louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04604483: Percutaneous Tibial Nerve Stimulation (PTNS) for the Treatment of Chronic Anal Fissure
Official title: Percutaneous Tibial Nerve Stimulation for Chronic Anal Fissure - a Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fissure in Ano
Keywords: Anal fissure
Percutaneous Tibial Nerve Stimulation
PTNS
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective non-randomized trial
Primary purpose: TREATMENT

Brief summary: Chronic anal fissure rarely heals spontaneously. About 50% heal on administration om topical muscle relaxants (e.g. diltiazem) and/or injection of Botulinum toxin, but for the remainder of patients surgery (with lateral internal sphincterotomy or fissurectomy) with subsequent risks of anal incontinence has been the golden standard. Treatment with PTNS (percutaneous tibial nerve stimulation) has been showed to produce healing of chronic anal fissures not responding to topical treatment, thus avoiding the risk for debilitating anal incontinence.

Detailed description: This study will prospectively include 52 patients with chronic anal fissure that have received topical treatment and stool softeners and have all been evaluated by experienced proctological surgeons. The treatment will be given for 10 consecutive work days and then evaluated at 3 and 12 months. If the patients symptoms are unimproved at 3 months alternative treatments will be offered.

Eligibility criteria: Inclusion Criteria:

* Verified anal fissure (Clinical assessement by experienced proctological surgeon)
* Full conservative treatment has been given

Exclusion Criteria:

* Inflammatory bowel disease
* Fistula and/or anal abscess
* Patients with compromised immunity
* Pregnancy
* Treatment with anti-coagulants (not aspirin)
* Previous irradiation towards pelvic floor
* Pacemaker or implanted defibrillator

Primary outcomes:
measure: Healing rate
timeFrame: 3 months after treatment
measure: Healing rate
timeFrame: 12 months after treatment
Secondary outcomes:
measure: Bowel movements
timeFrame: 3 months after treatment
measure: Bowel movements
timeFrame: 12 months after treatment
measure: Adverse effects
timeFrame: 3 months after treatment
measure: Adverse effects
timeFrame: 12 months after treatment
measure: Smoking
timeFrame: 3 months after treatment
measure: Smoking
timeFrame: 12 months after treatment
Other outcomes:
Locations:
city: Malmo
country: Sweden
facility: Skåne University Hospital
Study officials:
affiliation: Lund University
name: Louis B Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nelson RL, Thomas K, Morgan J, Jones A. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD003431. doi: 10.1002/14651858.CD003431.pub3.
Clinical trial NCT00944983: Clinical Validation of the Tiba Medical Ambulo 2400 ABPM According to the ISO 80601-2-30 Standard in Adults, Adolescents, and Children
Official title: Clinical Validation of the Tiba Medical Ambulo 2400 ABPM According to the ISO 80601-2-30 Standard in Adults, Adolescents, and Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
Hypotension
Clinical Validation
Blood Pressure Accuracy
ISO 81600 Standard
British Hypertension Society
European Society of Hypertension
International Protocol
Lead sponsor: Tiba Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Tennessee
First posted: 2009-07-23
Enrollment: 105
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults, Adolescents, and Children of different genders, ages, races \& sizes (height, weight \& particularly arm size) plus blood pressure ranges (normatensive, hypotensive and hypertensive).

Brief summary: Clinical validation of the Tiba Medical Ambulo 2400 ambulatory blood pressure monitoring system according to the accuracy guidelines of the ISO 80601-2-30 Standard in Adults, Adolescents, and Children.


Eligibility criteria: Inclusion Criteria:

* Ages \> 3 Years Old

Exclusion Criteria:

* Severe Arrhythmia

Primary outcomes:
measure: Series of blood pressure measurements obtained in 100+ subjects
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee Medical Group
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Bruce Alpert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02286583: Medical Radiometer - RTM - 01 - RES and Its Use in Detecting Hotspots in Female Breast
Official title: Early Detection of Breast Disease Using Medical Radiometer - RTM - 01 - RES
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: RTM
Female breast cancer
Lead sponsor: Labdom Suisse
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 2000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Medical Radiometer depends on detecting the microwaves that radiates from deep structure hot objects in the body. When it comes to the breast, causes of deep structure hot spots are numerous, it can be inflammatory, hormonal or neoplastic. Therefore, the primary objective of this study is to test the sensitivity of the Medical Radiometer in detecting the hot spots in the breast.

Detailed description: Several pathological lesions and physiological changes can cause spot in the breast to show higher temperature than it should be.

The causes can be:

\[I\] Physiological: During menarch, puberty, menstruation, lactation and after sexual Intercourse.

\[II\] Inflammatory: Mastitis and breast Abscess. \[III\] Endocrinal: any cause of increasing Oestrogen, Prolactin and/or Thyroid hormones.

\[IV\] Neoplastic: the neo-Vascularisation of the malignant tumors. Radiometer is a machine that can detect through its sensitive probe the microwave that radiate from the deep structures in the body.

The main aim of this study, first is to measure the sensitivity of the RTM in detecting the hot spots of different breast lesions.

The second Objective is to study the temperature patter of each disease trying to figure out a diagnostic code for the different lesions.

The tertiary objective is to combine the Echo-Dobbler in studying the hot spots in the neoplastic lesions trying to figure out an accurate protocol to early detect the malignant hot spots.

Eligibility criteria: Inclusion Criteria:

* The perfect sample should be 2000 females or more.
* 50 % already diagnosed breast cancer of any type
* 30% normal thought to be healthy females.
* 10% lactating
* 10% different breast diseases

Exclusion Criteria:

* Menstruating females.

Primary outcomes:
measure: Testing the sensitivity of the Microwave Thermography RTM-01-RES (ability to detect hotspots in breast lesions)
timeFrame: 6 months
Secondary outcomes:
measure: Study the Temperature pattern
timeFrame: 3 months
Other outcomes:
measure: The detected hotspots, to be studdied by the Echo-dobbler to see the ability of early detection of neo-Vascularisation of the malignant tumors.
timeFrame: 6 months
Locations:
city: Kota Kinabalu
country: Malaysia
facility: Poliklinik Permai Tanjumg Aru
state: Sabah
Study officials:
affiliation: Labdom Suisse
name: Dr. Alaa Abdelkarim M Mohammed Fouad, MRCGP [Int]
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03199261: A Study of Pharmacokinetic Comparison of Two Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects
Official title: The Pharmacokinetic Comparison and Bioequivalence Evaluation of Two 10-µg Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-26
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Evaluation of the pharmacokinetics and safety rE-4 Injection versus rE-4 Freeze-dried Powder in healthy subjects.

Detailed description: The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 7 days. During each session, the subjects will receive a subcutaneous single dose of rE-4 (rE-4 Injection 10µg or rE-4 Freeze-dried Powder 10µg) administered 30min prior to the start time of a standard breakfast.

Eligibility criteria: Inclusion Criteria:

* Healthy male adult volunteers of 18-45 years old, who can be inserted needle.
* Body mass index (BMI) of 19 to 26 kg/m2, inclusive BMI = weight (kg)/\[height(m)\]2，During Screening period body weight≥50 kg.
* Subjects are fully informed and voluntarily consent to participate in this study.

Exclusion Criteria:

* A positive result in hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test.
* History or presence of neurological, cardiovascular, renal, hepatic, pancreatic,gastrointestinal, pulmonary, metabolic, or musculoskeletal diseases.
* History or presence neurological disorder disease.
* Abnormal laboratory profiles, routine inspection, vitl signs and ECGs results with clinical significance.
* Participation in a clinical drug study 30 days prior to present study.
* FPG≥6.1mmol/L or \<3.9mmol/L.
* SBP\<90mmHg or \>140mmHg; DBP\>90mmHg.
* Use of any other drugs,vitamine and mineral substance.
* Blood donation more than 200 mL blood within 3 months prior to the study.
* Smoker (\>5 cigarettes/day) or alcoholist (355 ml alcohol/day).
* History or Family history of hypoglycemia.
* History of allergy or hypersensitivity.
* Subjects planning to give birth or donate sperm during the study or within 3 months after the study.
* Other unfavorable factors diagnosed by investigators.

Primary outcomes:
measure: Bioequivalency between the 2 formulations of rE-4
timeFrame: before injection and 0.25,0.5,0.75,1.0,1.5，2.0,3.0,4.0,6.0,8.0hour post-injection
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Affiliated Hospital Military Medical Sciences
Study officials:
affiliation: The Affiliated Hospital Military Medical Sciences
name: Hengyan Qu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00657761: Metabolic Effects of Enfuvirtide in Healthy Volunteers
Official title: Effect of Enfuvirtide on Lipid and Glucose Metabolism and Mitochondrial Function in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2008-04-14
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The metabolic effects of T-20 are not completely known, since the drug is used in combination with other antiretroviral agents. A short-term study in healthy volunteers, with a double-blind crossover design vs. placebo will illustrate if there may be some direct metabolic effects without the influence of HIV infection and the concurrent use of other drugs.


Eligibility criteria: Inclusion Criteria:

* Healthy adult males
* BMI between 19-24.9 kg/m2
* No active concomitant clinical conditions
* Negative HIV, HBV and HCV serologies
* Negative abuse drug urine test

Exclusion Criteria:

* Prior psychiatric illness
* Prior dyslipemia
* Alcohol consumption \> 30g/day
* Caffeine consumption \> 5 units/day
* Current smoker
* Known drug allergies
* Participation in other drug trials in the previous 3 months
* No medications in the previous 30 days

Primary outcomes:
measure: Change in fasting plasma total cholesterol
timeFrame: 6 weeks
Secondary outcomes:
measure: Changes in LDL- and HDL- cholesterol, triglycerides, oral glucose tolerance test, lactate and mt-DNA
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Neus Riba, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06509061: "I am a Physically Active Person!": A Randomized Controlled Trial Aimed to Increase Levels of Physical Activity Self-Definition and Physical Activity Among a Sample of Inactive Adults
Official title: "I am a Physically Active Person!": A Randomized Controlled Trial Aimed to Increase Levels of Physical Activity Self-Definition and Physical Activity Among a Sample of Inactive Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity Self-Definition
Physical Activity
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Research Manitoba
First posted: 2024-07-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This explanatory sequential mixed methods study investigated if an intervention can increase the physical activity identity and physical activity (PA) of inactive individuals. The intervention condition focused on increasing participant's physical activity self-definition (PASD) through educational sessions and group discussions on the five direct and indirect determinants of PASD (perceived enjoyment, perceived wanting, perceived commitment, perceived trying, perceived ability). The control condition was given general health behaviour education sessions. Researchers conducted interviews with some of the participants after the intervention was completed.


Eligibility criteria: Inclusion Criteria:

* Must be insufficiently active (\<150 minutes of moderate-vigorous PA per week)
* Scored below the mean in PASD
* Medically safe to participate in PA
* Intention to engage in PA over the next 6 weeks

Primary outcomes:
measure: Physical Activity Self-Definition
timeFrame: Measured pre-intervention, 5 weeks later at intervention end and 4 weeks post intervention
measure: ActiGraph Accelerometers
timeFrame: Measured pre-intervention, 5 weeks later at intervention end and 4 weeks post intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00614861: Pain Satisfaction Survey
Official title: A Clinical Survey on Satisfaction of Pain Management in Patients With Non-cancer Pain in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Non-cancer pain
Pain
Lead sponsor: Johnson & Johnson Taiwan Ltd
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 2929
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have visited out patient department (OPD) who are treated actively for pain

Brief summary: The purpose of this study is to survey pain management satisfaction in patients with non-cancer pain.

Detailed description: This is a multi-center, Observational study consisting of a one time survey to assess pain management satisfaction for patients with non-cancer pain. The purpose of this study is to develop a large clinical database for the results of the pain management satisfaction questionnaire. All information collected from hospitals will be used to evaluate patient satisfaction of pain management and to improve the quality of life for patients with non-cancer pain Observational study - No study drug administered

Eligibility criteria: Inclusion Criteria:

* Patients who have visited out patient department (OPD) and who are actively treated for pain

Exclusion Criteria:

* Patients with cancer pain
* Patients with known or suspected psychotic disease or mental retardation

Primary outcomes:
measure: To explore pain management satisfaction in patients with non-cancer pain in Taiwan.
timeFrame: Visit 1
Secondary outcomes:
measure: To collect the information about Quality of Life in patients with non-cancer pain
timeFrame: Visit1
measure: To collect information about medication for pain management
timeFrame: Visit1
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Taiwan Ltd
name: Johnson & Johnson Taiwan, Ltd. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT01088061: Adipose Expression of Leptin, Adiponectin and IL-6 and Plasma Levels of Adipocytokines in Women With and Without Polycystic Ovary Syndrome (PCOS)
Official title: Adipocytokines in Lean and Obese Women With and Without PCOS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Statens Serum Institut
First posted: 2010-03-17
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lean and obese women with and without PCOS, age 18-40 years.

Brief summary: The purpose of the study was to investigate adipose expression and plasma levels of different adipocytokine, which may play a role in the pathophysiology of PCOS. The investigators investigated lean and obese women with and without PCOS.


Eligibility criteria: Inclusion Criteria:

* women with PCOS according to the Rotterdam criteria

Exclusion Criteria:

* other known diseases

Primary outcomes:
measure: Adipose expression of adipocytokines
timeFrame: From February 2004 -April 2006
Secondary outcomes:
measure: Plasma levels of adipocytokines
timeFrame: From February 2004-April 2006
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital, Hvidovre
Study officials:
affiliation: Copenhagen University Hospital, Hvidovre
name: Pernille Fog Svendsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02343861: The Effectiveness of Tailored Messages on the Usage of Emollient in Patients With Atopic Dermatitis
Official title: The Effectiveness of Tailored Messages on the Usage of Emollient in Patients With Atopic Dermatitis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis, Atopic
Keywords: Behavioral Research
Emollients
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Atopic dermatitis is the most common chronic inflammatory skin disease in children and severely affects quality of life (QoL) of patients and their parents. The application of topical medications and emollient is the mainstay of the treatment, but complexity of the treatment and lack of self-care knowledge cause poor adherence, leading to therapeutic failure. Adequate education about the chronic disease and its treatment was known to improve the treatment adherence. There are a variety forms like generalized information leaflets and video clips for imparting information to patients and individualized tailoring education was considered more effective way to improve patients' adherence. The aim of this study is to determine the efficacy of tailored education in dermatology area, especially the emollient usage in patients with atopic dermatitis.


Eligibility criteria: Inclusion Criteria:

* A parent of 0-5 year old children with mild to moderate atopic dermatitis
* 20 years of age or older
* Apply emollient for themselves to their children with atopic dermatitis

Exclusion Criteria:

* Parents of children with severe atopic dermatitis or showing signs of acute infection (Oozing, vesicles, edema, redness or pain)

Primary outcomes:
measure: Change of the weekly amount of emollient used
timeFrame: Two weeks
Secondary outcomes:
measure: Average daily number of emollient usage
timeFrame: Two weeks
measure: Average daily number of topical medication (other than emollient) usage
timeFrame: Two weeks
measure: Investigator's Global Assessment (IGA)
timeFrame: Two weeks
measure: Eczema Area and Severity Index (EASI)
timeFrame: Two weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Dermatology, Seoul National University Boramae Hospital
Study officials:
affiliation: Department of Dermatology, Seoul National University Boramae Hospital
name: Hyun-Sun Yoon, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Park GY, Park HS, Cho S, Yoon HS. The Effectiveness of Tailored Education on the Usage of Moisturizers in Atopic Dermatitis: A Pilot Study. Ann Dermatol. 2017 Jun;29(3):360-362. doi: 10.5021/ad.2017.29.3.360. Epub 2017 May 11. No abstract available.