cyrilzakka/clinical-trials huggingface dataset:
MHealth for Psychosis Help-seeking

The proposed study research project aims to develop and test a mobile health intervention designed to improve the wellness of young people at risk for psychosis and facilitate users' engagement with treatment and thus reduce duration of untreated psychosis. This clinical trial will involve a remote pilot randomized controlled trial that will examine (1) the feasibility of the proposed research approach, (2) the acceptability and usability of the NORTH intervention as well as (3) the specific additive value of help-seeking support in the context of self-guided mHealth for early psychosis. The full intervention, which includes psychoeducational lessons, Cognitive-Behavior Therapy-based practices, a symptom tracking feature, and help-seeking resources will be compared to a "Lite" version that will include the lessons, practices, and tracking but exclude the help-seeking resources.


Eligibility Criteria:
Inclusion Criteria:

* Elevated risk for psychosis that warrants further evaluation (a distress score \>= 20 on the Prodromal Questionnaire, Brief \[PQ-B\], per Savill et al., 2018; and a positive frequency average score \>= 1.47 on the Community Assessment of Psychic Experiences \[CAPE-P15\], per Jaya et al., 2021 and Bukenaite et al., 2017) and confirmation of symptoms consistent with online data collection checks (per Moritz et al., 2013)
* Age 18-30 years old
* Lives in the United States
* Under five years since participant's first psychotic episode or awareness of symptom onset
* Owns an iPhone
* Unengaged in specialty mental health treatment, in which the participant has not done either of the following in the previous three months: (1) taken a prescribed antipsychotic medication, (2) attended regular (i.e. more than one session of) psychotherapy.

Exclusion Criteria:

* Failed to demonstrate understanding of study details in comprehension screening process.
* Engaged in specialty mental health treatment in the previous three months, defined as the following: (1) taken a prescribed antipsychotic medication, OR (2) attended regular (i.e. more than one session of) psychotherapy.
* Unengaged in treatment, but only as a result of having completed or "graduated" from a specialty mental health program.
Non-drug Study to Evaluate the Suitability of Neurocognitive Tests and Functioning Scales for the Measurement of Cognitive and Functioning Changes in Children With Down Syndrome

The aim of this study is to assess the suitability of selected scales (floor/ceiling effects, variability, test-retest reliability) to measure cognitive function in children with Down syndrome over 6 months, and to evaluate the influence of covariates such as age, gender or language on these neurocognitive scales.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 6 to 11 with diagnosis of Down syndrome (Trisomy 21). Children may have standard trisomy 21, Robertsonian translocation, isochromosome 21 (so called 21q21q Robertsonian translocation), Down syndrome with reciprocal translocation or mosaicism.
* Down syndrome children meeting clinical diagnostic criteria for generalized anxiety disorders, autism spectrum disorder, attention deficit and hyperactivity disorder, can participate in the study provided they are considered clinically stable or on stable medication for at least 8 weeks prior to the baseline visit.
* Parent or legal guardian/representative and caregiver willing to give written informed consent.
* Subjects with sufficient vision and hearing to engage in study evaluations as referred by their parents. Mild hearing loss will be allowed.

Exclusion Criteria:

* Children who may not be able to comply with the protocol or perform the outcome measures due to significant hearing or visual impairment or other issues judged relevant by the investigators
* Significant sleep disruption or moderate to severe untreated obstructive sleep apnea.
* Any condition which would make the individual or the caregiver, in the opinion of the investigator, unsuitable for the study.
Antimicrobial Resistance in Cirrhotic Patients

Cirrhotic patients are more vulnerable to bacterial infection, and infection is one of the most common causes of acute liver disease decompensation.

Cirrhotic patients are more vulnerable to bacterial infection which is a common cause of acute liver disease decompensation. The aim of this study will characterize the antimicrobial resistance and distribution of bacteria isolated from chronic hepatic patients with pulmonary infections, as well as to evaluate the antimicrobial susceptibility of bacteria isolated from sputum.

Eligibility Criteria:
Inclusion Criteria:

1. Adults' older than 18 years with clinical evidence of liver disease

Exclusion Criteria:

1. Pregnancy
2. Intensive care unite stay of more than 24 hours
3. Malignancy
4. Organ transplantation
5. Acquired immune deficiency syndrome
A Study of Brigatinib as Preferred First Therapy for Adults With Non-Small Cell Lung Cancer (NSCLC) ENTIRETY

This is a study of brigatinib in adults with Non-Small Cell Lung Cancer (NSCLC). The main aim of this study is to learn about the time period in which the condition does not worsen after the participant has received brigatinib. Another aim is to learn about the overall rate of participants who respond to the treatment with brigatinib.

Participants will receive brigatinib as part of their normal clinical practice. Data will be collected during regular visits to the hospital (a total of up to 12 visits is planned throughout study duration).

This is a non-interventional, prospective study of Polish participants with ALK positive NSCLC receiving Brigatinib as their first line of treatment in the scope of routine clinical practice within the frames of National Drug Program (NDP). This study will evaluate progression-free survival (from the time of the first dose of brigatinib).

This study will enrol approximately 50 participants. Participants will be enrolled in the following cohort to be observed at baseline, and every 3 months up to 33 months:

• Brigatinib

This multi-center trial will be conducted in Poland. The overall duration of the study will include approximately 18 months of enrolment and approximately 33 months of data collection and follow-up.

Eligibility Criteria:
Inclusion Criteria

1. Adult (aged ≥18) ALK positive NSCLC participants receiving brigatinib as a first-line treatment in the scope of NDP.
2. Participants willing to participate in the study and signed ICF.

Exclusion Criteria

1. Current or planned participation in an interventional clinical trial for ALK positive non-small cell lung cancer (NSCLC).
2. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Immunologic Response to Influenza Vaccination in Children and Adolescents

The purpose of this study is to evaluate immunologic response to different types of influenza vaccine among children/adolescents/young adults 4-20 years of age. This is a randomized controlled trial (RCT), that will assess immune response in 120 participants (60 per vaccine arm) pre- and post-vaccination to Flucelvax (egg-free inactivated flu shot) and Fluzone (egg-based inactivated flu shot).

This is a non-blinded, randomized controlled trial analyzing influenza vaccine immunogenicity response in children/adolescents/young adults aged 4-20 years given one of two FDA approved and licensed influenza vaccines: Flucelvax (egg-free inactivated flu shot) and Fluzone (egg-based inactivated flu shot). This study will enroll 120 healthy participants, 60 per vaccine arm. Participants will be randomized using a 1:1 allocation to receive either Flucelvax or Fluzone. Blood work will be conducted on all participants at baseline prior to vaccine receipt and post-vaccination at Day 7 (range 6-9 days) and Day 21 (range 21-35 days). The primary objective of the study is to determine pre and post serologic,responses to each vaccine type.

Eligibility Criteria:
Inclusion Criteria:

* aged 4-20 years;
* has prior vaccination history available (which can be determined based either on medical record review or through state registry review;
* plans to receive the current seasonal influenza vaccination at one of the recruiting sites

Exclusion Criteria:

* unable or unwilling to completed required study activities, including informed consent, randomization to vaccine, and bloodwork;
* has already received influenza vaccine for the current season;
* has a known immunocompromising condition or is on an immunosuppressing medication (e.g., high dose steroids \>10 days);
* is known to be pregnant;
* has a history of severe allergy to eggs or to influenza vaccine or any of its components
A Pilot Study of Demand Valve Oxygen Inhalation Therapy for Cluster Headache

Cluster headache is a disorder marked by frequent attacks of short-lasting, severe, unilateral head pain with associated autonomic symptoms. It is the most severe head pain syndrome known. Currently, the two most common treatments for cluster headaches are inhaled oxygen and injectable sumatriptan. These treatments do not work for all cluster headache patients, and patients who smoke may eventually develop contraindication to triptans. New treatment options are needed.

An alternative method of oxygen delivery (as opposed to continuous flow) uses a demand valve that is controlled by respiration rate, allowing increased oxygen flow in response to increased demand. This system may be more efficacious at stopping a cluster headache attack than the currently prescribed oxygen delivery system.

This study will compare the effectiveness of oxygen delivered via demand valve versus continuous high flow oxygen via non-rebreather face mask in the acute treatment of a cluster headache attack. All patients will treat one cluster headache with each of the 2 treatment methods.

Cluster headache is a primary headache disorder marked by frequent attacks of short-lasting, severe, unilateral head pain with associated autonomic symptoms. The goal of acute therapy for cluster headache is fast, effective and consistent relief.

In the currently recommended dosing strategy of continuous flow 100% oxygen given via a non-rebreather face mask at 7-15L/min, the time to improvement can sometimes take upwards of 20-30 minutes and is not effective for all cluster headache sufferers.

An alternative method of oxygen delivery (versus continuous flow) uses a demand valve which is controlled by the respiration rate, allowing increased oxygen flow in response to increased demand. This delivery system may be better at stopping a cluster headache attack than the continuous flow model as it can support hyperventilation which can enhance cerebral arterial vasoconstriction via a state of hyperoxia and hypocapnia. Arterial vasoconstriction is one hypothesized method by which oxygen can abort a cluster headache attack.

This proof of concept trial will evaluate if oxygen delivered via demand valve with a specific breathing technique is effective as a cluster headache acute treatment and is more effective than the traditional continuous high flow oxygen treatment with a non-rebreather face mask.

Eligibility Criteria:
Inclusion Criteria:

* Men or women 18 to 65 with history of moderate severe or very severe cluster headaches and currently in a cluster headache period or cycle are included.

Exclusion Criteria:

* Subjects who have a history of chronic obstructive lung disease, those who have major neurologic disorders other than cluster headaches, those with a history of syncope, or lightheadedness with hyperventilation and pregnant women are excluded.
Minimally Invasive Versus Open Surgery for PHC

Brief Summary: This is a multicentric, retrospective, real-world study to investigate the surgical outcomes of minimally invasive surgery compared with open surgery for Perihilar Cholangiocarcinoma (PHC), with the perioperative characteristics and long-term overall survival being compared. We aimed to find out whether the minimally invasive surgery is safe or feasible for PHC. And we also want to find out patients with what kind of characteristic can be benefit from the minimally invasive surgery compared with the open approach.


Eligibility Criteria:
Inclusion Criteria:

Histologically confirmed PHC.

Exclusion Criteria:

1. Peritoneal seeding or metastasis to the liver, para-aortic lymph nodes, or distant sites;
2. Non-adenocarcinoma histology;
3. Incomplete clinical data.
Botulinum Toxin Administration on Masticatory Performance

This study aimed to evaluate the effect of botulinum toxin type A (BTX-A) injection on masticatory performance and nutritional status in temporomandibular disorder patients with bruxism caused by both intra-articular and extra-articular pathologies based on Research Diagnostic Criteria for temporomandibular disorders (TMD). The baseline and end masticatory performance, pain intensity, nutrition and anxiety statuses, and anthropometric measurements will be compared.

The main purpose of this study is to determine the effect of BTX-A injection on masticatory performance and nutritional status in TMD patients with bruxism.

Sub-objectives of the study;

Determination of the effect of BTX-A on masticatory performance Determination of the effect of BTX-A on pain intensity Determination of the effect of BTX-A on anthropometric measurements Determination of the effect of BTX-A on nutritional status Determination of the effect of BTX-A on anxiety status.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 50 years old,
* Male or female,
* Able to communicate
* Able to read and write
* Volunteer to participate in the study,
* At least 3 months of splint treatment and no results
* Having Class 1 molar occlusion and not using removable prostheses
* Marmara University, Faculty of Medicine, Department of Oral and Maxillofacial Surgery, patients diagnosed with bruxism or myofascial pain in masticatory muscles will be included in the study.

Exclusion Criteria:

* Sensitivity to botulinum toxin,
* Have received botox treatment in the last 6 months,
* Injection site infection
* Pregnant or lactating women
* Those with diseases that may cause systemic neuropathy such as diabetes, hypertension, kidney disease,
* Those who do not want to sign the consent form,
* Patients with a history of malignancy, radiotherapy or chemotherapy will be excluded from the study.
Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer: Concordance Study

This study will examine genes in three different tissues and look for similarities and differences between normal cells and cancer cells. The tissues to be studies come from blood, lymph node and cancer.

Subjects will be given an informed consent to read and sign The medical chart will be reviewed for diagnosis and treatment history Blood (about 4 tablespoons) will be drawn at a clinically available time. The lymph node and breast tumor tissue in the University of Michigan pathology repository will be used for research purposes

Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years of age
* Able to read and sign the informed consent
* Able to provide specimens: one blood draw for white blood cells, provide permission to use tissue already collected.
Effect of rEPO in FGF23 in ESRD Patients

Objective: To evaluate the effects of recombinant Erythropoietin (rEPO) in plasma levels of Fibroblast Growth Factor 23 (FGF23) in End-Stage Renal Disease (ESRD) patients in hemodialysis.

Method: Prospective cohort of ESRD patients in HD, where patients with or without rEPO therapy were compared. Measurements of plasma FGF23 were performed at baseline and during the complete study. Demographic, clinical and laboratory data will be obtained.

Follow-up period: 12 weeks.

Experimental data has shown that recombinant erythropoietin (rEPO) increases plasma levels of Fibroblast Growth Factor 23 (FGF23) in murines, both health and with acute or chronic renal disease. Also, observational studies indicate an association between EPO and FGF23 levels in patients. Until now, it has not been demonstrated whether the use of rEPO does increase plasma FGF23 in End-Stage Renal Disease (ESRD) patients in hemodialysis (a population with a high use of this therapy for the management of chronic anemia).

Our objective was to evaluate whether the administration of rEPO increases plasma FGF23 levels in ESRD patients in hemodialysis.

We performed a prospective cohort with ESRD patients without rEPO therapy. We performed 2 groups: patients with requirements of rEPO therapy due to anemia (Hb \< 10 g/dL) and patients without rEPO therapy (Hb \> 10 g/dL).

We measured plasma FGF23 (intact and C-terminal) at baseline and during 12 weeks.

Demographic, clinical and laboratory data was obtained. Patients treated with rEPO received beta-epoetin (Recormon, Roche), according to current recommendations.

Patients were follow-up during 3 months to evaluate the effects of rEPO. Our primary outcome was changes in plasma intact FGF23 at 12 weeks, between both groups.

Eligibility Criteria:
Inclusion Criteria:

* End-Stage Renal Disease
* Requirements of Hemodialysis
* At least 6 months since initiation of hemodialysis

Exclusion Criteria:

* Pregnancy
* Treatment with rhEPO or analogs during the previous 6 months or earlier
Reliability of Topography Measurements in Keratoconus

The purpose of this study is to assess the reliability and repeatability of the parameters obtained using the Galilei dual-scheimpflug corneal topographer for monitoring progression in eyes with keratoconus.

Keratoconus is a progressive corneal degeneration characterized by progressive steepening and thinning of the central or paracentral cornea leading to corneal protrusion and resulting irregular astigmatism and high myopia. This disorder is usually bilateral and is linked to atopy and excessive eye rubbing, although the precise pathophysiology behind development of this condition is unclear. Keratoconus is the most common corneal degeneration in the United States, affecting between 50 and 230 subjects per 100,000 population.

Early diagnosis and appropriate management of keratoconus relies greatly on accurate assessment of corneal topographic measurements. It is therefore imperative that the data obtained via corneal topography devices is accurate and reliable.

The GALILEI Dual Scheimpflug Analyzer integrates Placido disc topography and dual Scheimpflug tomography to assess anterior and posterior corneal curvature data. Although there have been several studies performed assessing the ability of the Galilei to accurately distinguish keratoconus from unaffected eyes and investigating interdevice reliability between the Galilei analyzer and other tomographers, to our knowledge the repeatability of measurements obtained in this population via the Galilei device has been incompletely evaluated to date.

Corneal topography data obtained via the Galilei device is relied upon heavily in clinical decision making for keratoconic patients both in the Hershey Eye Clinic and in a great number of ophthalmology practices world-wide. It is vital that the accuracy and repeatability of these measurements obtained via the Galilei device are investigated.

The primary endpoint to be measured in the study will be the maximum (steepest) and minimum (flattest) keratometry values in the central zone.

Secondary endpoints will be maximum keratometry across the entire area scanned, axis of corneal astigmatism, anterior and posterior best fit spheres in float mode with the diameter set to 8 mm, maximum anterior and posterior elevations, thinnest corneal thickness, and corneal asphericity at 6 mm, root mean square (RMS) of the HOAs, RMS of the third-order coma, coma axis, vertical and horizontal coma and spherical aberration.

Eligibility Criteria:
Inclusion Criteria:

* Patientswho are older than 18 years of age
* Patients who are scheduled to undergo Galilei dual-scheimpflug corneal topography testing
* Patients who have been diagnosed with keratoconus
* Measurements with a reported reliability of 'good' from the topographer

Exclusion Criteria:

* Patients who have undergone any prior surgical intervention involving the cornea (i.e. cornea transplant or INTACS, or corneal cross linking)
Effect of Periodontal Treatment on Visfatin, fetuin-a and Sirtuin 1 of Patients With Periodontitis and Type 2 Diabetes

The aim of this study is to determine the concentrations of Visfatin, Fetuin-A and Sirtuin 1 in the gingival crevicular fluid and clinical periodontal parameters in diabetic and systemically healthy individuals and to determine whether non-surgical periodontal treatment had any effect on these biomarkers and periodontal clinical parameters at the end of a 3-month follow-up period. The hypothesis of our study is that gingival crevicular fluid Visfatin, Fetuin-A and Sirtuin 1 concentrations will change with non-surgical periodontal treatment in type 2 diabetic and systemically healthy individuals and that this change will be associated with diabetes and clinical parameters.

Sixty-six patients were divided into six equal groups; group 1: systemically and periodontally healthy individuals, group 2: systemically healthy individuals with periodontitis, group 3: controlled type 2 diabetes and periodontally healthy individuals, group 4: controlled type 2 diabetes and periodontitis, group 5: uncontrolled type 2 diabetes and periodontally healthy individuals, group 6: uncontrolled type 2 diabetes and periodontitis. The study was planned as a randomized, single-blind, parallel design. Periodontal clinical parameters (Silness-Löe plaque index, Löe-Silness gingival index, probing pocket depth, clinical attachment level, bleeding on probing) were recorded clinically and concentrations of visfatin, fetuin-A and sirtuin 1 in gingival crevicular fluid were assessed biochemically. After baseline examinations, periodontal treatment was completed using a nonsurgical periodontal treatment protocol completed in 24 hours. Periodontal clinical parameters and gingival crevicular fluid were recorded at baseline and 3 months after periodontal treatment. Biochemical analysis and statistical evaluation were performed.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* To be over 18 years old
* No periodontal treatment in the last 6 months
* Being systemically healthy except for type 2 diabetes
* Not taking medication for any reason except type 2 diabetes
* HbA1c \<7 in controlled Type 2 diabetes group
* HbA1c ≥7 in uncontrolled Type 2 diabetes group
* Not smoking or drinking alcohol

Exclusion Criteria:

* Not volunteering to participate in the study
* Under 18 years of age
* Periodontal treatment in the last 6 months
* Having any systemic disease affecting the periodontal condition
* Having used local or systemic antibiotics in the last 3 months
* Use of anti-inflammatory, steroid drugs in the last 3 months
* Taking vitamin, mineral or antioxidant supplements in the last 3 months
* Being pregnant or lactating
* Regular use of mouthwash
* Smoking or drinking alcohol