louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00700505: A Study to Determine the Safety and Efficacy of a New Non-invasive Heating Garment to Reduce Urinary Hesitancy
Official title: A Study to Determine the Safety and Efficacy of a New Non-invasive Heating Garment to Reduce Urinary Hesitancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia (BPH)
Urinary Retention
Urinary Hesitancy Intermittent
Keywords: Benign Prostatic Hyperplasia
BPH
Benign Prostatic Hypertrophy
Urinary Retention
Shy Bladder
Urinary Hesitancy
Bashful Bladder
Paruresis
Lead sponsor: ThermaRx, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-18
Enrollment: 20
Sex: MALE
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of the ThermaRx heating device for the application of controlled low level heat to improve symptoms of LUT dysfunction (hesitancy, urgency).

Detailed description: This study will assess the safety and efficacy of ThermaRx heat treatment in subjects who have urinary hesitancy.

The rationale for this approach is based on anecdotal evidence and case reports suggesting that urinary hesitancy can be effectively reduced by external skin heating (hot tub "Jacuzzi" effect, perineal hot water spray). However, to date, there have been no formal studies of this non-invasive form of treatment, and the mechanism of action is still unclear.

This is a two-day study in which each subject will receive an oral fluid load and then one (1) heating treatment with the device. Ultrasound-based measurements of bladder volume will be performed both before and after voiding. On Day 1, voiding will be performed in a standing position; on Day 2, voiding will be done in a sitting position.

Eligibility criteria: Inclusion Criteria:

* Male subjects 25-80 years of age at the screening visit.
* Subject must have mild-to-moderate urinary hesitancy symptoms (shown as an American Urological Association Symptom Index (AUA-SI) score of 7-19).
* Symptoms include (not limited to):
* Leaking or dribbling of urine
* More frequent urination, especially at night
* Urgency to urinate
* Urine retention (inability to urinate)
* Hesitant, interrupter or weak stream of urine
* Inability or difficulty to urinate in public

Exclusion Criteria:

* History of prostate cancer or prostate surgery
* Currently (or within the past 30 days) on active treatment for prostate problems

Primary outcomes:
measure: Post-void residual urinary volume (PVR)
timeFrame: Both Study Day 1 & 2 before/after oral fluid load
Secondary outcomes:
measure: Voided volume percentage (%) based on pre-void and post-void ultrasound volumes
timeFrame: Both Study Day 1 & 2 before/after oral fluid load
Other outcomes:
Locations:
city: Houston
country: United States
facility: Mobley Clinical Research Center
state: Texas
Study officials:
affiliation: Mobley Clinical Research Center
name: David Mobley, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mobley Clinical Research Center
name: John T La
role: STUDY_DIRECTOR
References:
Clinical trial NCT03738605: Vaginal Laser Therapy in Breast Cancer Survivors
Official title: Vaginal Laser Therapy for the Management of Genitourinary Syndrome of Menopause of Breast Cancer Survivors: Double-blind Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Genitourinary Syndrome of Menopause
Vaginal Atrophy
Breast Cancer
Dyspareunia
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of vaginal CO2 laser therapy in breast cancer survivors with symptoms of Genitourinary Syndrome of Menopause. Half of participants will receive active laser therapy, while the other half placebo therapy.


Eligibility criteria: Inclusion Criteria:

* breast cancer history
* dyspareunia
* dryness

Exclusion Criteria:

* Active genital infection (i.e herpes, vaginitis)
* Prolapse stage \>=2
* Underlying pathologies that could interfere with the protocol compliance

Primary outcomes:
measure: 10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness
timeFrame: Change from baseline at 1 month post-treatment
Secondary outcomes:
measure: 3 days voiding diary
timeFrame: Change from baseline at 1 month post-treatment
measure: Day-to Day Impact of vaginal aging questionnaire (DIVA)
timeFrame: Change from baseline at 1 month post-treatment
measure: Patients Global Impression of Improvement
timeFrame: At 1-month post-treatment
measure: 10-centimeter Visual Analogue Scale assessing intensity of itching, burning and dysuria
timeFrame: Change from baseline at 1 month post-treatment
measure: King's Health Questionnaire (KHQ)
timeFrame: Change from baseline at 1 month post-treatment
measure: Female Sexual Function Index
timeFrame: Change from baseline at 1 month post-treatment
measure: Vaginal Maturation Value
timeFrame: 6 months
measure: Vaginal Health Index Score
timeFrame: 6 months
measure: International Consultation on Incontinence Questionnaire Short Form
timeFrame: 6 months
measure: Modified Sexual Quality of Life Questionnaire-Male
timeFrame: 6 months
measure: Urogenital Distress Inventory 6
timeFrame: 6 months
measure: Epithelial thickness
timeFrame: 6 months
measure: Number of blood vessels
timeFrame: 6 months
measure: Size of blood vessels
timeFrame: 6 months
measure: Collagen
timeFrame: 6 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Urogynecological Unit of Alexandra Hospital
Study officials:
affiliation: National and Kapodistrian University of Athens, Greece
name: Stavros Athanasiou, Associate Proffesor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01535105: Impairment in Glucose Homeostasis Among Obese Adolescents in High Risk Diabetes Prone Population - Jisr Az-Zarqa Village
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glucose Metabolism Disorders
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-02-17
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects of the study will be selected from a primary care clinic

Brief summary: Obesity is increasing all over the world in adults, adolescents and children,and is followed by morbidity, including the metabolic syndrome.

Hypothesis: Among obese adolescents there is a subgroup with impaired glucose homeostasis

The aim of the study is to identify adolescents with impaired glucose metabolism, 12-18 years, among high risk diabetes prone population, for diagnosis and treatment.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of obesity

Exclusion Criteria:

* History of disease or drug therapy affecting glucose metabolism

Primary outcomes:
measure: Frequency of Impaired Glucose Homeostasis among obese adolescents in high risk diabetes prone population
timeFrame: one year
Secondary outcomes:
measure: Description of the metabolic profile in obese adolescents
timeFrame: One year
Other outcomes:
Locations:
city: Jisr az-Zarqa village
country: Israel
facility: Clalit Health Services Clinic
Study officials:
affiliation: Clalit Health Services
name: Nehama Zuckerman-Levin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03686605: The Edmonton Symptom Assessment System (ESAS) as a Screening Tool for Depression in Cancer Pain Patients
Official title: The Edmonton Symptom Assessment System (ESAS) as a Screening Tool for Depression in Cancer Pain Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Screening Tool for Depresion in Cancer Pain Patients
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Cancer pain patients

Brief summary: Compare Thai versions of the Edmonton Symptom Assessment System (ESAS) and the Hospiral Anxiety and Depression Scale (HADS) with Diagnostic and Statistical Manual (DSM-5), as a screening tool for depression in cancer pain patients


Eligibility criteria: Inclusion Criteria:

* Cancer patients who follow up as out patient at pain clinic, Siriraj hospital
* Age older than 18 years old
* Fluently read, write and speak in Thai language
* No cognitive impairment

Exclusion Criteria:

* Unstable clinical presentation
* Severe pain or pain numerical rating scale more than 7
* Severe associated symptoms such as nausea, vomiting
* The patient who do not know their diagnosis

Primary outcomes:
measure: Reliability and validity of Thai version of ESAS
timeFrame: 1 year
Secondary outcomes:
measure: Correlation of Thai version of ESAS, HADS and DSM-5
timeFrame: 1 year
measure: Internal consistency of Thai version of ESAS and HADS
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of medicine Siriraj Hospital Mahidol University
state: Bangkok
Study officials:
affiliation: Lecturer
name: Suratsawadee Wangnamthip, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03565705: Spinal Anesthesia and Peri-operative Opioid Consumption in Open Abdominal Prostatectomy
Official title: Impact of Spinal Anesthesia on Peri-operative Opioid Consumption in Open Abdominal Prostatectomy- a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Opioid Use
Analgesia
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 636
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We aim to include patients that are scheduled for elective, radical open abdominal prostatectomy. Thus only male patients of 18 years or older will participate. Patients with chronic pain therapy (e.g. out-of-hospital opioid therapy) will be excluded from the study.

Brief summary: Retrospective analysis to assess the impact of spinal anesthesia on peri-operative opioid consumption during open abdominal prostatectomy. The authors compare the group that had spinal anesthesia in combination with propofol sedation and a laryngeal mask to the second group that underwent the same procedure in general anesthesia with tracheal intubation.

Detailed description: Retrospective analysis to assess the impact of spinal anesthesia on peri-operative opioid consumption during open abdominal prostatectomy. The authors compare the group that had spinal anesthesia in combination with propofol sedation and a laryngeal mask to the second group that underwent the same procedure in general anesthesia with tracheal intubation.

...

Eligibility criteria: Inclusion Criteria:

* elective, radical abdominal prostatectomy
* \>18 years

Exclusion Criteria:

* chronic pain therapy (e.g. out-of-hospital opioid therapy)
* laparoscopic approach

Primary outcomes:
measure: Post-operative opioid consumption
timeFrame: 1 day
Secondary outcomes:
measure: Intra-operative opioid consumption
timeFrame: 1 day
measure: Pain maximum
timeFrame: 1 day
measure: Postoperative recovery time
timeFrame: 1 day
measure: PONV/Shivering
timeFrame: 1 day
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Rainer Nitzschke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Funcke S, Schick-Bengardt X, Pinnschmidt HO, Beyer B, Fischer M, Kahl U, Nitzschke R. The impact of spinal anaesthesia on perioperative opioid consumption, postoperative pain and oncological outcome in radical retropubic prostatectomy-a retrospective before-and-after effectiveness study. Perioper Med (Lond). 2022 Oct 3;11(1):49. doi: 10.1186/s13741-022-00281-0.
Clinical trial NCT05202405: A Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B
Official title: An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B in Healty Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperlipidemias
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-21
Enrollment: 64
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-221 in healthy male subjects.

Detailed description: The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-221 compared with coadministration AD-221A and AD-221B in healthy male subjects.

Eligibility criteria: Inclusion Criteria:

* Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
* The Age equal to or greater than 19 in healthy volunteers at the time of screening visit

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: pre-dose to 72 hours
measure: Area Under the Curve in time plot (AUCt)
timeFrame: pre-dose to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H+ Yangji Hospital
Study officials:
References:
Clinical trial NCT00893698: Bilateral Allotransplantation of Upper Limbs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients Private of Their Upper Limbs
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2009-05-06
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to realize a bilateral transplantation of upper limbs. The first objective is functional but there are aesthetic and psychologic imperatives too. This open and descriptive study needs compatible donor and recipient. The sample should be realized simultaneously and the transplantation should be made by two coordinated teams according to this sequence : osteosynthesis, vascular anastomosis, sutures of tendons and nervous sutures. An immunosuppressant treatment should be initialized from the beginning of the intervention and continued for life. Rejections should be screened by regular clinical and histological examinations.


Eligibility criteria: Inclusion Criteria:

Donor:

* State of brain death
* Compatibility with recipient about sex, size, age and color
* Blood compatibility; integrity of upper limbs

Recipient:

* Double amputation of hands or forearms with traumatic origin
* Personal motivation
* Good health condition
* Delay from 2 months to 34 years between amputation and transplantation

Exclusion Criteria:

Donor:

* Uncompatibility with sample
* Lesion on upper limbs
* Neoplasia
* Hepatitis B or C
* Positive CMV serology

Recipient:

* Uncompatibility with immunosuppressant treatment
* Psychosis
* Carcinosis
* Cardiovascular diseases
* Addiction to alcohol or smoking
* Pregnancy
* Feeding

Primary outcomes:
measure: Functional rehabilitation of patients by bilateral allotransplantation of upper limbs, evaluated by measure of the function of the transplanted extremities
timeFrame: 6 years
Secondary outcomes:
measure: Aesthetic and psychologic
timeFrame: 6 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
References:
Clinical trial NCT00302198: Amyotrophic Lateral Sclerosis Web Based Patient Care Database: ALSConnection.Org
Official title: Amyotrophic Lateral Sclerosis Web Based Patient Care Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis
Lead sponsor: Forbes Norris MDA/ALS Research Center
Sponsor class: OTHER
Collaborators: name: Muscular Dystrophy Association
First posted: 2006-03-14
Enrollment: 15000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient diagnosed with ALS by a licensed physician.

Brief summary: The purpose is to collect data for ALS research. The data will be used to learn more about the origin of ALS and to improve quality of care for people with ALS. The information you provide in the ALS registry will be used to evaluate variations in patient care, adherence to standards of care and also to help foster ALS research.

Detailed description: Any person who has been diagnosed with ALS by a physician can enroll into this registry.

The information you provide in the ALS registry will be used to evaluate variations in patient care, adherence to standards of care and also to help foster ALS research. An additional focus of this website will be to educate participating patients and visitors to this site about ongoing ALS research.

Eligibility criteria: Inclusion Criteria:

* There are no inclusion and exclusion criteria beyond the fact that a person needs to have ALS in order to enroll.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Forbes Norris MDA/ALS Center
state: California
Study officials:
affiliation: California Pacific Medical Center
name: Robert G Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02253498: The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette Syndrome
Official title: The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Tourette Syndrome
Lead sponsor: Beijing Pins Medical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Tiantan Hospital
First posted: 2014-10-01
Enrollment: 20
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: The purpose of this clinical study is to verify the long term effectiveness and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with cognitive, behavioral, and functional disability of Tourette Syndrome.


Eligibility criteria: Inclusion Criteria:

1. Subject is aged 18 or older
2. Patient Group with Tourette's syndrome, Diagnosis of Tourette Syndrome by DSM-IV

Exclusion Criteria:

1. Major Depressive Episode within the previous 6 months
2. Schizophrenia or other psychotic disorder.Participate in other clinical trial;
3. Has a life expectancy of \< 1 year.
4. The investigator and/or enrollment review committee, would preclude participation in the study.

Primary outcomes:
measure: Modified Rush Video Rating Scale (mRVRS)
timeFrame: 12 month
Secondary outcomes:
measure: Tourette Syndrome Symptom List (TSSL)
timeFrame: 12 month
measure: SF-36
timeFrame: 12 month
Other outcomes:
Locations:
Study officials:
affiliation: Tsinghua University
name: Li Luming, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02778698: Compassionate Use of Omegaven
Official title: Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in The Treatment of Parenteral Nutrition Induced Liver Injury in Children
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Cholestasis
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2016-05-20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 5
Standard ages: CHILD

Brief summary: This expanded access protocol is for infants or children with conditions preventing them from taking in enough nutrients from food and must receive nutrition intravenously. Standard intravenous nutrition contains fat emulsion made from soybean. If this fat emulsion is given over a long period of time, it can cause problems within the liver and if persistent and not addressed can even lead to severe and/or permanent injury to the liver.

It is believed that a type of fish oil blend, called Omegaven®, may be used in place of the soybean fat blend. The Omegaven® fish oil blend may greatly reduce the risk of liver injury.

Omegaven® is not approved by the Food and Drug Administration (FDA). It is only offered under an "expanded access" protocol as an alternative to the soybean fat blend.


Eligibility criteria: Inclusion Criteria:

1. Male or female
2. Older than 14 days and less than 5 years of age
3. Direct bilirubin value is greater than 2 mg/dL
4. Be expected to require intravenous nutrition for at least an additional 28 days
5. Parent/legal guardian has agreed to provide consent/parental permission

Exclusion Criteria:

1. Patients who have a congenitally lethal condition (e.g. Trisomy 13).
2. Patients who have clinically severe bleeding not able to be managed with routine measures.
3. Patients who have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
4. Patients who have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.

5 The parent/legal guardian is unwilling to provide consent/parental permission.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Geisinger Clinic
name: Edward A Everett, DO
role: PRINCIPAL_INVESTIGATOR
References: