cyrilzakka/clinical-trials huggingface dataset:
Gaining Real-Life Skills Over the Web

Gaining Real-life Skills Over the Web (GROW) is an online parenting-skills intervention for caregivers of children aged 0-4 who sustained traumatic brain injuries. GROW is designed to promote family and child coping and adjustment for caregivers.

This project develops and evaluates an online learning environment of web-based intervention modules designed to promote family and child coping and adjustment (GROW: Gaining Real-life Skills Over the Web) based on a comprehensive needs assessment of children aged 0 to 14 years old, who experienced a traumatic brain injury (TBI) between the ages of 0 to 4 years, and their families. The incidence of TBI peaks between the ages 0 to 4 years, yet there are no evidenced-based interventions to facilitate neurocognitive development and socio-emotional functioning of children injured during this critical development period. To address the unmet need of caregivers of infants and toddlers with TBI, the project uses a three-phase development process to generate proof of concept and initial proof of product. Phase 1 involves a comprehensive needs assessment that includes quantitative assessment of family and child needs, qualitative assessment through focus groups and interviews of families, feedback from family and professional advisory boards, and consultation with professionals implementing interventions with similar populations (e.g., families of children with very low birth weight). During Phase 2, the project develops the content and manual for the intervention modules, designs the online learning environment, and conducts intensive, iterative usability testing. Phase 3 involves a pilot of the GROW program with 20 families to evaluate its usability, acceptability, and qualitative and quantitative impact on stakeholder identified outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Age at injury and enrollment: ages 0-4, inclusive
2. Overnight hospitalization for traumatic brain injury
3. Mechanism of injury: Non-penetrating traumatic brain injury; abusive head trauma (AHT) will be included
4. Language: English must be the primary spoken language in the home

Exclusion Criteria:

1. Does not reside with the caregiver at least half-time
2. The caregiving situation is not stable (i.e., there must be no scheduled custody hearings)
3. English is not the primary language spoken in the home
4. Families of children who are non-responsive or in a persistent vegetative state will also be excluded
5. Caregivers with a psychiatric hospitalization in the past year will be ineligible to participate
6. If AHT is the suspected injury mechanism, the child must not reside with the suspected abuser, must have been in the current living situation for at least 6 months, and must be anticipated to remain in this living situation for the next 6 months. The study team will only recruit non-abusing caregivers (including foster parents) to participate.
Acupuncture for Enhancing Immunotherapy in Advanced NSCLC：a Pilot Study

This multicentre, randomized controlled trial evaluates the effect and safety of integrating acupuncture with immunotherapeutic sensitization in treating NSCLC. Participants will be randomly assigned to undergo either acupuncture or sham acupuncture concurrent with the initial four cycles of standard ICIs combined with chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Has a histologically-confirmed or cytologically confirmed diagnosis of stage IIIB or IV NSCLC.
2. PD-L1 TPS\<50%
3. EGFR/ALK wild-type
4. Has not received prior systemic treatment for advanced NSCLC. For patients who received preoperative neoadjuvant chemotherapy or postoperative adjuvant chemotherapy or radical chemoradiotherapy, if the disease progresses occurred one six months after the last treatment, they can be enrolled. Patients who received targeted therapy or immunotherapy can not be enrolled.
5. Has a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
6. Age≥18 years
7. Has a life expectancy of at least 3 months
8. Has measurable disease
9. Has adequate organ function
10. Voluntarily enrolled into the study, sign the informed consent form and have good compliance

Exclusion Criteria:

1. Unable to complete baseline assessments
2. Expected to receive radiotherapy within the next 4 cycles
3. With a combination of serious primary diseases of the heart, cerebrovascular, hepatic, renal, and hematopoietic systems
4. With dementia, neurological disorders, mental retardation, or language impairment, and pregnant or breastfeeding women
5. Combined autoimmune diseases, hematologic disorders, or long-term use of hormones or immunosuppressive drugs
6. Combined with a primary tumor from other sites
7. Had participated in any other clinical trial within the prior 3 months
8. Has known history of Human Immunodeficiency Virus (HIV) or solid organ transplantation
9. With legal incapacity
10. With skin breakdown at the acupuncture point that interferes with treatment
11. With a pacemaker
12. With a fear of acupuncture
13. Had received acupuncture treatment within 6 weeks
14. Has known active Hepatitis B
15. Has interstitial lung disease or a history of pneumonitis that required oral of IV glucocorticoids to assist with management
16. Has fever (\>38°C) or clinically significant infection within 1 week prior to enrolment
17. Has active tuberculosis or indications of severe or uncontrolled systemic diseases
18. With a bleeding tendency, and receiving thrombolytics or anticoagulants
Perioperative Ketamine for Pain With Gastric Bypass

Opioid medications such as morphine, hydrocodone and oxycodone are standard for treating pain after surgery, however there are disadvantages. Because of the way opioids work, gastric bypass patients may have an increased risk of having sedation or problems with breathing. In patients with sleep apnea, opioids may increase the risk of severe apnea.

Ketamine is an alternative pain medicine that can be used to treat pain after surgery and may have fewer effects on breathing. Using ketamine as part of the regimen may be a better choice for laparoscopic gastric bypass patients.

This study is being done to find out if intraoperative ketamine infusion combined with continuation for twenty-four hours post-surgery provides superior pain control and decreases post-operative opioid use versus standard non-ketamine therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing laparoscopic gastric bypass at Mayo Clinic in Arizona
2. BMI is ≥ 35 kg/m2
3. Consent is able to be obtained as per Mayo Clinic policy

Exclusion Criteria:

1. Intolerance to ketamine
2. History of schizophrenia, schizoaffective disorder, or other psychiatric diagnosis with psychotic features
3. Presence of unstable cardiovascular disease (presence of acute coronary syndrome, unstable angina, hypertension emergency, acute transient ischemic attack (TIA) or stroke)
4. Presence of acute elevation of intracranial or intraocular pressure
5. Presence of seizure disorder
6. History of substance abuse or addiction
7. Creatinine greater than 1.5 mg/dL
8. End-stage liver disease
9. Pregnancy
10. Patients with chronic pain and/or chronic opioid therapy will not be excluded to more closely replicate the study patient population of interest. However, patients taking greater than 50 morphine equivalents (ME) per day for greater than 1 month prior to surgery will be excluded.
Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease

The primary purpose of this study is to determine the efficacy and safety of KPI-121 ophthalmic suspension compared to vehicle (placebo) in subjects with signs and symptoms of inflammatory meibomian gland disease.

This is a Phase II, multicenter, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the efficacy and safety of KPI-121 ophthalmic suspension versus vehicle in subjects with signs and symptoms of inflammatory meibomian gland disease. The product will be studied over 28 days, with 1-2 drops instilled in each eye four times daily (QID).

Eligibility Criteria:
Inclusion Criteria:

Have a documented clinical diagnosis of inflammatory meibomian gland disease in both eyes.

Exclusion Criteria:

* Known hypersensitivity/contraindication to study product(s) or components.
* Be currently receiving treatment for glaucoma, have history of or current glaucoma, or an IOP (intraocular pressure) over 21mmHg at Visit 1 (Screening) or Visit 2 (Randomization).
* Be unwilling to discontinue warm compress therapy, lid expression, or lid massage 14 days prior to Day 1 and for the duration of the study.
* Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; severe/serious systemic disease or uncontrolled medical condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening.
* Have had ocular surgery in the past 90 days or require ocular surgery during the study.
* In the opinion of Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.
A Pilot Study to Develop a Behavior-based Screening Protocol for Early Diagnosis of Autism Spectrum Disorders

This study aims to collect basic data to develop a tool for early screening of autism spectrum disorder (ASD) in children and adolescents through eye tracking and motion analysis.

This study aims to collect basic data to develop a tool for early screening of autism spectrum disorder (ASD) in children and adolescents through eye tracking and motion analysis.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents under the age of 19 at the time of registration
* A person whose legal representative voluntarily decides to participate and agrees in writing to comply with the precautions after receiving a detailed explanation of this study and fully understanding it

Exclusion Criteria:

* Those with abnormalities in hearing and vision
* Those who are likely to have difficulty participating in the study according to the judgment of the clinical investigator
* If the visits set out in this research plan are not followed or the patient's guardian does not cooperate due to low understanding of the patient.
Adjuvant Gemcitabine Versus 5-FU/Leucovorin Based on hENT1 Immunostaining

Human equilibrative nucleoside transporter 1 (hENT1) is a membrane transporter which is a predicting marker for gemcitabine chemotherapy. However, there is a limited evidence of it as an indicator for adjuvant gemcitabine chemotherapy. In this study, investigators try to investigate the role of hENT1 as a indicator of selection of adjuvant chemotherapy regimen between gemcitabine and 5-fluorouracil (5-FU).

After surgical resection of pancreatic cancer, the tissue is immunostained by hENT1 antibody. The grades of immunostaining are categorized as 0 (0%), 1 (\<50%), and 2 (\>=50%). According to the grade, patients with grade 0 or 1 will be treated with 5-FU and those with grade 2 will be treated with gemcitabine. After the study, investigators will calculate the overall survival and recurrence free survival of the patients and investigate the role of hENT1 as a predictive biomarker for adjuvant gemcitabine chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with curatively resected pancreatic cancer
* Age between 18 and 75
* Eastern Cooperative Oncology Group performance score 0 or 1
* Patients with compliance
* Patients with informed consent

Exclusion Criteria:

* Patients refuse to enroll this study
* Patients with concomitant chemoradiation therapy
* Previous chemotherapy
* Pregnant or preparing a pregnancy
* Uncontrolled infection, diabetes, hypertension, ischemic heart disease, myocardial infarction within 6 months
* Enrolled another clinical trial within 30 days
* Patients will be expected to be risk because of enrollment
* Patients without informed consent
Oral Astaxanthin and Semen Quality, Fertilization and Embryo Development in Assisted Reproduction Techniques Procedures

The purpose of the study is to determine whether administration of dietary supplement of astaxanthin with vitamin E improves the quality of sperm, fertilization and embryo development in Assisted Reproduction Techniques (ART) procedures.

In the study male patients diagnosed with oligoasthenozoospermia - with an abnormal sperm concentration and motility, irrespective of the morphology of spermatozoa - treated with their female partner with assisted reproduction techniques (ISCI) will be included. In the double blind study male patients will be given astaxanthin with vitamin E (study group, 40 patients) or placebo (control group, 40 patients) for three months prior to ART. In the study and the control group the quality of sperm (spermiogram), DNA fragmentation and mitochondrial membrane potential of semen before and after the dietary supplementation will be evaluated. In the ART procedure (ICSI) the fertilization rate, the quality of embryos, pregnancy rates and miscarriages rates in 1st trimester will be compared between the study and control group.

Eligibility Criteria:
Inclusion Criteria:

* oligoasthenozoospermia with of without teratozoospermia by WHO criteria from the year 2010
* fresh semen
* female partner younger than 38 years
* idiopathic or tubal infertility in female partners
* at least 4 oocytes retrieved in previous ovarian punction in ART cycle, if previously performed
* 1st, 2nd or 3rd cycle of ART

Exclusion Criteria:

* genetic indication for ART procedure
* donated semen
* polycystic ovary syndrome in female partner
* dietary supplementation intake of antioxidants (selenium, zink, vitamin E, vitamin C, vitamin A) in male participant in the last three months
* smoking in male participant \>20 cigarettes per day
Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer

This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and Carboplatin versus placebo and trastuzumab plus docetaxel and Carboplatin given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

The investigators hypothesized that the experimental group (Pyrotinib+Trastuzumab+Docetaxel+ Carboplatin) could have a higher Pathological Complete Response (pCR) rate than the control group (Placebo +Trastuzumab+Docetaxel+ Carboplatin) in neoadjuvant chemotherapy.

It is proposed that 100 participants will be enrolled in this study. The target population is women with early breast cancer (stage of T1-4N0-3M0) who are eligible for primary systemic therapy.

The primary objective of the trial is to determine the pCR rate. The secondary objective of the trial is to determine the Event-free survival(EFS), Disease-free Survival (DFS), Distance Disease-free Survival (DDFS), Objective Response Rate (ORR) rate.

Eligibility Criteria:
Inclusion Criteria:

1. female patients, 18 years ≤ age ≤ 80 years；
2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
3. Histologically confirmed invasive breast cancer（early stage or locally advanced）
4. HER2 positive (HER2+++ by IHC or FISH+)
5. Known hormone receptor status.
6. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
7. Signed informed consent form (ICF)

Exclusion Criteria:

1. Metastatic disease (Stage IV) or inflammatory breast cancer
2. Previous or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin, Carcinoma in situ of the cervix.
3. Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
4. Unable or unwilling to swallow tablets.
ADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis B

This 3 arm study will compare the efficacy and safety of combination therapy with PEGASYS + adefovir dipivoxil (ADV) versus PEGASYS monotherapy, in HBeAg-negative chronic hepatitis B patients.Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by ADV 10mg po monotherapy for an additional 48 weeks, and a further 48 week treatment-free follow-up, 2)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by a 96 week treatment-free follow-up, or 3)PEGASYS 180 micrograms sc monotherapy weekly for 48 weeks, followed by a 96 week treatment-free follow-up. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-70 years of age;
* chronic hepatitis B;
* positive HBsAg, positive anti-HBe, negative anti HBsAg, negative HBeAg for at least the prior 6 months;
* either nucleoside analogue naive, or has not received IFN-a in the past 6 months.

Exclusion Criteria:

* positive for hepatitis A, C, D or HIV;
* history or other evidence of a medical condition associated with chronic liver disease other than hepatitis B;
* antiviral, antineoplastic or immunomodulatory treatment \<=6 months prior to first dose of randomized treatment.
Effects of Dexmedetomidine on Cough Response and Postoperative Recovery Quality in Patients Undergoing Thyroid Surgery With General Anesthesia

Coughing is a common adverse reaction of thyroid surgery,which could result in postoperative bleeding.Postoperative bleeding is a serious and potentially life-threatening complication，which could result in acute upper airway obstruction due to neck hematoma and increase the need for re-operation.The purpose of this study is to investigate whether dexmedetomidine can reduce the incidence of postoperative coughing and contribute to postoperative recovery in patients undergoing tyroid surgery with general anesthesia.

Thyroid surgery is a common clinical surgery,the incidence of postoperative coughing is up to 32.4%.Coughing response could result in postoperative bleeding,even cause respiratory tract obstruction,affect patients' postoperative recovery .Dexmedetomidine,an α2 adrenergic agonist,has hypnotic,analgesic, anxiolytic,antisympathetic effects,which could facilitate the sedation of patients while maintaining their consciousness and keep respiration and circulation stable .For these benefits,dexmedetomidine was widely used for general anesthesia.However,whether dexmedetomidine can reduce the incidence of postoperative coughing is unclear.Therefore,the investigators conduct this randomized controlled double-blind trial,to investigate the effects of dexmedetomidine on coughing and postoperative recovery quality in patients undergoing tyroid surgery with general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

1. Aged from 18 to 65 years old
2. American Society of Anesthesiologists (ASA) physical statusⅠor Ⅱ
3. Diagnosed by B ultrasonic or tissue biopsy show that patients thyrophyma,thyroid cancer,thyroid nodule,etc,who need to accept thyroid surgery

Exclusion Criteria:

1. large goiter or hyperthyroidism
2. Preoperative coughing caused by primary diseases of patients
3. Ⅱdegrees above atrioventricular block
4. Allergy to anesthesia
5. History of diabetes
6. Pregnant women
7. Serious mental disease
8. History of alcohol or drug abuse
9. Severe heart renal or liver dysfunction
10. The presence of an upper respiratory infection
11. Asthma
12. Anticipated difficult airway
Tow Maxillary Hybrid Expanders Screw Supported Versus Lateral Angulated One; a Prospective Randomized Clinical Study

in this study i will use to different designs of t maxillary hybrid expanders that consists of HYREX supported with tow miniscrews to treat the collapsed maxilla in Yonge adolescents

the maxilla is expanded by tow diffrent designs of maxillary hybrid expanders

Eligibility Criteria:
Inclusion Criteria:

1. Medically free male or female patients
2. Patients that necessitated maxillary expansion due to constricted maxillary arch shown by a unilateral or bilateral posterior crossbite.
3. The patient should have no missing teeth except third molars.
4. Age ranged from 12 to 18 years old.
5. The patient should have a good gingival condition.
6. The patient should have a good periodontal condition.

Exclusion Criteria:

1-hisory of previous orthodontic treatment. 2- Lack of cooperation. 3- Mental problems. 4- Skeletal open bite. 5- TMJ problem.

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Physiologic Range of Step-by-step Variations in Lower Limb Prosthesis Forces During Walking

In human gait there is a certain amount of variation between steps; some considered physiological and owed to variations in environment or posture, and some severe enough to be indicative of gait instabilities that may lead to stumbling and falling. In users of lower limb prosthetics, such gait instabilities are of especially great interest.

The study investigates the correlation between socket alignment quality and gait step-by-step variability in users of trans-tibial-prosthetics. It is hypothesized that a clearly defined range of step-by-step variability exists, and that therefore step-by-step variability is suitable as an outcome variable for the assessment of socket alignment.

A sample of ten persons with trans-tibial amputation will be recruited for this pilot study. Subjects will be asked to walk on different natural surfaces while the socket alignment is successively perturbed. Step-by-step variations in horizontal ground reaction forces and torsional moments will be measured and statistically compared.


Eligibility Criteria:
Inclusion Criteria:

* activity classification of K2 to K4
* experience in prosthesis use of at least one year
* stated ability to walk pain free for at least 30 minutes

Exclusion Criteria:

* age of less than 18 years
* acute or ongoing residual limb pain
* use of a prosthesis that is not suitable for installation of the load cell (e.g. is too short, or has non-removable cosmesis)
COVID19 Neurological Manifestation

This study is a prospective observational cohort study to document the prevalence and types of neurological manifestations among hospitalized patients with confirmed or suspected novel coronavirus infection (COVID-19).

This study is a prospective observational cohort study to document the prevalence and types of neurological manifestations among hospitalized patients with confirmed or suspected novel coronavirus infection (COVID-19). Severe acute respiratory syndrome 2 (SARS-CoV-2), the virus that causes COVID-19, shares significant structural and biological similarities with SARS-CoV, which is known to be neuroinvasive particularly with brainstem involvement. There are emerging reports of neurological symptoms associated with COVID-19 infections, including seizures, coma, encephalitis, Guillan-Barre syndrome, and cerebrovascular events including ischemic stroke, ICH, and cerebral venous sinus thromboses. However, the exact prevalence of these conditions and their impact on patient disease severity and outcomes is unknown. As the incidence and severity of COVID-19 infection continue to rapidly rise globally, it is imperative to capture prospective data to accurately document prevalence, severity and clinical characterization of neurological components of COVID 19, the influence of treatment regimens of neurological complications, and role of these confounders on patient and organizational outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients greater than or equal to 18 years old
* Admitted with suspected or confirmed COVID19 infection
* Patient exhibiting acute neurological symptoms

Exclusion Criteria:

* Patients under the age of 18 years old
* Pre-existing, baseline severe neurologic dysfunction including baseline coma/vegetative state, baseline quadriparesis, baseline refractory seizure disorder with frequent breakthrough seizures despite anticonvulsant use