cyrilzakka/clinical-trials huggingface dataset:
Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study

The purpose of this study is to determine whether Quillivant XR is effective in the treatment of ADHD in children with Autism Spectrum Disorder (ASD).

To evaluate the safety and tolerability of low to moderate dose effects of Quillivant XR (liquid methylphenidate) and to observe changes in ADHD symptoms and functional outcomes in children with ASD and ADHD. The investigators propose to investigate the low to moderate dose range of methylphenidate compared with a very low dose with a gradual dose escalation schedule because children with ASD have been found to be more sensitive to the adverse effects of methylphenidate (especially in medium to high doses) than children without ASD.

Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of Autistic disorder or Asperger's disorder by DSM-IV or Autism Spectrum Disorder by DSM-V.
* A DSM-V diagnosis of ADHD based upon the K-SADS-P.
* Clinical Global Impressions - Severity for ADHD (CGI-S-ADHD) rating \> 4.
* Findings on physical exam, labs and ECG are judged to be normal for age with pulse and blood pressure within 95% of age and gender mean.
* Informed consent by a parent or legal guardian, and assent for children with developmental age 7 years or older.
* At least one parent fluent in English

Exclusion Criteria:

* History of Seizure disorder (Febrile seizures are non-exclusionary).
* History of Intellectual Disability (IQ\< 70)
* Treatment with MAO Inhibitor (or within 14 days following discontinuation of MAO Inhibitor).
* Other psychotropic medication other than stable dose of Selective Serotonin Reuptake Inhibitors, which is permitted)
* Known to be hypersensitive to methylphenidate, or other components of Quillivant XR
* Cardiac or other medical contraindications for stimulant trial (e.g., family history of heart attack at age younger than 40 years, personal history of heart disease, history of fainting while exercising, structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac problems. If any doubt, children will be referred to a cardiologist for a cardiac clearance.
* Raynaud's disease
* Pregnancy or Breast-feeding.
Psychosocial Screening for Neuroendocrine Tumor Patients

This is a psychosocial screening application to usual care in a cohort of neuroendocrine tumor patients. The application involves monitoring using the NCCN Distress Thermometer(DT), Hospital Anxiety and Depression Scale(HADS), Self-Perceived Burden Scale(SPBS) and Connor-Davidson Resilience Scale(CD-RISC). These assessments will be completed at baseline, 3 months, 6 months, 12 months and 24 months. Patients will have the option of filling out questionnaires more frequently if desired.


Eligibility Criteria:
Inclusion Criteria:

1. sign written informed consent form;
2. age ≥ 18 years;
3. pathologically confirmed well-differentiated neuroendocrine tumors, G1-2 (Ki67≤20%);

Exclusion Criteria:

1. \<18 years;
2. Neuroendocrine carcinoma;
3. History of psychiatric or psychologic illness;
4. History of previous cancers or cancer distress;
5. Patients with central nervous system(CNS) disorder；
6. Severe, uncontrolled medical condition that would affect patients' compliance;
Acquisition of Breast Mammography Images

This is a case collection study of breast images using standard and new mammography technology.

This image acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. This study will create a library of image data that will be used for future projects.

Eligibility Criteria:
Inclusion Criteria:

For Screening Subjects

* Be at least 40 years of age, are
* Asymptomatic,
* Scheduled for a routine screening mammogram

For Recall Subjects

* Be at least 18 years of age,
* Received a BIRADS 0 within the last 60 days
* Are recalled for additional imaging

For Diagnostic Subjects

* Be at least 18 years of age,
* Scheduled for a biopsy due to an assessment of Breast Imaging and Reporting Data (BI-RADS®) 4 or 5 after diagnostic work-up of a suspicious screening or clinical finding within the last 60 days.
* Understand requirements and willing to participate in study

Exclusion Criteria:

* Presence of a breast implant.
* Women with only a single breast; for example, post mastectomy patients.
* Is pregnant or believes she may be pregnant.
* A woman who has delivered and who has expressed the intention to breast-feed or is currently breast-feeding.
* A woman who has significant existing breast trauma within the last one year.
* Have self-reported severe non-focal or bilateral breast pain affecting subject's ability to tolerate digital mammography and/or breast tomosynthesis examinations.
* A woman who has had a mammogram performed for the purpose of therapy portal planning within the last year.
* Cannot, for any known reason, undergo follow-up digital mammography and/or breast tomosynthesis examinations (where clinically indicated) at the participating institution.
* Is an inmate (see US Code of Federal Regulations 45CFR46.306).
Functional Voice and Speech Outcomes Following Surgical Voice Restorations: A Comparison of Pharyngeal Construction Approaches

The purpose of this study is to evaluate the nature and quality of speech after removal of the voice box and all or part of the swallowing tube.

The study is evaluating which type of surgery provides patients with the best speech and voice.

These data will be used to help surgeons to design better ways to restore voice function after removal of the voice box. Information about disease, its treatment, quality of life, and physical and vocal function will be collected. An audio recording of vocal tasks will also be done. All of this information will be analyzed and the two different subject groups will be compared to see if there are differences.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have undergone removal of the larynx and the entire pharynx by either traditional reconstruction or more advanced reconstructive techniques, which involve the use of tissue, such as skin or bowel, from other parts of the body. There is no time frame for reconstruction. All subjects who have previously undergone reconstruction are eligible.
* Subjects who use the tracheoesophageal puncture method of voice restoration as their primary communication technique.
* \> or equal to 18 years old

Exclusion Criteria:

* Do not have functional voice restoration.
* Do not speak English as a functional language.
Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Urological Surgical Operations

The aim of this study is to assess the effect of pregabalin administration on catheter-related bladder discomfort (CRBD). The study group includes patients that are about to be subjected to urological operations because of the high incidence of CRBD observed in this kind of surgical population.


Eligibility Criteria:
Inclusion Criteria:

* All patients about to be subjected to urinary operations
* Signed informed consent

Exclusion Criteria:

* Preoperative urinary bladder/kidney dysfunction as a result of spinal cord pathology
* History of overactive ((urinary frequency\>3 times at night and \>8 times in 24 hours), neurogenic bladder
* End stage renal failure
* Central nervous system dysfunction
* Mental illness/ substance abuse
* Sensitivity to pregabalin
* Preoperative administration of pregabalin for other indications
* Recent bladder catheterization \<3 months
Non-invasive Imaging With [18F]VM4-037

The purpose of this study is to determine the toxicity of the hypoxia PET-tracer \[18F\]-VM4-037 in cancer patients in two dose-steps:

* Step 1 (3-6 patients): a single dose of maximum 8 mCi (296 MBq) dose of \[18F\]VM4-037 via a bolus IV injection.
* Step 2 (3-6 patients): a single dose of maximum 12 mCi (444 MBq) dose of \[18F\]VM4-037 via a bolus IV injection


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmed solid tumour, primary or secondary stage IV and/ or tumours with no curative treatment options
* WHO performance status 0 to 1
* Normal white blood cell count and formula
* Normal platelet count
* No anaemia requiring blood transfusion or erythropoietin
* Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution)
* Calculated Creatinin clearance at least 60 ml/min
* No administration of Fluor-18 in the previous 24 hours
* The patient is capable of complying with study procedures
* 18 years or older

Exclusion Criteria:

* Only visible tumor sites in the upper abdomen (because the uptake of VM4-037 in the liver, stomach and the kidneys would interfere with image quality of the tumor)
* Known hypersensitivity for sulfonamides
* Recent (\< 3 months) myocardial infarction
* Uncontrolled infectious disease
* Less than 18 years old
* Pregnancy
* No concurrent anti-cancer agents or radiotherapy allowed
RITUXIMAB BS Intravenous Infusion 100mg・500mg [Pfizer] Post-marketing Database Study

To evaluate the incidence of the outcomes for the safety specifications in patients of Medical Data Vision database in Japan diagnosed with CD20 positive B-cell non- Hodgkin's lymphoma who were treated with Rituximab Pfizer to compare it with outcomes in patients who were treated with Rituxan from 01 January 2020 through 31 December 2024


Eligibility Criteria:
Inclusion Criteria:

1. Have prescription of Rituximab Pfizer or Rituxan within the enrollment period (Index Date: first prescription date within the enrollment period).
2. Have diagnosis of CD20 positive B-cell non- Hodgkin's lymphoma on the index month or within 6 months before index date
3. Have at least 6 months of Look back period and at least one medical record prior to 7 months before the Index date.
4. Have not prescription of Rituximab product before index date(Comparative Analysis Set only).

Exclusion Criteria:

1. Have any diagnosis of other indications of rituximab products other than CD20 positive B-cell non- Hodgkin's lymphoma before index date .
Oral Cleft Prevention Program

The purpose of this study is to asses if taking 4 mg of folic acid per day at preconception and during the first three months of pregnancy decreases the risk of having a child with cleft lip and palate compared to 0.4 mg folic acid for women who have an oral cleft or have had previously child with an oral cleft.

Cleft lip and palate is a common and burdensome birth defect that has large health ramifications and requires surgical, speech, behavioral, dental, and medical interventions. There is some evidence suggesting that taking folic acid particularly at large doses during preconception and first trimester of pregnancy may decrease the risk of oral cleft recurrence, which is the risk of having a child with an oral cleft for women who have an oral cleft or who have had a child with a cleft. However this evidence is based on study designs that are incapable of contributing the preventive effects to folic acid with adequate confidence, and the real effect of folic acid on cleft recurrence prevention remains to be identified. Taking 4 mg of folic acid per day at preconception and first trimester of pregnancy has also been shown to prevent the recurrence of neural tube defects by up to 70%, providing further support to evaluate this intervention for oral cleft recurrence.

This study evaluates the effects of supplementation with 4 versus 0.4 mg of folic acid per day at preconception and during the first three months of pregnancy on recurrence of cleft lip and palate. Up to 6000 women will be randomly assigned to 4 versus 0.4 mg groups. The primary aim is to compare the recurrence rates in the offspring of trial mothers in the two groups. Secondary aims are to compare the two groups on several outcomes including miscarriage, twinning, pre-eclampsia, serum and red cell folate levels, severity of oral clefts and occurrence of other birth defects in the offspring of trial mothers, and birth weight and gestational age of trial babies, and to compare the recurrence in the two groups to that in historic controls.

Eligibility Criteria:
Inclusion Criteria:

* Women with cleft lip with/out palate (CLP), 16 to 45 years of age registered at the study clinics in Brazil or Women (16 to 45 years of age) with at least one natural child of any age with CLP registered at the study clinics.
* Women must reside in the catchment area of the study, which includes the states where the study clinics are located and surrounding states.

Exclusion Criteria:

* Consanguineous couples (up to third degree, i.e. first cousins or closer).
* Pregnany at the time of recruitment. Women will be recontacted later at an appropriate time for participation in the study.
* Couples either one of which have been sterilized.
* Taking any form of seizure medication.
* Planning to move outside of the study catchment area within the next year.
* B12 deficiency (\<174 pg/mL or 129.15 pmol/L).
* Being allergic to folic acid.
Safety and Efficacy of Trastuzumab BS

To confirm the safety and efficacy of this drug under the actual use


Eligibility Criteria:
Inclusion Criteria:

* Patients with unresectable advanced/recurrent gastric cancer who are confirmed to have HER2 overexpression and started treatment with this drug\*
* Patients who receive this drug\* for the first time after this drug\* is launched \* Not including the biological product, HERCEPTIN, and biosimilars of HERCEPTIN other than this drug

Exclusion Criteria:

- not specified in this study
Open-Label Treatment Extension of Protocol MNTX 301

This study is an open-label extension allowing patients who have completed Protocol MNTX 301 to continue to receive SC MNTX.


Eligibility Criteria:
Inclusion Criteria:

1. Completion of protocol MNTX 301; Double-Blind Treatment and Open-Label Treatment
2. Negative pregnancy test

Exclusion Criteria:

1. Women who are pregnant and/or nursing
2. Any concurrent experimental drug therapy
3. Evidence of fecal impaction
4. Clinically significant active diverticular disease
A Phase II Study on Dose Optimization of Fruquintinib in Elderly mCRC Patients Refractory to Standard Treatment（DOFEMCRC）

A Phase II study on dose optimization of fruquintinib in elderly metastatic colorectal cancer patients refractory to standard treatment.

This is a prospective, multi-center, single arm, phase II study. In this study, the low-dose initial dose incremental optimization scheme was used in the first cycle in patients ≥65 years old who need to receive fruquintinib. The aim is to observe the safety, tolerability and efficacy of fruquintinib in elderly patients with mCRC refractory to standard treatment. The correlation between the efficacy, toxicity and geriatric evaluation of fruquintinib will also be analysed.

Eligibility Criteria:
Inclusion Criteria:

1. 65 years and older;
2. Histologically or cytologically confirmed unresectable metastatic colorectal cancer refractory to or unfit for standard therapies;
3. ECOG PS 0-1;
4. At least 4 weeks after the last anti-tumor therapy (chemotherapy, radiotherapy, biotherapy or hormone therapy) and more than 3 months after operation treatment before enrollment;
5. Life expectancy ≥ 3 months;
6. Cooperative in observation of adverse events and curative effect;
7. No other anti-tumor concomitant treatment (including steroid drugs);
8. Adequate organ and bone marrow functions;
9. At least one measurable lesion(s);
10. Signed the written informed consent and completed the geriatric questionnaire (G8 screening form) at the time of enrollment.

Exclusion Criteria:

1. Active upper gastrointestinal ulcer, obvious vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc which may affect drug absorption, distribution, metabolism, or clearance;
2. Evidence of central nervous system metastasis;
3. One of the following complications: uncontrolled hypertension, coronary artery disease, arrhythmia and heart failure;
4. Abuse of alcohol or drugs;
5. Less than 4 weeks from the last clinical trial;
6. Previous treatment with VEGFR inhibitors;
7. Severe uncontrolled disability with concurrent infection;
8. Proteinuria ≥ 2 + (1.0g / 24hr);
9. Uncontrollable gastrointestinal bleeding;
10. Arterial / venous thromboembolic events such as cerebrovascular accident (including transient ischemic attack) occurred within 12 months before the first dose;
11. Acute myocardial infarction, acute coronary syndrome or coronary artery bypass grafting occurred within 6 months before the first dose;
12. Fracture or wound that has not been cured for a long time;
13. Coagulation dysfunction, bleeding tendency or receiving anticoagulation treatment;
14. Congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (HBV DNA ≥ 103copies / ml after regular antiviral therapy);
15. Patients who are not suitable for the study judged by the researchers.
Goal Concordant Care Learning Laboratory

The goal-concordant care lab will develop and test strategies to optimize communication in advanced serious illness.

The goal-concordant care lab will develop and test strategies to optimize communication in advanced serious illness. The lab will test a variety of interventions, including triggered conversations and feedback to healthcare providers.

Eligibility Criteria:
Inclusion Criteria:

* Duke Health patient

Exclusion Criteria:

* None
Deploying POKE Within Intermountain Healthcare

To assess the impact of POKE on babies, the investigators will longitudinally track outcomes before and after implementation at Intermountain Healthcare's five NICUs. Process outcomes will include the number of total POKEs per baby and the number of painful POKEs per baby, each measured at both the patient-level and NICU-level. Clinical outcomes will include hospital acquired infections, length of stay, and mortality. Financial outcomes will include total variable costs and backfill rate. The effect of POKE on each of these outcomes will be measured using multivariable regression analysis with appropriate distributional families and interaction terms.

POKE was developed and implemented at Dixie Regional Medical Center's Neonatal Intensive Care Unit (NICU) over the past 10 years to eliminate waste and reduce harm in healthcare. POKE is a combination of a unique culture and process, with a supporting database, that is designed to guide and inform care decisions while minimizing POKEs. The program utilizes an implementation framework, educational materials, electronic health records (EHR), and decision support analytics. POKE's initial deployment showed extremely promising results for Intermountain, which included: (1) eliminating 11,000 POKEs per year (a 50% reduction in overall POKEs), (2) realizing $940,000 per year in cost savings (a 28% reduction of overall cost), (3) reducing length of stay by 2 weeks per average stay (a 21% reduction in length of stay), and (4) eliminating Hospital Acquired Infections (i.e., Central-line Associated Bloodstream Infection and Ventilator-associated Pneumonia), translating into 10 lives saved and a $5.2M savings over a decade. POKE will now be deployed and routinized within all Intermountain Healthcare NICUs and be developed as a commercial product for external customers. To assess the impact of POKE on babies, the investigators will longitudinally track several outcomes before and after implementation at Intermountain NICUs. Process outcomes will include the number of total POKEs per baby and the number of painful POKEs per baby, each measured at both the patient-level and NICU-level. Clinical outcomes will include hospital acquired infections, length of stay, and mortality. Financial outcomes will include total variable costs and backfill rate.

Eligibility Criteria:
Inclusion Criteria:

* All babies in Intermountain Healthcare NICU

Exclusion Criteria:

* None
Translation and Validation of Pelvic Girdle Questionnaire in Urdu Language

Urdu version of pelvic girdle questionnaire was drafted, tested for its reliability and validity on patients with pelvic girdle pain. Urdu version was linguistically acceptable and accurate for pregnant and post partum females with pelvic girdle pain. The result seems comparable to all the other versions and especially with original Norwegian version. This instrument is understandable and easy to find disability during pregnancy and post partum duration. It showed a good content, construct and convergent validity also present high internal consistency and test retest reliability.

The Pelvic Girdle Questionnaire is the only specific instrument designed to evaluate pain and activity limitations in pregnant or postpartum women with pelvic girdle pain. This study aimed to translate the Pelvic girdle questionnaire in Urdu language for Pakistani female patients and to verify the validation of the psychometric items of the Pelvic girdle questionnaire in population of Pakistan. The purpose of this study was to translate the Pelvic Girdle Questionnaire into Urdu and find out cross-culture validity and reliability of Urdu Pelvic girdle questionnaire among pregnant and postpartum females. A cultural adaptation and translation study was performing according to international guidelines. Study was conducted at different hospital settings. Pre test was conducted among 16 females during pregnancy \& post-partum.

Key words: Disability Evaluation, Female, Urdu, Pelvic Girdle Pain and physiopathology, Pregnancy, Surveys and Questionnaires, Translation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years
* Only Females
* Able to read Urdu Language
* Pregnant women (gestational week 30-38)
* Postpartum women (given birth less than one year earlier)

Exclusion Criteria:

* Any neurological diseases (reflex changes \& loss of sensation)
* Unstable medical conditions leading to fatigue
* Those that have prolapse or severe urinary disease
* Previous surgery on pelvis, lower limb or spine
* Cannot Understand Urdu
* Difficulty in understanding the Pelvic girdle questionnaire
Clinical Echocardiography and S' Wave for Early Recognition of Acute Coronary Syndrome in the Emergency Department, A Prospective Study

The goal of this prospective observational study is to assess the diagnostic accuracy of the tissue Doppler imaging (TDI) S' wave in detecting acute coronary syndrome (ACS) in adult patients presenting to the emergency department (ED) with acute chest pain. This study focuses on patients aged 18 years or older, who require continuous cardiac monitoring but do not show ST-elevation myocardial infarction (STEMI) on their initial ECG.

The main questions it aims to answer are:

* Can TDI S' wave velocity serve as an early diagnostic marker for ACS in the emergency department?
* How does the diagnostic performance of TDI S' compare with other echocardiographic markers (MAPSE, TAPSE, and diastolic parameters such as E, E', A, E/A, E/E')?
* Do demographic factors (age, sex, BMI, echogenicity) influence the diagnostic accuracy of echocardiographic parameters for ACS? If there is a comparison group: Researchers will compare TDI S' wave velocity findings with the final adjudicated diagnosis of ACS (determined after 3 months) to evaluate its sensitivity and specificity.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Presenting to the emergency department (ED) with acute chest pain
* No ST-elevation myocardial infarction (STEMI) on initial ECG
* Requiring continuous cardiac monitoring based on triage decision
* Able to provide informed consent (written consent required)

Exclusion Criteria:

* Known pre-existing cardiomyopathy (e.g., hypertrophic cardiomyopathy, dilated cardiomyopathy)
* Severe valvular heart disease
* Left bundle branch block (LBBB) or presence of a pacemaker
* Arrhythmias (e.g., atrial fibrillation, frequent premature ventricular contractions)
* Cardiac arrest or cardiogenic shock at presentation
* Pulmonary hypertension
* Pericardial effusion or tamponade
* Non-cardiac cause of chest pain suspected as the primary diagnosis
* Language barrier preventing informed consent (study materials available in English, French, and Dutch)