cyrilzakka/clinical-trials huggingface dataset:
Correlation of Weight Loss With Residual Gastric Volume and Shape on Computerized Tomography in Patients Undergoing Sleeve Gastrectomy

Laparoscopic sleeve gastrectomy (LSG) has been accepted as a primary bariatric procedure. The aim of the study was to evaluate the volume and the morphologies of remnant stomachs after LSG and their association with weight loss

Twenty patients who underwent Laparoscopic sleeve gastrectomy (LSG) were followed prospectively and evaluated at 12 months after operation using computed tomography CT with 3D reconstruction to evaluate the shape and volume of the residual stomach after LSG. Total sleeve volume (TSV), tube volume (TV), antral volume (AV) and tube/antral volume ratio (TAVR) were included.

Eligibility Criteria:
Inclusion Criteria:

* candidate for sleeve gastrectomy

Exclusion Criteria:

* revisional surgery
Philtrum Reconstruction Using Autogenous Fat Injection Versus a Surgical Repair in Secondary Unilateral Cleft Lip Revision

Two groups of patients with repaired unilateral cleft lip deformity having mild to moderate grooving and/or scarring of the philtral column and requiring a secondary cleft lip repair.

* The first group will receive upper lip fat injections into the philtral column (and other areas of volume insufficiency if needed) after manual fat liposuction from the abdomen.
* The second group will receive surgical lip revision with reconstruction of the orbicularis oris muscle using inverted horizontal mattress sutures for enhancement of the philtral ridge.

Interventions:

A. Intervention group: Fat injection

Harvesting fat from the donner site:

1. Surgical repair is to be done under general anesthesia.
2. IV infusion of cephalosporine antibiotic as surgical prophylaxis against infection
3. Tumescent fluid of normal saline and epinephrine 1:500,000 is to be hand infiltrated into the donor site (abdomen).
4. The lipoaspirate is to be harvested from the donor site using manual liposuction through a small incision (less than 0.5 cm). Fat is aspirated using a blunt tipped catheter on a 10-mL syringe.
5. The fat is emulsified.

Injecting fat into the lip:

1. The micro fat is reloaded into a 1-mL syringe and injected with a 1.5 mm blunt-tipped grafting needle.
2. Small aliquots of fat are injected into the philtral column.
3. Fat is to be injected in the vermilion and any other area of volume insufficiency if needed, depending on the contour of the lip.

B. Comparator group: Surgical revision with orbicularis oris muscle reconstruction.

1. Surgical repair is to be done under general anesthesia.
2. IV infusion of cephalosporine antibiotic as surgical prophylaxis against infection
3. The original scar will be marked on the skin with methylene blue.
4. The operating area will be injected with 0.5% lidocaine (containing 1:200,000 epinephrine).
5. The skin will be incised along the designed line with scar removal.
6. The orbicularis oris muscle stump is to be dissected medially and laterally.
7. In the medial segment, the dissection is restricted to within 5 mm medially to avoid crossing the center of the philtral dimple and to prevent any disruption of the normal philtral dimple. The muscle on the lateral cleft segment is to be freed from skin and mucosal by scissor dissection.
8. The medial and lateral orbicularis oris muscle stumps are approximated by means of 4-0 inverted horizontal mattress sutures.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with repaired unilateral cleft lip deformity.
2. Mild to moderate grooving and/or scarring of the philtral column.
3. Patients who require a secondary cleft lip repair.
4. Age of the patient between 4 \& 16 years
5. All patients are free from any systemic disease that may affect normal tissue healing.

Exclusion Criteria:

1. Patients older than 16 years old or whose caregivers declined a revisionary operation.
2. Patients with any systemic disease that may affect normal healing.
3. Patients with any other craniofacial malformation.
4. Syndromic cleft patients.
Influence of a Questionnaire on Patients' Emergency Room Expectations

The goal of this study is to determine whether a novel questionnaire designed to illicit patient's self-reported expectations across four domains (overall purpose of visit, medication intervention, imaging intervention and disposition) improves patient-provider communication as evaluated by an exit survey during an emergency room visit.


Eligibility Criteria:
Inclusion Criteria:

* Patients who arrive through the ED main entrance (non-EMS)
* Patients aged 18 years and older
* Patients who demonstrate decision making capacity
* Patients who willingly consent to participate

Exclusion criteria:

* Patients in distress (physical, emotional, or other) as determined by investigator
* Patients who demonstrate altered mental status or lack of capacity to consent
* Patients who require immediate medical intervention including diagnostic and/or treatment intervention
* Prisoners and patient under involuntary holds
Lung Cancer Screening: A Multilevel Intervention

The study will develop and test the feasibility of the Lung Cancer Assessment of Risk and Education (LungCARE) intervention to increase discussions about lung cancer screening between patients and physicians. This intervention will be designed to reach primary care patients and will be implemented at three levels of the healthcare structure: patient, physician, and system. The patient component includes a short lung cancer screening video and questions regarding screening preferences. Patients will receive immediate feedback in a report (patient report) that summarizes their lung cancer screening preferences and a handout summarizing the educational video. At the physician level, primary care physicians (PCPs) will receive a similar report (physician report), which will be delivered to them prior to the patient visit. The report contains additional information about documenting discussion related to risk, screening, and referrals in the electronic health record (EHR) system (system component). The investigators will develop the LungCARE intervention and have a comparison group that will receive usual care. Preliminary testing of LungCARE will occur via a randomized controlled trial (RCT) at the University of California, San Francisco, General Internal Medicine and Women's Health Primary Care clinics. The RCT will evaluate LungCARE among 50 PCPs and 120 high-risk current and former smoker patients. The investigators will determine whether the intervention is accepted by patients and physicians and whether patients who received LungCARE are more likely to discuss lung cancer screening with their physicians when compared to patients and physicians in the comparison group. The investigators will also determine whether the intervention affects knowledge of lung cancer and low-dose computed tomography (LDCT) screening, perception of risk, and worry about lung cancer in patients when compared to patients in the comparison group. The investigators expect their research to provide specific recommendations that will facilitate patient-physician discussions about LDCT screening and promote shared decision-making among patients and physicians.


Eligibility Criteria:
Inclusion Criteria:

* age 55-80
* smoked at least 30 pack-years in lifetime
* if former smoker, quit smoking within the last 15 years
* English speaker
* no prior history of lung cancer
* did not have a lung cancer screening test within the last year
* PCP does not object to patient's participation
* have a scheduled visit at University of California, San Francisco (UCSF) internal medicine clinics.

Exclusion Criteria:

* speaking a language other than English
* has a history of lung cancer
* had a lung cancer screening test within the last year
* PCP objects to patient's participation.
3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer

The investigators will propose a novel method to improve prostate cancer screening with PSA, using a 3-month treatment with finasteride, a drug used to treat Benign Prostatic Hyperplasia (BPH) and proven to reduce a man's risk of developing prostate cancer. The investigators will also examine three additional promising tests that may further improve diagnosis of prostate cancer.

The primary goal of this proposal is to determine if a 5-alpha reductase 'challenge' improves screening performance of PSA and DRE in men who are scheduled for prostate biopsy. Currently a higher PSA level leads to a recommendation for prostate biopsy, causing hundreds of thousands of unnecessary biopsies annually in the U.S. We will show that a three-month treatment with finasteride for men with high PSA levels will better predict the man who should have a prostate biopsy. PSA performance after finasteride 'challenge' will also be compared with new tests for prostate cancer. Finasteride is supplied by Merck and Company, Incorporated.

Eligibility Criteria:
Inclusion Criteria:

1. Risk of prostate cancer 20-60% calculated with the on-line Prostate Cancer Prevention Trial (PCPT) prostate cancer risk calculator. (www.prostate-cancer-risk-calculator.com). PSA value must be obtained within 3 months prior to study entry. A description of the frequency of these individuals in the population is provided in Specific Aim 2
2. Patient has been recommended to undergo and plans to have a prostate biopsy.
3. Patient is willing to delay prostate biopsy for a 3-month finasteride vs placebo treatment.
4. No allergy to finasteride or other five alpha reductase inhibitors.
5. Patient is willing to take finasteride vs placebo 5 mg orally daily for 3-month treatment period.
6. Age 55 or older. (This age is selected as the PCPT risk calculator is only valid for this age range.)

Exclusion Criteria:

1. Risk of cancer greater than 60% or less than 20%.
2. Prior history of prostate cancer.
3. Prior treatment with finasteride or dutasteride in the past 6 months
4. Younger than age 55.
PV Loop & Coarctation Study

Coarctation of the aorta accounts for 4-7% of all congenital heart disease. While stent therapy, when feasible, is the standard of care for coarctation, it may not completely improve the work (and afterload) of the heart due to its effects on the elasticity of the aorta. This study will provide the information needed to understand the effects of current management on the cardiac mechanics and work.


Eligibility Criteria:
Inclusion Criteria:

* Children 6 years of age and older and adults of all races and both sexes referred for elective cardiac catheterization and stent therapy for coarctation
* Those who provide informed consent for study participant.

Exclusion Criteria:

* Children who undergo other interventions in addition to the coarctation
* Children with single ventricle physiology.
* Renal impairment
* Participant unwilling to sign a consent form.
Study Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation

The objective of this study is to assess the efficacy and safety of oral valganciclovir versus intravenous ganciclovir in patients following allogenic stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Patient following allogeneic SCT
* Patient with a first episode of positive CMV-PCR (DNAemia) or pp65 antigenemia assay (antigenemia) up to 100 days after SCT
* Absolute neutrophil count (ANC) ≥1000 cells/µL on 2 consecutive follow-ups within 10 days before randomization
* Patient has a creatinine clearance of ≥25 mL/min (calculated by the Cockcroft-Gault formula, see Part I Section 6.1.2) with evidence of improving renal function,
* None or gastrointestinal graft-versus-host disease (GVHD) up to grade 2

Exclusion Criteria:

* Patient has a suspected or diagnosed CMV disease
* Patient has received syngeneic SCT
* Patient who received an investigational medicinal product (IMP) within the last 30 days prior to screening or who is simultaneously participating in another clinical study with an IMP
* Patient with a body weight \<50 kg or \>95 kg,
* Patient has received anti-CMV therapy within the past 30 days prior to screening (the use of acyclovir, valacyclovir, or famciclovir is permitted)
* Patient who has participated in this study before,
* Patient who shows a neutropenia, thrombocytopenia, or anemia within 10 days before or at the time point of randomization as following:

  * The ANC is \<1000 cells/μL on 2 consecutive follow-ups, or
  * A platelet count of ≥25000/μL can not be achieved/maintained with platelet transfusions
  * A hemoglobin level of ≥8g/dL can not be achieved/maintained by red blood cell transfusions
Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7)

This is a Phase 3, multicenter, open-label, randomized study of nemvaleukin in combination with pembrolizumab versus protocol-specific Investigator's choice chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Patients will be centrally allocated in a randomized fashion (3:1:1:3) to receive either:

Arm 1: Nemvaleukin and pembrolizumab combination therapy Arm 2: Pembrolizumab monotherapy (enrollment completed) Arm 3: Nemvaleukin monotherapy (enrollment completed) Arm 4: Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine.

Eligibility Criteria:
Inclusion Criteria:

* Patient is female and ≥18 years of age.
* Patient has histologically confirmed diagnosis of EOC (ie, high-grade serous, endometrioid of any grade, clear cell), fallopian tube cancer, or primary peritoneal cancer.
* Patient has platinum-resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy beyond first-line setting (resistant) or lack of response or disease progression while receiving the most recent platinum-based therapy (refractory). Patient must have progressed radiographically on or after their most recent line of anticancer therapy.
* Patient must have received at least 1 prior line of systemic anticancer therapy in the platinum sensitive setting, and no more than 5 prior lines of systemic anticancer therapy in the platinum-resistant setting. Patient must have received at least 1 line of therapy containing bevacizumab.
* Patient has at least one measurable lesion that qualifies as a target lesion based on RECISTv1.1.
* Patient is willing to undergo a pre-treatment tumor biopsy or provide qualifying archival tumor tissue.

Exclusion Criteria:

* Patient has primary platinum-refractory disease or primary platinum resistance, defined as disease progression during first-line platinum-based therapy (refractory) or disease progression \<3 months after completion of first-line platinum-based therapy (resistant).
* Patient has histologically confirmed diagnosis of EOC with mucinous or carcinosarcoma subtype.
* Patient has nonepithelial tumor (eg, germline or stromal cell tumor) or ovarian tumor with low malignant potential (ie, borderline or low-grade serous tumor).
* Patient requires fluid drainage (eg, paracentesis, thoracentesis, pericardiocentesis) of ≥500 mL within 4 weeks of first dose of study drug.
* Patient has received prior IL-2-based or IL-15-based cytokine therapy; patient has had exposure, including intralesional, to IL-12 or analogs thereof.
* Patient has prior exposure to any anti-PD1/PD-L1 therapy.
Stop, Focus, Plan, and Change: Predicting Parent and Child Responses to a Brief, Telehealth Parent Training

This study will look at who does not improve after doing a behavioral parent training program briefly through telehealth. It will also study ways to make the intervention better for those that do not improve.


Eligibility Criteria:
Inclusion Criteria:

* Parent speaks English or Spanish
* Parent has access to Internet
* Parent intends to complete treatment
* Parent reports child has elevated externalizing concerns

Exclusion Criteria:

* Child is a ward of the state
* Child diagnosed with severe medical or nonverbal developmental disability
Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders

The purpose of this study is the examine the effect of varenicline on cognition to a high dose (0.08 g/dL) of alcohol (vs. placebo alcohol) over the ascending and descending limb of the blood alcohol curve.


Eligibility Criteria:
Inclusion Criteria:

* 21 years old or older
* Able to read and write in English
* Smokers and nonsmokers
* Meet criteria for alcohol use disorders
* Currently enrolled in NCT00580645

Exclusion Criteria:

* Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol
* Significant hepatocellular injury
* Positive test results at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
* Women who are pregnant or nursing
* Suicidal, homicidal, or evidence of severe mental illness
* Prescription of any psychotropic drug in the 30 days prior to study enrollment
* Blood donation within the past 8 weeks
* Individuals who are seeking treatment for drinking or smoking or who have attempted to quit drinking or smoking within the past 3 months
* Known allergy to varenicline or taking H2blockers
* Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current protocol
* Subjects likely to exhibit clinically significant alcohol withdrawal during the study
Cardiac Implantable Electronic Device (CIED) Research Study

The study is designed to collect data on Cardiovascular Implantable Electronic Device (CIED) information, implant procedure details, and/or patient characteristics to support development of future CIED products and procedures.

This is a data collection, non-randomized, multi-center study. The study will consist of different cohorts with each cohort being independent from another cohort. Each cohort may have a distinct objective, cohort-specific subject population, procedures, and assessments. The study will follow subjects receiving routine care, who meet all of the inclusion criteria and none of the exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years of age.
2. Subject is willing and able to provide written informed consent.
3. Subject is willing and able to complete the study procedures and visits for the duration of data collection requirements

Exclusion Criteria:

1. Subject is unwilling or unable to comply with study procedures as defined in the protocol.
2. Subject with a medical condition that precludes the patient from participation in the opinion of the investigator.
3. Subject is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.
Involvement of Extrapancreatic Factors on Gastrointestinal-mediated Glucose Disposal

We want to investigate the mechanisms of extrapancreatic effects on gastrointestinal-mediated glucose disposal. In order to do so we will perform oral glucose tolerance tests and isoglycemic intravenous glucose infusions in total pancreatectomised patients and in healthy controls.

In the current project we wish to identify the possible contribution of extrapancreatic effects on gastrointestinal-mediated glucose disposal (GIGD). GIGD reflects the percentage of an individual's glucose disposal following oral glucose tolerance test (OGTT) which is caused by the oral route of glucose administration. In healthy subjects GIGD amounts to \~60%. GIGD describes not only the impact of the incretin effect (insulinotropic substances released upon intestinal stimulation) but includes all factors affecting glucose disposal differently during oral vs. iv administration of glucose (including neural reflexes, activation of afferent nerves in the intestinal mucosa, differences in glucagon secretion, hepatic glucose production and first-pass hepatic uptake of glucose, differences in portal and venous blood glucose concentrations and/or at the present unknown factors. It is likely that the incretin effect (pancreatic effect) constitutes a major contributor to GIGD, but so far it has been impossible to discriminate between pancreatic and extrapancreatic mechanisms underlying GIGD

Eligibility Criteria:
Inclusion Criteria:

* Pancreatectomized patients

  * Caucasians above 18 years of age who have undergone total pancreatectomy
  * Normal haemoglobin
  * Informed consent Healthy Subjects
  * Normal fasting plasma glucose (FPG) and normal HbA1C (according to the World Health Organization (WHO) criteria)
  * Normal haemoglobin
  * Age above 18 years
  * Informed consent

Exclusion Criteria:

* Pancreatectomized patients

  * Inflammatory bowel disease
  * Operation within the last 3 months
  * Ongoing chemotherapy or chemotherapy within the last 3 months
  * Ostomy
  * Nephropathy (serum creatinine \>150 µM and/or albuminuria)
  * Severe liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \>3×normal values)
  * Pregnancy and/or breastfeeding
  * Age above 80 years
  * Any condition that the investigator feels would interfere with trial participation Healthy Subjects
  * Diabetes mellitus (DM)
  * Prediabetes (impaired glucose tolerance and/or impaired FPG)
  * First degree relatives with DM
  * Inflammatory bowel disease
  * Intestinal resection and/or ostomy
  * Nephropathy (serum creatinine \>150 µM and/or albuminuria
  * Liver disease (ALAT and/or serum ASAT \>2×normal values)
  * Pregnancy and/or breastfeeding
  * Age above 80 years
  * Any condition that the investigator feels would interfere with trial participation
Efficacy of Bupivacaine-magnesium Combination Versus Bupivacaine Alone in Genicular Nerve Block

It is proved that the addition of magnesium sulfate to local anesthetics for neuraxial anesthesia improves the quality of analgesia and prolongs the duration of anesthesia . In-vitro and in-vivo studies have demonstrated that magnesium enhances the local anesthetics effect on peripheral nerves .

No previous studies were conducted on magnesium sulfate as an adjuvant to the local anesthetic in genicular nerve block. Hence, this study will be conducted to assess analgesic efficacy of magnesium sulfate when added to bupivacaine in ultrasound guided genicular nerve block


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist (ASA) I or II physical status.
* Between 18 and 70 years of age.
* Both genders.
* Patients undergoing total knee replacement surgery.

Exclusion Criteria:

* Patient refusal.
* ASA Ⅲ and Ⅳ patients.
* Known allergy to the study drugs.
* Hypermagnesemia.
* Central or peripheral neurological disease.
* Pregnancy.
* Drug or alcohol abuse.
* Localized infection at the site of the block.
* Bleeding disorder (platelets count less than 100,000 or international normalized ratio more than 1.4)