cyrilzakka/clinical-trials huggingface dataset:
A Study of the Safety and Efficacy Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Study GIPF-001 is phase 3 study designed to determine the safety and efficacy of IFN-g 1b administered by subcutaneous injection; compared to placebo in patients with IPF who are unresponsive to steroids. 330 patients have been enrolled and were assigned to either a IFN-g 1b group or a placebo group.


Eligibility Criteria:
Male or Female, 20-79 years old
Three-dimensional (3D) Holographic Display for Ultrasound-Guided Structural Heart Disease Procedures

This study is intended to evaluate the use of the holographic display of 3D images acquired during ultrasound based cardiac procedures and to assess the clinical use of the HOLOSCOPE-i, in providing 3D spatial understanding to the clinician performing the procedure. Patients scheduled to undergo an elective procedure in the Cardiac Catheterization Laboratory which use 3D echocardiography (ECHO) as part of the procedure will be enrolled to this study. In addition to the standard of practice imaging using ultrasound, patients anatomical structures will be evaluated using a 3D holographic system. The patients will complete their participation in the study, at the end of the procedure. No follow-up is required and patients will continue their routine medical care following the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18
* Patients are scheduled to undergo an elective procedure in the Cardiac Catheterization Laboratory which use 3D echocardiography (ECHO) as part of the procedure.

Exclusion Criteria:

* Denial of informed consent
* Any contraindications to three-dimensional echocardiographic imaging.
Emergent Laparoscopic Cholecystectomy With ICG Cholangiography

A consecutive case series report to share our experience in surgical outcome of patients who underwent emergency laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescence. The patients were recruited in PUMCH emergency department from 2023 to 2024.

Acute calculous cholecystitis, typically occurs in patients with gallstones, accounts for 90 to 95% of acute cholecystitis. Emergent laparscopic cholecystectomy (ELC) is the major treatment option. Traditionally, the time frame for ELC is generally considered to be within 72 hours from the onset of symptoms. However, with the development of surgical techniques, nowadays, ELC is also considered for patients with symptoms onset within 10 days and hospital stays within 7 days. The determination of the time frame for ELC in acute cholecystitis is primarily based on the risk of complications occurring. Comparing to delayed laparscopic cholecystectomy (DLC), ELC has advantages in post-operative complications in patients with symptoms onset within 72 hours. Post-operative complications for both DLC and ELC include bile leaks, intestinal obstruction, ascites, intraperitoneal hemorrhage, would bleeding and hematoma, wound infection and calculus remaining. Most of them associate with intraoperative procedures. Laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescence, comparing to conventional laparscopic procedures, can help the surgeons to identify bile tracts and therefore may reduce the complications. Therefore, we conduct this case series report to share our single center experience of surgical outcomes and economic effectiveness of laparoscopic cholecystectomy guided by ICG.

The surgical outcomes are evaluated by both intraoperative events and postoperative events. Intraoperative events contain the following items: (1) incidence of intraoperative accidental bile tract injury, (2) intraoperative bleeding (volume), (3) operation time. Postoperative events contain the following items: (1) incidence of complications staging 2 and above according to Clavien Dindo Grade during hospital stay, (2) duration of postoperative hospital stay. The economic effectiveness is evaluated by cost of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* All of the hospitalized patients of underwent emergent laparscopic cholecystectomy guided by ICG fluorescence by the emergent surgeon team from 1st August 2023 to 1st Feburary 2024 in the department of Emergency in Peking Union Medical College Hospital

Exclusion Criteria:

* Patients with incomplete medical records. Patients have other emergent conditions which warrant other emergent operations or major treatment simultaneously besides ELC.
Conventional Versus Rendezvous Technique of Intraoperative Endoscopic Retrograde Cholangiopancreatography

One of the new methods for management of common bile duct stones is intraoperative endoscopic sphincterotomy. It can be performed by many techniques. In the study the investigators compare two methods to find out the best technique for intraoperative endoscopic sphincterotomy.


Eligibility Criteria:
Inclusion Criteria:

* patients with MRCP evidence of common bile duct stones

Exclusion Criteria:

* cholangitis pancreatitis ASA GRADE III, IV Unfit for laparoscopy unfit for ERCP
Quantitative Rise in Intraocular Pressure in Steep Trendelenburg Position

This study analyse the rise in Intraocular Pressure while patient is in surgery in head low position.

Patient undergoing robotic surgeries requires steep trendelenburg position (upto 60 degrees) along with pneumoperitoneum. These both can cause a significant rise in intraocular pressure. Significant rise of pressure for prolonged period can cause post operative visual disturbances, which can be of medicolegal importance. Thus studying the quantitative rise and thus trend of intraocular pressure is first step in managing ophthalmic changes during robotic surgeries.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiologists (ASA) status 1-3
* without any ophthalmic complains or interventions

Exclusion Criteria:

* lasix given during preoperative or intraoperative period
* cardiac patients who are on medications for stents or post Coronary Artery Bypass Graft (CABG)
* pre-existing glaucoma, eye surgeries, cataract or retinal vascular diseases, corneal diseases which may affect IOP measurement were excluded
Safety and Efficacy Study of Gevokizumab to Treat Active Non-infectious Uveitis

The purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or pan- uveitis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye
* Active uveitic disease in at least one eye
* Currently on one of the following stable treatment regimens for uveitis: oral corticosteroids; systemic immunosuppressive medication; a combination of oral corticosteroids with at least one systemic immunosuppressive medication
* Effective contraceptive measures

Exclusion Criteria:

* Infectious uveitis and masquerade syndromes
* Isolated anterior uveitis
* Contraindication to mydriatics
* History of allergic or anaphylactic reactions to monoclonal antibodies
* Active tuberculosis disease
* History of recurrent infection or predisposition to infection; active ocular infection
* Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply
Is Myocardial Stunning Induced by Continuous Renal Replacement Therapy a Reality in Critically Ill Patients?

Myocardial stunning during chronic intermittent hemodialysis is a well-described phenomenon. Little case series of patients presenting myocardial stunning during renal replacement therapy for acute kidney injury in critically ill patients are reported, with intermittent hemodialysis and continuous renal replacement therapy. However, the small sample sizes and the absence of a control arm limit their interpretation, mainly whether the myocardial stunning may be related to cardiac loading conditions variations and whether it may impact the hemodynamic.

The investigator hypothesize that myocardial stunning induced by renal replacement therapy is frequent, independent from cardiac loading conditions and associated with peripheral hypoperfusion.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Acute Kidney Injury grade 3 (KDIGO)
* Indication for renal replacement therapy for the clinician in charge

Exclusion Criteria:

* Emergency indication to renal replacement therapy (pH\<7.15, Kaliemia \> 6mmol/L, refractory pulmonary oedema)
* Poor echogenicity with speckle tracking analysis failure
* Chronic hemodialysis
* Extra corporeal membrane oxygenation, left ventricular assist device.
In.Pact Flexion, Investigating the Performance of the In.Pact Admiral DEB for Popliteal Lesions

The objective of this study is to evaluate the performance of the In.Pact Admiral DEB for the treatment of popliteal lesions in comparison with literature results of stent treatment in popliteal lesions


Eligibility Criteria:
Inclusion Criteria:

* - De novo, restenotic or reoccluded lesion located in the popliteal artery, with or without superficial femoral artery involvement
* Patient presenting a score from 2 to 5 following Rutherford classification
* Patient is willing to comply with specified follow-up evaluations at the specified times
* Patient is \>18 years old
* Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
* Prior to enrollment, the guidewire has crossed target lesion
* Patient is eligible for treatment with the In.Pact Admiral drug-eluting balloon
* The target lesion, visually estimated, has a maximal length of 14 cm and can be categorized as either a type A or B lesion according the TASC II guidelines
* The target lesion has angiographic evidence of stenosis or restenosis \> 50% or occlusion which can be passed with standard guidewire manipulation
* Target vessel diameter visually estimated is \>3.5mm and \<7.5 mm
* There is angiographic evidence of at least one vessel-runoff to the foot, irrespective of whether or not outflow was re-established by means of previous endovascular intervention.

Exclusion Criteria:

* - Presence of another stent in the target vessel that was placed during a previous procedure
* Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
* Previous by-pass surgery in the same limb
* Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
* Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
* Perforation at the angioplasty site evidenced by extravasation of contrast medium
* Patients with known hypersensitivity to nickel-titanium
* Patients with uncorrected bleeding disorders
* Aneurysm located at the level of the SFA and/or popliteal artery
* Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
* Life expectancy of less than twelve months
* Ipsilateral iliac treatment before the target lesion procedure with a residual stenosis \> 30% or ipsilateral iliac treatment conducted after the target lesion procedure
* Use of thrombectomy, atherectomy or laser devices during procedure
* Any patient considered to be hemodynamically unstable at onset of procedure
* Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
The Implementation of Early Mobilization and Chest Physiotherapy on Weaning Rate of Prolong Weaning Patients.

Weaning from mechanical ventilator is essential to liberate patients to normal life. Prolong weaning is defined as failure of 3 times spontaneous breath trial (SBT) and requiring more than 7 days weaning from mechanical ventilation after first SBT. higher unsuccessful rate of extubation and higher mortality rate. Possible reasons to cause prolong weaning could be attributed to intensive care unit acquired weakness (ICU-AW) and poor lung hygiene. In order to solve these two problems and increase the weaning rate, early mobilization (EM) and chest physiotherapy (CPT) are considered as possible strategy to attain the goal. According to previous articles, lacking of control group and small sample size made it difficult to confirm the true effect of EM and CPT on prolong weaning patients. Thus, the aims of this articles are discussing the influence from EM with CPT on weaning rate and other hospitalization outcomes with larger sample sizes and control group.


Eligibility Criteria:
Inclusion Criteria:

* The subjects' data which met the inclusion criteria are: 1. Age\>20 2. Patient with or without 3. Patient who met the criteria of received physiotherapy (Figure 1.) 4. No usage of life support device such as ECMO and so on. 5. Continuous mechanical ventilator use over 21 days.

Exclusion Criteria:

* The exclusion criteria are 1. Patients diagnosed as brain death 2. Patients who were ventilator dependent before admission 3. Patients who were against advice discharge under critical condition. 4. Patients received emergency intervention during course. 5. Patient who didn't meet the criteria of received physiotherapy (Figure 1.).
GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse

The purpose of this study is to is to evaluate the success of the GYNECARE PROSIMA\* system in women with symptoms for pelvic organ prolapse (POP) requiring surgical correction of POP.

(\*TRADEMARK)

The GYNECARE PROSIMA\* system provides a simplified mesh repair, avoiding the need for dissection outside the pelvic cavity.

Eligibility Criteria:
Inclusion Criteria:

* Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair. Vaginal hysterectomy, perineal repair and/or mid urethral sling procedures for incontinence may be performed concurrently.
* Age ≥ 18 years.
* Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee / IRB approved informed consent.

Exclusion Criteria:

* Additional surgical intervention concurrent to the PROSIMA procedure (e.g. sacrocolpopexy, paravaginal repair, tubal sterilisation).
* Previous repair of pelvic organ prolapse involving insertion of mesh.
* Previous hysterectomy within 6 months of scheduled surgery.
* Experimental drug or experimental medical device within 3 months prior to the planned procedure.
* Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
* Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
* History of chemotherapy or pelvic radiation therapy.
* Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma).
* Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
* Nursing or pregnant or intends future pregnancy.
* In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
Sound Conduction of Infant Hips

The objective of this study is to collect data that will be used to later design a method for the early diagnosis of diagnosis of developmental dysplasia of the hip (DDH).

This will be a prospective study using an acoustic listening technique in combination with a standard clinical examination of DDH.

For both the clinical cases and healthy children that are enrolled, that all subjects will have an ultrasound completed for comparison to the use of the studied tuning fork method. The gold standard is POCUS (point of care ultrasound as performed by the pediatric orthopedic surgeon). Collected data will be compared to POCUS as performed by an expert and this is standard of care. Healthy subjects will be referred for evaluation and found to be healthy on subsequent US.

Eligibility Criteria:
Inclusion Criteria:

* Infants included in this study must be born at full term with a gestational age of 0-6 months
* Infants of both genders will be included
* Infants must have been screened for DDH.

Exclusion Criteria:

* Infants born prematurely
* Infants greater than six months of age.
* Nonviable neonates and neonates of uncertain viability
Immunogenicity and Safety of Tetanus, Diphtheria and Mono Component Acellular Pertussis (TdaP) Vaccine in Comparison to Tetanus and Diphtheria (Td) Vaccine When Given as Booster Vaccinations to Adults

The clinical trial is a phase III, double-blind, randomised, controlled, multi-centre, clinical trial, on the immunogenicity and safety of TdaP vaccine in comparison to Td vaccine when given as a booster vaccination to adults who were vaccinated with D, T and wP vaccine according to the Danish vaccination programme in their childhood.

Healthy, adult, female or male volunteers, who completed primary vaccination with diphtheria (D), tetanus (T) and whole cell pertussis vaccine (wP), typically during their childhood, is the target population.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy female or male adult of ≥ 18 years of age
2. Completed primary vaccination with diphtheria (D), Tetanus (T) and whole cell pertussis (wP) vaccines in Denmark
3. Signed informed consent
4. Prepared to grant authorised persons access to medical records
5. Likely to comply with instructions

Exclusion Criteria:

1. Congenital or acquired immunodeficiency or progressive neurologic disease
2. Uncontrolled epilepsy or progressive encephalopathy
3. Previous experience of serious adverse reaction(s) after vaccinations with diphtheria-, tetanus- acellular or whole cell pertussis- vaccines
4. Vaccinated with any diphtheria, tetanus or pertussis toxoid containing vaccine within 5 years before inclusion
5. Vaccinated with any tetanus toxoid, diphtheria toxoid or diphtheria CRM197 protein conjugated vaccine within 5 years before inclusion
6. Known tetanus-, diphtheria- or pertussis disease/infection within 5 years before inclusion
7. Known hypersensitivity or history of allergic reactions to any of the active or inactive constituents of the TdaP or Td vaccines
8. Vaccinated with a live or inactivated vaccine within 1 month before inclusion
9. Administration of immune modulating drugs (such as immunoglobulin, systemic corticosteroids, blood products, azathioprine, cyclosporine, infliximab) within 3 months before inclusion
10. Administration of any investigational drug product or vaccine within 1 month before inclusion
11. Females if pregnant or breastfeeding or not willing to use contraception during the trial
The Validation of a Novel Adherence Method for Oral Oncolytics

The long-term goal of this research is to apply technologic approaches to improve the use of oral oncolytics. The objective of this study is to assess patient adherence to oral oncolytics and to validate a currently available smart phone application (iRxReminder) partnered with an automated dispensing device, a "Pod", in affecting patient adherence. The rationale for this study is that medication adherence to oncolytics varies and strategies are needed to improve it.


Eligibility Criteria:
Inclusion Criteria:

* Must be \> 18 years of age
* Must have a smart phone
* Must be able to have their oral oncolytic filled at the University of Michigan Comprehensive Cancer Center pharmacy and be newly prescribed Capecitabine (Xeloda).

Exclusion Criteria:

* Patients who do not have a smart phone
* Patients who have a serious mental illness or cognitive impairment, e.g., psychosis or dementia.
* Patients who do not speak English
* Patients who cannot fill their oral oncolytic prescription at the University of Michigan Comprehensive Cancer Center Pharmacy
Clinical Controlled Study on the Efficacy of Denosumab in Treating Osteoporosis in the Domestic Population and Its Impact on Sarcopenia-related Outcomes

Through the method of a clinical randomized controlled trial, patients meeting the study criteria are randomly assigned to either the Denosumab treatment group or a placebo group. After a treatment period of 12 months, the differences in osteoporosis and sarcopenia-related baseline assessment changes between the two groups are compared. This is to explore the effect of Denosumab in treating osteoporosis and its impact on sarcopenia. The goal is to evaluate the efficacy of Denosumab in treating osteoporosis in the domestic population and its related impact on sarcopenia, with the aim of providing an effective treatment option for the domestic population suffering from 'osteoporosis-sarcopenia syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of postmenopausal/senile osteoporosis after examination and assessment.
* Clinical diagnosis of postmenopausal/senile osteoporosis combined with sarcopenia after examination and assessment.
* Have not previously taken any other anti-osteoporosis drugs.

Exclusion Criteria:

* Clinical diagnosis of pathological fractures.
* Have participated in another clinical trial within the past 3 months or have taken other anti-osteoporosis drugs within the past 6 months.
* Severe chronic metabolic diseases or serious organ failure.
A Community-Based Screening Program to Identify Participants at High Risk for Amyloid Pathology

The primary purpose of this study is to identify participants with or without symptoms of Alzheimer's Disease (AD) that are at high risk for brain amyloid pathology using blood-based biomarkers.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age 50 to 80 years inclusive, at the time of informed consent

   - Those 50 to 64 years of age must have 1 of the following risk factors confirmed prior to blood sample collection:
   * First degree relative with dementia onset before age 75,
   * Known before screening to have at least 1 Apolipoprotein E4 (APOE4) allele, or
   * Known before screening to have elevated brain amyloid according to previous positron emission tomography (PET), cerebrospinal fluid (CSF), or blood testing
2. Provide written informed consent
3. Willing and able to comply with all aspects of the protocol
4. Willing to be referred to a clinical site if the assessment results meet the criteria

Exclusion Criteria:

1. Known uncontrolled medical conditions (example, cardiac, respiratory, gastrointestinal, psychiatric, renal disease, malignant neoplasm)
2. Participation in an interventional clinical trial study at the time of consent