cyrilzakka/clinical-trials huggingface dataset:
Neurofeedback for Post-Traumatic Stress Disorder

A two-arm randomized pilot of standard neurofeedback and a waiting list for patients with treatment resistent PTSD.

This study will be a randomized-controlled pilot and in a later study virtual reality based neurofeedback will be tested. In this study 30 subjects will be randomised into one of two arms of the study. Treatment as usual (TAU) entails both psychotherapy, medication and other interventions.

1. TAU + Neurofeedback using a PC-screen (experimental group)
2. TAU as a waiting list (control group) - the participants in the control group will be offered to choose one of the two experimental treatments at the end of the trial.

The 30 participants will be randomized to one arm of the study (15 participants per group). The subjects will be recruited from Psychiatric Outpatient Care at Sahlgrenska University Hospital, Crisis and Trauma Center Gothenburg and Psychiatric Care Center in Tranås, Jönköping.

Participants in the experimental group will have 24 sessions in total, (twice a week. 12 week period) with a trained neurofeedback specialist or trained neurofeedback physician. Before session 1 and after session 24, a clinician will fill in the clinical scales and questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* CAPS Cutoff \>44
* Stable psychopharmacological treatment (stable dose, no planned changes during the course of the trial)
* AUDIT cut off \<16
* DUDIT cut off \<8
* Already undergone at least one treatment with psychotherapy and/or pharmacological treatment for a minimum of 6 months.
* 18 years or older

Exclusion Criteria:

* Diagnosis of traumatic brain injury (TBI) affecting capability to give informed consent
* Ongoing traumatic exposure (such as domestic violence)
* Balance problems
* Active suicide risk or life-threatening self-harm
* A diagnosis of schizophrenia or psychotic disorder
* Ongoing compulsory care
* If the patient changes dose or medication strategy during the trial.
* If the neurofeedback treatment is identified as a primary reason for worsening of participant's well being.
Nanopore Sequencing in Ophthalmology

In this pilot study, the feasibility of the Oxford Nanopore MinION to identify pathogens from vitrectomy samples in eyes with endophthalmitis shall be assessed. The MinION is a low cost commercially available device for DNA/ RNA analysis that, in studies, has been used for pathogen determination in various infectious diseases as well as for the genetic characterization of hematologic tumors.

Vitreous samples and anterior chamber taps from eyes with endophthalmitis are taken during routine vitrectomy. The gathered samples are divided in half to undergo routine culture for microbial growth and nanopore sequencing with the MinION Mk1b, a commercially available device for DNA/RNA sequencing. Base reads from Nanopore sequencing are then compared with available libraries for pathogen identification. The Nanopore sequencing results for pathogens are compared versus the results of the microbiological culture of the same eye as the gold standard. Clinical features and visual function before and after vitrectomy are gathered from patient charts. Treatment is not altered due to results of the Nanopore sequencing.

Eligibility Criteria:
Inclusion Criteria:

* Eyes of patients with endophthalmitis

Exclusion Criteria:

* No informed consent possible
* Participation in other studies
A Study of CG-806 in Patients With Relapsed or Refractory CLL/SLL or Non-Hodgkin's Lymphomas

This study is being done to evaluate the safety, tolerability and effectiveness of Oral CG-806 for the treatment of patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or Non-Hodgkin's Lymphomas who have failed or are intolerant to two or more lines of established therapy or for whom no other treatment options are available.

This is a multicenter, open-label, Phase Ia/b dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the MTD or recommended dose in patients with relapsed or refractory CLL/SLL or Non-Hodgkin's Lymphoma patients. This is to be followed by a cohort expansion phase at the MTD or recommended oral dose.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Life expectancy of at least 2 months
* ECOG Performance Status ≤ 2
* Patients must be able to swallow capsules
* Adequate hematologic parameters, unless cytopenias are disease caused
* Adequate renal, liver and cardiac function parameters

Exclusion Criteria:

* Patients with GVHD requiring systemic immunosuppressive therapy
* Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinical significant disease related metabolic disorder
* Clinically significant intravascular coagulation
* Treatment with other investigational drugs within 14 days prior to first study treatment administration
CDR Investing in Fatherhood Process Study & Evaluation

This study will evaluate the Investing in Fatherhood: New Pathways program of Child Development Resources (CDR), a Healthy Marriage and Responsible Fatherhood (HMRF) grantee. The program will deliver parenting education, relationship skills training, job preparedness and financial planning, and case management support. This research will consist of a descriptive process and program evaluation study, with research questions focusing on recruitment and retention and short-term participant outcomes.

This study will address three research questions:

1. Which recruitment strategies are the most successful for participation? CDR will work to expand recruitment efforts and encourage greater participation through a number of strategies, such as offering various incentives and hosting classes in other spaces (e.g. churches, restaurants, clinics). This study will examine which methods are the most effective.
2. Which engagement/retention strategies are the most successful? Current fatherhood services staff at CDR have expressed difficulty in getting fathers to participate on a regular and steady basis in fatherhood services. CDR will explore several strategies for increased retention and this study will evaluate these strategies.
3. Do fathers who participate in the program earlier in their fatherhood experience (e.g. when their oldest child is under five years of age) report better outcomes than fathers who begin receiving fatherhood services later? CDR has extensive knowledge working specifically with young children and families in early intervention programs. In early childhood development, many studies have shown that the highest return on investment comes from early intervention, from birth through age five. The hypothesis is that this principle holds true in responsible fatherhood programming as well.

Eligibility Criteria:
Inclusion Criteria:

* Any person enrolled in CDR's Pathways Fatherhood program.

Exclusion Criteria:

* Any participant who does not give informed consent.
Copanlisib Mass Balance Study

The study aims to provide understanding of the relative relevance of the different excretion pathways of Copanlisib in humans, as well as to characterize its metabolite profile.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject
* Age: 45 to 65 years
* Body weight greater or equal to 60 kg and body mass index (BMI): above/equal 18 and below/equal 30 kg/m²

Exclusion Criteria:

* Regular use of medicines
* Known recent (last 2 years) abuse of recreational drugs, suspicion of drug or alcohol abuse, or positive results of the drug and alcohol screen tests at screening or baseline
* Use of strong inhibitors of cytochrome P450 (CYP)3A4, as well as use of St John's Wort or strong inducers of CYP3A4 prohibited from 14 days before the administration of study drug until discharge from the clinic
* Smoking
* Average intake of more than 24 units of alcohol per week; Regular daily consumption of more than 1 L of methylxanthine-containing beverages
* Any condition, which may result in longer than usual retention of urine or feces in the body, such as pronounced (less than one defecation in 2 days) constipation or symptomatic prostatic hypertrophy.
* Participation in another mass balance study with a radiation burden \> 0.1 mSv in the period of 1 year before screening
Efficacy and Safety of BN101 in Subjects With Chronic Graft Versus Host Disease (cGVHD)

This is a phase 2, open-label, multicenter trial to evaluate the efficacy and safety of BN101 in subjects with Chronic Graft Versus Host Disease (cGVHD) after at least First Line of systemic therapy.

Approximately 30 subjects will be enrolled to receive orally administered BN101 200 mg QD (once daily)

Study drug will be administered in 28-day cycles until disease progression or unacceptable toxicity. Subjects may receive study drug in the inpatient or outpatient setting.

Curative Effect analysis The efficacy was analyzed based on MITT The point estimate and 95%CI of ORR were calculated based on the exact probability method of binomial distribution.If applicable, a logistic regression model will be used for multivariate analysis.

Descriptive statistical analyses were provided for all secondary efficacy endpoints.

The following subgroups will be analysed:

* Severe cGVHD (Yes/No)
* Number of organs involved (\<4 vs. ≥4)
* Number of previous systemic cGVHD treatment (1 vs. ≥2)
* Duration of cGVHD before inclusion (i.e., from the time of cGVHD diagnosis to the time of inclusion)
* Lung Involvement (Yes/No)

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects at least 18 years of age who have had allogenic hematopoietic cell transplant (HCT).
* Previously received at least 1 and not more than 5 lines of systemic therapy for cGVHD
* Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening;
* Have persistent cGVHD manifestations and systemic therapy is indicated

Exclusion Criteria:

* Subject has not been on a stable dose / regimen of systemic cGVHD treatments for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and extracorporeal photophoresis (ECP) are acceptable. Systemic investigational GVHD treatments are not permitted).
* Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
* Current treatment with ibrutinib. Prior treatment with ibrutinib is allowed with a washout of at least 28 days prior to treatment.
New Imaging Tools to Explore Impact of Bariatric Surgery on Pancreatic Lesions: PACHIBA- Bariatric Surg

The investigators propose an exploratory study aiming at assessing the impact of surgical bariatric treatment on the improvement of pancreatic lesions detected by MRI.

Pancreatic MRI will be performed in severe-obese patients with a planned bariatric surgery, before and 6 months after bariatric surgery.

To assess the impact of bariatric surgery on pancreatic Magnetic Resonance Imaging (MRI) parameters in severe-obese patients


Eligibility Criteria:
Inclusion Criteria:

* Adults (aged 18 to 65 years) with a planned for bariatric surgery (sleeve gastrectomy) according to HAS criteria
* Patients with severe obesity (BMI≥35)

Exclusion Criteria:

* Patients with problem of alcohol abuse (previous or current)
* Patients with problems of understanding
* Patients with previous acute or chronic pancreatitis
* Patients with contraindication to MRI (active implantable medical devices, pacemaker, claustrophobia ...)
* Inability to undergo MRI due to weight excess
* Pregnant or breastfeeding woman
* Absence of free and informed consent
* Non affiliation to a social security regime or CMU (Universal health coverage)
* Patient under AME (State medical aid)
* Patient deprived of freedom, subject under a legal protective measure
* Patients who have already had bariatric surgery

Secondary exclusion criteria :

* Patients who have undergone bariatric surgery other than a sleeve gastrectomy
Comparison of Complication Rates Between Initial and Re-operative Anterior Lumbar Interbody Fusion Surgery: Is There a Difference?

To identify the current mortality rate for initial ALIF procedures. Establish/prove mortality rates for this operation have dropped in the past decade.

Establish the mortality rate for "re-do" ALIF procedures \[i.e., is it different than that of initial ALIF procedures and - if so - postulate that there are interventions that can be done in the pre-operative period to ameliorate that risk. This study is not designed to "prove" the latter hypothesis.\]

This is a single sample study where medical records will be searched by CPT codes for ALIF codes (e.g. 22558, 22585, 22845, etc.) by trained researcher(s) at participating Methodist facilities going back 5-10 years to see if 1500-3500 cases can be identified within that time period.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 17 years of age, patients having had ALIF procedures as defined by CPT codes at participating Methodist facilities during 2010-2020 targeted.

Exclusion Criteria:

* Pediatric patients (as defined by age \<18 years old), pregnant women and incarcerated individuals. We do not anticipate any of these in an elective spine surgery group of patients. If they have emergency spine surgery it is normally not an ALIF.
A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)

To look at the ability of LY2127399 to reduce magnetic resonance imaging (MRI) lesions at 12, 16, 20, and 24 weeks compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* 18 through 64 years of age diagnosed with RRMS, who can walk without aid or rest for at least 200 meters (approximately 1/10 of a mile).
* Women who can become pregnant must use birth control.

Exclusion Criteria:

* Have had a live vaccination within 12 weeks before randomization, or intend to have a live vaccination during the course of the study.
* Have had had recent surgery or are scheduled to have surgery during the study.
* Are immunocompromised or have evidence of active infection \[such as hepatitis, tuberculosis or, human immunodeficiency virus (HIV)\].
* Have been on certain drugs that are being studied for RRMS or have recently received prescription drugs to treat RRMS.
* Have had a recent serious infection.
* Have serious or uncontrolled illnesses other than RRMS.
* Have clinically significant blood test values.
* Have multiple or severe drug allergies.
* Have contraindications for MRI "scanning" or claustrophobia (fear of an enclosed space) that cannot be managed.
A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB11 compared to Lucentis® in subjects with neovascular AMD.

Subjects will be randomised in a 1:1 ratio to receive either SB11 or Lucentis® (administered via intravitreal (ITV) 0.5 mg every 4 weeks). Investigational Products (IP) (SB11 or Lucentis®) will be administered up to Week 48, and the last assessment will be done at Week 52.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 50 years
2. Newly diagnosed, active subfoveal choroid neovascularisation (CNV) lesion secondary to AMD in the study eye
3. BCVA of 20/40 to 20/200 in the study eye
4. Written informed consent form

Exclusion Criteria:

1. Any previous ITV anti-vascular endothelial growth factor (anti-VEGF) treatment to treat neovascular AMD in either eye
2. Presence of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia
3. Any concurrent macular abnormality other than AMD in the study eye
Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivikar Tab. 5/40 mg in Healthy Adult Male Subjects

The purpose of this study is to assess the pharmacokinetic characteristics of olmesartan and S-amlodipine after single oral administration of Sevikar tab. 10/40mg, a combination formulation of olmesartan and amlodipine as reference drug and Lodivikar tab. 5/40mg, a combination formulation of olmesartan and S-amlodipine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male in the age of 20-45
* Body weight ≥ 55kg, IBW ± 20%
* Subject who sign on an informed consent form willingly

Exclusion Criteria:

* Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
* Subject with known for hypersensitivity reaction to S-amlodipine, amlodipine and olmesartan and dihydropyridine derivatives
* Clinically significant hypotension (SBP≤100mmHg, DBP≤60mmHg) or hypertension(SBP≥150mmHg, DBP≥95mmHg) when screening period
* Subject with known for history of disease or gastric surgery which affect on the absorption,
* Subject with any of the following conditions in laboratory test

  * AST or ALT \> UNL (upper normal limit) x 1.5
  * Total bilirubin \> UNL x 1.5
  * Renal failure with CLcr \< 50mL/min calculated on Cockcroft-Gault \[Cockcroft-Gault GFR = (140-age) \* (Wt in kg) / (72 \*Cr)\]
  * Serum potassium \< 3.5 mEq/L or \> 5.5 mEq/L
* Continued excessive use of caffeine (caffeine \>five cups/day), alcohol(alcohol\>30g/day) and severe heavy smoker(cigarette \>10 cigarettes per day)
* Participation in any clinical investigation within 60days prior to study medication dosing
* Subject with whole blood donation within 60days, component blood donation within 30days prior to study medication dosing
* Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
* Use of any prescription medication including oriental medication within 14 days prior to study medication dosing or over-the-counter medication within 7 days prior to study medication dosing
* Subject with mental illness or drug addiction
* Subject taking foods which affect on the absorption, distribution, metabolism or excretion of drug within 7days prior to study medication dosing
* Subject with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator
PROBIOTICS AND OZONATED OLIVE OIL TO MAINTAIN ORAL EUBIOSIS IN STAGE I AND II PERIODONTITIS PATIENTS

The goal of this clinical trial is to investigate the clinical benefits of the combined use of ozonized olive oil products (mouthwash and toothpaste) and probiotics on the health status of patients with Stage I and II periodontitis; could include any of the following:

* Male or female, aged between 18 and 70 years of any race.
* Diagnosis of stage I or II periodontitis according to the American Academy of Periodontology and the European Federation of Periodontology 2017 classification of periodontal diseases.
* Good general health.
* Ability to understand and comprehend the study's instructions and sign the informed consent.

The main question it aims to answer is: the single or combined use of ozonized olive oil products (mouthwash and toothpaste) and probiotics could improve the oral health status of patients with Stage I and II periodontitis compared to placebo?

Participants will proceed to their daily domiciliar oral hygiene maneuvers with the products given by investigators. The toothpaste was used twice daily, morning and evening, followed by rinsing with undiluted mouthwash for one minute. After rinsing, the patient did not rinse further with water and refrained from eating, drinking, and smoking for at least one hour. Domiciliary mechanical and drug therapies were continued, without modification, for 30 days. Moreover, the patients received a probiotic tablet daily.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged between 18 and 70 years of any race.
* Diagnosis of stage I or II periodontitis according to the American Academy of Periodontology and the European Federation of Periodontology 2017 classification of periodontal diseases.
* Good general health.
* Ability to understand and comprehend the study's instructions and sign the informed consent.

Exclusion Criteria:

* Pregnancy and breastfeeding.
* Periodontal or antibiotic therapy in the last two months.
* Systemic diseases that could influence the severity of periodontal disease or therapeutic success (e.g., Down syndrome, HIV, Diabetes Mellitus).
* Smoking \> 10 cigarettes per day.
* Need for antibiotic prophylaxis for dental procedures.
* Chronic use of anti-inflammatory drugs, calcium channel blockers, antidepressants, and anticonvulsants.
Pre-exposure Prophylaxis (PrEP) Adherence Intervention for Women with Substance Use Disorders

The goal of this clinical trial is to test an addiction-clinic based behavioral intervention for increasing PrEP uptake and adherence among women who engage in high-risk sexual behaviors and problematic substance use. The main question it aims to answer is:

• If the integrated intervention increase PrEP uptake and adherence compared to standard treatment

Participants will

* receive provision of PrEP information through 4 counseling sessions
* prevention navigation
* receive nurse practitioner prescribed PrEP in an addiction treatment setting

Researchers will compare intervention group with standard treatment to see if the integrated intervention help increase PrEP uptake and adherence


Eligibility Criteria:
Inclusion Criteria:

* Black/African American and Hispanic/Latina cisgender women
* diagnosed with a Substance use disorder (SUD) per Diagnostic and Statistical Manual of Mental Illnesses (DSM)-5 criteria
* HIV negative
* sexually active with an opposite sex partner within the past 6 months
* not using PrEP for HIV prevention at the time of screening
* able to speak, read, and write in English; and
* own or have regular access to a smart phone.

Exclusion Criteria:

* be concurrently participating in another SUD behavioral treatment program
* unable to provide informed consent for participation (e.g., have severe cognitive impairment that would interfere with their ability to consent, understand study procedures and/or effectively participate in therapy
* have psychological distress that would prohibit them from participating in the study
* be unable or unwilling to meet study requirements
* be ineligible for PrEP based on Centers for Disease Control and Prevention (CDC)-defined criteria for PrEP based on substance use and sexual risk
* have medical contraindications for PrEP (e.g., known renal impairment which can be exacerbated by PrEP use).
Peripheral Central Catheter (PICC) Care

Peripheral Central Catheter (PICC) is one of the painful interventions that are routinely performed repeatedly to establish a safe venous access in preterm babies.Nurses should reduce the pain of babies and ensure their comfort during interventions arising from the necessity of care processes.

Today, it is accepted that tactile stimuli, which have a pain-reducing effect on babies, should be used as a complementary treatment and care method. Palmar grasp reflex is one of the important tactile stimuli to reduce pain and provide comfort in babies. This research will be conducted to examine the effect of palmar grasp reflex stimulation on pain and comfort levels in PICC care in preterm babies.


Eligibility Criteria:
Inclusion Criteria:

* Without congenital defects,
* Not receiving sedation at least 3 hours before PICC care,
* No unexplained crying,
* Without neurological problems,
* Not undergoing surgical intervention,
* Babies with PICC insertion

Exclusion Criteria:

* Having had a painful procedure (invasive procedure, etc.) within the last hour,
* Babies for whom permission was not obtained from the parent through an informed voluntary consent form