cyrilzakka/clinical-trials huggingface dataset:
Home-based Intermittent Pneumatic Compression Therapy for Gynecologic Cancer

Investigators conducted a prospective study of cancer patients to investigate the efficacy, quality of life, satisfaction, and safety of a home-based intermittent pneumatic compression (IPC) device during the maintenance phase of lower extremity lymphedema. This device has a unique mode designed to mimic the manual lymphatic drainage (MLD) technique and thereby gently facilitate lymphatic draining of proximal extremities.


Eligibility Criteria:
Inclusion Criteria:

* stage 3 chronic unilateral secondary leg lymphedema
* aged 20-70 years
* underwent 1-2 cycle of treatment of decongestive phase with current inter-limb volume difference of more than 10%
* stable limb-volume change (within 10%) during the preceding 3 months
* capacity for self-maintenance care for lymphedema (multilayer limb bandaging, compression garments, and MLD)

Exclusion Criteria:

* bilateral leg lymphedema
* current cancer metastasis
* ongoing chemotherapy or radiation therapy
* acute inflammation
* venous thrombosis, or chronic venous insufficiency
* systemic etiologies of edema
* congestive heart failure
* patients taking medication that influenced body fluid or electrolytes
Longitudinal Development of Behavior and Its Underlying Neural Correlates in Human Infants

The unique importance of human brain development during the first years of life is unquestionable. During an infant's first year, the brain undergoes its most dramatic structural and functional changes, with factors such as early social experience having a significant effect on this development. This study proposes to investigate changes in both brain and behavior across the first 12 months of life. At three time points (\~3, 6, and 12 month), anatomical and diffusion magnetic resonance imaging (MRI), resting state functional magnetic resonance imaging (fMRI), electroencephalography (EEG), eye tracking, and observational data will be obtained from the same sample of infants. These measures will be used to track the development of important sensorimotor, socio-emotional, and cognitive skills and their underlying neural correlates, as well as investigate the effects of early social experience on specific aspects of this development


Eligibility Criteria:
Inclusion Criteria:

* Healthy newborns, boys and girls, aged 3 months
* Uncomplicated pregnancy and delivery, APGAR scores \>8
* Full-term birth without identified neuromotor problems at birth
* No congenital or developmental anomalies affecting the brain
* No reported history of neurological disorders or learning disabilities in the infants
* No reported specific visual, developmental and cognitive impairment
* Absence of medication having a cerebral or psychological impact
* Both parents/ legal guardian must provide their consent and signature prior to participation of their infant in the study

Exclusion Criteria:

* Severe congenital malformation
* Infants requiring a corrective surgery
* Any refusal of a parent
* Infants with severe impairment of the general condition and vital functions
* Infants with dermatitis of the face or scalp
* Infants who receive neurological treatment
* Infants born pre-term (birth before 37 weeks gestation)
* Infants whose mothers have significant medical conditions and/or had significant complications during pregnancy
* Infants who are adopted,
* Infants who have a first degree relative with autism, intellectual disability, schizophrenia, or bipolar disorder,
* Infants who have any significant medical and/or genetic conditions affecting growth, development, or cognition,
* Infants who have any contraindication to MRI (metallic object, surgical material like cochlear implant)
* Maternal pre- eclampsia, placental abruption, maternal HIV status, and maternal alcohol or illicit drug use during pregnancy.
The da Vinci Single Port Robotic System for Use in Abdominal and Pelvic Surgical Procedures

This phase II trial test the effectiveness and safety of a single-port robotic device (the da Vinci single port \[SP\]1098) for use in abdominal and pelvic surgeries. The da Vinci SP1098 robotic device can be used to perform less invasive surgeries that allow entry into the body through a single, small incision. The use of this device during surgery may allow surgeons to perform complex procedures that result in less pain, fewer complications and side effects, and improved recovery.

PRIMARY OBJECTIVE:

I. To evaluate the effectiveness and safety for abdominal and pelvic procedures of a single-port robotic device (da Vinci SP1098) that is Food and Drug Administration (FDA)-approved for other indications, specifically urological and transoral otolaryngology surgical procedures.

OUTLINE:

Patients undergo surgery using the da Vinci SP1098 robotic system on study.

Eligibility Criteria:
Inclusion Criteria:

* Documented informed consent of the participant and/or legally authorized representative
* Any patient scheduled to undergo robot-assisted abdominal or pelvic procedures
* Age \> 18 years

Exclusion Criteria:

* Body mass index (BMI) \> 45
* Contraindications to minimally invasive surgery including chronic obstructive pulmonary disorders
* Past history of failed attempt of minimally invasive abdominal or pelvic surgery
Virtual Reality Technology to Alleviate the Acute Pain of Scar Treatment With Fractional Laser Under Local Anesthesia

This study evaluates the effect of virtual reality technology alleviates the acute pain of scar treatment with fractional laser under local anesthesia

Fractional laser surgery under local anesthesia will accompany by the pain and anxiety. It's a bad experience for the patients. The effect of Virtual Reality (virtual reality, VR) to alleviate pain and anxiety of fractional laser treatment of scar is still not studied. Virtual reality technology is an important direction of simulation technology. Including the computer graphics technology, human-computer interface technology, multimedia technology, sensor technology, network technology and other collection technology. Usually generated by a real-time 3D animation of the computer system, a location tracker data. The handle and the head mounted display technology is commonly used in a variety of clinical invasive procedures, such as debridement and burn patients physical therapy, dental pain, injection pain, chronic itching. Previous study shows that VR as a distraction therapy, compared to the traditional methods ,for example watching video and listening to music, has stronger individual initiative and human-computer interaction, it shows a stronger analgesic effect.

HTC Vive is a VR headset, jointly developed by HTC company and Valve company. This equipment could improve the virtual reality experience and bring obvious analgesic effect. There are reasons to believe that HTC Vive could bring the best immersion experience and could be obviously decrease pain and anxiety of scar treatment with fractional laser under local anesthesia.

This study was conducted at department of burn, Changhai hospital, and all operations completed by experienced surgeons (researcher).

This study is a prospective randomized controlled study. A group of patients wear a blindfold and the other group treated with VR equipment (HTC Vive) after localized anesthesia with standard lidocaine cream. Finally, the differences of pain score,anxiety score, physiological indicators and satisfaction between two groups are compared. This study could provide a safe and non-drug intervention measure for patients receive fractional laser treatment under local anesthesia.

Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant women between the ages of 18 and 60；
2. The scar site to be treated is located outside the head and face, scar area ≥ 0.5% total body surface area (TBSA)；
3. All patients should be sign information.

Exclusion Criteria:

1. Poor physical condition before operative, it is estimated that can't tolerate local anesthesia surgery；
2. Associated with malignant tumors, all kinds of heart disease history, hypertensive patients;
3. Patients with mental illness, alcohol-dependent patients, post-traumatic stress disorder, drug abuse history, and drug addicts; patients with pregnancy; lidocaine cream allergies;
4. Patients can't tolerate VR experience or participate in other clinical trials；
5. Unable or unwilling to comply with research programs.
Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography

It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

GEHC has decided not to provide this detail

Eligibility Criteria:
Inclusion Criteria:

* Patients with a combination of diabetes mellitus (type I or II) and renal impairment who are referred for a contrast-enhanced CT examination.

Exclusion Criteria:

* Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not permitted.
* Patients undergoing dialysis or kidney transplantation will not be included.
Equitable Implementation of Cascade Screening for Familial Hypercholesterolemia

Design, refine, and pilot the two implementation approaches using behavioral economics and then seek further feedback prior to the proposed clinical trial, consistent with these recommendations.

Aim 1. Co-design both implementation strategies using behavioral economics in partnership with the Family Heart Foundation and key partners from diverse backgrounds.

Aim 2. Pilot strategies with 20 patients with high cholesterol and/or with familial hypercholesterolemia (FH) to ascertain feasibility, acceptability, appropriateness.

Aim 1. Conduct interviews with patients with high cholesterol and/or FH and clinicians to identify common barriers and facilitators for individuals to engage in cascade screening. These activities will occur in the first 7 months and will serve as inputs into the design of the implementation strategies to ensure that strategies address determinants identified in the interviews.

Aim 2. To maximize success, pilot test the implementation strategies and the planned data collection approaches.

Eligibility Criteria:
Inclusion Criteria:

* Patients with high cholesterol and/or FH (i.e., probands; Aim 1 Interviews, Aim 2 Pilot Testing Strategies, Aim 2 Interviews). Adults aged 18 and older with clinically diagnosed FH and/or high cholesterol who are treated within Penn Medicine.
* Family Members (Aim 2 Pilot Testing Strategies, Aim 2 Interviews). Adults aged 18 and older who have a family member who has been identified as a patient with high cholesterol and/or FH who is treated within Penn Medicine (i.e., family members of probands).

Exclusion Criteria:

- none
Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation

This is a prospective single-center randomized trial comparing the efficacy and safety of PV cryoablation with the Arctic Front® catheter versus the standard PV isolation using radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated from a clinical point of view and from the detection and quantification of AF episodes by means of the Reveal XT® implantable loop recorder.

Pulmonary vein (PV) isolation using a radiofrequency catheter is the most widespread technique for atrial fibrillation (AF) ablation. These procedures are difficult and time-consuming, because they require precise catheter manipulation and multiple radiofrequency applications. Thus, alternative techniques are being investigated to simplify the procedure. Recently, a cryoenergy balloon catheter has been developed for PV isolation (Arctic Front®, Cryocath Technologies). When this catheter is deployed at the PV antrum, it can create a circumferential lesion around the PV ostium by delivering a single cryoenergy application.

An implantable loop recorder for AF detection has been made available (Reveal XT®, Medtronic). It may help taking clinical decisions regarding anticoagulant and antiarrhythmic therapy and, at the same time, it may be a powerful tool to evaluate the efficacy of different therapeutic strategies.

This is a prospective single-center randomized trial comparing the efficacy and safety of PV cryoablation with the Arctic Front® catheter vs. the standard PV isolation using radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated from a clinical point of view and from the detection and quantification of AF episodes by means of the Reveal XT® implantable loop recorder.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic recurrent paroxysmal AF (\>2 episodes in the last 6 months), and
* Refractory to one or more class I or III antiarrhythmic drugs, and
* PV anatomy consisting of 4 single PV, with the long diameter of the right superior PV ostium ≤ 20 mm.

Exclusion Criteria:

* Age: \< 18 or \> 75 year-old
* Prior AF ablation
* Pregnancy
* Concomitant acute illness
* Hyperthyroidism
* Moderate to severe valvular heart disease
* Prior cardiac surgery
* Left atrium \> 50 mm (anteroposterior diameter, parasternal long-axis view)
* Intracardiac thrombus
* Contraindications for anticoagulant therapy
* Inability to be followed in our center for at least 1 year
Lichtenstein Versus TAPP and TEP in Groin Hernioplasty

The aim of the study is to evaluate the effectiveness of various methods of inguinal hernia repair and to evaluate techniques of synthetic mesh fixation during laparoscopic and open hernia repair.

In modern literature there is no conclusive evidence for the superiority of endoscopic over open inguinal hernia repair techniques, due to the lack of prospective, multicenter, randomized studies involving a sufficient number of patients. Both Lichtenstein and TAPP/TEP techniques are widely used and accepted methods of treatment. The clinical significance of this study is to show the differences in the incidence of perioperative complications, the evaluation of postoperative pain, full recovery time and improving the quality of life. The diagnosis of inguinal hernia will be based on a physical examination performed by an experienced surgeon based on the medical history of the patient and, if necessary, on ultrasound examination of the abdominal wall. Random assignment of patients to one of three treatment arms will take place the day before the surgery using computer-generated randomization list. The operating surgeon will be determined prior to randomization. Each patient before the study will receive complete information about the study which will be explained in detail regarding all planned procedures, the patient will obtain answers to any questions. After explaining any doubts the patient will sign the informed consent to participate in the study, in the presence of the investigator. Patients will be divided into three groups - TAPP, TEP and Lichtenstein method. Patients treated by TAPP and Lichtenstein will be further divided into subgroups - fixation glue or stitching - Lichtenstein method; fixation glue, tackers or implantation without fixation - TAPP method. Patients will receive preoperative antibiotic prophylaxis with a single dose of cephalosporin. Patients undergoing surgery will be hospitalized in the Department of Surgery until the first postop day. In justified cases, hospitalization will be extended.

Eligibility Criteria:
Inclusion Criteria:

* male
* age: 18 - 65
* planned inguinal hernia repair using synthetic implant
* BMI range: 20-35 kg / m2
* written informed consent

Exclusion Criteria:

* prior midline laparotomy
* contraindications for general anaesthesia
* ASA \> IV
* cirrhosis (Child B or C) or ascites
* active treatment with use of chemiotherapy
* incarcerated hernia
Plasma Trimethylamine N-oxide Elevation Induced by L-carnitine Supplementation and Insulin Resistance

The primary aims of the current study:

* using L-carnitine supplementation modulate the level of plasma trimethylamine N-oxide to assess its effect on circulating cytokines related to diabetes and metabolic syndrome;
* using simulated night-shift work intervention as a stress factor, explore the effect of circulating metabolites on insulin sensitivity

The secondary aim is to evaluate the effect of carnitine supplementation on gut microbiome composition.

Subjects will be randomly divided in two groups: supplemented by L-carnitine 2g/day for 12 weeks, and placebo group receiving leucine in identical gelatine capsules.

Subjects who successfully complete the protocol will be divided into four subgroups - two with a changed circadian cycle and two controls (supplemented and placebo). Subgroups with a changed daily cycle will be able to sleep between 8:00 and 17:00 for four consecutive days, while during the night they will stay active in the laboratory. The oral glucose tolerance test (OGTT) will be performed before and after the circadian cycle modification. Glucose levels will be monitored by FreeStyle Libre Sensor. Moreover, the activity of the participants will be monitored by wearable activity trackers.

Before supplementation, as well as before circadian cycle modification and after finishing the whole experimental procedure, fasting blood samples will be collected for determination of plasma trimethylamine N-oxide (TMAO), trimethylamine (TMA), carnitine (free and acyl derivatives), protein markers of diabetes and inflammation.

Moreover, the stool samples will be collected before and after 12 weeks of supplementation, to determine the composition of the gut microbiome. In addition diet of participants will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers,
* must be able to swallow tablets

Exclusion Criteria:

* smokers,
* cardiovascular disease
* liver disease
* kidney disease
* gastrointestinal disorders (including stomach ulcers and erosions)
* diabetes
Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis

During the past years many investigators have focused on the immunological changes in sepsis disease, and great attention has been paid to the development of practicable means of immunomonitoring. Little is known about diagnostic and prognostic vascular biomarkers during the time course of patients with sepsis.

Primary Outcome Measures:

New diagnostic and prognostic markers for septic patients

Estimated Enrollment: 300 patients Study Start Date: January 2012 Estimated Study Completion Date: open Estimated Primary Completion Date: open

Intervention Details:

Procedure: vein puncture comparison of different inflammatory markers in the blood of septic patients

Eligibility Criteria:
Inclusion Criteria:

* SIRS-Criteria
* Proven Infection
* One sepsis-induced organ-failure
* Adults \< 18 years old

Exclusion Criteria:

* Anemia
* Pregnancy
* Blood donor in the last 3 month
Selective Nerve Root Block With Ultrasound Guidance Improves Surgical Outcome of Selective Discectomy in Patients With Multilevel Cervical Disc Disease

Disc degeneration is a natural part of growing older. Up to 60% of asymptomatic people have MRI findings that are positive. As a result, MRI only provides morphological information and may not be able to determine the clinical significance of the findings.

Many authors believe that patients who suffer from cervical radiculopathy as a result of degenerative disease and have multilevel pathology on imaging studies still have moderate surgical outcomes. This occurs due to a misdiagnosis or the need to perform surgery on multiple levels despite a single painful lesion.

Although the complication rate for 1- and 2-level ACDF is so low that it is considered one of the safest procedures in spine surgery. There is concern that increasing levels of fusion will lead to more complications, such as a higher incidence of persistent axial neck pain, dysphagia, and vertebral artery injury, as well as more postoperative pain and higher narcotic dosages.

Eligibility Criteria:
Inclusion Criteria:

* all patients presented with unilateral brachialgia due to multilevel cervical disc disease

Exclusion Criteria:

* multilevel cervical disc disease who had bilateral brachialgia,
* myelopathy, double crush syndrome,
* ossified posterior longitudinal ligament (OPLL),
* combined anterior and posterior pathology requiring posterior decompression
Heterogeneity and Evolution of hepatoceLlular Carcinoma in Post-transplant HCC Recurrence

Objective of Study: This study will evaluate the heterogeneity and evolution pathway between primary HCC and tumor relapse after liver transplant.

According to the "Seed-Soil" theory, the primary hypothesis of this study is that HCC patients with different molecular-subtype experience altered different pattern of post-transplant recurrence, thus may have altered postoperative Recurrence-Free Survival (RFS). Because the donors' liver construct different microenvironment for CTC(circulating tumor cells) colonization. The investigators design this translational study to ①explore potential high recurrent risk HCC molecular-subtypes which might benefit from neoadjuvant systematic therapy or early adjuvant systematic therapy;②identify the molecular subtype heterogeneity of primary and recurrent HCC to guide the precision medicine.

40 specimens will be obtained from the primary tumor during liver transplant surgery and biopsy/specimens from intrahepatic tumor or lung metastasis when the patients experience postoperative relapse. The molecular-subtype of HCC will be determined via whole exom sequence(WES), immunohistochemistry(IHC) and RNA-Seq.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have pathologically or cytologically or by radiological criteria proven hepatocellular carcinoma; known mixed histology (e.g. hepatocellular carcinoma plus cholangiocarcinoma) or fibrolamellar variant is not allowed
* Patients have post-transplant HCC recurrence(cohort 1), Indication for being an candidate in the waiting list for liver transplant according to multidisciplinary board evaluation(cohort 2)
* The time frame between liver transplant and diagnosis of post-transplant HCC recurrence\> 6 months
* No prior hepatectomy or systemic therapy or local therapy (TACE etc.)

Exclusion Criteria:

* History of oncological systemic treatment
* early recurrence(\<6 months)
* multiple organ transplantation