cyrilzakka/clinical-trials huggingface dataset:
Open vs. Laparoscopic Surgery for Pediatric Choledochal Cyst

This is a retrospective cohort study designed to compare the outcomes of open surgery versus laparoscopic surgery in pediatric patients diagnosed with congenital choledochal cyst (CCC). The study includes children who underwent surgery at Guangdong Medical University Affiliated Hospital and Guangzhou Women and Children's Medical Center between January 1, 2010, and September 1, 2024. The aim of this study is to evaluate and compare the surgical outcomes, including surgery duration, intraoperative blood loss, hospital stay, and postoperative complications (e.g., bile leakage and intestinal obstruction), between the two surgical approaches. The data collected from the patient records will be analyzed to identify factors influencing surgical outcomes and to guide future treatment decisions for CCC in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

Pediatric patients diagnosed with congenital choledochal cyst based on preoperative imaging (e.g., ultrasound, computed tomography（CT）, or magnetic resonance cholangiopancreatography（MRCP)）.

Patients who underwent either open surgery (open cyst excision and Roux-en-Y hepaticojejunostomy) or laparoscopic surgery (laparoscopic cyst excision and Roux-en-Y hepaticojejunostomy) for the treatment of congenital choledochal cyst.

Informed consent for follow-up obtained from the patient's family or legal guardian.

Exclusion Criteria:

Patients lacking one or more key outcome measures, including surgery duration, hospital stay, intraoperative blood loss, incidence of postoperative bile leakage, or incidence of postoperative intestinal obstruction.

Patients with incomplete clinical data, such as missing sex, age, or other essential demographic information.

Patients with coagulation disorders that may interfere with surgery or recovery.

Patients with severe comorbidities or immune system disorders that may complicate surgical intervention or recovery.

Patients who underwent non-surgical treatment (e.g., endoscopic procedures) for congenital choledochal cyst.

Pregnant patients or those who are breastfeeding (if applicable to your study population).
Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow

The purpose of the proposed study is to investigate the usefulness of laser speckle contrast imaging (LSCI) compared to indocyanine green angiography (ICGA). We will collect data from a wide variety of neurovascular surgical procedures to determine when the technology is the most clinically useful. The intraoperative LSCI system provides high resolution images of blood flow in real-time without tissue contact and without the need for an exogenous contrast agent. Further study is needed to gain a better understanding of the use of the technique during surgery, but initial results suggest that the ability to identify blood flow changes with immediate feedback to the surgeon could be a significant advantage during many procedures.

Cerebral blood flow (CBF) is of paramount importance to human brain function, as the brain relies on a continuous blood supply to meet its energy needs. Blockage of a cerebral blood vessel during the course of surgery, even if transient and short-lived, may result in irreversible brain tissue damage (i.e. stroke) and loss of cortical function, if not identified quickly enough. During neurosurgery, vessel occlusion may occur either inadvertently or as a necessary part of the procedure, and yet current technologies do not adequately predict the consequences of such occlusion. Real-time CBF visualization during surgery could help neurosurgeons better understand the consequences of vascular occlusion events during surgery, recognize potential adverse complications, and thus prompt timely intervention to reduce the risk of stroke. The current standard for visualizing CBF during surgery is indocyanine green angiography (ICGA), which involves administering a bolus of fluorescent dye intravenously and imaging the wash-in of the dye to determine which vessels are perfused. Unfortunately, ICGA can only be used a few times during a surgery due to the need to inject a fluorescent dye, and provides only an instantaneous view of perfusion rather than a continuous view.

Patients will undergo standard craniotomy surgery. The surgical procedures will not be altered in any way by the proposed studies. As long as it is standard of care, neuromonitoring, intraoperative angiogram, and Indocyanine green angiography will be performed by the surgeon. LSCI imaging will be performed at the discretion of the surgeon following exposure of the cortex and will vary from patient to patient depending on the neurosurgical procedure. The LSCI measurements will not add any time to the surgery nor affect the normal operation of the neurosurgical microscope.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (18 years or older).
2. Size of craniotomy at least 2 cm.
3. Possibility of intraoperative ICGA.
4. Able to render written informed consent.
5. Women of child-bearing potential must have a negative pre-op pregnancy test.

Exclusion Criteria:

1. Patients unable to legally consent.
2. Patients with impaired cognitive function.
Effectiveness and Safety of Campath in Combination With Tacrolimus Monotherapy to Prevent Kidney Graft Rejection

The purpose of this study is to determine whether Campath following Tacrolimus monotherapy is more effective in the prevention of renal graft rejection (considering an acute rejection rate of 5% for Campath-1H/Tacrolimus and of 22% for Tacrolimus/MMF/Steroids).

Major advances in immunosuppressive therapy have resulted in long-term graft survival by the use of various drug combinations.However, these combinations carry the risk of e.g. infection, malignancy, renal damage, hypertension, diabetes, hyperlipidemia, hirsutism, cushingoid facial appearance and bone necrosis.Therefore one of the major goals should be to reduce immunosuppression without increasing risk of rejections.

Based on good results of a pilot study (not a single acute rejection episode during the 18-20 months observation period despite low level of Tacrolimus and absence of steroids) this randomised trial was designed to further evaluate the safety and efficacy of Campath-1H.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65
* endstage renal failure with no previous renal transplantation
* cadaveric donor
* written informed consent

Exclusion Criteria:

* pregnant or nursing women
* multi-organ transplant recipients
* live donor recipients
* re-transplants
* panel reactive antibodies (PRA) \> 25%
* previous treatment with Campath-1H
* use of other investigational agents within 6 weeks
* active systemic infection
* HIV positive patient or donor
* positive lymphocyte cytotoxicity cross-match between recipient serum and donor cells
* past history of anaphylaxis following exposure to humanized monoclonal antibodies
Protein Requirements in Endurance-trained Athlete

Protein requirements in individuals who participate in endurance-based exercise training have been suggested to be greater than the current recommended dietary allowance (RDA).

Nutritional requirements for dietary amino acids in adults have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein requirements. As a result, there is a need to re-evaluate recommendations in order to characterize how dietary amino acid needs may be modulated by physical activity.

Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 50% higher than RDA based on nitrogen balance data.

Therefore, the purpose of this study is to measure the protein requirement in endurance trained adults using the IAAO technique.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, male, endurance-trained participants who regularly more than 40 km/week
* Ability to perform the exercise stimulus (20 km run) on metabolic trial.

Exclusion Criteria:

* Inability to meet health and physical activity guidelines according to the physical activity readiness questionnaire (PAR-Q+)
* Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
* Regular tobacco use
* Illicit drug use
Position Differences and Physical Performance Among Female Team Handball Players

Our study was conducted to compare the physical performances of the upper extremity and lower extremity of handball players according to the positions they played.

In this cross-sectional study, a total of 39 elite female handball players with at least of 5 years playing experience were tested.Maximal voluntary isometric (MVIC) knee flexion and extension strength were measured using a handheld dynamometer (HDD) (Lafayette Instrument Company, Lafayette, IN). Lower extremity vertical power was identified through the use of the VertiMetric (Lafayette Instrument Company, Lafayette, IN) according to protocols suggested by Ambegaonkar et al. Trunk extension endurance was measured using the Biering-Sorensen test as previously described.The Davies test (DT) was used to assess upper body agility and stabilization.The Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST) was utilized to assess shoulder performance function and stability according to protocol suggested by Goldbeck and Davies.The Shark Skill Test (SST) was developed in order to assess lower extremity agility and neuromuscular control.


Eligibility Criteria:
All athletes were asymptomatic and had passed medical examinations prior to inclusion and participation in the study. Exclusion criteria included history of injury or surgery that may affect their lower and upper limbs and any lower and upper limb injuries within the last three months.
Treatment of Depression in Nursing Homes

This study will implement a treatment for depression in a nursing home setting.

Depression in long-term care facilities is a significant public health issue. Up to 50% of nursing home residents are affected by significant depressive symptoms. The decreased health and limited cognitive ability of many nursing home residents makes treatment and research extremely challenging. This study will attempt to identify and implement treatments for depressed nursing home residents.

Participants are randomly assigned to receive either an active intervention or treatment as usual for 6 weeks. The active intervention is followed by 4 weeks of maintenance. The intervention is implemented primarily by existing nursing facility staff and focuses on increasing opportunities for residents to experience pleasant events through increased levels of activity and positive affect. The maintenance treatment involves incorporation of protocol-based activities into patient care plans. Patients have a follow-up visit 12 weeks after the study. Psychiatric evaluations, depression and mood rating scales, observed affect and activity participation, behavior problems, and staff burden are assessed.

Eligibility Criteria:
Inclusion Criteria:

* Nursing home residents
* DSM-IV criteria for major depressive disorder or dysthymia or Research Diagnostic Criteria for minor depressive disorder with current Geriatric Depression Scale scores \> 11 and Mini Mental State scores \>= 14
68Ga-HSA PET/CT Imaging for Protein-losing Enteropathy

In this project, based on the DTPA-HAS kit, investigators plan to develop a positron nuclide 68Ga labeled DTPA-HSA molecular probe in order to obtain high sensitivity, signal-to-noise ratio and high-resolution PET/CT imaging images, aiming to find the specific site of intestinal leakage while diagnosing Protein-Losing Enteropathy (PLE), and analyze the pathological mechanism of intestinal leakage in combination with pathology, so as to provide molecular imaging guidance for the treatment of PLE patients. PLE is a rare gastrointestinal protein-losing syndrome, and the radiopharmaceutical 99mTc-DTPA-HSA (99mTc-human serum albumin) approved by the State Food and Drug Administration has the diagnostic ability of protein-losing enteropathy (PLE), but due to the low resolution of SPECT/CT, the image clarity and signal-to-noise ratio need to be improved, it is a classic probe in the last century, unable to meet the existing clinical needs.

This project developed a a new type of nuclide Ga-68 labeled DTPA-HSA probe, and with the inherent advantages of this nuclear medicine department, it has promoted the formulation of the production filing standard of the drug, and obtained the 68Ga-HSA injection that can be used for preclinical research and meets the clinical standards. Clinical research on 68Ga-HSA PET/CT imaging was carried out to provide a basis for the diagnosis and treatment of PLE patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with digestive system tumors;
2. Presence of hypoproteinemia or clinical manifestations of hypoplasma protein;
3. Serum albumin \<30 g/L, AAT\>80 ml/d;
4. Measurable lesions in imaging;
5. Predicted survival greater than 3 months;

Exclusion Criteria:

1. Severe hepatic or renal dysfunction;
2. Pregnant or nursing;
3. Known allergy to the investigational drug or its excipients in study;
4. Unable to comply with the PET/CT imaging procedures;
5. Claustrophobia or other psychiatric disorders;
6. Other conditions deemed unsuitable for participation in the trial;
Estimation of Therapeutic Effect of MDcure on Patients With Chronic Lower Back Pain

This study will assess the therapeutic effect of MDcure® device. MDcure® is an FDA Class 1 listed medical device, produced to ISO-13485 standards, that delivers extremely low intensity (nano Tesla; 10-9) and low frequencies (1-100 Hertz) electromagnetic fields (EMF) intended to reduce muscular aches and pains particularly of the lower back.

assessing the reduction of lower back pain. Half of participants will receive the MDcure device, while the other half will receive a mock device.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18-75
* Patients with chronic lower back for more then 3 month
* Patients who scored over 21% and below 60% in the Oswestry questionnaire

Exclusion Criteria:

* A neurological deficient in lower limbs
* Patients who scored more than 60% on the Oswestry questionnaire.
* Patients who underwent surgical intervention in spine including metal implant in lower back
* Patients diagnosed with cancer
* Patients with any type of vertebral fracture
* Patients who received steroid injection less then a month prior to starting the experiment
* Patients treated with steroids as a preventive treatment on a regular basis
* Patients using narcotic drugs for over a six month period or cannabis or any other sort of narcotic drug for over a six month period prior to their enrollment in the study
* Pregnant women
Prospective Real-world Registry Describing Treatment Regimens

This study is to describe the initial anti-thrombotic treatment strategy prescribed to the AF patient population undergoing PCI by using drug class description.

Coordinator of project has strong expertise in cardiovascular research and especially in ACS, PCI and antiplatelet therapy. The group led by pr Bonello has published several articles (appendix 3) including the VASP studies which have been presented at major cardiologic congresses (late breaking trials ACC 2007, AHA 2008, TCT 2011, EuroPCR 2010) including physicians and biologists. The group is composed of international experts in this research field (Pr Bonello, Pr Cuisset, Dr Barragan, Pr Lemesle). Additionally, coordinator center has a strong expertise in clinical research and a methodological support will be provided by the Clinical Research Platform of the AP-HM (responsible: Prof. Pascal Auquier, medical referent: Dr Karine Baumstarck).

The project brings together investigators that have been previously involved in many clinical studies in the field of ACS and PCI. In particular they have joined forces on multicenter trials leaded by the cardiology department of the Hôpital Universitaire Nord de Marseille (the VASP studies, the Early clinical trial) and they have regular meetings to share scientific data and research program design and advancement. There is a good capacity and ability of recruitment by the partner centers. The procedures to perform in this project are very simple and the disease is frequent. These are good criteria for the feasibility.

Eligibility Criteria:
Inclusion Criteria:

The eligible subjects must meet all of the following criteria:

* Man or woman 18 years old or over
* Subject requiring percutaneous coronary intervention according to physician's and with AF requiring chronic anticoagulation by dual therapy or triple therapy;
* Subject with pulmonary embolism risk score \> 1 for men and ≥ 1 for women in CHA2DS2-VASc classification
* Subject having declare its non-opposition to study participation

Exclusion Criteria:

* Child-bearing potential (1 year post-menopausal, contraceptive or surgically sterile)
* Lactation
* No health insurance
* Prisoners
N-acetylcysteine Effects on Tetrahydrocannabinol

The overall purpose of this study is to examine the effect of N-acetylcysteine (NAC) on the acute effects of Delta-9-tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with NAC and then assessing their responses to THC.


Eligibility Criteria:
Inclusion Criteria:

* Exposed to Cannabis at least once in lifetime

Exclusion Criteria:

* Cannabis Naive
* Individuals with a documented allergy to N-acetylcysteine
Clinical Applicability of Robot-assisted Gait Training System in Acute Stroke Patients

Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for acute stroke survivors. It is anticipated that robot-assisted gait rehabilitation will achieve significantly better gait and quality of life outcomes than the standing table rehabilitation.

Stroke is not only the second leading cause of mortality in Taiwan, it is also the primary cause of long-term physical and psychological disabilities in our society. Array of reasons have been suggested to be an obstacle for stroke patients to receive adequate physical rehabilitation, including the lack of physical capacity, severe neurological deficits or the loss of strength. Given the critical importance of high-intensity and high-repetitiveness of early rehabilitation for stroke patients in achieving sustainable long term outcomes, robot-assisted gait rehabilitation devices have gained great interest in the last decade and is slowly becoming part of the clinical rehabilitation program for stroke patients. However, despite the growing interest and the significant resources invested for the development of robot-assisted rehabilitation devices, there still lacks empirical evidence of its clinical applicability for stroke patients. Moreover, available evidence to date have mostly focused on sub-acute and chronic stroke patients and investigation in acute stroke population, especially in those with complete incapacitation for ambulation, is sparse. It is therefore the aim of the proposed project to fulfil this significant gap in our clinical knowledge by comparatively investigate the clinical applicability of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of psychological and functional capacity recovery status in acute stroke survivors.

Eligibility Criteria:
Inclusion Criteria:

* Between the age of 20-80 years;
* Diagnosis of first, single unilateral cortical-subcortical acute stroke verified by brain imaging;
* Paresis of a lower limb;
* Ability to walk for only a few meters either with or without aid.

Exclusion Criteria:

* Deemed by a physician to be medically unstable;
* Other prior musculoskeletal conditions that affected gait capacity;
* Co-existence of other neurological diseases;
* Cognitive impairments that would impact on the safe participation in the study (MMSE\<23)
Study to Determine the Accuracy of Prothrombin Time of Warfarinised Blood

The purpose of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving coumadin (warfarin) treatment on an experimental device and a commercially available device. This study will involve taking a finger-puncture and testing onto a strip and meter system for the experimental and commercially available devices.


Eligibility Criteria:
Inclusion Criteria:

* Are currently taking coumadin (warfarin)
* Are aged 18 years or older
* Able and willing to provide informed consent
* Can understand (read and write) English
* Required to provide a capillary sample as part of their routine medical check

Exclusion Criteria:

* Previously participated in this study
Ultrasound Detection of Position of Diaphragm During Laparoscopic Surgery

Position of diaphragm in the region of electrical impedance tomography measurement is to be determined by ultrasound in approx. 20 patients undergoing laparoscopic surgery. Data are to be obtained at three phases at supine horizontal position (during spontaneous breathing, at mechanically ventilated patient under general anesthesia with muscle relaxation and at mechanically ventilated patient under general anesthesia with muscle relaxation during insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during laparoscopic surgery).

During laparoscopic surgery, insufflation of carbon dioxide into the peritoneal cavity is conducted in order to optimize working space for surgeons. As a side effect, the abdominal pressure alters physiological thoraco-abdominal configuration and pushes the diaphragm and lungs cranially. Since lung image acquired by electrical impedance tomography (EIT) depends on the conditions within the thorax and abdomen, it is crucial to know the diaphragm position to analyze the effect of cranial shift of diaphragm on EIT images of the thorax. Presence of diaphragm in the region of EIT measurement is to be determined by ultrasound in approx. 20 patients undergoing laparoscopic surgery. Data are to be obtained at three phases at supine horizontal position (during spontaneous breathing, at mechanically ventilated patient under general anesthesia with muscle relaxation and at mechanically ventilated patient under general anesthesia with muscle relaxation during insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during laparoscopic surgery). The results of this study will serve during design of a subsequent study dealing with optimization of EIT electrode belt position during laparoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

- patients undergoing abdominal laparoscopic surgery

Exclusion Criteria:

* morbid obesity
* standard exclusion criteria for electrical impedance tomography according to the manufacturer
Problem Solving/Physical Interventions and Aging

The purpose of this study is to examine the relative and combined efficacy of a physical activity and health promotion program to help sedentary adults over age 70 maintain an independent life style.

The study recruited 273 participants from a community-based HMO for whom computerized health service utilization and cost data were already available, as well as cognitive, functional, and health status measures. The participants were randomly placed into one of four treatment groups: exercise, health promotion, combination exercise and health promotion, and routine medical care. Assessments for physical performance, emotional well-being, and physical and emotional health status were conducted at screening, baseline, after 3 months (post-treatment), and at 6, 12, and 18-month follow-up by interviewers blind to treatment assignment.

Eligibility Criteria:
Inclusion Criteria:

* age 70 or older
* live independently
* less than 150 minutes regular exercise per week
* able to walk across a room without a person assisting
* English speaking
* planning to stay in local area for at least 6 months (duration of active study)

Exclusion Criteria:

* cancer
* heart attack
* stroke
* uncontrolled arrhythmia
* uncontrolled hypertension
* uncontrolled diabetes
* surgery during the past year
* ongoing mental health or psychiatric condition