louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04090983: Cognitive-Behavioral Therapy for Adults With Attention-Deficit/Hyperactivity Disorder Inattentive Presentation
Official title: Group-Based Cognitive-Behavioral Therapy for Adults With Attention-Deficit/Hyperactivity Disorder Inattentive Presentation: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD Predominantly Inattentive Type
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using a randomized controlled design, standard treatment of group cognitive-behavioral therapy (CBT) according to the Hesslinger protocol is compared to a newly developed group treatment specifically designed for adult patients with ADHD inattentive presentation (ADHD-I) called CBT for ADHD-I (CADDI). Research setting is psychiatric outpatient clinics. Research hypotheses include: 1. The CADDI protocol is more effective than standard treatment in terms of behavioral activation, procrastination, depressive symptoms, functional impairment, and quality of life, 2. Is equally effective in terms of ADHD symptoms, 3. Is more appreciated and tolerable, and 4. Outcome is mediated by mindful awareness. Effects are followed up at 6 and 12 months post treatment.


Eligibility criteria: Inclusion Criteria:

1. Principal diagnosis of ADHD inattentive presentation
2. 18 years of age or older
3. If on medication, it needs to be well-established since three months, and
4. Prior psycho-educational intervention

Exclusion Criteria:

1. Intellectual impairment
2. Substance use disorder
3. Difficulties in adherence to medical or other treatment
4. Social and/or psychiatric problems to such an extent that they prevent focusing on treatment, or
5. Simultaneous psychological treatment

Primary outcomes:
measure: Behavioral Activation for Depression Scale
timeFrame: 14 weeks
measure: Pure Procrastination Scale
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Södertälje
country: Sweden
facility: Psychiatry Centre Södertälje
state: Stockholm
Study officials:
affiliation: Karolinska Institutet
name: Benjamin Bohman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03169283: Investigation of How Morning Nutrition Influences Cognitive Performance
Official title: Investigation of How Morning Nutrition Influences Cognitive Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Performance
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2017-05-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This project will assess the effects of the macro-nutrient make-up of morning food intake on cognitive performance using visual analog scale (VAS) measures, behavioral tests, and advanced high-density electrophysiological techniques (256-channel recordings). Two Isocaloric cereal products will be tested and compared to determine if measures of cognitive performance as well as satiety will change after consumption.


Eligibility criteria: Inclusion Criteria:

* Healthy and taking no regular medications other than birth control or hormone replacement therapy
* Willing to use an effective contraceptive during the study, if sexually active and capable of bearing children
* Willing and able to sign informed consent
* Normal or corrected-to-normal vision
* Normal or corrected-to-normal hearing
* No history of neurological or psychiatric illness, including major depressive disorder and attention deficit disorder
* No history of substance, nicotine or alcohol dependence
* BMI below 35

Exclusion Criteria:

* Women who are pregnant or nursing
* Gain or loss of \> 4kg in the last 3 months.
* Currently taking supplements or medications for weight loss
* Currently taking medications for neurological or psychiatric illness
* Diabetes mellitus (fasting glucose \>126 mg/dL) or history of diabetes
* Dietary restraint on the Three Factor Eating Questionnaire score greater than or equal to 14
* Allergy to any of the foods used for the test breakfasts (oats or milk)
* History of GI disorders or GI surgical procedures for weight loss
* History of eating disorders
* Daily consumption of more than 400 mg of caffeine

Primary outcomes:
measure: cognitive performance
timeFrame: 0-4 hours
Secondary outcomes:
measure: subjective measures of hunger
timeFrame: 0-4 hours
Other outcomes:
Locations:
city: The Bronx
country: United States
facility: The Sheryl and Daniel R. Tishman Cognitive Neurophysiology Laboratory
state: New York
Study officials:
affiliation: The Sheryl and Daniel R. Tishman Cognitive Neurophysiology Laboratory
name: John Foxe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilson TJ, Gray MJ, Van Klinken JW, Kaczmarczyk M, Foxe JJ. Macronutrient composition of a morning meal and the maintenance of attention throughout the morning. Nutr Neurosci. 2018 Dec;21(10):729-743. doi: 10.1080/1028415X.2017.1347998. Epub 2017 Jul 17.
Clinical trial NCT06174883: Salt-FA to Increase Folate Levels
Official title: Folic Acid-fortified Iodized Salt and Serum Folate Concentration in Reproductive-aged Women of Rural India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neural Tube Defects
Folic Acid Deficiency
Spina Bifida
Anencephaly-Spina Bifida
Lead sponsor: Hydrocephalus and Neuroscience Institute
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women of childbearing age who are non-lactating and willing to consume the study salt for the duration were recruited for voluntary participation into the study.

Brief summary: Question: How effective is folic acid-fortified iodized salt in increasing serum folate concentrations among non-pregnant and non-lactating women of reproductive age? Hypothesis: Folic acid-fortified iodized salt can increase serum folate levels and serve as a policy consideration in salt fortification with both iodine and folic acid to reduce serious and fatal birth defects.

Detailed description: Salt is an ideal vehicle for fortification because its universal consumption and often centrally processed with established distribution channels. Over 70% of households globally have access to iodized salt. Considering the success of salt iodization, it is logical to use the existing infrastructure to provide folic acid through this dietary mechanism.

AIM:To assess increase in blood folate concentrations among women of reproductive age after they consume folic acid-fortified iodized salt.

OBJECTIVES :

1. To examine the effect of consumption of salt fortified with folic acid on serum/plasma folate concentrations among women of reproductive age.
2. To estimate the raise in serum iron, B12 and folate levels after 3 months of study salt consumption.

Eligibility criteria: Inclusion Criteria: • Willing to voluntarily participate in the study

* Can comprehend and comply with study requirements
* Aged between 18 and 45 years.
* No documented issues with child bearing potential
* Resident of the area of study for duration of study.
* Consume only study salt during study

Exclusion Criteria:

* Taking multivitamins or FA during study
* Pregnant or lactating at recruitment or during study
* Co-morbidities such as Malabsorption disorders, severe anemia (Hgb \<8.0 g/dL), uncontrolled hypertension, (SBP ≥140 mm Hg or DBP ≥90 mm Hg), HIV, active TB or malaria infection
* History of prior SBA delivery
* Pre-existing medical conditions (i.e., cancer or need for regular medications)

Primary outcomes:
measure: Measure changes in median serum folate levels between baseline and study endpoint
timeFrame: 2-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Pediatric Neurosurgery
state: Florida
Study officials:
affiliation: Pediatric Neurosurgery
name: Jogi Pattisapu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02265783: Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable
Official title: Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Focus of Study: Healthy Volunteers
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2014-10-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to validate that the device posts a Sensor-Off message within the time frame stated in the proposed claims.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects 18 or older (inclusive)
* Subject is able to participate for the duration of the study
* Subject is willing to sign an informed consent

Exclusion Criteria:

* Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors
* Physiologic abnormalities that prevent proper application of pulse oximetry sensor
* Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes

Primary outcomes:
measure: Report the Time Until the Device Posts "Sensor Off" After the Sensor is Removed
timeFrame: 1 minute per event, multiple events per subject. Total duration up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Boulder Clinical Laboratory
state: Colorado
Study officials:
affiliation: Medtronic - MITG
name: Eric Heyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02956083: The Effect of Tear Supplements on Contact Lens Comfort
Official title: The Effect of Tear Supplements on Contact Lens Comfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Meibomian Gland Dysfunction
Lead sponsor: University of the Incarnate Word
Sponsor class: OTHER
First posted: 2016-11-04
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary goal of this investigation is to determine if lipid based artificial tear supplementation has an impact on contact lens discomfort (CLD).

Detailed description: Contact lens discomfort (CLD) is the most common cause of discontinuing contact lens wear. Despite years of research and innovations in technology, CLD remains highly prevalent, and thus it is a major concern for patients and practitioners. Studies suggest that meibomian gland dysfunction (MGD) is a cause of CLD. Several lipid-based artificial tears have recently been designed to address dry eye associated with MGD. In this study, the investigators examine if the benefits of lipid based artificial tears extend to improving contact lens comfort. Studies have demonstrated some usefulness of non-lipid based tear supplements in the management of contact lens discomfort. However, the relief was moderate and short-term. To date, no study has examined the impact of lipid based artificial tears on contact lens discomfort. In this study, the investigators will address this gap in knowledge.

Eligibility criteria: Inclusion Criteria:

* Patients complaining of contact lens associated discomfort

Exclusion Criteria:

* Patients who do not have contact lens discomfort; patients who have active inflammation or infection of the anterior segment of the eyes.

Primary outcomes:
measure: Contact Lens Discomfort Questionnaire
timeFrame: 1 months
Secondary outcomes:
measure: Fluorescein tear break-up time
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: University of the Incarnate Word
name: Srihari Narayanan, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06593483: Increasing Effectiveness of an Alcohol Use Reduction Exercise Using Self-Talk Videos
Official title: Increasing Effectiveness of an Alcohol Use Reduction Exercise Using Self-Talk Videos
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heavy Drinking
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 120
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 the current study is to develop and test an innovative, low-burden method of post-intervention contact that is based on principles of motivational interviewing and the elicitation of change talk. Participants will be randomly assigned to an assessment only control group, a standard BMI group or a BMI + video group. Participants in the BMI and BMI + video groups will complete a semi-structured, motivational intervention. Following the intervention, participants in the BMI + video group will be asked to create a personalized video in which they speak to their future self and describe their reasons for wanting to reduce their alcohol use and their commitment to change. Doctoral level psychology graduate students will assist participants in idea generation and creation of the post-intervention video. Video group participants will then be sent their personalized videos 21 days after the baseline session, a time when motivation to reduce drinking often begins to wane. It is hypothesized that participants in the BMI + video group will rate the video exercise as helpful, encouraging, and easy to complete. It is further hypothesized that, over the 6-week intervention period, (1) participants in the BMI + video group will reduce their alcohol use more than those in the standard BMI and control groups and (2) participants in the standard BMI group will reduce their alcohol use more than those in the control group.


Eligibility criteria: Inclusion Criteria:

* Meets National Institute on Alcohol Abuse and Alcoholism criteria for heavy drinking
* 18 year or older
* Accessibility to internet and laptop with camera and microphone

Exclusion Criteria:

* Failure to meet inclusion criteria

Primary outcomes:
measure: Alcohol Consumption
timeFrame: 6 weeks post intervention
measure: Motivation to Change Rating Scale
timeFrame: 6 weeks post intervention
Secondary outcomes:
measure: Rating Scales Assessing Satisfaction with the Intervention
timeFrame: 6 weeks post intervention
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
References:
Clinical trial NCT03131583: The Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With Gout
Official title: A Phase I, Single-Center, Open-Label, Single-Group Study to Evaluate Potential Pharmacodynamics of Drug-Drug Interaction Between SHR4640 and Febuxostat and Between SHR4640 and Colchicine in Patients With Gout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout
Keywords: SHR4640 Febuxostat Colchicine pharmacodynamics
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-04-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640, Febuxostat and Colchicine interaction in patients with gout.


Eligibility criteria: Inclusion Criteria:

1. Subject has a body mass index ≥18.5 and ≤30 kg/m2;
2. Screening sUA value ≥8mg/dl;
3. Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.

Exclusion Criteria:

1. Subject known or suspected of being sensitive to the study drugs or its ingredient；
2. sCr\>ULN;
3. History of kidney stones or screening kidney stones by B-ultrasound；
4. History of malignancy within 5 years；
5. History of xanthinuria；
6. Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood。

Primary outcomes:
measure: Maximun observed concentration (Cmax) of Febuxostat and Colchicine from plasma
timeFrame: Clinical significant changes from baseline up to Day 8
measure: Area under the concentration-time curve (AUC) of Febuxostat and Colchicine from plasma
timeFrame: Clinical significant changes from baseline up to Day 8
measure: Apparent terminal half-life (t1/2) of Febuxostat and Colchicine from plasma
timeFrame: Clinical significant changes from baseline up to Day 8
Secondary outcomes:
measure: Incidence of Adverse events
timeFrame: Clinical significant changes from Day-14 up to Day 16
measure: Changes in Laboratory Values
timeFrame: Clinical significant changes from Day-14 up to Day 16
measure: Changes in Electrocardiogram
timeFrame: Clinical significant changes from Day-14 up to Day 16
measure: Changes in Vital Signs Parameters
timeFrame: Clinical significant changes from Day-14 up to Day 16
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References:
Clinical trial NCT02163083: Detection of Lymphnodes Using ICG During RARP
Official title: Detection of Lymph Nodes by Means of Intraoperative Fluorescence Lymphography Using Indocyanine Green (ICG) During the Radical Robot-assisted Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: St. Antonius Hospital Gronau
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate, whether the detection of lymph nodes by means of intraoperative fluorescence lymphography as part of lymphadenectomy in robot-assisted radical prostatectomy is higher than without the use of indocyanine green (ICG).

Detailed description: ICG is a fluorescent dye that fluoresces green bound to proteins under illumination in the near-infrared range. Using this dye allows to visualize lymphatic nodes, by being injected into the tumor or directly surrounding tissue.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed locally limited prostate cancer;
* Intermediate or high risk tumor
* Recommended and planned prostatectomy;
* Completed and signed written consent;
* Voluntarily agreement to participate in this study
* Age of the study participants ≥ 18 years.

Exclusion Criteria:

* Allergic reaction to active ingredient (indocyanine green);
* Iodine allergy;
* Hyperthyroidism;
* High-grade renal impairment;
* High-grade hepatic insufficiency;
* Unwillingness to the storage and disclosure of pseudonymous disease and personal data
* psychiatric pre-existing conditions or other circumstances that make a cooperation by the patient in question

Primary outcomes:
measure: The total number of detection rate of (positive) lymph nodes using ICG
timeFrame: during the surgery
Secondary outcomes:
measure: Measurements of the time, that takes to remove the lymph nodes
timeFrame: During the surgery
Other outcomes:
measure: Determine the anatomical location of the ICG-positive lymph node
timeFrame: During th surgery
Locations:
city: Gronau
country: Germany
facility: St. Antonius Hospital Gronau, Department for Urology, Pediatric Urology and Urologic Oncology
state: Moellenweg 22
Study officials:
affiliation: St. Antonius Hospital Gronau
name: Jörn H. Witt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00177983: Web-based Support for People With Schizophrenia and Their Families
Official title: Support to Patients and Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Relapse Rates Related to Website Usage
Keywords: Schizophrenia
Relapse
Psychological distress
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-15
Enrollment: 80
Sex: ALL
Minimum age (years): 14
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: This study will assess the feasibility of using the internet and in-home computers to provide advice from health care professionals, social support, and health information to people with schizophrenia and their families.

Detailed description: The objective of this study is to assess the feasibility of using the World Wide Web (Web) and in-home computers to provide patients suffering from schizophrenia and their families advice from health care professionals, social support, and information.

The purposes of this intervention are to improve: 1) the availability, convenience and use of needed mental health services; 2) family support for their ill family members; and 3) patient and family outcomes.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia Able to speak and read English Regular contact with a family member

Exclusion Criteria:

* Enrolled in another study

Primary outcomes:
measure: The outcome, patient relapse, will be assessed for the patients in the intervention group and control group by estimating the size of the intervention's effect on relapse rate.
Secondary outcomes:
measure: For the primary caregiver, the distribution of the psychological distress measure will be examined and transformation will be made if necessary for further analysis.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Armando J Rotondi, PhD
role: PRINCIPAL_INVESTIGATOR
References: