cyrilzakka/clinical-trials huggingface dataset:
Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin for Local Advanced Non-small Cell Lung Cancer (NSCLC)

It is a trials to evaluate the overall survival (OS) of radiotherapy / EP combined with recombinant human endostatin in treatment of locally advanced (Ⅲ A / unresectable Ⅲ B) non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with pathologically or histologically confirmed and inoperable stage Ⅲ (Ⅲ A or unresectable Ⅲ B) NSCLC;
2. Patients with ages of 18\~70 years, general condition ECOG performance scale （PS）≤ 1, weight loss \<10% during last 6 months;
3. CT films of patients during last 4 weeks were accessible when patients were selected into the groups, the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, PET-CT, with the largest diameter≥ 20mm by ordinary CT and MRI.）
4. No major organ dysfunction, the function of heart, liver and kidney was normal, laboratory indicators should meet the following requirements: Blood: WBC\> 4.0 × 109 / L, absolute neutrophil count \> 1.5 × 109 / L, platelet count\> 100 × 109 / L, hemoglobin\> 110g / L; liver function: serum bilirubin was less than 1.5 × maximum normal value ; ALT and AST were less than 1.5 × maximum normal value; BUN, Cr within the normal range; FEV1 \> 1L or\> 40% of predicted value;
5. Patients could understand the circumstances of this study and those who have signed the informed consent form;

Exclusion Criteria:

1. Pregnant or lactating women; women of child-bearing age without contraception;
2. Acute infection or other serious underlying diseases;
3. Significant neurological, psychiatric history, including dementia which may influence the ability to understand and the informed consent;
4. Receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs a the same time; have joined other drug clinical trials 30 days before this clinical trial;
5. Diabetes without control (blood-glucose is unstable or ≥ 8mol / L after administration);
6. Patients who are allergic to E. coli preparation;
7. Patients who are unsuitable to participate in this trial determined by the researchers.
Investigation of the Ringer Perfusion Balloon Catheter

The objective of this study is to demonstrate reasonable assurance that the Ringer catheter can be safely used to manage hemorrhage due to coronary vessel perforations while facilitating distal perfusion under the conditions of use prescribed in the labeling.

A prospective, multicenter, single-arm clinical study. The study will be conducted at up to 15 investigational sites in the US and will enroll up to 30 participants. The population for this investigation is adult participants who suffer a perforation of the coronary artery during a percutaneous coronary intervention requiring management of hemorrhage while providing distal perfusion until definite treatment is determined.

This clinical investigation is being conducted under Exception from Informed Consent (EFIC) regulations because there is no reasonable way to identify patients likely to become eligible for the investigation, and a coronary perforation can be a life-threatening emergency that needs to be immediately controlled without enough time for the patient or their legally authorized representative to give consent. Patients will be notified of their enrollment as soon as feasible. For more information on the exception from informed consent, please use the contact information be.ow.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age at the time of the PCI procedure
* Subject has fluoroscopically confirmed vessel perforation (classified as any type) requiring management of hemorrhage until a definitive treatment is determined
* Female subjects of childbearing potential must have a negative pregnancy test per standard of care for PCI

Exclusion Criteria:

-The perforation location prevents complete inflation or proper placement of the Ringer catheter, as detailed in the Instructions for Use (IFU).
Johnston County ADHD Study: Environmental, Reporductive, and Familial Risk Factors for Attention-Deficit Hyperactivity Disorder (ADHD)

We propose a population-based case-control study among 7000 elementary school children in semi-rural Johnston County, NC. Teachers will complete a screening form on each child. Controls will be randomly selected. Mothers of potential cases and controls will be interviewed by telephone about their child's symptoms of ADHD and exposure history, their family history of ADHD, and their reproductive and exposure history. Children's shed baby teeth will be analyzed for lead. Mothers will complete brief parenting scales and the Child Behavior Checklist. School records will be collected. The study goals are to identify risk factors for ADHD including preterm delivery and childhood lead exposure.

We propose a population-based case-control study among 7000 elementary school children in semi-rural Johnston County, NC. Teachers will complete a screening form on each child. Controls will be randomly selected. Mothers of potential cases and controls will be interviewed by telephone about their child's symptoms of ADHD and exposure history, their family history of ADHD, and their reproductive and exposure history. Children's shed baby teeth will be analyzed for lead. Mothers will complete brief parenting scales and the Child Behavior Checklist. School records will be collected. The study goals are to identify risk factors for ADHD including preterm delivery and childhood lead exposure.

Eligibility Criteria:
* INCLUSION CRITERIA:

During the first phase of the study, all children will be screened by the homeroom teacher, EXCEPT for those students in certain self-contained classrooms. Self-contained classrooms for students with an IQ less than 70 or autism will be omitted from the screening. In the second phase of the study, children designated as "LEP", or Low English Proficiency, will be excluded from the study.
Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

The goal of this clinical trial is to compare buprenorphine patch for induction (starting) of buprenorphine in pregnant patients with opioid use disorder. The main questions it aims to answer are:

1. Is there a buprenorphine induction method that results in the least moderate-to-severe opioid withdrawal symptoms in pregnant patients with opioid use disorder?
2. Is there a buprenorphine induction method that results in a higher treatment success rate? Under normal circumstances, patients who are planning to start sublingual (under the tongue) buprenorphine for opioid use disorder must first go into withdrawal to start the medication safely. Study participants will be given a buprenorphine patch during the required withdrawal period before starting sublingual treatment, and be surveyed daily by phone to assess their withdrawal symptoms. They will also be followed at prenatal appointments to evaluate treatment success based on urine drug screen results. Researchers will compare patients receiving no buprenorphine patch according to the current standard care protocol.


Eligibility Criteria:
Inclusion Criteria:

* Viable pregnancy
* Meet diagnostic criteria for opioid use disorder
* Receive prenatal care through opioid use disorder specific clinic at our institution
* Opioid use within 24 hours prior to presentation
* Desire treatment with buprenorphine

Exclusion Criteria:

* Patients already receiving treatment for opioid use disorder
* History of prior induction attempt with buprenorphine
* Active withdrawal at time of presentation
* Medical contraindication to buprenorphine
* Requiring immediate hospitalization
PediRISE Feasibility

The goal of this research study is to learn whether investigators can successfully give the PediRISE program to families-in other words, whether most families are interested in participating in a study about the PediRISE program, including a 50-50 chance of receiving standard usual care, and a 50-50 chance of receiving the PediRISE support program.

The names of the study groups in this research study are:

* PediRISE Program Group
* Usual Care Group

This is a pilot, multi-center, randomized research study for the feasibility of the administration of the PediRISE program among 40 poverty exposed children with newly diagnosed cancer. Randomization means there is an equal chance of being assigned to the PediRISE Program Group or the Usual Care Group.

Study procedures include screening for eligibility, study visits, and completion of surveys and questionnaires.

Participation in this study will last for about 6-months.

It is expected that about 40 pediatric participants with parents/guardians will take part in this research study.

This study is being supported by grants from the American Cancer Society and the Children's Cancer Research Fund.

Eligibility Criteria:
Inclusion Criteria:

* Child diagnosed with de novo cancer
* Child has established care at a study site and initiated cancer-directed therapy in the prior 2-months
* Child planned to receive at least 4-months of cancer-directed therapy at study site from time of diagnosis per initial cancer treatment plan
* Child is \<18 years at time of enrollment
* Parent/guardian screened positive for self-reported low-income (\<200% FPL).
* Family primary residence in MA, NY or NJ
* Provider approval for permission to approach

Exclusion Criteria:

* Planned transfer of child to a non-DFCI or non-Columbia facility for cancer-directed therapy
* Foreign national family receiving care as an Embassy-pay patient
* Child is enrolled on embedded correlative health equity aims of open or upcoming clinical drug trials which are powered on descriptive parent-reported poverty data (e.g. AALL1731, AHOD2131, ANBL2131, DFCI 23-001).
* Child or household member receiving SSI.
ARIES for Vasculogenic Erectile Dysfunction

This study aims to evaluate the safety and efficacy of low-intensity extracorporeal shock wave therapy utilizing the Dornier Aries in the treatment of erectile dysfunction of vasculogenic origin.

An increasing number of men are suffering from the effects of Erectile Dysfunction (ED) each year. The development of oral therapies (phosphodiesterase 5 inhibitors) has been successful for many with the disease. However, these drugs may be contraindicated in patients with cardiovascular risk factors (which are often predecessors to developing ED) and are often ineffective in patients with other comorbid conditions, such as diabetes mellitus. The main objective of this study is to determine the safety and efficacy of low-intensity extracorporeal shock wave therapy using the Dornier Aries in the treatment of erectile dysfunction of vasculogenic origin.

This protocol allows for treatment of 23 men with 21-75 years of age with vasculogenic erectile dysfunction of at least 6 months' duration with low intensity extracorporeal shock wave therapy utilizing the Dornier Aries device.

This protocol includes the application of 5000 shockwaves per session in 5 treatment areas with 1000 SW each at energy level 4-5 (energy flux density (0.051-0.062 mJ/mm²), while moving the applicator along the penile shaft within the treatment areas. The maximum energy applied during this treatment would be 23.35J.

Conversely, the treatment protocol described within is designed to actually restore penile function as a disease-modifying therapy, and is not expected to require a maintenance regimen or continued treatments, as previous studies have demonstrated retained benefits at six months after the end of treatments.

Dornier MedTech hired an independent party to monitor data and perform internal audits to ensure the precision, quality, and integrity of the data collected. The investigator(s) agrees to permit access to study records, source data, and source documents for this purpose.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 - 75 years
* Presence of Erectile Dysfunction for at least 6 months
* Having some response to a PDE5i or injection therapy (ICI) without penile scarring
* Vasculogenic ED
* IIEF-ED score ≥11 up to ≤25 while taking PDE5i or on ICI
* In a stable heterosexual relationship of more than three months' duration
* Agree to suspend all ED therapy for duration of study
* Agree to maintain their normal sexual habits
* Consent to participate

Exclusion Criteria:

* Radical prostatectomy
* Previous radiation therapy to pelvis
* Previous stem cell or platelet rich plasma therapy
* Previous pelvic surgeries
* Untreated Hypogonadism or thyroid disease
* Hormone usage, other than testosterone, clomiphene or thyroid medication
* Illicit drug usage as demonstrated in the drug screen
* Psychogenic ED
* Peyronie's Disease or penile curvature that negatively influences sexual activity
* Current anticoagulation therapy or significant hematological conditions
A Two Week Nitazoxanidebased Quadruple Regimen

Helicobacter pylori (H. pylori) infection is a global health problem as it is associated with peptic ulcers, chronic gastritis, duodenitis, and stomach cancer.

Therefore, the eradication of the pathogen is of critical importance to reduce H. pylori-related complications .

However, due to increasing antibiotic resistance, eradication of Helicobacter pylori has become more challenging. With a great decline in the eradication rate of standard triple therapy for Helicobacter pylori to below 70% in many countries.

Treatment with triple therapy, which is the most frequently recommended, fails to eradicate H. pylori in approximately 20% of cases .

Designing a new rescue regimen that achieves greater than 85% eradication rate is an important target of current research.

Unfortunately, the most frequently used "rescue" or "salvage" therapy is bismuth quadruple therapy consisting of a proton pump inhibitor (PPI), tetracycline, metronidazole, and bismuth \[11\]. This rescue therapy is inexpensive, and relatively effective with average eradication rate of 70% when used as second-line therapy. However, disadvantages of bismuth based quadruple therapy include the large daily number of pills (sometimes exceeding 18 pills), increased dosing frequency (four times daily), and frequent side effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients with helicobacter infection.
* in whom the standard triple therapy (clarithromycin-based triple therapy) failed

Exclusion Criteria:

* Patients under 18 or over 65 years of age.
* Those with co-existing serious illnesses such as liver cirrhosis, uremia and gastrointestinal malignancies
* pregnancy/lactation
* having contraindication or allergy to any of the study drugs
The Addition of Sufentanil Interscalene Block in Shoulder Surgery

The purpose of this study is to compare the effects and side effects of interscale block performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery.

The purpose of this study is to compare the duration of postoperative analgesia and supplemental opioid consumption and side effects of interscale block performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Age 18-80
* Shoulder surgery performed under interscalene block and general anesthesia

Exclusion Criteria:

* Contraindication of interscalene block
* Severe chronic obstructive lung disease
* Non-cooperative patient
* Intolerance to opioids
* Pregnancy
* Rheumatoid arthritis and diabetes with peripheral polyneuropathy
* Chronic pain or daily opioid intake
Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

Idiopathic scoliosis is the most common spinal deformity in children and adolescents with an estimated prevalence of 3%. About one tenth of the children with scoliosis develop a deformity that requires treatment with brace or surgery with the current treatment protocol. When brace treatment for scoliosis is indicated, standard treatment consists of bracing 20 hours or more per day. Outcomes of brace treatment depend to a large extent on wearing time and since many adolescents feel uncomfortable in the brace, it is of importance to combine efficacy and comfortability of the brace.

Bracing with a rigid TLSO is gold-standard treatment in terms of halting progression of idiopathic scoliosis in skeletally immature adolescents and children. The treatment is cumbersome and demanding for adolescents during a vulnerable stage in life, and may be associated with poor compliance. Furthermore, the treatment lasts in many cases for several years and has shown to have a negative psychological effect for patients. Since time in brace is of utmost importance for best possible outcome, the braces need to be tolerated by the patients. As of today, 3D designed braces have received much attention and are thought to increase comfortability and ultimately increase wearing time, leading to better outcomes.

In a multicenter randomized controlled trial, we seek to compare standard Boston brace to a newly developed 3D designed Boston brace. Skeletally immature patients with idiopathic scoliosis will be randomized to receive either standard Boston brace or Boston 3D brace. All patients will be encouraged to be physically active for 60 minutes per day. Patients, outcome assessors and clinician in charge during follow-ups will be blinded for the type of brace the patients are being treated with. Thermal sensors will be installed in all braces to monitor compliance. Outcome include change in curve severity, quality of life and surgical rates. Patients will be evaluated with clinical and radiological follow-ups every six months until skeletal maturity and thereafter at 2, 5 and 10 years. Curve progression will not lead to change of brace. A total of 85 individuals are required in each group based on the hypothesis of a 2% failure rate in the 3D-brace group and 15% in the standard brace group with 5% significance level and 80% power and consideration for dropout of up to 20%.

For individuals who are not willing to be randomized and participate in the study, standard Boston brace will be offered and these individuals will serve as an observational group with similar follow-ups and will be asked to answer same survey as the study populations will do.

Eligibility Criteria:
Inclusion Criteria:

* Cobb 25-40 degrees
* Skeletally immature, Sanders score of 6 or less and Risser 2 or less.
* Menarche status maximum one year in females
* Aged 9-17 years
* No previous brace treatment or surgery for scoliosis
* Apex of the primary curve at T7 or caudal

Exclusion Criteria:

* Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis)
* Previous spine surgery
The Effect of Pharmacist Intervention on Blood Pressure Control

The purpose of the study is to test if a Pharmacist Intervention Program with home blood pressure monitoring (HBPM) improves or controls pharmacological adherence and blood pressure levels in hypertensive patients under pharmacological treatment, compared to those who receive usual care in a community pharmacy setting.

Hypertension is a major health concern worldwide due to its deleterious impact on the population in terms of excessive morbidity and mortality, especially when there is insufficient hypertension control and prevention at the community level.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders between the ages of 18 and 80 years, who access the pharmacy to fill their own prescription for hypertension.

Exclusion criteria:

* Patient living with an other Hypertensive patient treated with the same medications
* Pregnant women
* Hypertensive patients with levels of systolic/diastolic blood pressure ≥ 180mmHg/110mmHg
* Patient with secondary hypertension, kidney or liver failure
* Patients already included in a care program for hypertensive patients
* Patients with a new treatment for hypertension (less than 1 month)
Meditation for Burnout in PA Students

This study investigates the feasibility and effects of an app-based mindfulness meditation intervention for PA students.

The purpose of this study is to determine the feasibility of an app-based mindfulness meditation intervention for PA students.

The investigators will measure feasibility of using the Calm app for 10-minutes a day for four weeks in PA students. Feasibility will be measured with acceptability (i.e. satisfaction survey), demand (participation in the app as prescribed), and practicality (i.e., survey). Secondly, the investigators will determine the preliminary effects of a 4-week meditation intervention on burnout levels in PA students when compared to a wait list control group. Burnout symptoms (primary outcome), mindfulness, stress levels, and depressive symptoms (secondary outcomes) will be measured at baseline and post-intervention (4-weeks). Data gathered from this study will inform a future randomized controlled trial to determine the effects of a mindfulness meditation app on burnout in PA students. The information could also be used to design other studies assessing burnout in the workplace.

Aim 1: Determine the feasibility (acceptability, demand, practicality) of using the Calm app 10-minutes per day for four weeks in PA students. For the intervention group, our benchmarks will be as follows: 1) Acceptability (i.e., satisfaction) ≥70%, 2) Demand (i.e., participation in the app as prescribed, intention to use) ≥70%, 3) Practicality (i.e., survey) ≥70%.

Aim 2: Determine the preliminary effects of using the Calm app 10-minutes per day for four weeks on burnout (primary outcome) mindfulness, stress levels, and depressive symptoms (secondary outcomes) in PA students as compared to a wait-list control group.

Eligibility Criteria:
Inclusion Criteria:

* Physician assistant students currently enrolled in school who do not practice meditation regularly
* \> 18 years of age
* Able to speak/read/understand English
* Residing in the U.S.
* Regular internet access via mobile phone, tablet, etc.
* Willing to participate in app-based meditation program
* Burnout, classified as a score greater than or equal to 3 on the non-propriety single item burnout measure.

Exclusion Criteria:

* Physician assistant students who currently (within the last six months) practice meditation
* Professionals who identify as a practicing physician assistant
* People who are not currently enrolled in physician assistant school
* Individuals who are not burnt out, classified as a score less than or equal to 2 on the non-propriety single item burnout measure.
Quality of Information Provided During Antenatal Consultations

The objective of this questionnaire study is to evaluate the concordance between the information provided to parents during antenatal consultations and their subsequent experiences following childbirth.


Eligibility Criteria:
Inclusion Criteria:

* Patients were observed at the multidisciplinary prenatal diagnosis centre.
* Patients who had attended at least one antenatal consultation with a pediatric neonatologist
* Patients who gave birth between January 2020 and December 2022 and whose newborn was hospitalized in the neonatology department

Exclusion Criteria:

* a child who died in hospital or had a condition with a high risk of death in the first few years of life
* non-French speaking mothers
* Mothers who were minors at the time of the study