louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00306540: Use of Quetiapine as an Add on Therapy in the Treatment of Post Traumatic Stress Disorder
Official title: A Multicentre, Parallel Group, Randomised, Double Blind, Placebo Controlled Study of the Use of Quetiapine as an Add on Therapy in the Treatment of Post Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Traumatic Stress Disorder
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-03-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate how effective quetiapine versus placebo is when added to an existing therapy, in reducing the symptoms of PTSD.


Eligibility criteria: Inclusion Criteria:

* Hospitalised and non-hospitalised patients / Veteran or Civilian / Have had symptoms of PTSD for a minimum of 12 months prior to giving consent to the study

Exclusion Criteria:

* History of psychotic condition / quetiapine or other anti-psychotics not worked previously / Taking prohibited medications (mood stabilizers / substance abuse)

Primary outcomes:
measure: Clinical Administered PTSD Scale (CAPS2)
Secondary outcomes:
measure: Hamilton Depression Scale (HAM-D)
measure: Hamilton Anxiety Scale (HAM-A)
measure: Posttraumatic Stress Disorder Checklist (PCL)
measure: Clinical Global Impressions (CGI)
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Research Site
state: Queensland
city: Adelaide
country: Australia
facility: Research Site
state: South Australia
city: Melbourne
country: Australia
facility: Research Site
state: Victoria
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Australia Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00579540: Compare Effects of Flax Seed Oil, and Fish Oil on Blood Sugar Levels
Official title: CCRC: Prevention of Post-Prandial Hypoglycemia Using n-3/n-6 PUFA in PCOS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovarian Syndrome
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2007-12-24
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Flax seed oil, fish oil, and soy bean oil, are commonly recommended supplements for Polycystic Ovarian Syndrome (PCOS). These oils have different chemical structures and biological actions. It is not yet known which of these oils has the most beneficial effects in PCOS patients because they have never been compared to each other head to head. In this study the researchers hope to learn more about the effects of these oils on blood sugar and insulin levels.

Detailed description: The aim is to investigate whether n-3 PUFA's can be used to prevent postprandial hypoglycemia and its unfavorable consequences, such as stimulation of cortisol and adrenal androgen secretion, in women with polycystic ovarian syndrome.

Eligibility criteria: Inclusion Criteria:

* Females ages 18-45
* Women who are overweight, and have irregular periods or have been diagnosed with Polycystic Ovarian Syndrome

Exclusion Criteria:

* Use of oral contraceptives
* Impaired glucose tolerance
* Diabetes mellitus, and any other systemic illnesses such as renal, hepatic, gastrointestinal, severe hyperlipidemia and hypertension that require medication
* Schizophrenia
* Having a pacemaker
* Current viral infection
* Smoking alcohol intake (more than 2 drinks/week)

Primary outcomes:
measure: We hope to learn more about the effects of fish oil, flax seed oil, and soybean oil, on blood sugar and insulin levels in PCOS patients
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis
state: California
Study officials:
affiliation: UC Davis
name: Sidika Kasim-Karakas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01802840: Soy Fiber Improves Weight Loss and Lipid Profile
Official title: Soy Fiber Improves Weight Loss And Lipid Profile In Overweight And Obese Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Weight Loss
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 39
Sex: ALL
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to examine the effects of soy fiber on body weight, body composition and blood lipids in overweight and obese participants.

Detailed description: Thirty nine overweight and obese college adults (19-39 y of age) were randomly assigned to consume control biscuits or biscuits supplemented with soy fiber for 12 wk (approximately 100g/d). Information on body weight, body mass index, waist/hip circumference, blood pressure as well as measures of lipoprotein, glucose concentrations, and HbA1c was obtained at baseline, 8 and 12 wk after intervention. Body composition was also assessed at baseline and wk 12, respectively.

Eligibility criteria: Inclusion Criteria:

* BMI of 23-35 kg/m2

Exclusion Criteria:

* Subjects taking any drugs, botanicals or nutraceutical known to influence body weight or blood pressure
* significant history of eating disorders
* strenuous exercise to lose weight
* lipid-lowering medication
* use of steroids and other agents that may influence lipid metabolism
* hyperlipidemia
* hyperglycemia
* diabetes mellitus
* cardiovascular disease
* major systemic diseases
* gastrointestinal problems
* liver and renal failure

Primary outcomes:
measure: weight loss
timeFrame: 12 weeks
Secondary outcomes:
measure: serum levels of total cholesterol
timeFrame: 12 weeks
measure: serum levels of low density lipoprotein cholesterol
timeFrame: 12 weeks
measure: body fat
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Duo Li, Prof.
role: STUDY_DIRECTOR
References:
citation: Maki KC, Beiseigel JM, Jonnalagadda SS, Gugger CK, Reeves MS, Farmer MV, Kaden VN, Rains TM. Whole-grain ready-to-eat oat cereal, as part of a dietary program for weight loss, reduces low-density lipoprotein cholesterol in adults with overweight and obesity more than a dietary program including low-fiber control foods. J Am Diet Assoc. 2010 Feb;110(2):205-14. doi: 10.1016/j.jada.2009.10.037.
citation: Ludwig DS, Pereira MA, Kroenke CH, Hilner JE, Van Horn L, Slattery ML, Jacobs DR Jr. Dietary fiber, weight gain, and cardiovascular disease risk factors in young adults. JAMA. 1999 Oct 27;282(16):1539-46. doi: 10.1001/jama.282.16.1539.
citation: Hu X, Gao J, Zhang Q, Fu Y, Li K, Zhu S, Li D. Soy fiber improves weight loss and lipid profile in overweight and obese adults: a randomized controlled trial. Mol Nutr Food Res. 2013 Dec;57(12):2147-54. doi: 10.1002/mnfr.201300159. Epub 2013 Jul 23.
Clinical trial NCT06997640: Comparative Analysis of DS and NMT on Pelvic Inclination in Early Middle-Aged Patients With Radicular Low Back Pain
Official title: Comparative Analysis of Dynamic Stretching and Neural Mobilization Techniques on Pelvic Inclination in Early Middle-Aged Patients With Radicular Low Back Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Radicular low back pain (RLBP) is a common and debilitating condition characterized by nerve root irritation or compression, often resulting in altered biomechanics, muscular imbalances, and postural deviations such as anterior pelvic tilt.

Detailed description: Rehabilitation strategies commonly focus on improving flexibility, neuromuscular control, and nerve mobility. Among these, dynamic stretching and neural mobilization techniques have shown individual effectiveness, but limited evidence exists on their comparative or combined effects on pelvic alignment and functional outcomes, particularly in early middle-aged adults. Addressing this gap could support the development of more targeted, evidence-based rehabilitation protocols.

Eligibility criteria: Inclusion Criteria:

* Both Male and Female
* Early middle-aged adults (aged 35-55 years)
* Diagnosed with radicular low back pain (RLBP) lasting more than 4 weeks
* Positive Straight Leg Raise (SLR) or Slump test
* Able to participate in physical therapy sessions 3 times/week(26)

Exclusion Criteria:

* History of spinal surgery or fractures
* Severe neurological deficits (e.g., foot drop, bladder/bowel dysfunction)
* Diagnosed with inflammatory or systemic conditions (e.g., ankylosing spondylitis, rheumatoid arthritis)
* Concurrent participation in other physical therapy programs
* Pregnant women or individuals with severe cardiovascular conditions

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 12 Months
measure: Modified Schober Test
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: Pakistan
facility: Private clinic Hyderabad Sindh
state: Sindh
Study officials:
References:
Clinical trial NCT05410340: EEG and NIRS in Preterm Infants
Official title: Brain Activation and Oxygenation Through Reflex Locomotion Therapy (Vojta) and Massage in Preterm Infants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premature Birth
Keywords: Preterm
Premature
Infant
Baby
Child
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 80
Sex: ALL
Minimum age (years): 7
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Experimental cross-sectional study of a single application (vojta therapy or massage) in preterm and non-preterm infants to test whether there are differences in brain activation and oxygenation that occur with both techniques between term and preterm infants.

Secondly, the brain activation and oxygenation produced by both physiotherapy techniques will be tested separately to establish comparisons between the two groups.

Finally, between 3 - 6 months, we will analyse whether there are changes in gaze fixation (eye tracker) in the 4 study arms to see if there are differences between term and preterm infants but also the differences between the immediate effectiveness of both techniques.


Eligibility criteria: Inclusion Criteria:

* term and preterm babys
* first month after birth

Exclusion Criteria:

* intrumental delivery
* pathology associated

Primary outcomes:
measure: EEG (Alpha, Beta, Theta)
timeFrame: Change from Baseline brain activation at 3 months
measure: NIRS
timeFrame: Change from Baseline brain oxigenation at 3 months
Secondary outcomes:
measure: Eye tracker
timeFrame: Change from Baseline gaze fization at 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03100240: The Mechanism of Modified Utral-long Protocol in Improving Endometrial Receptivity in Patients With PCOS and IR
Official title: The Preliminary Mechanism Study of Modified Utral-long Protocol in Improving Endometrial Receptivity in Patients With PCOS and Insulin Resistance
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: PCOS
Lead sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 6
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: NF-κB pathway activation-induced endometrial insulin resistance was one of the causes of infertility patients with PCOS and insulin resistance whose endometrial receptivity is declined .The investigators' previous findings indicated that the use of modified utral-long protocols ( GnRH-a was used twice in mid-luteal phaes) can improve clinical outcomes by improving endometrial receptivity in patients with PCOS , but the mechanism was not clear. Previous research also found that GnRH-a reduced the activity of NF-κB pathway in endometrial stromal cells and depended the dose and time.Thus, The investigators' subject will try to applicate GnRH-a to explore the influence of NF-κB pathway activity 、the state of insulin resistance and embryo implantation rate ;then we will investgate GnRH-a whether reduce NF-κB pathway activity-induced insulin resistance and ultimately improve endometrial receptivity by using GnRH-a in infertility patients with PCOS and insulin resistance.The investigators' research attempt to provide ideas for seeking inflammatory medication target in assisted reproductive technology in patients with PCOS by exploring the immune mechanism of GnRHa on improving the endometrial receptivity .

Detailed description: The endometrial biopsy was performed in the previous cycle of the protocol. According to the expression of NF-κB in the endometrium random group. The difference of NF - κB expression in patients with different protocol were compared.

Eligibility criteria: Inclusion Criteria:

* age\<36years,
* PCOS,
* Insulin resistance (HOMA-IR = fasting insulin (FINS) × fasting blood glucose (FPG) / 22.5, HOMA-IR ≥ 2.69 ）;

Exclusion Criteria:

* uterine abnormalities (double uterus, bicornuate uterus, unicornuate uterus and uterine mediastinum),
* intrauterine adhesions,
* endometriosis, adenomyosis,
* Hydrosalpinx,
* uterine fibroids (submucosal fibroids, non-mucosal fibroids \> 4 cm and / or endometrial pressure),
* Hyroid dysfunction and hyperprolactinemia.

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 28 days after transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Reproductive & Genetic Hospital of CITIC-XIANGYA
state: Hunan
Study officials:
References:
Clinical trial NCT02777840: High Flow Oxygen With THRIVE Gives Better Oxygenation in Rapid Sequence Induction Patients
Official title: High Flow Oxygen With THRIVE Gives Better Oxygenation in Rapid Sequence Induction Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High Flow Oxygen in Rapid Sequence Induction
Airway Morbidity
Lead sponsor: St George's, University of London
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: High flow oxygen results in better oxygenation in emergency cases needing rapid sequence induction for anaesthesia. Secondary outcome measure is time for any desaturation.

Detailed description: The investigators intend to do the study using high flow oxygen for all emergency cases needing rapid sequence induction. As part of the study the Investigators will measure the oxygen levels in the blood gas sample of the patient and the heart rate of anesthetist in charge of the airway management. After the airway is secured the time for desaturation will be noted.

Eligibility criteria: Inclusion Criteria:

* Emergency patients needing rapid sequence induction for surgery
* ≥ 16 years
* Able to give consent

Exclusion Criteria:

* Patients age under 16 years
* Inability to give consent
* Severe respiratory disease

Primary outcomes:
measure: Oxygen levels in blood gas sample
timeFrame: intraoperative
Secondary outcomes:
measure: time to desaturation
timeFrame: intraoperative or 10 minutes after intubation
measure: heart rate of anaesthetist performing the intubation
timeFrame: During the process of induction of anaesthesia and intubation upto 5 minutes post intubation
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Georges Hospital NHS Trust
Study officials:
affiliation: St Georges hospital NHS trust
name: Fauzia Mir
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01224340: Active and Passive Distraction in Children Undergoing Wound Dressings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Minor Trauma
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The hypothesis was that an active distraction is more effective than a passive distraction in conjunction with procedural pain in children. The specific aim in this study was to test how an active distraction, serious gaming and a passive distraction, the use of lollipops influence pain, distress and anxiety in children during wound care.


Eligibility criteria: Inclusion Criteria:

Children aged five to twelve were recruited from the pediatric day care unit at the Queen Silvia Children's hospital, Gothenburg, Sweden. Included children had wounds that differed in size and location but were too extensive to be handled in a primary care setting. The wound dressing procedures were standardized and the pain experiences were expected to be similar in all included children.

Exclusion Criteria:

Children with longstanding wounds, care-related pressure wounds, and wounds in body areas with decreased sensitivity were excluded from this study.Children with cognitive impairments were excluded from the study, as were children or parents who did not have a good command of Swedish.

Primary outcomes:
measure: Self-reported pain intensity is measured on a Coloured Analogue Scale
timeFrame: Primary outcome, i.e. pain intensity during the wound dressing, is recorded after one wound dressing, an average time on 20 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: The Queen Silvia Children's Hospital, Sahlgrenska University Hospital
Study officials:
References:
Clinical trial NCT04930640: The Efficacy and Safety of SGF200 on Immune Enhancement
Official title: A 8 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of SGF200 on Immune Enhancement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunity
Keywords: SGF200
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was conducted to investigate the efficacy and safety of SGF200 on immune enhancement.

Detailed description: This study was a 8 weeks, randomized, double-blind, placebo-controlled human trial. 100 subjects were randomly divided into SGF200 group or placebo group. The investigators measured Natural Killer cell activity, Cytokines(IL-2, IL-12, IFN-γ, TNF-α), questionnaire scores of upper airway infection.

Eligibility criteria: Inclusion Criteria:

* Adult men and women over 50 years
* After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice

Exclusion Criteria:

* If screening shows that the white blood cell(WBC) is less than 3000/㎕ or more than 8000/㎕
* Those who received influenza vaccination within 3 months before first intake for test product
* Those who have a body mass index(BMI) of less than 18.5 kg / m\^2 or greater than 35 kg / m\^2 at the screening
* Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic
* Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
* Those who have received antipsychotic medication within 3 months before screening
* Those who alcoholic or drug abuse suspected
* Those who participated in other clinical trials within 3 months before screening
* Laboratory test by show the following results

  * Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
  * Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breast feeding
* Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.

Primary outcomes:
measure: Changes of Natural Killer cell activity
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes of Cytokines
timeFrame: 8 weeks
measure: Changes of Wisconsin Upper Respiratory Symptom Survey-21
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
Clinical trial NCT06151340: Delayed Language Development in Children With Cleft Palate at Sohag University Hospital
Official title: Delayed Language Development in Children With Cleft Palate at Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delayed Language in Cleft Palate
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 150
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cleft palate children

Brief summary: This is a retrospective study on children with cleft palate who came to the multidisciplinary cleft clinic at Sohag University Hospital from September 2017 to September 2023


Eligibility criteria: Inclusion Criteria:

* cleft palate children's

Exclusion Criteria:

* cleft lip only

Primary outcomes:
measure: Correlation analysis between IQ with degree of delayed language in children with cleft palate (CCP).
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Hadeel Ezeldin Mohamed
Study officials:
References: