louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06232005: Intralesional Injection of Mitomycin C Following Visual Internal Urethrotomy for Recurrent Urethral Stricture
Official title: Intralesional Injection of Mitomycin C Following Visual Internal Urethrotomy for Recurrent Urethral Stricture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Urethral Stricture
Keywords: Mitomycin C - Visual Internal Urethrotomy - Urethral Stricture
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 50
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 effectiveness of administering mitomycin C through intralesional injection after performing visual internal urethrotomy (VIU) for the treatment of recurring urethral stricture.

Detailed description: Numerous studies have investigated the impact of intralesional administration of antifibrotic drugs on urethral strictures following visual internal urethrotomy (VIU). These drugs include mitomycin C, botulinum toxin A, somatostatin analog, and glucocorticoids. Mitomycin C (MMC) is known for its potent chemotherapeutic and antibiotic properties. It effectively hinders mitosis and fibroblast proliferation, playing a crucial role in tissue healing and scar formation by reducing the release of matrix proteins through the inhibition of proliferative fibroblasts. With its anti-proliferative and anti-scarring characteristics, MMC proves to be a suitable option for treating recurrent urethral strictures.

thus we conduct a randomized controlled trial to evaluate the safety and efficacy of Mitomycin in decrease urethral stricture recurrence.

Eligibility criteria: Inclusion Criteria:

* All adult male patients aged above 18 years with a single bulbar urethral stricture measuring less than ( 1.5 cm), and had failed at least one prior intervention for urethral stricture(urethral dilation \&amp; VIU) were included in our study

Exclusion Criteria:

* Patients with urethral strictures more than (1.5 cm), multiple urethral strictures, complex stricture, complicated by a fistula or abscess, completely occluded urethral strictures and previous urethroplasty were excluded

Primary outcomes:
measure: Urethral stricture recurrence
timeFrame: 1 year
Secondary outcomes:
measure: urinary tract infection
timeFrame: 1 month
measure: uroflowmetery
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Maher
state: القاهرة
Study officials:
References:
Clinical trial NCT00432705: Changes in Unstable Ankles After Balance Training
Official title: Modulation of Sensorimotor Measures in Chronically Unstable Ankles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ankle Injury
Keywords: ankle
sensorimotor
reflex
training
Lead sponsor: University of North Carolina, Charlotte
Sponsor class: OTHER
First posted: 2007-02-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is evaluating reflex board training to see if it will help people who frequently roll their ankles. We are investigating several tests that evaluate the ability of the neuromuscular system to control ankle movement. This study is in 2 parts:Part 1 looks at changes after 1 day of reflex training; Part 2 looks at changes after 6 weeks of reflex training. It is thought that the reflex training will improve measures of static and dynamic balance as well as spinal reflex measures.

Detailed description: Research has utilized multiple measures in an effort to detect chronic ankle instability (CAI). Recently, investigations have focused on assessment of sensorimotor function in those who suffer from CAI. These measures have included traditional and functional postural control variables, as well as measures of joint position sense, neuromuscular control and recruitment, and nerve conduction velocity. This study seeks to modulate sensorimotor measures through both short- and long-term reflex training. This information may help to better assess sensorimotor deficits associated with CAI, to focus future research, evaluate rehabilitation protocols and to improve our understanding of this chronic disability.

Eligibility criteria: Inclusion Criteria:

* chronically unstable ankles with a history of at least 2 ankle sprains in the past year, M/F 18-30, healthy

Exclusion Criteria:

* ankle sprain within past 6 months, any chronic lower extremity injury or condition, neurological condition, balance-inner ear or vestibular condition, any other condition that would interfere with testing

Primary outcomes:
measure: postural control
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UNC Charlotte
name: JoEllen M. Sefton, MS, ATC, CMT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03122405: Performance Equivalence of Rainbow Acoustic Monitoring (RAM) Small Sensor and RAM Revision D Sensor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-20
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study was to conduct a side by side comparison of the accuracy of respiratory rate (RR) between our investigational Rainbow Acoustic Monitoring (RAM) small sensor and the FDA-cleared RAM Revision D sensor in healthy volunteers under controlled conditions.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Physical status of ASA I or II
* Must be able to read and communicate in English
* Has signed written informed consent

Exclusion Criteria:

* ASA physical status of III, IV, and V
* Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participating in this study
* Inability to tolerate sitting still or minimal movement for at least 30 minutes

Primary outcomes:
measure: Performance comparison of RAM sensors by ARMS calculation
timeFrame: 50 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Clinical Lab
state: California
Study officials:
References:
Clinical trial NCT02590705: Anesthesia Lumbar Puncture In Children
Official title: Anesthesia Lumbar Puncture In Children (ALPIC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Puncture
Anesthesia
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study is carried out in a prospectively randomly controlled way. In the context of acknowledgement and understanding from parents, by comparing with traditional process(no anesthesia), lidocaine surface anesthesia is randomly selected. All children will be evaluated by the FLACC (The face, legs, activity, cry, consolability behavioral tool) scale to quantitatively assess degree of pain during lumbar puncture. Time and success rate of the lumber puncture will be recorded and analyzed. A questionnaire about bad memory during lumbar puncture for all parents and children will be investigated in order to establish an optimized lumbar puncture management process.

Detailed description: The purpose of this study is to establish an optimized lumbar puncture management process on the basis of fully understanding of parents and children. An improved process consisting of painless lumbar puncture (LP) and comfortable LP will be established upon completion of this study.

Eligibility criteria: Inclusion Criteria:

* children with indications of lumbar puncture;
* voluntarily signed the informed consent

Exclusion Criteria:

* topical anesthetic skin allergies;
* skin infection in lumbar puncture site;
* severe intracranial hypertension;
* unstable vital signs;
* coagulopathy;
* intracranial hemorrhage and occupying;
* low back pain;
* headache and low back pain before lumbar puncture;
* past headache after lumbar puncture;
* mental retardation, neuropsychiatric symptoms;
* children could not immediately act after the lumbar puncture(such as disturbance of consciousness or suffering from underlying diseases or drainage);
* the case with repeated puncture in one operation

Primary outcomes:
measure: degree of adaptability
timeFrame: intraoperative
Secondary outcomes:
measure: time of lumbar puncture
timeFrame: intraoperative
measure: number of puncture
timeFrame: intraoperative
measure: success rate
timeFrame: intraoperative
measure: whether bad memories exist or not
timeFrame: up to four hours postoperation
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Childrens' Hospital
name: Gang Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00799305: Correlation of Airflow Limitation and Other Respiratory Characteristics With Radiologic Changes of Lung Structure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with COPD attending pulmonary clinic in the internal disease department at the Hillel Yaffe Medical Center

Brief summary: The aim of the study is to assess the correlation between airflow limitation, perception of dyspnea and functional capacity with anatomic changes in pulmonary structure as seen on High Resolution CT in COPD patients.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of COPD
* Able to perform pulmonary function testing

Exclusion Criteria:

* Pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT03570905: Radiographic and Clinical Comparison of Post-reduction Splinting Constructs in the Treatment of Acute Displaced Distal Radius Fractures
Official title: Radiographic and Clinical Comparison of Post-reduction Splinting Constructs in the Treatment of Acute Displaced Distal Radius Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radius Fractures
Keywords: acute, displaced distal radius fracture
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subjects with acute, displaced distal radius fractures will be randomized at the time of emergency room evaluation to one of two commonly accepted splinting methods for displaced distal radius fractures: sugar tong splints or volar/dorsal clam shell splints. Reduction will be performed in the usual, standard fashion and the selected splint applied. Standard radiographic measurements of alignment, including radial height, volar tilt and inclination will be measured on pre- and post- reduction radiographs by a single reviewer- who will be blinded to splint application type. At the first fracture follow-up visit, typically occurring between 5-10 days, as in standard practice, repeat radiographs of the wrist will be taken, and the same reviewer will measure alignment. As a secondary outcome, patients will also complete the disabilities of the arm, shoulder and hand (DASH) questionnaire at this visit, to compare patients' ability to perform activities of daily living with their respective splints.


Eligibility criteria: Inclusion Criteria:

* acute, displaced distal radius fracture
* isolated injury

Exclusion Criteria:

* polytrauma
* non-displaced fracture
* prior wrist fracture

Primary outcomes:
measure: Displacement of fracture, measured by radial height
timeFrame: 1 Week
measure: Displacement of fracture, measured by volar tilt
timeFrame: 1 Week
measure: Displacement of fracture, measured by radial inclination
timeFrame: 1 Week
measure: Disabilities of the Arm, Shoulder,and Hand (DASH) outcome score
timeFrame: 1 Week
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Nirmal Tejwani
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04252105: Antioxidant-rich Diet and Oxidative Stress in Healthy Preschoolers
Official title: The Effect of an Antioxidant-rich Kindergarten Diet on Oxidative Stress in Healthy Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Lead sponsor: University of Ljubljana, Faculty of Medicine
Sponsor class: OTHER
Collaborators: name: University of Ljubljana
First posted: 2020-02-05
Enrollment: 57
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Uncontrolled and prolonged oxidative stress plays an important role in the onset and progression of cardiovascular disease, hyperlipidemia, diabetes, and various cancers. Given that many diseases can start as early as childhood, eating patterns in childhood and preventing oxidative damage can have beneficial long-term health effects. Antioxidant-rich foods can slow down the progression of chronic diseases.

In Slovenian kindergartens (and schools) children consume up to 70% of their daily energy and nutritional needs, so what is offered to them is very important. This study will evaluate the hypothesis that providing an antioxidant-rich diet in kindergartens can result in the reduction of biomarkers of oxidative stress.


Eligibility criteria: Inclusion Criteria:

* • Healthy children aged 5-6 who will attend the compulsory medical examination before entering primary school

Exclusion Criteria:

* • Children with chronic conditions (e.g. diabetes, asthma)

  * Children with allergies to food (e.g. gluten, egg, milk, lactose intolerance)

Primary outcomes:
measure: Oxidative stress biomarkers
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University of Ljubljana, Faculty of Medicine
Study officials:
References:
Clinical trial NCT06654505: Can Village Health Volunteers/Workers Working As Male-Female Pairs Improve the Use of Postnatal Care Services in the Lao People's Democratic Republic
Official title: Effectiveness of Village Health Volunteers/Workers Working As Male-Female Pairs on Women's Use of Postnatal Care Services in Sepone District in Lao People's Democratic Republic: a Protocol for a Quasi-experimental Cluster Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnant Women
Lactating Mother
Lead sponsor: University of the Ryukyus
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 302
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study aims to assess the effectiveness of male-female VHV/Ws working in pairs on women's uptake of second PNC visits in rural Sepone, Lao PDR.

Methods A quasi-experimental cluster study will be conducted between July 2024 and October 2026 in 37 selected sites from two districts in southern Lao PDR. In 19 selected intervention villages in the Sepone district, female-male VHV/Ws pairs will promote postpartum services, whereas, in 18 similar control villages in the Vilabuly district, VHV/Ws will work as individuals.


Eligibility criteria: Inclusion Criteria:

* Women who gave birth within six weeks and twelve months before the study's baseline and end-line surveys.

Exclusion Criteria:

* Women whose births resulted in a loss,
* Women who do consent to participate in the surveys
* Women who face a language barrier with surveyors will not be enrolled.

Primary outcomes:
measure: Uptake of second postnatal care visit
timeFrame: 6 weeks after delivery
Secondary outcomes:
measure: Lenght of facility-based postpartum stay
timeFrame: cutoff is 12 hours
Other outcomes:
Locations:
city: Savannakhet
country: Lao People's Democratic Republic
facility: Sepon and Vilabouly districts
Study officials:
References:
Clinical trial NCT04022005: Chidamide + R-GemOx Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory DLBCL
Official title: Chidamide Combined With R-GemOx(Rituximab、Gemcitabine Plus Oxaliplatin) Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma: a Multi-center, Single Arm, Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Large B-Cell, Diffuse
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 54
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: The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide with R-GemOx(rituximab、gemcitabine plus oxaliplatin) regimen in the treatment of transplant-ineligible patients with relapsed/refractory diffuse large B-cell lymphoma.


Eligibility criteria: Inclusion Criteria:

* biopsy proved CD20+ DLBCL;
* relapse or refractory DLBCL#
* previously received systemic chemotherapy with anthracycline#
* not eligible for autologous hematopoietic stem cell transplantation#
* at least one evaluable lesion#
* ECOG PS 0-1;
* 18-75 years; without other malignancy;
* proper functioning of the major organs.

Exclusion Criteria:

* double-hit lymphoma;
* previously received treatment of HDAC inhibitor;
* plan to receive autologous stem cell transplantation;
* involvement of central nervous system;
* previously received gemcitabine within the past 6 months;
* patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;

Primary outcomes:
measure: ORR
timeFrame: 4-years
Secondary outcomes:
measure: DOR
timeFrame: 4-years
measure: PFS
timeFrame: 4-years
measure: OS
timeFrame: 4-years
Other outcomes:
measure: bio-marker analysis
timeFrame: 4-years
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT04323605: Assistance Program for Outpatients Following an Allogeneic Hematopoietic Stem-cell Transplant
Official title: Implementation of an Assistance Program for Outpatients Following an Allogeneic Hematopoietic Stem-cell Transplant: Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematologic Neoplasms
Keywords: allogeneic hematopoietic stem-cell transplant
outpatient assistance
"navigation" nurse
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: After the initial monitoring period during hospitalization and isolation, patients with recent transplants are regularly monitored in monthly consultations but are still fragile, immunosuppressed and undergoing many treatments. The implementation of an outpatient assistance program for transplant patients should be feasible and allow for the improvement in medical-psycho-social care for the patients during this fragile and risky period, improve the satisfaction and quality of life for these transplant patients and assist in their socio-professional and familial reintegration.


Eligibility criteria: Inclusion Criteria:

* Adult patients over 18 years of age
* Having received an allogeneic hematopoietic stem-cell transplant
* In full remission
* Outpatients
* Having given their informed consent for the participation in the outpatient assistance program with a navigation nurse (AMA-ALLO) at the first post-transplant consultation (starting on Day 100 +/- 10 days post-transplant i.e., when the patient passes the initial post-transplant monitoring period in hospitalization (conventional or by day) to the monitoring period in monthly medical consultations) and continuing for 12 months
* Affiliated with the social security system

Exclusion Criteria:

* Transplant patients not having given their informed consent for inclusion in AMA-ALLO
* Hospitalized or non-outpatient transplant patients
* Post-transplant patients in cytological relapse
* Patients under a legal regime of adult protection (guardianship, curatorship, etc.)

Primary outcomes:
measure: Rate of patients with all the navigation nurse intervention files received at 100%
timeFrame: 12 months
Secondary outcomes:
measure: Rate of refusal for participation in the study
timeFrame: 12 months
measure: Rate of ineligibility of the navigation nurse intervention files
timeFrame: 12 months
measure: Quality of life for transplant patients
timeFrame: Baseline
measure: Quality of life for transplant patients
timeFrame: 6 months
measure: Quality of life for transplant patients
timeFrame: 12 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse University Hospital
Study officials:
affiliation: University hospital of Toulouse
name: Anne HUYNH, MD
role: PRINCIPAL_INVESTIGATOR
References: