cyrilzakka/clinical-trials huggingface dataset:
The Incidence and Incubation Period of False Positive Cultures in Shoulder Surgery

This study will describe the time point at which a positive culture from a patient who has undergone shoulder surgery should be treated as an infection versus a false positive result that should be disregarded. Intraoperative biopsies will be taken and cultured from 50 subjects who have undergone an "open" surgical procedure and 50 from subjects undergoing an arthroscopic procedure.

Postoperative infection is a significant complication that requires timely identification and treatment. Indolent infections, such as those involving Propionibacterium acnes (P. acnes), pose a diagnostic dilemma as they present differently than the acute symptoms typically associated with most postoperative bone and joint infections. The workup of these suspected infections is also somewhat difficult, as these colonies are slow growing, necessitating that cultures be kept for an extended period of time. Previous studies have shown that positive cultures are typically identified between 7 and 13 days. In a recent study of patients undergoing primary shoulder arthroplasty, 41.8% of patients were found to have P. acnes growth from their joint fluid at a mean of 7 days (range 5-9 days). All of these patients were then treated immediately with 4 weeks of dual oral antibiotic therapy1.

As the incubation of laboratory cultures increases, there is the potential concern of false positive growth. Timely identification is critical in order to avoid performing unnecessary treatments on patients in whom no infection is actually present.

The investigators will enroll patients undergoing primary shoulder surgery for a clearly identified mechanical dysfunction, in which there is no clinical suspicion for infection. Infection should not exist in this population, making it an appropriate clinical sample in which to study results that the investigators would consider to be false positives.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary open and arthroscopic shoulder surgery in which there is a clear diagnosis of a mechanical problem that is felt to be amenable to surgical intervention and there is no suspicion of infection. Examples include, but are not limited to: rotator cuff tear, labral tear, instability, impingement, and osteoarthritis.

Exclusion Criteria:

* Prior shoulder surgery
* Prior glenohumeral injection within the last 6 months
* Systemic or shoulder inflammatory disorder
* Any clinical, imaging, or laboratory findings that raise suspicion of infection
* Minors
* Erythrocyte sedimentation rate (ESR) \>15 mm/hr for males less than 50 years old, \>20 mm/hr for males greater than 50 years old and females less than 50 years old, and \>30 mm/hr for females greater than 50 years old
* C reactive protein (CRP) \>1 mg/d,
* Procalcitonin (PCT) \>0.05 ng/ml.
Automated Assessment of Mental Health in the Workplace

The purpose of this study is to design, refine, and test for the effectiveness of a computer-based telephone system (Telephone-Linked Communications for Detection of Mental Health Disorders in the Workplace; TLC-Detect) that will screen workers for mental health distress; educate them about seeking treatment; and follow up with them over a 6 month period.


Eligibility Criteria:
Inclusion Criteria:

* Employment with benefits at Boston Medical Center, Boston University, or Florida Power and Light Company
* Ability to speak and understand conversational English
* \> 18 years of age
* Access to a touch-tone telephone
* Screen positive for the World Health Organization (WHO)-5 Well-Being Index

Exclusion Criteria:

* Being under treatment (medication or therapy) for a mental health disorder
* Taking medication for a serious/major medical disorder that interferes with normal life
* Taking medication prescribed for mental health treatment on a daily basis
* Diagnosed with schizophrenia
* Planning to go on leave for over 6 months
PPK Study Based on Quantitative Pharmacology in Patients With Pamipril

This is a non-intervention, prospective, one-arm, observational real-world clinical trial. The researchers plan to recruit at least 50 qualified patients. The main purpose of this study was to establish a population pharmacokinetic model of Pamiparib and to explore the correlation between its pharmacokinetic parameters and adverse reactions.

In recent years, the advent of poly(ADP-ribose) polymerase(PARP) inhibitors is one of the important breakthroughs in the field of tumor-targeted therapy, and its therapeutic effect on ovarian cancer is quite significant Pamiparib is a potent, selective, oral PARP 1/2 inhibitor. In preclinical models, pamiparib demonstrated PARP-DNA complex trapping, brain penetration, antitumor activity, and inhibition of PARylation.

Therefore, at least 50 patients using pamiparib will be included. Before and after treatment, the laboratory examination data ，blood concentration ，combined medication and adverse events of the patients will be collected. The population pharmacokinetic model of pamiparib was established to evaluate the correlation between pharmacokinetic parameters and adverse reactions.

Eligibility Criteria:
Inclusion Criteria:

1. The age of the patient is ≥ 18 years old and less than 80 years old.
2. Receive treatment with pamipalil.
3. The patient signed a written informed consent form.

Exclusion Criteria:

1. The expected survival time may be less than the treatment cycle.
2. Is being treated with other systemic trial drugs.
3. There are other factors that the researchers think are not suitable for joining the group.
VFI in Healthy Vessels

There is a wealth of evidence implicating the important role of blood flow throughout all stages of the process of atherogenesis. Two locations along the vascular tree at which atherosclerotic plaques are typically found are the carotid artery (CA) and the superficial femoral artery (SFA). Nowadays, ultrasound is the technique of choice for assessing the vascular condition in the CA and SFA. However, clinically used ultrasound techniques show a large variability in estimating the blood flow velocity, due to multiple limitations. With the advent of ultrafast ultrasound imaging, (almost) all elements of the transducer can be activated simultaneously. These so-called plane wave acquisition acquires thousands of images per second and makes continuous tracking of blood flow velocities in all directions in the field of view possible. This high-frame-rate acquisition opened up new possibilities for blood flow imaging at the CA and SFA, such as blood Speckle Tracking (bST) and ultrasound Particle Image Velocimetry (echoPIV). Both these vector flow imaging (VFI) techniques enable the quantification of 2D blood flow velocity profiles, where bST uses no contrast agents compared to echoPIV. Beside these novel ultrasound based techniques, 4D Phase Contrast Magnetic Resonance Imaging (4D flow MRI) enables a non-invasive quantification of the 4D blood flow velocity profiles (3D + time) and can be used as reference standard for blood flow assessments in-vivo. We therefore aim to evaluate the performance of both VFI techniques in comparison to 4D flow MRI measurements in the CA and SFA of healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female, without cardiovascular and pulmonary medical history and without the use of medication for cardiovascular risk factors
* Age between 20-30 year or 65-75 years old
* Willingness to undergo a 4D flow MRI scan and US examinations
* Informed consent form understood and signed, and agrees to the hospital visit

Exclusion Criteria:

* Hypersensitivity to the active substance(s) or any of the excipients in Sonovue
* Pregnancy
* MRI exclusion criteria (such as presence of pacemaker, cerebral vascular clips, claustrophobia)
Objective Markers of Pain Perception in Humans

Determine objective markers of pain perception remains a major scientific and medical issue. Various tools have been proposed to objectify pain, but their adaptability to different clinical contexts are limited. Our working hypothesis considers that the research for markers of immediate pain perception should be based on an electrophysiological approach, based on the combined analysis of EEG and autonomic responses.

This project aims to study the cortical and autonomic responses induced by tonic painful stimulation compared to those induced by comparable sensory and stressful stimulations, by combining high density EEG, cutaneous sympathetic, cardiovascular and pupillary recordings.

Eligibility Criteria:
Inclusion Criteria:

* Affiliate or beneficiary of social security
* Signature of consent

Exclusion Criteria:

* History of cardiovascular disease (vagal syncope, hypertension, etc ...), renal, metabolic (diabetes ...), psychiatric (depression, etc ...) or neurological (seizure, etc ...) syndromes;
* Reynaud's syndrome;
* Raynaud's disease;
* Acrocyanosis;
* Known rhythm disorders;
* Participation at the same time in another clinical trial;
* Taking a medical treatment;
* Suffering from acute (complaint of pain in the week before the test) or chronic pain,
* Allergic to conductive gel for electrodes.
Pharmacokinetic Study Of AGILE AG200-15 After Weekly Application Under Various Conditions in Healthy Female Volunteers

A study to evaluate pharmacokinetic profile, wearability and safety of AG200-15, transdermal delivery of levonorgestrel (LNG) and ethinyl estradiol (EE), under normal conditions and external conditions of heat, humidity, cold water and exercise.

Normal conditions - average daily living activities, Dry Sauna - 10 minutes at 168.8 - 179.6 degrees Fahrenheit, Whirlpool - 10 minutes at 102.2 - 105.8 degrees Fahrenheit, Treadmill - 20 - 30 minutes at 60-80% max heart rate, Cold Water - 5 - 15 minutes at 71.6 degrees Fahrenheit.

There will be three treatment periods. Subjects will be randomly assigned to one of the five conditions for the treatment period. The subject will be exposed daily to the condition assigned while wearing the patch. The study patch will be worn for a 7 day treatment period, followed by a 7 day washout period. The total duration of the study is 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women, ages 18-45
* Body mass index (BMI)of ≥18 and less than or equal to 32, and weight ≥ 110 lbs.
* Willing to use a non-hormonal method of contraception if of childbearing potential, or have already undergone previous bilateral tubal ligation or hysterectomy
* Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior to patch application until completion of each treatment period
* Willing to give informed consent to participate in study

Exclusion Criteria:

* Known or suspected pregnancy
* Breast-feeding or within 1 month after stopping breast-feeding
* Smokers
* Any disease that may worsen with hormonal treatment
* Hypersensitivity to transdermal preparations or sensitivity to surgical/medical tape
Mechanisms of Exercise Resistance in Metabolic Disease

This project will determine exercise capacity and molecular markers of the response to acute exercise in human subjects with impaired or normal glucose tolerance.

Low exercise capacity is an early clinical marker of metabolic impairment that predicts type 2 diabetes (T2D) risk, as well as future co-morbidities and complications. Aerobic exercise training is the only effective treatment to increase exercise capacity and reduce metabolic risk. However, despite maintaining similar levels of physical activity, exercise capacity remains lower in people with impaired glucose tolerance and T2D, compared to those with normal glucose tolerance, suggesting "exercise resistance". The mechanisms of exercise resistance in metabolic disease are unknown. In preclinical studies, exercise-induced increases in circulating angiogenic markers and skeletal muscle capillary density predict improved exercise capacity with training. Furthermore, it was demonstrated that impaired glucose tolerance precedes exercise resistance and impaired exercise-induce angiogenesis in muscle. Based on these data, it was hypothesized that exercise resistance in human T2D is caused by an impaired angiogenic response to exercise, secondary to impaired glycemic control. This study will determine whether the angiogenic response to a single bout of exercise in human subjects is blunted in patients with impaired glucose tolerance (IGT), compared to those with normal glucose tolerance (NGT). Angiogenic potential will be measured using a novel in vitro assay developed to assess endothelial tube-formation induced by circulating serum angiogenic regulators following exercise. In addition, a novel exercise-activated signaling pathway in skeletal muscle that is predictive of exercise resistance in animal models was identified. A second aim of the proposed investigation is to determine the effect of impaired glucose tolerance on molecular signaling in response to exercise in skeletal muscle. This investigation represents a critical step in determining the mechanisms that contribute to low exercise capacity in individuals at risk for diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-45, BMI 26-32 kg/m2, Sedentary Lifestyle

Exclusion Criteria:

* Type 1 or Type 2 diabetes, heart or lung disease, hypertension, contraindications to exercise testing, pregnancy
Aspergillus-specific PCR Assay in Cerebrospinal Fluid Samples for Detection of Central Nervous System Aspergillosis

Central nervous system (CNS) invasive aspergillosis (IA) is a fatal complication in immunocompromised patients. Confirming the diagnosis is rarely accomplished as invasive procedures are hampered by neutropenia and low platelet count. Cerebrospinal fluid (CSF) cultures or galactomannan (GM) regularly yield negative results thus suggesting the need for improving diagnostics. Therefore the performance of an established Aspergillus-specific nested PCR in CSF samples of immunocompromised patients with suspicion of CNS IA will be evaluated.

Central nervous system (CNS) invasive aspergillosis (IA) is a fatal complication in immunocompromised patients with hematological malignancies. Confirming the diagnosis is rarely accomplished as invasive procedures are impaired by neutropenia and low platelet count. Cerebrospinal fluid (CSF) cultures or galactomannan (GM) regularly yield negative results thus suggesting the need for improving diagnostic tools. Therefore the performance of an established Aspergillus-specific nested PCR assay in CSF samples of immunocompromised patients with suspicion of CNS IA will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Immunocompromised patients with suspected CNS infection, especially cerebral aspergillosis

Exclusion Criteria:

* proven CNS infections caused by pathogens other than Aspergillus
Lifestyleintervention for the Treatment of Severe Obesity

The overall purpose of this project is to study the acute, short- (≤ 1 year) and long- (\> 1 year) term effects on body composition and psychological health after a 10 to 14-weeks comprehensive lifestyle modification program for the treatment of severe obesity.

The aims of the PhD project are to investigate whether an intensive lifestyle intervention leads to acute and short term (\< 1 year) changes in:

1. The BMI/Weight
2. Body composition (waist circumference, fat mass, fat free mass, skeletal muscle mass and visceral fat area)
3. Psychosocial factors such as eating behavior, anxiety and depression symptoms and health-related quality of life

The study is based on data collected from patients at The Hjelp24 NIMI Ringerike Obesity Clinic, which is an inpatient program to address morbid obesity in adults. The study is a non-randomized clinical trial comparing the acute and long-term effects on physical and psychological health of the 10-14-weeks inpatient comprehensive lifestyle modification program for the treatment of morbidly obese patients.

In between the inpatient stay, the patients are followed up either by telephone, occasional mail and/or structured / weekly email.

In this project we prospectively follow two groups of patient included in the treatment programme in September 2010 and January 2011, respectively. In addition a control group with waiting-list patients is also included in the study, and they were recruited in October-November 2011

Eligibility Criteria:
Inclusion Criteria:

* morbidly obese

Exclusion Criteria:

* not able to walk slowly for 20 minutes
GamReg Sweden - Quality Register for Gambling and Gaming Disorders

This is a quality register for the monitoring of clinical assessment and treatment for gambling disorder and gaming disorder in Swedish health care.

This register is held by Region Skåne, the health care organization of Skåne in southern Sweden, and administered by Register center South, which is associated with health care services in the southern regions of Sweden (the establishment of quality registers in Swedish health care relies upon a national legislation). Quality registers by themselves do not represent formal research projects. However, future research projects can use quality registers, such as the present one, as a data source for future research projects in case they are approved by an ethics authority.

Clinical study variables collected in the register include the following (examples):

* gender, age, occupation, living conditions
* if applicable, types of gambling associated with the treatment needs
* if applicable, type of problematic video gaming
* type of referral to the present treatment contact
* treatment history in psychiatry, social services, enforcement agency
* history of suicidal behavior
* alcohol and drugs problems requiring assessment or treatment
* violence victimization
* type of treatment provided to the patient


Eligibility Criteria:
Inclusion Criteria:

* All patients assessed and treated at units where treatment of problem gambling or problem gaming is provided

Exclusion Criteria:

* Patients who - in a standardized opt-out procedure (following standard of national regulation for quality registers) - refuse participation in the quality register
Development of a Video-based Intervention for Suicide Prevention

The investigators will develop a brief video-based intervention for suicide prevention, called LifePlans. LifePlans will be tested in an initial open trial (n = 10) to examine its feasibility and acceptability. Investigators will recruit patients admitted to a psychiatric hospital for suicidal thoughts and behaviors who will receive the intervention for 4 weeks post-discharge. Patients will be assessed at hospital baseline, 1 month post-discharge, and 6 months post-discharge.


Eligibility Criteria:
Inclusion Criteria:

* current psychiatric hospitalization for suicidal thoughts and behaviors
* 18 years or older
* ability to speak and read English
* plan to continue outpatient treatment
* access to means for viewing videos (computer, tablet, smartphone)

Exclusion Criteria:

* current psychotic symptoms
Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients

Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.

This is a prospective, multicenter registry study in Chinese pediatric Crohn's disease patients. A total of 30 subjects were planned to be enrolled and treated with Infliximab. Subjects were observed for 102 weeks after administration to evaluate the clinical efficacy and safety of infliximab in the treatment of children with Crohn's disease in a real diagnostic setting.

Eligibility Criteria:
Inclusion Criteria:

1. Age ranged 6 to 17 years (both inclusive), no gender limitation.
2. A clear diagnosis was made in children with moderate to severe active stage (PCDAI≥30) Crohn's disease refer to the expert consensus on the diagnosis and treatment of inflammatory bowel disease in children (2019 edition).
3. Patients and/or their guardians must sign ICF, and the research agreement/ICF for data collection and data verification shall comply with local laws and regulations.
4. The patient received infliximab for the first time.

Exclusion Criteria:

1. Patients with contraindications to infliximab use (such as severe infection, active tuberculosis, lymphoma or other malignancies), moderate to severe heart failure, and allergies to other murine proteins, infliximab or any component of this product.
2. Those who accept other anti-TNF-α any biological drugs or any other biologicals.
3. Patients who plan to receive live vaccine within 3 months before signing the informed consent or during the treatment period
4. Those who have been or being enrolled in other clinical studies within 3 months prior to signing ICF
5. The investigator judges the subject inappropriate to be included in this study.
Non-invasive Central Venous Pressure Estimation in Pediatric Patients

Central Venous Pressure (CVP) is a standard parameter for hemodynamic monitoring and is currently measured through the insertion of a catheter. The pediatric population is especially vulnerable to risks associated to this invasive procedure, including infection, thrombosis, and pneumothorax. The proposed pilot study will evaluate safety and preliminary efficacy of a new non-invasive ultrasound-based venous occlusion pressure (VOP) monitoring device (CPMX2) in children equipped with an invasive catheter for CVP monitoring as part of standard of care.


Eligibility Criteria:
Inclusion Criteria

* Provision of signed and dated informed consent form
* Male or female
* Age: birth to 21 years of age
* Equipped with a central venous catheter (CVC) for central venous pressure (CVP) monitoring indication as part of standard of care, or undergoing cardiac catheterization.

Exclusion Criteria:

* Weight less than 2.5kg at the time of enrollment.
* Bilateral external jugular veins not accessible due to vascular access or dressing.
* Bilateral skin lesion contraindicating neck Ultrasound
* Active bleeding
* Clinically unstable, per clinical assessment by attending physician and/or surgeon