louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03932006: A Multicenter，Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis
Official title: A Multicenter，Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Keywords: ankylosing spondylitis
Fengshigutong Capsule
imrecoxib
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 180
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: TREATMENT

Brief summary: This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy and safety of Fengshigutong Capsule in the treatment of active ankylosing spondylitis(AS). The primary purpose is to assess the different maintaining treatment programme in AS patients with controlled inflammation by Imrecoxib. The trial will include 180 patients who will be divided into three group: Fengshigutong Capsule plus Imrecoxib group, Imrecoxib group and Fengshigutong Capsule group. Patients will complete the 4-week therapy.


Eligibility criteria: Inclusion Criteria:

* 18 to 65 years
* Meet 1984 modified New York criteria for AS
* The Bath AS Disease Activity Index (BASDAI) ≥4 on a 0-10-cm visual analog scale or the Ankylosing Spondylitis Disease Activity Score using the C-reactive protein level (ASDAS-CRP) ≥1.3
* NSAIDs washout period of at least 7 days prior to randomization
* DMARDs washout period of at least 4 weeks prior to randomization
* Corticosteroids washout period of at least 2 weeks prior to randomization
* Biological agents washout period of at least 3 months prior to randomization.

Exclusion Criteria:

* Peptic ulcer
* Unstable cardiac diseases
* Hematologic disorders
* Psychosis
* Malignancy
* Multiple sclerosis
* severe COPD
* fibromyalgia and other rheumatic disease
* Corticosteroids were injected into the articular cavity within 3 months
* Chinese medicine was taken within 28 days
* Pregnant and lactating women
* Alcohol and drug abuse
* Spinal cord compression

Primary outcomes:
measure: the proportions of patients reaching Assessment in Ankylosing Spondylitis 20%
timeFrame: 4 week
Secondary outcomes:
measure: the proportions of patients reaching Assessment in Ankylosing Spondylitis 50%
timeFrame: 4 week
measure: ASAS20 response
timeFrame: 4 week
measure: ASAS5/6 response
timeFrame: 4 week
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
name: Jieruo Gu, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT06511206: Determination of the Optimal Nutrient Mix to Acutely Increase Plasma Ketones
Official title: Determination of the Optimal Nutrient Mix to Acutely Increase Plasma Ketones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 11
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study will be performed to determine the optimal nutrient mix (predominantly based on medium-chain triglycerides (MCTs)) to induce a mild ketogenic state in healthy older (60-80y), overweight/obese (BMI: 25-35 kg/m2) individuals. Since the aim is to induce a mild ketogenic state, a 25g MCT-based nutrient mix, a 25g MCT-based nutrient mix + cofactors, or a non-ketogenic control will be compared.


Eligibility criteria: Inclusion Criteria:

* Aged 60-80 years
* Body mass index (BMI) 25-35 kg/m2
* Stable dietary habits (no weight loss or gain \> 5 kg in the past 3 months)
* Participants are able to provide signed and dated written informed consent prior to any study specific procedures

Exclusion Criteria:

* Type 2 diabetes
* Pre-diabetes based on one or a combination of the following criteria:

  * ImpairedFastingGlucose(IFG):Fasting plasma glucose ≥ 6.1mmol/l and ≤ 6.9 mmol/l.
  * HbA1c of 5.7-6.4%.
* Participants with active congestive heart failure and/or severe renal and or liver insufficiency
* Uncontrolled hypertension
* Alcohol consumption of \> 3 servings per day for man and \> 2 servings per day for woman
* Unstable body weight (weight gain or loss \> 5 kg in the last 3 months)
* Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the investigator which would possibly hamper our study results
* Significant food allergies/intolerance (seriously hampering study meals)
* Participants who do not want to be informed about unexpected medical findings
* Blood donation during or within 2 months prior to the study

Primary outcomes:
measure: Plasma ketone levels
timeFrame: Testday 1, 2, and 3
Secondary outcomes:
Other outcomes:
measure: Whole-body fat oxidation
timeFrame: Testday 1, 2, and 3
measure: Energy expenditure
timeFrame: Testday 1, 2, and 3
measure: Metabolites in the blood
timeFrame: Testday 1, 2, and 3
measure: Interstitial ketone levels
timeFrame: Testday 1, 2, and 3
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University
name: Joris Hoeks, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00418106: Kangaroo Holding Effects on Breast Milk
Official title: Early Kangaroo Holding Effects on Breast Milk Composition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Keywords: Premature birth
Pumping breast milk
Kangaroo holding
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: University of Delaware
First posted: 2007-01-04
Enrollment: 20
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mothers of preterm infants

Brief summary: Kangaroo holding is a skin-to-skin method of holding a baby. Many research studies have investigated the maternal and infant benefits associated with kangaroo holding. The purpose of this study is to determine if kangaroo holding a baby changes the amount and composition of breast milk pumped before and after the kangaroo holding session.

Hypotheses:

1. There is a significant difference in volume of maternal breast milk pumped after kangaroo holding premature infants as compared to maternal breast milk pumped after non-holding conditions
2. There is a significant difference in the composition of maternal breast milk pumped after kangaroo holding premature infants as compared to maternal breast milk pumped after non-holding condition.

Detailed description: This study will address two of the overwhelming challenges in the physiologic care of premature infants in the neonatal intensive care unit (NICU) environment. The first challenge is promoting neonatal growth through providing a careful balance of nutrition to caloric expenditure for premature infants. The second challenge is supporting parents in the intensive, technology driven environment of the NICU to merge physiologic care with parental-infant interaction through touch, communication, and maternal intervention. The vast majority of mothers with premature infants express breast milk for early feedings, however milk production tends to diminish three to four weeks after delivery. The practice of skin-to-skin holding is thought to promote the mother's ability to produce breast milk, but had not been empirically tested. This study will examine the relationship of kangaroo holding on mother's breast milk production and composition.

Eligibility criteria: Inclusion Criteria:

* Birth weight \</= 2000 grams
* Gestational age 26-34 weeks at birth
* Medically stable at start of study
* \< 14 days old at start of study

Exclusion Criteria:

* Infants receiving phototherapy
* Suspected congenital abnormalities
* Overwhelming sepsis
* Cardiac Abnormalities
* Suspected infections

Primary outcomes:
measure: Breast milk production and composition
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: Amy N. Johnson, DNSc, RNC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06697106: Can COX-2 Inhibitor Decrease Stricture Recurrence After Direct Vision Internal Urethrotomy?
Official title: Can COX-2 Inhibitor Decrease Stricture Recurrence After Direct Vision Internal Urethrotomy?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COX-2 Inhibitor
Meloxicam
Stricture Recurrence
Direct Vision Internal Urethrotomy
Lead sponsor: New Valley University
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 82
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of nonsteroidal anti-inflammatory drugs (NSAIDs) in preventing urethral stricture recurrence after direct visual internal urethrotomy.

Detailed description: The most common aetiology of urethral strictures is idiopathic, followed by iatrogenic causes, including transurethral resection, urethral catheterization, prostate cancer treatments, and previous hypospadias surgery.

The recurrence rates are higher with previously treated, long and multiple strictures, penile compared with bulbar strictures, and those with perioperative infection.

It has been reported that post-transurethral resection of the prostate (TURP) to receive or not receive a COX-2 inhibitor (rofecoxib 25 mg/day) for 20 days. At 1 year of follow-up, a urethral stricture had been diagnosed in 17 and 0 % of cases without and with COX-2 treatment, respectively

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* American Society of Anesthesiologists (ASA) score ≤3.
* Urethral stricture length ≤ 1.5 cm

Exclusion Criteria:

* Recurrent urethral stricture ≥ 2 times.
* Pelvic fracture urethral distraction defect (PFUDD).

Primary outcomes:
measure: Urethral stricture recurrence
timeFrame: 90 days postoperative
Secondary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: 90 days postoperative
measure: Quality of life (QOL)
timeFrame: 90 days postoperative
measure: Maximum flow rate
timeFrame: 90 days postoperative
measure: Incidence of complications
timeFrame: 90 days postoperative
Other outcomes:
Locations:
city: New Valley
country: Egypt
facility: New Valley University
Study officials:
References:
Clinical trial NCT04719806: MR Textural Analysis in Low Grade Gliomas
Official title: Textural Analysis in Low Grade Gliomas on Pre Operative MRI Exams to Determine Molecular Status : a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioma
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lower grade gliomas diagnosed at CHU of Nice with pre operative MRI and molecular data available

Brief summary: WHO classification of low grade gliomas now relies on tumoral molecular patterns, especially on IDH mutation and 1p/19q co deletion status. Textural analysis on medical imaging is studied in several fields, and could provide help in patients with brain tumor due to possible complications of brain biopsy. The purpose of this study is to determine if specific textural signature on MR imaging could be found for low grade gliomas. The investigators included patients with LGG diagnosed at CHU of Nice abd whose first MRI was available on the PACS of the CHU. Textural data are extraxted by tumoral contouring and specific logiciel (LifeX) and histopathologic data are assessed for each patient. Then the investigators analyze it to dtermine if textural indices can predict molecar status.


Eligibility criteria: Inclusion Criteria:

LGG diagnosed at CHU of Nice abd whose first MRI was available on the PACS of the CHU

Exclusion Criteria:

-

Primary outcomes:
measure: review of MRI images to find clues that can predict molecular status
timeFrame: 9 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References:
Clinical trial NCT04481906: Vaginal Mesh Procedures for Female Cystocele
Official title: Long-term Follow-up of Vaginal Mesh Procedures for Female Cystocele
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystocele
Keywords: cystocele
pelvic floor muscle exercise
anterior vaginal repair
vaginal mesh
Lead sponsor: Cathay General Hospital
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 160
Sex: FEMALE
Minimum age (years): 240
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women 20 years or older with cystocele

Brief summary: This study aimed to evaluate primarily the functional outcomes and secondly the morphological outcomes for women who had received standard managements for cystocele at mediate-term follow-up.

Detailed description: Pelvic organ prolapsed (POP) is an important health issue for women all over the world, with cystocele being the commonest type of POP. The side effects related to cystocele include voiding dysfunction, urinary retention, urinary tract infection, hydroureter, or hydronephrosis. The management for cystocele can be classified as non-surgical and surgical methods. Non-surgical methods comprise pelvic floor muscle exercise and vaginal pessaries, while surgical methods can be divided as conventional operations and operations applying mesh augmentation. Conventional surgeries for cystocele such as anterior colporrhapy have high surgical failure rates and complications including vaginal shortening or vaginal stenosis. Operations applying mesh augmentation are becoming the mainstream in the surgeries for cystocle. The Perigee System (American Medical Systems, Minnetonka, MN, USA), which has been approved by American FDA and Taiwan DOH in treating female cystocele, have promising short-term surgical outcomes. However, long-term reports incorporating both functional and morphological outcomes are lacking in the literatures. This study aimed to evaluate primarily the functional outcomes and secondly the morphological outcomes for women who had received standard managements for cystocele at mediate-term follow-up.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of cystocele

Exclusion Criteria:

* Pregnancy or possibility of future pregnancy
* Urinary tract infection
* Diabetes
* Neurological diseases
* Cardiovascular diseases

Primary outcomes:
measure: POP-Q Ba point
timeFrame: Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly
Secondary outcomes:
measure: Functional and ultrasound manifestations
timeFrame: Preoperative, as well as postoperative 3 months, 12 months, and then anuuanlly
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cathay General Hospital
Study officials:
References:
Clinical trial NCT03445806: IOP Monitoring After Trabeculectomy Using iCare Home
Official title: IOP Monitoring After Trabeculectomy Using iCare Home
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glaucoma, Open-Angle
Pseudo Exfoliation Syndrome
Keywords: IOP fluctuations
iCare Home
Trabeculectomy
self-tonometry
Lead sponsor: St. Erik Eye Hospital
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive male and female patients, older than 18 y.o., at St Erik's Eye Hospital in Stockholm, Sweden, diagnosed with POAG or PXG and listed for a trabeculectomy.

Brief summary: The purpose of this study is to investigate how much trabeculectomy influences intraocular pressure (IOP) fluctuations measured with iCare Home rebound tonometry (RTHome) in patients with primary open-angle glaucoma (POAG) or pseudo-exfoliation glaucoma (PEX).

Detailed description: Fifty glaucoma patients (POAG and PEX) planned for trabeculectomy will be recruited.

At baseline, patients will be trained to use the iCare Home tonometer (RTHome), a handheld device based on rebound tonometry and designed for patients to use at home. After the training session and when patients feel confident, a measurement will be recorded. At the same visit, a new measurement will be obtained by the study staff, an optometrist or a nurse, using the same device. No IOP values will be visible for the examiner at that point. A single IOP measurement will be obtained by the same study staff using Goldmann applanation tonometry (GAT). Patients will come for a second visit where new measurements will be made in the same way as at baseline.

In between visits, patients will borrow the iCare Home tonometer to measure their IOP at 06 and 10 am, and at 2, 6 and 10 pm during three consecutive days to obtain an IOP curve.

Two-three months after trabeculectomy, a new IOP curve will be obtained following the same procedure as pre-operatively. There will be no restrictions in patients' daily activities regarding diet, physical activity or slee. If patients use any eyedrops, they will continue to use them as prescribed.

Eligibility criteria: Inclusion Criteria:

* POAG
* PXG

Exclusion Criteria:

* previous trabeculectomy
* reduced hand and arm mobility (e. due to rheumatism)

Primary outcomes:
measure: Lowering of IOP levels after trabeculectomy
timeFrame: 2-3 months
Secondary outcomes:
measure: Lowering of IOP fluctuations after trabeculectomy
timeFrame: 2-3 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: St Erik Eye Hospital
Study officials:
References:
Clinical trial NCT02552199: A Non-Interventional Study To Assess Sweating
Official title: A Non-Interventional Study To Assess Sweating, As Measured By Gravimetry, In Subjects With Primary Hyperhidrosis And In Healthy Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperhidrosis
Lead sponsor: Botanix Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-09-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with palmar hyperhidrosis and healthy subjects

Brief summary: To evaluate the gravimetric sweat measurements in subjects who meet the subjective criteria for a diagnosis of palmar hyperhidrosis compared to subjects without hyperhidrosis.

Detailed description: This is a Non-Interventional Study To Assess Sweating, As Measured By Gravimetry, In Subjects With Primary Hyperhidrosis And In Healthy Individuals .

The objective of this study is to determine the threshold gravimetric measurement for subjects with palmar hyperhidrosis.

Eligibility criteria: Inclusion Criteria:

* Females should not be pregnant or lactating.
* For subjects with palmar hyperhidrosis: Primary palmar hyperhidrosis of at least 6 months's duration and Hyperhidrosis disease severity score of 3 or 4 at baseline
* For healthy participants: no history or current report of hyperhidrosis and Hyperhidrosis disease severity score of 1 at baseline

Exclusion Criteria:

* Recent therapeutic interventions or treatments for palmar hyperhidrosis
* Any major illness within 30 days before the screening
* Females who are pregnant, lactating, or planning a pregnancy

Primary outcomes:
measure: Comparison of Mean Average (Standard Deviation) Total Palmar Gravimetric Sweat Production (GMSP) Between Subject Groups (Adult Patients With Hyperhidrosis Versus Healthy Adult Volunteers).
timeFrame: Gravimetric assessments were conducted in a temperature controlled room on two separate occasions over a five minute period (two assessments/palm), assessing both palms.
Secondary outcomes:
Other outcomes:
Locations:
city: Carpinteria
country: United States
facility: Carpinteria Dermatology
state: California
Study officials:
affiliation: Botanix Pharmaceuticals
name: Patricia S Walker, M.D.,Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02669199: MSCs Source of Sweat Gland Cells of Large Area Skin Injury Patients Transplant of the Wound
Official title: Between Umbilical Cord Mesenchymal Stem Cells Sources Sweat Gland Samples of Large Area Skin Wound Injury Patients Before and After the Transplant Center, Open, Random, Own More Controlled Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: MSCs
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this test is to assess the umbilical cord mesenchymal stem cells (MSCs) UC between source sample sweat gland cells wound transplanted effectiveness and safety for the treatment of large area skin lesions of the subjects


Eligibility criteria: Inclusion Criteria:

* Sign the informed consent form when the age of 18 and 60 years old or less or more men or women (not pregnancy) The burned area: 10-20% TBSA, can satisfy the self control Time: early for skin grafts For location: limbs, chest and back

Exclusion Criteria:

* Serious allergic constitution; Have influence on the speed of wound healing of chronic disease patients; According to the researcher's judgment, may endanger the safety of the subjects or scheme compliance of any chronic disease or severe disease, including cancer, severe heart disease, kidney disease, liver disease, respiratory disease, nerve diseases of the nervous system, blood system diseases, etc.; Clinical researchers or for other reasons can't cooperate with the doctors, and other information is not suitable for clinical study of patients.

Can not meet the requirement of the long-term follow-up of patients.

Primary outcomes:
measure: Frequency of Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Relative Wound Area Regression of 40% or More at 12 Week
timeFrame: 12 Week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: xiaobing Fu
role: PRINCIPAL_INVESTIGATOR
References: