louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07011628: Transition to Ambulatory Bariatric Surgery (TABS) Trial
Official title: Transition to Ambulatory Bariatric Surgery (TABS) Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity and Obesity-related Medical Conditions
Bariatric Surgery
Keywords: ambulatory surgery
same day discharge
gastric bypass
sleeve gastrectomy
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2025-06-09
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare same day discharge and at least one night stay in the hospital after bariatric surgery. Patients undergoing bariatric surgery will be randomized (i.e. have an equal chance of either plan) to either group. The study's primary outcome is the frequency patients in the study require a visit to the emergency room within 7 days of their surgery.

Detailed description: This pragmatic, parallel, randomized, open-label trial aims to determine the safety and feasibility of same day discharge (SDD) for bariatric surgery including sleeve gastrectomy and gastric bypass. Investigators will investigate the frequency of 7-day emergency department visits with SDD after bariatric surgery (Aim 1). In addition, the investigators will compare total 30-day charges between participants who undergo same day discharge versus those receive post-operative hospital admission (Aim 2).

Eligibility criteria: Inclusion Criteria:

* BMI ≤ 60 kg/m2
* Primary Sleeve gastrectomy or Gastric Bypass,
* Undergoing bariatric surgery at sponsor site

Exclusion Criteria:

* Type 1 Diabetes
* Myocardial Infarction
* Unstable Angina or Heart Failure
* Prior Stroke
* Solid organ transplantation
* Systemic glucocorticoid prior 28 days
* Severe Obstructive Sleep Apnea
* Uncontrolled Hypertension (Systolic \> 150, Diastolic \> 90)
* Untreated Hyperthyroidism
* Chronic Kidney Disease (EGFR \< 60)
* Current anticoagulant use,
* Poorly controlled Type 2 diabetes (Hemoglobin A1c in last 3 months \> 8.5%)
* Chronic opioid use
* Insulin dependence.
* Need for extended venous thromboembolic event prophylaxis,
* \> 1 lifetime bariatric surgery (revisional or conversion bariatric surgery)
* Patient lives \> 130 miles from the hospital.
* Tobacco use in last 12 months
* Desire to become pregnant or active pregnancy
* Prisoners
* Unable or unwilling to follow-up
* Unable to understand or provide consent

Primary outcomes:
measure: Emergency Department Visits
timeFrame: baseline to seven days
Secondary outcomes:
measure: Readmissions to the hospital
timeFrame: baseline to 30 days
measure: The number of operations or procedures
timeFrame: baseline to 30 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT01230528: Childhood Reactive Thrombocytosis
Official title: Childhood Reactive Thrombocytosis (RT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reactive Thromobocytosis in Children
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-10-29
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators will enroll all pediatric hospitalized patients with platelet counts more than (500x109/l) at complete blood counts examination.The association of reactive thrombocytosis and clinical manifestation will be analyzed.

Brief summary: Reactive thrombocytosis (RT) in pediatric patients is common, but usually without symptoms. The incidence of RT is different depending on age. Mostly, we reasoned that RT is a phenomenon, nevertheless the diagnostic value of RT is little known. Therefore, the aim of this study was to determine the association of RT and clinical or laboratory characteristics in pediatric diseases.


Eligibility criteria: Inclusion Criteria:

* The platelet counts more than 500x109/l and age less than 18 years old.

Exclusion Criteria:

* repeated hospitalization ( more than 2 times)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University-WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Jinn-Li Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03883828: Bacterial Decolonization to Prevent Radiation Dermatitis
Official title: Bacterial Decolonization to Prevent Radiation Dermatitis: A Randomized Controlled Trial and Quality of Life Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Radiation Dermatitis
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether bacterial decolonization of the nares and skin prior to treatment with radiotherapy (RT) for patients with cancers of the head and neck or breast, can prevent high-grade radiation dermatitis (RD) and improve quality of life. This study is being conducted because prior studies from this research group have found bacterial colonization in the nose prior to initiation of RT to be associated with an increased risk of high-grade RD. Patients in the treatment arm will receive pretreatment with mupirocin ointment to the nares and chlorhexidine wash to the body while patients in the control arm will receive standard of care treatment. Bacterial cultures will be taken from the nares and skin, and participants will also complete a quality of life questionnaire before and after RT.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Diagnosis of a solid tumor of the breast or head and neck with plans for fractionated radiation therapy (≥ 15 fractions) with curative intent

Exclusion Criteria:

* Prior RT to the region of interest
* Existing dermatologic condition affecting the treatment area (eg: atopic dermatitis, psoriasis, and non-healing wounds)
* Known allergy to chlorhexidine or mupirocin

Primary outcomes:
measure: Number of Participants With Incidence of High Grade Radiation Dermatitis
timeFrame: Last treatment session (study week depends on patient's length of treatment), approximately 5 to 8 weeks
measure: Median Change in Quality of Life Scoring Rated by the Skindex-16 Dermatological Survey
timeFrame: From the first week (week 1) to the last week of treatment (study week depends on patient's length of treatment), approximately 5 to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Beth McLellan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03825328: A Trial of NS/GEMOX Chemotherapy in Patients With Untreated Pancreatic Cancer ( HZ-NS/GEMOX-PC )
Official title: A Phase II , Open-label , Investigator-initiated Trail of Sequential GEMOX/NS Chemotherapy in Patients With Untreated Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase II , Open-label , Investigator-initiated Trail of Sequential GEMOX/NS Chemotherapy in Patients With untreated Pancreatic cancer.

This study aims to evaluate the safety and efficacy of Sequential GEMOX/NS Chemotherapy as a first-line treatment of untreated Pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

1. Voluntarily participate in the trial and sign the informed consent form
2. 18 years old \<age \<75 years old
3. Histopathological or cytologically confirmed (inoperable) locally advanced or recurrent metastatic pancreatic ductal adenocarcinoma with lesions measurable according to RECIST criteria
4. ECOG score 0-1
5. Life expectancy \> 3 months
6. There must be a CT or MRI examination within a week
7. at least one lesion that can be measured by the RECIST v1.1 standard
8. No chemotherapy has been performed (the interval between postoperative adjuvant chemotherapy must be more than 6 months)
9. without radiation therapy (unless there is at least one measurable target lesion in the non-irradiated area)

Exclusion Criteria:

1. pregnant or lactating women; or those who have fertility but refuse to take contraceptive measures;
2. Severe active infections requiring intravenous antibiotic treatment during enrollment;
3. those who are allergic to the test drug;
4. There is ≥2 neuropathy (CTCAE 4.0);
5. uncontrolled, symptomatic brain metastases or those with a history of uncontrollable psychiatric disorders; severe intellectual or cognitive dysfunction;
6. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack;
7. Have other malignant tumors within 5 years, except for fully treated cervical carcinoma in situ or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin that has been basically controlled;
8. Patients who are unable to follow the protocol or who are unable to follow up;

Primary outcomes:
measure: PFS
timeFrame: from the first drug administration up to 6 months
measure: OS
timeFrame: from the first drug administration up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01833728: A Comparison of Nefopam-propacetamol Combination and Propacetamol for Postoperative Quality of Recovery After Laparoscopic Nephrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Tumor
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The multimodal analgesia for postoperative pain aims for optimal analgesia through additive or synergic drug effects. The multimodal analgesia results in the use of smaller doses of opioids and lowering opioid-related side effects.

Non-opioid analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), propacetamol (prodrug of acetaminophen), nefopam are often given along with opioids as part of multimodal analgesia after major surgery.

NSAIDS, commonly used non-opioid analgesics, have gastro-intestinal, renal, and cardiac side effects.

In contrast, propacetamol or nefopam, two drugs with central analgesic effects, can be safely used as analgesic adjuvants with opioid after nephrectomy, because these drugs do not alter renal function or cause hemorrhagic complications.

Recent study demonstrated that the antinociceptive properties of paracetamol (intravenous acetaminophen) associated with the analgesic effectiveness of nefopam could explain the observed synergy of the combination.

The aim of this randomized, double-blinded study is to compare the opioid-sparing effect and analgesic efficacy, as well as quality of recovery, of nefopam-propacetamol combination and propacetamol in patients undergoing laparoscopic nephrectomy.


Eligibility criteria: Inclusion Criteria:

* ASA status 1-3,
* aged 20 to 65 years,
* undergoing laparoscopic nephrectomy

Exclusion Criteria:

* Severe cardiac disease,
* hepatic insufficiency,
* chronic kidney disease stage ≥3,
* preoperative use of analgesics(corticosteroids, opioid),
* chronic alcoholics,
* hemolytic anemia,
* convulsions

Primary outcomes:
measure: Quality of Recovery
timeFrame: at 24 hours postoperative
Secondary outcomes:
measure: Postoperative opioid consumption
timeFrame: at 24 and at 48 hours after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Mimoz O, Incagnoli P, Josse C, Gillon MC, Kuhlman L, Mirand A, Soilleux H, Fletcher D. Analgesic efficacy and safety of nefopam vs. propacetamol following hepatic resection. Anaesthesia. 2001 Jun;56(6):520-5. doi: 10.1046/j.1365-2044.2001.01980.x.
citation: Girard P, Niedergang B, Pansart Y, Coppe MC, Verleye M. Systematic evaluation of the nefopam-paracetamol combination in rodent models of antinociception. Clin Exp Pharmacol Physiol. 2011 Mar;38(3):170-8. doi: 10.1111/j.1440-1681.2011.05477.x.
Clinical trial NCT05611528: Safety and Effectiveness of Evinacumab for the Treatment of Homozygous Familial Hypercholesterolemia
Official title: Safety and Effectiveness of Evinacumab for the Treatment of Homozygous Familial Hypercholesterolemia in a Real Life Setting in Canada
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Homozygous Familial Hypercholesterolemia
Keywords: ANGPTL3
Real-life study
Monoclonal antibody
Lead sponsor: Ecogene 21
Sponsor class: OTHER
Collaborators: name: Ultragenyx Pharmaceutical Inc
First posted: 2022-11-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label
Primary purpose: TREATMENT

Brief summary: This is an open-label study designed to evaluate the long-term safety and efficacy of evinacumab, a fully human ANGPTL3 antibody, in patients with homozygous familial hypercholesterolemia (HoFH), in a real-life setting in Canada.

Eligible patients for this study are male and female adult patients with HoFH. Evinacumab will be added on top of the patient's background lipid-modifying therapy (LMT), including statins, ezetimibe, PCSK9 inhibitors, lomitapide or other lipid lowering therapies. This study will be conducted using an hybrid (on-site, foldable sites) approach. Patients will enter the current study, in an open-label treatment period, following their screening. This study will continue until reimbursement of evinacumab in Canada or for a maximum of 24 months. The end of study (EoS) visit will be scheduled 4 weeks after the last dose has been injected and will be followed by a 52-week follow-up.


Eligibility criteria: Inclusion Criteria:

* HoFH patients having been previously or being currently treated with evinacumab or clinical diagnosis of HoFH requiring additional lipid lowering therapy.

Exclusion Criteria:

* Any new condition or worsening of an existing condition, which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study;
* Pregnant or breastfeeding women;
* Women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 24 weeks after the last dose of study drug.

Primary outcomes:
measure: Change in lipid profile
timeFrame: Every 4 weeks up to 2 years
measure: Change in aspartate transaminase (AST) plasma concentration
timeFrame: Every 4 weeks up to 2 years
measure: change in alanine aminotransferase (ALT) plasma concentration
timeFrame: Every 4 weeks up to 2 years
Secondary outcomes:
measure: Lipoprotein (a)
timeFrame: Yearly up to 2 years
measure: Complete blood count
timeFrame: Every 12 weeks up to 2 years
measure: Total bilirubin
timeFrame: Every 12 weeks up to 2 years
measure: Creatine phosphokinase
timeFrame: Every 12 weeks up to 2 years
Other outcomes:
Locations:
city: Saguenay
country: Canada
facility: Ecogene-21
state: Quebec
Study officials:
References:
Clinical trial NCT01828528: Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease
Official title: The Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease and Cardiovascular Risk Utilizing Non-invasive Measures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonalcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
Keywords: Nonalcoholic fatty liver disease
Nonalcoholic steatohepatitis
Obesity
Bariatric surgery
Weight loss
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-04-10
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 26 diabetic patients with NAFLD (diagnosed by ultra sound) undergoing sleeve gastrectomy (SG) at Surgery C department at Sheba Medical Center, Israel.

Brief summary: The purpose of this study is to investigate the effect of weight loss rate on liver steatosis, steatohepatitis, fibrosis and cardiovascular risk at different stages before and after bariatric surgery. The investigators also aim to study the short-term effect of bariatric surgery on gastric cholecystokinin levels before and 10 days after the bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* 20≤ age ≤80
* BMI\>35kg/m2
* Men and women
* Fatty infiltration in liver ultrasonography

Exclusion Criteria:

* Alcohol drinking \> 140g/week
* Presence of hepatitis B or C or HIV
* Known liver disease such as:

  1. Wilson's disease
  2. hemochromatosis
  3. α1-antitrypsin deficiency
  4. autoimmune liver disease
  5. primary biliary cirrhosis
  6. primary sclerosing cholangitis)

Primary outcomes:
measure: Change from baseline liver steatosis, steatohepatitis and fibrosis at different stages after bariatric surgery, measured by non-invasive measurements as described below.
timeFrame: Baseline is defined as three weeks to one month before surgery. Different stages to compare to baseline are as following: 8-12 days and 12, 24 and 48 weeks after surgery.
Secondary outcomes:
measure: Change of postoperative cardiovascular risk compared to baseline.
timeFrame: Baseline is defined as three weeks to one month before surgery. Change will be assessed 6-12 months after surgery.
measure: Change in cholecystokinin levels before and after the surgery.
timeFrame: Baseline levels of cholecystokinin at 1-2 days before surgery compared to 8-12 days after surgery.
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Liver Disease Center, Sheba Medical Center, Tel-Hashomer
Study officials:
affiliation: Director Liver Disease Center, Sheba Medical Center, Tel-Hashomer, Israel
name: Ziv Ben-Ari, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00736528: A Phase I, Multiple Dose Study of PF-04447943 in Healthy Elderly Volunteers
Official title: An Investigator And Subject-Blind, Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Doses Of PF-04447943 In Healthy Elderly Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Elderly
Keywords: safety, tolerability, pharmacokinetics, cognition
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-18
Enrollment: 10
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To describe the safety, tolerability and pharmacokinetics of PF-04447943 after administration of multiple, ascending, oral doses to healthy elderly subjects.

Detailed description: Additional Study Purpose Details: Phase I safety and pharmacokinetics study.

Detailed Description:

The study was terminated on 11/12/2008. There were no safety findings in this trial that resulted in the decision to terminate the trial. The study was closed in order to change the amount of drug that subjects would take and to shorten the number of days that the drug would be taken in a new study.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Elderly
* 65-85

Exclusion Criteria:

* Evidence or history of clinically significant unstable disease

Primary outcomes:
measure: Primary Safety: Adverse events, change from baseline in vital signs, triplicate ECG, clinical safety laboratory endpoints
timeFrame: 14 days
measure: Pharmacokinetic endpoints will include plasma PF 04447943 AUCt, Cmax and Tmax
timeFrame: 14 days
Secondary outcomes:
measure: Changes in cognition from baseline
timeFrame: 14 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05556928: Cancer and Aging Resilience Evaluation in Older Adults with Hematologic Malignancies: the CARE-Heme Registry
Official title: Cancer and Aging Resilience Evaluation in Older Adults with Hematologic Malignancies: the CARE-Heme Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Amyloidosis
Plasma Cell Leukemia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 5000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥50 years of age with a diagnosis of any Hematologic Malignancy having an appointment at any participating UAB entity.

Brief summary: The primary purpose of this protocol is to create a registry of older (≥50 years old) patients with Hematologic Malignancies. Our main objectives include: To understand the prevalence of frailty and geriatric impairments among patients aged ≥50y and above diagnosed with a hematologic malignancy at UAB and to gather information that would lend support for future research in this vulnerable population.

Detailed description: All participants will be invited to participate in a patient reported geriatric assessment questionnaire as well as an objective physical function testing. This includes the Short Physical Performance Battery (SPPB) that evaluates lower extremity performance and muscle strength assessment via hand grip dynamometer. Participants will also complete a 12 item modified version of PRO-CTCAE. This will be administered by trained research staff at the time of study enrollment. Repeat CARE instruments (Follow-up GA questionnaire and Physical Function test) will be administered after the baseline visit to measure changes in patient reported outcomes at 3 months, 6 months, and one year. A one-time blood or saliva sample will be requested and obtained at baseline or a follow-up visit.

Eligibility criteria: Inclusion Criteria:

* Patients are ≥50 years of age.
* Patients have a biopsy proven diagnosis of Hematologic Malignancy (Multiple Myeloma, AL Amyloidosis, Waldenstrom's Macrogloblunemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Myelodysplastic syndromes, Myeloproliferative Neoplasm, Acute/Chronic Myeloid Leukemia, Acute/Chronic Lymphoid Leukemia).
* Patients have appointments at UAB including if they are an inpatient or other clinic locations.

Exclusion Criteria:

* Individuals who are \<50 years old.
* Patients who do not read and/or speak English will not be eligible for this study as many of the questionnaires are not validated in other languages. No exclusions will be made based on gender, ethnicity or race.

Primary outcomes:
measure: Create the CARE-Heme Registry
timeFrame: 5 years
Secondary outcomes:
measure: To administer a patient reported geriatric assessment and a brief objective physical assessment.
timeFrame: 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Kirklin Clinic of UAB Hospital
state: Alabama
Study officials:
References: