louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02607670: Phase 2 Study of TAT4 Gel for Reduction of Nasolabial Folds
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study of TAT4 Gel for the Reduction of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasolabial Folds
Lead sponsor: Topokine Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-18
Enrollment: 111
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2, randomized, double-blind, placebo-controlled study of TAT4 Gel for the reduction of moderate to severe nasolabial folds.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe, bilateral nasolabial folds
* Must understand and provide informed consent

Exclusion Criteria:

* Pregnant or lactating women
* History of skin hypersensitivity of atopic dermatitis
* Any illness of disease that, in the investigator's opinion, would make trial participation inadvisable

Primary outcomes:
measure: Nasolabial Fold Severity Scale (Clinician-Reported)
timeFrame: Day 91
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Topokine Research Site
state: Massachusetts
Study officials:
References:
Clinical trial NCT04484870: Danshu Capsule and Ursodeoxycholic Acid Capsule in Preventing Recurrence of Choledocholithiasis
Official title: Comparative Study on the Efficacy of Danshu Capsule and Ursodeoxycholic Acid Capsule in Preventing Recurrence of Choledocholithiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Choledocholithiasis
Recurrence
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: \[objective\] to compare the efficacy of Danshu capsule and ursodeoxycholic acid (UDCA) in preventing recurrence of choledocholithiasis after operation. \[methods\] one hundred and fifty ERCP patients with choledocholithiasis were randomly divided into two groups: Danshu group (n = 75) and UDCA group (n = 75). The Danshu group took 2 Danshu capsules three times a day, and the UDCA group took 250 mg of Ursofalk twice a day. The clinical efficacy, changes of liver function indexes before and after treatment and stone recurrence were compared between the two groups.


Eligibility criteria: inclusion criteria:

1. Choledocholithiasis was diagnosed by B-ultrasound / CT/MRCP, The patients are generally in good condition, no surgical taboos, and can tolerate general anesthesia and ERCP surgery.
2. Agree to participate in the project research, know the benefits and possible risks of surgery, know the benefits and risks of drugs, and sign an informed consent form.

exclusion criteria：

1. patients with cholecystolithiasis, hepatitis B, biliary ascariasis, liver cirrhosis, hemolytic anemia, congenital jaundice and tumor were excluded.
2. Excluding serious primary diseases such as heart, brain, lung, kidney and blood system.
3. Those who are allergic or allergic to drugs in this test are excluded.
4. Pregnancy vibration or nursing women were excluded.

Primary outcomes:
measure: recurrence rate
timeFrame: 1 year
Secondary outcomes:
measure: improvement rate of liver function index
timeFrame: 3 days, 1 week and 2 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou first people's Hospital
state: Zhejiang
Study officials:
affiliation: First People's Hospital of Hangzhou
name: Xiaofeng Zhang, Zhang
role: STUDY_DIRECTOR
References:
Clinical trial NCT01667770: Dural Graft Equivalent Comparison Trial
Official title: Dural Graft Equivalent Comparison Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chiari Malformation
Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study is to find out which types of dural grafts used during surgery for Chiari Malformations are superior. We believe that autologous dural grafts are superior to non-autologous grafts.

Detailed description: The study compares autologous grafts vs. non-autologous grafts. Non-autologous grafts include synthetics and grafts from animals. Autologous grafts have a better side-effect profile than non-autologous grafts. We believe this improved side-effect profile will result in a decreased incidence of reoperation for post-operative infections and post-operative fluid collections (pseudomeningoceles and seromas). Study is open to all non-pregnant minor and adult subjects. Subjects must have symptomatic Chiari Malformation described as \> or equal to 6mm descent of the cerebellar tonsils below the foramen magnum with accompanying headaches and/or neurologic findings (arm pain/weakness, myelopathy, etc.). After the 12-month follow-up is completed on the first 100 subjects there will be an interim analysis of the results in order to determine whether one of the treatments has a statistically superior outcome. If a statistically superior outcome is noted, the trial will stop after being reviewed by a data monitoring committee. If no statistically significant difference is seen at one year, the study will continue until the 12-month follow-up is completed on the 200th patient.

Eligibility criteria: Inclusion Criteria:

* Minor or adult males and females
* Symptomatic Chiari Malformation
* Greater or equal to 6mm descent of the cerebellar tonsils below the foramen magnum
* Headaches and/or neurologic findings (e.g., arm pain/weakness, myelopathy, etc.)

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Complications encountered during the subject's post-operative care
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
Study officials:
affiliation: Barrow Neurosurgical Associates
name: Robert F Spetzler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05349370: Lactate Kinetics in Septic Shock
Official title: Lactate Kinetics in Patients Treated for Septic Shock
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Septic Shock
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: European Society of Intensive Care Medicine
name: The Scandinavian Society of Anaesthesiology and Intensive Care Medicine (SSAI)
First posted: 2022-04-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Lactate kinetics will be studied in hospitalized septic patients using a bolus injection of stable isotopically labeled lactate.

Detailed description: Adult septic patients admitted to the Intensive Care Unit (ICU) or Intermediary Medical Unit in Karolinska University Hospital will be recruited within 72 hours from start of symptoms.

Other than fulfilling the definition for sepsis-3, patients need to be equipped with an arterial catheter to be eligible for inclusion. After informed consent (from next of kin when applicable) baseline blood samples are drawn from existing catheter and the subject is given a bolus dose of 20umol/kg 13C-labeled lactate in 20 ml isotonic saline. After this a total of 14 blood samples á 2 ml is drawn in the following 120 minutes. All blood samples are centrifuged and stored in -800 C until analysis. After all subjects have been included sampled are thawed and analyzed for content of endogenous and labeled lactate. Through analysis between their relationship the lactate production and consumption can be quantified.

Eligibility criteria: Inclusion Criteria:

* Sepsis
* Age \>17 years
* Arterial catheter
* Lactate \> 2 mmol at any time point prior to inclusion

Exclusion Criteria:

* Mitochondrial defect
* Degenerative muscle disease
* Terminal liver failure

Primary outcomes:
measure: Whole body rate of appearance of lactate
timeFrame: 2 hours
Secondary outcomes:
measure: Clearance of lactate
timeFrame: 2 hours
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
citation: Grip J, Falkenstrom T, Promsin P, Wernerman J, Norberg A, Rooyackers O. Lactate kinetics in ICU patients using a bolus of 13C-labeled lactate. Crit Care. 2020 Feb 10;24(1):46. doi: 10.1186/s13054-020-2753-6.
Clinical trial NCT04569370: A Scoring System for Difficult Laparoscopic Cholecystectomy
Official title: A Scoring System for Laparoscopic Cholycystectomy to Pick up Difficult Cases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cholecystitis, Chronic
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic chronic calculous cholecystitis based on clinical and radiological correlation undergoing elective laparoscopic cholecystectomy at Assiut University hospitals

Brief summary: Laparoscopic cholecystectomy is the treatment of choice for gall bladder stone disease. Difficult laparoscopic cholecystectomy (LC) is the most common "difficult" surgical procedure performed today, which possesses the potential to place the patient at significant operative risk.The aim of this study was to put a scoring system to avoid difficult laparoscopic cholecystectomy.

Detailed description: Patients with symptomatic chronic calculous cholecystitis based on clinical and radiological correlation undergoing elective laparoscopic cholecystectomy at Assiut University hospitals will be included for the study of 100 patients will operated by single experienced laparoscopic surgeon.The scores are given on history, clinical examination and radiological findings one day prior to surgery on admission.

Eligibility criteria: Inclusion Criteria:

* Adults male and female age of or above 18 years
* Symptomatic chronic calculous cholecystitis
* Ultrasound confirmed Gall bladder stones

Exclusion Criteria:

* Complicated chronic calculous cholecystitis
* Malignant Gall bladder

Primary outcomes:
measure: Evaluation of preoperative scoring method for prediction of difficult laparoscopic cholecystectomy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor at faculty of medicine
name: Salah Ibrahim, Prof
role: STUDY_DIRECTOR
References:
citation: Veerank N, Togale MD. VALIDATION OF A SCORING SYSTEM TO PREDICT DIFFICULT LAPAROSCOPIC CHOLECYSTECTOMY: A ONE-YEAR CROSS-SECTIONAL STUDY. J West Afr Coll Surg. 2018 Jan-Mar;8(1):23-39.
Clinical trial NCT05805670: Preoperative Yoga and Meditation for Pediatric Idiopathic Scoliosis Surgery
Official title: Feasibility of Implementing Yoga and Meditation in the Preoperative Period of Pediatric Idiopathic Scoliosis Surgery, an Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Juvenile and Adolescent Idiopathic Scoliosis
Keywords: Yoga
Meditation
Mindfulness
Anesthesia
Idiopathic Scoliosis Surgery
Anxiety
Children
Pediatric
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study has to purpose Yoga and Meditation before surgery for idiopathic scoliosis.

Protocol's observance will tell the investigators if it is feasible and appropriate in a University hospital center.

Detailed description: Adolescent idiopathic scoliosis is the most common deforming orthopedic condition.

Preoperative anxiety is increased by operating time, post-operative pain level, neurological and hemorrhagic risk.

The aim of the study was to purpose five sessions of Yoga and Meditation before surgery, remotely and face-to-face.

Observance of the 5 sessions will tell us if this protocol is feasible and appropriate. Preoperative anxiety intensity will also be analyzed.

Eligibility criteria: Inclusion Criteria:

* Age from 8 to 17 years
* Female and male gender
* Planned idiopathic scoliosis surgery

Exclusion Criteria:

* Physical inability to do simple yoga postures during the initial session
* Neurological spinal deformity (cerebral palsy, severe epileptic disease, myopathy)
* Misunderstanding of the french language
* Recent history of characterized depressive episode: hospitalization and/or antidepressant treatment in the last 6 months
* Time between the first YOMEPOP session and the date of the operation less than 28 days
* Refusal of permission to take picture
* Failure to obtain informed consent from one of the parents with parental authority
* Absence of affiliation to a French social security scheme or beneficiary of such a scheme
* Patient with a legal protection measure

Primary outcomes:
measure: Percentage of patients with observance greater than or equal to 2
timeFrame: During the preoperative period
Secondary outcomes:
measure: VAS-anxiety scores
timeFrame: From preoperative period up to 1 day postoperative
measure: FPS-R scores
timeFrame: From preoperative period up to 1 day postoperative
measure: Assessment of satisfaction of Yoga and Meditation protocol
timeFrame: The day before the surgery
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH of Montpellier
Study officials:
affiliation: Hospital of Montpellier
name: Gabrielle VEISLINGER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02497170: Implementation of A Patient Centered Self-Management Program for Patients With Type 2 Diabetes
Official title: Implementation of A Patient Centered Self-Management Program for Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Translational study based on the American Association of Diabetes Educators 7 behaviors to manage Type 2 diabetes

Detailed description: The Primary Investigator will meet with patients that attend routine visits for Diabetes 2 in the primary care office on a monthly basis to set behavior goals. Behavior goals will be set by patient's choice of 4 out of 7 of the AADE7 recommendations. The goals are health eating, being active, monitoring,taking medications, problem solving, healthy coping, and reducing risk. Once the goal is chosen, the PI and patient will make a plan to address the goals on a monthly basis for four months. There will be pre and post questionnaires that will evaluate diabetes knowledge and self-efficacy. There will also be a pre and post measure of the patient's Hemoglobin A1c which is a measurement that helps determine the extent of glycemic control over a three-month period.

The goal of the study is to determine if translation of the AADE7 behavioral goals into the primary care setting will make a difference in diabetes knowledge, self efficacy, and Hemoglobin A1c.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 with Hemoglobin A1c 7 mmol/mol or higher will be included in the study
* Patients willing to attend minimum of 4 monthly appointments for diabetes treatment
* Patients who give written consent to participate

Exclusion Criteria:

* Patients below age 18, children are not treated in the facility for type 2 diabetes
* Patients who attend less than 4 monthly appointments for diabetes,
* Patients who do no give written consent to participate

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Somerdale
country: United States
facility: Melissa Souza
state: New Jersey
Study officials:
affiliation: Rutgers University Newark New Jersey
name: melissa souza
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05626270: Human Factors Testing for OTC Use of the Erchonia® LunulaLaser
Official title: Human Factors Validation Testing for Over-the-Counter Use of the Erchonia® LunulaLaser™ OTC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Onychomycosis
Lead sponsor: Erchonia Corporation
Sponsor class: INDUSTRY
First posted: 2022-11-23
Enrollment: 15
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: Human factors validation testing to assess the intended user's ability to correctly, safely, and effectively set-up, activate and operate the LunulaLaser™ OTC, to administer a treatment to a suitably qualified client, and to understand the information contained in the Erchonia LunulaLaser™ OTC Installation and Proper Use Reference Guide and box labeling.

Detailed description: This study is an uncontrolled simulated-use human factors validation testing design to assess the intended user's ability to correctly, safely, and effectively set-up, activate and operate the LunulaLaser™ OTC, to administer a treatment to a suitably qualified client, and to understand the information contained in the Erchonia LunulaLaser™ OTC Installation and Proper Use Reference Guide and box labeling.

The study design is comprehensive in scope and conducted in a manner such that the results will be able to be generalized to the actual intended user and client population under intended conditions of actual use and be adequately sensitive to capture use errors arising from either the user interface design and/or the instructional and informative materials. Study data will be collected in a manner that will facilitate analysis of the root causes of use errors or problems during the testing.

Eligibility criteria: Inclusion Criteria:

* 18 years or older.
* Male or female.
* Currently employed at a nail salon, beauty salon and/or spa, fitness and wellness spa, or the like.
* In possession of qualification(s), current licensure(s), certification(s), and/or accreditation(s), as applicable, to perform their designated tasks at their place of employment, e.g., cosmetology degree, nail technician, esthetician, massage therapist etc.
* Voluntarily signed consent form.

Exclusion Criteria:

- None

Primary outcomes:
measure: Human Factors
timeFrame: Each study session was completed on a single day, for up to 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: United States
facility: Erchonia Corporation
state: Florida
Study officials:
References:
Clinical trial NCT04834570: Breast Cancer Survivors: Main Physical and Psychosocial Problems After Completion of Treatment
Official title: Breast Cancer Survivors: Main Physical and Psychosocial Problems After Completion of Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Quality of life
Survivorship
Oncology
Lead sponsor: Instituto Brasileiro de Controle do Cancer
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 105
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recruitment of 100 breast cancer patients who have completed treatment within a minimum of 1 year and are currently undergoing outpatient follow-up

Brief summary: Breast cancer directly affects women physically, psychologically and socially in the process of diagnosis, treatment and post-treatment. Despite the improvement in conventional breast cancer treatments that led to longer disease-free survival, many patients still suffer from physical, psychological, social and spiritual problems after treatment. The neglect of physical and psychosocial problems faced by patients who are between 1 and 2 years after the end of treatment negatively impacts the quality of life of this population.

Detailed description: The purpose of the study is to assess the overall quality of life and measure the impact on women who have survived breast cancer for at least 1 year (12 months) and 2 years (24 months) after the end of primary treatment and to identify possible repercussions of breast cancer and its treatments associated with Quality of Life.

Eligibility criteria: Inclusion Criteria:

* Breast cancer
* Adult women (age ≥ 20 years old and less than 60 years old)
* Patient who has been treated by surgery, with or without adjuvant chemotherapy
* Clinical Stages I, II and III
* Patients considered cured, without history of recurrences
* Patients who completed treatment within a minimum of 1 year and are currently being undergoing outpatient follow-up

Exclusion Criteria:

* Initial diagnosis of another type of cancer, other than breast cancer
* Bilateral breast cancer
* Patient unable to fill out the QoL questionnaire
* Patient with disease recurrence
* Patient with metastatic breast cancer

Primary outcomes:
measure: Change in Global Health Status by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire)
timeFrame: 1 year after treatment ends; 2 years after treatment ends;
Secondary outcomes:
measure: Quality of life specific for breast cancer by EORTC QLQ-BR23 (European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire)
timeFrame: 1 year after treatment ends; 2 years after treatment ends;
measure: Quality of life by FACT-B+4 (Functional Assessment of Cancer Therapy-Breast)
timeFrame: 1 year after treatment ends; 2 years after treatment ends;
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: IBCC Oncologia
Study officials:
References: