louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06205186: Four Pillars of Defense: A Whole Health Approach to the Military
Official title: Four Pillars of Defense: A Whole Health Approach to the Military
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Behavior
Keywords: Soldier
Resilience
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 400
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The overall objectives of this study are to better define the construct of psychological resilience in the military, to identify potential modifiable risk factors and trainable skills of psychological resilience in Soldiers, and provide a scalable, integrated physical and mental optimization training app to be integrated into relevant systems. The proposed work would be a first step in identifying predictive risk factors that can be modified to increase the future resilience of Soldiers. With this crucial information, the investigators aim to gather data that will inform the development of a resilience-focused intervention (e.g., a skills training program) and test the feasibility of that intervention.


Eligibility criteria: Inclusion Criteria:

* Age 21+ and either a Soldier in the NG or NG family member

Exclusion Criteria:

* Under age 21 and not an NG Soldier or family member

Primary outcomes:
measure: Resilience
timeFrame: 1 month
measure: Resilience
timeFrame: 1 month
measure: Emotion Regulation
timeFrame: 1 month
measure: Experiential Avoidance
timeFrame: 1 month
measure: Intolerance of Uncertainty
timeFrame: 1 month
measure: Coping
timeFrame: 1 month
measure: Positive and Negative Social Exchanges
timeFrame: 1 month
measure: Post Traumatic Stress Disorder (PTSD)
timeFrame: 1 month
measure: Sleep
timeFrame: 1 month
measure: Social Support
timeFrame: 1 month
measure: Responses to Stressful Experiences
timeFrame: 1 month
measure: Unit Cohesion
timeFrame: 1 month
measure: Depression
timeFrame: 2 weeks
measure: Anxiety
timeFrame: 2 weeks
measure: Stress
timeFrame: 1 month
measure: Drug Abuse
timeFrame: 12 months
Secondary outcomes:
measure: Topics Ranking
timeFrame: 1 month
measure: Technology Use
timeFrame: 1 month
measure: Program Satisfaction
timeFrame: 6 Months
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
Clinical trial NCT00162786: Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance
Official title: Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Healthy
Keywords: Driving performance
Antihistamine
Lead sponsor: J. Uriach and Company
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to measure and compare the acute effects of rupatadine 10 mg, relative to placebo and hydroxyzine 50 mg as an active control on healthy volunteers' performance on a standard over-the-road driving test and a car-following test.

Detailed description: The study shall be conducted according to a three-way, double-blind, placebo and active controlled crossover design. Treatment groups are identified as follows.

* Rupatadine
* Hydroxyzine
* Placebo

Eligibility criteria: Inclusion Criteria:

1. Normal healthy males or females
2. Subjects must be experienced drivers.
3. Vision: normal binocular acuity, corrected, or uncorrected.

Exclusion Criteria:

1. Pregnant or nursing females.

Primary outcomes:
measure: Actual driving performance
Secondary outcomes:
measure: Daytime sleepiness
measure: Subjective sleepiness
measure: Alertness
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Brain and Behaviour Institute
Study officials:
affiliation: Maastricht University, Brain and Behaviour Institute
name: Erik Vuurman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00924586: Study of ONO-1101 in Patients Scheduled for Multi-Slice Computed Tomography (CT)
Official title: Study of ONO-1101 in Patients Scheduled for Multi-Slice Computed Tomography (CT), a Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2009-06-19
Enrollment: 258
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients scheduled for multi-slice CT, in a double-blind, randomized, placebo-controlled, parallel group, multi-center study.


Eligibility criteria: Inclusion Criteria:

* ≥ 20 years old
* Heart rate ≥ 70beats/min and ≤ 90beats/min at entering the CT room and just before dosing organic nitrates.

Exclusion Criteria:

* Previous allergic reactions to contrast agent
* Renal failure
* Asthma

Primary outcomes:
measure: Image quality
timeFrame: one day
Secondary outcomes:
measure: Heart rate
timeFrame: 5 days maximum
Other outcomes:
Locations:
city: Kanto
country: Japan
facility: Kanto Region
city: Kyushu
country: Japan
facility: Kyushu Region
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Mitsunobu Tanimoto
role: STUDY_DIRECTOR
References:
Clinical trial NCT05655286: Effectiveness of SDF With Different Post-treatment Protocols in Arresting Dental Caries
Official title: The Effectiveness of Silver Diamine Fluoride Treatment With Different Post-treatment Protocols in Arresting Dental Caries in Primary Teeth of Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: dental caries
preschool children
silver diamine fluoride
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 254
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effectiveness of the semi-annual application of 38% SDF with two post-treatment protocols in arresting dental caries in preschool children

Detailed description: Methods: The randomized clinical trial will recruit 254 healthy kindergarten children aged 3-4 years old with caries and with parental consent. All the tooth surfaces with carious lesions will receive the semi-annual application of 38% SDF solution. After the treatment, children will be allocated to two groups by an independent research assistant. Two post-treatment protocols are as follows.

Group A - Children are instructed to rinse their teeth with a cup of water containing about 50 ml immediately after SDF treatment. Afterwards, no post-treatment protocol is given to children.

Group B - Children are instructed not to eat and drink for at least 30 minutes. Clinical examinations after 6-months will be conducted to assess whether the caries is arrested. Information on confounding factors, such as oral hygiene habits and the use of other fluoride agents, will be collected through a parental questionnaire at the baseline and 12-months follow-up. The analysis will determine the significance of differences between the percentage of arrested caries at the various follow-ups.

Significance: This study will help determine the optimal post-op treatment in SDF treatment. The study provides an evidence-based protocol for the use of silver diamine fluoride to arrest tooth decay in primary teeth of young children.

Eligibility criteria: Inclusion Criteria:

1. 3-5 year old children attending the first to the third year of kindergarten;
2. free from any systemic conditions and generally healthy;
3. parents sign informed consent;
4. having at least 1 tooth with cavitated dentine carious lesion

Exclusion Criteria:

1. are uncooperative to accept oral examination or treatment;
2. have a significant systematic disease or long-term medications;
3. have abnormal dentition.
4. Teeth having signs or symptoms of irreversible pulpitis and non-vitality will be excluded.

Primary outcomes:
measure: Caries status
timeFrame: at 12-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The university of Hong Kong
Study officials:
References:
Clinical trial NCT05066386: Improving the Accuracy of Revised Cardiac Risk Index With HbA1C:Hemoglobin Ratio (HH Ratio)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Risk Stratification
Perioperative Medicine
Keywords: HbA1C: Hemoglobin ratio (HH ratio)
Risk model
RCRI
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 20099
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing non cardiac surgery in Singapore General Hospital

Brief summary: Retrospective observational study on the effects of altering components of RCRI to improve the predictive capacity.

Detailed description: The current Lee's Revised cardiac risk index (RCRI) was created in 1999. Validation studies have found RCRI to be only moderately discriminant. The "Diabetes Mellitus on insulin" component of the score does not accurately reflect the severity of the disease. A previously studied HbA1C:Hemoglobin ratio shows an improved association with outcomes than individual components alone and could be potentially used as a new marker for severity of the disease.

A retrospective cohort study was performed in consecutive diabetic patients undergoing non-cardiac surgery. Ethics approval was obtained. The objective of the study is to compare the predictive value of RCRI and substitution of the "DM on insulin" component with HH ratio for 30- and 90-day mortality, and postoperative acute myocardial injury(AMI) and acute kidney injury(AKI).

Eligibility criteria: * Above 18 years old
* Past medical history of Diabetes Mellitus or preoperative HbA1C \> 6.5% (within 3 months of surgery)
* Had HbA1C done within 3 months prior to date of surgery
* Undergoing non cardiac surgery
* Emergency and elective surgery

EXCLUSION:

* If patient is below 18 years old
* no History of DM
* No HbA1C done within 3 months prior to date of surgery

Primary outcomes:
measure: Mortality
timeFrame: 90 days
Secondary outcomes:
measure: Morbidity
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03875586: Consultation Reasons in Family Medicine
Official title: EMOCONSULT : Consultation Reasons in Family Medicine, a Tunisian National Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Evaluate the Reasons for Consultation in Family Medicine
Keywords: Reasons for consultation
Family Medicine
Lead sponsor: Dacima Consulting
Sponsor class: OTHER
Collaborators: name: Tunisian Society of Family Medicine (STMF)
First posted: 2019-03-15
Enrollment: 10822
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients consulting in general medicine / family medicine.

Brief summary: The Tunisian society of family medicine STMF proposes to coordinate a national, observational, transversal and multicenter survey, at the consultations of general medicine / family medicine.

Detailed description: The Tunisian society of family medicine STMF proposes to coordinate a national, observational, transversal and multicenter survey carried out during two weeks, at the consultations of general medicine / family medicine. The main objective of the survey is to describe the reasons for consultation in general medicine / family medicine. The results obtained from this survey will make it possible to specify the specificities inherent to the reasons for consultations of Tunisians but especially to the peculiarities of the local health system (public and private). This survey will help us to assimilate our practices and harmonize them in order to optimize patient care and reposition family medicine in the patient's care path as well as the degree of adherence of practitioners to international recommendations in the care of the patient.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Informed consent, read and signed

Exclusion Criteria:

• Consent not obtained

Primary outcomes:
measure: Describe the reasons for consultation in family medicine / general medicine
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: STMF - Société Tunisienne de Médecine de Famille
city: Tunis
country: Tunisia
facility: DACIMA
Study officials:
affiliation: STMF
name: Maha Ben Moallem Hachicha, MD
role: STUDY_CHAIR
affiliation: STMF
name: Zied Ben Lamine, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00000286: Effects of Nefazodone on Treatment of Female Cocaine Abusers - 3
Official title: Effects of Nefazodone on Treatment of Female Cocaine Abusers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Minnesota
First posted: 1999-09-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of nefazedone on cocaine self-administration in depressed and non-depressed female cocaine users.

Detailed description: This study evaluated the effect of nefazodone on reducing cocaine use and craving in both depressed and nondepressed women and if there was a greater effect in depressed women.

Eligibility criteria: Inclusion Criteria:

Females, ages 18-55, minimum use of 8 days of the last 30, minimum of 8th grade education, current diagnosis of cocaine abuse/dependence

Exclusion Criteria:

Unstable medical illness, dx of MR, OBS, bipolar

Primary outcomes:
measure: Craving
measure: Drug use
measure: Depression
measure: Life functioning
measure: HIV risk behaviors
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05564286: Triple Antiemetic Regimen for Chemoradiotherapy in Cervical Cancer or Nasopharyngeal Cancer
Official title: Fosaprepitant Combined With Tropisetron Plus Dexamethasone in Preventing Nausea and Emesis During Fractionated Radiotherapy With Weekly Cisplatin Chemotherapy in Cervical Cancer and Nasopharyngeal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Cancer
Nasopharyngeal Cancer
Chemotherapy-induced Nausea and Vomiting
Radiation-Induced Nausea and Vomiting
Antiemetic
Lead sponsor: Shantou University Medical College
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 116
Sex: ALL
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 study is to evaluate the antiemetic effect of adding fosaprepitant to biplet regimen of tropisetron and dexamethasone for patients with cervical cancer or nasopharyngeal cancer treated with radiotherapy and concomitant weekly cisplatin chemotherapy in a south Chinese cohort.

Detailed description: The study was designed as a prospective,randomized, single-blind control clinical trial aiming to assess the efficacy and safety of fosaprepitant combined with tropisetron and dexamethasone in preventing nausea and vomiting during 5 weeks of fractionated radiotherapy and concomitant weekly low-dose cisplatin chemotherapy in patients with cervical cancer or nasopharyngeal cancer.

Eligibility criteria: Inclusion Criteria:

* histologically confirmed nasopharyngeal carcinoma (AJCC 8th stage II-IVa) or cervical cancer (adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma, clinical FIGO stage Ib2-IVa;), planning to receive concurrent chemoradiotherapy),18 years or older, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Exclusion Criteria:

* took medications with antiemetic effect within 24 hours before initiation of concurrent chemoradiotherapy, had severe systemic diseases (such as uncontrolled diabetes/hypertension) or clinically unstable epileptic seizures require the use of anticonvulsants; allergic to fosaprepitant, tropisetron or dexamethasone.

Primary outcomes:
measure: cumulative incidence of emesis overall phase
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shantou
country: China
facility: Cancer Hospital of Shantou University Medical College
state: Guangdong
Study officials:
affiliation: Shantou University Medical College
name: Chuangzhen Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03956186: Can Right Toe Perfusion Index or Pleth Variability Index Predict Spinal Anesthesia Induced Hypotension?
Official title: Can we Predict Predict Spinal Anesthesia Induced Hypotension During Caesarean Section Using Right Toe Perfusion Index or Pleth Variability Index?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section Complications
Hypotension
Spinal Anesthesia
Perfusion Index
Pleth Variability Index
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Parturients scheduled for elective low segment caesarean section under spinal anesthesia

Brief summary: Spinal anesthesia for caesarean section is associated with a decrease in systemic vascular resistance and cardiac output and may cause hypotension in a significant portion of the parturients. Hypotension during delivery may cause maternal and fetal complications. If parturients who are likely to develop hypotension after spinal anesthesia can be identified before surgery, anesthesiologists would have opportunity to take measures such as prophylactic vasopressor administration. Perfusion index (PI) measured by pulse oximetry reflects vasomotor tone which affects the degree of hypotension after spinal anesthesia. This is a non-invasive method of assessing the relative vascular tone with the use of pulse oximeter which calculates the ratio of pulsatile versus the non-pulsatile component of the blood flow. A lower PI indicates greater peripheral vasomotor tone. Pleth variability index (PVI) is calculated using maximum and minimum values of perfusion index during respiratory cycles. PVI is one of the dynamic indices that can predict fluid responsiveness. There are several studies investigating the predictive value of finger PI and PVI on hypotension after spinal anesthesia. However the aortocaval compression by the gravid uterus directly effects the lower extremity perfusion. So, in this study we aimed to investigate whether the right toe PI and PVI values at supine and left lateral positions can predict hypotension during caesarean section.


Eligibility criteria: Inclusion Criteria:

* singleton parturient
* planned for elective LSCS under spinal anesthesia

Exclusion Criteria:

* gestational age \< 36 weeks

  * emergency cases
  * placenta previa, pre-eclampsia
  * BMI\>40
  * Reynauld disease
  * patient refusal
  * cardiovascular disease

Primary outcomes:
measure: pleth variability index (PVI)
timeFrame: perioperative
measure: Perfusion index (PI)
timeFrame: perioperative
Secondary outcomes:
measure: blood pressure (mmHg)
timeFrame: perioperative
Other outcomes:
Locations:
city: Kahramanmaras
country: Turkey
facility: Kahramanmaras Sutcu Imam University
state: In The USA Or Canada, Please Select...
Study officials:
affiliation: KSU school of medicine
name: MAHMUT ARSLAN
role: STUDY_DIRECTOR
References:
Clinical trial NCT02544386: Impact of Hemiplegia Due to Stroke on the Microarchitecture of the Bone
Official title: Impact of Hemiplegia Due to Stroke on the Microarchitecture of the Bone: Evaluation Using Micro CT 3D High Resolution and by Magnetic Resonance Imaging (MRI)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stroke
Hemiplegia
Keywords: bone microarchitecture
hemiplegia
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient aged at least 30 who have experienced a vascular hemiplegia within 30 days before enrollment

Brief summary: In hemiplegic, there is very little data on the impact of neurological deficit on the microarchitecture independent of bone mineral density and composition of the bone marrow. Rare studies have shown the relationship between some micro-architectural parameters and severity of neurological deficit. There is no study in humans on the evolution of the parameters of the microarchitecture assessed by 3D micro-tomography in the early phase of the installation of neurological deficits after stroke, in terms of a bearing bone, tibia, that a non-load bearing bones, radius.

Detailed description: Each patient must answer several questionnaires about their calcium intake and its ability to perform everyday tasks. They will also have 3 blood samples (15 ml each time), 3 measure of bone by 3D micro-tomography and 2 MRI examination. These examinations and sampling will take place after 30 days after stroke onset (except for MRI) and again after three months and six months after the stroke (the same day as the medical follow-up visit).

Eligibility criteria: Inclusion criteria

* at least 30 years
* vascular hemiplegia
* National Institute of Health Stroke Score equal 4 or greater with a motor of upper limb score greater than or equal 2 and a motor score of greater than or equal legs 2

Exclusion criteria

* Concomitant bone disease
* Endocrinopathies
* Phasic disorders understanding
* Contra-indication to MRI

Primary outcomes:
measure: Bone volume / tissue volume
timeFrame: 90 days
Secondary outcomes:
measure: Bone volume / tissue volume
timeFrame: 1 day
measure: intraosseous fat
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Thierry THOMAS, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: