cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder

Study ITI-007-020 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone as treatment for adolescent patients with schizophrenia or schizoaffective disorder.


Eligibility Criteria:
Main Inclusion Criteria:

* Male or female patients between 13 and 17 years of age, inclusive
* Clinical diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
* Free from acute exacerbation of their psychosis for at least 3 months prior to Screening
* Clinical Global Impression - Severity (CGI-S) score ≤ 4
* Body mass index (BMI) within 2 standard deviations of, age- and gender-specific body measurements (based on CDC Clinical Growth Chart, 2000)
* Ability to swallow capsules

Main Exclusion Criteria:

* Has a primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder
* Reports having experienced suicidal ideation within 6 months prior to Screening, any suicidal behavior within 2 years prior to Screening based on the Columbia-Suicide Severity Rating Scale (C-SSRS), and/or the investigator assesses the patient to be a safety risk to him/herself or others
* Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables
* History of a clinically significant cardiac disorder and/or abnormal screening electrocardiogram (ECG) or a QT interval corrected for heart rate using Fridericia formula \> 450 msec in males or \> 470 msec in females
Infrared Choroidal Reflectance Camera for the Detection of Childhood Cataract

Sensitivity and specificity of current screening methods for childhood cataracts is poor. This results in delayed diagnosis and management which can decrease the visual prognosis following cataract surgery. It also results in many false positives with resultant unnecessary healthcare costs in specialist paediatric ophthalmology services. This study compares the accuracy of cataract screening using infrared light compared to white light in a population of children attending eye clinic.

All babies born in the United Kingdom (UK) undergo eye screening to enable the early diagnosis and management of childhood cataract, a treatable but potentially blinding condition affecting 1 in 2000 newborns. The current technique involves the assessment of the "red-reflex" - the orange/red glow in the pupil seen during ophthalmoscopy (or flash photography) due to reflectance of light from the back of the eye. In reality, testing can be technically difficult because the pupil constricts to light during the examination and, particularly in babies of Asian and Afro-Caribbean ancestry, the red-reflex can be dim due to the effect of ocular pigmentation. As a result less than 50% of congenital cataracts are currently identified up by screening. Early visual experience is required for good visual development and a delay in the surgical management of cataracts results in sub-optimal visual development and visual impairment.

There are theoretical advantages to using Infrared (IR) light rather than white light to assess choroidal reflectance, including avoidance of pupil constriction. The study aims to determine if the assessment of the IR-reflex, using a prototype device, rather than the red-reflex, using a direct ophthalmoscope, improves screening accuracy in the detection of ocular media opacities in a pathology enriched childhood cohort.

Eligible children attending an eye clinic will be screened for cataract by a medical student (masked to the pathology) using the existing standard direct ophthalmoscope technique for red-reflex assessment and IR-reflex assessment using the prototype imaging device. A gold standard examination by an ophthalmologist will follow the screening examinations. Sensitivity and specificity of each screening technique will be calculated and compared.

Eligibility Criteria:
Inclusion Criteria:

* All children between 1 month and 5 years of age attending paediatric ophthalmology clinic

Exclusion Criteria:

* Parents / carers with poor conversant English
Effectiveness of Ultrasound Guided PECS Block on Opioid Consumption and Patient Satisfaction Through Adequate Pain Control Following Breast Cancer Surgery.

Breast cancer is the most common and leading cause of cancer deaths among females worldwide. Patients undergoing modified radical mastectomy (MRM) are associated with moderate to severe acute postoperative pain and shoulder mobility restriction.

This study aims to determine the effectiveness of ultrasound-guided PECS block for reducing opioid consumption, providing adequate postoperative pain management and improving patient satisfaction following breast cancer surgery.

The traditional pain management for patients undergoing MRM has relied heavily on opioids but a number of multimodal pain control strategies also exist including combining opioids with NSAIDs, cyclooxygenase-2 inhibitors, acetaminophen and regional blocks. Recently, literature underlines the importance of performing regional anaesthetic and analgesic techniques for postoperative analgesia following breast surgery. PECS (Pectoral nerve block) block provides analgesia for breast surgeries with few adverse effects.

OBJECTIVES To evaluate the effect of ultrasound guided pectoral block in reducing intraoperative and postoperative opioid consumption following modified radical mastectomy.

The secondary objective is to determine patient satisfaction levels associated with adequate pain control.

HYPOTHESIS Pectoral nerve blocks provides superior analgesia with less opioid consumption and improves patient satisfaction in postoperative period compared to conventional pain management for modified radical mastectomy patients

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective modified radical mastectomy (MRM)
* All adults aged between 18 and 65 years
* ASA (American Society of Anesthesiologists ) I \& II

Exclusion Criteria:

* Patient refusal
* Hypersensitivity to local anaesthetics
* Coagulopathy or bleeding diathesis
* Local infection at the site of block
* BMI more than 35 kg/m2
* Chest wall deformity or previous breast surgery
* MRM with latissimus dorsi or deep inferior epigastric perforator flap reconstruction
Combination of Cetuximab and NK Immunotherapy for Recurrent Non-small Cell Lung Cancer

The aim of this study is the safety and efficacy of Cetuximab plus natural killer(NK) immunotherapy to recurrent non-small cell lung cancer with EGFR mutation.

By enrolling patients with lung cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using Cetuximab and NK cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Diffusion Tensor Imaging to Assess the Functional Outcomes of Adults With Cervical Spinal Cord Injuries

Acute changes in axial diffusivity will correlate with the severity of injury in patients that suffer an acute spinal cord injury.

Diffusion tensor imaging (DTI) parameters will correlate with severity of spinal cord injury in SCI patients as seen in rodent models. We will test whether the quantitative decrease in axial (λ║) diffusivity (a biomarker of axonal injury), will predict long-term functional outcomes for patients with a SCI.

Specific Aim: To examine patients after an acute SCI using DTI and to correlate the extent of acute decrease in λ║ with the presenting ASIA motor score and long-term functional outcome of the patient.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Cervical spinal cord injury
* physically and mentally willing to comply with imaging
* lives in immediate area with no plans to relocate

Exclusion Criteria:

* Associated moderate to severe head injury
* Active malignancy
* Previous spinal cord injury
* pregnancy
* inability to tolerate MRI scanning
Realtime Diagnosis From Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation With Long Follow-Up (REGAL)

The purpose of this research is to test whether Apple Watch, used as a long-term monitoring device, can enable early detection of atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Had a 10-second 12-lead ECG done at Mayo Clinic
* Have a high AI-ECG risk score indicating a high likelihood of previously unrecognized AF
* Men with CHA2DS2-VASc2 ≥2 or women with CHA2DS2-VASc ≥ 3

Exclusion Criteria:

* Diagnosed atrial fibrillation
* Diagnosed dementia
* Diagnosed end-stage kidney disease
* History of intracranial bleeding
* Have an implantable cardiac monitoring device, including a pacemaker, a defibrillator, or implanted loop recorder
* Missing date of birth
* Residence outside of the U.S. or missing address information
Effect of Myofascial Release Technique in Patients with Unilateral Cervical Radiculopathy

The aim of the study is to investigate the effectiveness of myofascial release technique on pain, range of motion, muscle strength, functionality and quality of life in individuals diagnosed with cervical radiculopathy with unilateral arm involvement and compare this with exercise. The individuals included in the study will be randomized into two groups, 17 control and 17 study groups. Sessions will be 3 days a week for 4 weeks. Conventional physiotherapy and exercise program will be applied to the control group, conventional physiotherapy and myofascial release technique will be applied in the intervention group. Conventional physiotherapy methods; It will include Transcutaneous Electrical Nerve Stimulation (TENS), Ultrasound (US), hotpack agents. Exercise program; extension, right and left lateral flexion, right and left rotation exercises, chin-tuck, right and left upper trapezius muscle group stretching, neck extensor muscle group isometric strengthening exercises. Myofascial release will be applied to the fingers, wrist flexor-extensor muscle groups, elbow flexor-extensor muscle groups, pectoral muscles and rotator cuff muscle groups. Patients will be evaluated before and after treatment with Visual Analogue Scale (VAS), Goniometric measurements, algometer, myometer, Neck Disability Scale, "Disability of Arm, Shoulder and Hand" Questionnaire (DASH).


Eligibility Criteria:
Inclusion Criteria:

* Getting a diagnosis of cervical radiculopathy
* Unilateral upper extremity symptoms at least for a month
* The diagnosis is confirmed by the medical board report
* Being between the ages of 30-65
* Voluntary acceptance to participate in the study

Exclusion Criteria:

* Previous cervical surgery
* Previous cervical trauma
* Have had myofascial therapy or conventional therapy for cervical radiculopathy
* Long-term use of corticosteroids
* Congenital torticollis history
* Using nonsteroidal anti-inflammatory drugs for long time
* Migraine
* Cancer
* Tumor
* Osteoporosis
* Pregnancy
Efficacy and Safety of Potenfill for Temporary Penile Enhancement

The purpose of this study is to evlauate the efficacy and safety of poteinfill, compared to the powerfill.


Eligibility Criteria:
Inclusion Criteria:

1. Male subjects aged above 19 and below 65. (20≤male≥65)
2. be rating himself, when screening, as "Small or Very Small" on Self-Questioned Questionnaire ( SQQ) including the question: " How do you rate your penile size? // Very small, Small, Normal, Big, Very Big?"
3. Subjects will sign an informed consent form

Exclusion Criteria:

1. Prior treatment for penile enhancement (e.g. fat, dermal graft).
2. Subjects who have penile malformation (e.g. Peyronie's disease), which can make impossible to perform the intervention
3. Allergic to hyalluronic acid.
4. Inflammatory or/and infectious disease on penis that can affect on this study
Effectiveness of Qufeng Shengshi Fang on Treatment of Allergic Rhinitis.

This is a controlled clinical trials about traditional Chinese medicine named Qufeng Shengshi Fang，which consisted of cicada slough，bombyx batryticatus，radix angelicae，radix sileris，honeysuckle flower，forsythia，lithospermum and radix glycyrrhizae，and Loratadine on treatment of Allergic Rhinitis.There are 180 Patients with allergic rhinitis recruited from Department of Allergy and Traditional Chinese.To carry on statistical analysis of the result of the self and between-group cross-reference by two questionnaires filled before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* meet allergic rhinitis (include allergic rhinitis with asthma) diagnostic criteria at Peking Union Medical College Hospital Department of Allergy;
* have allergic rhinitis in episodes.
* without antihistamine,local anaesthetic or traditional Chinese medicine in last months.
* signed the informed consent form.

Exclusion Criteria:

* have severe deviation of nasal septum and nasal polyps.
* have nasal surgery or a history of cancer(tumor).
* have other serious illness or evidence of mental disorders.
* female in pregnancy and lactation
Direct Stimulation Of Spinal Nerve Roots To Determine Sensory And Motor Innervation Patterns

The purpose of this study is to collect data while monitoring muscles and nerves during spine surgery. The data being collected and analyzed will be used to learn more about how the body's nerves and muscles are distributed and develop a map of human muscle innervation patterns.

In this large scale study it is proposed to examine root-to-muscle innervation directly, using the standard Intra-Operative Monitoring procedures during scheduled cervical and lumbar spinal surgeries. The study would directly map muscle and sensory distributions of nerve root innervations with no additional risk to patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing either cervical or lumbar cord procedures at Lahey Clinic and during which the surgeon has requested intra-operative neurophysiologic monitoring.
* Surgery performed by a neurosurgeon
* Participant must be ≥ 18 years of age or ≤ 85 years of age
* Participant, or legally authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the Lahey Clinic IRB

Exclusion Criteria:

Past medical history significant for any of the following:

* Peripheral Neuropathy
* Patients with Diabetes Mellitus
* Neuromuscular disease that would interfere with intra-operative recordings
* The Investigator determines that the patient should not be included in the study for reason(s) not already specified
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.

The purpose of this study is to describe the safety, tolerability, and immunogenicity of a 2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to preterm infants with concomitant vaccines, compared to infants born at term.There will be a follow-up phase to assess the persistence of the antibody response at 24 and 36 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Infants between 42 and 98 days of age (approximately 2 months) at the time of enrollment.

Exclusion Criteria:

* Previous vaccination with pneumococcal vaccine,Haemophilus influenzae type B (Hib) conjugate vaccine, meningococcal type C conjugate vaccine, or diphtheria, tetanus, pertussis, or poliovirus vaccines.
* Previous anaphylactic reaction or allergy to any vaccine
* Contraindication to vaccination
* Known or suspected immune deficiency or immune suppression
* Major known congenital malformation or serious chronic disorder
* Significant neurological disorder
* Participation to another study
Intravesical Instillation of Botulinum Toxin Type A to Patients With Urge Urinary Incontinence

A pilot study to examine efficacy and safety of intravesical botulinum toxin type A.


Eligibility Criteria:
Inclusion Criteria:

* refractory urge urinary incontinence

Exclusion Criteria:

* neurological disease
* pregnant or lactating
* bladder neoplasias
α-lipoic Acid (ALA), Magnesium, Vitamin B6 and Vitamin D and Risk Factor for Pre-term Birth

Effects of oral administration of a food supplement constituted by α-lipoic acid, magnesium, vitamin B6 and vitamin D in tablets of 1,2 g administered daily to women presenting risk factors for preterm birth (PTB). The aim is to reduce the rate of short cervix at 19-21 weeks of gestational age and consequently reduce the occurrence of PTB.

The physiological course of pregnancy can be threatened by the onset of rhythmic and progressive uterine contractions, associated with a shortening and dilation of the cervix.

These modifications occur as a consequence of inflammatory processes that involve important changes in the extracellular matrix of connective tissues. For this reason, in the event of a threat of preterm birth, the appropriate tocolytic therapies should be associated with interventions able to counteract morphological changes in the uterine cervix. Women presenting high or low BMI, presence of uterine myomas, metrorrhagia during the first trimester and hypertensive disorders are at risk for PTB. Current management practices remain profoundly various, without a therapeutic tocolytic strategy, especially because most of the first-line tocolytic drugs used present important side effects \[8\]. It is to be assessed whether a supplementation during pregnancy with minerals, vitamins, anti-inflammatory and anti-oxidant agents can avoid PTB in women with risk factors.

ALA may interact synergistically with magnesium, vitamin B6 and vitamin D, limiting some of the main factors related to the risk of preterm delivery - probably via the inhibition of nuclear factor k beta (NF-kB)-signaling pathway - and reducing therefore the rate of uterine contractions.

Moreover, the administration of ALA, magnesium, vitamin B6 and vitamin D have been demonstrated to be safe in pregnancy.

The aim of the present study is to evaluate whether pregnant women presenting risk factors for PTB, treated with a combination of ALA, magnesium, vitamin 6 and vitamin D from 11-14 weeks of gestational age, until delivery, could present a reduced rate of cervical shortening measured by transvaginal ultrasound (TVS) at 11-14 weeks and 19-21 weeks of gestational age.

Eligibility Criteria:
Inclusion Criteria:

1. Nulliparous,
2. Previous History of preterm birth,
3. Age between 18 - 41 years,
4. 11-14 weeks of gestation,
5. BMI \< 18 kg/m2 or ≥ 30 kg/m2,
6. Uterine myoma,
7. Hypertensive disorders either chronic or induced by the pregnancy

Exclusion Criteria:

1. PPROM,
2. Cervical dilation ≥ 1 cm
Chidamide and PD-1 Inhibitor Plus Anlotinib for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed

This Phase II study was designed to assess the efficacy and safety of the combination of PD-1 inhibitor, Tucidinostat (chidamide), a histone deacetylase inhibitor, and anlotinib in advanced breast cancer.

Participants must have HER2-low and PD-L1 positive （CPS≥1）breast cancer that has been treated before.

Participants' cancer:

Cannot be removed by an operation Has spread to other parts of the body


Eligibility Criteria:
Inclusion Criteria:

1. Has pathologically documented breast cancer that:

   * Is unresectable or metastatic
   * Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
   * Is HR-positive
   * Has progressed on, and would no longer benefit from, endocrine therapy
   * Has been treated with 0 to 1 prior lines of chemotherapy in the recurrent or metastatic setting
   * Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing (per American Society of Clinical Oncology-College of American Pathologists \[ASCO-CAP\] guidelines)
   * PD-L1 positive （CPS≥1）
2. Has documented radiologic progression (during or after most recent treatment)
3. Has adequate archival tumor samples available or is wiling to provide fresh biopsies prior to randomization for:

   * assessment of HER2 status
   * assessment of post-treatment status
4. Has at least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors 1.1
5. Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
6. Male and female participants of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels)

Exclusion Criteria:

1. Allergies to any monoclonal antibody or tucidinostat preparation have been known, and hypersensitivity reactions of more than 3 levels have occurred
2. Previously received histone deacetylase inhibitors,or immune checkpoint inhibitor, or angiogenesis inhibitors.
3. Subjects with any active, known or suspected autoimmune disease or history of autoimmune disease.
4. Known active CNS metastases and/or carcinomatous meningitis.
5. Received a live vaccine within 4 weeks of the first dose of study medication.
6. Major surgery received or severe traumatic injury, fracture, or ulcer occurred within 4 weeks of the first dose of study medication.
7. Pregnant or lactating female.
8. Uncontrolled clinically significant systemic diseases, including active infection, unstable angina, angina occurred within 3 months,≥ NYHA II congestive heart failure, myocardial infarction occurred within 6 months, severe arrhythmia, liver, kidney, or metabolic disease.
9. Participate in other clinical trials currently or within 4 weeks prior to enrollment.