louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05913830: Effectiveness of Auricular Acupressure on the Methadone Patient
Official title: Effectiveness of Auricular Acupressure on the Methadone Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conditions:Effectiveness of Auricular Acupressure on the Methadone Patient
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Taipei City Hospital
First posted: 2023-06-22
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to investigate the effect of auricular point sticking on constipation in patients with methadone

Detailed description: This study is a randomized controlled trial, taking 72 methadone constipation patients from a hospital in the north as objects, and divided them into an auricular point group and a control group. The experimental group was given auricular point sticking, while the control group only used sticking cloth. The two groups were measured for constipation, TCM constitution, anxiety, depression and quality of life before the intervention and 2 weeks, 4 weeks, and 6 weeks after the start.

Eligibility criteria: Inclusion Criteria:

1. Methadone patients over 20 years old.
2. Those who have clear consciousness and can communicate in Chinese and Taiwanese.
3. The frequency of defecation is less than three times a week.
4. Willing to sign a written subject consent form.

Exclusions:

1. Those with wounds, broken skin, and blisters on the skin of both ears.
2. People with blood coagulation problems and related diseases, such as: purpura, hemophilia, etc.
3. Age \<20 years old.
4. Subjects who use drugs to improve constipation.

Primary outcomes:
measure: The effect of constipation after auricular acupressure
timeFrame: six weeks
measure: The effect of TCM constitution after the intervention of auricular acupressure
timeFrame: six weeks
measure: The effect of intervention on depression and anxiety after auricular acupressure
timeFrame: six weeks
measure: Effect of Interventional Auricular Acupressure on Quality of Life for Constipation
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Ya-Fang Lin
Study officials:
References:
Clinical trial NCT05231330: Clinical Evaluation of Silver Nanoparticles in Comparison to Silver Diamine Fluoride in Management of Deep Carious Lesions
Official title: Clinical Evaluation of Silver Nanoparticles in Comparison to Silver Diamine Fluoride in Management of Deep Carious Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries,Dental
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this clinical study will be carried out to evaluate the effect of fluoride varnish with silver nanoparticles in comparison to silver diamine fluoride in management of deep carious lesions.


Eligibility criteria: Inclusion Criteria:

* success will be evaluated by:

  1. Cold pulp testing: An ice-rod will be used for this test. Results should be positive or negative.
  2. Absence of spontaneous pain: Post-operative pain will be assessed using the visual Analogue Scale Score (VAS), which is a measurement method for subjective characteristics of pain. Respondents specify their level of agreement to a statement by indicating a position along a 10 cm line between two end-points, with the term "no sensitivity" at one end and "intolerable sensitivity" at the other end. A score from (0 to 10 is given).
  3. Sensitivity to percussion: (presence/ absence).
  4. Inspection for Sinus/fistula/swelling: using visual inspection (presence/ absence).
  5. Radiographic examination: Indicating presence of periapical radiolucencies, widening of lamina dura, internal and external root resorption (presence/ absence).

Exclusion Criteria:

* Patient-related criteria:

  * Medically compromised patients, who will not be able to attend multiple appointments or may require special management.
  * Pregnant women; as radiographs cannot be taken for them.
  * Allergy to any of the restorative materials, including anesthetics.
  * Uncooperative patients, will not abide by the instructions or attend the appointments.

Tooth related criteria:

* Retained deciduous teeth; as the study is targeting only permanent teeth.
* Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries.
* Teeth with cervical caries; which can't be evaluated on periapical radiographs

Primary outcomes:
measure: Cold pulp testing
timeFrame: 6 months
measure: Absence of spontaneous pain
timeFrame: 6 month
measure: Radiographic examination
timeFrame: 6 month
measure: sensitivity to percussion
timeFrame: 6 month
measure: visual inspection for sinus/ fistula swelling
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Suez
country: Egypt
facility: Suez canal university
Study officials:
References:
Clinical trial NCT02953730: The Study on the Pharmacokinetics of PEG-rhG-CSF in Children and Adolescents
Official title: The Study on the Pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Lymphoid Leukemia
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2016-11-03
Enrollment: 9
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the trail is to study the pharmacokinetics of Pegylated Recombinant Human Granulocyte Stimulating Factor（PEG-rhG-CSF） in Children and Adolescents


Eligibility criteria: Inclusion Criteria:

1. Age≤18 years old, gender no limited.
2. Patients with acute lymphoblastic leukemia diagnosed by bone marrow pathology or cytology.
3. Plan to receive CAM (cyclophosphamide,cytarabine,6-MP)chemotherapy regimen.
4. Previously not received radiotherapy.
5. Karnofsky Performance Scores ( KPS)≥60.
6. The expected survival time was \>3 months.
7. Neutropenia or agranulocytosis, no bleeding tendency.
8. No significant cardiac dysfunction or metabolic disease.
9. TBIL(total bilirubin ), ALT（alanine aminotransferase）,AST（glutamic-oxalacetic transaminase） \< 2.5×ULN（upper limit of normal）.
10. BUN（blood urine nitrogen），Cr（creatinine），UA（uric acid）\<1.5×ULN.
11. Written informed consent are acquired.

Exclusion Criteria:

1. With a history of systemic radiotherapy.
2. Infection difficult to control, the body temperature ≥ 38℃.
3. Other situation that investigators consider as contra-indication for this study.

Primary outcomes:
measure: peak concentration(Cmax)
timeFrame: 1 year
measure: elimination half life(t 1/2kel)
timeFrame: 1 year
measure: area under the curve(AUC)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
state: Tianjin
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Xiaofan Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04522830: A Study in Adults to Test the Effects of Low Dose Thimerosal on Symptoms of COVID-19
Official title: A Double-blind, Placebo-controlled, Phase 2 Trial of Sublingual Low-Dose Thimerosal in Adults With Symptomatic SARS-CoV-2 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: SARS-CoV-2 Infection
Keywords: Treatment for COVID-19
Lead sponsor: Beech Tree Labs, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Norwich Clinical Research Associates Ltd.
name: Curavit Clinical Research
First posted: 2020-08-21
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical trial to compare sublingual low does thimerosal in adults that have symptoms of SARS-CoV-2 Infection against placebo to show a difference in physical characteristics and viral levels.


Eligibility criteria: Inclusion Criteria:

* 40 years of age or older
* Provide written informed consent
* Have a SARS-COV-19 diagnostic test with positive results

Exclusion Criteria:

* Having an oxygen saturation level below 92% at baseline or currently on Oxygen therapy
* Subjects currently hospitalized
* Subjects who have received a COVID vaccination
* Subjects with a diagnosis of immunodeficiency

Primary outcomes:
measure: Mean duration and severity of disease
timeFrame: Two days
Secondary outcomes:
measure: Incidence/Safety of Adverse Events
timeFrame: Baseline through 10 days
Other outcomes:
Locations:
city: Draper
country: United States
facility: Intermountain Clinical Reserach
state: Utah
Study officials:
affiliation: Intermountain Clinical Research
name: Duane Harris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwich Clinical Research Associates (NCRA)
name: Lee Truax-Bellows
role: STUDY_DIRECTOR
References:
Clinical trial NCT01595230: Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips
Official title: Randomized Controlled Trial: Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Internal Hernias
Keywords: Internal Hernias
Clips
Gastric Bypass
Avoid
Lead sponsor: Region Zealand
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether closure of all mesenteric defects with clips at the time of Gastric bypass, can avoid the complication of late bowel obstruction- internal hernias


Eligibility criteria: Inclusion Criteria:

* All patients who meet the requirements for a Gastric Bypass at Køge Hospital.

Exclusion Criteria:

* Patients who do not meet the inclusion criteria
* Patients who converted to open surgeon

Primary outcomes:
measure: To avoid the risk of Internal Hernias in patient with a Gastric bypass
timeFrame: 5 year
Secondary outcomes:
measure: Postoperative pain score (VAS)
timeFrame: 5 years
measure: Operative time consumption, the amount of clips, trocar and sutures used
timeFrame: 3 years
Other outcomes:
measure: 30 days complication
timeFrame: 3 years
Locations:
city: Køge
country: Denmark
facility: Department of Surgery;Bariatric Clinic, Køge Hospital
state: Sealand
city: Køge
country: Denmark
facility: Bariatric clinic, Department of Surgery, Køge hospital
Study officials:
affiliation: Department of Surgery, Bariatric Clinic, Koge Hospital
name: Sara Kristensen, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kristensen SD, Gormsen J, Naver L, Helgstrand F, Floyd AK. Randomized clinical trial on closure versus non-closure of mesenteric defects during laparoscopic gastric bypass surgery. Br J Surg. 2021 Mar 12;108(2):145-151. doi: 10.1093/bjs/znaa055.
citation: Kristensen SD, Naver L, Jess P, Floyd AK. Effect of closure of the mesenteric defect during laparoscopic gastric bypass and prevention of internal hernia. Dan Med J. 2014 Jun;61(6):A4854.
Clinical trial NCT00306930: Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement
Official title: Multi-center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Rheumatoid Arthritis
Arthritis
Avascular Necrosis
Acute Fracture
Keywords: Total Hip Replacement
post-traumatic arthritis
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2006-03-27
Enrollment: 1593
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a clinical evaluation of survivorship of an acetabular cup system after total hip replacement using patient examinations and questionnaires.

Detailed description: The primary objective of this investigation is to evaluate survivorship at five years of the Pinnacle™ acetabular cup system in primary total hip arthroplasty.

Eligibility criteria: Inclusion Criteria:

* Primary hip replacement
* Sufficient bone stock to support implant
* Signed Informed Patient Consent form

Exclusion Criteria:

* Prior renal transplant
* History of active joint sepsis
* Recent high dose of corticosteroids
* Primary or secondary carcinoma in the last 5 years
* Neurological disease
* Psychosocial disease that would limit rehabilitation
* Use of structural bone graft
* Simultaneous participation in another hip study

Primary outcomes:
measure: Survivorship
timeFrame: 5 years
Secondary outcomes:
measure: Harris Hip Score
timeFrame: Pre-operative, 6 month and 1, 2, 3, 4, and 5 years.
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.
measure: Short Form-36 (SF-36)
timeFrame: Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.
Other outcomes:
Locations:
city: Warsaw
country: United States
facility: DePuy Orthopaedics
state: Indiana
Study officials:
affiliation: DePuy Orthopaedics
name: Dave Whalen, BS, DC
role: STUDY_DIRECTOR
References:
Clinical trial NCT05540730: Analysis of Foot Plantar Pressure Behavior of Children With Obstetric Brachial Plexus Paralysis
Official title: Analysis of Foot Plantar Pressure Behavior of Children With Obstetric Brachial Plexus Paralysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brachial Plexus Palsy
Gait Disorders in Children
Keywords: Brachial Plexus Palsy
Gait Disorders in Children
Biomechanics
Gait Analysis
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
Collaborators: name: Medipol University
First posted: 2022-09-15
Enrollment: 29
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with obstetric brachial plexus paralysis

Brief summary: The aim of this study was to investigate the foot plantar pressure behavior alterations during gait for children with obstetric brachial plexus (OBBP). 19 children with OBBP and 10 healthy children will be included in the study. The inclusion criteria of the study were to be between the ages of 7-15, not have a history of surgery or botox in the last 6 months, and not have any other disease. Foot plantar pressures of all participants will be analyzed with a pedobarography device. For arm swing analysis, a video camera will be recorded during walking and arm flexion/extension angles will be measured with Kinovea software.


Eligibility criteria: Inclusion Criteria:

- Between the ages of 7-15. No other disease

Exclusion Criteria:

- Having undergone surgery or botox intervention for orthopedic problems in the last 6 months.

Having health problems in the unaffected extremity or adversely affecting general body health.

The participant's parent has not signed the consent form.

Primary outcomes:
measure: Stance Time
timeFrame: during gait analysis.
Secondary outcomes:
measure: Step Length
timeFrame: during gait analysis.
measure: Ground reaction force
timeFrame: during gait analysis.
measure: Single limb support phase
timeFrame: during gait analysis.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
References:
Clinical trial NCT04977830: Pulmonary Assessment in Thoracic Insufficiency Syndrome Patients
Official title: New Strategies for Pulmonary Assessment in Spinal and Chest Wall Deformity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Thoracic Insufficiency Syndrome
Keywords: Hyperpolarized MRI
Dynamic Lung MRI
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Xemed LLC
First posted: 2021-07-27
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Thoracic insufficiency syndrome (TIS) is a complex condition that involves chest wall deformities that can affect normal breathing and lung growth. In most cases, children with TIS are also born with spine disorders such as scoliosis. The inability of the thorax to support normal respiration or lung growth can cause respiratory distress and even mortality. Investigators aim to validate MRI imaging sequences to use as an assessment tool for pulmonary function.


Eligibility criteria: Inclusion Criteria:

* Males or females 6 to 18 years old diagnosed with thoracic insufficiency syndrome who are undergoing surgery

Exclusion Criteria:

* patients not diagnosed with thoracic insufficiency syndrome

Primary outcomes:
measure: Analyze volume of lungs at end-inspiration and end-expiration
timeFrame: up to 2 years
measure: Xenon-129 MRI Ventilation Maps
timeFrame: up to 2 years
Secondary outcomes:
measure: oxygen partial pressure (PAO2) maps
timeFrame: up to 2 years
measure: Forced vital capacity (FVC)
timeFrame: up to 2 years
measure: Forced expiratory volume (FEV1)
timeFrame: up to 2 years
measure: Xenon-129 MRI apparent diffusion coefficient (ADC) maps
timeFrame: up to 2 years
measure: total lung capacity
timeFrame: up to 2 years
measure: functional residual capacity (FRC)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hopsital of Philadelphia
name: Patrick Cahill, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04690530: Cerebral Hemodynamics and Oxygenation in Critically Ill Patients
Official title: Cerebal Hemodynamics and Oxygenation in Critically Ill Patients : Characterization and Effects of Therapeutics
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Septic Shock
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients admitted in our Medical Intensive Care Unit requiring mechanical ventilation and sedation and in whom the attending physician decides to perform one of the studied therapeutics within the first 72h of ventilation onset. Cerebral hemodynamics (cerebral blood flow and cerebral autoregulation) as well as cerebral oxygenation will be non-invasively studied before and after therapeutics.

Brief summary: Critically-ill patients frequently experience marked changes in mean arterial pressure and carbon dioxide partial arterial pressure, the two major determinants of the cerebral blood flow. In addition, many therapeutics (fluids, vasopressors or inotropes administration, blood transfusion, prone positioning...) can influence these two determinants of cerebral blood flow and thus cerebral blood flow, especially in patients with altered cerebral autoregulation. Nevertheless, cerebral hemodynamics and oxygenation, as well as the effects of the different therapeutics on it have been poorly studied in critically-ill patients. In addition, it has been suggested that impaired cerebral blood flow and impaired cerebral microcirculation may be involved in the pathophysiology of septic encephalopathy in patients with sepsis and/or septic shock. In this study, we aimed to characterize and investigate the effects of different therapeutics on cerebral hemodynamics and oxygenation in critically-ill patients.


Eligibility criteria: Inclusion Criteria :

* Patients under mechanical ventilation and sedated within the first 72h of ventilation onset
* Indication to one of the studied therapeutics left at the discretion of the attending physician Exclusion criteria
* Age \< 18 years
* Pregnancy
* Inability to obtain a Doppler signal
* Medical history or clinical evidence of neurological disease
* Known severe carotid stenosis (\>70%)
* Significant cardiac arrhythmias
* Care-limitation decision.

Primary outcomes:
measure: Cerebral blood flow
timeFrame: Within the first 72 hours of ventilation onset, before and after therapeutics
Secondary outcomes:
measure: Cerebral autoregulation
timeFrame: Within the first 72 hours of ventilation onset, before and after therapeutics
Other outcomes:
measure: Cerebral oxygenation
timeFrame: Within the first 72 hours of ventilation onset, before and after therapeutics
Locations:
city: Nice
country: France
facility: CHU de NICE
Study officials:
References:
Clinical trial NCT03845530: The Inflammatory Burden in Hemodialysis vs. Peritoneal Dialysis Patients: the Role of Alpha-defensin
Official title: The Inflammatory Burden in Hemodialysis vs. Peritoneal Dialysis Patients: the Role of Alpha-defensin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Failure
Inflammation
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-02-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine the levels of alpha-defensin throughout the hemodialysis course compared to the levels at the end of a course of peritoneal dialysis, as a reflection of the inflammatory burden.


Eligibility criteria: Inclusion Criteria:

* Kidney failure patients undergoing hemodialysis or peritoneal dialysis

Exclusion Criteria:

* Active inflammatory or infectious disease

Primary outcomes:
measure: Alpha-Defensin Levels
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Rami Abu Fanne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: