louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00098241: Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients
Official title: Multicenter Trial of the Safety & Efficacy of Certican in Pediatric de Novo Renal Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Keywords: pediatric
renal
transplant recipients
de novo
De novo renal pediatric transplant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-06
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of RAD001 (Certican) administered to pediatric renal transplant recipients, and to provide additional safety data.


Eligibility criteria: Inclusion Criteria:

* Male and female patients no more than 16 years of age.
* Patients receiving a primary cadaveric or non-HLA identical living donor (related or unrelated) renal transplant.
* The graft must be functional within 48 hours post transplantation.

Exclusion Criteria:

* Cold ischemia time greater than 40 hours.
* Patients who are recipients of multiple solid organ transplants, including dual and en bloc kidneys, or who have previously received transplanted organs.
* Patients with panel reactive T cell antibodies of 50 % or higher at the last assessment before transplantation.

Primary outcomes:
measure: Safety and tolerability at 6 and 12 Months as measured by adverse events, laboratory abnormalities and infections.
Secondary outcomes:
measure: Efficacy at 6 and 12 Months as measured by rejection, graft loss, death and loss to follow up.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Columbus Children's Hospital
state: Ohio
city: Leuven
country: Belgium
facility: Dienst Pediatrie UZ Gasthuisberg, Herestraat 49
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Ettenger RB, Grimm EM. Safety and efficacy of TOR inhibitors in pediatric renal transplant recipients. Am J Kidney Dis. 2001 Oct;38(4 Suppl 2):S22-8. doi: 10.1053/ajkd.2001.27838.
Clinical trial NCT06925841: Psychosocial Effects of Coloring in Preeclamptic Pregnant Women
Official title: The Effect of Mother-Baby Themed Coloring on Stress, Anxiety, and Psychosocial Health in Pregnant Women Diagnosed With Preeclampsia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia
Anxiety
Pregnancy
Stress
Keywords: preeclampsia
anxiety
pregnancy
mandala
stress
cortisol
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
Collaborators: name: necmettin erbakan university Scientific Research Projects (BAP)
First posted: 2025-04-13
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with intervention group and control group
Primary purpose: OTHER

Brief summary: Preeclampsia is one of the major causes of maternal and neonatal mortality and morbidity, affecting approximately 3-5% of pregnancies. A diagnosis of preeclampsia may lead to psychological problems such as psychosocial distress, depression, and anxiety due to prolonged hospitalization, concerns about the future health of the baby, separation from family, and adapting to a foreign environment. Health professionals play a crucial role in the diagnosis, treatment, and care of high-risk pregnancies and also implement non-pharmacological supportive methods such as yoga, progressive muscle relaxation, and mindfulness. One of these non-pharmacological methods is mandala. According to the literature, integrating mandala coloring into perinatal care is believed to have beneficial effects.

Therefore, the primary aim of this study is to investigate the effects of mother-baby themed coloring on anxiety. The secondary aim is to determine its effects on psychosocial health and cortisol levels.

H1a: Is there a difference between anxiety scores in preeclamptic pregnant women who were and were not exposed to dyeing activity?

H1b: Is there a difference between psychosocial health scores in preeclamptic pregnant women who were and were not exposed to dyeing activity?

H1c: Is there a difference between cortisol levels in preeclamptic pregnant women who were and were not exposed to dyeing activity?


Eligibility criteria: Inclusion Criteria:

* Having a single and healthy fetus
* Gestational age ≥ 20 weeks
* Diagnosed with preeclampsia by a physician
* Not having a history of treated pregnancy

Exclusion Criteria:

* Using psychiatric medication (self-report)
* Receiving psychological counseling during the intervention
* Diagnosed with severe preeclampsia

Primary outcomes:
measure: Anxiety
timeFrame: nine months
Secondary outcomes:
measure: Psychosocial health
timeFrame: nine months
measure: Cortisol
timeFrame: nine months
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
Study officials:
affiliation: Necmettin Erbakan University
name: Kamile Altuntuğ, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05404841: Investigating the Effect of Whole-fruit Coffee Extract on Exercise Performance
Official title: Investigating the Effect of Whole-fruit Coffee Extract on Exercise Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caffine and Endurance Performance
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: VDF FutureCeuticals Inc.
First posted: 2022-06-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Caffeine is a widely used efficacious supplement by both the general public, and athletes, with the goal of improving performance. The effects of caffeine alone are well known, but it is not clear whether a multi-ingredient supplement (containing both caffeine and polyphenols) can affect exercise performance.

This study aims to determine if a low dose of caffeine, in the form of a whole-fruit coffee extract also containing polyphenols, can improve exercise performance compared to a placebo condition, with a secondary objective of identifying if this supplement can improve post exercise refuelling (glycogen resynthesis).

Participants will consume either the supplement or a placebo before engaging in an exercise protocol. Muscle biopsies will then be obtained so as to measure subsequent glycogen resynthesis, with multiple blood samples being taken through the day. The following morning another biopsy will be taken before the exercise protocol will be repeated.

This research will inform us of the efficacy of caffeine and polyphenols on improving exercise performance.


Eligibility criteria: Exclusion criteria:

* Allergy to Lidocaine
* Exclusion critera
* Any diagnosed metabolic health condition
* Pregnant
* Non-habitual caffeine intake
* Smoker
* No endurance training
* Diagnosed Cardiovascular disease
* Beta-Blockers
* Recent history of musculoskeletal injury

Inclusion criteria:

* Age 18-40
* Heathy
* Highly trained endurance athletes (V̇O2max: males \>55 and females \>50 mL⋅kg bm-1⋅min-1)
* Both males and females are allowed to participate. If females are on the oral contraceptive pill they are to be tested on consecutive weeks. If they are not on the oral contraceptive pill, then female subjects are to be tested every 4 weeks, at the same point of their menstrual cycle.

Primary outcomes:
measure: Exercise performance
timeFrame: 15 Minitues
Secondary outcomes:
measure: Glycogen Resynthesis
timeFrame: 24 Hours
measure: Alertness
timeFrame: 1 Minitue
measure: Motivation
timeFrame: 1 Minitue
measure: Rate of perceived exertion
timeFrame: 1 Minitue
measure: Urine osmolarity
timeFrame: 24 Hours
measure: GI comfort
timeFrame: 1 Minitue
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Sport & Health Sciences University of Exeter
state: Devon
city: Exeter
country: United Kingdom
facility: University of Exeter
Study officials:
References:
Clinical trial NCT02854241: Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging for HCC Surveillance
Official title: Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging as a Surveillance Test for HCC in Patients With Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cirrhosis
Hepatocellular Carcinoma
Keywords: MRI
HCC
surveillance
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography.

Detailed description: The purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography. In addition, the relationship between non-contrast MR parameters and clinical manifestation of liver function is investigated.

Eligibility criteria: Inclusion Criteria:

* equal to or older than 40 years
* under surveillance using biannual ultrasonography (USG) and presence of liver USG within 6 months (+/- 1month)
* risk index is equal to or higher than 2.33 (Risk Index = 1.65 (if the prothrombin activity is \<=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is \<=100x10(3)/mm3) + 0.74 (if the presence of HCV or HBsAg is positive)).
* signed informed consent

Exclusion Criteria:

* under 40 years
* history of HCC
* patients with pregnancy or nursing
* any contraindication of MRI
* any contraindication of CT

Primary outcomes:
measure: sensitivity for detecting HCC
timeFrame: 6 months after last patient's MRI
Secondary outcomes:
measure: specificity for detecting HCC
timeFrame: 6 months after last patient's MRI
Other outcomes:
measure: Apparent diffusion coefficient (ADC)
timeFrame: 1 month after each MR scan
measure: T2 relaxation time
timeFrame: 1 month after MR scan
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06871241: Public Awareness and Understanding of PC in the UAE
Official title: Public Awareness and Understanding of Palliative Care in the United Arab Emirates: Insights from a Population-Based Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Palliative Care
Keywords: Supportive care
Lead sponsor: Burjeel Cancer Institute
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 824
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population included residents of the UAE, both Emiratis and expatriates, who could read and respond in either English or Arabic.

Brief summary: Palliative care (PC) is essential medical care for improving the quality of life for patients with life-threatening illnesses and their families. There has been substantial evolution of PC services in the United Arab Emirates (UAE), yet public awareness regarding PC remains shallow, hindering its utilization and acceptance on a large scale.

Detailed description: This study aimed to evaluate public perceptions and awareness of PC in the UAE. A cross-sectional survey was conducted in both Arabic and English. This study emphasizes the need of addressing these gaps to integrate PC effectively into the UAE healthcare system, ensuring equitable access and improved quality of life for patients and their families.

Eligibility criteria: Inclusion Criteria:

* UAE residents
* Provided informed consent to participate
* Completed the survey in either Arabic or English

Exclusion Criteria:

* Non-UAE residents
* Incomplete survey responses (if applicable)

Primary outcomes:
measure: Familiarity and Understanding of Palliative and Supportive Care as Measured by a Structured Survey
timeFrame: Surveys were conducted in Arabic from July 25, 2024, to August 18, 2024, and in English from August 5, 2024, to August 18, 2024.
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Burjeel Cancer Institute
Study officials:
References:
Clinical trial NCT01469741: Rehabilitation of Everyday Memory Impairment in Parkinson Disease: A Pilot Study
Official title: Rehabilitation of Everyday Memory Impairment in Parkinson Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2011-11-10
Enrollment: 74
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cognitive impairment is common among non-demented individuals with Parkinson disease (PD) and is a significant source of disability and reduced quality of life. Unfortunately, there are no successful interventions to address these impairments. Prospective memory impairment is a particularly functionally- and clinically-relevant problem in PD. The investigator's project will determine if a targeted intervention strategy improves PD participants' prospective memory. The investigator's goal is to improve PD patients' everyday prospective memory so they can successfully perform desired activities and roles.

Detailed description: Cognitive impairment is common among non-demented individuals with Parkinson disease (PD) and is a significant source of disability and reduced quality of life. Unfortunately, there are no successful interventions to address these impairments. Prospective memory impairment is a particularly functionally- and clinically-relevant problem in PD. The investigator's project will determine if a targeted intervention strategy improves PD participants' prospective memory. The investigator will use a randomized controlled design and a laboratory-based assessment of prospective memory to test the effect of the strategy in a controlled environment. The investigator will also see if PD participants, with support from an occupational therapist (OT), can generalize the strategy to their complex, real-world environments and tasks. Our goal is to improve PD patients' everyday prospective memory so they can successfully perform desired activities and roles.

Eligibility criteria: Inclusion Criteria:

* Participants will be males and females over age 50 who meet criteria for idiopathic typical PD, are Hoehn \& Yahr39 stage I-III (mild-moderate disease) and are treated with levodopa/carbidopa.

Exclusion Criteria:

* Possible dementia,
* treatment with certain medications that interfere with cognition (e.g., anticholinergics),
* change in medications over the study period, other neurological disorders, brain surgery (e.g., STN DBS),
* history of psychotic disorder or significant current psychiatric disorder, or any condition that would interfere with testing (e.g., vision problems).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine, Department of Occupational Therapy
name: Erin Foster, OTD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00615641: Diet, Exercise and Body Fat in 3-5 Year Olds
Official title: Relationship of Dietary Factors and Physical Activity to Body Fat in 3-5 Year Old Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Children
Nutrition
Body Fat
Physical Activity
Diet
Childhood Obesity
Healthy Children
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: University of Arkansas
name: United States Department of Agriculture (USDA)
name: Life Measurement Inc.
name: Texas Woman's University
First posted: 2008-02-14
Enrollment: 65
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are seeking healthy 3-5 year old children in the greater Little Rock area.

Brief summary: To determine how practical and precise different body composition methods are for measuring body fat and lean tissue in young children and to determine if certain dietary factors and physical activity patterns are related to body fat in children.


Eligibility criteria: Inclusion Criteria:

* 3-5 year old children
* Full term at birth
* English as primary language
* Weighed at least 5.5# at birth
* Parent or guardian is at least 18 years of age

Exclusion Criteria:

* Child has any chronic condition, metabolic disorder, pulmonary disorder, bone disorder, condition that may affect growth, ADD or ADHD
* Child on any medication thought to interfere with study parameters as determined by the investigator

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: Arkansas Children's Nutrition Center
name: Tina Crook, M.S., R.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06892041: Diffusion MRI for Quantitative Assessment of Myofascial Pain
Official title: Development of RPBM for Quantitative Assessment of Myofascial Pain
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Masticatory Myofascial Pain Syndrome
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: New York University
First posted: 2025-03-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants from the community

Brief summary: The purpose of this study is to assess the diagnostic accuracy of diffusion MRI for evaluation of the jaw muscles for patients with masticatory myofascial pain syndrome.


Eligibility criteria: Inclusion Criteria:

* Men and women 18-65 years of age
* Ability to give informed consent
* Symptoms meeting criteria for normal or latent/active temporomandibular myofascial pain

Exclusion Criteria:

* Contraindications to MRI scanning including severe obesity or difficulty in laying in a supine position, intracranial clips, metal implants, external metallic devices/objects/clips within 10mm of the head, suspected or confirmed metal in the eyes (history of welding or similar activity), claustrophobia, cardiac pacemaker or pacing wires
* Pregnancy or breast feeding
* Dental implants with metal on the same side of the temporomandibular pain
* Traumatic injury of masticatory muscles or temporomandibular joint within last 12 months
* Mandibular fracture within last 12 months
* Initiation of additional treatment of myofascial pain within the past 1 month

Primary outcomes:
measure: Difference in mean diffusion MRI parameters of temporalis and masseter muscles between patients at the normal stage and those at the latent/active pain stage.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: New York City
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Gene Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02811341: The Application of Spasmolytic in PCLE Examination of Superior Gastrointestinal Endoscope
Official title: A Clinical Analysis of Scopolamine Hydrobromide in Probe-based Confocal Laser Endomicroscopy for Gastroendoscopy Examination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Using Copolamine Butylbromide in Probe-based Confocal Laser Endomicroscopy for Gastroendoscopy Examination
Keywords: Scopolamine butylbromide PCLE
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Scopolamine butylbromide might be helpful for the outcome of superior gastrointestinal endoscope examination.

Detailed description: The peristalsis of gastrointestinal tract has a adverse affection on the process of the PCLE examination .Scopolamine butylbromide is a widely used spasmolytic，which can reduce the peristalsis of gastrointestinal tract effectly.The application of it may benefit the images'quality ,the acurrate of diagnosis and shorten the examination time.

Eligibility criteria: Inclusion Criteria:

* outpatients attending endomicroscopy
* able to give written informed consent

Exclusion Criteria:

* coagulopathy
* acute upper digestive tract bleeding
* pregnancy or breast feeding
* allergy to fluorescein sodium
* impaired renal function

Primary outcomes:
measure: endomicroscopic image quality
timeFrame: 7months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanqing Li, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Gastroenterology, Qilu Hospital, Shandong University
name: Yanqing Li, PhD. MD.
role: STUDY_DIRECTOR
References: