louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01700062: Medium Calorie Parenteral Nutrition on Patients With Gastrointestinal Cancer Undergoing Surgery
Official title: Assessment the Effect of Medium-Calorie TPN on Patients With Gastrointestinal Cancer Undergoing Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Neoplasms
Keywords: medium-calorie
standard calorie
parenteral nutrition
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: aimed at investigating the efficacy, safety, and clinical outcome of Medium-Calorie or standard-calorie total parenteral nutrition (TPN) for patients with gastrointestinal cancer undergoing surgery

Detailed description: biochemistry data Various inflammation-related cytokines clinical outcome hospital stay

Eligibility criteria: Inclusion Criteria:

* Patients considered for major surgery for colorectal cancer Expected requirement for post operative PN or TPN of at least for 7 days Age \>18 Hemodynamically stable Written Informed Consent

Exclusion Criteria:

* Hemodynamic failure of any organ Renal insufficiency Patients with severe liver dysfunction Albumin \< 3g/dL DM with poor blood sugar control

Primary outcomes:
measure: biochemistry data; Various inflammation-related cytokines ;
timeFrame: 7 days
Secondary outcomes:
measure: clinical outcome(hospital stay..)
timeFrame: 2 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
affiliation: Department of pharmacy, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
name: JF CHUANG, M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: Departments of Surgery Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
name: JY WANG, M.D.
role: STUDY_CHAIR
affiliation: Departments of Pharmacy, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
name: YB HUANG, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00457262: Effects of Soy Protein on Serum paraoxonase1 Activity and Lipoproteins in Postmenopausal Women
Official title: Effects of Soy Protein on Serum paraoxonase1 Activity and Lipoproteins in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopausal
Hyperlipidemia
Keywords: paraoxonase1 activity
LDL
HDL
postmenopausal women
postmenopausal women and hyperlipidemia
Lead sponsor: Iran University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-04-06
Enrollment: 42
Sex: FEMALE
Minimum age (years): 51
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: paraoxonase 1 is involved to prevent LDL and HDL oxidation,so increase of it's activity leads to lower risk of coronary heart disease.In postmenopausal women ,we have decrease of paraoxonase1 activity and soy proteins may increase paraoxonase1 activity

Detailed description: In a double blind clinical randomised clinical trial with parallel design this study was done.52 postmenopausal women were randomly assigned to 50 g/d soy protein or placebo for 10 weeks.serum lipoproteins and pon1 activity were measured at baseline and 10th week.There were significant increase in PON! activity and significant decrease in LDL-C,LDL-C/HDL-C,TC/HDL-C and TG/HDL-C in soy group compare to placebo group.

Eligibility criteria: Inclusion Criteria:

* Cessation of menes for more than 1 year, elevation for more than 1 year
* Elevation of FSH level
* Total cholesterol
* Triglyceride more than 200 mg/dl

Exclusion Criteria:

* Chronic disease (heart disease, cancer, diabetes, hepatic, kidney and thyroid disease)
* Antihypertensive drugs
* Antibiotics
* Lipid lowering drugs
* Sex hormone treatment
* Hysterectomy
* Diet rich in soy protein

Primary outcomes:
measure: decrease of LDL,increase of HDL,increase of paraoxonase 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: assistant professor of nutrition,Iran university of medical sciences
name: farzad Shidfar, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT03109691: Ultrasound Guided Bilateral Superficial Cervical Block for Post-operative Pain Therapy in Thyroid Surgery
Official title: Dexamethasone Effect Using Ultrasound Guided Bilateral Superficial Cervical Block for Postoperative Pain Therapy in Thyroid Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bilateral Superficial Cervical Block
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ultrasound Guided Bilateral Superficial Cervical Block for Postoperative Pain Therapy in Thyroid Surgery


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) class I and II

Exclusion Criteria:

* allergy to local anesthetics, bleeding diatheses, and local infection or sepsis thyrotoxicosis and , malignancy.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: through first 24 h postoperative.
Secondary outcomes:
measure: HEART RATE
timeFrame: 5,10,15,30,60,90,120 min introperative
measure: postoperative nausea, vomiting
timeFrame: through first 24h postoperative
measure: The time period for the first analgesic requirement
timeFrame: through first 24h postoperative
measure: blood pressure
timeFrame: 5,10,15,30,60,90,120 min intraoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References:
Clinical trial NCT01219491: Egg Donor Recipient Characteristics Preferences
Official title: Do Egg Donor Recipient Characteristics Change Over Time?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Egg Donor Recipient Characteristics
Keywords: egg donor
recipients
donor characteristics
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 131
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are planning to undergo an egg donor cycle are eligible

Brief summary: To identify the characteristics in an egg donor that are important to a recipient and to see if those characteristics change over time.

Detailed description: No study has explored how recipients' attitudes and reactions change over time regarding the selection criteria for their donors. Consequently, programs have no guidance in how to counsel prospective recipients as to whether their donor preferences will change over time. Participants will complete a survey at 4 points in time as they go through the process of selecting an egg donor and pursuing a pregnancy using that egg donor.

Eligibility criteria: All patients planning to undergo an egg donor cycle are eligible- there are no specific inclusion or exclusion criteria beyond that.

Primary outcomes:
measure: Characteristics of Donors
timeFrame: duration of study
Secondary outcomes:
Other outcomes:
Locations:
city: Norwalk
country: United States
facility: Reproductive Medicine Associates of Connecticut
state: Connecticut
city: Morristown
country: United States
facility: Reproductive Medicine Assoicates of New Jersey
state: New Jersey
city: New York
country: United States
facility: Reproductive Medicine Associates of New York
state: New York
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Andrea M Braverman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05639491: Petro-trigeminal Line and Petrous Apex Cephaloceles
Official title: The Petro-trigeminal Line: a Simple Radiological Marker for the Diagnosis of Cephaloceles of the Petrous Apex on MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Petrous Apex Meningioma
Keywords: Petrous apex cephaloceles
Petrous apex
meckel's cave
cavum-trigeminale-cephaloceles
arachnoïd kyst
meningoceles
trigeminal nerves
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subjects (≥18 years old) who underwent an MRI with high resolution 3D T2 sequence between 01/01/2003 and 09/31/2020:

* consulting for ENT pathology such as vertigo
* or presenting the radiological criteria in MRI of a cephalocele of the petrous

Brief summary: cephaloceles are rare lesions of the petrous apex, inconsistently listed as meningoceles or arachnoid cysts. They're consistent with a herniation posterolateral of the Meckel cavum within the petrous apex. These lesions may be the cause of a symptomatology varied, or be discovered by chance in subjects who have not been asymptomatic. Currently, there is no evidence in the literature a simple, fast and reproducible radiological marker that allows for the diagnosis of cephaloceles of the petrous apex, in particular the small ones. The purpose of this study is to validate a radiological benchmark simple and reproducible, the trigeminal petrol line, in order to improve the diagnosis of petrous apex cephaloceles


Eligibility criteria: Inclusion criteria:

* Major subjects (≥18 years old)
* patients who underwent an MRI with high resolution 3D T2 sequence between 01/01/2003 and 09/31/2020:
* 200 patients consulting for ENT pathology such as vertigo
* 9 patients presenting the radiological criteria in MRI of a cephalocele of the petrous apex according to the current data of the literature on a T2 3D HR sequence
* - Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Subject who expressed their opposition to participating in the study
* Kinetic Artifacts
* Subject under guardianship or curatorship
* Subject under safeguard of justice

Primary outcomes:
measure: Validate a radiological landmark allowing MRI diagnosis cephaloceles of the petrous apex
timeFrame: Files analysed retrospectively from from January 01, 2003 to September 31, 2020 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Radiologie 1 - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT01344291: Turmeric Effect on Reduction of Serum Prolactin and Related Hormonal Change and Adenoma Size in Prolactinoma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hyperprolactinoma
Keywords: hyperprolactinoma
turmeric
amenorrhea
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prolactinoma is the most prevalent anterior hypophysis tumor. The principal treatment for this disorder is Dopamine agonist drugs including bromocriptin and Cabergoline. However, 50% of Bromocriptin treated and 17% of Cabergoline treated patients are resistant to these drugs. Curcumin is the main derivative of turmeric ,an old spice which is used frequently in Indian and Iranian cuisine. It has been proved that curcumin can reduce mammotrope cells proliferation and also intracellular hormone production. The purpose of this study is to evaluate the effect of turmeric on prolactinoma patients.


Eligibility criteria: Inclusion Criteria:

* hyperprolactinemia
* microprolactinoma

Exclusion Criteria:

* pregnancy
* macroadenoma
* neurologic signs due to tumor

Primary outcomes:
measure: serum prolactin level
timeFrame: 2weeks and one month after treatment
Secondary outcomes:
measure: change in LH,FSH and estradiol from baseline
timeFrame: one month ofter treatment
Other outcomes:
Locations:
city: Mashad
country: Iran, Islamic Republic of
facility: Mashad University of Medical Sciences
state: Khorasan Razavi
Study officials:
References:
Clinical trial NCT05049291: Pilot Study of an Advance Care Planning Intervention Among Persons With Dementia
Official title: Pilot Study of an Advance Care Planning Intervention Among Persons With Dementia in Long-term Services and Support Facilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Care Planning
Dementia
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2021-09-20
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Advance care planning allows people to have their wishes taken into account even in the advanced stages of the persons' condition and at the end of life when the person may be unable to communicate. However, a recent review found an absence of high-quality guidelines for advanced care planning in dementia care. Since few evidence-based resources exist, the investigators propose a study to generate, refine, and pilot test an education information sheet designed to promote advanced care planning among families of persons with dementia.

Detailed description: To determine the feasibility, acceptability and preliminary efficacy of an education information sheet to promote advance care planning among family members of persons with advanced dementia in long-term services and support facilities.

Introducing an education information sheet containing prognosis and outcomes will be feasible, acceptable, and increase self-efficacy and do-not-hospitalize decision preferences among family members of persons with advanced dementia.

Eligibility criteria: Inclusion Criteria:

* Family member of a person with a diagnosis of dementia (any type)
* English-speaking family member
* Family member of a person with dementia admitted to a nursing home

Exclusion Criteria:

* Inability to understand/read English
* Advance directive already in patient chart

Primary outcomes:
measure: Feasibility of Information Sheet among Study Population
timeFrame: 6 months
measure: Acceptibility of Decision Aid Tool
timeFrame: 6 months
Secondary outcomes:
measure: Decision Self-efficacy Scale
timeFrame: 6 months
measure: Family Member Decision-Making Self-Efficacy Scale
timeFrame: 6 months
measure: Adaptation of Advance Care Planning Engagement Survey
timeFrame: 6 months
measure: Preparation for Decision-Making Scale
timeFrame: 6 months
measure: Adaptation of Advance Care Planning Engagement for Surrogates Survey
timeFrame: 6 months
measure: Knowledge about Dementia
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05055791: A Study to Evaluate the Safety and Tolerance of SYHX1903 in Patients With Relapsed/Refractory Hematologic Malignancies
Official title: A Phase Ⅰ/Ⅱ Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Efficacy of SYHX1903 in Patients With Relapsed/Refractory Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Acute Myeloid Leukemia
Lymphoma
Multiple Myeloma
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-24
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is an open-label, multi-center, dose escalation, dose expansion, and cohort expansion phase I/II clinical study of SYHX1903 in patients with relapsed/refractory hematologic malignancies. This trial aims to evaluate the safety, tolerance, pharmacokinetics, and preliminary antitumor activity of SYHX1903 in patients with relapsed/refractory hematologic malignancies.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of relapsed/refractory hematologic malignancies confirmed by the World Health Organization (WHO) criteria.
* Eastern Cooperative Oncology Group (ECOG) score ≤ 1.
* Life expectancy ≥ 3 months.

Exclusion Criteria:

* Pregnant and lactating females.
* Proven hematologic malignancies of the central nervous system.
* Diagnosed acute promyelocytic leukemia (predominantly granulocytic promyelocytes in bone marrow, which are ≥ 30% in NEC).
* History of other malignant tumors within 5 years, except for cured skin basal cell carcinoma, skin squamous cell carcinoma or cervical carcinoma in situ.

Primary outcomes:
measure: Dose limiting toxicities
timeFrame: 28 days
measure: Incidence of adverse events
timeFrame: 1 year
measure: Antitumor activity of SYHX1903 in patients by assessing overall response rate (ORR)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01857791: Efficacy of a Clinic-based, Multi- Disciplinary, Pediatric Weight Management Program
Official title: Efficacy of a Clinic-based, Multi- Disciplinary, Pediatric Weight Management Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Body Weight Changes
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Childhood obesity has more than tripled in the past 30 years. From 1980 to 2008, the prevalence of obesity among adolescents aged 12 to 18 years, increased from 5.0% to 18.1%.1 Although several pediatric weight management programs are available, access to these programs may not always be possible.

The proposed study will be an ongoing research program with approximately 40 children ages 12-18 years enrolled into the study over a year. All study participants will participate in a baseline evaluation which will include body composition measures, aerobic testing, as well as nutrition and physical activity questionnaires. Study participants will be assigned to the clinic-based group. The clinic- based group will participate in a 12-week multi-disciplinary weight management program. All study participants will then participate in a 12-week follow-up evaluation similar to the baseline visit. New participants will be enrolled every 12 weeks. Every 12 weeks, active participants (those that have completed a minimum of 12 weeks) will have the option to continue in the program or, discontinue their active participation in the program and enroll into the maintenance phase which will consist of measures only every 12 weeks.

The objective of the proposed study includes examining the efficacy of the clinic-based, multi-disciplinary, pediatric weight management program.


Eligibility criteria: Inclusion Criteria:

* Phone screening
* Approval to participate in a weight management program from the child's pediatrician
* Children between the ages of 12 and 18 years
* Children overweight (\>85th-\<95th BMI percentile) or obese (\>95th BMI percentile)

Exclusion Criteria:

* Children with evidence of significant cardiovascular disease or cardiac arrhythmias
* Children with liver disease
* Children on chronic use of medications including diuretics, steroids and adrenergic-stimulating agents
* Children with emotional problems such as clinical depression or other diagnosed psychological condition and currently use prescription medication for psychological conditions
* Children with evidence of family and/or medical neglect or physical, mental or sexual child abuse

Primary outcomes:
measure: weight loss
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
References:
Clinical trial NCT06320691: General vs Spinal Anesthesia for Total Joint Arthroplasty-Anterior Approach: A Single-Institution Observational Study
Official title: General vs Spinal Anesthesia for Total Joint Arthroplasty-Anterior Approach: A Single-Institution Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty Complications
Anesthesia
Keywords: total hip arthroplasty
general anesthesia
spinal anesthesia
direct anterior approach
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 437
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - patients who underwent direct anterior approach primary total hip arhtroplasty with hip osteoarthritis

Brief summary: The study compares the effects of various anesthetic techniques on anterior approach total hip arthroplasty results retrospectively

Detailed description: Under general (GA) or spinal anesthesia (SA), total hip arthroplasty using the anterior approach (THA-A) can be safely performed. The best method is not sufficiently described in the literature currently in existence.This observational study was carried out at a single facility with consecutive enrollment of patients getting primary THA-A. The investigators compared the difference in complication rates, intraoperative blood loss, length of hospital stay, and duration of surgery, acetabular and femoral component orientation and stem subsidence.

Eligibility criteria: Inclusion Criteria:

* patients who underwent direct anterior approach primary total hip arthroplasty with general anesthesia
* patients who underwent direct anterior approach primary total hip arthroplasty with spinal anesthesia

Exclusion Criteria:

* patients who underwent revision total hip arthroplasty
* patients who underwent total hip arthroplasty with approaches other than direct anterior approach
* patients who underwent primary total hip arthroplasty due to hip fractures

Primary outcomes:
measure: Mean intraoperative estimated blood loss
timeFrame: from preoperative session to postoperative 1 day
measure: mean duration of surgery
timeFrame: from preoperative session to postoperative 1 day
measure: length of hospital stay
timeFrame: from the date of total hip arthroplasty operation until the day that patients discharge, assesed up to 7 days
measure: stem subsidence
timeFrame: postoperative 1 year
measure: stem varus/valgus degrees
timeFrame: postoperative 1 year
measure: acetabular abduction
timeFrame: postoperative 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
References: