaging Reporting and Data System (BI-RADS) 4C or 5;
3. Lesion depth is \< 6 cm from skin surface;
4. Non-palpable lesions;
5. Informed consent obtained.

Exclusion Criteria:

1. Multicentric breast cancer;
2. Pregnant or lactating;
3. Known or suspected nickel-titanium allergy.
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis

The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in pediatric participants aged 4 to \<18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to \<18 years) and Cohort 2 (age 4 to \<12 years), with two parts; for each cohort. Part A will evaluate the drug levels of BMS-986165 to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in pediatric participants with moderate to severe plaque psoriasis. The 5-year long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in pediatric participants with psoriasis who have completed Parts A or B of the study.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 12 to \<18 years for Cohort 1. Males and females aged 4 to \<12 years for Cohort 2.
* Plaque psoriasis for at least 6 months
* Moderate to severe disease
* Candidate for phototherapy or systemic therapy
* Must have completed the Week 52 treatment period in Part A or B for long-term extension (LTE) period

Exclusion Criteria:

* Participants weighing ≤ 30.0 kg at screening for Cohort 1 (age 12 to \< 18 years), Part A and Part B. Participants weighing ≤ 18.0 kg at screening for Cohort 2 (age 4 to \< 12 years), Part A and Part B.
* Other forms of psoriasis
* History of recent infection
* Prior exposure to deucravacitinib (BMS-986165) or active comparator
* Evidence of active TB for LTE period

Other protocol-defined inclusion/exclusion criteria apply
Clinical Survey of Different Abutment Topologies

This study is designed to compare two different surfaces of bone anchored hearing aid abutments in terms of bacterial colonization, inflammatory response and skin reactions.


Eligibility Criteria:
Inclusion Criteria:

* Any adult (18 years of age or older) patient eligible for a bone anchored hearing system

Exclusion Criteria:

* Inability or unwillingness to participate in follow-up
* Skin thickness of \> 10 mm
* Diseases known to compromise bone quality
* Irradiated in the implant area
Performance of the Poseidon System for Fluid Management During Water-aided Colonoscopy

To validate the performance of the Poseidon System™ for fluid management during water-aided endoscopic procedures in the colon.

The Poseidon System is a fluid management system that is investigationally indicated to provide a pathway to control waste fluid during irrigation of the colon. The Poseidon device is a manually placed and controlled device that provides support and sealing on the perimeter of an endoscope while managing fluids naturally exiting the anus, during a colonoscopy procedure. The device consists of a introducer and hand piece that allows for passage of an endoscope with valves and a retention balloon that minimize fluid passage with a single-use waste bag for collecting fluid and debris. The Poseidon™ System is not yet FDA 510(k) cleared.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years of age or greater.
2. Patients that have an indication to undergo water-aided colonoscopy.
3. Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments.

Exclusion Criteria:

1. Subject unable or unwilling to provide informed consent.
2. Subjects with prolapsing hemorrhoids that require intervention or hemorrhoids that have been treated within last 3 months.
3. Prior TAMIS (Trans-anal minimally invasive surgery) or TEMS (Trans-anal micro endoscopic surgery).
4. Any condition that in the opinion of the Investigator would create an unsafe clinical situation that would not allow the patient to safely undergo an endoscopic procedure.
5. Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.
6. Patient is enrolled in another trial that could interfere with the endpoint analyses of this trial.
Oxytocin and Dopamine's Effect on Vicarious Optimism

To investigate the effect of intranasal Oxytocin and L-DOPA's effect on vicarious optimism.

The current study adopted a double-blind, double-dummy, placebo-controlled mixed design, with Treatment (oxytocin, dopamine, and placebo) as a between-subjects factor, and Target (self, friend, and an identifiable stranger) and Feedback (desirable vs. undesirable) as within-subjects factors. Upon arrival, participants first completed a set of questionnaires, including mood measurements and other questionnaires related to optimistic or prosocial tendency. Participants then self-administered with the pharmacological challenge 40 min before the main task, i.e., the belief updating task where participants indicated and updated their beliefs about the future of oneself, a gender-matched best friend, and a gender-matched identifiable stranger. At the end, participants completed the mood measurement again, as well the debriefing questionnaires which designed to measure their beliefs about the experimental process.

For the vicarious optimism task, participants completed three blocks of the two-session belief updating task where they were asked to estimate the likelihood of adverse life events happening to three targets: themselves (referred as Self), a gender-matched best friend (referred as Friend), and an identifiable stranger (whose name, brief description and picture were presented to the participants to get familiar with before the estimation, such as "The stranger is Zhexing, a 25-year-old male, Chinese"; referred as Stranger).

Participants completed two estimation sessions for one target before beginning with the next target, and the order of targets was counterbalanced across participants within each group. For the first session of each target block, participants were first presented with 30 different adverse life events (in a random order) and estimated the likelihood of each event happening to the target in the future (the 1st estimation, referred to as E1) on a self-paced basis. Participants were then presented with the probability of each event occurring to an average person in a similar environment (Feedback) for 2s. In the second session, participants estimated the likelihood of the same 30 events (in a random order) happening to the target person again without receiving feedback (the 2nd estimation, referred to as E2).

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* subjects with past or current psychiatric or neurological disorders
LDH as a Biochemical Biomarker to Predict Organ Failure in the Emergency Department Setting

The purpose of this study is evaluate if K3, a novel biomarker, sampled at arrival to the emergency department can be used to predict the development of organ failure measured as SOFA score. K3 consists of lactate dehydrogenase, albumin and magnesium combined.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Admitted to emergency department, Karlstad Central Hospital, Sweden

Exclusion Criteria:

* Not in need of venous blood sample
Dynamic Data-Driven Management of Atrial Fibrillation Using Implantable Cardiac Monitors: The MONITOR-AF Study

Observational, multi-center, retrospective study to evaluate the use of ICM (implantable cardiac monitor) versus traditional, non-ICM (non-implantable cardiac monitor) methods such as ECGs (electrocardiogram), Holter, and mobile cardiac outpatient telemetry (MCOT) units.

Even with its increasing popularity and use, the impact of ICMs on AF (atrial fibrillation) management is still being determined and can even be conflicting. Furthermore, the use of ICM is dependent on physician preference. It is hypothesized that dynamic monitoring with ICMs is superior to conventional methods and should be used for all patients with AF. Thus, it aimed to measure the outcomes of using ICM versus more traditional approaches in patients with AF.

Eligibility Criteria:
Inclusion Criteria

* Patients \> 18 years of age
* Present for management of AF
* ICM is inserted at the discretion of the treating physician

Exclusion Criteria

* Patients \< 18 years of age
* Presence of a permanent pacemaker, implantable cardiac defibrillator, or cardiac resynchronization therapy
* Unable to tolerate ICM or traditional monitoring with ECG, Holter, or MCOT monitoring
* Unable to tolerate AAD, OAC, and CA as part of AF standard of care
* ICM inserted for cryptogenic stroke or syncope
* Was not followed \> 12 months
* CA performed for AF before ICM implant
Partially-blind (Observer-blind) Study of Safety and Immunogenicity of Two Malaria Vaccines in Ghanaian Children

This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

This study will be conducted in a partially blind fashion: it will be observer-blind as to which vaccine was administered, and open as to the vaccination schedule. One group of children on the 0, 1, 2-schedule will receive a Rabies vaccine as a control. One group on the same schedule will receive the RTS,S/AS02D experimental vaccine as an active comparator.

Eligibility Criteria:
Inclusion Criteria:

* A male or female child between 5 months and 17 months of age at the time of first vaccination.
* Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
* Proof that child has received a full 3-dose regimen of licensed Hepatitis B vaccine in infancy.

Exclusion Criteria:

* Acute disease at the time of enrolment.
* Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
* Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of acceptable limits.
* Planned administration/administration of a vaccine (not in the scope of the study) within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled Yellow fever or Measles vaccine.
* Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of the study vaccine, or planned use during the study period.
* Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Simultaneous participation in any other clinical trial;
* Previous participation in any other malaria vaccine trial;
* Any twins
* History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.