cyrilzakka/clinical-trials huggingface dataset:
Bridging the Gap to Improve Mental Health Treatment Utilization

Bridging the Gap aims to improve access to effective mental health treatment in a primary care setting through utilization of single session growth mindset interventions for parents and for youths. This project will also utilize focus groups and qualitative interviews to gain feedback on a single session online intervention in a rural pediatric primary care practice.

Bridging the Gap purposes to collect feedback on a single session growth mindset intervention (GMI) for parents and for youths designed to instill beliefs that personal traits (including mental health problems) are malleable. Feedback will also be collected to identify ways to improve implementing single session interventions (SSIs) in a primary care setting as well as identifying the impact on work-flow of this GMI. Patients presenting with depression and/or anxiety will all receive the GMI and will have the option of participating in focus groups/interviews pre and post-intervention to provide feedback on the intervention. Providers at this rural pediatric primary care practice will also have the chance to participate in focus groups/interviews pre and post-intervention implementation.

Assignment of Interventions: As an open trial, all participants will be assigned to the intervention arm and will receive the GMI.

This study is an open trial pilot project to collect feedback on a single session growth mindset intervention (GMI) (n=25 youth/caretaker dyads). Feedback from pre and post-intervention focus groups/interviews will be collected for 8 parents, 8 youth, and 8 treatment providers.

The aims of the study are to:

1. Collect feedback from providers, parents, and participants pre and post- GMI to identify ways to improve implementing single session interventions (SSIs) in a primary care setting.
2. Identify the impact on work-flow of using an online single session called Growth Mindset Intervention in a primary care setting.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with depression and/or anxiety, as identified by the patient, parent, or provider
* 10-18 years old
* CBT is recommended by provider. Receipt of mental health services upon enrollment will be monitored but will not preclude participation
* Participants must reside with a legal guardian
* English speaking

Exclusion Criteria:

* Participants will be excluded if they have conditions that might impair their ability to effectively engage in Bridging the Gap, i.e
* Those in a current manic episode
* Those in a current psychotic episode
* Those diagnosed with Autism Spectrum Disorder
* Those who have issues with substance abuse
* Participants with current involvement with child welfare.
Study of the Links Between Suicidal Intentionality and Acute Alcoholism

There is a strong link between the alcohol consumption and the suicidal risk. Indeed there is an increase of the risk of suicide in case of chronic or acute alcohol consumption. However why the alcohol consumption increase the suicidal risk is unknown.

The hypothesis of this study is that the alcohol consumption induced disinhibition and facilitates the suicide attempt without premeditation

People hospitalized after a suicide attempt will answer to two questionnaires about the suicide intentionality and the acute alcohol consumption.

There is 2 arms:

people doing suicide attempt and with positive level of alcohol (up to 0.1g.L) people doing suicide attempt and with negative level of alcohol

110 patients will be included in this study so 55 in each arm.

Eligibility Criteria:
Inclusion Criteria:

* patient hospitalized in emergency department for a suicide attempt by voluntary drug intoxication
* speaking and understanding french

Exclusion Criteria:

* Patient who has used other psychoactive substances (attested by toxicological analyzes and / or interrogation)
* Known neurodegenerative pathology
Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea

The purpose of this study is to assess the safety and efficacy of azelaic acid (AzA) foam, 15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea compared to its vehicle.

To determine the efficacy of AzA foam, 15% compared to vehicle topically applied twice daily in papulopustular rosacea evaluated by therapeutic success rate according to Investigators Global Assessment (IGA) and change in inflammatory lesion count from baseline to end of treatment.

Evaluation of all adverse events will be covered in Adverse Events section.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of papulopustular rosacea
* Free of any clinically significant disease, which could interfere with the study
* Male or female subject aged ≥ 18 years
* Willingness of subject to follow all study procedures
* Signed written informed consent before any study-related activities are carried out

Exclusion Criteria:

* Subjects who are known to be non-responders to azelaic acid
* Presence of dermatoses that might interfere with rosacea diagnosis
* Ocular rosacea; phymatous rosacea; subjects with plaque-type rosacea lesions, papulopustular rosacea that requires systemic treatment
* Topical use of any prescription or non-prescription medication to treat rosacea within 6 weeks prior to randomization and throughout the study
* Systemic use of any prescription or non-prescription medication to treat rosacea (Retinoids within 6 months, Tetracycline within 2 months, Corticosteroids, erythromycin, azithromycin, and/or metronidazole within 4 weeks) prior to randomization and throughout the study
* Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to randomization
* Known hypersensitivity to any ingredients of the investigational product formulation
* Participation in another clinical research in parallel or within the last 4 weeks before randomization in this study
* Any condition or therapy that in the investigator's opinion may pose a risk to the subject or that could interfere with any evaluation in the study
Loss and Return of Sensation After Axillary Brachial Plexus Nerve Block - Distally or Proximally

Peripheral regional anesthesia is the current gold standard of opioid-sparing perioperative analgesia, especially in shoulder, upper limb, and leg surgery. Axillary brachial plexus nerve block is one possible block for upper limb surgery. Loss and return of sensation require time and loss of sensation is supposed to spread from the proximal part to the distal part of the upper limb. Interestingly, until now there is no study about the return of sensation related to the anatomic region.

The investigators hypothesize that the loss and return of sensation after axillary brachial plexus nerve block will first occur in the proximal part of the upper limb and last in the distal part.

Peripheral regional anesthesia is the current gold standard of opioid-sparing perioperative analgesia, especially in shoulder, upper limb, and leg surgery.(1-8) Axillary brachial plexus nerve block is one possible block for upper limb surgery.(4, 5, 9) Loss and return of sensation require time. It is known from clinical practice that loss of sensation occurs from the proximal part of the arm to the distal part of the upper limb.

Interestingly, until now there is no study about the return of sensation related to the anatomic region. The investigators hypothesize that return of sensation after axillary brachial plexus nerve block will develop in the same direction like loss of sensation, what means from proximal to the distal part of the upper limb.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients with planed surgery with axillary brachial plexus nerve block
* Informed consent as documented by signature
* Age ≥ 18 years

Exclusion Criteria:

* Patients with a known allergy towards the local anaesthetic
A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care

The purpose of this study is to assess the effectiveness of a parenting intervention+usual care compared to usual care on postpartum depression and other mental health and parenting outcomes, as well as the feasibility and acceptability of the parenting intervention.

Eligible and consenting participants will be randomized in a single blind manner (research visitor will be blinded to condition) at a 1:1 ratio to either MInD (parenting intervention and usual perinatal collaborative care) or usual collaborative care in their second trimester of pregnancy. Research assessments will be administered during pregnancy and post-partum.

Eligibility Criteria:
Inclusion Criteria:

* English speaking pregnant women between gestational age (GA) 13 - 24 weeks
* ≥ 18 years,
* EPDS score ≥10,
* Ability to send and receive text messages (TM)

Exclusion Criteria:

* Severe substance use disorder in the past 6 months (score of 4 or above on the Alcohol Use Disorders Test AUDIT-C or a score of 6 or more on the Drug Abuse Screening Test (DAST).
* Active suicidal ideation as measured by follow up to a positive answer to question 10 on the EPDS.
* Bipolar disorder (Composite International Diagnostic Interview score ≥7) or psychotic disorder (assessed by chart review);
* Multiple gestation (assessed by self-report and medical record);
* Ongoing active treatment with psychotropic medications by mental health specialist (but not a PCP or Obstetrician).
QLESP Block Versus Periarticular Infiltration for Postoperative Analgesia in Hip Surgery

Local and/or regional analgesia techniques are critical components of an optimal multimodal analgesia technique, as they have been shown to improve pain relief as well as reduce opioid requirements. Optimal pain management technique balances pain relief with concerns about safety and adverse effects associated with analgesic techniques. Periarticular infiltration (PAI) is increasingly included as a component of multimodal analgesia technique for patients undergoing THA, as it provides improved postoperative pain relief with no effects on quadriceps function. Recently, our group has developed a novel transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block, which is characterized by simple operation, high efficiency, and wide dermatomal coverage of sensory block. Therefore, we designed a randomized controlled trial to compare ultrasound-guided QLESP with PAI as a component of non-opioid analgesic regimen in patients undergoing THA via posterior approach. We hypothesized that QLESP would provide superior analgesia when compared with PAI. The primary outcome of the study was postoperative opioid requirements within the initial 24-h postoperative period after THA. The secondary objectives were to compare pain scores, postoperative quadriceps strength, the time to first rescue analgesia, opioid-related adverse effects, time to ambulation, and the time to hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 yrs
2. American Society of Anesthesiologists classification 1-3
3. Body mass index between 20 and 35 (kg/m2)
4. Undergo elective primary unilateral THA via a posterolateral approach
5. Informed consent

Exclusion Criteria:

1. A known allergy to the drugs being used
2. Pre-existing neuropsychiatric disorders or language barrier
3. Analgesics intake, history of substance abuse
4. Contraindications to peripheral nerve block
5. Acute cerebrovascular disease
6. Severe liver failure
Overcoming Psychiatric Barriers to the Treatment of Hepatitis C

The purpose of this study is to develop and evaluate a 9-month psychosocial intervention that will assist patients with hepatitis C in overcoming barriers that prevent them from becoming appropriate candidates for interferon therapy.

The purpose of this study is to develop and evaluate a 9-month psychosocial intervention that will assist patients with hepatitis C in overcoming barriers that prevent them from becoming appropriate candidates for interferon therapy. Patients who have been deferred from therapy due to mental health or substance abuse issues will work with the team psychologist on following through with the hepatologist's treatment recommendations that would lead to becoming eligible for interferon therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patient has confirmed diagnosis of HCV;
* Patient has expressed an interest in undergoing interferon treatment;
* Patient is deferred from interferon therapy for psychiatric, alcohol use, or other psychosocial issues;
* Patient must be completely medically cleared by the hepatologist with no outstanding medical conditions that would deem them ineligible from treatment;
* Patient must have only psychiatric issues and/or substance use issues; but otherwise no other contraindications for treatment.

Exclusion Criteria:

* Patient has a diagnosis of schizophrenia, psychosis;
* Patient resides in a psychiatric residential facility;
* Patient attempted suicide in the past five years;
* Patient is a current intravenous drug user;
* Patient is cognitively or decisionally-impaired due to brain disease or injury;
* Patient has advanced liver disease that precludes them from interferon treatment;
* Patient has other medical comorbidities that may exclude them from interferon treatment;
* Patient does not want to pursue interferon treatment at the present time;
* Patient has significant financial constraints, such as no insurance or homelessness, that would prevent them acquiring mental health or substance abuse services;
* No access to telephone service;
* Non-English speaking.
Use of Export in Primary Percutaneous Coronary Intervention

Aim of this single center randomized open label trial with blinded in-hospital outcomes assessment is designed with aim to compare manual thrombus aspiration followed by percutaneous coronary intervention (PCI) strategy with PCI alone.

Clinical benefit of manual aspiration has been a contentious point of debate and it is Class III indication in current clinical practice guidelines, however, recent observational data by Kumar D et al. showed benefits of usage of export in terms of favorable in-hospital outcomes and lesser complication rate in patients with total occlusion, furthermore, benefits of usage of export was observed to be directly associated with duration of chest pain at the time of thrombus aspiration. However, these observations are limited to immediate and in-hospital outcomes and data regarding efficacy of manual thrombus aspiration are not available.

Hence this single center randomized open label trial is designed with specific aim to test the following hypothesis for STEMI patients with total occlusion undergoing primary PCI;

* Whether use of export catheter reduces in-hospital and short term adverse events
* Whether use of export reduces slow flow or no reflow
* Whether use of export reduces the use of intracoronary drugs
* Whether use of export within 6 hours of symptom onset significantly reduces in-hospital and short term adverse events

Consecutively recruited patients will be randomized to either primary PCI with export or primary PCI alone group in 2:1 ratio. Post aspiration immediate TIMI flow will be observed and all the patients will be observed for adverse outcomes (MACE) and complications including slow flow/no-reflow. Follow-up intervals will be at the end of one month of randomization and end of 6 month of randomization.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with:-Symptoms of myocardial ischemia lasting for ≥30 minutes
* Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads
* Chest pain \< 12 hours duration
* Total occlusion (TIMI 0 flow)
* Patients undergoing primary PCI
* Informed consent

Exclusion Criteria:

* Patients with prior history of cardiac related surgery or intervention
* Performance of a rescue PCI after thrombolysis
* Known existence of a disease resulting in a life expectancy of less than 6 months
* Killip class III, IV
A Phase 1 Study of ABBV-CLS-7262, Rosuvastatin, and Digoxin in Healthy Subjects

This study follows an open-label, single arm design with two periods with rosuvastatin, digoxin and ABBV-CLS-7262

Period 1: One single dose of rosuvastatin and one single dose of digoxin on Day 1.

Period 2: Multiple doses of ABBV-CLS-7262 once daily from Day 1 to Day 8. On Day 5, one single dose of rosuvastatin and one single dose of digoxin with the dose of ABBV-CLS-7262 on that day.

Eligibility Criteria:
Inclusion Criteria:

* Adult volunteers in general good health
* Must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures
* Individuals between 18 and 65 years of age inclusive at the time of screening
* BMI is ≥ 18.0 to ≤ 32.0 kg/m2
* All male subjects who are sexually active and not surgically sterilized must agree to use an acceptable contraceptive method. Additionally, male subjects must agree to not donate sperm during the study until 30 days after the final dose of study drug
* All female subjects who are sexually active and of childbearing potential must agree to use a highly effective contraceptive method. Additionally, female subjects must agree to not donate eggs during the study and for 30 days after the final dose of study drug.

Exclusion Criteria:

* Subject who, in the opinion of the investigator, is incapable of completing study-required visits and procedures
* Pregnant or breastfeeding.
* Treatment with any other investigational treatment within 30 days
Tele-Anesthesia - Trans-Continental Anesthesia Compared to Standard Practice

Patients in Pisa will undergo thyroid gland surgery. In the protocol group anesthesia will be performed using an automated anesthesia delivery system; preoperative and intra-operative assessment of patients will be performed via video-conferencing from Montreal, which will also monitor and control anesthesia delivery via distant Internet connection - as supervision of functioning of the automated anesthesia delivery system. In the control group anesthesia will be performed in a standard fashion with manual control of the syringe pumps infusing anesthetics drugs.

The hypothesis is that Tele-anesthesia, considered as preoperative assessment and anesthetic control of an automated anesthesia delivery system is feasible and reliable via standard means of internet communication (distant control via virtual network) and performed as well or even better than manual control of the anesthetic drugs infusion.


Eligibility Criteria:
Inclusion Criteria:

* Elective patients
* Patient scheduled for surgery under spinal anesthesia
* Patients aged 18 to 85 years

Exclusion Criteria:

* Unable to provide informed consent
* Comatose patients
* Patients with dementia
* Allergy to Propofol
Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet

Ketogenic diet therapies (KDTs) emphasize high fat and very low carbohydrate intake and help to control seizures in adults who fail to respond to medications. However, KDT use can lead to increased cholesterol levels in some adults with epilepsy (AWE). Treatments that can reverse elevations in cholesterol observed with long-term KDT use without compromising diet adherence and seizure control are needed. The proposed study will explore the feasibility and safety of diet modification and statin use to lower cholesterol in this population. Study findings will help guide doctors utilizing KDTs in adults with epilepsy on how to approach managing elevations in cholesterol.

The scientific premise of this proposal is that established or long-term (≥ 12 months) Modified Atkins diet (MAD) use in AWE influences atherosclerotic cardiovascular disease (ASCVD) risk and can be modified to reduce dyslipidemia when observed. Hence, the overarching goals of this proposal are to explore the safety and feasibility of dyslipidemia management strategies to reduce ASCVD risk in AWE on MAD without increasing seizure risk. This study will collect data before and after randomly assigned interventions to reduce LDL in AWE on long-term MAD recruited from patients receiving clinical care in the Johns Hopkins Adult Epilepsy Diet Center.

AWE with dyslipidemia on long-term MAD will be randomized 1:1 to either MAD modification (10% reduction of dietary energy from saturated fat, replaced with poly-unsaturated fat ) or moderate-intensity statin use (atorvastatin 10mg) for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Modified Atkins Diet use ≥ 12 months
2. Dyslipidemia based on American College of Cardiology/American Heart Association guidelines (i.e., LDL ≥190 mg/dL, 10-year ASCVD risk ≥5% with risk enhancers, etc.)
3. 18 years of age or older
4. Body mass index (BMI) \> 18.5
5. Stable anti-seizure medication regimen for \> 1 month.

Exclusion Criteria:

1. \< 18 years of age
2. Body mass index (BMI) \< 18.5
3. Changes in anti-seizure medication regimen \< 1 month prior to participation
4. Known ASCVD (history of acute coronary syndrome, myocardial infarction, angina, stroke, transient ischemic attack, or peripheral artery disease)
5. Current statin medication use
6. Prior serious adverse response to atorvastatin or other statin medications
7. Uncorrected carnitine deficiency
8. Pregnancy
Comparison Study of Psoriasis Severity Assessment Tools

This study evaluates the performance of objective psoriasis severity assessment tool compared with a subjective assessment tool for the assessment of the improvement of psoriasis after oral cyclosporine A or methotrexate treatment.

Patients with moderate-to-severe psoriasis were randomly assigned to treatment for 16 weeks with either cyclosporine A (20 patients; male 200 mg/day, female 150 mg/day) or methotrexate (20 patients; initial dose with 10 mg/week, increased up to 15 mg/week). The primary outcome was to compare the difference between the conventional subjective Psoriasis Area and Severity Index (PASI) and the objective PASI by using Colorimeter at 2, 4, 8, 12, and 16 weeks of treatment. The secondary outcome was differences between cyclosporine and methotrexate for treatment of psoriasis, evaluating clinical efficacy and side effects.

Eligibility Criteria:
Inclusion Criteria:

* Present with chronic plaque psoriasis based on a clinical diagnosis
* Have \> 5% body surface area involvement at screening
* Are a candidate for systemic therapy
* Are male or female patients 18 years or older
* Have given written informed consent approved by the Institutional Review Board

Exclusion Criteria:

* Have predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis
* Have had any of the systemic non-biologic psoriasis therapy (including neotigason, cyclosporine, and methotrexate) within 4 weeks prior to baseline
* Have had etanercept within 4 weeks prior to baseline
* Have had adalimumab and infliximab within 8 weeks prior to baseline
* Have had ustekinumab within 16 weeks prior to baseline
* Presence of significant hepatic or renal disorders
* Have uncontrolled arterial hypertension
* Are women who are lactating, breastfeeding or planning pregnancy
* Have any other condition that precludes from following and completing the protocol
REGistry of Long-term AnTithrombotic TherApy-1

To assess the rates of ischemic and hemorrhagic complications of long-term antithrombotic therapy in patients with chronic coronary syndromes

The register is a Russian prospective single-center observational study of patients who have indications for long-term antithrombotic therapy in connection with chronic coronary syndromes

Eligibility Criteria:
Inclusion Criteria:

* coronary artery disease , confirmed by history of myocardial infarction, or revascularization, or definitive evidence of CAD on imaging

Exclusion Criteria:

* Subjects who are unwilling or unable to provide informed consent.
* Acute coronary syndrome within 12 months before inclusion
* Severe chronic heart failure (NYHA IV)
* Stroke within 6 months before inclusion
* Severe liver or muscle disease
* Severe kidney disease / renal failure with creatinine \> 3 mg/dl
* Conceivable impossibility to come in touch with the patient or his family at 1-year after the intervention -