cyrilzakka/clinical-trials huggingface dataset:
Study of Efficacy, Pharmacokinetics and Safety of Continuous Intravenous Infusion of Org 9426 (Study P05977)

The purpose of this study is to compare the infusion rate of Org 9426 following intubating dose of Org 9426 0.6 mg/kg or 0.9 mg/kg in adult surgical patients.


Eligibility Criteria:
Inclusion Criteria:

* Subjects at least 20 but under 65 years of age.
* Subjects of asa class 1, 2 or 3 for general elective surgery.
* Subjects who are not considered to be pregnant.
* Subjects scheduled for elective surgery under sevoflurane or propofol anesthesia, with anticipated duration of surgery of 2-5 hours.
* Subjects with normal laboratory values for serum electrolytes (Na+, K+, Cl-), BUN, creatinine, total bilirubin, ALP, ALAT and ASAT as judged by the investigator or the sub-investigator.
* Subjects who received an explanation of the trial and agreed informed consent in writing to participate in the trial in advance.

Exclusion Criteria:

* Subjects with renal dysfunction as a complication or in the history.
* Subjects with serum creatinine level greater than 1.6 mg/dL.
* Subjects with severe hepatic dysfunction as a complication or in the history.
* Subjects with known significant metabolic or neuromuscular disorders.
* Subjects with showing dyspnea, airway obstruction or bronchial asthma.
* Subjects with a history of hypersensitivity to pancuronium bromide, vecuronium bromide or bromine.
* Subjects with atopic diseases.
* Subjects who have developed any systemic allergic symptoms related to drugs or general anesthesia.
* Subjects receiving antihistamines and antiallergic agents for 1 month or more.
* Subjects receiving any of the following drugs known to affect on the action of neuromuscular blocking agents on surgery day: calcium antagonists; anticonvulsants; aminoglycoside antibiotics; polypeptide antibiotics; or metronidazole.
* Subjects under hypothermic anesthesia.
* Subjects who participated as research subjects in another trial within the last 6 months or is now participating in other trials.
* Other subjects judged to be ineligible as subjects in this trial by the discretion of the investigator or sub-investigator.
CUFF-assisted Colonoscopy vs Standard Colonoscopy

The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate in routine colonoscopy.

This is a prospective comparative cohort, on 1034 patients, 517 patients with ECV in prospective group and 517 without ECV in retrospective group


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for total colonoscopic exploration, during the period study
* Patient over or equal to 18 years
* ASA 1, ASA 2, ASA 3
* No participation in another clinical study
* Certificate of non opposition signed

Exclusion Criteria:

* Patient under 18 years old
* ASA 4, ASA 5
* Pregnant woman
* Patient with coagulation abnormalities preventing polypectomy: prothrombin level \<50%, -Platelets \<50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress.
* Inflammatory bowel disease
* Known colonic stenosis
* Diverticulitis less than 6 weeks old
* Patient unable to give consent or protected by law
* Opposition expressed for inclusion in the study
Assessment of a Teachable Moment for Smoking Cessation

A teachable moment (TM) refers to life events or transitions, such as physician visits, early detection screening feedback, pregnancy, and hospitalization for, and diagnosis of, disease, that inspire health behavior change. Despite strong intuitive appeal of the TM concept and over 150 studies of interventions implemented in a TM, there has been little investigation of the influence of TMs for smoking, particularly for promoting smoking cessation among those indirectly affected by a TM (e.g., relatives of cancer patients). This prospective observational study using a matched-group design will assess whether a lung cancer diagnosis increases enrollment in a smoking cessation program and cessation, and reduces smoking, among the patient's relatives/spouse who smoke. We will compare enrollment in a cessation program and cessation and smoking rates in 2 groups of smokers: 1) relatives/spouses of newly-diagnosed lung cancer patients, and 2) relatives/spouses of patients with an orthopedic condition. We will also explore mediators and moderators of a lung cancer diagnosis as a TM. This study could clarify the TM concept for smoking cessation, shed light on the underlying mechanisms of TMs, and guide future development and implementation of TM-based smoking cessation interventions.


Eligibility Criteria:
Inclusion Criteria:

1. A relative (i.e., sibling, parent, child, grandparent, aunt, uncle, cousin) or spouse of a newly-diagnosed lung or head and neck cancer patient or orthopedic patient (e.g., arthritis, bone and joint infection, foot and ankle conditions, hand, wrist, and elbow conditions such as carpal tunnel syndrome, shoulder and elbow conditions, such as rotator cuff injury, and knee conditions, such as ligament damage repair);
2. A regular smoker (i.e., smoke 10 cigarettes/day on average);
3. Able to use NRT (see contraindications under Key Exclusion Criteria);
4. Age 18 or older (to use NRT); and
5. Living within \~50 miles of PENN (to allow for meetings at PENN).

Exclusion Criteria:

1. Cannot communicate in English;
2. Have current alcohol abuse/dependence;
3. Are or have been diagnosed with cancer, asthma, HIV, emphysema, or COPD;
4. Have a current medical problem for which NRT is contraindicated such as uncontrolled hypertension (\> 150 over 90), unstable angina, heart attack or stroke within the past 6 months, and liver and/or kidney failure in the last 6-months;
5. Currently use monoamine oxidase inhibitors or benzodiazepines, anti-psychotics, and antidepressants, including bupropion;
6. Are allergic to adhesive tape or latex, and
7. Are a female who is pregnant or nursing.
A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.

To assess the functionality and safety of the test products and also assess the products ability to collect stool without interfering with the stoma.


Eligibility Criteria:
Inclusion Criteria:

1. Had given written informed consent
2. Was at least 18 years of age
3. Was able to handle the appliances themselves or with help from a caregiver (e.g. spouse)
4. Had an ileostomy with a diameter between 15-45 mm
5. Have had an ileostomy for at least 3 months
6. Currently used a 2-piece flat appliance

Exclusion Criteria:

1. Used irrigation during the investigation (flush stoma with water)
2. Currently received or had within the past 2 months received radio- and/or chemotherapy.
3. Currently received or had within the past month received local or systemic steroid treatment in the peristomal area.
4. Was pregnant or breast feeding
5. Participated in other interventional studies that could interfere with this one or had previously participated in this investigation.
6. Had a baseplate wear time of more than three days
7. Suffered from peristomal skin problems that precluded participation in the investigation (assessed by the investigation nurse)
A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Complicated Urinary Tract Infections

The purpose of the study is to compare the safety and effectiveness of oral levofloxacin (an antibiotic) with that of oral ciprofloxacin in the treatment of complicated urinary tract infections in adults.

Levofloxacin is an antibacterial agent used for the treatment of a many types of acute infections in adults. This is a randomized, double-blind study of the safety and effectiveness of levofloxacin compared with ciprofloxacin in the treatment of adults with a complicated urinary tract infection. Complicated urinary tract infections include those associated with fever, chills, kidney involvement or anatomic and functional abnormalities of the bladder. Patients in one group are treated with 250 mg of levofloxacin taken once daily for 10 days, and the other group is treated with 500 mg of ciprofloxacin, also an antibacterial agent, taken twice daily for 10 days. Patients are followed for 5 to 9 days after completion of treatment (post-therapy) to assess clinical signs and symptoms of infection. Long-term follow up (4 to 6 weeks after the end of treatment) of those patients who respond to therapy provides further evaluation of clinical signs and symptoms. The primary assessments of effectiveness include the microbiological response (the eradication at post-therapy of the infectious organism identified at the start of the study) and the clinical response (the resolution of signs and symptoms at post-therapy compared with those at the start of the study). An additional assessment of efficacy includes the overall clinical response, which is described as cured, improved, or failed. Safety assessments include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, serum chemistry, and urinalysis) and physical examinations at the start of the study and post-therapy. The study hypothesis is that levofloxacin is at least as effective therapeutically and as well tolerated as ciprofloxacin in the treatment of adults with complicated urinary tract infections. Two levofloxacin 125 mg tablets taken orally once daily (and two placebo tablets taken once daily, 12 hours later) for 10 days; or one ciprofloxacin 500 mg tablet and one placebo tablet taken orally twice daily for 10 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a urinary tract infection with complicating factors such as anatomical or functional abnormalities
* capable of taking medication by mouth
* previous antibacterial therapy of less than 24 hours, or previous antibacterial therapy of greater than 24 hours that did not eliminate or stabilize the infection.

Exclusion Criteria:

* Patients having any medical condition that requires antimicrobial therapy to be given intravenously or by hypodermic needle
* complete obstruction of any part of the urinary tract
* inflammation of the prostate gland
* previous allergic or serious adverse reaction to similar antibiotics
* pregnant or nursing females, or those lacking adequate contraception.
TDCS to Improve Motivation and Memory in Elderly (TIME)

Fundamental advancements in understanding successful aging are limited by the lack of causal, rather than just correlational methods to connect age-related changes in memory ability to changes in brain structure and function. In this study, non-invasive electric brain stimulation will be used as a tool to create causal links between successful memory function in aging and brain structures associated with motivation. Recently, it was shown that a group of elderly, dubbed "superagers", are indistinguishable from young adults in memory performance and the structure of cortical limbic regions. A key superaging region is mid-cingulate cortex (MCC), a brain structure associated with motivation and tenacity. The MCC is a hub region that synchronizes information flow between three core brain networks. The goal of the research is to explore the contribution of motivation to memory performance by modulating MCC connectivity with transcranial direct current stimulation (tDCS) to provide the first causal evidence that experimentally induced motivation can improve memory performance. Since MCC has not been stimulated with tDCS before, we will test three different stimulation protocols and compare against a placebo. The stimulation protocols were computationally optimized for this project. The primary aim is to find the stimulation protocol most successful at improving memory performance. In order to elucidate the mechanisms behind these changes, effects of stimulation on motivation and network connectivity will be investigated. If indeed memory can be improved by increasing motivation and effort via stimulating MCC, this study will generate new insights into the motivational mechanisms of successful aging.


Eligibility Criteria:
Inclusion Criteria:

* between the ages of 65 and 80
* normal or corrected to normal vision
* fluent in speaking, reading and understanding English
* right-handed

Exclusion Criteria:

* any metal implants that may cause harm through MRI scanning
* other metals that may interfere with obtaining MRI signals
* claustrophobic
* pregnancy
* history of neurological or psychiatric illnesses
* history of fainting, seizures or epilepsy
* history of migraines
* history of drug abuse
* learning disability
* intracranial lesion
* any prescription or regular medication except for birth control
* any uncontrolled medical condition
* skin disease or damage on scalp
* hair style or head dress that prevents electrode contact with the scalp
* any condition affecting agility of hands (e.g. acute or chronic tenosynovitis, active joint deformity of arthritic origin)
The Burden of Acute Respiratory Failure in Chinese ICUs: a National Cohort Study

We aim to prospectively assess the burden, management and therapeutic approaches and outcomes of acute respiratory failure requiring respiratory support, during the winter months in China.

The purpose of this study is to provide new and current data on the disease burden of acute respiratory failure and ARDS. It will answer the following questions:

* The frequency and disease burden of acute respiratory failure in China;
* The incidence of ARDS based on the new global definition within this patient cohort.
* The mortality of ARDS within this cohort, and how does this vary based on ARDS categories and severity.
* The long-term outcomes (1-year mortality and survivor quality of life) of ARDS within this cohort.
* The nature course of ARDS (different stages and severity of ARDS).
* The respiratory support management strategies, such as recruitment maneuvers, prone positioning, ECCO2R, and ECMO.
* The use of drugs during ICU stays, including glucocorticoid, anticoagulant, nitric oxide, sivelestat, Xuebijing, and ulinastatin.
* The economical burden of acute respiratory failure within this patient cohort.
* The impact of occupation, incomes and education levels on the incidence and mortality of ARDS.

1. The goal of this study will focus on the following items:

   * The frequency and disease burden of acute respiratory failure in China;
   * The incidence of ARDS based on the new global definition within this patient cohort.
   * The mortality of ARDS within this cohort, and how does this vary based on ARDS categories and severity.
   * The long-term outcomes (1-year mortality and survivor quality of life) of ARDS within this cohort.
   * The nature course of ARDS (different stages and severity of ARDS).
   * The respiratory support management strategies, such as recruitment maneuvers, prone positioning, ECCO2R, and ECMO.
   * The use of drugs during ICU stays, including glucocorticoid, anticoagulant, nitric oxide, sivelestat, Xuebijing, and ulinastatin.
   * The economical burden of acute respiratory failure within this patient cohort.
   * The impact of occupation, incomes and education levels on the incidence and mortality of ARDS.
2. Methods 2.1 Study Design This is a national prospective observational study, aimed at collecting an adequate dataset on a large cohort of patients admitted to a large number of ICUs in China. Each ICU will be requested to recruit for 8 consecutive 'winter' weeks between January 2024 and April 2024.

   2.2 Inclusion and exclusion criteria
   * Inclusion criteria: All patients admitted to the participating ICU receiving invasive, non-invasive ventilation or high-flow nasal cannula (HFNC) will be screened and included in the database.
   * Exclusion criteria:Age\<18
3. Sample size calculation Our aim is to obtain a sample of at least 1500 ARDS patients within the cohort.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the participating ICU receiving invasive, non-invasive ventilation or high-flow nasal cannula (HFNC) will be screened and included in the database.

Exclusion Criteria:

* Age\<18.
Study of LUMA Cervical Imaging System as Adjunct to Colposcopy

This is a post-approval, multi-center, single-arm study (n=950) designed to address the relationship of the LUMA device performance to patient age, patient human papillomavirus (HPV) status and colposcopist experience.


Eligibility Criteria:
Inclusion Criteria:

* Documented abnormal pap test
Robotic Versus Hybrid Assisted Ventral Hernia Repair

Laparoscopic ventral hernia repair (LVHR) may be associated with chronic pain, seroma formation, bulging and failure to restore abdominal wall function. These outcomes are risk factors for hernia recurrence and poor quality of life (QoL). Our study evaluates whether robotic-assisted ventral hernia repair (rVHR) diminish these complications compared to LVHR with primary closure of the defect (hybrid).

Thirty patients undergoing incisional ventral hernia operation with fascial defect size from 3 to 6 cm will be recruited. Fifteen patients undergo rVHR and fifteen undergo hybrid operation.The main outcome measure is postoperative pain, evaluated with visual analogue scale (VAS: 0-10) preoperatively, at 1-week, at 1-month and at 1-year. Hernia recurrence will be evaluated with ultrasound examination at 1-year and QoL using the generic SF-36 short form questionnaire preoperatively, at 1-month and at 1-year.

Eligibility Criteria:
Inclusion Criteria:

* ventral hernia size 3-6 cm

Exclusion Criteria:

* previous ventral hernia
A Clinical Trial to Compare Pharmacokinetics of Two Different PEG-rhGH Preparations

The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations after a single administration.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male aged ≥18 years old and≤45 years old;
* The Body mass index (BMI): 19-26 kg/m2 (inclusive), and body weight ≥50 kg;
* Normal results of physical examination, vital signs, laboratory tests, 12 lead-ECG, chest X-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above.

Exclusion Criteria:

* Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing;
* Subjects with a clear history of disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic system, etc., or other diseases deemed unsuitable for participation in the trials by the investigators;
* Subjects with severe infection, severe trauma, or major surgery prior to screening;
* Subjects who have received blood transfusions, had blood donors, or lost blood before screening;
* Subjects who have positive results of human immunodeficiency virus antibodies (HIV-Ab), or hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV-Ab), or syphilis specific antibodies (TPPA);
* Subjects who have participated in clinical trials for medication or medical device prior to screening;etc.
Effect of Whole Body Vibration Versus Core Stability Exercises on Balance and Muscle Strength in Children With Down Syndrome

Children had Down syndrome often have impaired balance and postural control and result as less active than their peers that can lead to reduced quality of life and movement skills. Effects of physical activity may be important in preventing falling risk and health consequences in those children

Sixty children from both genders (boys and girls) participated in this study, their ages ranged from 10 to 16 years and they were randomized into three groups of same number (A, B and C). Groups (A) received conventional physical therapy program, group (B) received the same conventional physical therapy program of group (A) and core stability exercises while group (C) received the same conventional physical therapy program of group (A and B) and whole body vibration exercise

Eligibility Criteria:
Inclusion Criteria:

* Aged between 10 to 16 years.
* Able to recognize commands given to them.
* Understand our verbal command and encouragement.
* Stand and walk independently without repeated falling.

Exclusion Criteria:

* Children with any neurological (signs of epilepsy and instability of atlantoaxial joint).
* Musculoskeletal, or mobility disorders.
* Cardiac anomalies.
* Vision or hearing loss.
Methadone in Pediatric Anesthesia

This study will determine the pharmacokinetics of intravenous (IV) methadone in children undergoing surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 5-18
* Undergoing General anesthesia and surgery with anticipated postoperative inpatient stay of greater than or equal to 3 days
* Signed, written, informed consent from legal guardians and assent from patient

Exclusion Criteria:

* History of or known liver or kidney disease
Intervening Early With Neglected Children

This study will assess early and middle childhood outcomes of an intervention for neglecting parents that was implemented in the children's infancy. We expect that parents who received the Attachment and Biobehavioral Catch-up Intervention in infancy will be more nurturing and will follow children's lead more than parents who received a control intervention, and that children will show better outcomes in attachment, inhibitory control, emotion regulation, and peer relations than children of parents who received the control intervention.

Children were randomly assigned to receive the ABC intervention or a control intervention (DEF) in infancy. These two groups, plus a group of low-risk children, will be studied in early and middle childhood. Of interest will be differences in parent and child outcomes that result from the intervention.

Hypothesis 1: Neglected children whose parents received the ABC intervention and low-risk comparison children will show better inhibitory control than neglected children whose parents received the DEF intervention.

Hypothesis 2: Children in the ABC intervention condition and low-risk comparison children will show better emotion regulation than children in the DEF condition.

Hypothesis 3: Children in the ABC intervention condition and comparison children will show less reactive aggression and less hostile attributional bias than children in the DEF condition.

Hypothesis 4: Children in the ABC condition and comparison children will show more normative cortisol production than children in the DEF condition.

Although we expect that sustained changes in parenting are critical for sustained changes in child behaviors, several alternative models will be tested. First, it is possible that when parents change as a result of the intervention in a child's infancy, there are positive outcomes for children regardless of whether the changes in parenting are sustained. If this is the case, early parenting will mediate the effects of the intervention when controlling for later parenting. Second, if concurrent parenting is what is critical to child functioning, current parenting will mediate intervention effects on child outcomes when controlling for early parenting. Third, longitudinal modeling of both parent and child behaviors allows for analysis of cross-lagged associations using structural equation modeling. Such modeling can examine concurrent and transactional associations between parent and child. We can also examine associations between change at behavioral and biological levels.

Longitudinal modeling will be used to examine models of change in parenting behaviors and how those influence child outcomes.

Eligibility Criteria:
Inclusion Criteria:

* must have been in earlier randomized clinical trial

Exclusion Criteria:

-