cyrilzakka/clinical-trials huggingface dataset:
Brexpiprazole in Patients With Acute Schizophrenia

To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* The patient has schizophrenia, diagnosed according to DSM-IV-TR™ and confirmed by the Mini International Neuropsychiatric Interview (MINI).
* The patient has an acute exacerbation of psychotic symptoms and marked deterioration of usual function.
* The patient is willing to be hospitalised from the Screening Visit through Week 6.
* The patient will benefit from hospitalisation or continued hospitalisation for treatment of a current acute relapse of schizophrenia at study entry.
* The patient has a history of relapse and/or exacerbation of symptoms when not receiving antipsychotic treatment, excluding the current episode.
* The patient agrees to protocol-defined use of effective contraception.

Exclusion Criteria:

* The patient has a current Axis I diagnosis (DSM-IV-TR™ criteria) other than schizophrenia established as primary diagnosis.
* The patient suffers from a current Axis II diagnosis (DSM-IV-TR™ criteria).
* The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
* The patient, in the opinion of the investigator or according to Columbia Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
* The patient has clinically significant tardive dyskinesia or severe akathisia at enrolment.
* The patient has a history of neuroleptic malignant syndrome.
* The patient has any relevant medical history or current presence of systemic disease.
* The patient has, at the Screening Visit an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant.
* The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for \>5 years prior to the first dose of brexpiprazole.
* The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.
Pilot Study of an Internet-based Program for Prevention and Early Intervention of Adolescent Depression

Major depression is a highly prevalent and severe mental disease that negatively alters the lives of people, their families, and their social environment.

Organizations that promote mental health policies have recognized the potential of new information technologies for the prevention and treatment of mental disorders. In this direction, information and communication technologies (ICTs) generate opportunities for increasing patient well-being through the use of on-line software. Such programs often include interactivity, self-monitoring, information materials (sometimes in multimedia format), and exercises on problem solving, recognition and challenging of dysfunctional thoughts, scheduling of activities, behavioral experiments, and other psycho-educational activities.

In Colombia, there are few preventive mental health interventions scientifically oriented and seeking to demonstrate efficacy in context.

The purpose of this study is to determine whether an internet-based program is effective to prevent and to intervene early the depression in adolescents between 11 and 20 years of age in 2 schools in the Antioquia Region, Colombia.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents who study in schools in Antioquia from sixth grade to tenth grade, who can access the internet and a psychological service in case of moderate or severe depressive symptoms.

Exclusion Criteria:

* High suicide risk defined by: A score equal to or greater than 2 in the question 9 of the PHQ-9A, an adolescent who is undergoing treatment with antidepressants and / or currently attends psychotherapy
Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy

This is a prospective, randomized, multicenter, double-blinded, placebo-controlled trial. Eighty-eight patients with primary membranous nephropathy (PMN) will be randomly divided into the intervention and control groups. The intervention group will be administered maximum tolerable dose of ACEI/ARB and finerenone 20 mg QD. Control patients will be administered maximum tolerable dose of ACEI/ARB and a placebo. The primary endpoint is the relative change in urinary protein content from baseline to 6 months.

After more than 4 weeks of maximum tolerated dose of ACEI/ARB, the patients will be randomly divided into the control and intervention groups in a 1:1 ratio in a double-blinded manner. The intervention group will then be administered finerenone 20 mg QD, while control cases will receive a placebo.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age≥18,and ≤75) with primary MN.
* Administration of the maximum tolerable dose of ACEI/ARB for ≥4 weeks.
* BP ≤140/90 mmHg.
* Urine protein content of 1.0-5.0 g/d.
* eGFR ≥60 (CKD-EPI).
* Postmenopausal or postoperatively infertile status or on medical contraception (considering the potential risk of thromboembolism in patients with kidney disease) in women.
* Voluntary signing of informed consent.

Exclusion Criteria:

* Type 1 or type 2 diabetes. Patients with a recent history of steroid-induced diabetes were eligible with renal biopsy showing no evidence of secondary diabetic nephropathy within 6 months before the screening period.
* Patients with secondary membranous nephropathy (e.g., due to hepatitis B and C, systemic lupus erythematosus, drug therapy, malignant tumors and other secondary causes).
* Uncontrolled arterial hypertension.
* Treatment with glucocorticoids, immunosuppressants and/or biological agents in the past 6 months.
* Treatment with any other study drug within the last month.
* Females with a positive pregnancy screening test, lactating or planning to become pregnant in the next 24 months. Female or male patients unwilling to use contraceptive methods throughout the study.
* A history of mental illness.
* Laboratory tests meeting the following criteria:

  1. Hemoglobin levels \<80 g/L;
  2. Platelet count \<80×109/L;
  3. Neutrophil count \<1.0×109/L;
  4. Aspartate aminotransferase (AST) or amino aminotransferase (ALT) \>2.5 times the upper limit of normal, except in relation to the primary disease.
* Very high-risk cases (life-threatening nephrotic syndrome or unexplained rapid deterioration of renal function).
* Unsuitability for inclusion in the trial as judged by the investigator.
The Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Anxiety in PD

This study is a double blind comparative study examining the effectiveness of the transcutaneous auricular vagus nerve stimulation treatment on Parkinson's disease patients with anxiety. The investigators hypothesize that taVNS will improve anxiety and cortical activity in Parkinson's disease patients with anxiety.

Participants in the Experimental group underwent fourteen consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time) , whereas participants in the sham stimulation group underwent fourteen consecutive daily sessions of sham taVNS. Assessments of anxiety symptoms, motor symptoms were performed three times: at baseline, one day post intervention and 2 weeks post intervention. The cortical activity (using Functional near-infrared spectroscopy) were assessed at baseline, one day post intervention.

Eligibility Criteria:
Inclusion Criteria:

* (1) diagnosed with idiopathic PD according to the Movement Disorder Society Clinical Diagnostic Criteria for PD;
* (2) meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for anxiety and Hamilton Anxiety Scale (HAMA) score ≥ 12;
* (3) stable pharmacotherapy for PD at least one month prior to the study;
* (4) 40-80 years old;
* (5) willing to sign written informed consent.

Exclusion Criteria:

* (1) with cognitive impairment, according to Montreal Cognitive Assessment (MOCA) \< 23;
* (2) took antianxiety drugs;
* (3) with taVNS contraindications;
* (4) received VNS treatment during the past month;
* (5) with concomitant severe neurologic, renal, cardiovascular, or hepatic disease.
Study Whose Purpose is to Find an Optimal Dose for the Treatment With AK 3012 in Patients With Actinic Keratosis

In this three-armed dose-finding trial 3 AK 3012 topical formulations shall be investigated with respect to safety and efficacy in order to identify the optimal concentration in the topical formulation.

The main objective of the trial is to determine the optimal concentration of the active agent in the topical formulation as quantified by the change of the number of skin alterations in pre-defined areas in a time period from inclusion in the trial until the end of treatment (3 months) or prior complete healing.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18 years
* Gender: male and female
* Actinic Keratosis (Olsen grade I/II)
* at least 5 actinic keratoses on the scalp, forehead, face, extremities, and/ or decollete
* no treatment of the actinic keratoses within the previous 3 months before inclusion in the study
* histologic confirmation of the diagnosis actinic keratosis by biopsy
* good general condition
* normal laboratory values (creatinine, urea, Glutamate-Oxalacetate Transaminase (GOT),Glutamate-Pyruvate Transaminase (GPT), gamma-glutamyl transferase (GGT), Lactate dehydrogenase (LDH)) and blood count at study start not higher than 1.5 x upper norm limit
* Female patients must be tested negative for pregnancy before inclusion in the trial. During the trial, female patients have to apply a generally accepted form of birth control (i.e. oral estrogen- and gestagen containing contraceptives; estrogen containing skin plaster/ tape, hormone implant, hormone contraceptive coil, sterilisation; sexual abstinence) or being post-menopausal for at least 2 years.
* Willing and able to participate in the screening and all trial specific procedures in compliance with the protocol
* Signed written informed consent

Exclusion Criteria:

* Known allergy against nonsteroidal antiphlogistics and/ or against excipients of the investigational medicinal product
* Presence of immunosuppression
* Treatment with 5-fluorouracil, cyclosporine, retinoids, glycolic acid, imiquimod, trichloroacetic acid during the trial or 12 weeks before inclusion in the trial
* Continuous treatment with nonsteroidal antiphlogistics with the exception of low-dose acetylsalicylic acid (100 mg) for inhibition of thrombocyte aggregation
* Planned treatment with photodynamic therapy during participation in the trial
* Pregnancy or lactation
* Participation in another clinical trial within 3 months before inclusion in the current trial
Predictive Factors of ANTI-TNF Response in Luminal Crohn's Disease Complicated by Abscess

To identify predictive factors of adalimumab (anti TNF) response in patients with luminal Crohn's disease complicated by intra-abdominal and/or pelvic abscess after complete resolution of infection.

Multicenter prospective observational cohort.

Initial management of sepsis and abscess (Before anti-TNF therapy initiation) i. Antibiotics. ii. Percutaneous drainage will be performed every time when possible iii. Surgical drainage will be performed if percutaneous drainage is not accessible or fails iv.

Concomitant medications :

* Steroids will be rapidly tapered and stopped.
* Azathioprine, 6-mercaptopurtine, 5-ASA derivatives and methotrexate will be maintained at a stable dose.
* If not present at inclusion, immunosuppressors could be introduced at the discretion of investigator
* Antibiotics could be used if needed for infections not related to intra-abdominal abscess recurrence and Crohn's disease. v.

Supportive care including artificial nutrition will be started if necessary.

2. Anti-TNF therapy:

- The anti-TNF agent will be adalimumab, administered as subcutaneous injection of 160 mg at W0, 80 mg at W2, followed by 40 mg every 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years.
* Diagnosis of Crohn's disease (confirmed by clinical evaluation and a combination of endoscopic, histological, radiological, and/or biochemical investigations according to European guidelines)
* AND diagnosis of spontaneous intra-abdominal and/or pelvic abscess according to radiologic criteria confirmed by US, CT or magnetic resonance enterography (MRE).
* In patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant or who are intolerant to or have medical contraindications for such therapies
* Written consent MAIN

Exclusion Criteria:

* Age under 18 years. - Absence of written consent. - Post-operative abscess (occurring within 12 weeks after intestinal resection). - Isolated intra-parietal abscess of small intestine or colon. - Need for immediate surgery including irreversible bowel obstruction, peritonitis or uncontrolled sepsis. - Perineal abscess complicating perianal Crohn's disease. - Abscess developing under anti-TNF therapy. - Previous failure or intolerance to adalimumab. - Contraindication to anti-TNF therapy.
Effect of Tyrosine Supplementation on Cognitive Performance and Mood During Military Stress

The objective of this research is to determine if tyrosine, an amino acid found in protein-containing foods, will mitigate the cognitive deficits and adverse effects on behavior and mood produced by exposure to military stress. This study was conducted at the US Navy Survive, Evade, Resist, Escape (SERE) school at Brunswick, Maine (ME).

Tyrosine is the dietary precursor of the catecholamine norepinephrine, a key brain neurotransmitter that is critical for the central nervous system (CNS) response to various types of acute stress. Psychological stress increases catecholamine turnover in the brain, increasing the requirement for tyrosine to support synthesis of norepinephrine. Animal and human studies have shown that tyrosine supplementation can produce beneficial effects on cognitive and physiological functions during exposure to a variety of acute stressors.

This project will determine if volunteers treated with supplemental tyrosine during stressful phases of SERE training experience less degradation in cognitive performance and mood than volunteers treated with placebo. Tyrosine or placebo will be administered in a specially developed food bar provided to volunteers. The bar is part of a prototype of ration-component designed for use during assault operations. A between-subjects, double blind experimental design will be employed. Tyrosine, an amino acid found in most protein-containing foods, has been tested in hundreds of volunteers without adverse effects.

Approximately 100 volunteers will be recruited from several SERE classes to ensure up to 80 volunteers complete the study. They will be tested during several portions of SERE. A comprehensive but brief battery of cognitive tests, as well as saliva samples, and heart rate data will be collected in a manner that does not interfere with ongoing training.

Hypotheses:

1. Exposure to the stressors of SERE school will adversely impact cognitive performance and mood of volunteers.
2. The adverse effects of psychological stress on cognitive performance and mood during SERE school will be reduced when volunteers are given supplemental tyrosine compared to placebo treatment.


Eligibility Criteria:
Inclusion Criteria:

* Active duty military enrolled in the US Navy SERE School, Brunswick, ME.
* Fluent in English (non-native English speakers can be enrolled).

Exclusion Criteria:

* None.

\[All volunteers enrolled in SERE school require a medical clearance. No additional inclusion or exclusion criteria are necessary.\]
Community-Based Nutrition-Lifestyle Therapy for Pregnant Latina Women With Diabetes

Socioeconomically disadvantaged (SED) pregnant Latina women are disproportionately burdened by type 2 diabetes (T2D). Although lifestyle interventions can help to improve diabetes control, there are barriers to SED, Spanish-speaking pregnant people participating. The purpose of this proposal is to develop and test a culturally tailored, dietary-lifestyle behavioral intervention that supports eating plant-based foods such as fruits, vegetables, nuts and grains instead of processed foods and meat, and is implemented through community health workers (CHWs) to prevent excessive weight gain during pregnancy and improve control of blood sugar levels in pregnant Latina women with T2D. This study takes advantage of our existing strong relationships with the local Latino community, CHWs, and Santa Barbara County Public Health, which includes eight multidisciplinary healthcare clinics with sliding fee programs, and Rooted Santa Barbara, a community plant-based lifestyle organization. Cultural sensitivity focuses on delivering health information based on norms, values, beliefs, environmental factors, and historical context that is unique to a racial/ethnic population. Therefore, for our program to be culturally sensitive, it will include delivery of the program by CHWs primarily in the Spanish language with English as needed and incorporation of culturally relevant eating and physical activity recommendations. The specific aims of the project are: 1) in year one, develop the dietary-lifestyle behavioral intervention that encourages a plant-forward diet for pregnant Latina women with T2D to prevent excessive weight gain during pregnancy and improve blood sugar control in collaboration with CHWs and participants by conducting focus groups to incorporate feedback on the program; 2) initiate in year one, and in year two, conduct a randomized controlled trial with 30 pregnant Latina women with T2D to evaluate the how well the nutrition-behavior lifestyle program works; and 3) evaluate the acceptance and delivery of the dietary-lifestyle behavioral intervention in CHWs and participants. If successful, this study will establish the how well a culturally sensitive program delivered by CHWs incorporating plant-forward diets for pregnant Latina women with T2D prevents excessive weight gain during pregnancy, and control of blood sugar levels.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes in pregnancy
* ≥ 18 years old
* Self-reported Hispanic and/or Latino/a heritage
* BMI ≥ 26.0 kg/m2 and ≤ 42.0 kg/m2

Exclusion Criteria:

* Type 1 Diabetes
* Active substance abuse with alcohol or drugs by self-report
* Treatment with non-diabetes medications (e.g., corticosteroids, anti-psychotics) known to have metabolic/body weight effects that could affect outcome measures
* Non-singleton fetus
* Evidence of fetal malformation
* HbA1c ≥ 10%
* Unable to provide informed consent or unwilling to complete the study
Paracervical Block During Office Hysteroscopy

The purpose of this study is to determine the effectiveness of paracervical block for pain relief in office hysteroscopy - particularly with the placement of the Essure device. Subjects will be randomized to receive either paracervical block or saline, and will have pain assessments performed throughout the procedure. Subjects and physicians will be blinded to group assignments.


Eligibility Criteria:
Inclusion Criteria:

* Women eligible and scheduled for office hysteroscopic placement of essure devices

Exclusion Criteria:

* Planned secondary procedures
* Lidocaine allergy
* Repeat procedures
Impact of Progestin-only Contraception on Bleeding Patterns in Individuals Initiating GATT

Gender diverse individuals who use gender-affirming testosterone therapy (GATT) to reduce gender dysphoria may also use progestins for contraception and to manage or suppress uterine bleeding. Research is limited, however, regarding expected bleeding patterns for individuals who choose to initiate GATT concurrently with a progestin. Clinicians who prescribe GATT do not have sufficient data to adequately counsel patients on side effects of concurrent progestin use and therefore extrapolate from studies conducted in cisgender women. This study is a prospective cohort study evaluating bleeding patterns and satisfaction among patients initiating GATT with or without concurrent initiation of a progestin contraceptive. The results from this study will enable clinicians to more accurately counsel patients using GATT on how the use of a progestin might affect their bleeding and whether this differs by progestin method.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking currently have a uterus and ovaries
* desire to initiate GATT
* potential desire to initiate a progestin (within 14 days of GATT initiation)

Exclusion Criteria:

* previous gender-affirming surgery to remove their uterus and/or ovaries
Real-life Study of the Characteristics of Patients Treated With Ilaris® (Canakinumab) for Gouty Arthritis in France

This was a non-interventional, retrospective, cross-sectional, descriptive study, conducted on the National Health Data System (Système National des Données de Santé, SNDS).

The study did not modify the doctor-patient relationship, nor the management or follow-up of patients. Patients with dispensation of canakinumab for gouty arthritis were selected over the period from 08 April 2018 to 07 April 2020; index date was defined as date of the first dispensation of canakinumab in community pharmacy during study period.

Patients were described at index date. Medical history and comorbidities, and previous treatments for gouty arthritis were assessed during 3 years prior to index date. Co-treatments of interest for which standard treatments for gouty arthritis were contraindicated or required precautions for use were assessed during 6 months prior to index date.


Eligibility Criteria:
Inclusion Criteria:

* Received at least one reimbursement of Ilaris® from 08 April 2018 to 07 April 2020.
* Benefited from at least one of the following healthcare consumptions during 3 years prior to index date:

  o At least one hospitalization with a main diagnosis or a related diagnosis in a Medical Unit Summary or a significant associated diagnosis in a Standardized Discharge Summary corresponding to the International Classification of Diseases, 10th Revision (ICD-10) code:
  * M10.0 "Idiopathic gout"
  * M10.1 "Saturnine gout"
  * M10.2 "Medicated gout"
  * M10.3 "Gout due to impaired renal function"
  * M10.4 "Other secondary gout"
  * M10.9 "Gout, unspecified"
* And/or an active long-term disease (Affection Longue Durée, ALD) with an ICD-10 code: "M10 Gout"
* And/or at least one dispensation of colchicine and urate-lowering therapy (allopurinol and/or febuxostat and/or benzbromarone and/or probenecid) at any time.

Exclusion Criteria:

None