louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05506930: ITM vs QL for Pediatric Open Lower Abdominal Procedures
Official title: Intrathecal Morphine Versus Bilateral Quadratus Lumborum Blocks for Perioperative Analgesia in Pediatric Patients Undergoing Open Lower Abdominal Procedures: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain Control
Ureteral Reimplantation
Pediatrics
Intrathecal Morphine
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 14
Sex: ALL
Minimum age (years): 12
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients between the ages of 12 months and 11 years who are undergoing an open lower abdominal procedure will be randomized to receive intrathecal morphine, or bilateral quadratus lumborum block. The investigators will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of pain control as demonstrated by charted pain scores and morphine equivalents in the first 48 hours. This study will also assess the side effects of each intervention such as nausea and vomiting, and itching.


Eligibility criteria: Inclusion Criteria:

* Ages 12 months to 11 years old
* Undergoing an open lower abdominal procedure

Exclusion Criteria:

* Allergy to morphine or amide local anesthetics
* Localized rash at site of planned regional anesthetic block
* Bleeding diathesis
* Spinal dysmorphism
* Previous spinal surgery with instrumentation of the lumbar spine
* Inability or unwillingness of parent or legal guardian to give informed consent.
* Prior enrollment and randomization in this study

Primary outcomes:
measure: Duration of Analgesia - Pain Score 0-10
timeFrame: Up to 24 hours post-op
measure: Duration of Analgesia - MME/kg in First 24 Hours
timeFrame: Up to 24 hours post-op
Secondary outcomes:
measure: Number of Participants With Side Effects of Each Intervention
timeFrame: up to 48 hours post-operative
measure: Severity of Side Effects With Each Intervention
timeFrame: 0-48 hours post-operatively
measure: Patient/Family Satisfaction
timeFrame: up to 48 hours post-operative
measure: Total Length of PACU Stay - Minutes
timeFrame: time to discharge after surgery, (an expected average length of hospital stay is approximately 2-4 days)
measure: Total Length of Hospital Stay - Length of Stay, Days
timeFrame: time to discharge after surgery, (an expected average length of hospital stay is approximately 2-4 days)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Natalie Barnett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01226030: Dose Escalation and PK Study of M2ES in Subjects With Advanced Solid Tumors
Official title: Dose Escalation and PK Study of M2ES in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Advanced Solid Tumors
Lead sponsor: Protgen Ltd
Sponsor class: INDUSTRY
First posted: 2010-10-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is dose-escalation open-label study to determine the MTD of M2ES in Subjects With Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES will be selected to perform the pharmacokinetic study profiles.

Detailed description: This study is a Phase I dose-escalation open-label study to determine the MTD of M2ES in Subjects With Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES will be selected to perform the pharmacokinetic study profiles.

Eligibility criteria: Inclusion Criteria:

1. 18 to 60 years of age
2. patients had histologically or cytologically confirmed solid tumors that was refractory to standard therapy.
3. life expectancy of at least 3 months.
4. ECOGPS ≤ 1
5. Adequate hematologic, renal, and hepatic function was required as determined by the following: WBC ≥4×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥ 9g/dL, total bilirubin ≤1.5 upper limit of normal \[ULN\],AST ≤ 2.5 ULN, or ≤ 5 ULN if there was evidence of liver metastases; alkaline phosphatase ≤ 2.5 ULN, or ≤ 5 ULN if there was evidence of liver Metastases; creatinine clearance ≥50 mL/min.

Exclusion Criteria:

1. Pregnant and latent women, no contraception for women of childbearing age
2. Have taken other treatments
3. Be allergic to endostatin and other ingredient
4. Gastrointestinal Hemorrhage
5. Have Participated any clinical trail during the last 4 week
6. ECG: QTC ≥ 480 ms
7. patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, carcinomatous meningitis.)
8. Cardiovascular and mental disease
9. HIV-1 infected
10. HBV, HBV infected ,Hepatitis B surface antigen positive
11. Patients on therapeutic doses of heparin or antiplatelet agents.

Primary outcomes:
measure: The maximum tolerate dosage
timeFrame: 4 weeks
Secondary outcomes:
measure: Pharmacokinetic (PK) behavior of M2ES in tumor subject
timeFrame: 4 week
measure: The incidence rate of adverse event
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Li Zhang, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03439930: The Effect of Balance Training on Neuromuscular Control in Subjects With CAI
Official title: The Effect of Balance Training on Neuromuscular Control in Subjects With CAI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Inversion Sprain
Instability, Joint
Treatment
Neuromuscular Control
Reaction Time
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is evaluate the effect of uni-axial versus multidirectional balance training on muscle reaction time in subjects with chronic ankle instability. Muscle reaction time is measured on a trapdoor simulating an inversion sprain before and after a 6 week lasting balance training protocol.


Eligibility criteria: According to the consensus statement of the International Ankle Consortium

Inclusion Criteria:

* History of an ankle sprain
* Repetitive ankle sprains AND feelings of instability AND giving way
* Ankle functionality is documented (not as inclusion criteria)

Exclusion Criteria:

* Fracture
* Surgery
* equilibrium disorder

Primary outcomes:
measure: muscle reaction time
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Ghent
name: Roel De Ridder
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01790230: LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection
Official title: LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: LifeBond Ltd.
Sponsor class: INDUSTRY
First posted: 2013-02-13
Enrollment: 10
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: A preliminary Study in Subjects Undergoing Low Anterior Resection


Eligibility criteria: Inclusion Criteria:

1. Subject, or authorized representative, signed a written Informed Consent
2. Subject is at least 18 years of age
3. Subject is scheduled for elective open resection
4. Stapled anastomosis created within 10cm of the anal verge
5. Subject is willing to comply with the follow-up requirements of the study

Exclusion Criteria:

1. Subject has a history of hypersensitivity to porcine derived gelatin or collagen
2. Subject has unacceptable baseline hematological results
3. Subject on chronic preoperative treatment with steroids and anticoagulants
4. Subject with elevated liver function tests
5. Subject with abnormal kidney function
6. Subject with a BMI higher than 35
7. Subject participating in any other study for either drug or device which can influence collection of valid data under this study
8. Subject with a history of MI, CVA or ASA status IV or a life expectancy of less than 1 year
9. Anastomosis was performed differently from what was defined
10. Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the LifeSeal™
11. Subject has intraoperative bleeding in excess of 500cc
12. Subject has peritoneal carcinomatosis

Primary outcomes:
measure: Assessment of subject's safety by incidence of related Adverse Events
timeFrame: Approx. 1 month
Secondary outcomes:
measure: Assessment of the device's application technique
timeFrame: Intra-operative
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
References:
Clinical trial NCT02496130: Perioperative Outcomes of Common Methods of Minimally Invasive Contained Tissue Extraction
Official title: A Partners Prospective Study Assessing the Perioperative Outcomes of Common Methods of Minimally Invasive Contained Tissue Extraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hysterectomy
Keywords: minilaparotomy
morcellation
laparoscopy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2015-07-14
Enrollment: 70
Sex: FEMALE
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: 70 adult women scheduled to undergo a laparoscopic hysterectomy

Brief summary: The goal of this study is to compare common methods of tissue extraction at the time of minimally invasive surgery.

Detailed description: The goal of this study is to compare common methods of tissue extraction at the time of minimally invasive surgery, including vaginal extraction and mini-laparotomy; both performed within a containment system. The primary aim is to assess return to normal daily activities after each of the surgical techniques. Return to daily activities will be recorded on a post-operative patient activity diary recording the following tasks: a) work (if applicable), b) domestic tasks, c) driving a vehicle (if applicable) and d) physical exercise (if applicable). Additional information regarding post-operative pain (measured on a Likert scale), potential complications of each technique, such as tearing of the bag or leakage, and peri- and post-operative outcomes will be collected. In order to aid in detection of leakage, blue dye (either indigo carmine or methylene blue) will be added to the containment bag prior to morcellation.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or greater
* eligible to undergo laparoscopic Hysterectomy, as determined clinically by the operating surgeon

Exclusion Criteria:

* suspected malignancy
* medical illness precluding laparoscopy
* inability to give informed consent
* allergy to indigo carmine or methylene blue dye

Primary outcomes:
measure: Return to daily activities
timeFrame: assessed between 2 and 6 weeks after surgery (at post-op visit)
Secondary outcomes:
measure: OR Time
timeFrame: At the time of surgery
measure: Estimated Blood Loss
timeFrame: At the time of surgery
measure: Spillage of the morcellated tissue or fluids in the abdomen and pelvis
timeFrame: At the time of surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Faulkner Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jon I Einarsson, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02082925: Dyspnea Threshold During 6 Minutes Walk Test
Official title: Self-perception of Dyspnea Threshold During the 6-minute Walk Test (DT6): A New Tool for Individualized Exercise Training With Chronic Obstructive Pulmonary Disease Patients (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Exercise training
Dyspnea threshold
6MWT
Lead sponsor: 5 Santé
Sponsor class: OTHER
First posted: 2014-03-10
Enrollment: 82
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In view of the multiple limitations and restrictions relative to CPET (technical, time, physical...), determination of individualized training threshold from this evaluation is today not possible for a lot of patients.

The aim of this study was to propose a new clinical tool from 6MWT for individualized exercise training: the dyspnea threshold (DT6).


Eligibility criteria: Inclusion Criteria:

* COPD
* with or without rest and/or ambulation oxygen therapy

Exclusion Criteria:

* exacerbation in the previous four weeks
* with a restrictive or mixed respiratory syndrome, angina , recent heart attack (\< 1 month) or coronary progressive pathology
* under beta-blockers
* cognitive or motor problems which limit significantly comprehension or achievement of evaluations

Primary outcomes:
measure: Change of heart rate between 1st and 2nd 6MWT
timeFrame: at baseline (2 days after entry in pulmonary rehabilitation)
Secondary outcomes:
measure: Change of heart rate between VT (CPET) and DT6 (6MWT)
timeFrame: At baseline
Other outcomes:
Locations:
city: Lodève
country: France
facility: Clinique du Souffle La Vallonie
Study officials:
name: Nelly HERAUD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00160225: Study to Evaluate the Efficacy and Safety of Daglutril Compared to Placebo on Top of Losartan in Type 2 Diabetics With Overt Nephropathy and Well Controlled Hypertension
Official title: A Randomized, Double-Blind, Placebo Controlled, Two-Treatment and Two-Period Cross-Over, Mono-Center Study to Evaluate the Efficacy and Safety of Daglutril 300 mg Once Daily Compared to Placebo on Top of Losartan in Type 2 Diabetics With Overt Nephropathy and Well Controlled Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: blood pressure, diabetic nephropathy, proteinuria
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the end of treatment effect of Daglutril compared to placebo on top of losartan.


Eligibility criteria: Inclusion Criteria:

* treated with optimized dose of losartan (constant dose for at least four weeks before randomization and throughout the whole study period) for at least four weeks
* urinary albumin excretion ≥ 20 and \< 1000 µg/min
* sitting systolic/diastolic blood pressure (SBP/DBP) \< 140/90 mmHg at the end of placebo run-in phase

Exclusion Criteria:

* known secondary hypertension
* decompensated congestive heart failure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ranica
country: Italy
facility: Site 1
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
citation: Parvanova A, van der Meer IM, Iliev I, Perna A, Gaspari F, Trevisan R, Bossi A, Remuzzi G, Benigni A, Ruggenenti P; Daglutril in Diabetic Nephropathy Study Group. Effect on blood pressure of combined inhibition of endothelin-converting enzyme and neutral endopeptidase with daglutril in patients with type 2 diabetes who have albuminuria: a randomised, crossover, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2013 Sep;1(1):19-27. doi: 10.1016/S2213-8587(13)70029-9. Epub 2013 Jun 13.
Clinical trial NCT02610725: Online Yoga for Individuals With Mood Disorders
Official title: Online Yoga for Individuals With Mood Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood Disorders
Bipolar Disorder
Depression
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2015-11-20
Enrollment: 281
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: We are seeking to understand the acceptability of an online yoga class for individuals with mood disorders. MoodNetwork members who are 18 years old or over who have experienced depression, mania, or hypomania are invited to participate. About 200 MoodNetwork participants will take part in this study.

Detailed description: Yoga practitioners view yoga as a way to promote good physical and mental health, rather than as a treatment for poor health. This world view may be appealing to patients, especially those concerned with the stigma of conventional mental health treatment, or with the narrow focus on decreasing symptoms (instead of a broader focus on living to one's full potential) that defines much of conventional mental health treatment. Yoga classes are widely available and relatively inexpensive compared to other depression treatments. Yoga can be practiced at home with the aid of video recordings or books. We propose to examine the acceptability and feasibility of online yoga practice for individuals with depression, mania, or hypomania.

Eligibility criteria: Inclusion Criteria:

* Fluent in English
* Over age 18
* Self-report of having experienced depression, mania, or hypomania in their lifetime

Exclusion Criteria:

* Any contraindication to exercise (e.g., pregnant, physical injuries or any other reason prohibiting exercise).

Primary outcomes:
measure: Positive and Negative Affect Scale
timeFrame: Pre- and post-intervention, 40 min
Secondary outcomes:
measure: Feasibility/Acceptability Questionnaire
timeFrame: Post-Intervention
measure: Adverse Event Questionnaire
timeFrame: Post-Intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Louisa G Sylvia, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00642525: Detection of Anastomotic Leakage After Esophageal Surgery
Official title: Radiologic vs. Endoscopic Evaluation of the Conduit After Esophageal Resection: a Prospective, Blinded, Intraindividual Controlled Diagnostic Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Anastomotic Leakage
Keywords: detection of anastomotic leakage
esophageal resection
diagnostic safety
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2008-03-25
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Anastomotic leakage is a major complication in esophageal surgery. Although contrast swallow is the current standard to exclude anastomotic leakage postoperatively, endoscopy may be superior. This is the first study to compare radiographic contrast study and endoscopy for the identification of local complications after subtotal esophagectomy.

Detailed description: This prospective, blinded, intraindividual controlled study will be conducted with patients with transthoracic esophagectomy due to esophageal cancer. A radiographic contrast study will be performed prior to endoscopy at the 5th to 7th postoperative day. The investigators will not be aware of the results of the corresponding examination. Sensitivity, specificity and feasibility of the radiologic and endoscopic evaluation of the esophageal substitute will be compared.

Eligibility criteria: Inclusion Criteria:

* Patients with primary esophageal cancer undergoing transthoracic esophagectomy.

Exclusion Criteria:

* no transthoracic resection
* no primary anastomosis
* recurrent disease
* refusal to participate

Primary outcomes:
measure: Detection of anastomotic leakage
timeFrame: 5-7 days after surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Surgery, University of Heidelberg
Study officials:
References:
Clinical trial NCT06257225: Evaluation of Horizontal Bone Gain in the Lower Posterior Partially Edentulous Patient Comparing the Stabilization of Membranes With and Without Tacs
Official title: Radiographic And Clinical Evaluation of Horizontal Bone Gain in the Lower Posterior Partially Edentulous Patients Comparing the Stabilization of The Resorbable Collagen Membrane With and Without Tacs
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Guided Bone Regeneration
Keywords: GBR
Tacs
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Misr International University
First posted: 2024-02-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To address the gap of knowledge in comparing between the bone augmentation outcomes with or without tacks for membrane stabilization


Eligibility criteria: Inclusion Criteria:

* Patients with at least 1 missing tooth in the posterior mandibular area Patients with an age above 18 years Systemically healthy patients

Healed alveolar ridge for implant placement with:

* Deficient buccolingual dimension ( ≤5mm)
* Sufficient vertical height (≥ 10 mm)
* Sufficient mesio-distal width (≥ 6.5 mm) Inter-arch space ≥ 7 mm to allow space for implant-supported crown Presence of neighboring and opposing dentition Soft tissue phenotype with keratinized tissue width (KTW) (≥2 mm) and gingival thickness (≥2 mm) Good oral hygiene Cooperative patients who accepted the trial follow up period and sign the informed consen

Exclusion Criteria:

* Systemic diseases or medications that might affect bone metabolism, increase surgical risk or complicate post-operative healing Untreated periodontal diseases History of radiation therapy to the head and neck Heavy smokers (≥ 10 cigarettes per day) Pregnant or lactating females Alcoholism or drug abuse Psychiatric problems Patients with signs of acute infection related to the area of interest

Primary outcomes:
measure: Horizontal bone gain assessed radiographically (mm)
timeFrame: Baseline , 4 month
Secondary outcomes:
measure: Horizontal bone gain assessed clinically (mm)
timeFrame: Baseline , 4 month
measure: Amount of Pain
timeFrame: 7 days
measure: Amount of Pain
timeFrame: 7 days
measure: Patient satisfaction
timeFrame: 4 month
measure: Surgical Time
timeFrame: During Surgery
measure: Histological Evaluation
timeFrame: 4 month
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Hani ElNahass, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Omnia Tawfik, PhD
role: STUDY_CHAIR
References: