louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05359809: Peripheral Intravenous Central Catheter Intervention in Preterm Infants
Official title: The Effect of Grasping Palmar Reflex on Pain and Stress in Peripheral Intravenous Central Catheter Intervention in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm
Pain, Acute
Stress
Nursing Caries
Keywords: Preterm
Pain, Acute
Stress
Nursing Caries
Lead sponsor: Ataturk University
Sponsor class: OTHER
Collaborators: name: MSc İknur Budancamanak
First posted: 2022-05-04
Enrollment: 40
Sex: ALL
Minimum age (years): 26
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will be conducted to evaluate the effect of grasping reflex stimulation applied during peripheral intravenous central catheter (PIC) intervention on pain and stress in preterm infants receiving treatment and care in the neonatal intensive care unit.

Detailed description: The study was planned in a parallel randomized controlled trial design. The population of the research will be preterm infants followed in the Newborn Intensive Care Unit of Atatürk University Health Research and Application Center between May 2022 and September 2022. Randomization in the sample of the study will be done in the computer environment. Sample size was determined by power analysis. In the collection of data; Preterm Baby Information Form, Preterm Baby Follow-up Form, Neonatal Stress Scale and ALPS-NEO pain and stress assessment scale will be used. In the control group, the PIC intervention will be performed by the investigator in accordance with clinical procedures. In the experimental group, the baby's grasping reflex stimulation will be provided during the PIC attempt.

Eligibility criteria: Inclusion Criteria:

* Between 26-32 weeks of gestation,
* Birth weight of 1500 g and below,
* No congenital defects
* who need PIC intervention while receiving treatment and care in the NICU,
* Not receiving sedation at least 3 hours before the PIC procedure,
* No neurological problems
* No surgical intervention
* Recipient of noninvasive mechanical ventilation
* infants whose parents approved the informed voluntary consent form

Exclusion Criteria:

* Painful procedure (invasive procedure, etc.) has been performed in the last hour,
* Infants without parental informed consent form

Primary outcomes:
measure: Pain Level
timeFrame: 12 week
measure: Stress Levell
timeFrame: 12 week
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
Clinical trial NCT02362607: Integrated Diabetes Management Protocol Using Smartphone
Official title: Integrated Diabetes Management Protocol Using Smartphone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Chungbuk National University
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aim to assess whether using integrated diabetes management protocol using smartphone would increase glucose control among diabetes patients.

Detailed description: Smartphones and digital healthcare is expected to provide better diabetes care. The investigators aim to assess whether using integrated diabetes management protocol using smartphone would increase glucose control among diabetes patients.

Smartphone apps for food diary, activity monitor, blood glucose will be used for three months.

Blood glucose control and patient satisfaction will be assessed.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes, type 1 diabetes, gestational diabetes

Exclusion Criteria:

* Medications which interfere glucose control
* Cancer
* Chronic kidney injury

Primary outcomes:
measure: Blood Glucose Control Status Measured by HbA1c
timeFrame: After three months
Secondary outcomes:
measure: Patient Satisfaction Measured by Questionnaire
timeFrame: After three months
Other outcomes:
Locations:
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University
state: Chungcheongbuk-Do
Study officials:
References:
Clinical trial NCT04648007: Validation of Kaihani Score for Gambling Addiction
Official title: Diagnostic Ability of Plasma Based Neuromodulatory Cytokine Production (Kaihani Score) in Gambling Addiction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gambling Addiction
Keywords: addiction
BDNF
Lead sponsor: Therapeutic Solutions International
Sponsor class: INDUSTRY
First posted: 2020-12-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will comprise of 10 healthy volunteers, as well as 20 patients with gambling addictions. 10 of the patients will have moderate and 10 will have severe gambling addiction.

Brief summary: The Kaihani Score is a blood based means of assessing molecules believed to be associated with gambling addiction.

The current clinical trial will assess the Kaihani Score in 3 groups:

Group 1: 10 patients with no personal or family problems with gambling as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS).

Group 2: 10 patients with moderate gambling addiction as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS).

Group 3: 10 patients with severe gambling addiction as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS).

The goal of the study is to confirm preliminary efficacy of the Kaihani Score as a blood based means of assessing gambling propensity.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of pathological gambling (DSM IV criteria)
* First-time consultants.
* Without psychotropic treatment or treatment with a stable and unchanged for over a month.

Exclusion Criteria:

* Pregnant women and patients with hearing disorders
* Epilepsy (untreated or poorly balanced)
* Focal brain injury, whatever its origin (vascular, traumatic, tumor or infectious)
* History of head trauma with loss of consciousness,
* Administration of drugs or substances lowering the seizure threshold
* Sleep deprivation, jet lag, or drug withdrawal.
* Participants with a problem of uncorrected visual acuity.
* Other current addiction.

Primary outcomes:
measure: Assessment of Kaihani Score
timeFrame: 1 Week
Secondary outcomes:
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: Therapeutic Solutions International
state: California
Study officials:
affiliation: Therapeutic Solutions International
name: James Veltmeyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06889207: Physical Exercise Prehabilitation Program in MEtabolic SuRgery
Official title: Physical Exercise Prehabilitation Program in MEtabolic SuRgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity and Overweight
Bariatric Surgery
Prehabilitation
Exercise
Physical Fitness
Six Minute Walk Test
Lead sponsor: Flevoziekenhuis
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 58
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 goal of this clinical trial is to learn if an exercise program before bariatric surgery works to treat obesity, could improve physical condition and weight loss before bariatric surgery and induce a lifestyle behavior change. The main questions it aims to answer are:

* Does a supervised exercise program lead to improved physical condition prior to bariatric surgery?
* Does a supervised exercise program prior to bariatric surgery lead to reduced surgery related complications?
* Does a supervised exercise program prior to bariatric surgery lead to maintained lifestyle changes after surgery?

Participants will:

* Receive either no training program or physical exercise training program twice a week, supervised by a physical therapist, for a duration of 8 weeks.
* Have their fitness measured at the start and at the end of the 8 weeks, measured with a six minute walking test.
* Fill in a survey on their perceived quality of life and exercise habits at the start of the trial, and at 1 year after surgery.


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18 years)
* Body-Mass-Index (BMI) 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, heart and/or vascular diseases, obstructive sleep apnea (OSA), dyslipidemia, or arthritis).
* Primary bariatric patients; without previous bariatric surgery. For inclusion the investigators will follow the National Guidelines on metabolic surgery.

Exclusion Criteria:

Patients with:

* mobility problems (patients who are not able to exercise)
* cognitive disabilities
* illiteracy (patients who are not able to read and understand the language of the country where the study will be performed)

Primary outcomes:
measure: six-minute walk test
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Almere
country: Netherlands
facility: FlevoZiekenhuis
state: Flevoland
Study officials:
References:
Clinical trial NCT01446107: Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries
Official title: A Randomized Controlled Trial on the Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: tooth decay
fluoride
sealant
prevention
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2011-10-05
Enrollment: 502
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Nearly half of the 12-year-old children in China have dental caries (tooth decay) and most of the lesions are in the fissures of the first permanent molars. This study aims to investigate the effectiveness of three methods in preventing fissure caries in permanent teeth in Chinese children, namely resin fissure sealant, sodium fluoride varnish, and silver diamine fluoride solution. The cost-effectiveness of these methods will also be compared. About 400 children, aged 8 to 9 years, will be recruited. Clinical examination of the children will be conducted in school using portable dental lights and instruments to identify teeth that need caries prevention. The children will be randomly allocated to one of the three test or the control groups. Treatments will be provided in the study primary schools according to standard clinical protocols. Follow-up examinations will be carried out every six months for 30 months to assess whether the preventive methods are successful, i.e. no dental caries develops in the treated teeth. The findings of this study will be of great value to dentists and public health authorities in deciding on the most appropriate dental caries prevention programme for school children in China and other developing countries.


Eligibility criteria: Inclusion Criteria:

* school children in good general health
* have at least one permanent first molars that has deep occlusal fissures, or fissures with signs of early caries

Exclusion Criteria:

* children with major systemic disease or taking long-term medications
* not cooperative or refuse dental treatments

Primary outcomes:
measure: dental caries
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Edward CM Lo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu BY, Lo EC, Chu CH, Lin HC. Randomized trial on fluorides and sealants for fissure caries prevention. J Dent Res. 2012 Aug;91(8):753-8. doi: 10.1177/0022034512452278. Epub 2012 Jun 26.
Clinical trial NCT06191107: Removable Partial Dentures Made of PEEK
Official title: Clinical Performance of Removable Partial Dentures With Clasps Made of PEEK
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tooth Loss
Keywords: Removable Partial Denture
Polyetheretherketone
Oral Health Related Quality of Life
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Medical University Innsbruck
name: Merz Dental GmbH
First posted: 2024-01-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: As part of the clinical study, 25 patients each were provided with removable partial dentures with clasps made of PEEK in two centres (University Hospital Heidelberg, Department of Prosthodontics and University Hospital for Dental Prosthetics Innsbruck). The patients were examined over a period of 3 years for the number and type of technical or biological complications and questioned about their oral health-related quality of life.


Eligibility criteria: Inclusion Criteria:

* Indication for a clasp-anchored removable partial denture

Exclusion Criteria:

* Minors and adults unable to give consent
* Pregnancy or breastfeeding
* Severe general illnesses
* Allergies or other intolerances to one of the materials used (PEEK, PMMA)
* Suspicion of lack of compliance

Primary outcomes:
measure: Oral-Health-Related Quality of Life
timeFrame: 3 months
measure: Biological complications
timeFrame: 3 years
measure: Technical complications
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg, Department of Prosthodontics
Study officials:
affiliation: University Hospital Heidelberg
name: Peter Rammelsberg, Prof. / Head
role: STUDY_CHAIR
References:
Clinical trial NCT00823407: Clinical Pharmacology of MDA [3,4-methylenedioxyamphetamine]
Official title: Clinical Pharmacology of MDA [3,4-methylenedioxyamphetamine]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: MDA
MDMA
Ecstasy
entactogen
pharmacokinetics
pharmacodynamics
Pharmacokinetics and pharmacodynamics of MDA studies in healthy volunteers
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of California, San Francisco
First posted: 2009-01-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the pharmacological and cognitive effects of MDA in healthy humans.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females age 18-50
* Fluent English speaker
* Willing and able to give written consent

Exclusion Criteria:

* Body mass index \> 30 or \< 18
* Pregnancy or lactation

FOR MORE DETAILS CONTACT THE RESEARCH CLINIC.

Primary outcomes:
measure: MDA will be metabolized to hydroxyamphetamine (HMA) and dihydroxyamphetamine (DHA) and will produce dose-dependent increases in neuroendocrine measures.
timeFrame: 0-48 hours post dose
Secondary outcomes:
measure: MDA will produce dose-dependent increases in self-report entactogen-like and stimulant like measures.
timeFrame: 0-48 hours post dose
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: CPMC Addiction & Pharmacology Research Laboratory (APRL)
state: California
Study officials:
affiliation: CPMC Research Institute
name: John E Mendelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baggott MJ, Siegrist JD, Galloway GP, Robertson LC, Coyle JR, Mendelson JE. Investigating the mechanisms of hallucinogen-induced visions using 3,4-methylenedioxyamphetamine (MDA): a randomized controlled trial in humans. PLoS One. 2010 Dec 2;5(12):e14074. doi: 10.1371/journal.pone.0014074.
Clinical trial NCT04038307: Pre-emptive Paracetamol for Prevention of Intraoperative Shoulder Tip Pain
Official title: Pre-emptive Intravenous Paracetamol for Prevention of Intraoperative Shoulder Tip Pain in Patients Undergoing Caesarean Section: A Randomized Double Blind Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Cesarean Section
Keywords: shoulder tip pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: the aim is to determine the efficacy of Paracetamol in reducing the incidence and severity of intraoperative shoulder pain in patients undergoing cesarean section.

Detailed description: pregnant females scheduled for cesarean section under spinal anesthesia will be enrolled . two groups of patents will be recruited . the study group will receive paracetamol pre operative .

Eligibility criteria: Inclusion Criteria:

* Healthy pregnant women (ASA II) having singleton pregnancy at term (≤ 37 weeks of gestation) aged between 18 and 40 years.

Exclusion Criteria:

* Patients having allergy to study drug,
* gestational diabetes
* cardiovascular or biliary disorders
* asthma
* renal impairment
* preeclampsia
* any chronic pain condition or trauma in the shoulder, forearms or upper limbs
* patients with any contraindication to SA were excluded from the study.

Primary outcomes:
measure: incidence shoulder tip pain
timeFrame: intraoperative
Secondary outcomes:
measure: numerical rating scale
timeFrame: intraoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine
Study officials:
References:
Clinical trial NCT00278707: GTA-Glyceryltriacetate for Canavan Disease
Official title: Phase 1 Treatment With GTA in Two Infant With Canavan Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Infantile Canavan Disease
Deficiency Disease, Aspartoacylase
Keywords: Canavan Disease
Aspartoacylase Deficiency
NAA
Acetate
Glyceryltriacetate
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-01-18
Enrollment: 5
Sex: ALL
Minimum age (years): 0
Maximum age (years): 15
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 determine whether oral supplementation of glyceryl triacetate improves the clinical prognosis of Canavan Disease.

Detailed description: Canavan Disease is caused by a deficiency in the enzyme named Aspartoacylase (ASPA). This disease is a devastating, progressive disease with no available treatment. As a result of the ASPA deficiency, there are high levels of N-acetylaspartate (NAA) and low levels of L-aspartate and acetate.

We hypothesize that one of the functions of ASPA is to provide sufficient levels of acetate for CNS myelinization. For this reason, we offer to supplement acetate levels by the oral administration of glyceryl triacetate (GTA). Such treatment must be offered to patients before the age of 18 months, prior to the termination of CNS myelinization.

1. Two patients, aged less than 15 months, will receive daily doses of oral GTA
2. The daily dose will be increased incrementally until the maintenance dose is reached. This will be done under close monitoring of the patients, including periodic blood gas sampling.
3. GTA has not been shown to cause any known toxicity, according to the Cosmetic Ingredient Review Expert Panel (Fiume, 2003).

Eligibility criteria: Inclusion Criteria:

* Age below 15 months
* Biochemically diagnosed with Canavan Disease

Exclusion Criteria:

* None

Primary outcomes:
measure: All primary outcome will be evaluated 4 months following the initiation of treatment:
measure: Neurological Status
measure: Brain Imaging: MRI & MRS
measure: NAA Levels in Urine
measure: Ophthalmologic Examination
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Dr. Y. Anikster
Study officials:
affiliation: Director Metabolic Disease Unit
name: Yair Anikster, MD PI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mathew R, Arun P, Madhavarao CN, Moffett JR, Namboodiri MA. Progress toward acetate supplementation therapy for Canavan disease: glyceryl triacetate administration increases acetate, but not N-acetylaspartate, levels in brain. J Pharmacol Exp Ther. 2005 Oct;315(1):297-303. doi: 10.1124/jpet.105.087536. Epub 2005 Jul 7.
citation: Madhavarao CN, Arun P, Moffett JR, Szucs S, Surendran S, Matalon R, Garbern J, Hristova D, Johnson A, Jiang W, Namboodiri MA. Defective N-acetylaspartate catabolism reduces brain acetate levels and myelin lipid synthesis in Canavan's disease. Proc Natl Acad Sci U S A. 2005 Apr 5;102(14):5221-6. doi: 10.1073/pnas.0409184102. Epub 2005 Mar 22.
Clinical trial NCT05992207: Utilization of Motor Imagery Training for Improvement of Balance of Ataxic Children After Medulloblastoma Resection
Official title: Motor Imagery Training for Improvement of Balance of Ataxic Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebellar Ataxia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: after resection of medulloblastoma in children they suffer from signs and symptoms of ataxia which impedes their activities of daily living. purpose: to investigate the effect motor imagery training on balance, severity of ataxia and gait parameters on children after resection of medulloblastoma. Methods: Fifty children surfing from cerebellar ataxia after medulloblastoma resection were selected from tumors hospital of Cairo University, their age ranged from seven to nine years old, they were randomly assigned into two matched control and study groups. The control groups received the selected physical therapy program while, the study group received motor imaginary training in addition to the selected physical therapy program. Both groups were evaluated by ataxic rating scale, pediatric berg balance scale and kinematic gait analysis by kinovea software.

Detailed description: Motor imagery is an effective method to enhance motor performance applied in rehabilitation programs it did not impose a physical load on patients, was confirmed through clinical evidence from meta#analysis. Motor imagery means thinking in motor task with executing it to activate motor cortical areas as 25% of the brain neurons are mirror neurons and fire by thinking.

Eligibility criteria: Inclusion Criteria:

* The children had signs of ataxia
* loss of balance
* able to understand and execute test instructions
* the children are in the follow up period after medulloblastoma resection

Exclusion Criteria:

* medically unstable
* visual impairment
* increased intracranial pressure
* any other neuromuscular diseases.

Primary outcomes:
measure: Severity of ataxia
timeFrame: 3 months
measure: Pediatric berg balance scale
timeFrame: 3 months
measure: Kinematic gait assessment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Reham Alsakhawi
Study officials:
affiliation: Cairo University
name: Reham Alsakhawi
role: PRINCIPAL_INVESTIGATOR
References: