cyrilzakka/clinical-trials huggingface dataset:
Patient Specific PEEK Versus Titanium Patient Specific Plates in The Fixation of Computer-Guided Advancement Genioplasty

Evaluation of polyetheretherketone (PEEK) versus titanium patient specific plates in the fixation of computer-guided advancement genioplasty.

Aim: Comparison between polyetheretherketone (PEEK) and titanium patient specific plates in the fixation of computer-guided advancement genioplasty.

Patients and Methods: This study included fourteen patients indicated for advancement genioplasty. Patients were assigned randomly into one of two equal groups. Group A (Control group) included seven patients who were treated by computer guided advancement genioplasty using patient specific titanium plates and Group B(Study group) involved seven patients who were treated by computer guided advancement genioplasty using patient specific PEEK plates.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are indicated to advancement genioplasty.
* Patients with completed growth.
* Physically and psychologically able to tolerate surgical procedures.

Exclusion Criteria:

* Presence of any medical conditions that contraindicate the surgical procedure.
* Any medical condition that compromises the healing and surgical outcome.
Postspinal Hypotension and Cardiac Performance in the Elderly

Patients, scheduled for elective arthroplasty were monitored with Lithium Dilution Cardiac Output monitor (LiDCOplus™) before and 45 minutes after spinal anesthesia. Hypotension was defined as systolic blood pressure ≤ 100 mmHg or ≥ 30% decrease from baseline. Associations between hypotension and the hemodynamic changes after preanaesthetic fluid loading and spinal anesthesia were analysed by logistic regression analyses.


Eligibility Criteria:
Inclusion Criteria:

* hip or knee arthroplasty
* spinal anaesthesia
* age 65 years or more

Exclusion Criteria:

* weight \<40kg
* concomitant lithium medication
* written informed consent not obtained
* research team unavailable
Radiolabel ADME (Absorption, Distribution, Metabolism, and Excretion) Study Of [14C] PF-00868554 In Healthy Adult Male Subjects

This is a phase 1 study to assess the routes of elimination of a single oral dose of \[14C\] PF-00868554 and to characterize the metabolic profile following single dose administration.


Eligibility Criteria:
Inclusion Criteria:

* Male, healthy volunteers.

Exclusion Criteria:

* Females.
Abbott Ventricular Tachycardia PAS

This post-approval study (PAS) is designed to provide continued clinical evidence to confirm the long-term safety and effectiveness of the FlexAbilityTM Ablation Catheter, Sensor EnabledTM (FlexAbility SE) for the treatment of ventricular tachycardia in a post-market environment. This is a prospective, single arm, open-label, multi-center, observational study.


Eligibility Criteria:
Inclusion Criteria:

1. Patient or legally acceptable representative or parent/guardian (as applicable) must provide written informed consent prior to any clinical investigation-related procedure
2. Subjects who have recurrent, drug-refractory, sustained MMVT with non-ischemic structural heart disease and a clinical decision has been made to use FlexAbility SE for an ablation procedure prior to enrollment in the research study
3. Refractory (i.e. not effective, not tolerated or not desired) to at least one Class I/III anti-arrhythmic medication for treatment of MMVT
4. Implanted with a market released ICD or CRT-D prior to the Index Ablation Procedure
5. Able and willing to comply with all study requirements

Exclusion Criteria:

1. Documented or known intracardiac thrombus or myxoma
2. Active systemic infection
3. History of atriotomy or ventriculotomy within 4 weeks prior to the Index Ablation Procedure
4. Patients with prosthetic valves as the catheter may damage the prosthesis
5. Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
Long Term Treatment of Patients With Major Depressive Disorder With MK0869 (0869-065)(COMPLETED)

A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression.

The duration of treatment is 20 months.

Eligibility Criteria:
Patients with Major Depressive Disorder
Child Adult Relationship Enhancement in Pediatric Primary Care Parenting Group to Reduce Child Behavior Problems

The purpose of this study is to evaluate the effectiveness of PriCARE in decreasing child behavior problems and improving parenting capacity and skills at 4 primary care clinics in Philadelphia.

Child behavioral concerns are common among families served by The Children's Hospital of Philadelphia (CHOP) urban primary care centers. To address this, we developed Child Adult Relationship Enhancement Model in Primary Care Parenting Program (PriCARE), a scaled down version of Parent Child Interaction Therapy designed for urban primary care clinics. The objectives of this study are to 1) evaluate the efficacy of the modified PriCARE to decrease child behavior problems and improve parenting capacity and skills and 2) understand parents' perceptions of the efficacy of PriCARE and strategies for improving its implementation and dissemination. We will perform a randomized controlled trial (RCT) of the effectiveness of the modified PriCARE on decreasing child behavior problems and improving positive parenting among 2- to 6-year-old children with behavior problems and their parents at CHOP's urban Primary Care Centers. We intend to randomize 120 child-parent pairs (240 subjects) to receive PriCARE immediately plus usual treatment (intervention group) and 60 child-parent pairs (120 subjects) to receive PriCARE at a later time plus usual treatment (control group) for a total of 180 child-parent pairs (360 subjects). All child-parent pairs randomized to the control group will be placed on a waitlist and offered PriCARE after completion of data collection. Child behavior and parenting style will be measured at baseline (time 1), at 6-19 weeks (time 2), and at 14-27 weeks (time 3).

Eligibility Criteria:
Inclusion Criteria:

1. Parent is 18 years or older
2. Parent is English speaking
3. Child is 2-6 years old
4. Parent reports that child has a behavior problem
5. Child attends CHOP Urban Primary Care Center 6) Parental/guardian permission is provided (informed consent)

Exclusion Criteria:

1. Child has a cognitive age less than 2 years old as determined by the referring clinician
2. Child is already receiving behavioral health therapy or medication (other than medication for ADHD)
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors

This is a Phase 1, open-label, multicenter, single-arm, dose escalation study, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of single-agent ASC61(an orally bioavailable small-molecule inhibitor of PD-L1) in subjects with advanced solid tumors for whom no standard therapy is available.

Except for the first starting dose of 200 mg once daily (QD), a traditional "3 + 3 design" will be followed for dose finding with dose escalation and/or de escalation as appropriate. Each subject in each dose cohort will use 2 dose schedules: single dose on Day 1 (D1), and repeated doses on daily basis for 28 days starting from Day 3. One treatment cycle is 28 days. Subjects will be sequentially enrolled in a dose-escalation design to receive ASC61 at initial dose of 200 mg QD. Subsequent doses of 200 mg twice a day (BID), 300 mg BID, 400 mg BID, and 600 mg BID are planned.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age at the time of screening
* Histological or cytological diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available, regardless of cancer stage and previous experienced therapies
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* At least one measurable lesion, as defined by RECIST 1.1

Exclusion Criteria:

* Known symptomatic brain metastases requiring steroids
* Known history of another primary solid tumor
* Subjects discontinued prior therapy with immune checkpoints due to toxicity if previously received therapy with this class of drugs
* Known history of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or evidence of active pneumonia or pneumonitis
* Gastrointestinal disorders that might affect drug absorption
Robotic Brace Incorporating Electromyography (EMG) for Moderate Affected Arm Impairment After Stroke

Stroke is the leading cause of disability in the United States. One of the reasons that it is so disabling is because of upper extremity hemiparesis (weakness in one arm), which is commonly seen after stroke.

The objective of this research is to see if a robotic system worn on the weakened arm like a brace is more useful in improving the strength and coordination of the affected arm, and those of other stroke survivors, than therapy only. Muscle weakness and lack of coordination after a stroke have great effects on how severely disabled the arm is and on quality of life after a stroke.

In this study, patients may be administered a new robotic brace as part of treatment for their affected arms. If they use this brace, your electromyography (EMG) signals will be used to control the powered arm brace. EMG signals are the small electrical signals that result from the actions of the muscles. The system will "listen" to patients' muscles, using small sensors that sit on top of the skin. The device will give the arm a "power-assist" when patients bend or straighten their elbows. The investigators want to test how easy and effective this system is to use. The investigators hypothesize that people using the robot will be more successful in their rehabilitative efforts - and that their movement will improve more - than people receiving traditional therapy.


Eligibility Criteria:
Inclusion Criteria:

* Upper extremity Fugl Meyer score \>10-\< 25
* presence of volitionally activated EMG signal from the paretic biceps brachii of at least 5 ųV in amplitude
* stroke experienced \> 1 month prior to study enrollment;
* a score \> 24 on the Folstein Mini Mental Status Examination (MMSE)
* age \> 35 \< 85
* have experienced one stroke
* discharged from all forms of physical rehabilitation
* Myomo brace fits on affected arm properly and without discomfort (i.e., no red marks or discomfort observed in 10 minutes of use during fitting).

Exclusion Criteria:

* \< 35 years old
* excessive pain in the affected hand, arm or shoulder, as measured by a score \> 5 on a 10-point visual analog scale
* excessive spasticity at the affected elbow, as defined as a score of \> 4 on the Modified Ashworth Spasticity Scale
* currently participating in any experimental rehabilitation or drug studies
* apraxia (\< 2.5 on the Alexander scale)
* severe sensory loss in affected hand (Nottingham sensory scale at least 75% of normal)
* severe language deficits (score \< 2 on NIH Stroke Scale question 9)
* Stroke that occurred in the brainstem
* A current medical history of uncontrolled cardiovascular, or pulmonary disease, or other disease that would preclude involvement in a therapeutic treatment
* History of neurological disorder other than stroke (other neurological disorders may affect the upper extremity motor performance of subjects.)
* Other significant pain or skin irritation in the upper extremity that would be exacerbated if by the use of the brace
* Substantial contracture of elbow, defined as \> 20 degrees of elbow flexion, as measured at the baseline evaluation.
ATLANTIS:Extensive Type A Dissections and Thoracic/ Thoraco-Abdominal Aneurysms Repair With LupiAe Hybrid TechNique

To prospectively evaluate the safety and efficacy of the LUPIAE hybrid technique for the treatment of

* thoracic or thoraco-abdominal aortic aneurysms
* thoracic aortic type A dissections 2. to compare the safety and efficacy of the LUPIAE hybrid technique with historical groups (literature review, other hybrid techniques, LUPIAE retrospective patients)

LUPIAE technique:

Hybrid repair of thoracic or thoraco-abdominal aneurysms of different etiology and type A dissections with a two-stage procedure:

1. surgical arch reconstruction with a Dacron multibranched surgical prothesis
2. endovascular implantation of a thoracic stent graft

Eligibility Criteria:
Inclusion Criteria:

1. Patient willing to sign the informed consent, or In case of acute patients that should arrive at the hospital in unconsciousness status, patient's first degree relatives willingness to sign the informed consent and patient's willingness to re-consent for the study participation once he/she is again conscious.

   and
2. Patients with extensive thoracic or thoraco-abdominal aortic aneurysms (\>55 mm diameter), involving the ascending, arch and descending aortic segments, but not involving the renal arteries (at least 15 mm of healthy tissue above the most proximal renal artery).

   Or
3. Patients with extensive type A aortic dissection (DeBakey type I) with at least one of the following minimum criteria:

   * An initial false lumen diameter measured in the upper descending thoracic aorta \>22 mm;
   * Total aortic diameter measured in the descending thoracic aorta \>45 mm;
   * True lumen's compression (True lumen \<10% of total aortic lumen);
   * Non-controlled hypertension;
   * Persistent pain;
   * Rupture or imminent rupture;

Exclusion Criteria:

1. Patient has a standard contraindication to the implant of thoracic stent graft;
2. Patient unable to commit to follow-up schedule;
3. Patient has medical conditions that preclude protocol required testing or limit study participation;
4. Patient is enrolled or intend to participate in another clinical trial during the course of this study;
5. Less than 18 years of age;
6. Pregnancy;
7. A life expectancy of less than one year, except for Patients with extensive type A aortic dissection (DeBakey type I)
Understanding Sleep in Hospitalized Older Patients

The overall goal of this research is to elucidate how environmental, healthcare, and patient-level factors and patients' level of perceived control impact sleep duration and quality in hospitalized older patients and to assess whether better in-hospital sleep is associated with improved physical activity and health outcomes.

We hypothesize that environment, healthcare disruptions and patient symptoms will be significantly associated with objective and subjective sleep duration and sleep quality in hospitalized older patients.

We also hypothesize that a high level of perceived control will be associated with improved sleep duration and quality in hospitalized older patients.

We further hypothesize that shorter sleep duration and quality in hospitalized older adults will be associated with adverse health outcomes, namely higher blood pressure and blood sugar.

This research can lead to a better understanding of the effects of inpatient sleep on health outcomes for hospitalized older patients and can help inform the design and evaluation of interventions designed to improve sleep in hospitalized older patients. This work can also form the foundation for understanding the longer term health effects of inpatient sleep loss for older patients that are potentially modifiable.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 or above
* Hospitalized on General Medicine service
* Ambulatory
* Community Dwelling
* MMSE \>17

Exclusion Criteria:

* transfer from the ICU or another hospital
* cognitively impaired
* not ambulatory
* residents of a nursing home or skilled nursing facility
* on bedrest
* documented sleep disorder in their medical history
Development and Validation of Nomogram Predicting Survival in Chinese SCLC Patients

In this retrospective study, patients diagnosed with SCLC between January 2011 to September 2022 were identified from database of the Second Hospital of Shandong University. Following inclusion criteria should be met: (1) Had histologically or cytologically confirmed newly diagnosed SCLC; (2) No cancer treatment has been done before; (3) Complete clinical, laboratory, imaging, treatment data and follow-up information. The exclusion criteria included: Patients without complete records for pathological information, complete epidemiology and other key clinical information.

The investigators classified qualitative variables according to clinical practice. Age included less than 60 years, 61-66 years, and more than 67 years. The primary tumor location included left-sided and right-sided. The anatomic sites included lower and others. The smoking status included never smoker and ever smoker. The forms of performance status according to the Eastern Cooperative Oncology Group scale (ECOG PS) were ECOG ≤ 2, and ECOG ≥ 3. Five groups were formed according to clinical T stage (T0-1, T2, T3, T4, and T stage that could not be evaluated). Three groups were formed according to clinical N stage (N0-1, N2-3, and N stage that could not be evaluated). Some stages were unevaluated, on account of a portion of non-measurable tumor size and lymph node. Three groups were formed according to clinical M stage (M0, Ma-b, Mc). Four groups were formed according to clinical TNM stage (Ⅰ-Ⅱ, Ⅲ, Ⅳ and TNM stage that could not be evaluated). The common metastatic sites(brain, liver, and bone) of tumor was divided into none and yes. The hematologic markers (serum natrium , lactate dehydrogenase, carcinoembryonic antigen, neuron-specific enolase, cytokeratin 19 fragment, and pro-gastrin-releasing peptide) were divided into normal and abnormal. The above information was collected before treatment. The RECIST version 1.0 was used to assess tumor responses after initial imaging studies of commencing chemotherapy. Initial chemotherapy response is the first imaging examination of SCLC patient after starting chemotherapy. Six groups were formed according to initial response to chemotherapy (CR, PR, SD, PD, response that could not be evaluated, and no chemotherapy). Other treatments (radiotherapy, surgery, targeted therapy, immunotherapy, Interventional therapy, and whole-brain prophylactic cranial irradiation) was classified none and yes.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosis of small cell lung cancer
2. No cancer treatment has been done before
3. Complete clinical, laboratory, imaging, treatment data and follow-up information

Exclusion Criteria:

1. Without complete records for pathological information, complete epidemiology and other key clinical information
Causes of Appetite Loss in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The project looks at causes of appetite loss in patients with COPD. It is know that active systemic inflammation can lead to appetite loss and COPD is classified as a disease lead by inflammation. But it has never been investigated if the patient with COPD has other causes of appetite loss such as physical, psychological or social barriers for not reaching a sufficient dietary intake.

The study uses a homemade questionnaire, the CAT-scale and the CNAQ-score to evaluate the extent of appetite loss and certain demographic characteristics of the participants. There will be made correlation analysis for CNAQ-score and continuous variables and there will be tested for significant differences between the group who scores as low appetite and the group that scores with a normal appetite via CNAQ.

The second part of the study invites patients to participate in a semi-structured interview, that focuses on the patient's experience with appetite loss, meals and food. The interviews will be transcribed and analysed.


Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis

Exclusion Criteria:

* None
Maintenance Therapy With Anti-PD-1 Antibody for Patients With NK/T-cell Lymphoma

For patients with NK/T-cell lymphoma, plasma EBV-DNA has been found to be a prognostic factor, and those with positive plasma EBV-DNA at the end of treatments are more likely to suffer from disease relapse. Thus, this study aims to evaluate the role of maintenance with anti-PD-1 antibody.

For patients with NK/T-cell lymphoma, plasma EBV-DNA has been found to be a prognostic factor, and those with positive plasma EBV-DNA at the end of treatments are more likely to suffer from disease relapse. The investigators previously reported one-year progression free survival rate of 22.2% for patients with positive plasma EBV-DNA at the end of treatments. Recently, anti-PD-1 antibody has been shown to be highly effective in the treatment of NK/T-cell lymphoma. Thus, this study aims to evaluate the role of maintenance with anti-PD-1 antibody for patients with positive plasma EBV-DNA at the end of treatments.

Eligibility Criteria:
Inclusion Criteria:

* Pathology confirmed diagnosis of NK/T-cell lymphoma.
* Plasma EBV-DNA was positive at the end of first-line pegaspargase-based regimens.
* ECOG score of 0-3 points.
* The lab tests within 1 week before enrollment meets the following:

  * Blood routine: Hb≥80g/L, PLT≥50×10e9/L.
  * Liver function: ALT, AST, TBIL≤2 times the upper limit of normal.
  * Renal function: Cr is normal.
  * Coagulation: plasma fibrinogen≥1.0g/L.
  * Cardiac function: LVEF≥50%, ECG is normal
* Sign the informed consent form.
* Voluntary compliance with research protocols.

Exclusion Criteria:

* Patients had relapsed NK/T-cell lymphoma.
* Active infection requires ICU treatment.
* Concomitant HIV infection or active infection with HBV, HCV.
* Serious complications such as fulminant DIC.
* Significant organ dysfunction:

  * respiratory failure
  * NYHA classification≥2 chronic congestive heart failure
  * decompensation Hepatic or renal insufficiency
  * high blood pressure and diabetes that cannot be controlled
  * cerebral vascular events within the past 6 months.
* Pregnant and lactating women.
* Had a history of autoimmune diseases, and disease was active now. Those who were known to be allergic to drugs in the study regimen.
* Patients with other tumors who require treatments within 6 months.
* Other experimental drugs are being used.
Comparison of Carotenoid Bioavailability From Fresh Papaya, Tomato and Carrot

The goal of this study is to determine if papaya fruits are an exceptionally good food source for carotenoids in humans, particularly when compared more common carotenoid sources like carrots and tomatoes. This objective will be accomplished by quantitation of the immediate post-prandial plasma concentrations of parent carotenoids and vitamin A metabolites from subjects who consumed a meal containing fresh papaya, tomato, and carrot.

The main purpose of this study is comparing bioavailability of papaya carotenoids versus carrot and tomato carotenoids. Previously, vitamin A deposition in rat livers was studied, showing that carotenoid bioavailability from papaya is higher than from spinach, parsley and carrots. Detailed knowledge about human carotenoid absorption and conversion from papaya fruit compared to other food sources is still lacking.

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals

Exclusion Criteria:

* lactating, pregnant, or planned to be pregnant
* smokers/those who use tobacco products
* metabolic or malabsorption disorders
* had a history of cancer
* history of liver insufficiency or other gastro-intestinal diseases
* allergy to papaya, carrots or tomatoes
* obesity