louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01154894: Dietary Fatty Acids Improve Social Impairment in Autism Spectrum Disorders
Official title: Double-blind Randomized Placebo-controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorders
Keywords: arachidonic acid
autism spectrum disorders
social interaction
randomized controlled trial
DHA
Lead sponsor: Ashiya University
Sponsor class: OTHER
First posted: 2010-07-01
Enrollment: 13
Sex: ALL
Minimum age (years): 6
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In a double-blind, placebo-controlled 16-week trial investigators administered daily doses of either youths with autism spectrum disorders.ARA and DHA supplementation significantly improved communication as well as social withdrawal symptoms. This pilot study provides the first evidence that supplementation with larger ARA doses added to DHA improve impaired social interaction in youths with Autism Spectrum Disorders (ASD).

Detailed description: We recruited 13 individuals who met the DSM-IV criteria for a diagnosis of high functioning autistic disorder (n=1) or Asperger's Disorder (n=12),corroborated by the Autism Diagnostic Interview-Revised. Participants were free of any medical or comorbid psychiatric disorders. Other inclusion criteria included weigh of at least 16 kg, either a verbal or performance intelligence quotient (IQ) above 80, and a score greater than 10 on the social withdrawal subscale of the Aberrant Behavior Checklist-Community.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of high functioning autistic disorder or Asperger's Disorder. Free of any medical or comorbid psychiatric disorders.

Exclusion Criteria:

* Any medical treatment for other psychiatric disorders

Primary outcomes:
measure: Aberrant Behavior Checklist-community (ABC)
timeFrame: Pretreatment and at 4 weeks after intervention for 16-weeks trial
Secondary outcomes:
measure: Social Responsiveness Scale (SRS)
timeFrame: pretreatment and at 4 weeks after intervention for 16-weeks trial
Other outcomes:
Locations:
Study officials:
References:
citation: Yui K, Koshiba M, Nakamura S, Kobayashi Y. Effects of large doses of arachidonic acid added to docosahexaenoic acid on social impairment in individuals with autism spectrum disorders: a double-blind, placebo-controlled, randomized trial. J Clin Psychopharmacol. 2012 Apr;32(2):200-6. doi: 10.1097/JCP.0b013e3182485791.
Clinical trial NCT03467594: BE@Work: Brief Exercise at Work
Official title: BE@Work: A Pilot Controlled Before and After Trial of a Workplace Physical Activity Programme.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High-intensity Interval Training
Lead sponsor: Teesside University
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: BE@Work (Brief Exercise at Work) is a pilot controlled before and after trial of a workplace physical activity programme.

Detailed description: The aim of this study is to investigate the effect of an 8 week workplace physical activity programme on various markers of physical fitness, cardiometabolic health and wellbeing of employees. The primary outcome measures are the following: aerobic fitness, grip strength, leg extensor power, blood pressure, fasting blood glucose levels, lipid profiles, body mass index, waist and hip circumference and self-report measures of psychological wellbeing. The secondary outcome measure is total physical activity. The primary and secondary outcomes measures will be assessed in the control and intervention groups at baseline and at the end of the intervention (8 weeks).

Eligibility criteria: Inclusion Criteria:

* Participants will be adult (≥18 years) with no health conditions that preclude them from exercise (information obtained via their self-report) and able to understand written and spoken English. Participants will be cleared for exercise participation via the Physical Activity Readiness Questionnaire Plus (PARQ+)

Exclusion Criteria:

* Exclusion criteria are: Individuals who are not cleared for exercise participation via the PARQ+ will not be eligible to participate. Additionally those unable or unwilling to give informed consent, have any diagnosis or symptoms of cardiovascular or metabolic disease (such as history of heart attack, stroke or diabetes), have been advised by a health professional to avoid physical exercise or activity, are pregnant or might be pregnant and cannot understand and speak English will not be eligible to participate.

Primary outcomes:
measure: Aerobic fitness
timeFrame: 8 weeks
measure: Alternative measure of aerobic fitness
timeFrame: 8 weeks
measure: Hand grip strength
timeFrame: 8 weeks
measure: Leg extensor power
timeFrame: 8 weeks
measure: Resting blood pressure
timeFrame: 8 weeks
measure: Blood lipid concentration
timeFrame: 8 weeks
measure: Body Mass Index
timeFrame: 8 weeks
measure: Health related quality of life
timeFrame: 8 weeks
measure: Mental wellbeing
timeFrame: 8 weeks
measure: Stress
timeFrame: 8 weeks
measure: Blood glucose concentration
timeFrame: 8 weeks
measure: Waist circumference
timeFrame: 8 weeks
Secondary outcomes:
measure: Accelerometer assessed habitual physical activity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: Teesside University
Study officials:
References:
Clinical trial NCT00708994: Cannabinoids, Neural Synchrony, and Information Processing
Official title: Cannabinoids, Psychosis, Neural Synchrony, and Information Processing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cannabis
Psychotic Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-07-03
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study examines the effects of delta-9-tetrahydrocannabinol (Δ9-THC), the principal active ingredient of cannabis, on neural synchrony. Neural synchrony is studied using electroencephalography (EEG).


Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 and 55 years (extremes included) on the day of the first dosing.
* Exposed to cannabis at least once.

Exclusion Criteria:

1. Cannabis naïve
2. Positive pregnancy screen during screening
3. Hearing deficits

Primary outcomes:
measure: EEG
timeFrame: +30
measure: Clinician Administered Dissociative Symptoms Scale, Positive and Negative Symptom Scale, Visual Analog Scale
timeFrame: Baseline, +10, +80
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University Medical School
name: Deepak D'Souza, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ranganathan M, Radhakrishnan R, Addy PH, Schnakenberg-Martin AM, Williams AH, Carbuto M, Elander J, Pittman B, Andrew Sewell R, Skosnik PD, D'Souza DC. Tetrahydrocannabinol (THC) impairs encoding but not retrieval of verbal information. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Oct 3;79(Pt B):176-183. doi: 10.1016/j.pnpbp.2017.06.019. Epub 2017 Jun 20.
Clinical trial NCT03146494: The Role of Thyroid Function in the Development and Prognosis of Stanford Type A Aortic Dissection.
Official title: The Role of Thyroid Function in the Development and Prognosis of Stanford Type A Aortic Dissection.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stanford Type A Aortic Dissection
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 300 consecutive cardiac patients will receive preoperative thyroid function profile evaluation, including 150 patients with Standford type A aortic dissection (STAAD) and 150 normal human.

Brief summary: A total of 300 consecutive cardiac patients will receive preoperative thyroid function profile evaluation, including 150 patients with Standford type A aortic dissection (STAAD) and 150 normal human.For one thing, we will compare the two groups and study the role of thyroid function in the develoment of STAAD. For another, we will collect all the perioperative data of the STAAD group and study the role of thyroid function in the prognosis of STAAD.


Eligibility criteria: Inclusion Criteria:

Adult patients with STAAD will underwent aortic surgery who are willing and able to give informed consent for participation in the study.

Exclusion Criteria:

The main initial exclusion criteria included clinical evidence of sepsis or cachexia or concomitant presence of any predominant severe systemic disease.

Primary outcomes:
measure: The Role of Thyroid Function in the Development of STAAD.
timeFrame: 30 days
measure: The Role of Thyroid Function in the Prognosis of STAAD.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Wenjian Jiang
state: Beijing
Study officials:
References:
Clinical trial NCT06647394: Efficacy of Application of Myriad Matrix to Split Thickness Skin Graft Sites
Official title: Efficacy of Application of Myriad Matrix to Split Thickness Skin Graft Sites
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Skin Grafts
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing a split thickness skin graft

Brief summary: To determine if application of Myriad Matrix to split thickness skin graft donor sites improves post-operative pain and appearance of the wound.

Detailed description: In the head and neck practice at UAB, split thickness skin grafts are a commonly used procedure for simple reconstruction. The standard dressing for donor sites is a strip of vaseline gauze which remains on the site the wound dries, and the gauze eventually falls off. Post operative pain and poor wound healing is a well established complication of the donor site, and various methods have been studied in an attempt to reduce these complications for patients in the post operative period. (1, 2, 3)

Myriad matrix is an engineered extracellular matrix (Ovine Forestomach Matrix) used for soft issue repair in complex wounds. This has been sporadically used by some of the faculty members at UAB for split thickness skin graft donor site dressings with anectodal improvement in pain and healing, though this has not yet been studied to our knowledge.

Eligibility criteria: Inclusion Criteria:

* Patients 18 and over who are undergoing a split thickness skin graft at UAB.

Exclusion Criteria:

* Patients who are not planned to undergo a split thickness skin graft or who are unable or do not plan to attend follow up appointments will not be included.

Primary outcomes:
measure: Pain Improvement
timeFrame: 48 hours, 2 weeks, 4-6 weeks post operative visit
measure: Wound Healing
timeFrame: 2 weeks and 4-6 weeks post operative visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00749294: Anogenital Wart Burden and Cost of Illnesses
Official title: Measurement of Anogenital Wart Burden, and Cost of Illnesses in Bangkok
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Warts
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2008-09-09
Enrollment: 150
Sex: ALL
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: Patients presenting with anogenital warts, conducted at Rajavithi General Hospital and Bangrak Hospital

Brief summary: The study will be a prospective study of patients presenting with anogenital warts. The objective are to assess proportion of anogenital warts to the total number of sexual transmitted infection patients, to quantify direct and indirect cost of illnesses and psychological burden associated with anogenital warts and to estimate government program expenditure for the prevention and control and treatment of the STI/anogenital HPV infection.

Detailed description: An observational study, multiple visit, 2-center study will be conducted in Rajavithi General Hospital, and Bangrak Hospital. One hundred and fifty subjects will be enrolled from both hospitals. Anogenital wart patients presented in Rajavithi General Hospital and the STI clinic at Bangrak Hospital will be recruited prospectively. All patients will be treated according to standard medical guidelines or usual care of the institutes. After the baseline assessment, the patients will have follow up visits with their physicians and will also be interviewed at the clinical sites three time approximately at day 7 (-2+7 days), month 1 (+-7 days), and month 6 (+-7 days) until they are cure. At month 6 (+-14 days), telephone assessment for the capture of any signs of disease recurrence will be done. All patients will be followed for 6 months under the same schedule.

Eligibility criteria: Inclusion Criteria:

* Subject is 18 years of age or older and has anogenital warts
* Physician confirmed clinical diagnosis of anogenital warts
* Subject is capable of understanding the study and the content of the consent form and has agreed to participate in the study by signing the informed consent
* Subject will be available for the study follow up period

Exclusion Criteria:

* Subject is unable to give informed consent
* Subject has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives such as other concurrent/active STI

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Clinical Infectious Diseases Research Unit
Study officials:
affiliation: Mahidol University
name: Prof. Punnee Pitisuttithum, M.B.,B.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01786694: Feasibility of Microdialysis by Laparoscopy
Official title: Feasibility of Microdialysis by Laparoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rectal Cancer
Keywords: rectum
microdialysis
quality of life
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2013-02-08
Enrollment: 11
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: The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in order to identify anastomotic leaks after rectal surgery.


Eligibility criteria: Inclusion Criteria:

* rectal disease requiring proctectomy with anastomosis and stomy
* proctectomy by laparoscopy
* written consent

Exclusion Criteria:

* history of colorectal surgery
* rectal surgery without anastomosis
* breastfeeding or pregnancy
* ASA score IV

Primary outcomes:
measure: functional success of microdialysis
timeFrame: postoperative day 5
Secondary outcomes:
measure: anastomotic leaks rate
timeFrame: postoperative day 30
measure: superficial surgical site infection rate
timeFrame: postoperative day 30
measure: the mortality rate
timeFrame: postoperative day 30
measure: the quality of life after the surgery
timeFrame: postoperative day 30
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
Study officials:
affiliation: CHU amiens
name: jean marc regimbeau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hogberg N, Carlsson PO, Hillered L, Meurling S, Stenback A. Intestinal ischemia measured by intraluminal microdialysis. Scand J Clin Lab Invest. 2012 Feb;72(1):59-66. doi: 10.3109/00365513.2011.629307. Epub 2011 Nov 21.
citation: Deeba S, Corcoles EP, Hanna GB, Pareskevas P, Aziz O, Boutelle MG, Darzi A. Use of rapid sampling microdialysis for intraoperative monitoring of bowel ischemia. Dis Colon Rectum. 2008 Sep;51(9):1408-13. doi: 10.1007/s10350-008-9375-4. Epub 2008 May 24.
citation: Verdant CL, Chierego M, De Moor V, Chamlou R, Creteur J, de Dieu Mutijima J, Loi P, Gelin M, Gullo A, Vincent JL, De Backer D. Prediction of postoperative complications after urgent laparotomy by intraperitoneal microdialysis: A pilot study. Ann Surg. 2006 Dec;244(6):994-1002. doi: 10.1097/01.sla.0000225092.45734.e6.
Clinical trial NCT03178994: The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne
Official title: The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post - Adolescence Acne
Keywords: Post - adolescence acne
Topical 2% ketoconazole cream
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 42
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study efficacy (total numbers of acne reduction) and safety of 2% Ketoconazole cream in Thai females with Mild degree Post-Adolescence acne comparing with placebo for a period of 12 weeks.


Eligibility criteria: Inclusion Criteria:

* regular menstrual cycle with mild degree of post - adolescence acne
* agree to stop topical and systemic medication for acne treatment for 2 and 4 weeks respectively.

Exclusion Criteria:

* Pregnancy or lactation
* Other active rashes on faces.
* Allergic to ketoconazole or other ingredients of preparation.
* Signs of hyperandrogenism
* Taking anti-androgenic medications.

Primary outcomes:
measure: Total numbers of acne reduction
timeFrame: 10 weeks
Secondary outcomes:
measure: Proportion of patients who achieve clear or almost clear after treatment
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Medicine, Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Chanat Kumtornrut, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00073294: Insulin Resistance and Insulin Secretion
Official title: Phenotypic Assessment of Insulin Resistance and Insulin Secretory Capacity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-11-20
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a pilot study to examine the prevalence of metabolic risk factors (impaired insulin release and impaired insulin sensitivity) for type 2 diabetes mellitus in children and adults from a population that is at high risk for this disease. We hypothesize that at least one of these pre-diabetic traits will be evident in a large proportion of relatives of known type 2 diabetic children as compared to a control group of subjects without a family history of type 2 diabetes. By isolating these traits, it will be possible to determine the relative contributions of genes and environment to each trait and to identify those at risk for subsequent development of type 2 diabetes by virtue of having one trait. Ultimately, those individuals at risk, especially those with impaired insulin release, would hopefully benefit from intervention to prevent the weight gain that will 'unmask' their underlying pancreatic dysfunction and thus prevent or retard the development of type 2 diabetes.


Eligibility criteria: Ascertainment criteria for probands:

* age 10-20 years and
* obesity (BMI \>85% for sex and age)
* diabetic criteria as described above or family history (first or second degree relative) with type 2 diabetes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia Presbyterian Medical Center/ Irving Center
state: New York
city: New York
country: United States
facility: Russ Berrie Pavilion
state: New York
Study officials:
References:
Clinical trial NCT06088394: Effect of Acupuncture Augmented With Pelvic Floor Exercises on Overactive Bladder
Official title: Effect of Pelvic Floor Exercises Versus Pelvic Floor Exercises and Acupuncture on Overactive Bladder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overactive Bladder Syndrome
Keywords: pelvic floor exercises and acupuncture
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pelvic floor exercises and acupuncture
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of pelvic floor exercises augmented with acupuncture on overactive bladder

Detailed description: Overactive bladder syndrome (OAB) is a common complaint affecting 11.8% of the population. OAB is defined by the International Continence Society as "urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology."Urinary frequency accompanies OAB in 20%-25% of cases, and nocturia is present in 70%-75% of cases. Around one in three people with OAB also experience urinary incontinence. . OAB can be further categorized into "OAB-dry" (urinary incontinence is absent) and "OAB-wet" (urinary incontinence is present). 2 OAB is a long-term condition that reduces quality of life, leading to anxiety and depression and a negative effect on self-esteem.

Pelvic floor exercises and acupuncture play an important role in overactive bladder.This trial has 2 groupes ,one will recieve pelvic floor exercises augmented with acupuncture ,the second will recive pelvic floor exercises only for 12weeks.

Eligibility criteria: Inclusion Criteria:

Patients with a clinical diagnosis of idiopathic OAB syndrome. Willingness to take part in the study protocol. Ability to complete outcome measures. Ability to give informed consent. Acupuncture not contra-indicated. Age:50-60 years. Vaginal delivery.

-Parity:2-3times. Body mass index \<35kg/m2.

Exclusion Criteria:

* - Evidence of other pathology that may be contributing to OAB symptoms i.e., urinary tract infection or a neurological condition.
* Smoking.
* Taking sedative and hypnotic drugs.

Primary outcomes:
measure: Modified Oxford scale
timeFrame: 12 weeks
Secondary outcomes:
measure: patient perception of intensity and urgency scale (PPIUS)
timeFrame: 12 WEEKS
Other outcomes:
measure: 8 Items overative bladder questionnaire
timeFrame: 12 weeks
measure: 3days bladder diary test
timeFrame: 12 weeks
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy
Study officials:
affiliation: faculty of physical therapy
name: cairo U Egypt
role: STUDY_CHAIR
References: