cyrilzakka/clinical-trials huggingface dataset:
Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)

In this 5-year, two-site randomized clinical trial, we propose to test the efficacy of the CATCH-IT primary care/Internet based depression prevention intervention against Attention Monitoring Psychoeducation (AMPE) in preventing the onset of depressive episodes in an intermediate to high risk group of adolescents aged 13-17. We plan to (a) identify high risk adolescents based on elevated scores on the PHQ-A, a screening measure of depressive symptoms; (b) recruit 400 (200 per site) of these at-risk adolescents to be randomized into either the CATCH-IT or the AMPE group; (c) assess outcomes at 2, 8, 12, 18, and 24 months post intake on measures of depressive symptoms, depressive diagnoses, other mental disorders, and on measures of role impairment in education, quality of life, attainment of educational milestones, and family functioning; and (d) conduct exploratory analyses to examine the effectiveness of this intervention program, moderators of protection, and potential ethnic and cultural differences in intervention response.


Eligibility Criteria:
Inclusion Criteria:

* Youth ages 13 through 17.
* Youth must be experiencing elevated level of depressive symptoms on the Center for Epidemiologic Studies Depression46 (CES-D) scale (score \>/= 16) and have at least two core symptoms of Major Depression on the Patient Health Questionnaire, Adolescents.
* Youth will be included if they have a past history of depression, anxiety, externalizing symptoms, or substance abuse.

Exclusion Criteria:

* Current DSM-IV diagnosis (Kiddie Schedule of Affective Disorders) of Major Depressive Disorder, current therapy for depression, or be taking antidepressants (e.g., SSRIs, TCAs, MAOIs, bupropion, nefazodone, mirtazapine, venlafaxine).
* Current CES-D score \>35
* DSM-IV diagnosis of schizophrenia (current or past) or bipolar affective disorder
* Current serious medical illness that causes significant disability or dysfunction
* Significant reading impairment (a minimum sixth-grade reading level based on parental report), mental retardation, or developmental disabilities
* Serious imminent suicidal risk (as determined by endorsement of current suicidality on CES-D or in KSADS interview) or other conditions that may require immediate psychiatric hospitalization
* Psychotic features or disorders, or currently be receiving psychotropic medication
* Extreme, current drug/alcohol abuse (greater than or equal to 2 on the CRAFFT).
Etanercept Survival in Elderly Population

Evaluate the 3-year survival of etanercept in patients over 60 years with psoriasis in moderate / severe plaque and the reasons that led to the abandonment. Besides factors that might have had a positive or negative influence on adherence to treatment and analysis of efficacy (PASI 75) and safety will be identified.

All variables were collected through retrospective review of medical records of patients dermatology unit are made.


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate / severe psoriasis (with / without psoriatic arthritis,PAs) defined by: PASI(Psoriasis Area and Severity Index)\> 10 and / or BSA(Body Surface Area)\> 10% and / or DLQI(Dermatology Life Quality Index)\> 10
* PASI\> 10 and / or BSA(Body Surface Area)\> 10% and / or DLQI(Dermatology Life Quality Index)\> 10
* Over 60 years of age at the start of treatment
* Receiving etanercept at any time
* Available history in the Dermatology

Exclusion Criteria:

* Patients with insufficient clinical data in the medical record
Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria

The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg Q.D., compared to Levocetirizine 5 mg Q.D. and placebo for the treatment of Chronic Idiopathic Urticaria.

A total of 540 patients with CIU will be enrolled in this pivotal, randomised, multicentre, international, double-blind, placebo and active-comparator controlled, parallel study . Patients will be selected from both public and private clinical practices. The study population includes males and females between 18 and 70 years of age, suffering from CIU for at least 6 weeks prior to entry in the study with no identifiable cause.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years old.
* Documented history of CIU for at least 6 weeks prior to entry in the study.

Exclusion Criteria:

* Dermatological pathology other than chronic idiopathic urticaria.
* History of autoimmune disorders, Hodgkin's disease, lymphoma, leukemia and generalized cancer.
* Pregnant or breast-feeding women.
* Patients who will be operating heavy machinery or need to drive motor vehicles as an essential part of their profession.
* Patients who have a recent history (within previous 12 months) of drug addiction or alcohol abuse.
* Patients who are currently participating in or have participated in another clinical trial within the last 3 months
A Study to Investigate Interleukin-6 (IL-6) and IL-6/Soluble IL-6 Receptor (sIL-6R) Complex Levels in Subjects With Active Inflammatory Bowel Disease

The purpose of this study is to measure IL-6 and IL-6/sIL-6R complex levels in subjects with active moderate to severe ulcerative colitis or Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with active moderate to severe ulcerative colitis (\*partial Mayo ≥ 5) or Crohn's disease (Harvey \& Bradshaw ≥ 8) \*partial Mayo: 9-point scale that excludes the endoscopic components of the Mayo score

Exclusion Criteria:

* Presence of another inflammatory disease, except for mild cutaneous psoriasis
* Concomitant gastrointestinal infection or otherwise serious infection including Crohn's disease infectious complication
* Treatment with Infliximab, Adalimumab, Certolizumab Pegol or other immune-modulating biologics within 8 weeks prior to the visit
* Having a known or suspected gastrointestinal or otherwise serious infection within 8 weeks prior to the visit
* Concomitant diagnosed or suspected malignant disease
Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

The impact of cerebrovascular procedures on patients experiencing anxiety and depression is not well studied despite the high prevalence of these mental health disorders. Unruptured Intracranial aneurysms (UIAs) have a prevalence of approximately 3% and an annual risk of 1-2% in the general population. Despite the high risk of fatality following aneurysm rupture with a rate of 40-50%, the overall aneurysm growth and rupture risks are rare (less than 3% per aneurysm per year) and many patients can be observed with serial follow-up imaging over years. Nevertheless, due to the gravity of the bad consequences of aneurysm rupture, simply informing many patients of UIA diagnosis has been found to result in worse outcomes of health-related quality of life. This study aims to investigate the impact of awareness of untreated UIA on the patients' mental health utilizing the Hospital Anxiety and Depression Scale (HADS) tool.

This is a controlled, non-randomized, prospective cohort study with parallel arms of treatment arm with microsurgical and endovascular treatment and comparison control arm with conservative management/observation of UIA. The goal of this study is to investigate the impact of the awareness of an untreated UIA on the psychiatric and mental status of the patients enrolled in the control arm compared to patients with a treated UIA. All patients presenting to the outpatient clinic upon the initiation of the trial and for 2 years ahead with UIA diagnosed on any of the angiographic imaging modalities including Computed Tomography Angiography (CTA), Magnetic Resonance Angiography (MRA), and Digital Subtraction Angiogram (DSA) will be included.

Eligibility Criteria:
Inclusion Criteria:

* Unruptured intracranial aneurysms (UIA)
* mRS scores between 0-1
* Observation Group: All patients with UIAs that are eligible for conservative management.

  1. Specific locations that are not good candidates for interventional treatment, such as cavernous internal carotid artery and very distally located aneurysms.
  2. Aneurysm size (largest dimension) is less than 4 mm.
* Treatment Group: All Patients with UIAs that are decided to be treated either with endovascular or microsurgical treatments due to several reasons, such as aneurysm size above 4 mm, patient's decision.

Exclusion Criteria:

* Prior history of intracranial hemorrhage.
* Prior history of intracranial aneurysm
* Severe comorbidities that impact the mental health of the patients, such severe psychiatric disease, and chronic end stage diseases.
Parkinson Disease: A Model of National Digital Interventions to Prevent or Slow a Rise of Non-Communicable

According to Parkinson's Disease Medical Center of Excellence's project which was registered Parkinson's disease patients in 2008-2011, it was found that there were more than 60,000 people with Parkinson's disease in Thailand, approximately 1 over 3 of all elderly people.

It is estimated that the prevalence of Parkinson's disease is approximately 242.57 per 100,000 people of all elderly people, and it is likely to increase due to the current situation of Thailand which is entering aging society. The current diagnosis of Parkinson's disease still relies heavily on medical history and physical examination. The accuracy of diagnosing Parkinson's disease by neurologists is approximately 80 percent, especially when they have been following up consistently. Nonetheless, if they have Parkinson's disease in the early stages, the signs and symptoms will not be severe. Therefore, diagnostic accuracy will decrease around 40-50 percent, making it difficult to diagnose Parkinson's disease patients at an early stage and as a consequence, there still are many undiagnosed patients in 2022. Consequently, Parkinson's Disease Medical Center of Excellence is planning to establish this pilot research project to develop and analyze advanced data of the screening system for people at risk and precursor symptoms to Parkinson's disease, Chulalongkorn Hospital, Thai Red Cross Society. Dividing patients into 3 groups, those who have precursor symptoms, who are at risk of developing disease and Parkinson's disease patients, using the digital platform on mobile application that includes general information, health information, congenital diseases, regularly used medications, initial abnormal symptoms, various risk factors, writing and handwriting, pronunciation assessments, and get diagnosis from experts for referral in the public health system.

1. Flipping the Paradigm of Parkinson's Disease: A Model of National 'Eat, Move, Sleep' Digital Interventions to Prevent or Slow a Rise of Non-Communicable Diseases in Thailand
2. Principal Investigator: Roongroj Bhidayasiri
3. Study centers and Address: Chulalongkorn Center of Excellence for Parkinson's disease and related to movement disorder 1183 RAMA 4 Rd. Pathum wan, Bangkok 10330 and 76 provinces of Thailand.

The Screening of Parkinson's patients with digital technology and sensors and analyze with artificial intelligence the following information

1. Innovative prototype questionnaire. Screening of Parkinson's patients with digital technology.
2. Sound screening that can detect speech
3. Handwriting test by writing sentences and spiral circles.
4. Testing finger dexterity and alternating tap test
5. Tremor analysis
6. Gait analysis
7. Assessing your ability to get out of bed
8. Sleep quality
9. Sleep assessment by polysomnography test
10. Ability to smell

Eligibility Criteria:
Inclusion Criteria:

1. Thai Adult age more than 40 years old.
2. Family history with Parkinson's disease.

Exclusion Criteria:

1. Thai Adult age less than 40 years old
A Phase II Study of Oral JAK1/JAK2 Inhibitor INC424 in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma

Phase II study to assess the efficacy of 6 cycles of oral JAK1/2 inhibitor ruxolitinib in patients with advanced Hodgkin's lymphoma for whom no curative option is available.


Eligibility Criteria:
Inclusion critera:

* Patients ≥ 18 years with classical HL relapsing or refractory after at least 1 prior systemic therapy. Patients must have relapsed after high-dose therapy with ASCT, or have been deemed ineligible for high-dose therapy with ASCT
* ECOG performance status ≤ 3
* Measurable nodal disease: 1 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan (MRI is allowed only if CT scan cannot be performed).
* Patient has the following laboratory values:

  * Absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L \[SI units 1.0 x 10\^9/L\]
  * Platelet count ≥ 75 x 10\^9/L\]
  * Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
  * Serum bilirubin ≤ 1.5 x ULN (or ≤ 3.0 x ULN, if patient has Gilbert syndrome)
  * AST/SGOT and/or ALT/SGPT ≤ 2.5 x ULN or ≤ 5.0 x ULN if the transaminase elevation is due to liver disease involvement
* Signed written informed consent
* Life expectancy ≥ 3 months
* Corrected QT interval ≤ 450 mSec
* Men and women of childbearing potential must agree to use an adequate method of contraception during the study treatment and for at least 1 week after the last study drug administration
* The patient must be covered by a social security system (for inclusions in France)

Exclusion criteria:

* Previous treatment with ruxolitinib or another JAK inhibitor
* Contraindication to ruxolitinib
* Patient received chemotherapy or radiotherapy or any investigational drug within 14 days prior to starting study drug or whose side effects of such therapy have not resolved to ≤ grade 1
* Patient treated with allogeneic hematopoietic stem cell transplant who is currently on, or has received immunosuppressive therapy within 90 days prior to start of screening and/or have ≥ Grade 2 graft versus host disease (GvHD).
* Patient with prior history of another active primary malignancy ≤ 2 years before study entry, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
* Any serious active disease or co-morbid medical condition that, according to the investigator's decision, will substantially increase the risk associated with the subject's participation in the study.
* Uncontrolled infectious disease, including active HBV infection defined by either detection of HBs Antigen or presence of anti HBc antibody without detectable anti HBs antibody.
* HIV, HCV or HTLV serology positivity and/or documented infection with active hepatitis B
* Prior history of CNS involvement with lymphoma
* Pregnant or lactating woman
* Adult patient unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness.
Treatment of Anemic Patients With Cancer Who Are Not Receiving Chemotherapy or Radiotherapy

The purpose of this study is to examine the effectiveness of epoetin alfa in treating anemia in patients who have cancer or who no longer have any signs of the cancer, but remain anemic as a result of their treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Body weight \>/= 99lbs
* ECOG 0-2
* Anemia results from cancer, chemotherapy, radiotherapy or an association with hormonal therapy or immunotherapy
* Screening hemoglobin level of \</= 11.0 g/dL for men or \</= 10.0 for women

Exclusion Criteria:

* History of or concurrent second malignancy
* Evidence of primary or metastatic malignancy involving the Central Nervous System
A Multi-Centre Clinical Trial to Evaluate a Left-Right Design in Adults With Mild to Moderate Atopic Dermatitis

The purpose of this study is to validate a left-right design with respect to detecting a difference in efficacy after 3 weeks of treatment between an active treatment and a vehicle in adults with mild to moderate atopic dermatitis


Eligibility Criteria:
Inclusion Criteria:

* 1. Male and female subjects, 18 years or older
* 2. Subject with atopic dermatitis with mild to moderate disease severity
* 3. Two symmetrical and comparable atopic dermatitis treatment areas
* 4. Female volunteers of childbearing potential must either be surgically sterile or agree to use a reliable method of contraception

Exclusion Criteria:

* 1. Any condition in the target areas that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash other than atopic dermatitis, sunburn, hyper- or hypopigmentation, scars
* 2. Dark-skinned persons whose skin colour prevents reliable clinical assessments
* 3. Any permanent (or transient within 28 days prior to dosing) disease that may interfere with the subjects safe participation in the trial, with the subjects ability to participate in the trial or with the clinical assessments
* 4. Pregnancy or breastfeeding
A Retrospective Chart Review of Patients Treated With Ocriplasmin for Symptomatic VMA

The purpose of this study is to retrospectively review and further characterize anatomic and symptomatic changes over six months immediately following treatment of symptomatic vitreomacular adhesion (VMA) with JETREA® (ocriplasmin), including incidence, time to onset and resolution of anatomy and symptoms.

This study (TG-MV-022) is a retrospective study utilizing Spectral-domain optical coherence tomography (SD-OCT) in patients treated previously with JETREA® for VMA. The objectives of this study are to retrospectively review and further characterize anatomic and symptomatic changes over six months immediately following treatment of VMA with JETREA® (ocriplasmin), including incidence, time to onset and resolution of anatomy and symptoms. The retrospective study will collect Heidelberg Spectralis® SD-OCT images which will be masked and uploaded to a Central Reading Center (CRC) for review and analysis. The CRC will evaluate anatomic endpoints of interest from both baseline optical coherence tomography (OCT) images and all follow-up OCT scans over the 6 month follow up period. Endpoints of interest include ellipsoid zone disruption, development of subretinal fluid, resolution of VMA and macular hole changes. Further, trained clinical personnel at the participating centers will transcribe data from the patients' records, to be entered into the study database.

Eligibility Criteria:
Inclusion Criteria:

1. Must be at least 18 years of age or older.
2. Have been treated with JETREA® for vitreomacular adhesion (VMA) between April 1, 2013 and December 31, 2013 with at least six months of follow up visits post injection. Note: If a patient's second eye was treated, only the first eye treated is eligible for study participation.
3. Have been imaged with Heidelberg Spectralis SD-OCT at least one time within 30 days prior to JETREA® injection.
4. Have been imaged with Heidelberg Spectralis SD-OCT at least two times post JETREA® injection with at least one scan between Days 1-21 and the second scan within six months,, including a corresponding visual acuity (VA).
5. Be willing and able to provide informed consent.

Exclusion Criteria:

1. Patients treated with JETREA® for medical conditions outside of the product label.
2. Patients with other retinal conditions that affect the vitreo-retinal interface, or can lead to retinal atrophy, including but not limited to:

   * Neovascular age-related macular degeneration;
   * Fibrovascular scar;
   * Diabetic macular edema; and
   * Proliferative diabetic retinopathy.
Relating Abdominal Complications With Peritoneal Pressure Estimation and Reporting

This is a prospective observational study in people treated with peritoneal dialysis for kidney failure to investigate whether estimated intraperitoneal pressure (eIPP) is correlated with non-infectious PD-related complications in end-stage renal failure patients. It looks to understand how both peritoneal dialysis complications (including fluid leaks and hernias) along with gastrointestinal symptoms are associated with eIPP in people treated with PD.

Peritoneal dialysis is an important treatment option for kidney failure. It involves the instillation of fluid into the peritoneal cavity. The choice of volume of fluid used has a limited evidence base but will be between 1 liter to 2.5 liters depending on clinical preference. The intraperitoneal pressure (IPP) that results from this fluid varies widely between patients. However, IPP is difficult to implement clinically. There is some evidence that higher IPP is associated with an increased rate of non-infectious PD complications. These complications are mainly leaks (escape of peritoneal fluid from the peritoneal cavity) and hernias.

New methods for estimating IPP (eIPP) have been recently developed but not validated clinically. This study looks to the association of eIPP and non-infectious PD complications as well as understanding whether there is an association between eIPP and patients' burden of symptoms.

This is an observational study, no changes to fill volume or treatment will result from the eIPP. Clinicians and nurses involved in the care of the patient will not receive feedback on the eIPP measurement. This simple study will look to recruiting patients with informed consent. Those who agree to enter the study will have a small number of non-invasive measurements made at the time of a routine clinic visit. A short survey will also be administered both at the initial visit, along with 3 and 12 months later. The research team, will review the patients' notes at 12 months following recruitment for evidence of non-infectious PD-related complications.

This research proposal has informed by interaction with people with lived experience. The scientific rationale has been tested by a discussion with experts in PD in other centres.

Given that this is an observational study, individuals will not be exposed to increased clinical risk through the alteration of PD fill volume or novel procedures. The greatest burden for participants will be the completion of three short, validated survey questionnaires over 12 months.

Confidentiality will be maintained with the use of pseudonymisation to maintain participants confidentiality.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Diagnosis of end-stage renal failure requiring peritoneal dialysis as renal replacement therapy
* Ability to give informed consent and comply with study procedures.

Exclusion Criteria:

* Known allergy or hypersensitivity to any component of the dialysis solution.
* Inability or unwillingness to comply with study procedures.
Contribution of Attachment and Educational Practices in the Expression of ADHD in School-aged Children

ADHD is a neurodevelopmental disorder characterized by the presence of persistent signs of associated hyperactivity-impulsivity and/or inattention that impair the child's functioning or development.

The involvement of genetic factors has been shown in numerous studies. Other studies have also highlighted the contributions of parent-child interaction in the development, expression and persistence of symptoms.However, the mechanisms by which parenting practices and attachment may influence ADHD symptoms remain unclear.

The aim of this study is to evaluate the influence of attachment style of the child, the educational practices and the presence of attentional/executive disorders of parents on the expression of ADHD in children aged 7 to 10.

This prospective empirical research will compare children with ADHD and their parents to a matched control group.


Eligibility Criteria:
Inclusion Criteria:

Male or female patients ages 7 to ≤10 years with ADHD (study group) or TD children matched by gender and socio-economic factors (control group) and their parents.

French-speaking population Willing and able to comply with scheduled visits and study procedures. Written informed consent/assent, according to local guidelines, signed by the patient and / or by the parents or legal guardian prior to any study related screening procedures are performed.

Exclusion Criteria:

Children with intellectual disabilities (IQ \<80). Epilepsy. Prematurity. Objectified neurological sequelae. Specific language impairment or severe learning disabilities. Contraindication to stopping treatment for ADHD