louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01261819: "Laparoscopic" Cystoscopy Versus Traditional Cystoscopy
Official title: "Laparoscopic" Cystoscopy Versus Traditional Cystoscopy in Patients Undergoing Minimally Invasive Hysterectomy: A Prospective Comparison Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Urinary Tract Injury
Keywords: cystoscopy, minimally invasive hysterectomy
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2010-12-17
Enrollment: 66
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study aimed to compare the use of a transurethral laparoscope to the use of a traditional cystoscope for evaluation of the bladder and ureters at the time of laparoscopic hysterectomy. The hypothesis was that visual inspection of the bladder and ureters can be done safely using a transurethral laparoscope, takes less time than traditional cystoscopy, and is more cost effective than traditional cystoscopy.


Eligibility criteria: Inclusion Criteria:

1. any female patient scheduled for a laparoscopic supracervical hysterectomy (LSH) or total laparoscopic hysterectomy (TLH) with or without adnexectomy for benign disease
2. able to comprehend and sign the informed consent form
3. able to provide clean-catch urine specimens
4. able to complete a urinary symptom questionnaire pre- and post-operatively

Exclusion Criteria:

1. participants in another research protocol involving an investigational product 30 days before planned randomization
2. pregnant women
3. patients undergoing concomitant incontinence or pelvic support procedures (e.g. transvaginal tape, transobturator tape, pelvic organ prolapse surgery)
4. patients known to have a history of recurrent urinary tract infections

Primary outcomes:
measure: Time Required to Perform Procedure (in Seconds)
timeFrame: During Procedure (Up to 15 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Winter Park And Celebration
country: United States
facility: Florida Hospital
state: Florida
Study officials:
affiliation: AdventHealth
name: Katherine Kratz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kratz KG, Spytek SH, Caceres A, Lukman R, McCarus SD. A randomized, single-blinded pilot study evaluating use of a laparoscope or a cystoscope for cystoscopy during gynecologic surgery. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):606-14. doi: 10.1016/j.jmig.2012.06.002. Epub 2012 Jul 17.
Clinical trial NCT02021019: Renal Denervation to Improve Outcomes in Patients With End-stage Renal Disease
Official title: Renal Denervation to Improve Outcomes in Patients With End-stage Renal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Renal Disease
Hypertension
Lead sponsor: Baker Heart and Diabetes Institute
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 3
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: Sympathetic activation is a hallmark of end-stage renal disease and adversely affects cardiovascular prognosis. Hypertension is present in the vast majority of these patients and plays a key role in the progressive deterioration of renal function and in the exceedingly high rate of cardiovascular events. Selective catheter-based renal denervation has been shown to be safe and effective in attaining improved and sustained blood pressure control in patients with resistant hypertension and normal renal function. The investigators hypothesize that catheter-based renal denervation is a safe and effective intervention to achieve sustained reduction in sympathetic nerve activity, BP and target organ damage in hypertensive End-Stage Renal Disease (ESRD) patients, which will result in improved cardiovascular outcomes.


Eligibility criteria: Inclusion Criteria:

* end stage renal disease
* hypertension (BP≥140/90mmHg)

Exclusion Criteria:

* Individual has renal artery anatomy that is ineligible for treatment as assessed by the interventionalist.
* Individual has experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within 3 months of the screening visit.

Primary outcomes:
measure: Blood Pressure change
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Baker IDI Heart and Diabetes Institute
state: Victoria
Study officials:
affiliation: Baker Heart and Diabetes Institute
name: Markus P Schlaich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06576219: 'My Life is Music' Group Therapy Model - a Feasibility Study for Adolescents with Persistent Pain
Official title: 'My Life is Music' Group Therapy Model - a Feasibility Study for Adolescents with Persistent Pain
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pediatric Pain
Keywords: Pediatric Pain
Music Therapy
Group Therapy
Music Intervention
Persistent Pain
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 24
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this multi-method feasibility study is to learn if a group therapy model using music can be applied in the treatment of adolescents with persistent pain. We are interested how the patients find participating in the group therapy as part of their rehabilitation and if the patient´s experience of music changes during the therapy process.


Eligibility criteria: Inclusion Criteria:

* persistent pain (3 months)
* fluency in finnish language

Exclusion Criteria:

- a psychiatric illness that significantly impairs functioning

Primary outcomes:
measure: Semi-structured interviews
timeFrame: 12 weeks
measure: Patient Diaries
timeFrame: Weekly entries for 8 weeks during intervention
Secondary outcomes:
measure: PROMIS Pediatric Profile
timeFrame: Baseline, 12 weeks
measure: Music Questionnares
timeFrame: Baseline, 12 weeks
measure: Feedback Informed Treatment (FIT)
timeFrame: Baseline, weekly entries for 8 weeks during intervention
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: New Children´s Hospital
Study officials:
References:
Clinical trial NCT00913419: To Demonstrate the Relative Bioavailability of Cyclobenzaprine HCl Tablets
Official title: Bioavailability of Cyclobenzaprine HCl Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Keywords: Antidepressant
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Cyclobenzaprine HCl tablets.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 33 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: PharmaKineticsLaboratories, Inc
name: A. Orson Brod, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01923519: Study of Genic Expression Profiles of the Epithelium of the Nose and Bronchi in Healthy and Allergic Subjects
Official title: Study of Genic Expression Profiles of the Epithelium of the Nose and Bronchi in Healthy and Allergic Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Allergy
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2013-08-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The respiratory epithelium plays a leading role in the development of allergic respiratory disease with barrier function alteration, its repair mechanisms, of anti-viral fight and the ability to induce by itself Th2 responses. The majority of allergic asthmatic patients have reached concomitant ENT: the concept of "one airway, one disease." Access to this material of epithelial study in the different phenotypes of the disease appears to be crucial. Nasal and bronchial epithelial tissues reveal essential differences in particular related to their environment (remodeling less intense and a lower sensitivity to the virus in the nose), but they nevertheless share many common cellular characteristics.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years and \<30 years
* isolated allergic rhinitis according to clinical criteria ARIA
* absence of asthma whose diagnosis is made based on clinical criteria or mild to moderate persistent asthma controlled with a diagnosis is made based on clinical criteria

Exclusion Criteria:

* recent rhino-bronchial infection (\<6 weeks)
* asthma exacerbation in the previous 6 weeks
* Chronic disease may in the opinion of the investigators interfere with the results of the study or expose them to additional risk.
* Treatment with nasal corticosteroids, inhaled or systemic in the past 6 weeks
* Current smoking no history of smoking or not smoking for at least 12 months and weaned smoking history \<5 pack-years)
* Special Needs

Primary outcomes:
measure: genic expression profile of the epithelium
timeFrame: 3 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpital Pasteur
Study officials:
References:
citation: Giovannini-Chami L, Paquet A, Sanfiorenzo C, Pons N, Cazareth J, Magnone V, Lebrigand K, Chevalier B, Vallauri A, Julia V, Marquette CH, Marcet B, Leroy S, Barbry P. The "one airway, one disease" concept in light of Th2 inflammation. Eur Respir J. 2018 Oct 25;52(4):1800437. doi: 10.1183/13993003.00437-2018. Print 2018 Oct.
Clinical trial NCT01138319: Biomarkers in Patients With Acute Myeloid Leukemia
Official title: Mitochondrial Mutations and AML
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: adult acute myeloid leukemia
childhood acute myeloid leukemia/other myeloid malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-06-07
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of acute myeloid leukemia

Brief summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:

* To determine whether clonally expanded somatic mitochondrial DNA mutations are associated with acute myeloid leukemia.

OUTLINE: Genomic DNA from blood samples obtained at diagnosis, remission, and relapse are analyzed for mitochondrial DNA mutations via PCR.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia
* Available blood samples from diagnosis, remission, and relapse

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Association between clonally expanded somatic mitochondrial DNA mutations and acute myeloid leukemia
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Jason H. Bielas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03311919: Exploratory Study of "Natural Killer" Inflammatory Lymphocytes in Waste Per-operating of Tonsillectomy
Official title: Exploratory Study of "Natural Killer" Inflammatory Lymphocytes in Waste Per-operating of Tonsillectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tonsillectomy
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient with tonsillectomy

Brief summary: The aim of this study is to describe the frequency of the presence of cells Natural Killer (NK) expressing CD86 and HLA - DR in tonsils


Eligibility criteria: Inclusion Criteria:

* patient with programmed tonsillectomy as part of the care

Exclusion Criteria:

* patient opposition to use its waste of per-operating tonsillectomy for research purposes
* patient with immunosuppressive and/or corticoid treatment (\> 1 mg/kg)

Primary outcomes:
measure: presence of lymphocytes NK expressing CD86 and HLA - DR
timeFrame: inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Loyon R, Picard E, Mauvais O, Queiroz L, Mougey V, Pallandre JR, Galaine J, Mercier-Letondal P, Kellerman G, Chaput N, Wijdenes J, Adotevi O, Ferrand C, Romero P, Godet Y, Borg C. IL-21-Induced MHC Class II+ NK Cells Promote the Expansion of Human Uncommitted CD4+ Central Memory T Cells in a Macrophage Migration Inhibitory Factor-Dependent Manner. J Immunol. 2016 Jul 1;197(1):85-96. doi: 10.4049/jimmunol.1501147. Epub 2016 May 27.
Clinical trial NCT03218319: Study of the Variations of the Blood Pressure After Nephrectomy for Renal Cancer (VAPANCR)
Official title: Study of the Variations of the Blood Pressure After Nephrectomy for Renal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Cancer
Nephrectomy
Blood Pressure
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2017-07-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study evaluates the impact of nephrectomy in renal cancer on blood pressure and renal function. The patients will have a follow-up of their blood pressure and renal function until 6 months after their operation.


Eligibility criteria: Inclusion Criteria:

* Nephrectomy programmed for located renal cancer

Exclusion Criteria:

* Patients with metastatic renal cancer
* Incapacity to use a self-measurement tensiometer
* Patients treated for high blood pressure
* Patients with laxative

Primary outcomes:
measure: Blood pressure change
timeFrame: One time before the operation and twice after : 1 month and 6 months
Secondary outcomes:
measure: Renal function
timeFrame: One time before the operation and one after 6 months
measure: Cardiovascular risk
timeFrame: A clinical exam will perform before the surgery and 1 month and 6 months after
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01389219: Post Partum Maternal and Neonatal Intervention Package
Official title: Post Partum Maternal and Neonatal Intervention Package: A Cluster Randomized Control Trial in District Sukkur, Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Postpartum and Newborn Care
Maternal Mortality
Neonatal Mortality
Keywords: Post partum
Neonate
community health care workers
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Pakistan Ministry of Health
name: John Snow, Inc.
name: Population Council
First posted: 2011-07-08
Enrollment: 1200
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Introduction of a community-based intervention package including prevention strategies, early recognition and management of common postpartum \& neonatal problems, as well as prompt referral of high risk/complicated cases through trained first level primary health care workers, will result in a significant reduction in Postpartum maternal and neonatal mortality in Pakistan

Detailed description: Introduction of a community-based intervention package including prevention strategies, early recognition and management of common postpartum \& neonatal problems, as well as prompt referral of high risk/complicated cases through trained first level primary health care workers, will result in a significant reduction in Postpartum maternal and neonatal mortality in Pakistan.

Eligibility criteria: Inclusion Criteria:

* Neonates delivered within the study area

Exclusion Criteria:

* Neonates delivered outside the study area

Primary outcomes:
measure: Visit by LHWs
timeFrame: Within 48 - 72 hours of birth
Secondary outcomes:
Other outcomes:
Locations:
city: Sukkur
country: Pakistan
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Zulfiqar A Bhutta, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04556019: Results of Surgical Treatment of the Hepatobiliopancreatic Surgical Unit
Official title: Results of the Surgical Treatment of Patients From Hepatobiliopancreatic Surgical Unit at the Complejo Hospitalario de Navarra
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreas Disease
Liver Diseases
Surgical Procedure, Unspecified
Bile Duct Diseases
Keywords: Hepatobiliopancreatic surgery
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All out-patients and in-patients at the HPB Surgical Unit

Brief summary: The main aims of this study are:

1. - to evaluate post-surgical morbidity and mortality outcomes, following the criteria and the definitions from Claven-Dindo and ISGPS international classifications, of the patients operated by the HPB Surgical Unit.
2. - to evaluate survival and disease-free survival rates of the patients operated by the HPB Surgical Unit due to tumoral cause.


Eligibility criteria: Inclusion Criteria:

* All patients operated by the HPB Surgical Unit in the last 10 years (retrospective)
* All patients being operated by the HPB Surgical Unit from January 2019 onwards who provide inform consent (prospective).

Exclusion Criteria:

* Patients not eligible for surgery
* Patients not interested in taking part in the study

Primary outcomes:
measure: Rate of patient with post-surgical morbidity and mortality operated by the HPB Surgical Unit
timeFrame: 90 days post-surgery
measure: Survival rate of patients operated by the HPB Surgical Unit
timeFrame: 5-years post-surgery
measure: Disease-free survival rate of patients operated by the HPB Surgical Unit
timeFrame: 5-years post-surgery
Secondary outcomes:
measure: Assessment of standardization of pre and post-surgical care
timeFrame: 90 days
measure: Evaluation of the result of the multimodal treatment
timeFrame: 90 days
measure: Assessment of the oncological quality standards of patients operated by HPB Surgical Unit due to tumoral cause
timeFrame: 5 years
measure: Assessment of the results from minimally invasive techniques in HPB surgery
timeFrame: 90 days
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
Study officials:
affiliation: Complejo Hospitalario de Navarra
name: Francisco Javier Herrera Cabezón, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03329118: Drug-drug Interaction Between Simvastatin and SHR3824
Official title: Drug Interaction Study of Henagliflozin and Simvastatin in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: SHR3824,simvastatin, drug-drug interaction
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-11-01
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: the purpose of thr study is to investigate the potential interation between multiple oral doses of SHR3824 and single oral dose of Simvastatin in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2

Exclusion Criteria:

* History of hypoglycemia
* History of urinary tract infections,or genital infections
* History of current clinically significant medical illness as determined by the Investigator
* Known allergy to SHR3824 or Simvastatin or any of the excipients of the formulation of SHR3824 or Simvastatin

Primary outcomes:
measure: The maximum plasma concentration (Cmax) of SHR3824
timeFrame: At protocol-specified times up to Day 7 and Day 8
measure: The area under the plasma concentration-time curve (AUC) of SHR3824
timeFrame: At protocol-specified times up to Day 7 and Day 8
measure: The area under the plasma concentration-time curve (AUC) of Simvastatin and simavastatin acid .
timeFrame: At protocol-specified times up to Day 1 and Day 8
measure: The maximum plasma concentration (Cmax) of simvastatin and simavastatin acid.
timeFrame: At protocol-specified times up to Day 1 and Day 8
measure: The number of volunteers with adverse events as a measure of safety and tolerability.
timeFrame: up to day 15
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: