louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02738229: Should We Use Oral Valacyclovir in Acute Herpetic Gingivostomatitis in Children?
Official title: Should We Use Oral Valacyclovir in Acute Herpetic Gingivostomatitis in Children? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Herpetic Gingivostomatitis
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Association of Emergency Physicians
First posted: 2016-04-14
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary herpetic gingivostomatitis is a frequent problem in pediatrics. Complications of this are dehydration, pain and hospitalisation. The objective of this randomized controlled trial is to assess the clinical efficacy of oral Valacyclovir to decrease the duration of symptoms associated with acute herpes gingivostomatitis in children. This study will involve 80 children aged 1 to 8 years old to receive weight adjusted doses of valacyclovir for 7 days. The primary outcome measure will be the duration (in days) of feeding and/or drinking difficulties.


Eligibility criteria: Inclusion criteria are :

* Children from 10 to 28 Kg of weight. The inclusion of participants is based on weight for practical/feasibility reasons because the study medication will be provided in tablet format. The lower limit of 10 kg is to limit to three strata of weight and limit costs engendered by the preparation of medication.
* Clinical diagnosis of herpetic gingivostomatitis according to the treating physician. This is described by the presence of:

  * Fever (\>38.5° rectal, \>38° oral) AND
  * Vesicular or ulcerative lesions located in the anterior of the mouth
  * Associated or not with perioral vesicular lesions Visiting the emergency department within the first 96 hours of the disease begin.

Exclusion criteria are :

* Duration of fever \> 4 days
* Hospitalised patients
* Immunocompromised patients
* Patients with known hypersensitivity to Valacyclovir
* Patients with renal failure
* Children with complete incapacity of oral treatment intake
* Unable to be contacted for phone follow-up

Primary outcomes:
measure: Duration of feeding and/or drinking difficulties
timeFrame: 2 weeks
Secondary outcomes:
measure: duration of fever
timeFrame: 2 weeks
measure: duration of pain
timeFrame: 2 weeks
measure: duration of oral lesions
timeFrame: 2 weeks
measure: global parent satisfaction
timeFrame: 2 weeks
measure: duration of school or work absence
timeFrame: 2 weeks
measure: utilisation of medical resources
timeFrame: 2 weeks
measure: adverse side effects
timeFrame: 2 weks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
References:
Clinical trial NCT06176729: Pola-R2 in Newly Diagnosed Non-fit Elderly DLBCL Patients
Official title: A Prospective Phase II Study of Polatuzumab, Rituximab, and Lenalidomide(Pola-R2) in Newly-diagnosed Non-fit Elderly DLBCL Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
name: Peking University First Hospital
name: Chinese PLA General Hospital
First posted: 2023-12-20
Enrollment: 30
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-arm, phase II study, and the purpose of this study is to evaluate the efficacy and safety of Pola-R2 regimen in newly diagnosed elderly diffuse large B cell lymphoma classified into un-fit or frail group by comprehensive geriatric assessment(CGA).

Detailed description: In this prospective study, all the eligible patients will be given Pola-R2 regimen(polatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days). An interim evaluation will be performed after 4 cycles, the patients who achieve CR or PR will receive another 4 cycles of Pola-R2.

The patients with stable disease (SD) or progressed disease (PD) will withdraw from the trial and receive salvage regimens.

Eligibility criteria: Inclusion Criteria:

* The patient volunteered to participate in the study and signed the Informed Consent
* Histopathologically confirmed DLBCL and treatment naive(corticosteroids alone is not considered as a line of treatment)
* Age≥ 70 years old, and was un-fit or frail according to comprehensive geriatric assessment
* Adequate organ function and adequate bone marrow reserve

Exclusion Criteria:

* Coexisting malignancy other than lymphoma
* Active HBV infection
* Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy

Primary outcomes:
measure: complete remission rate
timeFrame: evaluated every 3 months，up to 24 months
Secondary outcomes:
measure: overall remission rate
timeFrame: evaluated every 3 months，up to 24 months
measure: 2 year progression-free survival rate
timeFrame: 2 years after last patient included
measure: 2 year overall survival rate
timeFrame: 2 years after last patient included
measure: any adverse event occurred during this study
timeFrame: 2 years after last patient included
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yan Zhang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02440529: Surgeon-Patient Communication: A Randomized Controlled Trial Evaluating the Impact of an Orthopaedic Related Smoking Cessation Discussion After Fracture Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Orthopaedic Decision Making
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 1
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: In this study, the investigators are interested in evaluating the impact of an orthopaedic related smoking cessation discussion after fracture surgery.


Eligibility criteria: Inclusion Criteria:

* Patients 18 year old or older,
* daily smoker
* inpatient post fracture operation,
* patient that have never received an orthopaedic related smoking cessation discussion

Exclusion Criteria:

* Younger than 18,
* patients unable to provide consent
* patients that suffer from auditory/visual/mental disability requiring another individual as a decision-maker

Primary outcomes:
measure: Patient Comprehension
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Truman Medical Center
state: Missouri
Study officials:
affiliation: UMKC DEPT OF ORTHOPAEDIC SURGERY
name: Nkem Egekeze, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMKC DEPT OF ORTHOPAEDIC SURGERY
name: Jonathan Dubin, MD
role: STUDY_DIRECTOR
affiliation: UMKC DEPT OF BIOINFORMATICS
name: Karen Williams, PhD
role: STUDY_DIRECTOR
affiliation: UMKC DEPT OF ORTHOPAEDIC SURGERY
name: Akin Cil, MD
role: STUDY_DIRECTOR
affiliation: UMKC DEPT OF ORTHOPAEDIC SURGERY
name: Mark Bernhardt, MD
role: STUDY_CHAIR
affiliation: UMKC DEPT OF ORTHOPAEDIC SURGERY
name: Dane Church, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02561429: Comparison of Difference Histamine Concentration (1, 5 and 10 mg/ml) for Skin Prick Test Positive Control
Official title: Comparison of Difference Histamine Concentration (1, 5 and 10 mg/ml) for Positive Control of Skin Prick Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immediate Hypersensitivity
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-09-28
Enrollment: 180
Sex: ALL
Minimum age (years): 7
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Skin prick test (SPT) was used for diagnostic test for type 1 hypersensitivity. The efficacy and safety of SPT were proved. The positive control of SPT is histamine.

In Thailand, the most common concentration of histamine for SPT is 10 mg/ml. However, in some practice they use other concentration (1, 2.5 mg/ml).

This study will find the proper concentration of histamine for positive control use in SPT.

Detailed description: Appropriate concentration of histamine positive control is important in interpretation the result of skin prick test.

Eligibility criteria: Inclusion Criteria:

* Parcitipate person who attented allergy clinic, ENT clinic
* Legible in Thai language

Exclusion Criteria:

* Patient cannot withhold antihistamine drug
* Pragnancy and lactation mother
* comorbid disease such as cardiac disease, liver, renal, hypertension and severe asthma

Primary outcomes:
measure: Mean wheal diameters of SPT of different histamine concentrations.
timeFrame: 1 years
Secondary outcomes:
measure: Mean wheal diameters of SPT of local and imported histamine positive concentration
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Nualanong Visitsunthorn, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Menardo JL, Bousquet J, Rodiere M, Astruc J, Michel FB. Skin test reactivity in infancy. J Allergy Clin Immunol. 1985 Jun;75(6):646-51. doi: 10.1016/0091-6749(85)90088-0.
citation: Berkowitz RB, Tinkelman DG, Lutz C, Crummie A, Smith K. Evaluation of the Multi-Test device for immediate hypersensitivity skin testing. J Allergy Clin Immunol. 1992 Dec;90(6 Pt 1):979-85. doi: 10.1016/0091-6749(92)90471-d.
Clinical trial NCT02415829: Efficacy and Safety of Oxaliplatin Combined With Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Colon Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: Neoajuvant chemotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2015-04-14
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study aims to identify the efficacy and safety of capecitabine plus oxaliplatin (XELOX) in patients with local advanced colorectal cancer.


Eligibility criteria: Inclusion Criteria:

1. Performance status (ECOG) 0\~2
2. Histologically confirmed colon cancer.
3. No prior treatment
4. CT-defined T4 or lymph node-positive colon cancer
5. Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 8 g/dL Bilirubin level ≤ 1.0 x ULN
6. AST and ALT \< 1.5 x ULN
7. Serum creatinine ≤ 1.0 x ULN
8. Life expectancy of ≥ 3 months
9. Signed written informed consent

Exclusion Criteria:

1. Final stage with cancer cachexia
2. Allergy for capecitabine or oxaliplatin
3. Any evidence of extrahepatic metastases and/or primary tumor recurrence
4. Severe organ failures or diseases, including: clinically relevant coronary disease, cardiovascular disorder or myocardial infarction within 12 months before study entry, severe psychiatric illness, severe infection and DIC

Primary outcomes:
measure: The tumor regression grade of all the patients enrolled
timeFrame: from the first cycle of treatment (day one) to tumor resection
Secondary outcomes:
measure: Number of Participants receiving complete tumor resection
timeFrame: From date of randomization until the date of the last patients receiving the surgery
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: from the first cycle of treatment (day one) to six month after the last cycle
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Colorectal Surgery Fudan University Shanghai Caner Center
state: Shanghai
Study officials:
References:
citation: Liu F, Yang L, Wu Y, Li C, Zhao J, Keranmu A, Zheng H, Huang D, Wang L, Tong T, Xu J, Zhu J, Cai S, Xu Y. CapOX as neoadjuvant chemotherapy for locally advanced operable colon cancer patients: a prospective single-arm phase II trial. Chin J Cancer Res. 2016 Dec;28(6):589-597. doi: 10.21147/j.issn.1000-9604.2016.06.05.
Clinical trial NCT02985229: Acceptability and Feasibility of Medical Abortion in Singapore
Official title: Acceptability and Feasibility of Medical Abortion in Singapore: A Study of 800 μg Buccal Misoprostol Following 200 mg Mifepristone for Abortion Through 70 Days Gestation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Medical Abortion
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 130
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To test the hypothesis that a regimen of 200 mg oral mifepristone, with the option of home administration, followed by 800 μg buccal misoprostol 24 hours later for abortion through 70 days LMP will be feasible and acceptable in Singapore.


Eligibility criteria: Inclusion Criteria:

* Have an intrauterine pregnancy consistent wit gestational age ≤ 70 days
* Be 21 years of age or over
* Be willing and able to sign consent forms
* Be eligible for abortion according to current hospital guidelines
* Be able to return to the clinic and able to contact study staff or emergency medical services if needed
* Be willing to provide an address, email and/or telephone number for purposes of follow-up
* Agree to comply with the study procedures and visit schedule

Exclusion Criteria:

* confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
* chronic renal failure
* concurrent long-term corticosteroid therapy
* history of inherited porphyrias
* IUD in place (must be removed after mifepristone is administered).

Primary outcomes:
measure: Rate of successful abortion
timeFrame: 7-10 days after mifepristone administration
Secondary outcomes:
measure: Satisfaction with the medical abortion method
timeFrame: 7-10 days after mifepristone administration
measure: Preferred location of mifepristone administration
timeFrame: The day of enrollment
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02410629: To Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises to Subacute Stroke Patients
Official title: Influence of Timing on Motor Learning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: Stroke
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators are trying to determine the therapeutic effect of the music glove and conventional hand exercise program to the subacute stroke patients. All participants will be randomized into two groups: AB and BA. They will all exercise at least 3 times a week for 3 weeks with a minimal 3 hours exercise time per week. Participants will receive the other intervention at 3-month post stroke date. Clinical evaluations will be performed at baseline, post therapy after first intervention, 3-week post intervention follow up, 3-month post stroke, post therapy after second intervention, 3-week post second intervention follow up, and 6-month post stroke follow up visits.


Eligibility criteria: Inclusion Criteria:

* History of a single stroke at least 1 week prior to enrollment
* Upper Extremity weakness measured on a standard clinical scale
* No active major psychiatric problems, or neurological/orthopedic problems affecting the stroke affected upper extremity
* No active major neurological disease other than the stroke
* Absence of pain in the affected upper extremity

Exclusion Criteria:

* Severe tone at the affected upper extremity as measured on a standard clinical scale
* Severe aphasia as measured on a standard clinical scale
* Severe reduced level of consciousness
* Severe sensory/proprioception deficit at the affected upper extremity as measured on a standard clinical scale
* Currently pregnant
* Difficulty in understanding or complying with instructions given by the experimenter
* Inability to perform the experimental task that will be studied
* Increased pain with movement of the affected upper extremity

Primary outcomes:
measure: Box and Block Test
timeFrame: From baseline to end of therapy (3 weeks)
Secondary outcomes:
measure: Fugl-Meyer Motor Assessment of the Upper Extremity
timeFrame: From baseline to end of therapy (3 weeks)
measure: Action Research Arm Test
timeFrame: From baseline to end of therapy (3 weeks)
measure: 9-Hole Peg Test
timeFrame: From baseline to end of therapy (3 week)
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: An Do, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04920929: PICC Asymptomatic Thrombosis Study: A Pilot Study
Official title: A Prospective, Randomized, PICC Asymptomatic Thrombosis Study: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral ICC
Lead sponsor: Access Vascular Inc
Sponsor class: INDUSTRY
First posted: 2021-06-10
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control
Primary purpose: OTHER

Brief summary: The study purpose is to perform a preliminary, comparative evaluation of the Hydrophilic Biomaterial technology to confirm the performance of the catheter, by using UltraSound technology in-vivo.

Detailed description: This study will compare two different materials to evaluate asymptomatic thrombosis using ultrasound technology.

Eligibility criteria: Inclusion Criteria:

1. Patient is indicated for a medically necessary PICC for therapeutic delivery medication
2. Patient is eligible to receive a single lumen PICC
3. Patient is an adult who is prescribed a PICC line
4. Patient's expected duration of treatment requiring a PICC for a minimum of 16 days post device implantation
5. Patient understands and is willing to comply with all study requirements and has voluntarily signed the Informed Consent Form (ICF).

Exclusion Criteria:

1. Is pregnant, lactating, or is planning to become pregnant during the time of the study
2. Has been previously enrolled in this post market clinical evaluation, or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation
3. Venous thrombosis in any portion of the vein to be catheterized
4. Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy
5. Orthopedic or neurological conditions affecting the extremity
6. Anticipation or presence of dialysis grafts or other intraluminal devices, including pacemakers, within a month of patient enrollment start
7. Patients who are on anticoagulation therapy prior to the study (10-14 days). Note: (If patients are placed on anticoagulation (low dose) therapy while hospitalized, these patients are allowed.)
8. Patient has relinquished control of care to a guardian and/or facility
9. Patient has any significant medical or physical condition that, in the opinion of the PI, would make the subject unsuitable for participation in the post market clinical evaluation
10. Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons

Primary outcomes:
measure: Asymptomatic Thrombosis Rate
timeFrame: 7 days post insertion
Secondary outcomes:
measure: Symptomatic Thrombosis Rate
timeFrame: 14 days post insertion
measure: Symptomatic Thrombosis Rate
timeFrame: 7 days post insertion
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
Study officials:
affiliation: Beaumont Hospital
name: Amit Bahl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04064229: ivWatch Sensor: Device Validation for Infiltrated Tissues
Official title: ivWatch Sensor: Device Validation for Infiltrated Tissues
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infiltration of Peripheral IV Therapy
Lead sponsor: ivWatch, LLC
Sponsor class: INDUSTRY
First posted: 2019-08-21
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A single arm trial consisting of 98 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.


Eligibility criteria: Inclusion Criteria:

* Informed Consent
* Pass health screen by clinician
* 18 years or older

Exclusion Criteria:

* Fail health screen

Primary outcomes:
measure: Red Notification Sensitivity to Infiltrated Tissues
timeFrame: After each participant has been infiltrated, an expected average of 1 hour
Secondary outcomes:
measure: Yellow Notification Sensitivity to Infiltrated Tissues
timeFrame: After each participant has been infiltrated, an expected average of 1 hour
measure: Infiltrated Volume When Red Notification Issued
timeFrame: After each participant has been infiltrated, an expected average of 1 hour
measure: Infiltrated Volume When Yellow Notification Issued
timeFrame: After each participant has been infiltrated, an expected average of 1 hour
measure: Significant Skin Irritation or Disruption to Skin Integrity
timeFrame: After each participant has been infiltrated, an expected average of 1 hour
Other outcomes:
Locations:
city: Williamsburg
country: United States
facility: ivWatch, LLC
state: Virginia
Study officials:
References: