louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05371561: Effect of PPE on Children's Fear in Dental Office
Official title: Influence of Different Personal Protective Equipment on Children's Fear in Dental Office: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Infections
COVID-19 Virus Infection
Keywords: PPE
Dentist attire
Child behavior
dental fear
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: the aim of the current study is to compare the effect of conventional facial PPE as 1)goggles + surgical masks, and 2)face shields + surgical masks versus 3)half-face and 4)full-face reusable respirators; on preoperative child's fear in the dental office.

Detailed description: Each patient meeting the inclusion criteria and assigned to a specific study group will enter the clinic for dental examination. The examining dentist, wearing the selected PPE will communicate with patient and parent, taking personal, previous and current history, and carrying out simple examination not involving the use of sharp instruments, provoking pain or investigations as radiographs. The process should take from three to five minutes. Then, the child will be escorted to another room to meet a blinded accessor, where he assesses the child's anxiety using the Arabic version of children's fear survey schedule-dental subscale CFSS-DS.

Eligibility criteria: Inclusion Criteria:

* Six to ten-year-old patients

Exclusion Criteria:

* emergency patients
* patients who have systemic, mental or psychological conditions as indicated by their medical history,

Primary outcomes:
measure: Arabic version of children's fear survey schedule-dental subscale (CFSS-DS)
timeFrame: just after examination
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Faculty of Dentistry, Fayoum university
Study officials:
References:
citation: Azab MM. Influence of different personal protective equipment on children's anxiety in dental office: a randomized controlled trial. BMC Oral Health. 2022 Sep 22;22(1):421. doi: 10.1186/s12903-022-02442-5.
Clinical trial NCT00666861: Type 2 Diabetes and Exercise - A Pilot Study
Official title: Understanding the Acute Effects of Prolonged Sedentary Behaviour (Sitting) on Post-meal Glucose and Lipids - A Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type 2 Diabetes
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: International Diabetes Institute, Australia
name: Baker Heart Research Institute
First posted: 2008-04-25
Enrollment: 2
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Type 2 Diabetes

Brief summary: A randomised, cross-over trial targeting a small sample of older (age 45-65 years) overweight adults with type 2 diabetes the aims of this pilot study are to:

1. Determine the feasibility of investigating the acute effects of prolonged sedentary behaviour (sitting) in this target group.
2. Compare the acute effects of a single prolonged (8 hour) bout of sedentary behaviour (sitting) on glucose and triglyceride concentrations and key muscle and adipose regulatory enzymes to a similar bout of sedentary behaviour combined with intermittent bouts of light-intensity activity.

Detailed description: The proposed study will involve a randomised cross-over experimental trial conducted in the laboratory setting in older overweight adults with type 2 diabetes. Participants will receive both of the acute testing conditions in a randomised manner.

Study design: Randomised cross-over pilot trial of 20 overweight/obese older adults with diet-controlled type 2 diabetes involving 2 acute treatment conditions, with a one-week wash-out period between testing conditions (Figure 1 a).

Setting: Acute, supervised laboratory setting within the Alfred and Baker Heart Institute Medical Unit.

Outcomes: We will measure acute responses in laboratory-measured plasma glucose \& triglyceride levels (every 60 mins) and glucose concentrations determined from continuous glucose monitoring (CGMS).

Eligibility criteria: Inclusion Criteria:

1. Diet controlled Diabetes
2. Overweight (BMI \> 27 kg/m2 but \<50 kg/m2)

Exclusion Criteria:

1. Hypoglycaemic Agents
2. Lipid Lowering Agents

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: Baker Heart Research Institute
name: Bronwyn A Kingwell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05531461: Cognition and Imaging With Tigertriever
Official title: COGNITIVE Study- Cognition and Imaging With Tigertriever
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Lead sponsor: Rapid Medical
Sponsor class: INDUSTRY
First posted: 2022-09-08
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The COGNITIVE Study will include male or female subjects age 18-75 who present with LVO and treated with the Tigertriever as indicated per approved IFU.

Brief summary: The objective of the COGNITIVE Study is to evaluate whether successful reperfusion with Tigertriever is associated with cognitive benefit.


Eligibility criteria: Inclusion Criteria:

1. Patients admitted with large vessel occlusion (LVO) and treated with the Tigertriever, as indicated per the approved IFU.
2. Tigertriever was used as the first line treatment in the target vessel.
3. A signed informed consent.
4. Age 18-75 years (inclusive).
5. No known significant pre-stroke disability (pre-stroke mRS 0 or 1).

Exclusion Criteria:

1. Use of any other IA recanalization device prior to the Tigertriever in the target vessel, including aspiration catheter.
2. Evidence of acute brain hemorrhage on CT and/or MRI at admission.
3. Prior hemorrhage, stroke, thrombolysis, and/or endovascular therapy in the last 3 months.
4. Probable cerebral amyloid angiopathy.
5. Pre-stroke diagnosed dementia and/or prescribed cholinesterase inhibitors.
6. Pre-stroke diagnosed and/or currently treated major depression.
7. Pre-stroke learning or intellectual disability.
8. Anticipated inability to obtain 6-month follow-up assessments.

   -

Primary outcomes:
measure: Association between successful reperfusion* and cognitive benefit**
timeFrame: 180 days post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California
state: California
city: Grand Rapids
country: United States
facility: Corewell Health Research Institute
state: Michigan
city: New York
country: United States
facility: Westchester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT05498961: The Effect of Gallstone Characteristics for the Severity of Gallstone Pancreatitis
Official title: The Effect of Gallstone Characteristics for the Severity of Acute Gallstone Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Gallstone Pancreatitis
Keywords: Pancreatitis
Gallstone
Severity
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute gallstone pancreatitis patients

Brief summary: The purpose of this study was to determine the effect of gallstone characteristics for the severity of acute gallstone pancreatitis (GSP)

Detailed description: The timing of cholecystectomy is closely related to the severity of acute gallstone pancreatitis (GSP). The effect of gallstone characteristics (including stone size, number, etc.) for the severity of GSP are currently unknown.

Eligibility criteria: Inclusion Criteria:

* Acute gallstone pancreatitis (GSP) patients.

Exclusion Criteria:

* Pancreatitis with bile duct stones, trauma, drugs, and surgery;
* Recurrent gallstone pancreatitis;
* Combined with other malignant tumors, such as liver cancer, cholangiocarcinoma, pancreatic cancer, gastric cancer, Hematologic tumor, and lymphoma;
* Previous hepatobiliary and pancreatic surgery, Organ transplantation;
* Intestinal obstruction or other obstructive diseases;
* Chronic pancreatitis or pancreatic duct stones;
* Thrombotic disease;
* Alcoholic pancreatitis and hyperlipidemia pancreatitis.

Primary outcomes:
measure: Number of severity of GSP patients
timeFrame: 1 month
Secondary outcomes:
measure: Modified computed tomography severity index (MCTSI) score
timeFrame: 1 month
measure: Gallstone size
timeFrame: 1 month
measure: Number of stones
timeFrame: 1 month
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Hepatopancreatobiliary Surgery Institute of Gansu Province
state: Gansu
Study officials:
affiliation: LanZhou University
name: Wenbo Meng, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013 Jun;144(6):1252-61. doi: 10.1053/j.gastro.2013.01.068.
citation: Boxhoorn L, Voermans RP, Bouwense SA, Bruno MJ, Verdonk RC, Boermeester MA, van Santvoort HC, Besselink MG. Acute pancreatitis. Lancet. 2020 Sep 5;396(10252):726-734. doi: 10.1016/S0140-6736(20)31310-6.
Clinical trial NCT04327661: Motion Syros: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
Official title: Motion Syros: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness During Travel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Motion Sickness
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-03-31
Enrollment: 366
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: TREATMENT

Brief summary: A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in subjects affected by motion sickness during travel


Eligibility criteria: Inclusion Criteria:

* History of motion sickness
* Age 18-75

Exclusion Criteria:

* Nausea-inducing disorder other than motion sickness
* BMI\>40
* History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists

Primary outcomes:
measure: Prevention of Vomiting Measured by Vomiting Assessment (VA)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Pacific Research Network, LLC
state: California
city: Santa Monica
country: United States
facility: Santa Monica Clinical Trials
state: California
city: Fort Myers
country: United States
facility: Gulfcoast Psychiatric Associates
state: Florida
city: North Miami Beach
country: United States
facility: Harmony Clinical Research
state: Florida
city: Tampa
country: United States
facility: Avita Clinical Research
state: Florida
city: Quincy
country: United States
facility: Beacon Clinical Research
state: Massachusetts
city: New York
country: United States
facility: Manhattan Medical Research
state: New York
Study officials:
References:
Clinical trial NCT06446661: Using Text Messages to Improve Oral Chemotherapy for Adolescents and Young Adults With Acute Lymphoblastic Leukemia
Official title: Improving Oral Chemotherapy Adherence in Maintenance for Adolescents and Young Adults With Acute Lymphoblastic Leukemia Using Text Messages
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Keywords: Oral Chemotherapy
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 38
Sex: ALL
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this section is to learn how text message reminders might help with regularly taking chemotherapy medications for Adolescents and Young Adults (AYA) with Acute Lymphoblastic leukemia (ALL).

Detailed description: This study aims to compare adherence to oral mercaptopurine and methotrexate during the first 84-day cycle of maintenance therapy for adolescent and young adult patients with Acute Lymphoblastic Leukemia on pediatric-based regimens between those who receive the high intensity text message intervention and those who receive standard-of-care. It is believed that high-intensity text messages will increase patient adherence within cycle 1.

Eligibility criteria: Inclusion Criteria:

* Age of 15-39 years-old at the time of initial ALL diagnosis
* Diagnosed with ALL
* Currently receiving treatment with pediatric-based regimen that includes maintenance with mercaptopurine and methotrexate (e.g., CALGB 10403). Study participation begins with the start of maintenance, so enrollment occurs prior to the start of maintenance.

Exclusion Criteria:

* Patient or caregiver who would receive text message reminders does not have a cell phone that receives text messages
* Patient does not wish to participate

Primary outcomes:
measure: To compare adherence to oral chemotherapy with mercaptopurine and methotrexate
timeFrame: 84 days
Secondary outcomes:
measure: To describe the relationship between oral chemotherapy adherence and AYA patient factors
timeFrame: 1 year
Other outcomes:
measure: To compare percentage of time during maintenance at goal absolute neutrophil count (ANC) and platelet count for AYA patients
timeFrame: 1 year
measure: To compare clinical outcomes during and after maintenance therapy for AYA patients
timeFrame: 1 year
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Wendy Stock
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01021761: A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification
Official title: A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail, Xibrom and Nevanac in Patients Undergoing Phacoemulsification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataracts
Lead sponsor: Bucci Laser Vision Institute
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2009-11-30
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.


Eligibility criteria: Inclusion Criteria:

* Subjects must be 18 years of age or older
* Scheduled for cataract surgery by phacoemulsification
* Subjects must be willing to comply with all study requirements and be willing to give informed consent

Exclusion Criteria:

* Any subject that has a history of uveitis or active iritis
* Subject can have o previous eye surgery with the exception of refractive surgery but not within 6 month
* No ocular use of prostaglandins within 2 weeks of surgery
* Use of oral, injectable or topical ophthalmic steroids, NSAIDs of immunosuppressants within 14 days prior to surgery
* Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)
* Active ocular infection

Primary outcomes:
measure: Aqueous PGE2 Inhibition
timeFrame: Day 4 of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bucci Laser Vision
name: Frank A Bucci, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05237661: Study to Evaluate Your Super's Moon Balance and Its Impact on Premenstrual Syndrome
Official title: Study to Evaluate the Efficacy of Your Super's Moon Balance and Its Impact on Premenstrual Syndrome and Menstrual Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PMS
Menstrual Discomfort
Menstrual Pain
Lead sponsor: Your Super, INC.
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2022-02-14
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label observational single-group clinical trial to study the efficacy of a commercially available dietary supplement and its effect on common PMS and menstrual symptoms, as well as health-related biomarkers.

Detailed description: It is hypothesized that the dietary supplement marketed as "YOUR SUPER Moon Balance" will improve subjective wellbeing in trial participants by alleviating common symptoms of PMS and menstrual symptoms, such as pain, cramps, bloating, and lack of energy. Further, the ability of the supplement to reduce biomarkers of inflammation (CRP) and stress (cortisol), and promote sleep, will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Individuals with a regular menstruation
* Age 18-40
* Moderate self-reported discomfort during menstruation-related to bloating, cramps, fatigue, mood swings, or other PMS-related symptoms
* Must be in generally good health - no unstable, uncontrolled health condition
* BMI under 35
* Self-reported sleep-issues
* Willingness to refrain from ibuprofen or naproxen sodium (such as Advil, Aleve, Motrin or Midol) during each period (pill bleed) during the study
* Agree to not change their diet significantly during the duration of the study
* Agree to not change the intensity of their workouts for the duration of the study
* Must get their period regularly

Exclusion Criteria:

* Severe chronic conditions, including oncological and psychiatric disorders
* Known to have any severe allergic reactions
* Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study
* Participants unwilling to follow the study protocol
* Have used a similar product (ingredients) in the 6 weeks prior to the study

Primary outcomes:
measure: Change in perceived discomfort associated with menstruation
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in blood biomarkers: C-reactive protein
timeFrame: 12 weeks
measure: Changes in saliva cortisol levels
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
affiliation: Citruslabs
name: Susanne Mitschke
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06932861: Exploratory Study of Personalized mRNA Vaccine in Patients With Refractory Rhabdomyosarcoma
Official title: Exploratory Study of Personalized mRNA Vaccine in Patients With Refractory Rhabdomyosarcoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Rhabdomyosarcoma
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 5
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Exploratory Study on the Use of mRNA Tumor Vaccines in the Treatment of Refractory Rhabdomyosarcoma


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with rhabdomyosarcoma confirmed by pathological or molecular testing;
2. Age ≥ 6 years;
3. No known effective treatment available or no treatment proven to prolong survival with an acceptable quality of life;
4. Expected survival time greater than 6 months;
5. ECOG performance status score of 0-1; -

Exclusion Criteria:

* 1.History of or concurrent with other untreated malignant tumors, except for previously cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and superficial bladder cancer; 2.History of or current active autoimmune diseases. 3.Has uncontrolled cardiovascular diseases.

Primary outcomes:
measure: Adverse Event
timeFrame: From the first administration of the study drug until the occurrence of death, loss to follow-up, withdrawal of informed consent, initiation of a new anti-tumor therapy, or 21 days after the last dose, whichever comes first.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04988061: Proactive Counselling Towards Follow-ups in Newborn Hearing Screening
Official title: Result of Proactive Parental Educating and Counselling Towards Follow-ups in Parents Whose Infant Fail Newborn Hearing Screening
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hearing Loss
Newborn Morbidity
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims to investigate if proactive parental educating and counselling can minimize loss to follow-ups of parents whose infant fail newborn hearing screening.


Eligibility criteria: Inclusion Criteria:

* The parents whose infants do not pass hearing screening

Exclusion Criteria:

* The parents whose infants have illnesses and are not ready for hearing screening
* The parents who decide to migrate to other areas

Primary outcomes:
measure: Number of participants with loss to follow-ups in all participants whose infants require follow-ups
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Faculty of Medicine, Prince of Songkla University
state: Songkhla
Study officials:
References: