cyrilzakka/clinical-trials huggingface dataset:
Donor Outcomes Following Hand-Assisted and Robotic Living Donor Nephrectomy: a Retrospective Review

1.1. Background: Renal transplantation is the treatment of choice for eligible patients with end-stage renal disease. It provides better outcomes in terms of life expectancy and quality of life than dialysis (Liu, Narins, Maley, Frank, \& Lallas, 2012). Kidney transplants from living donors also have additional benefits in terms of graft function and survival compared to transplants from cadaver donors (Galvani et al., 2012). Living donor transplants provide an opportunity to have good quality grafts and to perform the procedure when the recipient is in an optimal clinical status (Creta et al., 2019).

Laparoscopic donor nephrectomy was first introduced in 1995 and is currently accepted as the gold standard for kidney procurement from living donors. The first worldwide robotic assisted laparoscopic donor nephrectomy was performed in 2000 by Horgan et al. (Horgan et al., 2007).

The main obstacle to living donation is the exposure of a healthy subject to the risks of a major surgical intervention. Therefore, efforts have been made to reduce complications and postoperative pain, achieve faster recovery, and minimize the surgical incisions.

Minimally invasive procedures like hand-assisted and robotic approaches greatly enhance living donation rates, and in 2001 the number of living donors exceeded the number of cadaver donors (Horgan et al., 2007).

1.2. Aim(s)/Objective(s): The objective of this study is to compare intra- and postoperative patient outcomes of kidney donors following hand-assisted and robotic kidney transplants at a single center.

1.3. Rationale for the study: More research is needed regarding the differences between minimally invasive approaches to kidney transplantation.

This is a retrospective, single-center cohort study. Clinical data will be collected from electronic medical records (EMRs) on donors and recipients who underwent a minimally invasive kidney transplantation procedure. Data from all patients who had a hand-assisted or robotic minimally invasive kidney transplantation procedure at Methodist Dallas Medical Center (MDMC) between January 2006 and November 2019 will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Kidney donors and recipients who underwent a hand-assisted or robotic kidney transplant

Exclusion Criteria:

* Patients that do not meet the Study Inclusion Criteria laid out above
The Effect of Play on Social and Motor Skills of Children With ASD

In this study, the investigators will compare effects of two types of 8-weeklong interventions: a) multimodal or b) general movement to facilitate social communication and motor skills of school-age children with Autism Spectrum Disorder (ASD). Recently, the investigators have identified cortical dysfunction patterns as markers of imitation/interpersonal synchrony difficulties in children with ASD using functional near-infrared spectroscopy. In this project, the investigators want to validate whether cortical markers can determine treatment responders and if such markers are sensitive to training-related changes. Following training, the investigators expect to see a variety of behavioral and neural changes in both groups. If the study aims are achieved, the investigators will validate the use of cortical markers as a treatment response measure. This research will build evidence for the use of various movement interventions for school-age children with ASD.

46 children with ASD between 5 and 15 years of age will be randomly assigned to the multimodal or general play or seated play groups. Each child will participate in 9 testing sessions (4 pretests, 3 posttests, and 3, 2-month follow-ups) and 8 weeks of multimodal or general intervention between pre-tests and post-tests. In the 8-week phase between the pre- and post-tests, each child will complete group-specific intervention-related activities with the expert clinician twice per week via telehealth or face-to-face interactions. Each session will last for around 1-1.5 hours. If the study aims are achieved, the investigators will validate the use of cortical markers as a treatment response measure. Findings from this research will offer evidence for the use of various movement interventions to promote motor, social communication, and cognitive skills in school-age children with ASD.

Eligibility Criteria:
Inclusion Criteria:

* Children with Autism Spectrum Disorder (ASD) between 5 and 15 years of age

Exclusion Criteria:

* Significant hearing or vision impairment
* Significant behavioral problems
* Significant medical (cardiovascular or respiratory), orthopedic, or surgical problems that prevent study participation.
* History of seizures.
* Significant mobility problems that prevent study participation.
A Pilot Study of Intraoperative Gamma Camera Imaging During Sentinel Node Biopsy for Melanoma

This is a single-institution pilot study seeking preliminary evidence of the usefulness of mobile gamma cameras in patients undergoing sentinel node biopsy for melanoma.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older, AND
* plan to go to the operating room for sentinel node biopsy using technicium-99 labeled colloid.

Exclusion Criteria:

* under 18 years of age,
* unable to give informed consent, OR
* not planned to go to operating room for sentinel node biopsy using technicium-99 labeled colloid.
IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy

Patients with the symptoms of generalized GI dysmotility, including gastroparesis, are sometimes refractory to available medications, devices and other interventions/ Some of these patients have serologic and/or endo organ abnormalities and findings consistent with autoimmune neuropathies, primarily involving the GI tract. These disorders have been known as autoimmune gastrointestinal neuropathies (GAIN) or also as autoimmune gastrointestinal dysmotility (AGID), among other terms. Some patients respond to intravenous immunoglobulin (IVIG) and this study, which is an observational clinical series, documents the patients, their findings and standardized responses to therapy with IVIG.

Gastrointestinal dysmotility disorders encompass a large group of patients including a subset with autoimmune findings, either on serologic testing and/or end organ anatomic and physiologic effects.

The identification of patients with autoimmune gastrointestinal neuropathies (GAIN) or also as autoimmune gastrointestinal dysmotility (AGID), has led to trial with autoimmune therapies. Most promising therapy has been intravenous immunoglobulin (IVIG) and this, usually given in 12-week courses with standard dosing, has helped a number of patient's refractory to other available therapies including diet, drugs, devices and enteral diversions/disruptions.This observational study documents clinical observations in consecutive patients meeting entry criteria who received IVIG.

Patients will have their gastrointestinal (GI) symptoms documented by a standardized patient reported outcome (PRO) survey at baseline and use the same assessment tools after at least one course of IVIG therapy.

Eligibility Criteria:
Inclusion Criteria: Patient with otherwise refractory symptoms of gastrointestinal (GI) motor disorders.

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Exclusion Criteria: Inability to receive intravenous immunoglobulin.

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Effects of Oral Citrulline on Protein Metabolism in Patients With Intestinal Failure (Citrugrêle 2)

The specific aim of this study is to determine whether oral citrulline administration enhances whole body protein synthesis in patients with intestinal failure. Protein metabolism will be assessed using an intravenous infusion of stable isotope labeled leucine. The investigators hypothesize that citrulline supplementation will decrease leucine oxidation without altering proteolysis, and consequently stimulate protein synthesis.


Eligibility Criteria:
Inclusion Criteria:

* Adult between 18 and 75 years
* Patient with short bowel syndrome
* Patient with an incompetent small intestine after intestinal resection
* Patient fed orally and beyond more than 6 weeks after surgery
* Absence of any earlier supplementation with citrulline, glutamine, ornithine a-ketoglutarate, or stimol®
* No current artificial feeding (parenteral)
* No low-sodium diet- No renal, cardiac, respiratory or hepatic insufficiency
* No chronic inflammatory disease (intestinal or other)
* No current corticosteroid treatment
* Fasting blood glucose below 6mmol/L
* Patient able to understand benefits and risks of protocol
* Women who are of childbearing potential must have a negative serum pregnancy test and agree to use a medically acceptable method of contraception throughout the study and for 15 days following the end of the study
* Signed informed consent

Exclusion Criteria:

* Subject not fulfilling inclusion criteria
* Subject mentioned in articles L1121-5 to L1121-8 of "code de la santé publique"
* Pregnancy
Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration

Intranasal fentanyl has been found to be safe and effective in the reduction of pain among pediatric and adult populations. The investigators hypothesize that patients who receive 100 mcg of intranasal fentanyl for pain control before first-trimester uterine aspiration will report lower pain scores than those who receive placebo. The investigators will test this hypothesis using a randomized, double-blind, placebo-controlled trial comparing pain reported during uterine aspiration between patients who receive either intranasal fentanyl or intranasal saline prior to the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Seeking office based uterine aspiration
* Gestational age at 14 weeks or less
* Age 14 years or older with parental consent to participate in this research study if 14-17 years old
* Able to read, speak, and understand English
* Ability to understand materials and consent forms

Exclusion Criteria:

* Seeking medical abortion, operating room based surgical abortion, or operating room based miscarriage management
* Gestational age greater than 14 weeks
* Age less than 14 years old
* Inability to read, speak, and understand English
* Current incarceration
* Weight less than 40kg
* Self-reported or documentation of significant cardiopulmonary disease
* Self-reported or documentation of alcohol or substance dependence or abuse
* Contraindications, relative contraindication to fentanyl use
A Registry Study of Sanwujiaowan Capsule Used in Clinical Real World

The purpose of this study is get to know what and how Sanwujiaowan capsule in hospital results in drug-induced liver injury or adverse drug reactions from a cohort event monitoring as registration research.

In order to improving monitoring drug-induced liver injury or adverse drug reactions of Chinese medicine containing Radix Polygoni Multiflori in hospital, registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of drug-induced liver injury. Calculate the incidence of drug-induced liver injury or adverse drug reactions is one of the main aims for this study. Safety surveillance on Chinese medicine containing Radix Polygoni Multiflori is an important problem that needs to be sorted out through large sample observational study. According to the relevant regulations of the CFDA, 3000 cases need to be registered at least. The aim population is who using Sanwujiaowan capsule 's with abnormal liver function before medication from June 2017 to December 2018.

Eligibility Criteria:
Inclusion Criteria:

Patients using Sanwujiaowan capsule 's with abnormal liver function before medication from June 2017 to December 2018.

Exclusion Criteria:

NONE
A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes

The reason for this study is to compare the effect of the study drug tirzepatide to semaglutide on blood sugar levels in participants with type 2 diabetes. The study will last approximately 47 weeks and may include about 12 visits.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with type 2 diabetes mellitus (T2DM)
* Have HbA1c between ≥7.0% and ≤10.5%
* Be on stable treatment with unchanged dose of metformin \>1500 mg/day for at least 3 months prior to screening
* Be of stable weight (±5%) for at least 3 months before screening
* Have a body mass index (BMI) ≥25 kilograms per meter squared (kg/m²) at screening

Exclusion Criteria:

* Have type 1 diabetes mellitus
* Have had chronic or acute pancreatitis any time prior to study entry
* Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment
* Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
* Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level \>3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range
* Have an estimated glomerular filtration rate \<45 milliliters/minute/1.73 m² (or lower than the country specific threshold for using the protocol required dose of metformin per local label)
* Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
* Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
* Have been taking any other diabetes medicines other than metformin during the last 3 months
* Have been taking weight loss drugs, including over-the-counter medications during the last 3 months
Estimating Blood Concentrations of Anaesthetics During One-Lung Ventilation (OLV)

The aims of the study is to determine if end-tidal concentrations of the anaesthetic gases isoflurane and sevoflurane as measured by a standard gas monitor are related to the blood levels during one-lung ventilation.

Measurement of the anaesthetic gases such as isoflurane and sevoflurane allow anaesthetists to gauge their blood levels and in turn their brain levels and so help assess how deep the patient is under anaesthesia. These measurements, made as the patient breathes out, are known as end-tidal concentrations of anesthetic gases and are routinely made with gas monitors. Measurement of blood levels of anaesthetic gases is possible but infrequently done as it is time-consuming, expensive, and requires a scientist in a laboratory with specialized equipment. Depth of anaesthesia is assessed using clinical signs along with end-tidal concentrations though more recently it can be assessed by monitoring the brain's electrical waves. This technique remains controversial.

Mechanically supporting the patient's breathing using only one of the two lungs, known as one-lung ventilation, is used in lung surgery to allow the surgeon to gain access to one side of the chest whilst the anaesthetist supports the lung on the other side. One-lung ventilation markedly alters the exchange of gases in the lungs, including anaesthetic gases. Because of this derangement, it is not known if the end-tidal concentrations are related to blood levels of anaesthetic gases during this type of mechanical ventilation. The aims of the study is to determine if end-tidal concentrations of anaesthetics as measured by a standard gas monitor are related to the blood levels of the gases isoflurane and sevoflurane during one-lung ventilation.

Patients over 18 years old undergoing planned lung surgery with one-lung ventilation and anaesthesia with isoflurane or sevoflurane, and who have a routine tube inserted into an artery in their wrist to monitor blood pressure will be recruited for the study. During the study, two blood samples the size of two teaspoons each will be taken from the tube in the artery and two end-tidal concentration recordings.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* Admitted for elective thoracic surgery using one-lung ventilation obtained by the use of a double-lumen endotracheal tube or bronchial blocker.
* Elective surgery planned between 1 August and 30 November 2016
* Planned insertion of an arterial cannula by anaesthetist for routine monitoring of systemic arterial pressure
* Planned inhalational anaesthesia technique with isoflurane or sevoflurane.
* Patients who have provided consent to take part in the study

Exclusion Criteria:

* Patients under the age of 18
* History of malignant hyperthermia
* Emergency thoracic surgery
* Patients who have not consented to take part in the study
Second Primary Lung Cancer Cohort Study (SPORT)

Patients who have had curative treatment for lung cancer are at an increased risk of developing second primary lung cancers (and other cancers) over the next 10 years. Doctors need to develop better ways of monitoring patients during follow up so we can intervene as quickly as possible with further treatments. Measuring DNA in the blood which has come from the tumour, so called circulating tumour DNA (ctDNA), may be one way to do this.

This is a multi-centre, observational basic science study to follow patient who have undergone radical treatment, surgery or radiotherapy for Non-small Cell Lung Cancer (NSCLC) between two and five years previously. Following consent, participants will be asked to provide blood samples every six months for up to the next five years. Information from their routine clinical care, including information from any imaging, diagnostic tissue samples and blood tests will be collected. We will also request access to any original surplus diagnostic material, as well as future, excess tissue from diagnostic samples.

Blood samples will be analysed using various new scientific techniques looking to correlate emergence of new primary cancer (or recurrence of original NSCLC) with blood based markers.

Eligibility Criteria:
Inclusion Criteria:

* previous treatment with curative intent (surgery or radical (chemo)radiotherapy) for stage I-IIIA primary NSCLC
* at least two years post first treatment date of first primary NSCLC
* able to provide informed consent

Exclusion Criteria:

* Primary lung tumour was a carcinoid tumour
* in the opinion of the managing clinician, thought unlikely to survive 12 months from time of potential recruitment.
Patient Education in Adherence on Acne (PEAce)

This is a multi-center, randomised and controlled study in subjects with acne vulgaris. The main objective of this study is to evaluate the effect of a supplementary patient education intervention (in addition to the standard-of-care patient education) on treatment adherence and satisfaction among acne patients receiving once-daily EpiduoTM gel treatment in primary care clinics.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects age of 12 years or older,
2. With facial acne vulgaris that can be managed in primary care

Exclusion Criteria:

1. Female subjects who are pregnant, nursing or planning a pregnancy during the study,
2. Subjects have a very severe variant of acne such as fulminating acne with systemic symptoms (acne fulminans)
[18F] FACBC and [18F] FLT PET Imaging in Central Nervous System Tumors

The purpose of this study is to help us understand gliomas, one type of brain tumor. This research protocol makes pictures of gliomas. We will take pictures of the glioma before and after treatment. The pictures are made with a positron emission tomography (PET) scanner. PET scans use radioactive markers to "see" cancer cells. We plan to use two different radioactive markers, \[18F\]FACBC and \[18F\]FLT, to "see" if the glioma responds to the treatment being recommended by the doctor. We are investigating whether one or both of these types of PET scans can help us to better understand gliomas and their response to treatment.

We expect these pictures will give us information the your tumor and may help us to understand why the treatment that the patient is receiving is affecting the tumor the way that it is. We also hope to collect information about the amount of radioactivity exposure. We will measure radioactivity exposure to the tumor, brain and other organs.


Eligibility Criteria:
Inclusion Criteria:

* Registered patient at MSKCC.
* Child-bearing age females must be non-pregnant,(documented by a negative pregnancy test within the last 2 weeks), non-lactating, and must be using adequate contraception or be surgically sterile.
* Patients with gliomas
* Patients planning to start anti-AKT and/or anti-VEGF directed therapies .
* Patients with measurable disease on MRI or CT neuroimaging.

Exclusion Criteria:

* Patient is incontinent of urine or stool (which would make them unable to tolerate lying still for 60 minutes).
* Patient cannot tolerate lying still for a 60 minute session in the PET tomograph.
Effects Of Income Supplements On 30-Day Readmissions For Vulnerable Older Adults

Unplanned 30-day hospital readmissions are an critical healthcare quality metric, with meaningful effects on patients and health systems operations. Interventions to reduce unplanned readmissions have primarily operated within a healthcare-centric frame, with enhancements to either pre- or post-discharge care planning, medication reconciliation, or visit frequency. Associations of 30-day readmission rates with poverty status and other social factors, however, suggest that attending to unmet social needs may yield added benefits to models focused on healthcare delivery. The purpose of the present trial is to provide evidence regarding the effects on 30-day readmissions of providing a one-time post-discharge income supplement to socially vulnerable older adults with medical complexity participating in an enhanced care coordination program.


Eligibility Criteria:
Inclusion Criteria:

* A participant in the underlying enhanced care planning program
* aged 55 years or older
* attending an outpatient clinic appointment as part of the underlying enhanced care planning program within 10 days of being discharged from an inpatient hospital stay
* able to understand the study consent form (with interpretation services if needed)

Exclusion Criteria:

* The candidate is not discharged from the index admission to a community setting (e.g., they will be excluded if they are discharged to a skilled nursing facility)
* The candidate has a legal guardian with control over financial decision-making
* The candidate has been approached about the study during a previous encounter
* The index hospitalization was a planned admission
Effect of Furlow Palatoplasty With Buccal Myomucosal Flap on the Speech Development

About 20 patient will be collected according to the eligibility criteria and grouped into Group I : 10 patients were treated with furlow with buccinators flap Group II : 10 patients were treated with 2 flap palatoplasty All patients will be examined by an expert Phoniatrician by Recording of speech samples in Arabic language for the children in a soundproof room including repeated syllables, sentences with high-pressure sounds and counting from 1 to 10. The records will be analyzed to assess the degree of hypernasality, speech intelligibility and compensatory speech errors


Eligibility Criteria:
Inclusion Criteria:

* 3-5 years old childreen with previous treated complete cleft lip and palate, nonsyndromic.
* lip and palate repair performed by one craniofacial surgeon

Exclusion Criteria:

* Patients with syndromic cleft lip.
* Redu cases
* Bilateral cleft lip
* Patient older 5years or younger 3 years.
* Associated Cardiac anomalies.
* Any systemic condition