louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00451165: Bowel, Urinary and Sexual Function After Laparoscopic Colorectal Surgery
Official title: Outcome Study of Bowel, Urinary and Sexual Function After Laparoscopic Colorectal Surgery, Using Questionnaire and Function Tests
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery, Laparoscopic
Sexual Dysfunction, Physiological
Colorectal Surgery
Keywords: Laparoscopic
Colon
Rectal
Surgery
Urinary function
Sexual function
Bowel function
Male
Lead sponsor: Kyoto University Hospital
Sponsor class: OTHER
First posted: 2007-03-23
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male patients who will receive laparoscopic colorectal surgery

Brief summary: Research Populations: Male patients scheduled for laparoscopic colorectal surgery

Study Method: Questionnaire and function tests

Hypothesis: A laparoscopic nerve-sparing operation is not inferior to reported open surgery in preserving urinary and sexual function.

Detailed description: There have been some reports that laparoscopically assisted rectal resection is associated with a higher rate of male sexual dysfunction compared with the open approach. But these reports are studied retrospectively.

We examine the frequency of bowel, urinary and sexual dysfunction prospectively in patients who received laparoscopic colorectal surgery.

We examine before operation, 7 days after, 3 months after, 6 months after and 12 months after operation, by questionnaires (International Index of Erectile Function (IIEF) 、Short Form-8 (SF8)、International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF)、International Prostate Symptom Score(IPSS)、Gastro-Intestinal Functional Outcome(GIFO)) and function tests (uroflowmetry and US).

Eligibility criteria: Inclusion Criteria:

* Male
* Laparoscopic right colon resection/laparoscopic rectal surgery
* 20-80 years old
* ECOG performance status (PS) 0-2

Exclusion Criteria:

* Emergent operation
* Previous proctectomy
* Severe urinary dysfunction

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto University Hospital
Study officials:
affiliation: Kyoto University Hospital
name: Yoshiharu Sakai, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT02711865: Predictive Biomarkers for IGF1R Targeted Therapy in Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-03-17
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twenty fresh ovarian cancer specimens will be obtained from patients operated on and treated at the Hillel Yaffe Medical Center.

Brief summary: The main goal of this study is to employ a novel proteomic approach to identify predictive tumor biomarkers that will increase the efficacy of insulin-like growth factor (IGF1R) targeted therapy in epithelial ovarian cancer. It is expected that these predictive biomarkers will be applied to increase the response rate in selected groups of patients.


Eligibility criteria: Inclusion Criteria:

* Patients with ovarian cancer

Exclusion Criteria:

* All others

Primary outcomes:
measure: Responsive to IGF1R therapy
timeFrame: One year
Secondary outcomes:
measure: Proteomic Signature of IGF1R Responsive Tumors
timeFrame: One year
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Ilan Bruchim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03786965: Evaluating of Role of Myeloperoxidase in Prediction of Outcomes of Cardiac Surgery Procedures.
Official title: Evaluating of Role of Myeloperoxidase in Prediction of Outcomes of Cardiac Surgery Procedures.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Procedure Complication
Ischemic Heart Disease
Valve Heart Disease
Defect Septal
Keywords: Ischemic Heart Disease
Valve Disease
Septal Defect
Myeloperoxidase
Molecular biology
Gene analysis
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main objection is to investigate molecular biology of myocardial damage during cardiac surgery procedures.

Detailed description: To assess outcomes after cardiac surgery procedures. To investigate serum level of myeloperoxidase, morphology of left atrium appendage, to perform genetic analysis and cell biology.

Eligibility criteria: Inclusion Criteria:

* ischemic heart disease with indications for operation
* valve disease with indications for operation
* ischemic heart disease combined with valve disease with indications for operation

Exclusion Criteria:

* patient refusal

Primary outcomes:
measure: Death within 30 days after procedure.
timeFrame: within 30 days after procedure.
measure: Acute myocardial infarction.
timeFrame: within 30 days after procedure.
measure: Stroke.
timeFrame: within 30 days after procedure.
measure: Arrhythmia
timeFrame: within 30 days after procedure.
measure: Renal dysfunction.
timeFrame: within 30 days after procedure.
measure: Infection or febrile.
timeFrame: within 30 days after procedure.
measure: Respiratory dysfunction.
timeFrame: within 30 days after procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: Nikolai Bunenkov
state: Non-US/Non-Canadian
Study officials:
affiliation: First Saint-Petersburg Medical University
name: Alexander Nemkov, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01826565: Comparison of Two Insertion Technique of I-gel
Official title: Comparison of Two Insertion Technique of I-gel: Standard Versus 90-degree Rotation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Prostate Tumor
Bladder Cancer
Bladder Tumor
Keywords: success
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of rotational technique in the insertion of i-gel

Detailed description: The i-gel is one of the 2nd generation supraglottic airways. The rotational technique is known to increase the success rate of insertion of other supraglottic airways. The investigators try to evaluate the efficacy of rotational technique in the insertion of i-gel.

Eligibility criteria: Inclusion Criteria:

- Patients scheduled for general anesthesia(transurethral resection of bladder tumor or transurethral resection of the prostate) using i-gelTM

Exclusion Criteria:

* History of recent postoperative sore throat
* History of difficult airway
* Mouth opening \< 2.5 cm
* Emergency operation

Primary outcomes:
measure: The success rate of insertion
timeFrame: up to 30 min.
Secondary outcomes:
measure: postoperative sore throat
timeFrame: up to 2 days
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University of Hospital
name: Hee-Pyung Park, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University of Hospital
name: Hyun-Chang Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03486665: Characterization of White Blood Cells Sub-populations From Multiple Sclerosis Patients.
Official title: Characterization and Quantitative Analysis of White Blood Cells in the Blood and Cerebrospinal Fluid of MS Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Lead sponsor: Bioimmunate
Sponsor class: INDUSTRY
First posted: 2018-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 to 70 years old patients with MS defined according to the revised diagnostic criteria of MacDonald and are followed by the neurology or physical medicine and rehabilitation center or healthy volunteers.

Brief summary: Multiple sclerosis (MS) is a chronic progressive neurological autoimmune disease, that gradually affects patient's quality of life. There are about 2.5 millions patients world wide, with an increasing cost Burdon. Up to date, it remains unclear who are the exact cells to initiate the disease. During the disease, the repertoire of cells expands and undergoes changes. The purpose of this study is to characterize those changes.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of MS according to the revised criteria of McDonald or healthy volunteers
* Ability to provide written informed consent.

Exclusion Criteria:

- Active malignant disease

Primary outcomes:
measure: Quantification of disease related white blood cells from blood and/ or CSF
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References:
Clinical trial NCT00010465: Nervous System Manipulation and Botanicals for the Treatment of Recurrent Ear Infections in Children
Official title: Osteopathic Manipulation and Echinacea for the Treatment of Recurrent Ear Infections in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Otitis Media
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2001-02-05
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of echinacea therapy and osteopathic manipulation for the prevention of further ear infections in children with recurrent ear infections (otitis media).

Detailed description: Acute otitis media (inflammation of the middle ear) occurs in 60% of infants during the first year of life and in 85% by age 3. Approximately 17% of children suffer recurrent otitis media during the first year of life. Following acute otitis media, middle ear fluid effusions can persist for weeks to months. Approximately 40% of children with middle ear effusions have mild to moderate hearing loss for the duration of the effusion, and several studies have found evidence for impaired speech and language development among children with prolonged middle ear effusion. Since antibiotic use has become widespread, concern has emerged regarding antibiotic resistant S. pneumoniae strains and other bacteria. Children with recurrent otitis media commonly receive prophylactic antibiotic therapy or surgical insertion of tubes to prevent accumulation of middle ear effusion. The prevalence of pediatric use of complementary alternative medical (CAM) approaches for prevention of otitis media has not been widely quantified. This study will evaluate the use of osteopathic manipulation and echinacea therapy to prevent ear infection in children with recurrent otitis media.

Eligibility criteria: Inclusion Criteria:

* Written informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Michael Aldous
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wahl RA, Aldous MB, Worden KA, Grant KL. Echinacea purpurea and osteopathic manipulative treatment in children with recurrent otitis media: a randomized controlled trial. BMC Complement Altern Med. 2008 Oct 2;8:56. doi: 10.1186/1472-6882-8-56.
Clinical trial NCT05233865: Hemodynamic Effects During Land vs Water Exercise for Older Adults With Orthostatic Hypotension
Official title: Hemodynamic Effects During Land vs Water Exercise for Older Adults With Orthostatic Hypotension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthostatic Hypotension
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 25
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to understand how blood pressure, heart rate, and symptoms of low blood pressure (such as dizziness or nausea) are affected by positional changes and exercise when on land or in the water for people who tend to experience orthostatic hypotension.


Eligibility criteria: Inclusion Criteria:

* Self-report of dizziness upon standing (from sit or supine position) or known diagnosis of orthostatic hypotension
* Able to stand independently for 3-5 consecutive minutes
* Able to walk independently (with or without an assistive devise)
* Medically stable for last month
* Score of 3 or greater on Mini-Cog (standardized outcome measure to detect dementia)
* Full coronavirus vaccination

Exclusion Criteria:

* Diagnosis of dementia
* Contraindication for pool exercise (such as infected open wounds, fecal incontinence, diarrhea.)

Primary outcomes:
measure: Systolic blood pressure (mmHg)
timeFrame: <1 minute upon standing
measure: Diastolic blood pressure (mmHg)
timeFrame: <1 minute upon standing
measure: Self-reported orthostatic hypotension symptoms
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Cardiovascular Aging Research Laboratory at UT Austin
state: Texas
Study officials:
References:
Clinical trial NCT03614065: Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC
Official title: Endostar Combine With Radiotherapy in Brain Metastasis of NSCLC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Observe the effect os radiotherapy plus or not plus endostar in the treatment of brain metastasis in NSCLC

Detailed description: The investigators will observe the time controlled by the brain lesion after the test and the total survival time of the patients. Meanwhile, during each follow-up, the investigators will extract cerebrospinal fluid for genomic analysis of cerebrospinal fluid

Eligibility criteria: Inclusion Criteria:

* NSCLC Brain metastasis

Exclusion Criteria:

* KPS\<60

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From date of randomization until the date of first documented progression of brain lesions, and the maximum evaluation time is 36 months
Secondary outcomes:
measure: Overall survival （OS）
timeFrame: From date of randomization until the date of death, assessed up to 36 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital
state: Hubei
Study officials:
affiliation: china goverment
name: dong xiaorong, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT05395065: Silver Diamine Fluoride Gel: Case Series
Official title: Evaluation of the Response of Caries Lesions in Dentin After Application of Silver Diamine Fluoride Gel: A Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries in Children
Keywords: Silver Diamine Fluoride
Sodium Fluoride Varnish
Dental Caries
Primary Dentition
Peru
Lead sponsor: Advantage Silver Dental Arrest, LLC
Sponsor class: INDUSTRY
Collaborators: name: Universidad Nacional Del Altiplano Puno
name: University of Washington
First posted: 2022-05-27
Enrollment: 235
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The children will be recruited from five schools (Centro Educativo Inicial) in Puno, Peru

Brief summary: A clinical case series to determine the clinical response of dental caries lesions in primary teeth where 38% silver diamine fluoride gel is applied and cover with 2.5% sodium fluoride varnish. Additionally, to assess parent satisfaction with treatment with 38% silver diamine fluoride.

Detailed description: A clinical case series of 235 children ages 3 and 4 with severe early childhood caries where the lesions are treated with 38% silver diamine fluoride and covered with 2.5% sodium fluoride varnish at baseline and 6 months. The primary objective is to determine the response of dental caries lesions (caries arrest) into the dentin in primary teeth at one year of follow-up. The secondary objective is to assess parent satisfaction with treatment with 38% silver diamine fluoride and 2.5% sodium fluoride varnish.

Eligibility criteria: Inclusion Criteria:

* At least one active caries lesion Good general health by parent report

Exclusion Criteria:

* Unable to cooperate with exam or procedure

Primary outcomes:
measure: Lesion Activity
timeFrame: 5 months
measure: Lesion Activity
timeFrame: 12 months
Secondary outcomes:
measure: Caries Increment
timeFrame: 5 months
measure: Caries Increment
timeFrame: 12 months
measure: New Caries Lesions
timeFrame: 5 months
measure: New Caries Lesions
timeFrame: 12 months
measure: Satisfaction with Color Changes in Teeth
timeFrame: 5 months
Other outcomes:
Locations:
city: Puno
country: Peru
facility: UGEL Manazo
city: Puno
country: Peru
facility: UGEL Puno 210001 Las Torres
city: Puno
country: Peru
facility: UGEL Puno Magisterial
city: Puno
country: Peru
facility: UGEL San Jose
city: Puno
country: Peru
facility: UGEL Villa del Lago
Study officials:
affiliation: Universidad Nacional del Altiplano
name: Taina Padilla Caceres, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chu CH, Lo EC, Lin HC. Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children. J Dent Res. 2002 Nov;81(11):767-70. doi: 10.1177/0810767.
citation: Kiesow A, Menzel M, Lippert F, Tanzer JM, Milgrom P. Dentin tubule occlusion by a 38% silver diamine fluoride gel: an in vitro investigation. BDJ Open. 2022 Jan 13;8(1):1. doi: 10.1038/s41405-022-00095-8.
Clinical trial NCT00821665: Blood Glucose Homeostasis in Type 2 Diabetes: the Effects of Saccharose
Official title: Blood Glucose Homeostasis in Type 2 Diabetes: the Effects of Saccharose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Glycemic Control
Keywords: Type 2 diabetes
Glycemic control
(postprandial) Hyperglycemia
Sucrose
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Suikerstichting Nederland (Baarn)
First posted: 2009-01-13
Enrollment: 39
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Hyperglycemia forms a direct and independent risk factor for the development of cardiovascular co-morbidities in type 2 diabetes. Consumption of sucrose-sweetened soft drinks might further increase the prevalence of hyperglycemic episodes.

The objective of the study was to assess glycemic control in type 2 diabetes patients and healthy lean and obese controls under strict dietary standardization but otherwise free living conditions, with and without the consumption of soft drinks.


Eligibility criteria: Inclusion Criteria:

Lean NGT Group

* Normoglycemic (according to 2006 ADA guidelines)
* BMI \< 27 kg/m2

Obese NGT Group

* Normoglycemic
* BMI 30- 35 kg/m2

Obese type 2 diabetes Group

* BMI 30- 35 kg/m2
* Oral blood glucose lowering medication

Exclusion Criteria:

* Exogenous insulin use
* Cardiac disease (any cardiac event in the last 5 years)
* HbA1c \>10%
* Microalbuminuria: albumin:creatinine ratio \>2,5

Primary outcomes:
measure: Hyperglycemia
timeFrame: 24h
Secondary outcomes:
measure: Hyperglycemia
timeFrame: Postprandially
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limbrug
Study officials:
affiliation: Maastricht University
name: Luc J van Loon, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03612765: The Effectiveness of the Push-Pull-Hold Program on Improving Self-Care in Patients With Heart Failure
Official title: The Effectiveness of the Push-Pull-Hold Program on Improving Self-Care in Patients With Heart Failure: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
self-care
behavio*
intervention
randomized controlled trial
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: National Heart Centre Singapore
First posted: 2018-08-02
Enrollment: 144
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized controlled trial that tests the effectiveness of a novel intervention called the Push-Pull-Hold program on improving self-care in patients with heart failure. This intervention was developed based on our previous quantitative and qualitative findings and existing psychological concepts. Results would inform current understanding of the intention-behavior link in self-care and inform future policy and intervention development to improve patient and caregiver outcomes.


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed with chronic heart failure for at least 1 month
* More than 21 years old
* Able to read and understand English or Chinese

Exclusion Criteria:

* Dependent on caregivers
* Awaiting implantable devices or surgery
* Pregnant

Primary outcomes:
measure: Changes in Self-Care of Heart Failure Index (SCHFI) maintenance subscale
timeFrame: weeks 1, 12 and 24
Secondary outcomes:
measure: Changes in the Consideration of Future Consequences Scale (CFCS)
timeFrame: weeks 1, 12 and 24
measure: Changes in intention to change behaviours
timeFrame: weeks 1, 12 and 24
measure: Changes in the Self-Report Habit Index (SRHI)
timeFrame: weeks 1, 12 and 24
measure: Changes in Mindfulness Attention Awareness Scale (MAAS)
timeFrame: weeks 1, 12 and 24
measure: Minnesota Living with Heart Failure Questionnaire (MLHFQ)
timeFrame: weeks 1, 12 and 24
Other outcomes:
measure: Changes in readmission
timeFrame: Weeks 1 and 24
measure: Changes in emergency department visits
timeFrame: Weeks 1 and 24
measure: Mortality
timeFrame: Week 24
Locations:
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
Study officials:
affiliation: The Nethersole School of Nursing
name: Jocelyn H.S. Chew, BSc(Nursing)
role: PRINCIPAL_INVESTIGATOR
References: