cyrilzakka/clinical-trials huggingface dataset:
Optimization of Cervical Nodal CTV for Early and Medium Stage NPC

Current radiotherapy guidelines and consensus statements uniformly recommend elective region irradiation (ERI) as the standard strategy for nasopharyngeal carcinoma (NPC). However, given the scarcity of skip-metastasis, the improved assessment accuracy of nodal involvement, and the striking advancements in chemotherapy for NPC, a one-fits-all delineation scheme for clinical target volumes for the nodal region (CTVn) may not be appropriate anymore, and modifications of the CTVn delineation strategy may be warranted. Involved site irradiation (ISI) covering merely the initially involved nodal site and potential extranodal extension has been confirmed to be as effective as ERI with decreased radiation-related toxicities in some malignancies, but has not yet been investigated in NPC. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of ISI with conventional ERI in NPC patients with a limited nodal burden.

ISRT-NPC is a prospective, multicenter, open-label, noninferiority, phase III randomized controlled trial. A total of 488 patients will be randomly assigned in a 1:1 ratio to receive ISI or ERI. Randomization will be stratified by institution and N stage. Generally, in the ISI group, the high-risk CTV1 (dose: 60 Gy) includes a 1-cm expansion of the positive LN as well as the VIIa and the retrostyloid space above the bilateral transverse process of the atlantoaxial spine (C1), regardless of N status. The low-risk CTV2 (Dose: 50 Gy) covers the cervical nodal region with a 3-cm caudal expansion below the transverse process of C1 for N0 disease and a 3-cm expansion below the positive LN for positive LNs (at least covering the level II).

Eligibility Criteria:
1. Age between 18 and 75 years;
2. Karnofsky performance status (KPS) score ≥ 70;
3. Pathologically confirmed World Health Organization (WHO) type II-III NPC;
4. TNM stage I-III (T1-3N0-2M0) according to the 8th American Joint Committee on Cancer / Union for International Cancer Control (AJCC/UICC) staging system with a maximum diameter (MAD) of cervical involved LNs ≤ 3 cm, namely LB-LN;
5. Available baseline nasopharynx and neck computed tomography (CT) or magnetic resonance imaging (MRI) (strongly advocated) data (including functional MRI sequences) and measurable tumor lesions;
6. All procedures for defining the tumor burden completed within 4 weeks of registration;
7. Survival expectancy of at least 6 months;
8. Normal marrow and organ function: hemoglobin ≥ 120 g/L, WBCs ≥ 4 × 109 /L, platelets ≥ 100 × 109 /L; liver and kidney function-related indicators within 1.25\*the normal upper limit;
9. Patient willingness to comply with the protocol;
10. Patient willingness and ability to provide an informed consent form.
Muscle Strength and Functional Autonomy of Elderly Women

This study shows an evaluation of the correlation between the muscle strength levels and functional autonomy of elderly women.

The aim of this study was to evaluate the correlation between the muscle strength levels and functional autonomy of elderly women with impaired muscle-skeletal system depending on the normal IGF-1 level. The target-population was composed by elderly women aged between 60 and 75 years (age: 67.79 ± 5.11 years, BMI: 28.01 ± 5.4), residents of an asylum, with IGF-1 levels within the normal values for the age (normo-IGF-1). Evaluations of the muscle strength (1-RM test) and the functional autonomy (GDLAM Protocol) in the performance of activities of daily living (ADL), and a measurement of basal serum levels of IGF-1 (Chemiluminescence method) were performed.

Eligibility Criteria:
Inclusion Criteria:

* present a muscle-skeletal dysfunction, such as osteoporosis, arthritis, tendinitis, but being able to perform their ADL without help from others;
* did not practice physical activity for at least 12 months;
* provide a normal IGF-1 level for their age;

Exclusion Criteria:

* elderly women unfit to perform the strength and functional autonomy tests for the medical assessment;
Evaluation of the Baha SoundArc in Pediatric Patients

The purpose of this study is to gather clinical performance data on the Baha SoundArc

Current Baha recipients that are using a Baha SoftBand will be recruited to be fitted with an alternative non-surgical option for using their Baha Sound Processor. The subjects will be tested with there existing Baha Sound Processor on the SoftBand and will then be fitted with the Baha SoundArc where they will perform a one month take home trial. At the end of this trial, the subject will return for testing and evaluation of their experience with this new fitting option.

Eligibility Criteria:
Inclusion Criteria:• Existing recipients using a Baha sound processor on a Softband for at least three months

* Subjects aged 5 through 12 years of age
* Subjects should be able to perform clinical testing adapted for age and developmental status, (Threshold sound field audiometry and basic monosyllabic word test, PBK)
* Willingness on behalf of the subject's parent or guardian to complete study questionnaire

Exclusion Criteria:• Subject's inability to perform requisite test measures as described in the study protocol

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Xeroderma Pigmentosum Patient Experiences

Xeroderma Pigmentosum (XP) is a rare skin condition that causes extreme sensitivity to the sun and an increased incidence of skin cancers. The purpose of this study is to find out more about XP patient experiences and their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of xeroderma pigmentosum
* Any age
* Access to a public or private computer

Exclusion Criteria:

* Patients who do not have a confirmed diagnosis of XP
* Patients under 18 who do not have a parent/guardian able to read or speak English
* Patients who are unable to read or speak English
Characteristics of Infective Endocarditis in East China

This was a retrospective observational study of consecutive cases of definite or possible infective endocarditis (IE) as per the modified Duke criteria between January 2008 and December 2015, which was performed at the Second Affiliated Hospital of Zhejiang University, School of medicine (SAHZU), a tertiary care referral hospital located in East China.

Infective endocarditis (IE) is a rare but life-threatening serious disease that still has a high mortality, even in developed countries. The objective of this study was to evaluate the clinical presentations, treatment and outcomes of IE patients in a tertiary hospital in East China over an 8-year period. This was a retrospective observational study of consecutive cases of definite or possible IE as per the modified Duke criteria between January 2008 and December 2015.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of infective endocarditis.

Exclusion Criteria:

* Patients did not meet the modified Duke criteria.
Immunometabolism in Pediatric Obesity

This is a study to learn about obesity and how insulin resistance and Type 2 Diabetes develops in children.

The main purpose of this proposed study is to determine whether the immunometabolic phenotypes of CD4+T cells from obese children is skewed towards Teff with mTOR-driven glycolysis and away from Tregs with AMPK-driven OXPHOS and whether metformin can reverse the immunometabolic phenotypes.

This study consists of:

1. An observational cross sectional immune and metabolic analysis of several groups of children including lean, overweight/obese, and T2D.
2. A prospective immune and metabolic analysis of newly diagnosed children with T2D or insulin resistance who will be or were recently prescribed metformin as part of their clinical care.

Children with T2D or insulin resistance who will be or were recently prescribed metformin, will be asked to complete two study visits. If completed, the second visit will occur 6 months (+/- 2 weeks) after beginning metformin as part of their clinical care. All other children, will be asked to complete only the first visit.

Eligibility Criteria:
Inclusion Criteria:

* Age 5-17 years, inclusive
* Either healthy lean (BMI≥ 5th percentile and \<85th percentile for age/sex) or overweight (BMI ≥ 85th percentile and \<95th) or obese (BMI ≥ 95th percentile for age/sex)
* For those with BMI≥ 85th percentile for age/sex, parental verbal confirmation that the child had a history of BMI≥ 85th percentile for age/sex for at least six months prior to study enrollment OR
* Age 5 years - 17 years 5 months, inclusive
* Either overweight or obese (BMI≥ 85th percentile for age/sex)
* Parental verbal confirmation that the child had a history of BMI≥ 85th percentile for age/sex for at least six months prior to study enrollment
* Diagnosed with type 2 diabetes mellitus or insulin resistance
* Prescribed metformin (either not yet taking or began taking within 3 weeks of enrollment)

Exclusion Criteria:

* Having an infection (viral, respiratory, gastrointestinal) in the previous 4 weeks
* Genetic or physical conditions impacting mobility over past year as determined by the PI
* Having known chronic illnesses/disorders that may independently affect study outcome measures: type 1 diabetes mellitus, neurologic (e.g. epilepsy), developmental (developmental delay, autism spectrum disorder), endocrine (thyroid, Cushing's), hepatic, autoimmune, cardiac and renal disorders. Also, chronic lung disorders except well controlled asthma that does not require permanent use of inhaled/oral steroids
* Taking any of the following medications that can affect study outcome: antipsychotics, thyroid hormone replacement therapy, inhaled/oral steroids, insulin, anabolic drugs (growth hormone replacement therapy and oxandrolone) and stimulants
* Taking metformin prescribed as part of their clinical care for longer than 3 weeks at the time of enrollment (may begin metformin therapy prescribed as part of their clinical care while enrolled in the study)
* BMI\<5th percentile for age/sex (classified as underweight based on CDC growth charts)
* Subjects determined ineligible by the PI or delegated staff.
Occlusal Bite Force Changes After Surgical Correction of the Increased Vertical Dimension

The aim of this study was to record the OBF changes after surgical correction of mandibular prognathism in patients with or without increased vertical skeletal dimensions at different time intervals (T0: before surgery; T1: at debond; T2: 3 months post-retention).

Forty-two patients who presented to orthodontic clinics with severe Class III skeletal malocclusion and were already into orthodontic preparation for orthognathic surgery were selected to participate in thestudy.

Patients were allocated into one of 2 groups as follows: - Group 1: - Class III patients with increased vertical relationship Included 22 patients (8 males, 14 females).These patients were scheduled for bimaxillary surgical procedures (Maxillary advancement and mandibular setback with posterior maxillary impaction) to correct the antero-posterior and vertical skeletal discrepancies.

Group 2: - Class III subjects with normal vertical relationship Included 20 patients (8 males, 12 females).These patients were scheduled for mandibular setback surgical procedure (with no posterior maxillary impaction) to correct the antero-posterior skeletal discrepancy.

Diagnostic records (orthopantomogram, lateral cephalogram, study casts, clinical photographs) were taken for all subjects before surgery. The same records were taken post surgery just before fixed orthodontic appliance debond.

The included patients were treated by orthodontic teaching staff and postgraduate residents at orthodontic clinics/JUST using pre-adjusted edgewise fixed appliance (3M Gemini Uniteks, 0.022" MBT prescription brackets).

Bite force was measured bilaterally in the first molar region using a portable occlusal force gauge (GM10, Nagano Keiki, Tokyo, Japan), that consisted of a hydraulic pressure gauge and a biting element made of a vinyl material encased in a polyethylene tube. 3 OBF measurements were recorded on each side and incisally with a 15 second rest between each bite, the average of the three readings was used. Three OBF measurements were considered in the analysis: the maximum OBF (MOBF) achieved by the subject, the averaged OBF on molars (AOBF), and the OBF at the incisal region (IOBF).

Number of teeth in contact was measured using double-sided articulation paper strips that was smeared with a thin layer of petroleum jelly prior to its' use so as to improve the visualization of the markings of the contact points that existed in a subject's intercuspal position.

Eligibility Criteria:
Inclusion Criteria:

* adults ≥18 years
* severe skeletal class III malocclusion
* patients willing to undergo surgery
* no systematic medical conditions

Exclusion Criteria:

* poor oral hygiene
* heavily restored or endodontically treated first molars
Dexmedetomidine Hydrochloride in the Prevention of Organ Failure Following Severe Acute Pancreatitis

Cytokines such as such as TNF-a, IL-1, IL-6 correlate with the severity of pancreatitis.Neuroendocrine pathways, such as the sympathetic nervous system or parasympathetic nervous system, in turn, have some impact on the immune systems, through a-2 adrenoreceptor stimulation or the cholinergic anti-inflammatory pathway. The investigators aim to use Dexmedetomidine Hydrochloride to decrease the activity of sympathetic nervous system, thus relieve inflammation response.

Infected pancreatic necrosis (IPN) and multiple organ dysfunction syndrome (MODS) are major complications of acute pancreatitis which determine disease severity and outcome.It is concluded that systemic inflammation in SAP characterized by the endocrine release of different cytokines, such as TNF-a, IL-1, IL-6 and many others. These cytokines correlate with the severity of pancreatitis.

Neuroendocrine pathways, such as the sympathetic nervous system or parasympathetic nervous system, in turn, have some impact on the immune systems, through a-2 adrenoreceptor stimulation or the cholinergic anti-inflammatory pathway. Dexmedetomidine Hydrochloride is a high selected a-2 adrenoreceptor agonists.Some studies have shown that Dexmedetomidine Hydrochloride could improve the outcome of sepsis patients and decrease the development of organ failure.

The investigators aim to use Dexmedetomidine Hydrochloride to decrease the activity of sympathetic nervous system,thus relieve inflammation response.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with severe acute pancreatitis within 48h
* APACHE II≥8
* Patients or the family agreed to receive the treatment, and signed the informed consents

Exclusion Criteria:

* Patients were allergy to the drug
* Patients were diagnosed with Arrhythmia
* Patients with artificial permanent pacemaker implantation
Timing of Post-prostatectomy PSMA Imaging

The investigators will randomize patients presenting with early BCR with a negative baseline PSMA PET/CT, to upfront SRT or surveillance. Early BCR is defined as a PSA relapse of \>0.1 to \<0.3 ng/mL. Patients in the surveillance arm will be monitored with PSA every 3 months. A repeat PSMA PET/CT will be undertaken when the PSA reaches a target level of \>0.5 to \<1.0 ng/mL. Both early radiation treatment and surveillance with repeat PSMA PET/CT imaging are within patterns of practice locally; therefore, the investigators believe that there is clinical equipoise on this subject.


Eligibility Criteria:
Inclusion Criteria:

* Histologically-proven prostate cancer
* pT1-T4 pN0/Nx cM0
* PSA at BCR \>0.1 - \<0.3 ng/mL post-radical prostatectomy
* PSMA PET/CT negative at BCR post radical prostatectomy
* Planned SRT to prostate bed +/- pelvic lymph nodes
* ECOG 0 or 1
* Age ≥ 18 years
* Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.

Exclusion Criteria:

* Active or post prostatectomy androgen deprivation use
* Previous pelvic radiotherapy
* Other contraindications to radiotherapy
Improving Access to Abortion in the Republic of Georgia

In the Republic of Georgia, the medical abortion regimen involves three in-person visits. This study aims to pilot and evaluate a simplified medical abortion service delivery model that will reduce the number of in-person visits to only one visit for diagnosis and counseling. Medication will be mailed along with two multi-level pregnancy tests to study participants, who will assess their abortion outcome at home.

This prospective cohort study of patients obtaining medical abortion medications by mail. The study investigators aim to recruit approximately 120 patients for this study across three study sites that have extensive experience providing early medical abortion. Five days after undergoing in-person consultation and necessary exams to assess eligibility for medical abortion, study team will mail study participants medical abortion pills and two multi-level urine pregnancy tests. Medical abortion follow-up will occur at the participant's home approximately two weeks after the initial visit, and the multi-level pregnancy test will be used to assess abortion outcome. At follow-up, study participants will be asked questions about the results of the multi-level pregnancy test, and their experience and feedback about the acceptability of the process. At the conclusion of the study, investigators will interview providers to better undertand their experience with the simplified medical abortion service delivery model.

Eligibility Criteria:
Inclusion Criteria:

* Women seeking medical abortion through 58 days gestation
* Eligible for medical abortion according to study provider's assessment
* Able to receive physical mail
* Have access to a phone
* Be willing and able to consent to participate in the study
* Be willing to follow study procedures

Exclusion Criteria:

* Not seeking medical abortion
* Contraindications to medical abortion
Tyrosine for Methamphetamine Dependence - 1

The purpose of this study is to evaluate efficacy of tyrosine as a treatment for methamphetamine dependence in an outpatient treatment setting providing group psychosocial interventions. Examine effect of tyrosine on abstinence, retention in treatment, and craving."

Evaluate efficacy of tyrosine as a treatment for methamphetamine dependence in an outpatient treatment setting providing group psychosocial interventions. Examine effect of tyrosine on abstinence, retention in treatment and craving.

Eligibility Criteria:
Inclusion Criteria:

18-65 years of age. Able to provide informed consent. Desire to reduce/eliminate methamphetamine use. Used within the past two weeks. Meet DSM criteria for methamphetamine dependence.

Exclusion Criteria:

No dependence (within the past 12 months) for other durgs except nicotine. No history or family history of tyrosine intolerance.
Tailored Messaging for CRC Screening

This is a randomized controlled trial to to determine whether direct, tailored messaging to patients prior to scheduling colonoscopy will increase patient adherence to provider recommendation for screening colonoscopy.

The proposed study is a prospective, randomized trial. All eligible subjects (patients identified to be contacted to schedule screening colonoscopy) will be randomized to one of three study arms: usual scheduling process (control), a generic message arm, or a tailored message arm. Patients in the "tailored message" arm will receive a telephone call and be asked a series of questions that will be used to assign patients to one of four messaging cohorts. After these questions have been answered, the patient will then receive a tailored message corresponding to his or her respective messaging cohort, encouraging them to schedule a colonoscopy with a directed script. In the "generic message" arm, patients will receive a telephone call and be asked to answer the same series of questions as the "tailored message" group, then receive a single, standard script encouraging them to schedule a colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

1. University of Pennsylvania Health System (UPHS) patients with an active order for screening or surveillance colonoscopy without an existing colonoscopy appointment
2. 50-75 years of age
3. Due for CRC screening or surveillance (defined as no evidence of: colonoscopy in the past 5 years, fecal immunochemical testing in the past 12 months, flexible sigmoidoscopy or CT colonography in the past 5 years, stool DNA test or Cologuard in the last 3 years)

Exclusion Criteria:

1. Age \<50 or \>75
2. Pregnant woman
3. Evidence of prior colonoscopy in the past 5 years, fecal immunochemical testing in the past 12 months, flexible sigmoidoscopy or CT colonography in the past 5 years, fecal DNA test or Cologuard in the last 3 years
4. History of colorectal cancer
5. History of inflammatory bowel disease (Crohn's disease or Ulcerative colitis)
6. History of colon surgery or resection
7. History of symptoms concerning for colorectal cancer, such as lower GI bleeding, within the past 6 months
8. Family history of a hereditary colorectal cancer syndrome, such as familial adenomatous polyposis (FAP) or hereditary non-polyposis colon cancer (HNPCC)
9. Current serious medical condition with estimated life expectancy of less than 6 months, such as incurable cancer, end-stage congestive heart failure, decompensated cirrhosis, end stage renal disease, etc.
10. Dementia
11. Does not speak English
12. No telephone number listed in electronic medical record
13. Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
Trial for Tobacco Cessation With Intensive Advice in Diabetic Patients: the ITADI Project

This study addresses an important problem in public health, smoking in diabetics. The morbidity and mortality observed in diabetics is linked to macro and microvascular problems. The consumption of tobacco has a multiplying effect on these vascular problems in diabetics. This study aims to evaluate the effectiveness of an intensive intervention in tobacco addiction in diabetic patients in primary care.

Other objectives of the study are:

1. To study the effectiveness of an intensive smoking cessation intervention in the evolution of the phases of change, as based on the Prochaska and DiClemente model, in diabetic patients attended in primary care.
2. To evaluate the effectiveness of an intensive smoking cessation intervention in the evolution of tabacco consumption in diabetic patients attended in primary care.
3. To quantify the time spent in the intensive smoking cessation intervention compared with the usual care in primary care.

Eligibility Criteria:
Inclusion Criteria:

* diabetic patients who are active smokers
* over the age of 14
* receive routine care in their respective health center

Exclusion Criteria:

* patients with communication difficulties (cognitive deterioration, language barrier)
* patients who normally receive their habitual care in a different health center
* patients with terminal diseases, psychiatric diseases that are unstable, or with addictions to other substances
* patients that are already receiving treatment to quit smoking at the time of recruitment
* patients that are difficult to locate during the study period
* patients that refuse to participate in the study