cyrilzakka/clinical-trials huggingface dataset:
SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors

To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors


Eligibility Criteria:
Inclusion Criteria:

1. ECOG performance status of 0 to 1.
2. Life expectancy of more than 3 months.
3. At least one measurable lesion exists.(RECIST 1.1)
4. Histologically or cytologic confirmed HER2 positive metastatic solid tumor which failed prior standard treatment or have no standard treatment.
5. Required laboratory values including following parameters:

   ANC: ≥ 1.5 x 109/L Plt count: ≥ 90x 109/L Hb: ≥ 90 g/L TBIL: ≤ 1.5 x ULN, ALT and AST: ≤ 2.5 x ULN and creatine clearance rate: ULN or≥ 50 mL/min
6. Toxicity from previous antitumor therapy returned to baseline (except for residual hair loss effects) or CTCAE≤ class 1.
7. Blood pregnancy test was negative within 3 days prior to first dose.

Exclusion Criteria:

1. Subjects who have received the prescribed treatment at the prescribed time prior to first dosing.
2. Known active infection within 2 weeks prior to baseline.
3. Subjects with third space fluid that can not be controled.
4. Subjects with uncontrolled or severe cardiovascular disease.
5. Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
6. Subjects with severe lung disease.
7. Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
8. Using a potent CYP3A4 or CYP2C8 inhibitor or inducer.
9. Steroid treatment for more than 50 days before, or in need of long-term use of steroids.
10. Uncured other tumors within 5 years.
11. Subjects with symptomatic CNS metastasis, pia meningeal metastasis, or spinal cord compression due to metastasis.
12. Evidence of chronic active hepatitis B or C
13. Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment.
14. Receive any live or attenuated live vaccine within 28 days prior to baseline.
15. Evidence of severe allergies.
16. Evidence of alcohol or drug abuse.
17. Evidence of neurological or psychiatric disorders.
Auricular Acupuncture vs SOC in Migraine HA

Patients with migraine headache will be offered the opportunity to participate in this randomized study evaluating auricular acupuncture versus standard treatment for migraine headaches for patients in the pediatric emergency department (ED).

Potential subjects will be identified using the diagnosis of migraine headache classified by the modified ICHD-II (International Classification for Headache Disorders) criteria proposed by Hershey et. al. This diagnosis will be confirmed by the investigators prior to enrollment of the subject and will be documented in the study documents. Subjects will be recruited during the scheduled work or research hours of the investigators in the ED.

Eligible patients will be informed of the study including a discussion of the two possible interventions. After informed consent and assent are obtained, patients will be randomly assigned 1 of the 2 arms of the study. The target is 40 subjects in each arm. Subjects will be assigned to a study group using a computer generated randomization schema. This randomization will only be known to one unblinded collaborator that will not be enrolling subjects or be involved in the data analysis.

If assigned to receive intravenous migraine medications the subject will be treated with the standard of care medications which include ketorolac (0.5mg/kg, max 30mg), metoclopramide (0.1 mg/kg, max 10mg), diphenhydramine (1mg/kg, max 50mg) plus a normal saline fluid bolus (20mL/kg, max 1000mL).

If assigned to the auricular acupuncture arm, efficacious ear points will be located by a needle contact test and/or an electrical point finder which emits an acoustic alarm when a change in electrical resistance is detected signifying a potential active auricular acupoint. If the subject does not improve with acupuncture, they will be assessed by the ED physician and at the MD discretion further emergency department treatment will be administered which may include intravenous migraine medications as this is the current standard of care in the Norton Children's Hospital/Norton Children's Medical Center (KCH/KCMC) ED.

All subjects will be contacted 2 to 6 days after discharge to determine their clinical status. If the darts are still in place at the follow-up call, the subjects will be contacted at 2 weeks and weekly thereafter until all darts have fallen out.

Eligibility Criteria:
Inclusion Criteria:

* Confirmation of the diagnosis of migraine headache

Exclusion Criteria:

* Patients who received ED migraine medications (including ibuprofen or other NSAIDS) prior to study evaluation.
* Allergy to any of the medications used in our migraine regimen protocol.
* Patients exhibiting focal clinical neurological exam findings that the investigator deems makes the patient not a good candidate for this study.
* Patients with underlying abnormal brain pathology (e.g. mass or bleed) as the potential cause of the migraine
Characterization of Fetal Lung With Quantitative Ultrasound

The purpose of the study is to show if it's possible to use a special kind of ultrasound called backscatter quantitative ultrasound (bQUS) to check on a baby's lungs when the mother is 36 weeks pregnant. 12 participants will be on study for a single 30 minute ultrasound between 32 and 36 weeks of pregnancy.

Primary Objective:

* Demonstrate the feasibility of performing bQUS analysis on ultrasound echo signals acquired of the fetal lung acquired with clinical ultrasound scanners during third -trimester ultrasound scans

Secondary Objectives:

* Design and implement a protocol to acquire non-processed (raw) echo signals from a commercial ultrasound scanner necessary to perform bQUS at the UPH-Meriter Center for Perinatal Care (CPC).
* Quantify the populational variance of quantitative features extracted from bQUS applied to ultrasound data collected from third trimester ultrasound scans of the fetal lung.

The study will be divided into two phases: (i) feasibility phase and (2) hypothesis-testing phase recruitment phase. Phase 1 will provide evidence of the technical viability of data acquisition at UPH-Meriter CPC and will involve 5 participants. Technical challenges will be discussed with the research team and the supporting vendor (GE) to decide whether the technique is viable to move forward. In case the decision is favorable, recruitment will continue to complete 12 subjects to estimate the populational variance of the quantitative features. If the decision is not favorable due to technical complications, the study will be terminated.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant females ages 18 to 45 years old with singleton pregnancy, live fetus, gestational age between 32.1 and 36.7 weeks, not in labor, scheduled for routine ultrasound growth evaluation.
* Gestational age determined by the date of the last menses, and confirmed by measurement of the crown-rump-length on transabdominal ultrasound.

Exclusion Criteria:

* Subjects unable to consent.
* Active Labor
* Fetal malformations of the lungs
* Prescription of corticosteroids prior to ultrasound evaluation
* Pre-gestation or gestational diabetes mellitus
* Low English proficiency, needing an interpreter
TDF and Entekavir - Hepatitis B Reactivation

This is a non-interventional retrospective multi-center study for the patients received Entekavir or TDF for Hepatitis B prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Patients used entekavir or TDF for Hepatitis B prophylaxis

Exclusion Criteria:

* Patients lower then 18 years old.
Vactosertib with Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition

This is Phase 2, open label, non randomized single arm study to determine whether the administration of vactosertib with durvalumab will provide meaningful increases in the Overall Response Rate (ORR) in patients with urothelial cancers that fail to achieve a response with anti-PD-1/PD-L1 based regimens

This is a Phase 2, open-label, non-randomized, two-cohort multi center study with a safety run-in of 6 patients in Cohort 1. It is anticipated that a total of 48 patients will be enrolled.

Durvalumab will be administered with the standard regimen of 1500 mg intravenously (IV) every four weeks. Vactosertib will be administered at a dose of 300 mg PO BID for 5 days per week All treatment will be administered up to two years and the trial is anticipated to be completed over a period of 36 months.

Eligibility Criteria:
Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrollment
2. Histologically or cytologically documented locally advanced/inoperable or metastatic urothelial bladder carcinoma (UBC), including renal pelvis, ureters, urinary bladder, and urethra.
3. Prior anti-PD-(L)1 treatment.
4. Measurable disease per RECIST 1.1 assessed by computed tomography (CT) scan or MRI.
5. Recurrent disease after any prior platinum-based chemotherapy regimen or ineligible for platinum therapy.
6. Adequate organ and marrow function as defined
7. Must have a life expectancy of at least 12 weeks.
8. Body weight \> 30 kg

Exclusion Criteria:

1. History of allogeneic organ transplantation.
2. Active or prior documented autoimmune or inflammatory disorders
3. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure .
4. History of another primary malignancy
5. History of leptomeningeal carcinomatosis.
6. History of active primary immunodeficiency.
7. Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen \[HBsAg\] result), hepatitis C, or human immunodeficiency virus .
8. Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
Vitamin D, Oxidative Stress and Inflammation in Hemodialysis

Vitamin D deficiency is now considered a global problem in general population, but it seemed to be more prominent in chronic kidney disease (CKD) patients, especially those on regular hemodialysis. Being a key regulator in mineral metabolism, there's also emerging evidences linking vitamin D deficiency with inflammation and oxidative stress, which are both recognized as constant threats to cardiovascular outcomes in hemodialysis patients.

It's prospective, randomized trial that's carried out to evaluate the effect of weekly versus, monthly oral cholecalciferol, on vitamin D (25(OH)D) levels, oxidative stress markers, inflammatory markers and secondary hyperparathyroidism in hemodialysis patients. Fifty eligible hemodialysis patients were randomly assigned to either Group A (Oral 50.000IU Cholecalciferol, once weekly) or Group B (Oral 200.000IU Cholecalciferol, once monthly), for 3 months. Serum levels of (25(OH)D), serum malondialdehyde (MDA), serum superoxide dismutase (SOD), serum high sensitive (hsCRP), calcium, phosphorus, and intact parathormone (iPTH) levels, were all assessed at baseline and at the end of the study


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged between 18-70 years, on maintenance hemodialysis for a duration of 3 months or more, in a stable clinical condition (no hospitalization in the previous 3 months), with serum vitamin D levels of \< 30 ng/ml.

Exclusion Criteria:

* Patients with hypersensitivity to cholecalciferol, ongoing cholecalciferol therapy, liver failure, digestive malabsorption disease, being participating in an another clinical trial within the past 4 weeks, females that are pregnant or breastfeeding, or patients being judged to be unsuitable to be enrolled by the attending physician.
A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease

The primary objective of this study is to evaluate change in non-motor symptoms from baseline to Week 12 as measured by the Non-Motor Symptom Scale total score.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have a diagnosis of idiopathic Parkinson's disease (PD) according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
* Demonstrate persistent motor fluctuations in spite of individually optimized treatment
* Subject must experience a minimum of 3 hours "Off" time

Exclusion Criteria:

* Subject's PD diagnosis is unclear or there is a suspicion that the subject has a Parkinsonian syndrome such as secondary Parkinsonism (e.g., caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndrome (e.g., Multiple System Atrophy, Progressive Supranuclear Palsy, Diffuse Lewy Body Disease, Corticobasilar Degeneration), or other neurodegenerative disease that might mimic the symptoms of PD.
* Subject has undergone neurosurgery for the treatment of Parkinson's disease
* Subject for whom the placement of a PEG-J tube for LCIG treatment is contraindicated or is considered a high risk for the PEG-J procedure according to the gastroenterology evaluation (e.g., pathological changes of the gastric wall, inability to bring the gastric wall and abdominal wall together, blood coagulation disorders, peritonitis, acute pancreatitis, paralytic ileus).
Efficacy of Metformin in Achieving Glycaemia Goals as Recommended for the Treatment of Gestational Diabetes in Non Obese Women

Gestational diabetes (GD) is defined by a hyperglycemia discovered during pregnancy, leading to fetal and maternal complications which may be prevented by reaching very strict glycaemia targets. Prevalence depends on patient's ethnic group and is about 6 to 14%. This prevalence is increasing due to increased GD risk factors (obesity, pregnancy over 35) and also because criteria of screening have been strengthened after the results of last studies. Usual treatment is diet and in case of failure insulin therapy with multiple injections which may lead to hypoglycemia and weight gain and is very difficult to manage for patients. Some studies have shown the comparable effect of metformin and insulin in about 50% of GD obese patients. The aim of our study is to evaluate efficacy of metformin, outcomes in mother and fetus and baby of metformin. In case of metformin failure, insulin will be added in order to obtain glycaemia in desired goals.Oxidative stress will be assessed in mother blood, baby umbilical cord blood, baby umbilical cord and placenta in 90 women and the oxidative stress compared between insulin and metformin alone treated patients.


Eligibility Criteria:
Inclusion Criteria:

Women.

* Age more than 18 and less than 40 years.
* Unique spontaneous pregnancy.-BMI less than 30kg/m2 before pregnancy.
* 24 to 30 weeks of amenorrhea or 22 to 28 weeks of gestation.
* Gestational diabetes.
* Social Security affiliated subject.- Patient able to understand and signed informed consent.

Exclusion Criteria:

* Contraindications to metformin.
* Metformin treatment prior to protocol inclusion.
* Multiple pregnancies.
* Diabetes diagnosed prior to pregnancy.
* High blood pressure prior to pregnancy.
* Pregnancy hepatic complication
* High blood pressure prior to study inclusion.
* Pre or eclampsia.- Premature membranes rupture.
A Study to See if an iPhone Weight Management App Can Help Promote Weight Loss in Adolescents and Young Adults After a Stem Cell Transplant

This early phase I trial studies how well a behavioral weight loss intervention consisting of a smartphone application and coaching works for the promotion of weight loss in adolescents and young adults after a stem cell transplant. This study may help researchers learn more about how adolescents and young adults can lose weight and develop healthy eating habits.

PRIMARY OBJECTIVE:

I. To evaluate the effectiveness of an addiction-based weight loss intervention, embodied as a smartphone application (app) with telephone coaching, on weight outcomes of overweight and obese post hematopoietic stem cell transplantation (HSCT) adolescents and young adults.

SECONDARY OBJECTIVES:

I. To evaluate the changes in metabolic parameters and physical activity levels, in addition to modifications in addictive eating behaviors, motivation, and self-regulatory behaviors.

II. To evaluate the feasibility, adherence, and satisfaction of this intervention.

OUTLINE:

Patients receive an iPhone with W8Loss2Go app, a body scale and a digital food scale to weigh themselves and food daily. Patients interact with coaches via text messages for 4 days weekly and receive weekly 15 minute phone calls for appointment reminders, emotional support, progress discussion, and follow up on items discussed in a prior visit or phone call. Patients also have telemedicine interviews with the coach lasting 60 minutes at 2 and 4 months to elicit both positive and negative impacts on weight management and to identify barriers such as emotional eating, displacement behaviors, poor coping skills to life stressors, and social challenges. Patients who opt to extend the intervention until month 12 attend an additional telemedicine meeting with the coach. Patients also complete questionnaires over approximately 1.5 hours.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of HSCT of any type, at least 100 days post-transplant at initial consultation of the study, will be eligible for the study
* Patients must classify as obese, represented as body mass index (BMI) \>= 85th percentile for age and gender
* Patients must also be able to read English since the app intervention is only available in English form
* No patients will be excluded for any specific underlying medical condition, but decisions will be made on a case by case basis if a patient's functioning is deemed to significantly interfere with intervention participation
* PARENT:
* His/her child meets all inclusion criteria
* \>= 18 years of age
* Can speak English

Exclusion Criteria:

* Patients who are \< 100 days post-transplant at initial consultation will not be eligible for the study, but may become eligible if they are \> 100 days post-transplant at their next consultation that falls within the enrollment window
* Patients whose BMI does not fall under the obese category will be excluded
Augmentative and Alternative Communication (AAC) and Lexical Gain in Children With Down Syndrome

Children with Down syndrome (DS) have language development particularities that have negative effects in the communication capacity. By this way, Augmentative and Alternative Communication (AAC) is indicated to this population. The aim of this study was to verify the AAC impact in the lexical gain of children with DS.

Five children with DS, with the same cognitive level, participated in this study. Longitudinal follow-up of twelve months of speech-language therapy with AAC use was undertaken. A lexical evaluation was done at the beginning and the end of this follow-up. Correct responses in the lexical evaluation were increased, but not necessarily in the spoken modality. The comparisons showed significant results in use of substitutions processes, and to no-answers.

Eligibility Criteria:
Inclusion Criteria:

* genetic diagnosis of Down syndrome
* be at the preoperational period
* good health conditions
* expressive language impairment (communication by vocal and gestures, predominantly)

Exclusion Criteria:

* presence of major malformations
* presence of another genetic syndrome
* severe neonatal asphyxia, hearing impairment or visual
Neuropsychological Assessment Of The Oldest-Old Population.(NEUROPSIC-GR)

Neuropsychological tests currently considered to evaluate the cognitive performance of the oldest-old population (more than 80 years) are not adapted to this group population. This trial aims to determine the normal limits for this group population of a set of 18 neuropsychological test. Results may improve the diagnostic cognitive evaluation of this population.

120 subjects more than 80y old (non-institutionalized) grouped in 4 age categories (80-84, 85-89, 90-94, 95 or more) will be evaluated through 18 neuropsychological tests (usually considered at Memory Clinics).

Subjects will be recruited from 5 Primary Care Centers by a random selection method (stratified by age group).

Normal limits will be defined by the percentiles of test punctuation. Previously, punctuation will be adjusted by age and education level by lineal regression.

Eligibility Criteria:
Inclusion Criteria:

* 80 or more years old
* Residence at Comarca del Garraf
* Able to be transfered to study center
* Sufficient reading and writing capacity to carry out the neuropsychological tests, at the evaluator's discretion.

Exclusion Criteria:

* Patient at end-of-life situation or with a very short life expectancy (days-weeks).
* Hospital admission in the previous 3 months.
* History of relevant mental illness: major depression, psychosis, bipolar disorder, obsessive-compulsive disorder.
* Disease of the central nervous system with possible cognitive impairment: Parkinson's disease, multiple sclerosis, brain tumor, stroke with cognitive impairment, epilepsy, severe traumatic brain injury.
* History of alcoholism or substance abuse.
* Severe sensory deficit that prevents performing neuropsychological tests, at the discretion of the evaluator.
* Positive Shortened Spanish Informant Questionnaire for Cognitive Decline in the Elderly questionnaire (SS-IQCODE) or Lobo's Cognitive Mini-examination Test (spanish adaptation of Minimental of Folstein test) with a score \< 23 (20 in people with low schooling or illiteracy).
* Dementia criteria according to the Diagnostic and Statistical Manual of Mental Disorders IV.