louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01649596: Impact of Expanded Peri Operative Warming
Official title: Impact of Expanded Peri Operative Warming for Patients Undergoing Elective Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Complications
Lead sponsor: Ascension Health
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2012-07-25
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this proposed study is to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery.

Detailed description: This study was designed to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery. It compares short term outcomes in patients for whom warming is expanded by commencing in the pre operative area and is maintained through post operative recovery versus patients receiving the standard warming at time of induction. Patients were randomly assigned to either a warming blanket device or standard warming procedures. The study tested for differences in the rate of hypothermic events between the two groups. A secondary goal was to test for differences in the complication rate and patient satisfaction between the two groups.

This study is testing the hypothesis that expanded warming significantly reduces rates of hypothermia and complications over standard warming used only during surgery.

Eligibility criteria: Inclusion Criteria:

* Subjects are adult patients 18 years and older elective surgery of \> 1 hour

Exclusion Criteria:

* Emergency and/or trauma cases
* Patients with diminished mental capacity unable to fill out or respond to survey questions.

Primary outcomes:
measure: Incidence of Hypothermic Events
timeFrame: 12 hours
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 12 hours
Other outcomes:
Locations:
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
Study officials:
affiliation: Ascension Health
name: Tarik Wasfie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01938196: A Single-blind, Dose-titration Study of KWA-0711 in Patients With Chronic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Constipation
Keywords: Chronic Constipation
Constipation
Functional gastrointestinal disorders
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-09-10
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of titrated KWA-0711 dose in chronic constipation patients.


Eligibility criteria: Inclusion Criteria:

* The patients who experienced fewer than three spontaneous bowel movements per week for more than 6 months prior to the enrollment.
* The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation

Exclusion Criteria:

* Patients who have secondary constipation caused by systemic disorder.
* Patients who have organic constipation.
* Patients who received intestinal resection

Primary outcomes:
measure: Improvement of signs and symptoms associated with constipation
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
References:
Clinical trial NCT06956196: Study of Stapokibatrt in Children Subjects With Atopic Dermatitis
Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Stapokibatrt in Children With Moderate-to-severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2025-05-04
Enrollment: 240
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, Pharmacokinetics(PK), PharmacoDynamics(PD) and immunogenicity of Stapokibatrt in children with moderate-to-severe atopic dermatitis.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 2 and ≤ 11 years old.
* Diagnosis of AD according to the American Academy of Dermatology Consensus (2014) Criteria.
* With moderate-to-severe AD, and inadequate response to topical medications.

Exclusion Criteria:

* Prior treatment with Stapokibart
* Treatment with dupilumab within 13 weeks prior to the baseline visit, or treatment with anti-IgE(Immunoglobulin E) monoclonal antibody，other biological agents within 5 half-lives prior to the baseline visit .
* Treatment with immunosuppressants/immunomodulatory drugs, ultraviolet therapy, or systemic traditional Chinese medicine for AD within 4 weeks prior to the baseline visit.
* Treatment with a topical corticosteroids (TCS), topical calcineurin inhibitor (TCI) or topical Phosphodiesterase-4(PDE-4) inhibitor within 1 weeks prior to the baseline visit.
* History of atopic keratoconjunctivitis invading cornea.
* Acute attacks of Atopic Dermatitis within 4 weeks prior to the baseline visit.
* Planned major surgical procedure during the patient's participation in this study.

Primary outcomes:
measure: Proportion of subjects achieving Eczema Area and Severity Index(EASI-75) at week 18
timeFrame: Up to week 18
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital Capital Medical University
Study officials:
affiliation: Beijing Children's Hospital
name: Lin Ma
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01167296: Safety of Leaving Cook Balloon Uterine Stent in Uterus for One Month
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intrauterine Adhesion
Keywords: Intrauterine adhesion
Cook balloon uterine stent
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2010-07-22
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To use Cook balloon uterine stent to prevent intrauterine adhesion (IUA), and to see if leaving it in the uterus will cause uterine infection.

Detailed description: Background：Intrauterine adhesion (IUA) can cause infertility. Hysteroscopic surgery can effectively treat most IUA. In order to prevent adhesion reformation after surgery, most gynecologists will prescribe high-dose estrogen to stimulate endometrial growth, and leave an IUD or a Foley catheter in uterus for 1-3 months. But neither IUD nor Foley catheter conform to the uterine cavity. The Cook balloon uterine stent was designed to fit into the uterine cavity. But it was designed to tamponade the uterus to prevent post-operative uterine bleeding. It's not known if it can be left in the uterus for 30 days.

Study Design：Uterine culture was done before hysteroscopic surgery, and 30 days later. The study group comprise patients with uterine stent; the control group comprise patients who undergo hysteroscopic surgeries but without uterine stent.

Method：Immediately before hysteroscopic surgery, a culture tip is inserted into the uterine cavity and sent for culture. Another culture was done 30 days later, and a second-look hysteroscope is done to evaluate the healing of uterine cavity. The removed uterine stent was sent for bacterial culture too. The same procedures are done for patients with and without uterine stent. The bacterial counts will be compared before and after hysterosocpic surgeries, and between the two groups of patients.

Effect：If leaving the uterine stent in the uterus up to 30 days does not cause bacteria to grow, we can be confident to leave the stent for 30 days.

Eligibility criteria: Inclusion Criteria:

* intrauterine adhesion women

Exclusion Criteria:

* allergic to Cook balloon uterine stent

Primary outcomes:
measure: intrauterine bacteria count
timeFrame: one year
Secondary outcomes:
measure: intrauterine adhesion
timeFrame: one year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Obstetrics and Gynecology, Shin-Kong Wu-Ho-Su Memerial Hospital
Study officials:
References:
citation: Lin YH, Jang TN, Hwang JL, Huang LW, Seow KM, Hsieh BC, Huang CH. Bacterial colonization with balloon uterine stent placement in the uterus for 30 days: a randomized controlled clinical trial. Fertil Steril. 2015 Feb;103(2):513-8.e2. doi: 10.1016/j.fertnstert.2014.10.032. Epub 2014 Nov 20.
Clinical trial NCT04754516: Diagnosis of Short Stature in Children : Study of a Cohort of Small-sized Consulting Patients
Official title: Diagnosis of Short Stature in Children : Study of a Cohort of Small-sized Consulting Patients in 2017 and 2018
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Short Stature
Growth Delay
Keywords: Constitutional bone disease
Pediatrics
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 479
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the children who consulted for the first time because of their short stature, in pediatric endocrinology at the Montpellier University Hospital between January 2017 and December 2018

Brief summary: Many patients consult in pediatric endocrinology because of their small size. In the majority of cases, this growth delays can be explained by a hormonal, gastroenterological cause, or a chronic disease.

Sometimes the reason for stunted growth can be constitutional bone disease, a genetic cause of short stature that is still underdiagnosed.

The investigators wish to describe and take stock of the various additional analyzes carried out and the various diagnoses made in patients who consulted in endocrino-pediatrics at the Montpellier University Hospital due to their short stature, in 2017 and 2018, in order to better screen patients with constitutional bone disease


Eligibility criteria: Inclusion criteria:

All the children who consulted for the first time because of their short stature, in pediatric endocrinology at the Montpellier University Hospital between January 2017 and December 2018

Exclusion criteria:

Patient already undergoing specialized medical follow-up due to his small size Major patient

Primary outcomes:
measure: Study the prevalence of different diagnoses of stature delay in children
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Cyril Amouroux
role: STUDY_DIRECTOR
References:
Clinical trial NCT02240316: An Observational Study of Patients With Malignant Lymphomas Treated With MabThera® SC in Everyday Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, B-Cell, Lymphoma, Follicular
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-09-15
Enrollment: 688
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: CD-20 positive, diffuse large cell B-cell non-Hodgkin lymphoma (DLBCL) and CD-20 positive follicular non-Hodgkin lymphoma (NHL)

Brief summary: This observational study aims to assess the therapeutic responsiveness of MabThera SC in patients with malignant lymphomas under everyday clinical practice conditions. Patients with previously untreated CD-20 positive follicular non-Hodgkin's lymphoma (NHL) or previously untreated CD-20 positive diffuse large B-cell lymphoma (DLBCL) who are planned for therapy with MabThera SC according to the assessment of the physician will be prospectively enrolled for observation. No study specific measures are required; treatment and documentation will be performed according to usual clinical practice.


Eligibility criteria: Inclusion Criteria:

* Women and men aged \>=18 years
* Previously untreated CD-20 positive follicular NHL
* Previously untreated CD-20 positive DLBCL
* Planned therapy with MabThera SC according to the assessment of the physician (before the start and independent from this study)
* Suitability for the therapy with MabThera SC

Exclusion Criteria:

All contraindications, interactions and incompatibilities for therapy with MabThera SC

Primary outcomes:
measure: Proportion of patients in both indications (DLBCL and follicular NHL) who have reached a complete remission (CR), including unconfirmed complete remission (CRu)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Total response rate
timeFrame: Up to 2.5 years
measure: Two-year progression-free survival rate for patients with follicular lymphoma under maintenance therapy
timeFrame: 2 years
measure: Safety profile: incidence, nature, severity, and outcomes of all adverse events and pregnancies (composite outcome measure)
timeFrame: Up to 2.5 years
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Universitätsklinikum Essen; Klinik für Hämatologie
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03184116: Effects of Individual Intervention for Men in Focused Deterrence Program
Official title: Reducing Violence Among High Risk African American Men in Focused Deterrence Program Through Individual Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Violence
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project will implement and evaluate a community-based intervention to improve individual outcomes in violence-related injuries and homicide. Young African American men participating in a focused deterrence program (the Birmingham Violence Reduction Initiative, BVRI) will be randomized to receive an additional individual intervention based on the cognitive-behavioral Reasoning and Rehabilitation program.


Eligibility criteria: Inclusion Criteria:

* African American male identified as at high risk for violence by the Birmingham Violence Reduction Initiative

Exclusion Criteria:

* Mental retardation, serious mental illness (eg, psychosis)

Primary outcomes:
measure: Violence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
References:
Clinical trial NCT01916616: A Multidisciplinary Approach to Vocal Cord Dysfunction: A Novel Pilot Study
Official title: A Multidisciplinary Approach to Vocal Cord Dysfunction: A Novel Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vocal Cord Dysfunction
Keywords: paradoxical vocal fold motion
cognitive-behavioral therapy
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Vocal Cord Dysfunction (VCD) is characterized by involuntary closure of the vocal cords while inhaling. Children and adolescents with VCD may experience multiple symptoms, including difficulty breathing, coughing, wheezing, neck tightness, and voice changes. There is limited information on optimal management of VCD. In our proposed study, we will use cognitive-behavioral therapy (CBT) techniques to change how patients respond to their VCD symptoms. Measurements of airflow during breathing as well as symptom frequency and intensity will be examined prior to and following a series of four therapy sessions with a clinical psychologist that are focused on teaching patients strategies to decrease symptom reactivity.


Eligibility criteria: Inclusion Criteria:

* Adolescent patients presenting to West Virginia University, Charleston Division Sub-specialty Clinic for Pediatric Pulmonology with a clinical diagnosis of vocal cord dysfunction.
* Diagnosed with VCD within 12 months prior to study enrollment. between the ages of 13 and 18 years old.
* Currently symptomatic for VCD.
* Must have a baseline PFT to reference at the time of diagnosis. Additionally in patients who were diagnosed with VCD 6 months or more prior to study enrollment, current PFT results as part of routine care, are required.
* A parent or guardian must agree to participate in the four behavioral therapy sessions with his or her child.

Exclusion Criteria:

* Severe psychiatric disorders (ex. psychosis, suicidal ideation)
* Developmental delay
* Previous speech therapy for the treatment of VCD.
* Currently receiving psychological counseling.
* In open Child Protective Services cases.

Primary outcomes:
measure: Change in frequency and intensity of VCD symptoms
timeFrame: Post intervention at 1 to 3 weeks
Secondary outcomes:
measure: Change in pulmonary function testing (PFT) measures
timeFrame: Post intervention at 1 to 3 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Department of Pediatric, West Virginia University-Charleston Division
state: West Virginia
Study officials:
affiliation: WVU Charleston Division
name: Kevin Maupin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02340416: Tissue Oxygen Index and Pulsatility Index in Orthopedic Surgery: a NIRS and TCD Pilot Trial
Official title: Tissue Oxygen Index and Pulsatility Index in Orthopedic Surgery: a NIRS and TCD Pilot Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Microemboli
Keywords: orthopedic surgeries
general anesthesia
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-01-16
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: orthopedic patients

Brief summary: Cerebral microemboli (ME) are frequently generated during major orthopaedic surgery. The primary objective of this study was applying novel transcranial Doppler (TCD) ultrasound software algorithm to quantify (ME load/15 minutes) and qualify (particulate vs. gaseous) ME, detected as high-intensity transient signals (HITS) in both middle cerebral arteries (MCAs) before and after orthopaedic surgery.


Eligibility criteria: Inclusion Criteria:

* hip prosthesis
* knee prosthesis
* shoulder prosthesis
* spine surgery

Exclusion Criteria:

* severe valvular heart defect
* acute neurological disorder

Primary outcomes:
measure: Cerebral microemboli detection
timeFrame: prior and directly after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Dept. of Anaesthesiology & Intensive Care, Vienna General Hospital, Medical University of Vienna
Study officials:
References:
citation: Kietaibl C, Engel A, Horvat Menih I, Huepfl M, Erdoes G, Kubista B, Ullrich R, Windhager R, Markstaller K, Klein KU. Detection and differentiation of cerebral microemboli in patients undergoing major orthopaedic surgery using transcranial Doppler ultrasound. Br J Anaesth. 2017 Mar 1;118(3):400-406. doi: 10.1093/bja/aex001.
Clinical trial NCT06031116: Efficacy of Ceramic Soft Tissue Trimming Bur Versus Conventional Scalpel Technique in Ginigival Depigmentation Procedure
Official title: Efficacy of Ceramic Soft Tissue Trimming Bur Versus Conventional Scalpel Technique in Ginigival Depigmentation Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperpigmentation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split mouth (dental arches)
Primary purpose: TREATMENT

Brief summary: the investigator compares the clinical outcomes and pain levels after gingival depigmentation by ceramic soft tissue bur vs scalpel surgery

Detailed description: This clinical study will be carried out to compare the efficacy of ceramic soft tissue trimming bur versus the conventional surgical scraping technique in the management of gingival hyperpigmentation.

This study will be conducted to assess:

Primary objectives:

1. Clinical outcome of the gingival depigmentation procedure.
2. Assessment of postoperative pain using the visual analogue scale.
3. Patients' satisfaction will be assessed using the patient satisfaction questionnaire (short-form, PSQ-18) and the global aesthetic improvement scale.

Secondary objectives:

1. Operating time.
2. Wound healing.

Eligibility criteria: Inclusion Criteria:

* Males and females within age range of 20-50 years.
* Systemic (medically) free individuals.
* Gingival pigmentation score \> 3 on Hedin melanin index15.
* Patients with good oral hygiene.
* Patients with thick gingival phenotype.

Exclusion Criteria:

* Smokers.
* Teeth with compromised periodontium.
* Pregnant and lactating females.
* The vulnerable group: patients with mental or physical disabilities.
* Medications that cause gingival pigmentation.
* Pathologies that cause gingival pigmentation.

Primary outcomes:
measure: clinical outcomes of depigmentation procedure
timeFrame: 3 month postoperative
measure: patient satisfaction
timeFrame: 3 months postoperative
measure: Percieved pain
timeFrame: 7 days
Secondary outcomes:
measure: operating time
timeFrame: during surgery
measure: Wound healing
timeFrame: 7 days postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams university
state: القاهرة
Study officials:
affiliation: Ain Shams University
name: Yasmine El sayed, Phd
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Hala Abu elela, Phd
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Sally Nassar, Bds
role: PRINCIPAL_INVESTIGATOR
References: