louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04108663: Supporting Cognitive Control Training With tDCS
Official title: Lasting Amelioration of Deficient Cognitive Control by Transcranial Direct Current Stimulation (tDCS)-Enhanced Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Control
Keywords: Brain stimulation
Cognitive training
Cognition
Cognitive enhancement
Transcranial direct current stimulation
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Cognitive control (CC) is an important prerequisite for goal-directed behaviour and often associated with dysfunctional prefrontal activity within the cortex. This can be ameliorated by non-invasive brain stimulation. In this randomised single-blind study we compare effects of transcranial direct current stimulation (tDCS) on CC in healthy subjects. The study includes 162 subjects who undergo a two-week (six sessions) training of cognitive control (adaptive paced auditory serial addition task, PASAT) supported by tDCS. Subjects are randomised to receive either concurrent anodal, cathodal, or sham tDCS with an intensity of 1 mA or 2 mA of their left (F3) or right (F4) PFC, resulting in eight stimulation groups. Stimulation effects on performance changes are compared to a sham control group.Changes in Affective state are measured by the positive and negative affect schedule (PANAS), possible transfer effects are assessed by the Eriksen Flanker task. Stability of effects is measured up to three months after the last intervention.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Right-handed (assessed by Edinburgh Handedness Inventory)
* No other concurrent brain stimulation during participation
* Proficient in German (min. CEFR level B)
* Ability to strictly adhere to study timeline

Exclusion Criteria:

* Diagnosed neurological illnesses
* Diagnosed psychiatric disorders
* Achromatopsia
* Metallic implants / tattoos on or near electrode sites
* Consumption of tobacco to an equivalent of ten or more cigarettes per day
* Prior participation in experiments involving the PASAT

Primary outcomes:
measure: Cognitive performance
timeFrame: 2 to 14 weeks
Secondary outcomes:
measure: Affective state
timeFrame: 2 weeks
measure: Transfer effect
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University of Tübingen, Department of Psychiatry and Psychotherapy
Study officials:
affiliation: University of Tübingen, Department of Psychiatry and Psychotherapy
name: Christian Plewnia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weller S, Nitsche MA, Plewnia C. Enhancing cognitive control training with transcranial direct current stimulation: a systematic parameter study. Brain Stimul. 2020 Sep-Oct;13(5):1358-1369. doi: 10.1016/j.brs.2020.07.006. Epub 2020 Jul 18.
Clinical trial NCT06360263: OSSEODENSIFICATION BY DENSAH BURS WITH ACTIVATED PLASMA ALBUMIN GEL FOR SINUS LIFTING WITH SIMULTANEOUS IMPLANT PLACEMENT
Official title: OSSEODENSIFICATION BY DENSAH BURS IN COMBINATION WITH ACTIVATED PLASMA ALBUMIN GEL FOR TRANSCRESTAL MAXILLARY SINUS LIFTING WITH SIMULTANEOUS IMPLANT PLACEMENT (CLINICAL TRIAL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Loss, Alveolar
Keywords: transcrestal sinus lifting
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of the current study is to evaluate clinically and radiographically transcrestal sinus lifting with densah burs with the use of activated plasma albumin gel associated with simultaneous implant placement.


Eligibility criteria: Inclusion Criteria:

* Patient with missing maxillary premolars and molars.
* Vertical bone height of 3-5 mm.
* Good oral hygiene.
* Non smokers.

Exclusion Criteria:

* Bad oral hygiene.
* Presence of infection or periapical lesions in adjacent teeth.
* Acute maxillary sinusitis.
* Bruxism or clenching.
* Medically compromised patients with a condition that affects the procedure (patients with bone diseases such as osteogenesis imperfecta and polyarthritis and patients on radiotherapy and chemotherapy)

Primary outcomes:
measure: Postoperative pain
timeFrame: up to one week
measure: Implant stability
timeFrame: up to 6 months
measure: Vertical bone height gain
timeFrame: up to 6 months
measure: Bone density around implant
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT02500563: Exploratory/Proof of Principle Microbiota Study
Official title: Exploratory/Proof of Principle Microbiota Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Microbiota
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
Collaborators: name: Midwest Children's Health Research Institute
First posted: 2015-07-16
Enrollment: 78
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.

Detailed description: This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.

Eligibility criteria: Inclusion Criteria:

* Singleton, 1-7 days of age at registration or randomization
* Term infant with appropriate birth weight for gestational age
* Either solely formula fed or exclusively receiving mother's own breast milk
* Signed Informed Consent and Protected Health Information

Exclusion Criteria:

* Caesarean delivery
* Infant was born from a mother with Type 1 diabetes
* History of underlying metabolic or chronic disease or immunocompromised
* Feeding difficulties or history of formula or human milk intolerance
* Signs of acute infection of current use of antibiotics

Primary outcomes:
measure: Fecal microbiota measured at each visit
timeFrame: 8 weeks
Secondary outcomes:
measure: Body weight measured at each visit
timeFrame: 8 weeks
measure: Body length measured at each visit
timeFrame: 8 weeks
measure: Head circumference measured at each visit
timeFrame: 8 weeks
measure: Parental recall of formula intake at each visit
timeFrame: 8 weeks
measure: Stool collection at each visit
timeFrame: 8 weeks
measure: Serious adverse events collected throughout the study period
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institue
state: Nebraska
Study officials:
affiliation: Mead Johnson and Company
name: Jon Vanderhoof, M.D.
role: STUDY_DIRECTOR
References:
citation: Kok CR, Brabec B, Chichlowski M, Harris CL, Moore N, Wampler JL, Vanderhoof J, Rose D, Hutkins R. Stool microbiome, pH and short/branched chain fatty acids in infants receiving extensively hydrolyzed formula, amino acid formula, or human milk through two months of age. BMC Microbiol. 2020 Nov 9;20(1):337. doi: 10.1186/s12866-020-01991-5.
citation: Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
Clinical trial NCT01460563: Valproic Acid, Magnesium Sulphate, Rocuronium Requirement, Postoperative Analgesia
Official title: Effects of Valproic Acid and Magnesium Sulphate on Rocuronium Requirement and Postoperative Analgesia in Patients Undergoing Craniotomy for Cerebrovascular Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Aneurysm
Keywords: craniotomy
sodium valproate
rocuronium
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2011-10-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators hypothesized that valproic acid will increase rocuronium requirement and MgSO4 infusion would reduce requirement of muscle relaxant in craniotomy patients preloaded with sodium valproate.

Detailed description: Magnesium sulfate (MgSO4) is known to reduce requirement of muscle relaxant.

Eligibility criteria: Inclusion Criteria:

* 18- 65 years
* American society of anesthesiology physical status 1,2
* scheduled for elective craniotomy for aneurysm clipping or for superficial temporal artery-middle cerebral artery anastomosis

Exclusion Criteria:

body mass index \<18.5 or \>24.9 kg m-2; neuromuscular, renal, cardiovascular or hepatic insufficiency; Glasgow coma scale (GCS) \<15; allergy to the study drugs; medications influencing NDMRs; breast feeding; pregnancy; and preoperative epilepsy.

Primary outcomes:
measure: Rocuronium
timeFrame: participants will be followed for the duration of the surgery, an expected average of 5.5 hours.
Secondary outcomes:
measure: hemodynamics
timeFrame: participants will be followed for the duration of the surgery, an expected average of 5.5 hours; postoperative 24 hour; postoperative 48 hour
measure: total amount of anesthetics
timeFrame: participants will be followed at the end of the surgery, an expected average of 5.5 hours after induction of anesthesia..
measure: Magnesium concentration
timeFrame: from the induction of anesthesia until end of the surgery
measure: side effects
timeFrame: participants will be followed for the duration of the surgery, an expected average of 5.5 hours; postoperative 24 hour; postoperative 48 hour.
measure: pain, nausea & vomiting, analgesics use, antiemetics use, nicardipine use
timeFrame: patients will be followed from the end of the operation until postoperativ 48 h
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang hopital
state: Gyeonggi-Do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Sanghwan Do, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT00687063: Observational Study of Safety and Efficacy of Levemir® in Type 2 Diabetes
Official title: An Observational, Safety and Efficacy Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-05-30
Enrollment: 10008
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetics

Brief summary: The study is conducted in Asia. The aim of this observational study is to evaluate the weight change from baseline while using Levemir® in subjects with type 2 diabetes mellitus under normal clinical practice conditions in India.


Eligibility criteria: Inclusion Criteria:

* Any subject with type 2 diabetes

Exclusion Criteria:

* Subjects with a hypersensitivity to insulin detemir or any of its excipient
* Children below 6 years
* Subjects who are pregnant, lactating or planning to become pregnant

Primary outcomes:
measure: Weight change from baseline
timeFrame: after 26 weeks
Secondary outcomes:
measure: Number of serious adverse events
timeFrame: after 26 weeks
measure: Number of all adverse events
timeFrame: after 26 weeks
measure: Number of all hypoglycemic episodes (24 hr, daytime and nocturnal)
timeFrame: after 26 weeks
measure: HbA1c change from baseline
timeFrame: after 26 weeks
measure: FBG (Fasting Blood Glucose) change from baseline
timeFrame: after 26 weeks
measure: Percentage of patients achieving targets of HbA1c less than 7 % and less than 6.5 %
timeFrame: after 26 weeks
measure: Insulin dose and frequency at the end of the study
timeFrame: after 26 weeks
Other outcomes:
Locations:
city: Bangalore
country: India
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452), MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05506163: Development and Validation of a Predictive Model for Postoperative Pulmonary Complications in Elderly Patients
Official title: Development and Validation of a Predictive Model for Postoperative Pulmonary Complications in Elderly Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pulmonary Complications
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 10000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: older patients received general anesthesia in Wuhan Union Hospital from January 1, 2014 to December 31, 2019.

Brief summary: Although several clinical predictive models have been developed to predict postoperative pulmonary complications, few predictive models have been developed for elderly patients. In this study, the researchers aimed to develop a new, simplified model to assess the risk of postoperative pulmonary complications in elderly patients using perioperative database information.

Detailed description: Postoperative pulmonary complications occur frequently, which is an important cause of death and morbidity. Age has always been an significant predictor of postoperative pulmonary complications. With an aging population worldwide, more and more elderly people are undergoing surgery due to the expansion of surgical indications. As a result of this phenomenon, the elderly are also an important group for the prediction and intervention of postoperative pulmonary complications. In order to better assess the risk of postoperative pulmonary complications in elderly patients, we constructed a model using database information.

Eligibility criteria: Inclusion Criteria:

* Age 65 years or older
* receiving invasive ventilation during general anesthesia for surgery

Exclusion Criteria:

* preoperative mechanical ventilation
* operations related to previous postoperative complications
* a second operation after surgery
* organ transplantation
* discharged within 24 hours after surgery
* cardiac and thoracic surgery

Primary outcomes:
measure: Postoperative pulmonary complications
timeFrame: within one week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT03281863: Clinical Audit on the Managment in Assiut University Children Hospital
Official title: Clinical Audit on the Managment of Rheumatic Fever in Assiut University Children Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatic Fever
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Clinical audit on the managment of rheumatic fever in assiut university children hospital

Brief summary: clinical audit on the Managment of rheumatic fever in assiut university children hospital.

Detailed description: Acute rheumatic fever,an auto immune response to Group A streptococcus infection of the upper respiratory tract,may result in carditis.when the inflammation leads to permenant damage of the valves the individual has rheumatic heart disease.

Recurrences of rheumatic fever are likely in the absence of preventive measures and may cause further cardiac valve and muscle damage,leading to heart failure,stroke and premature death.bacterial endocarditis is also a complication.

Eligibility criteria: Inclusion Criteria:

* patients with confirmed diagnosis of rheumatic fever based on laboratory investigations.

Exclusion Criteria:

* No

Primary outcomes:
measure: laboratory investigations (ASOt , ESR . CRP)
timeFrame: One year from October 2017 to september 2018
Secondary outcomes:
measure: clinical measures
timeFrame: One year from October 2017 to september 2018
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Egypt
Study officials:
References:
Clinical trial NCT03532763: Anti-Inflammatory Effect of Tocotrienol Supplementation in Subjects With Moderately Elevated Inflammation
Official title: Anti-Inflammatory Effect of Tocotrienol Supplementation in Subjects With Moderately Elevated Inflammation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammation
Cardiovascular Risk Factor
Keywords: Inflammation
Tocotrienols
Cardiovascular disease
Lead sponsor: Malaysia Palm Oil Board
Sponsor class: OTHER_GOV
Collaborators: name: Universiti Putra Malaysia
First posted: 2018-05-22
Enrollment: 180
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double blind, placebo-controlled, parallel
Primary purpose: PREVENTION

Brief summary: The objective of this study is to address the anti-inflammatory effect of tocotrienol supplementation in subjects with moderately elevated inflammation.

It is hypothesized that 6 months supplementation of tocotrienols will reduce inflammatory markers of subjects.

Detailed description: A double-blind, randomized, placebo-controlled, parallel study comparing the effect of tocotrienols vs. placebo will be conducted in subjects with moderately elevated inflammation. Subjects will be supplemented with Tocovid Suprabio 200 mg twice daily or placebo for 6 months. Fasting blood samples will be collected at baseline, 3 months, 6 months. A post-study fasting blood sample will be collected at 9 months.

Eligibility criteria: Inclusion Criteria:

* Age 30-60
* Elevated plasma hs-CRP level of \> 1 mg/L \< 10 mg/L

Exclusion Criteria:

* Subjects with very high LDL-cholesterol ≥ 4.9 mmol/L
* Subjects with very high hs-CRP level ≥ 10 mg/L
* Pregnancy or lactation
* Current use of vitamin E or corticosteroids
* Significant hepatic and renal impairment
* Fever, cold or infection during bleeding day

Primary outcomes:
measure: Inflammation
timeFrame: 0, 3, 6, 9 months
Secondary outcomes:
measure: Inflammatory markers
timeFrame: 0, 3, 6, 9 months
measure: Thrombotic markers
timeFrame: 0, 3, 6, 9 months
measure: Lipid profile
timeFrame: 0, 3, 6, 9 months
measure: Glucose homeostasis
timeFrame: 0, 3, 6, 9 months
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Malaysian Palm Oil Board
state: Selangor
Study officials:
References:
Clinical trial NCT00229463: Study of Genetic Differences in People With Depression
Official title: Study of Genetic Differences in People With Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder, Major
Keywords: Depression
genetic
gene
antidepressant
research
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2005-09-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from previous studies conducted at the Laboratory of Brain, Behavior, and Pharmacology, where subjects' response to treatment has already been determined. This strategy offers the advantage that no new subjects need to be enrolled in placebo-controlled treatment studies.

Brief summary: The purpose of this study is to identify genes involved in depression. Specifically, the investigators will analyze some genes that may be related to whether or not a person responds to antidepressant medication. This project is part of basic scientific research to increase understanding of the role of genetic influences in psychological and mental processes involved in the response to treatment for depression.


Eligibility criteria: Inclusion Criteria:

* History of Unipolar Major Depression
* Control subjects must be healthy normal adults

Exclusion Criteria:

* Subjects with mood symptoms that are not severe enough to qualify for MDD
* Subjects with any active medical illness that may be related to ongoing mood disorder
* Normal subjects must be free from: a psychiatric diagnosis, substance abuse, a history of seizure disorder, and any serious medical illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Semel Institute for Neuroscience and Human Behavior
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Andrew F. Leuchter, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02543463: Navigation With X3 vs Non-Navigation With X3 Study
Official title: Comparison X3 Study Between Navi-THA and Non-navi-THA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Joint Disease
Lead sponsor: Stryker Japan K.K.
Sponsor class: INDUSTRY
First posted: 2015-09-07
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of the large head in THA with a navigation system and without a navigation system.


Eligibility criteria: Inclusion Criteria:

1. Patient who is a candidate for a primary total hip arthroplasty (THA) with cementless acetabular and femoral components.
2. Patient who has a diagnosis of degenerative joint disease and no bacterial infectious disease.
3. Patient who is age 20 or over.
4. Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
5. Patient who is willing to and able to comply with postoperative scheduled evaluations.

Exclusion Criteria:

1. Patient who has a bacterial infectious disease or has a high risk of a bacterial infection.
2. Patient who requires revision surgery of a previously implanted total hip arthroplasty.
3. Patient who is morbidly obese, defined as having a Body Mass Index (BMI) \> 45.
4. Patient who is or may be pregnant female.
5. Patient who has neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
6. Patient with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
7. Patient who is immunologically suppressed or receiving chronic steroids.
8. Patient who is judged ineligible with specific reason by primary doctor.

Primary outcomes:
measure: Range of motion (ROM) during surgery
timeFrame: intraoperative
Secondary outcomes:
measure: Measuring accuracy of the ROM during surgery
timeFrame: Intraoperative
measure: implantation accuracy
timeFrame: Intraoperative
measure: Postoperative dislocation
timeFrame: From intraoperative to 1yr
Other outcomes:
Locations:
city: Osaka City
country: Japan
facility: Osaka Rosai Hospital
state: Osaka
Study officials:
affiliation: Stryker Japan
name: Yasuyuki Inatsugu
role: STUDY_DIRECTOR
References: