louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05995314: Effects Of Caffeine On Cognitive Performance
Official title: Effects Of Different Doses Of Caffeine On Cognitive Performance In Healthy Physically Active Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caffeine
Keywords: ergogenic aid
sport performance
reaction time
anticipation
attention
memory
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Caffeine is a potent central nervous system stimulant that increases the activity in the prefrontal cortex and can improve cognitive skills. An improvement in these cognitive skills can lead to further benefits in athletic performance. Therefore, it is necessary to clarify the dose-response of caffeine on cognitive performance.The aim of this research will be to determine the effects of different doses of caffeine on sport-related cognitive aspects.

Detailed description: The investigators will require healthy, physically active young adults to complete three trials under the conditions: a) placebo, b) 3 mg/kg, or c) 6 mg/kg body mass of caffeine. In each trial, different cognitive abilities will be assessed using the following test batteries: reaction time (DynavisionTM D2), anticipation (Bassin Anticipation Timer), sustained attention (Go/No-Go and Eriksen Flanker Test) and memory tests. In addition, side effects and the perceived sensation index will be recorded 24 h after each test.

Eligibility criteria: Inclusion Criteria:

* Physically active individuals ( \>150 min/week moderate physical activity or \>75 min/week vigorous physical activity)
* Individuals without serious and undiagnosed health problems.

Exclusion Criteria:

* Individuals with color blindness.
* Regular caffeine consumers (\>3 cups of coffee/day).

Primary outcomes:
measure: Reaction Time
timeFrame: 10 minutes
measure: Anticipation
timeFrame: 5 minutes
measure: Sustained attention
timeFrame: 10 minutes
measure: Memory
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Performance and Sport Rehabilitation Laboratory
Study officials:
affiliation: University of Castilla-La Mancha
name: Javier Abián-Vicén, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01792414: Transcranial Electrical Stimulation (TES) for the Treatment of Depression.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 70
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: This study is a RCT of transcranial electrical stimulation in depressed patients. Mood, cognitive test performance and biomarkers will be measured during the trial.


Eligibility criteria: Inclusion Criteria:

* DSM-IV Major Depressive Episode (as part of a Major Depressive Disorder or Bipolar Disorder), of minimum 4 weeks duration.
* MADRS score ≥ 20 at study entry.

Exclusion Criteria:

* DSM-IV psychotic disorder;
* drug or alcohol abuse or dependence (preceding 12 months);
* inadequate response to ECT (current episode of depression);
* anticonvulsant or benzodiazepine medication;
* rapid clinical response required, e.g. high suicide risk; clinically defined neurological disorder or insult;
* metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites;
* pregnancy.

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale for Depression (MADRS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Beck Depression Inventory II
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Black Dog Institute / University of New South Wales
state: New South Wales
Study officials:
References:
citation: Nikolin S, Alonzo A, Martin D, Galvez V, Buten S, Taylor R, Goldstein J, Oxley C, Hadzi-Pavlovic D, Loo CK. Transcranial Random Noise Stimulation for the Acute Treatment of Depression: A Randomized Controlled Trial. Int J Neuropsychopharmacol. 2020 Apr 21;23(3):146-156. doi: 10.1093/ijnp/pyz072.
Clinical trial NCT05158114: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Testicular Injury and Oligospermia
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Testicular Injury and Oligospermia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Testicular Injury
Oligospermia
Keywords: Oligospermia
Testicular Injury
stem cell treatment
Lead sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Testicular Injury and Oligospermia

Detailed description: This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Testicular Injury and Oligospermia. Patients will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Testicular Injury or Oligospermia
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Previous organ transplant
* Hypersensitivity to sulfur

Primary outcomes:
measure: Safety (adverse events)
timeFrame: Four year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: St. John's
country: Antigua and Barbuda
facility: Medical Surgical Associates Center
Study officials:
affiliation: The Foundation for Orthopaedics and Regenerative Medicine
name: Chadwick Prodromos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03511014: Efficacy of Microcurrent Therapy for Treatment of Knee Pain
Official title: Efficacy of Microcurrent Therapy for Treatment of Knee Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Knee Pain
Lead sponsor: Omron Healthcare Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Elon University, Department of Physical Therapy Education
First posted: 2018-04-27
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
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 the effect of microcurrent therapy at the knee pain.


Eligibility criteria: Inclusion Criteria:

* Pain perceived as a minimum of 3/10 on a 0-10 pain scale
* No phobia of electrical stimulation
* No pain or anti-inflammatory medication will be taken during study
* Injury that began prior to 6-weeks ago before the onset of pain
* Grade II soft tissue injury

Exclusion Criteria:

* Pregnancy
* Diabetes Mellitus
* Neuropathy
* Smoker
* Uncontrolled HTN
* Past surgery in the region to be treated by microcurrent
* Arthritis (RA) in the area to be treated by microcurrent
* Cardiovascular disease
* Allergic to tape/electrodes
* Ligament injury
* Patella Femoral Pain Syndrome (Anterior knee pain)
* Dementia
* Grade III soft tissue injury

Primary outcomes:
measure: Numeric Pain scale (NRS) for pain (0-10)
timeFrame: 4weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Muko
country: Japan
facility: Omron healthcare Co.,Ltd.
Study officials:
References:
Clinical trial NCT00886314: Clown Doctors and a Sedative Premedicant for Children Undergoing Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: children
surgery
anxiety
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2009-04-22
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the present investigation will be to determine whether a combination of clown doctor and parental presence is more effective than a combination of sedative premedication and parental presence for reducing anxiety in children and their parents and for improving parental satisfaction.


Eligibility criteria: Inclusion Criteria:

* children aged 2 to 12 yr, scheduled for minor surgery under general anesthesia will be included in the present study.

Exclusion Criteria:

* Children with prematurity, development delay, previous anesthetic experience will be excluded from this study

Primary outcomes:
measure: Preoperative anxiety
timeFrame: Prior to induction of anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center, Jerusalem, Israel
name: Yaacov Gozal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05597514: Three-dimensional Airway Suction Model
Official title: The Application of Three-dimensional Printing High-fidelity Simulation Respiratory Models in Airway Suction and Advanced Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satisfaction, Personal
Keywords: 3D printed
airway suction
respiratory therapy
medical education
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main purpose of this study is to use 3D printing technology to high-fidelity simulation respiratory models Furthermore, the results of this study will extent to medical school and hospital.

Detailed description: Background：

Most clinical teaching materials are expensive and inaccessible. To promote the accessibility of anatomy models and student learning effects in our medical school and hospital, we use 3D printing technology to print high-fidelity simulation respiratory models and apply them in medical education.

Study Design：

This is a single-site prospective study of medical education. Participants who are students of the School of respiratory therapy will be randomly divided into to control group and experimental group. Both groups will receive the same teaching program. The traditional education model will be used in the control group, and the 3D printed model will be used in the experimental group.

Methods：

The 3D scanning technology will be applied to create drawing files of high-fidelity simulation respiratory models, which are drawn by professional 3D drawing staff. Then, we print out the models with 3D printing technology. The output material will be close to the softness of the human models. The medical education of this study will be divided into two parts. The first part is the teaching of realistic airway suction; the second part is the simulation of advanced mechanical ventilation.

Effect：

We expect benefits that the use of 3D printing high-fidelity simulation respiratory models in medical education. For example, it can reduce the cost of education models and enhance efficacy in medical education. The experience and outcome will be shared with the medical school and hospital.

Keywords：

3D printing; medical education model; high-fidelity simulation; respiratory care.

Eligibility criteria: Inclusion Criteria:

* Student of Fu Jen Catholic University.

Exclusion Criteria:

* Refused to participate in the study.

Primary outcomes:
measure: Examination score of pre-intervention
timeFrame: pre-intervention
measure: Examination score of post-intervention
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University
Study officials:
affiliation: Fu Jen Catholic University Hospital
name: Ke-Yun Chao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00852514: The Optimization of Blood Pressure and Fluid Status Control With Eight-Polar Bioelectrical Impedance Analysis
Official title: The Optimization of Blood Pressure and Fluid Status Control With Eight-Polar Bioelectrical Impedance Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Fluid Overload
Heart Diseases
Keywords: Bioimpedance
ultrafiltration
blood pressure
pulse pressure
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2009-02-27
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Peritoneal dialysis (PD) is a widely used modality of renal replacement therapy. Due to its continuous nature of therapy, better control of fluid status and preservation of residual renal function were presumed by most nephrologists. However, recent evidences showed that it might not be the case. The severity of fluid overloading and the need for anti-hypertensive agents to control blood pressure seems to be more severe for PD patients. Therefore, more aggressive strategy to control dry weight is mandatory in PD patients. However, over reduction of dry weight might affect residual renal function (RRF) and, probably, the survival of PD patients. A balance between reduction of dry weight and preservation of RRF is crucial for the care of PD patients. Currently, only clinical measures like cardiothoracic ratio on chest X-ray and absence of pedal edema were used to evaluate PD patient's dry weight. There is no objective method to determine dry weight accurately. In this prospective and randomized study, the investigators will use multi-frequency bio-impedance (MF-BIA) to detect intracellular and extracellular water (ECW) content of patients.


Eligibility criteria: Inclusion Criteria:

* age 18 to 80

Exclusion Criteria:

* type I DM
* Severe heart failure
* unstable angina

Primary outcomes:
measure: systolic blood pressure
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Division of Nephrology, Taipei Veterans General Hospital
name: Jinn-Yang Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00367614: Study Evaluating Pantoprazole in Adolescents With GERD
Official title: A Multicenter, Randomized, Open-Label, Single And Multiple Dose Study Of The Pharmacokinetics And Safety of Two Dose Levels of Pantoprazole Sodium Tablets In Adolescents Aged 12 Through 16 Years With A Clinical Daignosis Of GERD.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux
Keywords: Adolescents
GERD
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-23
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is characterize the PK profile of single and multiple doses of pantoprazole in adolescents aged 12 to 16 years with Gastroesophageal Reflux Disease (GERD).


Eligibility criteria: Inclusion Criteria:

* 12-16 years old
* clinical diagnosis of GERD
* ability to swallow tablets

Exclusion Criteria:

* GI or malabsorption disorders
* chronic use of warfarin
* positive pregnancy test

Primary outcomes:
measure: Characterization of the PK profile of single and multiple doses of pantoprazole.
Secondary outcomes:
measure: Assess the safety and tolerability of pantoprazole.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02955914: The Effect of Patient Optimism & Pessimism on Recovery From Elective Cardiac Surgery
Official title: The Effect of Patient Optimism & Pessimism on Recovery From Elective Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Stress
Keywords: Optimism
Pessimism
Recovery
Elective Cardiac surgery
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2016-11-04
Enrollment: 419
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will be elective cardiac surgical patients undergoing major cardiac surgery.

Brief summary: Before a heart operation, patient outlook may be either pessimistic or optimistic. Previous research on this topic has focused on patient reported quality of life but has never examined measurable clinical outcomes such as length of hospital stay.This pilot study hopes to establish whether patient outlook (optimistic or pessimistic) before a heart operation can influence recovery and length of hospital stay. If there is a difference, then a case can be made for providing psychological support before an operation in the hope of modifying outlook and thus improving patient care and reducing hospital stay and NHS costs. Patients will be recruited over a 12month period. Their outlook (pessimistic or optimistic) will be ascertained using two standardised questionnaires. Their recovery and length of stay will be recorded. The study will answer the research question and determine whether outlook has an impact on recovery. Depending on the results, this study could provide opportunities for additional future research into modifying outlook with a view to improving patient care and recovery.


Eligibility criteria: Inclusion Criteria:

* Age over 18
* Elective planned cardiac surgery
* Consent to participate

Exclusion Criteria:

* Patients diagnosed with clinical depression
* Patients deemed not competent to provide consent

Primary outcomes:
measure: Length of hospital stay
timeFrame: Discharge from hospital (average of 10 days)
Secondary outcomes:
measure: Length of ITU stay
timeFrame: 2 days
measure: Risk-adjusted survival
timeFrame: Discharge from hospital (average of 10 days)
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
Study officials:
affiliation: Papworth Hospital NHS
name: Christine Mills
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06133114: Psychopharmacological Treatment of Emotional Distress
Official title: Psychopharmacological Treatment of Emotional Distress: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Suicide Crisis Syndrome
Psychological Distress
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 80
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: This is an inpatient four-arm randomized control trial comparing single drug clonazepam (S arm), a two-drug combination clonazepam/olanzapine (D arm), and a three-drug combination clonazepam/olanzapine/buprenorphine (T arm) with treatment as usual (TAU arm) in the treatment of emotional distress, specifically the Suicide Crisis Syndrome (SCS). All participants in experimental arms receive 2-day pulse treatments targeting four out of five of the acute emotional distress symptoms. The primary outcome measure is SCS at discharge and one-month follow-up. The secondary outcome measures include questions about suicidal behaviors associated with emotional distress at a one-month follow-up.


Eligibility criteria: Inclusion Criteria:

* Patient admitted to an inpatient unit and ruled in for SCS diagnosis using SCS-C
* Willing to stay in the hospital voluntarily, if medically necessary, for at least 4 days after enrolling in the study.
* Patient admitted to an inpatient unit as a result of a recent (i.e., past-month) suicide attempt, as defined by the C-SSRS (Columbia Suicide Rating Scale).
* Admitted to an inpatient unit in the last 36 hrs.
* Able to understand the nature and the substance of the consent form.
* Currently domiciled.
* Able and willing to provide verifiable contact information for follow-up.

Exclusion Criteria:

* Intellectual disability, cognitive impairment, or linguistic limitation precluding understanding of the consent or research questions.
* Past adverse reactions to clonazepam, olanzapine, or buprenorphine
* Past history of opiate or benzodiazepine use d/o in the last 2 years
* On agonist therapy for opiate addiction
* Ongoing treatment with clonazepam or olanzapine.
* Significant medical or neurological disease or possible delirium that might interfere with study participation or capacity to provide informed consent.
* Receiving involuntary treatment in psychiatric unit
* Clinical suspicion of malingering by a CP.
* Undomiciled.

Primary outcomes:
measure: Suicide Crisis Syndrome-Checklist (SCS-C)
timeFrame: up to 1 month follow up after discharge
Secondary outcomes:
measure: Suicide Crisis Inventory-Short Form (SCI-SF) for Severity
timeFrame: up to 1 month follow up after discharge
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Igor Galynker, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: