louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04731597: Drug Interactions and Hip Fracture Risk in Older Adults
Official title: Drug Interactions and Hip Fracture Risk in Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 9721
Sex: ALL
Minimum age (years): 64
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cases:

* Affiliated patients to the HMO Plan de Salud Hospital Italiano at least 6 months affiliated.
* older than 64 years old. affiliated between 01/07/2014 al 31/12/2019.
* traumatic hip fracture. controls:
* Affiliated patients to the HMO Plan de Salud Hospital Italiano at least 6 months affiliated. \* older than 64 years old.
* affiliated between 01/07/2014 al 31/12/2019.
* without traumatic hip fracture.

Brief summary: Older people are in great risk of hip fracture for multiple reasons. Also they often are on medications for medical conditions. Hip fracture risk increases in relation to some medications. When older peoples take 2 or more medications they are in increase risk of hip fracture.

Detailed description: In this study the investigators describe medication intake profile and identify older people risk of hip fracture in relation to their medication when they are taken together.

Eligibility criteria: Inclusion Criteria:

\* Affiliated patients to the HMO Plan de Salud Hospital Italiano at least 6 months affiliated.

older than 64 years old

\* affiliated between 01/07/2014 al 31/12/2019.

Exclusion Criteria:

* Pathological Hip fracture
* bilateral elective hip replacement previous study period

Primary outcomes:
measure: hip fracture
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Buenos Aires
Study officials:
References:
Clinical trial NCT06113497: A Prospective Study on the Comparison of Postoperative Pain According to the Use of Cocktail Therapy in Laminoplasty
Official title: A Prospective Study on the Comparison of Postoperative Pain According to the Use of Cocktail Therapy in Laminoplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Adverse Effects in the Therapeutic Use of Analgesic, Antipyretic and Anti-Inflammatory Drug, Unspecified
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is the first prospective randomized controlled trial to analyze the effects and safety of multimodal cocktail injections after cervical laminoplasty

Detailed description: This study is the first prospective randomized controlled trial to analyze the effects and safety of multimodal cocktail injections after cervical laminoplasty. Through this study, we anticipate that the potential usefulness of multimodal cocktail analgesic injections in various aspects of spinal surgery will be demonstrated, offering valuable insights and possibilities.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with cervical myelopathy or radiculopathy and scheduled to undergo laminoplasty
* Recorded preoperative upper limb pain (Visual Analog Scale \[- VAS\] ), neck pain (VAS), Japanese Orthopaedic Association (JOA) scores, and Neck Disability Index (NDI) scores.
* Adults aged 20 years and above, but below 80 years capable of articulating their own pain or functional abnormalities
* Cognitive function at a level that enables them to comprehend and adhere to study procedures

Exclusion Criteria:

* Previous surgical treatment of the cervical spine.
* Adolescents aged 20 years or below, pregnant individuals, or those with the potential for pregnancy.
* Hypersensitivity reactions to mixed medications used in Cocktail therapy. (morphine 5 mg, ropiva 150 mg, tamceton 40 mg, epinephrine 1 mg, ketocin 60 mg, jetiam 1 g).
* Patients who lack the capacity for medical consent or are unable to communicate effectively in a medical context.

Primary outcomes:
measure: Change from Baseline in Pain (VAS/Visual Analog Score)
timeFrame: Baseline and Post operation 7 days
measure: Change from Baseline in function (JOA/Japanese Orthopaedic Association Score) score
timeFrame: Baseline and Post operation 7 days
measure: Change from Baseline in function (NDI/Neck Disability Index score) score
timeFrame: Baseline and Post operation 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kyunghee University
name: Kyung-Chung Kang, Associate Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06712797: Physical Activity and Nutrition to Halt Elevated Risk in the Pancreas Interception Center
Official title: Physical Activity and Nutrition to Halt Elevated Risk in the Pancreas Interception Center (PANTHER-PIC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Ductal Adenocarcinoma
Intraductal Papillary Mucinous Neoplasm
Keywords: Pancreatic Ductal Adenocarcinoma
Intraductal Papillary Mucinous Neoplasm
Pancreatic Cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Miles for Moffitt
First posted: 2024-12-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-arm trial evaluating the feasibility and acceptability of a 6-month Physical Activity (PA) and Nutrition (N) intervention for Intraductal Papillary Mucinous Neoplasm (IPMN) patients who are overweight and viscerally obese (on MRI) and/or have elevated levels of SOC incretin, cytokine, or adipokine biomarkers.

Patients with IPMNs (\>15 mm) who have received or will receive care in Moffitt Cancer Center's Pancreas Interception Center (PIC) will be recruited.
Primary purpose: PREVENTION

Brief summary: The purpose of this Study is to assist in implementing a practical, easy-to-adopt lifestyle intervention that optimizes patient outcomes and minimizes pancreatic ductal adenocarcinoma (PDAC) risk.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Endoscopically, radiologically, or biopsy-proven pancreatic intraductal papillary mucinous neoplasm (IPMN) over 15 mm in size
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Ability to sign informed consent
* Ability to read and speak English or Spanish
* Body Mass Index (BMI) greater than or equal to 25 kg/m2
* Visceral obesity based on MRI quantification of visceral and subcutaneous fat; ratio of visceral to subcutaneous fat area greater than 0.4 and/or elevated cytokine, incretin or adipokine biomarkers

Exclusion Criteria:

* No diagnosis of an IPMN
* IPMN with high grade dysplasia, cancer or other high-risk features
* Screen failure for exercise safety
* Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
* Recent fracture or acute musculoskeletal injury
* Numeric pain rating scale of 7 or more out of 10
* Myopathic or rheumatologic disease that impacts physical function

Primary outcomes:
measure: Retention Feasibility
timeFrame: Up to 6 Months
measure: Physical Activity (PA) Adherence Feasibility
timeFrame: Up to 6 Months
measure: Nutrition (N) Adherence Feasibility
timeFrame: Up to 6 Months
measure: Acceptability of Lifestyle Modifications
timeFrame: Up to 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Shaffer Mok, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05105997: Dexamethasone/ Erector Spinae Plane Block Analgesia in Laparoscopic Cholecystectomy
Official title: Dexamethasone as a Bupivacaine Adjuvant in Ultrasound-guided Erector Spinae Plane Block for Patients Undergoing Laparoscopic Cholecystectomy: a Randomized Double-blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Post Operative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Although considered a minimally invasive procedure, laparoscopic cholecystectomy (LC) frequently results in moderate to severe immediate postoperative pain.

Detailed description: Although considered a minimally invasive procedure, laparoscopic cholecystectomy (LC) frequently results in moderate to severe immediate postoperative pain. In addition to predominant visceral pain, nearly half of all patients suffer from shoulder pain in the early postoperative period. The most likely reason is sub-diaphragmatic irritation, which is transmitted by the phrenic nerve, causing referred pain in the C4 dermatome. Due to multiple sources of pain, multimodal analgesia approaches have been used in the perioperative period following LC.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective LC under general anesthesia, ASA status I-II, aged from 18 to 65 years old of both sex

Exclusion Criteria:

* Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis)
* Altered conscious level
* Pregnancy
* Body mass index (BMI \> 35)
* Advanced hepatic or renal failure
* Chronic opioid consumption

Primary outcomes:
measure: The intensity of postoperative pain
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02940197: Comparison of Two Calorie Restricted MediterrAsian Diet on Weight Loss in FTO rs9939609 Overweight Carriers
Official title: Comparison of the Effect of MediterrAsian Diet With Two Different Calorie Restriction on Anthropometric Indices in Carriers of FTO rs9939609 Polymorphism With Overweigh: Toward Personalized Nutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Dietary Modification
Keywords: overweight
Caloric Restriction
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 145
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Obesity treatment should be individualized since some calorie restricted diet doesn't work for some individuals.

Objective: we assess the effect of two different calorie restriction with MediterrAsian diet on weight loss of FTO rs9939609 carriers with overweight.

Methods: we recruit 80 healthy overweight participants aged 20-45 years that randomly allocated in two interventional group \[group 1: Mediterrasian diet according to adjusted ideal body weight with 500 calories restriction (RD) and group 2: without 500 calories restriction (NRD)+ Moderate physical activity\]. Anthropometric indices will be assesses for all participants weekly for two month. The criteria for weight loss is 250-500 grams weekly. Metabolic indices, physical activity and psychologic aspects will be assesses at baseline and the end of the intervention. Dietary adherence will be checked by 24hr recalls at day 0, 30 and 60. At the end of the study, we compare carriers with different alleles (AA+TA and TT) in two intervention groups to find out which calorie restriction is appropriate for each genotype. Significant p-value is less than 0.05.

Detailed description: no data yet

Eligibility criteria: Minimum age: 20 years Maximum age: 45 years Gender: Both Accepts Healthy Volunteers?: Yes

Criteria: Inclusion Criteria:

* BMI range: 24.9-29.9 (overweight)
* Ethnicity: Persian

Exclusion Criteria:

* History of any metabolic diseases like Diabetes, CVD, Thyroid problems and ... .
* History of depression
* Pregnancy, trying to become pregnant or breast feeding
* Smoking
* Use of alcohol
* Significant weight loos during last two months (\>5 kilograms)
* being on a diet during last two months
* Use of any drug or supplement

Primary outcomes:
measure: weight loss
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz university of medical sciences
state: Fars
Study officials:
References:
Clinical trial NCT01231997: Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients
Official title: Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Insufficiency
Kidney Diseases
Urologic Diseases
Keywords: Udenafil
DA-8159
renal impairment
healthy volunteers
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Dong-A Pharmaceutical Co., Ltd.
First posted: 2010-11-02
Enrollment: 27
Sex: MALE
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designed to assess the effect of renal impairment on the pharmacokinetics, safety and tolerability of udenafil in subjects with renal impairment compared to healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Adult males aged 19 to 64 years at screening.
* Subjects with body weight ≥ 55 kg and within ±30% of the ideal body weight : Ideal body weight = (height \[cm\] - 100)x0.9.
* Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion Criteria:

* Subjects with the test results of QTc \> 430 ms or non-sinus cardiac rhythm by ECG analysis.
* Subjects with hypotension or hypertension.
* Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
* Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Primary outcomes:
measure: Pharmacokinetics (AUC and Cmax)
timeFrame: up to 48 hours
Secondary outcomes:
measure: Safety
timeFrame: up to 48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyun-Seop Bae, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000597: Multi-Center Trial of Anti-Thymocyte Globulin in Treatment of Aplastic Anemia and Other Hematologic Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia, Aplastic
Hematologic Diseases
Pancytopenia
Blood Disease
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 1999-10-28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: To determine the therapeutic effects of anti-thymocyte globulin (ATG) in patients with aplastic anemia and related bone marrow failure diseases.

Detailed description: BACKGROUND:

Aplastic anemia has been shown to respond to ATG. An immunological basis for aplastic anemia has been suggested by previous observations although the precise mechanism of action of ATG has not been defined. This serum, produced by immunization of horses with human thymocytes, may have broad reactivity with many human cells.

DESIGN NARRATIVE:

Patients in Group I with acute severe disease were randomized to receive ATG in either ten day or twenty-eight day courses. Patients in Group II with moderate or chronic disease were randomized to receive either ATG for ten days or high doses of the androgen, nandrolone decanoate. Patients in Group III with a variety of bone marrow diseases were also treated with ATG.

The study completion date listed in this record was inferred from the last publication listed in the Citations section of this study record.

Eligibility criteria: Men and women with moderate or acute, severe, aplastic anemia.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Laboratory of Hematology, NHLBI
name: Neal Young
References:
citation: Young N, Griffith P, Brittain E, Elfenbein G, Gardner F, Huang A, Harmon D, Hewlett J, Fay J, Mangan K, et al. A multicenter trial of antithymocyte globulin in aplastic anemia and related diseases. Blood. 1988 Dec;72(6):1861-9.
Clinical trial NCT06698497: Boosting COVID-19 Vaccination Uptake Using Wastewater Surveillance
Official title: Boosting COVID-19 Vaccination Uptake Using Wastewater Surveillance: A County-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vaccine Uptake
Keywords: COVID-19 vaccine
wastewater surveillance
vaccine campaign
communication campaign
vaccine uptake
vaccine hesitancy
health belief model
COVID-19
SARS-CoV-2
coronavirus
Lead sponsor: Syracuse University
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Vaccinations are among the most successful and critical public health interventions. Despite the enormous protection that vaccines provide to public health, both delays and refusals of vaccines (vaccine hesitancy) are on the rise. Given that low vaccination rates present both an individual and community risk, it is critical that measures are taken to increase vaccination uptake in both rural and urban counties in New York. Wastewater surveillance of SARS-CoV-2 has been shown to be a leading indicator of pending surges. This study will examine whether a communications campaign based upon SARS-CoV-2 wastewater surveillance data can increase COVID-19 vaccine uptake.

Forty counties have been selected for the communication campaign (20 in the treatment group and 20 in the control group). A difference-in-differences method will be applied to assess the impact of the communications campaign on vaccine uptake, which observes the outcomes between a control and treatment group over pre- and post-intervention time periods. The communications campaign will be evaluated using the change in vaccination status of residents of the treatment and control counties. Outcomes will also be compared between demographic groups including race and ethnicity because of differences in vaccination rates that have been already observed.

We hypothesize that information regarding COVID-19 provided by wastewater surveillance that is geographically based and more local to communities will increase COVID-19 vaccine uptake. This theory of local information having an impact on health behavior is a novel application of the health belief model to increase vaccine uptake.


Eligibility criteria: Inclusion Criteria:

* Counties in New York State

Exclusion Criteria:

* Counties outside of New York State

Primary outcomes:
measure: COVID-19 Vaccine Uptake
timeFrame: 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse University
state: New York
Study officials:
References:
Clinical trial NCT04643197: Effect of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Diseases (BARBHER)
Official title: Effects of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Disease (BARBHER)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 174
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2\*2 factorial design Primary randomization: Barbed suture vs. Non-barbed suture in fascia closure Secondary randomization: subcutaneous drain insertion vs. non-insertion The effect of secondary randomization is one of secondary objectives.
Primary purpose: TREATMENT

Brief summary: Investigators will compare the incidence of incisional hernia in women who underwent midline laparotomy whose abdominal fascia was closed with barbed suture vs. conventional non-barbed suture.


Eligibility criteria: Inclusion Criteria:

* Anticipating midline laparotomy for gynecologic diseases
* ECOG performance status 0 - 2

Exclusion Criteria:

* Previous or current abdominal incisional hernia
* Pregnant
* Previous radiation on abdomen area
* Allergy to PDS or irgacare MP
* Having disease affecting wound healing such as uncontrolled DM, autoimmune vasculitis, liver cirrhosis, coagulopathy
* BMI \> 35
* Current or anticipated use of drugs affecting wound healing such as bevacizumab (with 4 week drug free period, bevacizumab user is eligible)
* Abdominal midline laparotomy within 6 months
* Surgery for infection control

Primary outcomes:
measure: Cumulative incidence of incisional hernia
timeFrame: from surgery to 1 year
Secondary outcomes:
measure: Time-event curve of incisional hernia
timeFrame: from surgery to 1 year
measure: Cumulative incidence of surgical site infection
timeFrame: from surgery to 4weeks
measure: Incidence of wound dehiscence
timeFrame: post-surgery 4weeks
measure: Brief Pain Inventory - Korean (BPI-K) score
timeFrame: Baseline, postoperative day 2, 4
measure: Treatment related adverse event
timeFrame: from surgery to 1 year
measure: NRS
timeFrame: from surgery to postoperative 4 day
Other outcomes:
Locations:
Study officials:
References: