cyrilzakka/clinical-trials huggingface dataset:
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD

The project aims to develop and implement the Strategies for Toddler Autism spectrum disorder(ASD) with Remote-therapy (STAR) model for early toddlers with ASD in local community sites in Shanghai. It's a randomized control trial lasting 3 years. The children will be divided into 2 groups, one for STAR intervention group and the other for community intervention group. The STAR intervention group will be performed STAR other than community intervention.

Autism spectrum disorder (ASD) brings enormous economic and emotional burdens to families and society with its ever-increasing prevalence. Early intervention has been proved as the key treatment to ASD. Along with increasing number of ASD children identified and diagnosed at early stage, the needs for effective early intervention are dramatically increasing. Though therapist-delivered intensive programs for toddlers yield substantive developmental gains, they tend to be costly and with extremely limited resource. The lockdowns during the COVID-19 pandemic brings even more obstacles for the children and families to get access to the resource of intervention. As such, the traditional intervention models are not fit for wide implementation within the Chinese public health systems and pandemic situation.

To solve this dilemma, this project aims to develop and implement the Strategies for Toddler ASD with Remote-therapy (STAR) model for early toddlers with ASD in local community sites in Shanghai. To maximize the intervention effect, the intervention strategies in STAR model are designed under the Naturalistic Developmental Behavioral Intervention (NDBI) framework which are implemented in natural settings targeting at improving social and communicational capabilities. The structure of the STAR model is with 2 modules and 16 sessions. Module I derives from our previous offline parent-tutoring courses with 8 intervention strategy topics combining academic instruction and real child demonstration but modified into on-line version. Module II is designed specifically for long-term consolidation of parents' intervention skills containing 8 biweekly sessions of distance coaching with parents practicing intervention with their children in real time at home.

Eligibility Criteria:
Inclusion Criteria:

* Children screened as positive for ASD.
* Two-tiered screening process combing Level 1(The Modified Checklist for Autism in Toddlers-Revised/Follow-Up , M-CHAT-R/F) and Level 2 (The Screening Tool for Autism in Toddlers and Young Children, STAT)

Exclusion Criteria:

* Other neurologic or degenerative diseases;
* Severe hearing or visual impairment;
* Genetic anomaly which may affect impact on intervention;
* Not available for regular intervention and follow-up.
A Study to Evaluate ICP-022 in Patients With R/R PCNSL and SCNSL

The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.

Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with Recurrent/Refractory Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL) will be evaluated in approximately 82 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects .

Eligibility Criteria:
Key Inclusion Criteria:

1. Men and women ≥ 18, and ≤75 years of age
2. Histologically documented PCNSL, or histologically documented systemic diffuse large B-cell lymphoma (DLBCL) for SCNSL.
3. Subjects with refractory or relapsed disease, one prior CNS directed therapy, and ≤ 4 systemic treatments.
4. ECOG performance status of 0-2
5. Able to provide signed written informed consent

Key Exclusion Criteria:

1. Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded
2. T-cell lymphoma.
3. Patient requires more than 8 mg of dexamethasone daily or the equivalent.
4. Non-hematological toxicity must recover to ≤ Grade 1 from prior anti-cancer therapy (except for alopecia)
5. Known active infection with HBV, HCV or HIV.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Validating the New Remote Hypnotic Induction Profile (rHIP)

The purpose of the study is to determine if hypnotizability can be reliably tested over the phone, without having to see or touch a patient. The scores from a new test for hypnotizability by phone will be compared to the scores from a standard in-person test, to make sure the results are similar.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old.
* Able to schedule a 15 minute in-person and phone appointment within a week of each other, during the study period.

Exclusion Criteria:

* Severe psychiatric or structural brain disease (ie. psychosis, stroke with functional impairment, dementia)
* Has had prior hypnotizability testing using the HIP or enrolled in another hypnosis-related trial.
* hearing impairment that would preclude phone interviewing
* non-English speakers
Platelet Activation Markers in Pediatric Cardiac Surgery

In this study the focus will be on correlating the levels of platelet activation markers (proteins that are released when blood cells are activated)to the duration of cardiopulmonary bypass, temperature during cardiopulmonary bypass and the weight of the patient.

This research is being done because we would like to learn more about platelet dysfunction in children undergoing cardiopulmonary bypass.

It has been an established fact that cardiopulmonary bypass causes dysfunction in platelets. Activation of platelets during cardiopulmonary bypass is implicated as being a major factor in causing platelet dysfunction.

For all participants, approximately 3.15 ml of blood will be collected in special tubes called CTAD tubes, before and after cardiopulmonary bypass (6.30ml in total). This amount of blood draw is well within the guidelines of NIH (National Institute of Health).

Enzyme-linked immunosorbent assay (ELISA) will be performed using this plasma to make quantitative assessment of Platelet factor 4 and Transforming growth factor beta.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to have surgery involving cardiopulmonary bypass for congenital cardiac abnormalities.
* Age: Newborn to 7 years
* Gender: male and female

Exclusion Criteria:

* Emergency surgery
* Weight less than 3 kg
* Age greater than 7 years
* Patients with low platelet counts (\<100,000)
* Patients on medications that are known to interfere with platelet function such as prostacyclins, non-steroidal anti-inflammatory drugs, plavix.

Patients whose parents not willing to give consent
Short Physical Activity Program in Coronary Artery Disease.

Coronary artery diseases (CAD) are multifactorial diseases which prognosis and risk factors are improved with increased physical activity (PA). Thus, CAD rehabilitation (CR) program is mainly based on recovering sufficient exercise capacity and promoting regular personalized PA associated to modifications in lifestyle habits to improve control of cardiovascular risk factors and health-related quality of life. However, most of patients do not achieve the recommended levels of PA which may be partly due to numerous barriers that hamper the return to a physically active lifestyle. One promising interventions strategy is so-called 'brief interventions' (BI) to increase PA in health care settings used to initiate change for an unhealthy behavior in individuals and consisting in "verbal advice, discussion, negotiation or encouragement, with or without written or other support or follow-up". An 'extended brief intervention' (EBI) is similar but usually lasts more than 30 minutes and is delivered on a one-to-one or group basis and can be composed of multiple brief sessions. However, in CAD patients, the effect of such interventions on PA level and behavior remains unclear, as well as predictor patterns associated with better outcomes.

The investigators aimed to assess the effect of a 4-day PA education program with multiple EBI and exercise on the level and barriers to PA in CAD patients and characterize the profile of participants (barriers to PA) with better outcomes.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years and older
* stable coronary artery disease with appropriate medical certificate of fitness and no current medical conditions affecting sports participation.

Exclusion Criteria:

* Patients unable to give written constent
* Patients with impaired cognitive functions
* Patients with chronic motor deficiency or severe medical disorder (other than heart disease) significantly affecting functional abilities
* Patients with insufficient information about medical history of documented coronary disease
Comparison of the Efficacy Between Transurethral Coagulation and Transurethral Resection of Ulcer in Bladder Pain Syndrome Patients

On the EAU (European Association of Urology) guidelines, the ulcer type bladder pain syndrome (BPS) should be treated with transurethral resection (TUR) or coagulation (TUC) of ulcer.

But, Up to date, there was no study to compare the therapeutic efficacy of TUR with TUC in ulcer type BPS patients.

We assume TUR have a more therapeutic effect than TUC.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female aged 18 yrs or greater
2. Patients diagnosed with BPS(Bladder Pain Syndrome)
3. Symptom persisted more than 6 months
4. Pain VAS ≥4
5. O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) scores 12 or greater with pain and nocturia domain scores \> 2.
6. Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) \>13
7. No history of cystoscopy within 2yrs.

Exclusion Criteria:

1. History of augmentation cystoplasty or previous transurethral coagulation/resection due to BPS
2. Child-bearing potential, pregnant or nursing women.
3. Mean voided volume lesser than 40ml or over than 400ml.
4. Hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
5. Urinary tract infection during run-in periods.
6. Genitourinary tuberculosis or bladder,urethral and prostate cancer
7. Recurrent urinary tract infection
8. History of hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate operation or treatment etc within 6months.
9. Neurologic disease history of cerebral infarction,multiple sclerosis or parkinsonism etc.
Assessment of Peripheral GABA Receptors for Local Pain Relief

The effect of peripheral GABAA receptor activation on pain and sensitivity in healthy human subjects has never been investigated. However, as earlier studies suggest that activation of peripheral GABAA receptors is anti-nociceptive in rats, it is important to determine if these findings can be translated into human subjects to determine if peripheral GABAA receptors are a viable target for future analgesic drug development.

Subproject I This study will test if oral administration of GABA containing solutions will reduce the pain and sensitivity induced by application of capsaicin to the tongue of healthy human subjects. Thirty, pain-free men (n=15) and women (n=15) for the oral cavity study.

Subproject II This study will test the hypothesis that intramuscular injection of GABA alone will not be painful, but will reduce muscle pain sensitivity in healthy human subjects. Thirty, pain-free men (n=15) and women (n=15) will be recruited for the intramuscular GABA injection studies

Subproject III This study will test the hypothesis that intramuscular injection of GABA with glutamate will decrease the intensity of glutamate-evoked muscle pain in healthy human subjects. Thirty, pain-free men (n=15) and women (n=15) will be recruited for the intramuscular glutamate and GABA injection studies.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20-40 years
* Free from ongoing or chronic pain
* Adequate conversational English

Exclusion Criteria:

* Pregnancy or intent to become pregnant, breast feeding
* Signs or symptoms of any serious systemic diseases
* Current malignancies
* High blood pressure
* Requirement for chronic administration of psychiatric, analgesic or other medications that might influence their response to pain
* Frequent recreational drug or alcohol use
* Previous neurologic, musculoskeletal or mental illnesses
* Lack of ability to cooperate
A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen

This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.


Eligibility Criteria:
Inclusion Criteria:

* advanced measurable Non-Small Cell Lung Cancer (NSCLC);
* progressed after 1-2 prior chemotherapy;
* Eastern Cooperative Oncology Group (ECOG) 0-2;
* tissue available for future KRAS/ EGFR testing

Exclusion Criteria:

* prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
* active or untreated Central Nervous System (CNS) metastases;
A Study to Evaluate the Safety, Tolerability and Efficacy of BMN 110 in Subjects With Mucopolysaccharidosis IVA

This multicenter, open-label study is designed to assess safety, dose-response using pharmacokinetic (PK) and pharmacodynamic (PD) measures, and clinical efficacy of BMN 110 in subjects between 5 and 18 years of age, diagnosed with Mucopolysaccharidosis IVA (MPS IVA).


Eligibility Criteria:
Inclusion Criteria:

* Documented history of reduced GALNS activity relative to the normal range of the laboratory performing the assay, or documented result of molecular genetic testing confirming diagnosis of MPS IVA.
* Willing and able to provide written, signed informed consent, or in the case of subjects under the age of 16 years, provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures.
* Between 5 and 18 years of age, inclusive.
* Sexually active subjects must be willing to use an acceptable method of contraception while participating in the study.
* Females of childbearing potential must have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study.
* Willing to perform all study procedures as physically possible.

Exclusion Criteria:

* Previous hematopoietic stem cell transplant (HSCT).
* Has known hypersensitivity to BMN 110 or its excipients.
* Pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) at any time during the study.
* Use of any investigational product or investigational medical device within 30 days prior to Screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
* Concurrent disease or condition that would interfere with study participation or safety, including, but not limited to, symptomatic cervical spine instability.
* Any condition that, in the view of the Principal Investigator (PI), places the subject at high risk of poor treatment compliance or of not completing the study.
Describe Relations Between qCON and qNOX Indicies During Propofol-Remifentanil General Anesthesia

CONOX is a neuromonitoring EEG- device for sedation (qCON) and analgesia (qNOX) monitoring during general anesthesia.

It is unknown on how the indicies can differentiate themselves so aim of this study is to determine the relationship bewtween the 2 indicies.

CONOX is a neuromonitoring EEG- device for sedation (qCON) and analgesia (qNOX) monitoring during general anesthesia.

It is unknown on how the indicies can differentiate themselves so aim of this study is to determine the relationship bwtween the 2 indicies, as well as with EMG, Concentration of Propofol (CeP) and Remifentanil (CeR) during Total Intravenous Anesthesia with Target Controlled Infusion (TIVA-TCI).

Eligibility Criteria:
Inclusion Criteria:

* Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld or Schnider model) and Remifentanil (Minto model) and CONOX monitoring

Exclusion Criteria:

* Neurological disease
* Psychiatric disease
* Obesity
* Locoregional anesthesia
Feasibility Study for the Comprehensive Overweight/Obesity Management Pre-Kidney Transplant (COMPKT) Program

This project will be a single-arm feasibility study, with a treatment intervention that includes three interrelated components: (1) patient education using a proven weight loss curriculum, and (2) technology tools for making healthy lifestyle choices.

To optimize care for overweight/obese patients who are awaiting kidney transplants by implementing a referral process and a multi-pronged, team-based nurse/pharmacist/dietitian weight loss treatment intervention to help these patients achieve transplant criteria. Obesity, hypertension, and ESRD disproportionately affect the Black community, and Black patients have been historically disadvantaged by race-inclusive calculations that overestimated their kidney function. Effective January 5, 2023, the Organ Procurement and Transplantation Network Board of Directors requires use of a race-neutral estimated glomerular filtration rate (eGFR) to qualify candidates for kidney transplant. They also required transplant programs to identify Black candidates who may have been wrongly denied qualification

Eligibility Criteria:
Inclusion Criteria:

* on the waiting list for kidney transplant at VCUHS
* BMI greater than 35 kg/m2

Exclusion Criteria:

* Children, prisoners, pregnant women
Effect of Panretinal Photocoagulation on Optic Nerve Head Topography

The purpose of this study is to evaluate the optic nerve head changes consequent to panretinal photocoagulation done for diabetic retinopathy.

Panretinal photocoagulation thermally ablates the retina to effect the regression of the neovascular process seen with diabetic retinopathy.2-6 Photocoagulative damage also damages the nerve fiber layer in the process. Since this should theoretically be associated with loss of nerve fibers it is expected to manifest as changes in optic nerve head cupping. There is no available literature to support this hypothesis. In fact the only available study done of the subject refuted the hypothesis.7 The study had a retrospective design and was done before any of the current technology to evaluate optic nerve head morphology was available.

Patients with concurrent glaucoma and diabetes often undergo panretinal photocoagulation as a part of their diabetes treatment. Optic disc cupping is a standard outcome measure for glaucoma diagnosis and progression. If PRP were to cause increased cupping, this can be a significant confounder in determining glaucoma progression based on optic nerve cupping. The findings of the study will help us determine as to how much cupping can be attributed to the PRP, if any at all.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy otherwise undergoing panretinal photocoagulation for treatment.

Exclusion Criteria:

* Any patient with uncontrolled glaucoma (IOP above target on any occasion in the preceding 6 months) or other optic neuropathy that may confound the analysis of optic nerve head morphology.
* Patients with media opacities (significant cataract, corneal opacity, vitreous hemorrhage) precluding imaging of the optic nerve.
* No PRP done in the previous 6 months.
Levels of Anti-Mullerian Hormone (AMH) During Ovarian Stimulation With Gonadotropins

Anti-Mullerian Hormone (AMH) is produced only in small ovarian follicles with quite stable levels during the cycle. There is not yet sufficient data to inform couples undergoing IVF about the effect of ovarian stimulation on the levels of AMH due to the increasing size of follicles and chances of success of the method.

Patients undergoing IVF will be included in the study. All patients will be counseled regarding their prognosis. Anti-Mullerian Hormone (AMH) will be measured prior to the initiation of IVF and during ovarian stimulation. Patients will be stimulated with a short GnRH-antagonist protocol. All women will have measurements of serum FSH and estradiol (E2) and a pelvic sonogram on the second day of their cycle. Ovarian stimulation will be initiated with of gonadotropins either in the form of a combination of highly purified urinary FSH and LH or with a combination of Rec FSH and Rec LH. The dose of gonadotropins will depend on the levels of estradiol and FSH prior stimulation. All patients will be re-evaluated on day 3 and 5 of the stimulation (measurment of AMH, E2 and pelvic sonogram), and dosage adjustments will be made and the antagonists (Cetrorelix or ganirelix 0.25 mg/day) will be initiated on day 5. Measurment of AMH, E2 and pelvic sonogram to conferm the size of follicles will be continue every second day untill the oocyte retrieval. When at least 2 follicles reach an average diameter of 17 mm, final oocyte maturation will be triggered with 10,000IU of hCG ( Pregnyl, Organon, Greece Inc.). Oocyte retrieval will be performed 34 to 36 hours later. Patients with successful fertilization will have embryo transfer under sonographic guidance on day 3 after retrieval.

Eligibility Criteria:
Inclusion Criteria:

* All infertile women undergoing ovarian stimulation for IVF.

Exclusion Criteria:

* Women who can not undergo IVF
Cognitive and Psychophysiological Effects of Delta-9-Tetrahydrocannabinol in Bipolar Disorder

The overarching goal of this study is to characterize the acute cognitive and psychophysiological effects of the main psychoactive constituent of cannabis, 9-delta-tetrahydrocannabinol (THC) in individuals with euthymic bipolar disorder (BD), and to begin probing the mechanisms that may underlie its effects in this illness.

This study is expected to contribute to a better characterization of specific effects of THC in individuals with BD compared to healthy controls (HC).

To compare the dose related acute effects of inhaled THC, administered through a vaporizer over approximately 20 minutes, between HC and euthymic BD individuals (referred to as eBD) on a range of subjective and objective parameters as described below:

Primary Aims:

* Verbal memory, measured by a modified computer version of the Rey Auditory Verbal Learning Test (RAVLT) and/or the CogState battery, administered while EEG data is collected.
* Executive functioning measured by the CogState battery and/or Trails Making Test-Part B.

Secondary Aims:

* Attention, measured by the Continuous Performance Test-Identical Pairs (CPT-IP).
* Working memory, measured by the Wechsler Memory Scale-3 Letter-Number Sequencing.
* Mood, measured by the Profile of Mood States (POMS).
* Psychotic-type experiences, measured by the Psychotomimetic States Inventory (PSI) and/or the Clinician Administered Dissociative Symptoms Scale (CADSS).
* Anxiety symptoms, measured by the Visual Analog Scale for Anxiety (VAS-A).
* Impulsivity, measured by the Balloon Analogue Risk Task (BART).

Exploratory aims:

•Serum prolactin, serum ACTH, serum cortisol and serum endocannabinoid levels.

Eligibility Criteria:
Inclusion Criteria for individuals with Bipolar Disorder (BD)

1. Men and women aged 18-55 years (extremes included).
2. Able to provide informed consent in English.
3. A diagnosis of BD type I or BD type II and good physical health.
4. Current euthymic state for at least 4 weeks.

Inclusion Criteria for Healthy Control (HC) individuals:

1. Men and women aged approximately 18-55 years (extremes included).
2. Able to provide informed consent in English.
3. No psychiatric diagnoses and in good physical health.

General exclusion criteria:

1. Cannabis naïve
2. Unwillingness to remain alcohol-free, cannabis-free for at least 1 week (in infrequent cannabis users) prior to each test day.
3. Evidence of a hearing deficit.
4. IQ less than 80.
5. Positive pregnancy test, lactation, and refusal to practice birth control.