louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02640066: Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children
Official title: Acupuncture for Acute Viral Lower Respiratory Infection in Hospitalized Children: A Single Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Viral Respiratory Tract Infection
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2015-12-28
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute viral respiratory infections are among the most common causes of hospitalization in the pediatric population. The usual presentation of viral respiratory tract infections (VRTI) includes fever, malaise, wheezing and or coughing, rhinorrhea and loss of appetite. Up to 50% of children will have at least one viral-induced wheezing illness by school age. Currently treatment of VRTI is essentially supportive and no specific and efficient treatments are known. Given the lack of effective medications, current treatment for severe viral lower respiratory tract infection (LRTI) in infants relies on supportive measures only. These measures include supplementation of oxygen, monitoring of apnea, nasal/gastric tube feeding or intravenous fluids, and, if required, respiratory support with nasal bi-level positive-airway pressure. VTRI therefore represent an important unmet need for improved treatment strategies. Acupuncture's effect on has also been studied. Acupuncture has been shown to be a safe and effective in various respiratory tract inflammations. A review published in 2011 have found that acupuncture is safe for pediatric patients. Acupuncture's effect on acute viral induced wheezing and cough in hospitalized children has yet to be studied. Since the current standard of care is supportive care only, using acupuncture as an additional treatment may provide benefit in reducing wheezing, respiratory distress, and shorten hospitalization.


Eligibility criteria: Inclusion Criteria:

* The presence of acute viral respiratory disease

Exclusion Criteria:

* Evidence of chronic cardio-pulmonary disease, immune-suppression or any chronic systemic disease or disability

Primary outcomes:
measure: presence of fever
timeFrame: 5 days
measure: presence of cough
timeFrame: 5 days
measure: presence of rhinitis
timeFrame: 5 days
measure: symptoms of pharyngitis
timeFrame: 5 days
measure: presence of crepitations
timeFrame: 5 days
measure: presence of dyspnea or tachypnea
timeFrame: 5 days
measure: oxygen saturation
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zefat
country: Israel
facility: Ziv Medical Center
Study officials:
References:
Clinical trial NCT05030766: Testing Integrative Smoking Cessation for HIV Patients
Official title: A Pilot SMART Pre- and Post-testing of an Integrative Mindfulness-Based Smoking Cessation Intervention for HIV Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking
Smoking Cessation
HIV Infections
Keywords: Mindfulness Training
Contingency Management
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The purpose of this study is to examine the feasibility, acceptability and effect of a combined smoking cessation intervention integrating contingency management (reward-based) strategies with Mindfulness training to identify the optimal dynamic strategy to promote smoking cessation among HIV patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with HIV (based on self-report).
* Be 18 years and older
* Have smoked ≥ 5 cigarettes/day in the past year
* Be interested in making a quit attempt in the next 30 days
* Own a smartphone (apple/android), and plan to keep it active for the next 6 months
* Able to consent
* Have no plans to move in the next 6 months
* Are not pregnant or planning to be pregnant in the following 6 months
* Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements

Exclusion Criteria:

* Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)
* Are currently being treated for a psychiatric condition.
* Are currently being treated for smoking cessation, alcoholism, or illicit drug use
* Are adults unable to consent
* Are individuals who are not yet adults
* Are pregnant women
* Are prisoners

Primary outcomes:
measure: Number of Participants Reporting 7-day Point-prevalence Abstinence
timeFrame: 4 weeks (end of treatment), and 3 months
Secondary outcomes:
measure: Retention Rate
timeFrame: 3 months
measure: Treatment Specific Adherence Rates
timeFrame: 3 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Taghrid A. Asfar, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03267966: Margin Status After Pancreaticoduodenectomy for Cancer
Official title: Margin Status After Pancreaticoduodenectomy for Cancer. Results of a Multicentric Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Cholangiocarcinoma
Ampullary Cancer
Keywords: periampullary cancer
margin status
R1 resection
clearance margin
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
Collaborators: name: Humanitas Hospital, Italy
name: Azienda Ospedaliero, Universitaria Pisana
name: Medical University of Silesia
First posted: 2017-08-31
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This multicentric prospective randomized controlled trial (RCT) compares the Leeds Pathology Protocol (LEEPP) with other "conventional" pathological protocol of PD specimen for periampullary cancer. Our aims were to evaluate the impact of the protocol and of the clearance on R1 rate and its prognostic value.


Eligibility criteria: Inclusion Criteria:

* pancreaticoduodenectomy for periampullary cancer

Exclusion Criteria:

* diagnosis of neuroendocrine neoplasm;
* previous pancreatic surgery;
* frozen section of each transection margins not performed or presence of positive transection margins without further resection (R1 intraoperative resection);
* presence of macroscopic residual tumor (R2 resection).

Primary outcomes:
measure: R1 resection rate
timeFrame: 1 month
Secondary outcomes:
measure: pathological data
timeFrame: 1 month
measure: oncological results
timeFrame: 60 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04899466: Efficacy Evaluation of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
Official title: A Prospective Study Evaluating the Efficacy of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dehiscence Wound
Lead sponsor: RedDress Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-24
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single arm study, consisting of 20 women with abdominal surgical wound dehiscence that requires secondary closure. The participants will receive a weekly application of ActiGraft for 4 weeks, or until complete healing of the wound (the earlier of the two).

An historic matched-control group of 20 patients will be compared retrospectively


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Women that had a laparotomy no more than 3 weeks before accrual.
* Surgical wound dehiscence that requires a secondary closure.
* Time from wound dehiscence \>24 hours and \<6 days.
* The open wound includes epidermis, dermis and sub cutaneous fat.
* The patient can sign an informed consent form.

Exclusion Criteria:

* Patients with necrotizing fasciitis
* Patients with fascial dehiscence
* Cannot withdraw blood in the required amount (up to 18 mL per week).
* Known coagulation problems, abnormal thrombocytes level or if heparin is given intravenously. Subjects who are taking oral anti-coagulants or anti-agreganrts will not be excluded.
* Pregnancy
* Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive systemic steroids (Prednisone- more than 10mg/d or equivalent).

Primary outcomes:
measure: Incidence of complete wound closure
timeFrame: 4 weeks
Secondary outcomes:
measure: Wound Percent Area Reduction (PAR)
timeFrame: 2, 4 and 6 weeks
measure: Mean time of complete wound closure
timeFrame: 4 weeks
measure: Durability of wound closure 2 weeks after complete healing
timeFrame: Up to 6 weeks
measure: Comparison of time to complete closure between study cases and historic control
timeFrame: 4 weeks
Other outcomes:
measure: Change in pain level
timeFrame: 1, 2, 3 and 4 weeks
measure: Patient satisfaction
timeFrame: 1, 2, 3, 4, 6 weeks and 42 days
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: RedDress Ltd.
name: Sharon Sirota
role: STUDY_DIRECTOR
References:
Clinical trial NCT03938766: Upregulation of PSMA Receptors After Androgen Deprivation Therapy on PSMA PET/CT Imaging in Prostate Cancer
Official title: Upregulation of PSMA Receptors After Androgen Deprivation Therapy on PSMA PET/CT Imaging in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 2
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein, which is overexpressed on prostate cancer cells and is well-characterized as an imaging biomarker of prostate cancer. Studies have shown that PSMA PET/CT can detect prostate cancer lesions with excellent contrast and a high detection rate even when the level of prostate specific antigen is low. PSMA imaging is considered the gold standard in imaging of biochemical recurrence, with detection rate of recurrence in 79.5% of patients, in the largest series of 1007 patients. Despite these excellent results, there remains approximately 20% of patients in whom the site of biochemical recurrence cannot be identified and further research is needed into improving detection rates.

Androgen deprivation therapy (ADT), represents the standard of care treatment for most men with a rising serum PSA and no evidence of disseminated disease on imaging modalities. There has been some preliminary data that imaging patients early after initiation of ADT therapy may increase detection rates of recurrence sites.

The objective of this study is to evaluate if prostate cancer patients with biochemical recurrence and negative PSMA PET/CT can demonstrate in-vivo upregulation of PSMA receptors in an attempt to improve detection rates of recurrent prostate cancer. Patients who are started on ADT when clinically indicated, will have repeat PSMA PET/CT at 4 weeks following initiation of ADT therapy.


Eligibility criteria: Inclusion Criteria:

* Male sex
* Age 18 years or older
* Previous diagnosis of prostate cancer following radical prostatectomy or primary radiation therapy, with biochemical recurrence.
* Prior negative PSMA PET/CT within 2 months prior to study entry
* ECOG performance status 0 - 3, inclusive
* Able to understand and provide written informed consent
* Initiation of androgen deprivation therapy within 5 weeks prior to study PSMA PET/CT
* Able to tolerate the physical/logistical requirements of a PET/CT scan

Exclusion Criteria

* Medically unstable patients
* Patients who exceed the safe weight limit of the PET/CT bed (200 kg) or who cannot fit through the PET/CT bore (70 cm diameter)
* Patients with unmanageable claustrophobia

Primary outcomes:
measure: Detection rates of recurrence
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT02898766: Glycemic Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus
Official title: Plasma Glucose and Insulin Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2016-09-13
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This will be a randomized, cross-over design. Subjects will be randomized to one of two interventions on two separate study days, 1 week apart.


Eligibility criteria: Inclusion Criteria:

* Age 20-75 yrs
* Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide, Glucotrol/GlucotrolXL) and glyburide (DiaBeta, Micronase, (Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alphaglucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
* Hemoglobin A1C less than 9.0%
* Fasting blood glucose less than 180 mg

Exclusion Criteria:

* Abnormal thyroid function
* Creatinine \>2.0 mg/dL
* Potassium \<3.5 mEq/L
* Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
* History of bypass surgery, midface trauma, esophageal varices, coagulation abnormalities
* Patients currently on any anti-coagulant medication
* Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
* Unable to give informed consent or follow instructions
* Current insulin therapy or insulin therapy within the past month
* Patient who are pregnant
* Allergies to milk, fish oil or any component of the test product
* Patient who in the Investigators assessment cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial.

Primary outcomes:
measure: Area under the blood glucose curve (AUC 0-240)
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary outcomes:
measure: Area under the insulin curves (AUC 0-240)
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
measure: Insulinogenic index (Ins30/(Glu30))
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
measure: AUC (0-30min) for insulin
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Other outcomes:
Locations:
city: Tustin
country: United States
facility: Orange County Research Center
state: California
Study officials:
affiliation: Orange County Research Center
name: Joel Neutel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06444165: Lebrikizumab Pen Ease of Use in Participants With Atopic Dermatitis
Official title: Study to Assess Lebrikizumab Pen Ease of Use in Patients With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Eczema
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-06-05
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the ease of use of the lebrikizumab pen. Participants will use a practice pad to simulate administration of a dose. Participants will complete the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ) following the simulated injection.

This study involves one study visit.


Eligibility criteria: Inclusion Criteria:

* Self-report being diagnosed with atopic dermatitis (AD) by a physician and able to provide approximate diagnosis date.
* Autoinjector or Pen naïve \[have not used an autoinjector or pen previously; permissible to have used a pre-filled syringe (PFS) or vial and syringe\].
* Willing and able to attend an in-person interview session.
* Able to complete the protocol requirements.

Exclusion Criteria:

* Cognitive or physical difficulties that could interfere with ability to understand the training, perform the injection tasks, or complete the study questionnaires as judged by the investigator.
* Are currently enrolled or have participated in the last 3 months, in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Is a health care practitioner who is trained in giving injections.
* Currently pregnant.
* Known hypersensitivity to any component of lebrikizumab or its excipients.
* Treatment with a live (or live attenuated) vaccine within the past 12 weeks.
* Current or chronic infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) per participant self-report.

Primary outcomes:
measure: Number of Participants Who Responded Agree or Strongly Agree to the Ease of Use Question Using the Modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ)
timeFrame: Day 1
measure: Number of Participants Who Responded Agree or Strongly Agree to the Confidence of Use Question Using the mSQAAQ
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Concentrics Research
state: Indiana
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 : Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06177665: Comparison of Erector Spina Plan Block and Rhombodid Intercostal Block in Breast Surgery
Official title: Comparison of Erector Spina Plan Block and Rhombodid Intercostal Block for Postoperative Pain Managment in Patients Undergoing Unilateral Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Analgesia
Keywords: Regional Anesthesia
Erector Spinae Plane Block
Rhomboid Intercostal Block
Breast Surgery
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: In this study, the investigators compared ultrasound-guided erector spinae plane (ESP) block and rhomboid intercostal block (RIB) on postoperative analgesic effect in unilateral breast surgery.

Detailed description: After being informed about the study and potential risks, written consent was obtained from all patients.Patients who meet eligibility requirements will be randomized in a 1:1 ratio to erector spinae plane block and rhomboid intercostal block.

Eligibility criteria: Inclusion Criteria

* Patients who will undergo unilateral breast-conserving surgery (BCS) or modified radical mastectomy (MRM) with or without axillary lymph node dissection
* Patients undergoing elective surgery
* ASA (American Society of Anesthesiologists) physical status classification I-III

Exclusion Criteria:

* Use of anticoagulants
* Allergy to the medications to be used
* Patients who use analgesic drugs due to a history of chronic pain
* ASA (American Society of Anesthesiologists) physical status classification IV-V
* Patients with psychiatric disorders
* Presence of infection in the area where the block will be applied
* Presence of deformity in the patient's spinal, paraspinal and area where the block will be applied
* The patient does not accept the block application or cannot cooperate with the patient

Primary outcomes:
measure: Morphin Consumption
timeFrame: during postoperative 24 hours
Secondary outcomes:
measure: Numerical Rating Scale(NRS)
timeFrame: during postoperative 24 hours
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Sevim Cesur Okan
role: STUDY_DIRECTOR
References:
Clinical trial NCT04901065: Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs
Official title: Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs: a Randomized, Double-Blinded, Placebo Controlled-Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Covid19
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 88
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Since the beginning of the COVID-19 pandemic, nasopharyngeal swabs (NPS) have been recommended to detect the virus. This procedure has been reported to be painful by 85% of children The aim of the study was to assess whether pretreatment with topical lidocaine reduces the discomfort experienced by children during a nasopharyngeal swab.

This was a RCT among children aged 8-17 years old who need a NPS. The primary outcome was pain intensity as measured by the Visual Analog Scale .


Eligibility criteria: Inclusion:

* 6-17 years old inclusively
* Children for whom a NPS was ordered

Exclusion:

* Children presenting with the following acute conditions, which could either prevent the lidocaine from being properly administered, or pose a risk for the patient as increased absorption of the medication might occur:

  * Nasal or airway burns, trauma or major anomaly
  * Cardiorespiratory compromise
* Children for whom an informed consent could not be obtained

  * Any other life-threatening condition or priority one patient requiring emergency support
  * Language barrier
* Children presenting with conditions that could prevent their ability to reliably report their pain:

  * Severe intellectual disability
  * Severe pain upon presentation
  * Administration of opiates prior to the NPS
* Children presenting with the following chronic conditions, which could either prevent the lidocaine from being properly administered, or pose a risk for the patient:

  * Hypersensitivity/allergy to the medication or a known component
  * Methemoglobinemia
  * G6PD deficiency
  * Familial malignant hyperthermia
  * Pseudocholinesterase deficiency
  * Severe hepatic impairment
  * Severe cardiac condition or use of antiarrhythmic medication
  * Risk of airway aspiration

Primary outcomes:
measure: Pain during the procedure
timeFrame: During procedure
Secondary outcomes:
measure: Anxiety during the procedure
timeFrame: During procedure
measure: Discomfort
timeFrame: During procedure
measure: Pain 2 NRS
timeFrame: During procedure
measure: Number of patients with physical restriction
timeFrame: During procedure
measure: Utility according to nurses
timeFrame: During procedure
measure: Adverse event
timeFrame: 48 hours following intervention
measure: Desire to reuse the intervention in a futur procedure, at follow up
timeFrame: 48 hours following intervention
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Evelyne D Trottier
state: Quebec
Study officials:
References: