cyrilzakka/clinical-trials huggingface dataset:
Three Dimensional Changes on Nasal Septum and Alveolar Cleft After Maxillary Expansion

This study evaluates, by means of cone beam computed tomography (CBCT), the alterations in the nasal septum and alveolar cleft volume that occur in cleft lip and palate (CLP) patients after rapid maxillary expansion(RME). 40 unilateral CLP patients (mean age, 11.1 ± 2.2 years) with transverse maxillary deficiency that underwent to RME will be evaluated in this investigation. CBCT images were taken prior to RME (T0) and after the removal of the expander (T1), for adequate secondary bone graft surgical planning. The scans will be used to analyze the effects on the nasal septum, anterior and posterior maxillary basal width (MBW) and alveolar cleft volume.

Rapid maxillary expansion (RME) is performed to correct crossbite in CLP patients as part of the orthodontic treatment, being able to improve the maxillary transverse dimension, that is an essential condition for alveolar bone grafting. The primary aim of the secondary graft surgery is to restore the function and structure of the maxillary arch at the cleft side, providing support to arch width, minimizing its transverse collapse. However, since RME exert heavy forces to separate the two maxillary helves, it may significantly widen the alveolar cleft defect, possibly compromising bone graft success.

Moreover, RME has an important impact on the geometry and function of the nasal cavity, providing a lateral displacement of the walls and facilitating the airflow through the upper airways. These effects are very important to CLP patients, since they usually present reduced upper airway dimensions, adenoid hypertrophy, sleep disorders, oral breathing, and a marked nasal septal deviation. The nasal septal deviation is one of the major causes of nasal obstruction in non-cleft patients, and often results in blocking of the nasolacrimal ducts, sinusitis, ear infections and mouth breathing. However, nasal septum deviation in CLP patients commonly persists even after surgical repair of the cleft, leading to a chronic obstruction of the air passage, until the septorhinoplasty, at the age of 14-18 years.

Each expander was cemented with a fluoride releasing cement, and the activation regimen was established at 2 turns/day until the tip of the lingual cusps of the maxillary teeth touched the tips of the buccal cusps of the mandibular teeth. After the 3-month retention period, the expander was removed, and a post-expansion CBCT scanning (T1) was acquired for adequate secondary bone graft surgical planning.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria comprehended the presence of unilateral cleft lip and palate, rapid maxillary expansion as an initial part of the orthodontic treatment, and absence of previous orthodontic treatment.

Exclusion Criteria:

* The exclusion criteria were absent maxillary permanent first molars, signs of active periodontal disease, and presence of any additional craniofacial syndrome.
Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults

This is a pilot human experimental study to evaluate whether the use of an e-cigarette affects lung function, exhaled CO levels, and quantitative tobacco cigarette consumption in active tobacco smokers. Subjects recruited from the Winchester Chest Clinic (WCC), Adult Primary Care Clinic (PCC) and the Smilow Cancer Hospital Smoking Cessation Service will be randomized to 1 of 2 groups: (1) nicotine patch and intensive counseling (standard care) plus nicotine e-cigarette; (2) nicotine patch and intensive counseling plus non-nicotine e-cigarette.


Eligibility Criteria:
Inclusion:

* Smoking 1 or more tobacco cigarettes per day.
* Residence within reasonable driving distance to New Haven..

Exclusion:

* Unstable psychiatric conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia.
* Unstable medical conditions requiring hospitalization.
* Acute myocardial infarction or acute cerebrovascular accident within the past 30 days.
* Unstable angina.
* History of allergic reactions to adhesives.
* Women of childbearing potential who are pregnant, nursing, or not practicing effective contraception.
* Current use of an electronic cigarette.
* Subject unable or unwilling to complete study protocol for any reason.
Safety, PK, PD, and Antitumor Activity of Vecabrutinib (SNS-062) in B Lymphoid Cancers

This is an open-label Phase 1b/2 study in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)or non hodgkin's lymphoma (NHL) who have failed prior standard of care therapies including a BTK inhibitor where one is approved for the indication.

This study includes 2 parts: phase 1 (dose escalation) and phase 2 (cohort expansion) in patients with CLL/SLL or NHL who have failed prior standard of care therapies including a BTK inhibitor where one is approved for the indication. NHL indications include lymphoplasmacytoid lymphoma/Waldenström's macroglobulinemia (LPL/WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), diffuse large B-cell lymphoma of the activated B-cell subtype (DLBCL-ABC), and follicular lymphoma (FL). In Phase 1b, cohorts of 3 to 6 patients are studied at each dose level, starting with 25 mg vecabrutnib BID in oral capsule form. Following identification of the MTD and/or recommended dose, in Phase 2 only CLL/SLL patients will be enrolled to expansion cohorts to further characterize the clinical activity, safety, and pharmacology of vecabrutinib. Cycle length is 4 weeks.

Eligibility Criteria:
Inclusion Criteria (Key factors listed):

* Eastern Cooperative Oncology Group Performance Status of ≤2.
* Confirmed malignancy with relapsed/refractory disease after ≥2 lines of standard systemic therapy including prior BTK inhibitor therapy having CLL, LPL/WM, MCL or MZL and for DLBCL-ABC and FL, after ≥2 lines of standard systemic therapy (Phase 1b). For Phase 2, CLL/SLL patients with confirmed malignancy with relapsed/refractory disease after ≥1 line of standard systemic therapy including prior BTK inhibitor therapy
* Presence of measurable disease through various assessments depending on specific cancer type.
* Current medical need for therapy of the B-lymphoid malignancy.

Exclusion Criteria (Key factors listed):

* Active central nervous system involvement.
* History of second primary malignancy that has progressed or required systemic treatment in the past 2 years. Exceptions include: local cancers of the skin, cervix or breast cancers, non-invasive bladder cancer, hormone sensitive prostate cancer with stable PSA ≥3 months, and other localized solid tumors in situ/other low risk cancers.
* Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
* Ongoing risk for bleeding due to bleeding diathesis, platelet function disorder, uncontrolled peptic ulcer disease, oral anticoagulation medications.
* Evidence of uncontrolled systemic bacterial, fungal or viral infections at the start of drug therapy.
* Demonstrated intolerance to BTK inhibitor as shown by discontinuation due to adverse effects.
* Use of a moderate or strong inhibitor or inducer of CYP3A4 within 7 days prior to start of study therapy (e.g., some antibiotics, antifungals, anticonvulsants, grapefruit).
68Ga-P16-093 PET/CT Imaging in the Salivary Gland

Prostate specific membrane antigen (PSMA) is a type II transmembrane protein and acts as a glutamate carboxypeptidase enzyme. It is first described in prostate cancer cell lines and later identified in various tissues, include salivary gland. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093 in primary sjogren's syndrome patients.

Primary sjogren's syndrome (pSS) is a systemic autoimmune disease mainly presented hyperglobulinemia and exocrine gland involvement,and lack of diagnostic gold standard.Prostate-specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. However, PSMA is also expressed by various solid organs , such as salivary gland,which is often observed damage in primary Sjogren's syndrome patients.Therefore, PSMA may be an ideal target for evaluating salivary gland injury.

Eligibility Criteria:
Inclusion Criteria:

* pathological diagnosis confirmed by operation or biopsy.
* Obtain written informed consent and accepted follow-up.

Exclusion Criteria:

* Pregnant, lactating women or having parenting plans during the study
* Head and neck radiotherapy history ;
* Active hepatitis C infection (PCR positive), include immunodeficiency syndrome, sarcoidosis, amyloidosis, graft versus host disease, IgG4 related diseases.
* Other situaition researchers considered it was not appropriate to participate in trials.
Caffeine and Neurologic Recovery Following Surgery and General Anesthesia

The ongoing opioid epidemic is a public health crisis, and surgical patients are particularly vulnerable to opioid-dependency and related risks. Emerging data suggest that caffeine may reduce pain after surgery. Thus, the purpose of this study is to test whether caffeine reduces pain and opioid requirements after surgery. The investigators will also test whether caffeine improves mood and brain function (e.g., learning, memory) after surgery.

Opioid-related deaths have quadrupled in the last 20 years, and nearly half of these deaths currently involve prescription opioids. Surgical patients often experience moderate-to-severe pain is common after major surgery, and surgery is associated with a 14-fold increased risk of opioid dependency compared to non-surgical controls, even after minor surgery. Furthermore, mood disorders (e.g., depression) are independently associated with persistent opioid use postoperatively, and signs of postoperative depression are common after major surgery. Thus, given these risk factors, surgical patients are at particularly high risk for opioid dependency postoperatively. Interventions that (1) reduce opioid burden, and (2) improve mood and neuropsychological function may mitigate the risk of postoperative opioid dependency. Preliminary laboratory and clinical findings demonstrate that caffeine may reduce pain after surgery, which may translate to lower opioid requirements. The study tests the hypothesis that intraoperative caffeine administration will improve opioid consumption, pain, and neuropsychological recovery in patients undergoing surgery. Through validated assessment measures, the research team will study the effects of caffeine in relation to postoperative opioid requirements, pain, and neuropsychological (e.g., cognition, depression, anxiety) trajectory after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>/= 18 years old) undergoing non-cardiac, non-neurologic, non-major vascular surgery requiring general anesthesia

Exclusion Criteria:

* Emergency surgery
* Cognitive impairment precluding capacity for informed consent
* Uncontrolled cardiac arrhythmias
* Seizure disorders
* Preoperative opioid use
* Diabetes
* Liver failure
* Pregnancy
* Breastfeeding
* Severe visual or auditory impairment (may hinder cognitive function testing)
* Patients unable to speak English.
Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty

1. Evaluate whether AMH and SHBG have differential expression before and after the diagnosis of rapid and slow progression types of early puberty and whether this difference has a predictive effect on the rapid progression type. 2. Assess the therapeutic effect of nourishing yin and purging fire traditional Chinese medicine on girls with rapid progression type of early puberty providing a standardized clinical basis for the formulation of diagnostic and treatment guidelines (or protocols) for the rapid progression type of early puberty using traditional Chinese medicine


Eligibility Criteria:
Inclusion Criteria:

* Girls with an onset age \>8 years and ≤9 years;
* Breast bud Tanner stage II breast bud diameter \<3 cm;
* Ultrasound examination: unilateral ovarian volume ≥1-3 ml and/or follicle diameter ≥4 mm;
* Bone age does not exceed actual age by more than 1 year;
* LHRH stimulation test: LH/FSH ≥0.6 LH peak ≥5.0 IU/L.
* Good compliance;
* Patients and their parents are willing to actively cooperate with the clinical trial;
* Legal guardian signs the informed consent form.

Exclusion Criteria:

* Disorders of gonadal development such as chromosomal abnormalities hypospadias intersex conditions etc.;
* Use of treatments that affect gonadal function such as chemotherapy radiotherapy;
* Diabetes thyroid dysfunction obesity lipid metabolism disorders or other congenital diseases.
School Nurse-directed Secondary Obesity Prevention for Elementary School Children

Primary Aim: To test the efficacy of an elementary school-based, school nurse-led weight management program to reduce excess weight gain among children, 8 to 12 years old who are overweight and at risk of overweight by increasing healthy dietary practices and physical activity levels and decreasing sedentary practices.

Primary Hypothesis: Relative to the control condition, the children receiving the intervention will have a significantly lower body mass index (BMI), following implementation of the 9-month intervention, controlling for baseline values.

Primary Hypothesis: Relative to the control condition, the children receiving the intervention will have a significantly lower body mass index (BMI), following implementation of the 9-month intervention, controlling for baseline values.

Eligibility Criteria:
Inclusion Criteria for child participants:

* 3rd 4th and 5th grade student the year the intervention is implemented,
* ≥ 8 and ≤ 12 years old,
* age- and gender-adjusted BMI ≥ 75th percentile,
* child must live in a primary residence with the participating parent

Exclusion Criteria for child participants:

* plans to move outside the school district within the next 12 months,
* food allergies,
* physical limitations,
* medical conditions that prohibit participation in the intervention program or measurement,
* does not speak and write in English.
Real Life Automatic Atrial Capture Device Control

The main objective of this study is to verify the effectiveness of the new ACAP ® Confirm algorithm in the automatic management of atrial capture.


Eligibility Criteria:
Inclusion Criteria:

* Patients had undergone first implantation or device replacement with a Medical device (PM, ICD, CRT-P, CRT-D) endowed with ACAP Confirm ® algorithm features between May 2011 and March 2012

Exclusion Criteria:

* Atrial fibrillation
A Study of Degarelix in Taiwanese Patients With Prostate Cancer

A phase III trial investigating the efficacy and safety of degarelix one-month depot in Taiwanese patients with prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* 20 years or older
* Has a histological confirmed prostate cancer
* Has a screening serum testosterone above 1.5 ng/mL
* Has a Eastern Cooperative Oncology Group (ECOG) score of ≤ 2
* Has a screening PSA value of ≥2 ng/mL
* Has a life expectancy of at least 168 days

Exclusion Criteria:

* Current or previous hormone therapy
* Is currently treated with 5-α-reductase inhibitor
* Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
* Is considered to be a candidate for curative therapy, i.e radical prostatectomy or radiotherapy
* Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
* Has a clinically significant disorder (other than prostate cancer) or any other condition , including alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the trial as judged by the investigator
* Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial
Caregiver Support in the Coping of Patients Who Are Undergoing a Donor Bone Marrow Transplant

RATIONALE: Questionnaires that measure coping may improve the ability to plan supportive care for patients undergoing donor bone marrow transplant.

PURPOSE: This clinical trial is studying coping in patients who are undergoing a donor bone marrow transplant.

OBJECTIVES:

* Investigate the relative importance of having a consistent inpatient lay care-partner for patients undergoing allogeneic bone marrow transplantation, in terms of the effects on modes of adjustment to illness and survival.

OUTLINE: Patients undergo a 40-minute recorded oral interview in person to provide personal and social demographic data using a 20-item questionnaire (The Adjustment to Illness Questionnaire-Bone Marrow Transplantation) at baseline (pre-transplant) and at day 100 post-transplant.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Medically suitable for allogeneic bone marrow transplantation

PATIENT CHARACTERISTICS:

* Resides locally in the Cleveland, Ohio area

PRIOR CONCURRENT THERAPY:

* Not specified
Verubulin, Radiation Therapy, and Temozolomide to Treat Patients With Newly Diagnosed Glioblastoma Multiforme

This, international, multi-center, Phase 2 study of verubulin will be conducted in patients with newly diagnosed Glioblastoma Multiforme (GBM). The study will be conducted in two parts. Part A is an open-label dose finding study that will determine the safety and tolerability of verubulin in combination with standard treatment. Part B is a randomized open-label study that will investigate progression-free survival and overall survival of patients receiving verubulin, at the dose determined in Part A, in combination with standard treatment versus standard treatment alone.


Eligibility Criteria:
Inclusion Criteria:

1. Have histologically proven, newly diagnosed glioblastoma multiforme
2. Age ≥ 18 years and \< 70 years
3. Have an ECOG performance score of 0, 1, or 2, or KPS ≥ 70
4. Have adequate bone marrow function , liver function, and kidney function before starting therapy
5. Begin study therapy no more than 6 weeks after surgery or biopsy
6. Subjects that have had surgery must have an MRI ≤ 72 hours after surgery

Exclusion Criteria:

1. Have a carmustine implant (e.g., Gliadel® Wafer)
2. Have uncontrolled hypertension (SBP \> 140 mmHg or DBP \> 90 mmHg for more than 1 week)
3. Have a left ventricular ejection fraction below the lower limit of the reference range for the institution, as measured by multiple gated acquisition (MUGA) or echocardiogram (ECHO)
4. Have Troponin-I or Troponin T at Screening visit elevated above the upper limit of the reference range of the local institution
5. Have an increasing steroid requirement, indicative of a rapidly progressive disease
6. Have evidence of new, active intra tumor hemorrhage ≥ CTCAE Grade 2
7. Have had prior cranial radiotherapy
8. Have history of stroke and/or transient ischemic attack within 2 years of screening
9. Have history of cardiovascular disease (e.g., angina, myocardial infarction, congestive heart failure, etc.) within 2 years of screening
10. Be pregnant or breast feeding
11. Have a history of hypersensitivity reaction to Cremophor® EL
12. Have a history of hypersensitivity reaction or intolerance to temozolomide or dacarbazine (DTIC)
LVSP Based CRT vs. RVAP Based CRT

To find out whether left ventricular septal pacing (LVSP)-based cardiac resynchronization therapy (CRT) is superior to right ventricular apical pacing (RVAP)-based CRT in patients with failed left bundle branch pacing at the beginning of chronic heart failure.


Eligibility Criteria:
Inclusion Criteria:

1. Chronic heart failure, LVEF ≤35% after at least 3 months of guideline-optimized drug therapy, NYHA class II-IV with complete left bundle branch block (QRSd≥130 ms), OR Atrioventricular block with LVEF ≤ 50% with the indication of cardiac pacing; 3. Age between 18 and 90 years old; 4. The expected survival period is greater than 12 months; 5. Signed the informed consent form for the study.

Exclusion Criteria:

1. Previous mechanical tricuspid valve replacement.
2. Previous pacemaker or other devices implanted and for device replacement or upgrading for this time.
3. Patients have a history of unstable angina, acute myocardial infarction, CABG, and PCI surgery within three months.
4. Persistent atrial fibrillation without AV block, the proportion of biventricular pacing is not expected to less than 95%.
5. Patients participated in any of the other studies at the same time, which may confound the results of this study.
6. Pregnancy, planning to become pregnant.

8. Patients with a history of heart transplantation.
Evaluating the Impact of Online Educator Microskill Training on Educator Knowledge and Skill

The goal of this clinical trial is to evaluate the efficacy of SkillTalk, a subscription-based microskills video training library designed to enhance the skills of high school sex educators to implement the frequently used core components of sexual and reproductive health (SRH) curricula.

The overall goal of this study is to evaluate the impact of SkillTalk on educators' demonstrable sexual health education skills.

Participants will be asked to:

* Complete a consent form.
* Attend two simulated classroom sessions, either in person or virtually, during which they will teach two prepared lessons that have will be provided to them.
* Be video recorded while teaching.
* Complete a baseline survey and a post-survey.
* If assigned to the treatment group, they will be granted access to SkillTalk for one week to view the videos associated with the answering sensitive questions and using trauma-informed strategies skill sets.

Researchers will compare the treatment group to the control group to see if SkillTalk has an impact on educators' demonstrable sexual health education skills.


Eligibility Criteria:
Inclusion Criteria:

* Teach or have taught groups of youth in a school, clinic or community setting. Group is defined as 4 or more youth. Youth is defined as high school aged youth in grades 9-12.
* Have fewer than three years of experience teaching sexual health education
* Comfortable participating in the role
* Must reside in the U.S.
* Must be at least 18 years of age.
Eye Movement Behaviour and Pupil Size in Natural Outdoor and Indoor Scenes

In this study, the researchers will be using eye tracking and detailed lighting measurements to understand how different types of indoor and outdoor lighting affect the eye movements and pupil sizes of our participants. Participants will be paired up and undergo six eye tracking sessions, split across two appointments. Each appointment will involve viewing either indoor or outdoor scenes, and before each session, participants will spend time adapting to the lighting conditions. Overall, each participant will spend 24 minutes being tracked, and the entire study will take about 2-3 hours to complete. The investigators expect differences in eye movements and pupil size between indoor and outdoor scenes.


Eligibility Criteria:
Inclusion Criteria:

* No previous eye-surgeries or ocular impairments like anisometropia, amblyopia, strabism, cataract, watery eyes or hanging eye lids
* Normal or corrected-to-normal visual acuity (+3dpt. to -5dpt.)
* Normal colour vision
* Normal binocular vision

Exclusion Criteria:

* Any use of medications or drugs that influence photosensitivity or the ability to concentrate
* Excessive alcohol and/or drug use
* Presence of psychiatric disorders
* Poor sleep quality
* Diagnosed with epilepsy