cyrilzakka/clinical-trials huggingface dataset:
Longitudinal and Biological Study of Childhood Disintegrative Disorder

OBJECTIVES:

I. Compare the developmental course (language acquisition, diagnostic stability, predictors of outcome, and restricted interests and behaviors) of childhood disintegrative disorder versus autism and non-autistic developmental delays.

II. Collect data on molecular genetics of proband and family members.

PROTOCOL OUTLINE:

Patients are evaluated with the following questionnaires at ages 2-3 years and again at ages 5-9: The Autism Diagnostic Interview (ADI); The Autism Diagnostic Observation Schedule (ADOS); Assessment of cognitive functioning; Expressive and receptive language; Adaptive functioning; Measures of burden and functional assessment; The Aberrant Behavior Checklist; The Connors Rating Scale - Parent and Teacher version; and Autism Behavior Checklist

An MRI and EEG are performed, and blood samples are collected from patients and family members for molecular genetic studies.

Eligibility Criteria:
* Psychologically diagnosed (DSM-IV) as Childhood Disintegrative Disorder
* No known genetic or medical syndrome (Down syndrome or cerebral palsy)
* Must speak English
A Brief Mind-Body Bridging Intervention for Suicidal Ideation

The aim of this study is to determine whether a Brief Mind-Body Bridging Intervention for Suicidal Ideation (MBB-SI) will result in short or longer-term reduction of psychological factors associated with suicidal ideation (SI) and/or suicide-related behaviors (SRB's) compared to Treatment as Usual (TAU).


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be Veterans aged 18-80 admitted to Substance Abuse Residential Rehabilitation Treatment Program (SARRTP) with addictive disorders and/or co-occurring psychiatric disorder with suicide risk factors.

Exclusion Criteria:

* None
Effects of Social Determinants of Health on IV Iron Treatments

This study investigates how social determinants of health (SDOH) like income, employment, transportation, food, and housing affect patients' ability to receive IV iron treatments. It aims to understand how these factors influence patients' healthcare behaviors, particularly their attendance at IV iron appointments.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving one of the following IV iron products: Ferric Carboxymaltose, Ferric Derisomaltose, Ferumoxytol, Iron Sucrose, or Iron Dextran
* Patients 18 years of age or older
* Patients who speak English or Spanish

Exclusion Criteria:

* Patients receiving an alternative IV iron product: Sodium ferric gluconate
* Patients under 18 years of age
* Patients who do not speak English or Spanish
A Study to Learn About Tafamidis in Patients With Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in India

The purpose of this study is to learn about the safety of Tafamidis for the treatment of Transthyretin amyloid cardiomyopathy (ATTR-CM) in India.

ATTR-CM is a condition that affects people's hearts. Transthyretin is a protein that is made in the liver. In some people this protein stops working and forms clumps called as amyloid. Transthyretin amyloid builds up in heart and stops the heart from pumping properly.

This study is seeking for participants who are:

* confirmed with ATTR-CM.
* given Tafamidis capsules to be taken by mouth.

The safety of Tafamidis capsules will be checked based on side effects. These side effects can happen within 6 months after taking Tafamidis. A side effect is something (expected or unexpected) that you feel was caused by a medicine or treatment you take. The study doctor will collect side effect information and put the information on patient's case form.

Follow-up of the patient's will be performed via clinic re-visit or over a call. It is not a rule for the participants to visit the clinic in this study.

This study will help to see if Tafamidis is safe.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥18 years) with diagnosis of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM).
* Patients to whom VyndaMx® Capsules is prescribed for the treatment of wild or hereditary ATTR-CM.

Exclusion Criteria:

* Patient with hypersensitivity to VyndaMx® Capsule or to any of the excipients in the product.
* Patients with rare hereditary problems of fructose intolerance.
* Patient who has a contraindication to VyndaMx® Capsules according to the approved local product label.
Impact of M-health Based Intervention on Adherence to Healthy Physical Activity After Stroke.

The aim of this study is to determine the impact of an m-health based intervention on long term adherence to a rehabilitation program for stroke survivors.

This is a 8-week multimodal exercise rehabilitation program (MERP) based on aerobic exercise, task oriented activities, balance and stretching exercises complemented with a mobile app technology. The aim of the MERP is to improve walking speed, walking ability, activities of daily living and quality of life among people who have suffered a stroke. The mobile app technology complements the MERP in order to achieve long term adherence to healthy physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ischemic or hemorrhagic stroke
* age ≥18;
* Functional Ambulation Classification (FAC) ≥3
* Barthel Index ≥45

Exclusion Criteria:

* Cognitive impairment (Mini Mental State Examination ≤24)
* Unstable cardiovascular disease (acute heart failure, recent myocardial infarction, unstable angina and uncontrolled arrhythmias)
* Alcohol or other toxic substances abuse
* Decompensated psychiatric disorders that prevented from following a group session
Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by the Food and Drug Administration (FDA) for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking adefovir dipivoxil.


Eligibility Criteria:
Inclusion Criteria:

* Documented compensated chronic hepatitis B defined by clinical history compatible with compensated chronic hepatitis B
* Detectable serum HBsAg at the Screening visit

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patient is pregnant or breastfeeding.
* Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV
* Patient previously received lamivudine, adefovir dipivoxil, or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide analog at any time
* Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study

Other protocol-defined exclusion criteria may apply.
Examination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy

The aim of this study is to examine the efficacy and adverse events in the following 3 groups in osteoporosis patients:

1. The administration period of teriparatide is less than 6 months and thereafter, denosumab for 24 months.
2. The administration period of teriparatide is from 6 to 12 months and thereafter, denosumab for 24 months.
3. The administration period of teriparatide is more than 12 months and thereafter, denosumab for 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Osteoporotic patients who want to take teriparatide and denosumab

Exclusion Criteria:

* Patients who are allergic to teriparatide or denosumab Patients who are pregnant or breast-feedin
Assessment in Work Productivity and the Relationship With Cognitive Symptoms in Patients With MDD Taking Vortioxetine

The purpose of the study is to describe the association/correlation between change in patient-reported cognitive symptoms and work productivity in gainfully employed patients receiving vortioxetine for a Major Depressive Episode (MDE).

This is an interventional, Canadian, multi-site, open-label, single cohort, flexible-dose study. The study will emulate a naturalistic real-life setting. Investigators will include Primary Care Physicians and Psychiatrists working in outpatient clinics. The study will include adult patients diagnosed with MDD according to the DSM-5™. Approximately 200 patients will be enrolled in the study. There will be approximately 100 patients who receive vortioxetine as a first treatment for the current MDE and 100 patients switched to vortioxetine due to inadequate response to their current antidepressant medication treatment. All patients will be treated with vortioxetine as per the product monograph, and at the doses determined appropriate by the investigator. The total study duration from Baseline to the end of follow-up will be approximately 56 weeks.

Eligibility Criteria:
Inclusion Criteria:

* The patient is a man or woman, aged ≥18 years and \<65 years (In the province of British Columbia, the patient must be aged 19 years or older in order to give Informed Consent)
* The patient is engaged in volunteer work or gainful employment (working ≥20 hours per week) or is enrolled full-time in post-secondary studies or vocational training.
* The patient is an outpatient consulting a Primary Care Physician or a Psychiatrist.
* Patients must have a diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5™) classification code 296.3x.
* The current MDE is confirmed by the investigator.
* The reported duration of the current MDE is at least 3 months.
* The patient has a Baseline score ≥15 on the QIDS-SR.
* The patient reports at least a minimal level of cognitive symptoms as defined by Baseline score of ≥30 on the PDQ-D-20.
* The patient is capable of communicating with the site personnel and is able to conduct the digit-symbol substitution test (DSST).

Exclusion Criteria:

* The patient score is \>69 on the DSST at Screening/Baseline.
* The patient is, in the opinion of the investigator, not able to complete all the study assessments including, but not limited to, patient-reported assessments and the DSST.
* The patient has a current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features.
* The current depressive symptoms are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each at the maximum recommended dose (according to Canadian labeling).

Other protocol defined inclusion and exclusion criteria do apply.
ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

The purpose of the run-in phase of this study is to determine the appropriate and tolerable dose of ZD6474 (200mg or 300mg) to be administered in combination with paclitaxel and carboplatin in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.

The purpose of the randomized phase of this study is to determine the efficacy of ZD6474 alone versus that of ZD6474 in combination with paclitaxel and carboplatin versus that of paclitaxel and carboplatin alone in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* 18 years or older
* Histologically or cytologically confirmed locally advanced or metastatic NSCLC
* No prior chemotherapy/biological therapy/radiation therapy
* One or more measurable lesions
* Life expectancy more than 12 weeks

Exclusion Criteria:

* Brain metastases or spinal cord compression
* Currently active skin disease
* History of significant hemoptysis
* Abnormal blood chemistry
* Cardiac abnormalities
* Recent significant cardiac event
* Coexisting malignancies
Efficacy of Auditory Training and Combined Auditory-working-memory Training in Improving Communication in Older Adults

Using a randomized controlled trial, we are going to examine whether a training program that incorporates both auditory training and working memory training (AT-WMT) would generate significantly better results in communication and cognition than an auditory training program and a mindfulness training program (active-control). Participants are 120 older adults (40 per group) with untreated mild-to-moderate sensorineural hearing impairment .

There will be three training groups: the Auditory training (AT) group, the Auditory-working memory training (AT-WMT) group, and the control group (mindfulness training). All training programs are home-delivered, non-clinician-administered, and computer-based. That is, training will be self-paced and administered by the participants themselves at home using a computer. A software program (see Figure 2) has been created to facilitate the administration of the AT and AT-WMT. All training groups will spend one hour per day and five days per week for 4 weeks.

Before the training, two baseline test sessions (T1 and T2, a maximum of one week apart) will be used to account for the test-retest effects. The same measurements will be administered again one day (T3) and three months (T4) after completion of the training.

Eligibility Criteria:
Inclusion Criteria:

* Native Cantonese speakers and having been living in Hong Kong for at least 20 years.
* Aged between 55 and 80 years.
* Normal cognitive function, as screened with the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) with a cutoff of 18/19.
* Mild-to-moderate sensorineural HI, in which the four-frequency pure-tone average at 500, 1000, 2000, and 4000 Hz of the better ear is between 26 and 55 dB HL.

Exclusion Criteria:

* Outer or middle ear pathologies.
* Wearing hearing aids or cochlear implants.
* No computers and internet access at home.
Investigation on the Current Situation and Risk Factors Analysis of Exocrine Insufficiency in Chronic Pancreatitis

Pancreatic exocrine insufficiency (PEI) is one of the common complications of chronic pancreatitis (CP). Mild to moderate PEI may present with atypical digestive tract symptoms such as abdominal distension and abdominal pain, while severe PEI can lead to related complications such as foul-smelling stools, steatorrhea, weight loss, and malnutrition. Currently, there is no relevant report on the status quo of PEI in Chinese CP patients. This study aims to analyze the status quo of PEI and related risk factors in Chinese CP patients, with the hope of providing safe and effective intervention and treatment methods to improve the quality of life of patients.

Pancreatic exocrine insufficiency (PEI) is one of the common complications of chronic pancreatitis (CP). Mild to moderate PEI may present with atypical digestive tract symptoms such as abdominal distension and abdominal pain, while severe PEI can lead to related complications such as foul-smelling stools, steatorrhea, weight loss, and malnutrition. Currently, there is no relevant report on the status quo of PEI in Chinese CP patients.This study aims to analyze the current status and related risk factors of PEI in CP patients in China by detecting pancreatic exocrine function with FE-1, in order to provide safe and effective intervention and treatment methods and improve the quality of life of patients.

Eligibility Criteria:
Inclusion Criteria:

1. patients who underwent inpatient care at Shanghai Changhai Hospital (a WHO Collaborating Center for Pancreatology) between June 2022 and September 2024.
2. patients diagnosed with chronic pancreatitis (CP)
3. Voluntarily preserve feces for the detection of fecal elastase-1 (FE-1)

Exclusion Criteria:

1. Patients who were diagnosed with pancreatic cancer within 2 years after being diagnosed with chronic pancreatitis (CP)
2. patients with groove pancreatitis,
3. patients with autoimmune pancreatitis.
Clinical and Radiographic Success of MTA vs Biodentine

The purpose of this prospective study is to compare the clinical and radiographic success of MTA and Biodentine as a medicament in vital pulp therapy in maxillary and mandibular primary molars in a pediatric population. There is limited research currently on Biodentine since it's a novel product. Biodentine is less expensive than MTA and does not cause discoloration like MTA. Biodentine may be an alternative medicament used for vital pulp therapy in primary molars.

This is a interventional randomized split mouth prospective study that evaluates the clinical and radiographic success of mineral trioxide aggregate (MTA) and Biodentine as pulpotomy and indirect pulp cap (IPC) medicaments. Male and female participants ages two to twelve who need at least two quadrants of treatment will be enrolled in the trial. Participants will be treated at Geisinger Medical Center, Danville, and Geisinger Bloomsburg Hospital operating rooms for full mouth rehabilitation. Each participant must have at least two matched bilateral carious primary molars that require either pulpotomy or indirect pulp cap. Maxillary and mandibular primary first and second molars who receive pulpotomy and /or indirect pulp cap will be compared. The research will be split mouth design where the primary molar on one side will get MTA as the pulpotomy or IPC medicament and the corresponding primary on the other side will get Biodentine as the pulpotomy or IPC medicament in the same arch.

The procedures will be performed according to standards of the American Academy of Pediatric Dentistry (AAPD), by Institutional Review Board approved investigators. Data will be extracted from the electronic health record (EHR) and TigerView dental radiograph imaging software. Data will be recorded using REDCap. Clinical and radiographic follow up of patients will be every 6 months since date of procedure for 3 years. Follow up will be done at the Geisinger Pediatric Dental Clinic at Danville or Milton.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ages of 2 to ≤12 years.
* Bilateral symptomatic or asymptomatic vital primary molars with caries approximating or into the pulp.
* Patient who need a pulpotomy and/or indirect pulp cap treatments in two or more quadrants.
* Parents of patients who can provide consent in English.
* Patients who need treatment in an operating room setting at Geisinger.

Exclusion Criteria:

* Pre-operative radiographic or clinical symptoms associated with irreversible pulpitis or necrotic pulp.
* Radiographs not displaying furcation region of the tooth.
* Patients with cardiac conditions who need prophylaxis for infective Endocarditis.
* Patients with any type of cancer in the past or present.
* Non-restorable molars.
PF-07225570 Alone or in Combination With an Anti-PD-1 Antibody in Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)

The primary objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of PF-07225570 alone or in combination with an anti-PD-1 antibody in participants with recurrent non-muscle invasive bladder cancer. This study consists of 2 parts, single agent dose escalation (Part 1A), dose finding of PF-07225570 in combination with anti-PD-1 antibody (Part 1B) and dose expansion (Part 2).


Eligibility Criteria:
Inclusion Criteria:

Histological confirmed and documented diagnosis of non-muscle invasive urothelial carcinoma

Participants with recurrent non-muscle invasive bladder cancer (intermediate risk or high risk)

Ineligible for or elected not to undergo radical cystectomy

No evidence of upper tract urothelial cancer or cancer within the prostatic urethra as documented by imaging studies performed within 6 months of enrollment

Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

Adequate bone marrow, renal and liver function

Exclusion Criteria:

Evidence of muscle-invasive, locally advanced or metastatic urothelial carcinoma or concurrent extravesical, non-muscle invasive urothelial carcinoma

Macroscopic hematuria, traumatic catheterization or active urinary tract infection

Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent

Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) Hepatitis B, Hepatitis C, and known Human Immunodeficiency Virus infection or Acquired Immunodeficiency Syndrome-related illness
Sutures for Treatment of Knee Arthroscopy

For a knee arthroscopy, two small incisions are made at the level of the joint line on each side of the patellar tendon. Closure of surgical incisions consists of using either nonabsorbable or absorbable sutures. Some surgeons prefer using nonabsorbable sutures due to it being easier to tie, these sutures are less likely to break prematurely, and that they elicit a minimal inflammatory response. On the other hand, some surgeons prefer using absorbable sutures due to the time savings of not having to remove the sutures at a later date and that these sutures decrease patient anxiety and discomfort. The purpose of this study is to prospectively investigate and compare patient's pain, swelling and cosmesis following knee arthroscopy surgery between patients who had their arthroscopy portals closed using resorbable sutures vs. patients who had their portals closed using nonabsorbable sutures.


Eligibility Criteria:
Inclusion Criteria:

* Patients ages 18 and older undergoing primary knee arthroscopy for diagnostic arthroscopy, removal of a loose body, chondroplasty, or a partial meniscectomy will be included in this analysis

Exclusion Criteria:

* Patients undergoing revision knee arthroscopy as well as patients undergoing ACL reconstruction or meniscal repair surgery will be excluded from this analysis.
* Patients under the age of 18 will be excluded as well.
Evaluation of Paclitaxel Coated Balloon in the Treatment of Dialysis Access Dysfunction

Recent studies of paclitaxel DCB in the treatment of stenosis at dialysis vascular access have shown promising results. Paclitaxel, an anti-proliferation drug, is released during balloon inflation and potentially improve primary patency by slowing down NIH effect. However, meta-analysis have suggested that the use of paclitaxel in lower limbs have increased risk of death in patients. The effect of paclitaxel DCB on dialysis access however remains unknown. Hence, we aim to set up a database to track long-term treatment outcomes of patients treated with Paclitaxel DCB at SGH for their stenosed dialysis access


Eligibility Criteria:
Inclusion Criteria:

* All patients above 21 that is undergoing AVF/AVG fistuloplasty with paclitaxel DCB at SGH is included

Exclusion Criteria:

* All patients below 21