louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04872673: The Professional Values and Ethical Sensitivities During the COVID-19 Pandemic
Official title: The Professional Values and Ethical Sensitivities of Turkish Senior Nursing Students in Distance Education During the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Professional Values
Ethical Sensitivities
Keywords: COVID-19
ethical sensitivity
nursing student
professional value
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: senior nursing students

Brief summary: This study was conducted to examine the professional values and ethical sensitivities of senior nursing students in distance education during the COVID-19 pandemic. During the COVID-19 process, senior nursing students continue their education with distance education practices. The sample consisted of 302 senior nursing students.


Eligibility criteria: Inclusion Criteria:

* being over the age of 18
* being a fourth level student
* agreed to participate in the research

Exclusion Criteria:

* being diagnosed with a neuropsychiatric disease

Primary outcomes:
measure: The first evaluation- Pre-test
timeFrame: February-2020
measure: The first evaluation- Pre-test
timeFrame: February-2020
measure: The second evaluation- Post-test
timeFrame: July-2020
measure: The second evaluation- Post-test
timeFrame: July-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
state: Çubuk
Study officials:
References:
Clinical trial NCT00752973: Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice
Official title: Phase II, Multi-Center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pediculosis
Keywords: Head Lice
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2008-09-16
Enrollment: 12
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population.

The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.


Eligibility criteria: Inclusion Criteria:

* Confirmed active head lice infestation

Exclusion Criteria:

* Allergy to pediculicides or hair care products
* Scalp conditions other than head lice
* Previous head lice treatment within the past 4 weeks
* Current antibiotic treatment

Primary outcomes:
measure: Participants With a Change in Cholinesterase Level at 1 Hour (Day 0).
timeFrame: Change from Baseline to 1 hour
measure: Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day).
timeFrame: Change from baseline to 24 hrs (1 day)
measure: Participants With the Clinical Evidence of Cholinesterase Inhibition
timeFrame: at Baseline
measure: Participants With the Clinical Evidence of Cholinesterase Inhibition
timeFrame: at 1 hr (Day 0)
measure: Participants With the Clinical Evidence of Cholinesterase Inhibition
timeFrame: at 24 hrs (Day 1)
measure: Participants Clinically Cured of Head Lice 14 Days After Last Treatment
timeFrame: Day 7±1 and Day 14 or Day 21
Secondary outcomes:
measure: Evaluation of the Local Safety of Malathion Gel, 0.5% Based Upon Reported Adverse Events and Observed Scalp Reactions.
timeFrame: Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)
Other outcomes:
Locations:
city: Bentonville
country: United States
facility: Investigator Site
state: Arkansas
city: Jonesboro
country: United States
facility: Investigator Site
state: Arkansas
Study officials:
References:
citation: Meinking TL, Vicaria M, Eyerdam DH, Villar ME, Reyna S, Suarez G. A randomized, investigator-blinded, time-ranging study of the comparative efficacy of 0.5% malathion gel versus Ovide Lotion (0.5% malathion) or Nix Creme Rinse (1% permethrin) used as labeled, for the treatment of head lice. Pediatr Dermatol. 2007 Jul-Aug;24(4):405-11. doi: 10.1111/j.1525-1470.2007.00460.x.
Clinical trial NCT05390073: Growth Hormone in EB
Official title: Assessment of Growth Hormone and Insulin-like Growth Factor 1 in Children With Epidermolysis Bullosa Dystrophia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epidermolysis Bullosa Dystrophica
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children with EB dystrophica

Brief summary: Growth is extremely affected in epidermolysis bullosa patients

Detailed description: Studying the role of growth hormone and ILGF-1 in EB may pave the to new therapeutic modality that could improve the growth in those children and avoid the irreversible sequelae that affected subjects experience after adulthood

Eligibility criteria: Inclusion Criteria:

- Children with EB dystrophica

Exclusion Criteria:

* Adults with the same disease

Primary outcomes:
measure: level of growth hormone and insulin like growth factor 1
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05722873: The Metabolic Effects of Intermittent Fasting
Official title: The Effects of Fasting on Reprogramming of Lipid Metabolism and Bone Metabolism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Normal and Overweight Individuals at High-risk of Diabetes
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-02-10
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled study
Primary purpose: PREVENTION

Brief summary: Caloric restriction has beneficial metabolic effects in humans including weight loss and improvement in blood pressure and lipid levels. Intermittent fasting has emerged as a popular alternative to caloric restriction as it does not require daily adherence to a dietary protocol, but whether the benefits of fasting protocols are dependent on weight loss is not known. In this study, the investigators will explore the metabolic effects of fasting and evaluate whether these effects, including negative effects on bone metabolism, are independent of weight loss.


Eligibility criteria: Inclusion Criteria:

1. Men and women, ages 25-45 years
2. BMI of at least 21 kg/m2 and up to and including BMI of 29 kg/m2
3. Normal thyroid function
4. Regular menses (women)
5. At least one first-degree relative with type 2 diabetes (T2D) and/or history of gestational diabetes

Exclusion Criteria:

1. Any chronic diseases including hypertension and Type 2 diabetes mellitus
2. Indication for lipid-lowering therapy in non-diabetics, using the more stringent AHA guideline cutoff (LDL\>190 or an estimated 10-year ASCVD risk of \>7.5%)
3. Chronic medications, including oral contraceptive pills
4. Pregnant and/or breastfeeding
5. History of an eating disorder
6. 25-OH vitamin D level \< 20 ng/mL
7. Active substance abuse, including alcohol
8. Subjects with a prior history of intermittent fasting
9. The study physician feels that the subject may not be able to safely complete the protocol or may place themselves at risk by undergoing the protocol

Primary outcomes:
measure: Triglyceride carbon content and degree of saturation
timeFrame: Baseline, 3 months
measure: Trabecular bone microarchitecture
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Insulin sensitivity
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Pouneh Fazeli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03789773: Holographic Mm-Wave Imaging in Patients Undergoing Radiation Therapy
Official title: Holographic Mm-wave Imaging in Radiation Oncology
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Unspecified Adult Solid Tumor
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-12-31
Enrollment: 0
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: This trial studies the quality of holographic mm-wave imaging in patients undergoing radiation therapy. Holographic mm-wave imaging is a common type of imaging used in airport body scanners that may be helpful in improving the efficiency and positioning of radiation oncology patients and their overall experience.

Detailed description: PRIMARY OBJECTIVES:

I. To obtain patient images in a clinical setting and assess their quality.

SECONDARY OBJECTIVES:

I. To assess the registration agreement through a voxel-voxel distance-to-agreement metric.

OUTLINE:

Patients undergo holographic mm-wave imaging in radiotherapy treatment position after initial computed tomography (CT) simulation.

Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled to receive either an optical or CBCT imaging scan as part of their treatment management.
* The study will be open to English and Spanish speaking participants.

Exclusion Criteria:

* Patients that are not scheduled for fluoroscopic or optical imaging as part of the normal course of radiotherapy.

Primary outcomes:
measure: Qualitative assessment of holographic image quality
timeFrame: Up to 1 year
Secondary outcomes:
measure: Image registration agreement between mm-wave holographic images and a cone-beam computed tomography (CBCT)/optical surface image
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Michael Reilly
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02990273: The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures
Official title: The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cirrhosis, Coagulopathy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 1
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: Cirrhosis results in decreased synthesis of both procoagulants and anticoagulants resulting in "rebalanced homeostasis". However, conventional blood tests (platelets/ INR levels) that are performed prior to invasive procedures do not accurately reflect the coagulation changes that occur in cirrhotics, resulting in unnecessary transfusion of blood products. Thromboelastography (TEG) is a global hemostasis assessment tool that is being used in surgery (including liver transplant) to help guide blood product transfusion in the operating room. The investigators would like to compare the use of TEG vs. INR/platelets to help guide blood product transfusion in cirrhotic patients undergoing inpatient endoscopy. The investigators will evaluate to see if there is a decrease in prophylactic blood transfusions prior to endoscopy when using TEG.


Eligibility criteria: Inclusion Criteria:

* All 18 yo + cirrhotic patients who are being scheduled for inpatient endoscopy

Exclusion Criteria:

* Patients on blood thinners (prophylactic anticoagulation is permissible)
* Hemodynamically unstable patients requiring pressors (ie ICU level patients)
* Pregnant or lactating individuals
* Inability to provide consent for any reason

Primary outcomes:
measure: Units of fresh frozen plasma (FFP) and platelet transfused
timeFrame: 2 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Tinsay Woreta
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06292273: Bupivacaine With Dexmedetomidine Versus Bupivacaine Alone for Transversus Abdominis Plane Block in Caesarean Section
Official title: Bupivacaine With Dexmedetomidine Versus Bupivacaine Alone for Transversus Abdominis Plane Block for Post-operative Analgesia in Patients Undergoing Caesarean Section: A Comparative Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double blind case control
Primary purpose: PREVENTION

Brief summary: Transversus Abdominis plane (TAP) block is a regional technique for providing analgesia of the anterolateral abdominal wall. TAP block are commonly given in patients who have undergone various abdominal as well as pelvic surgeries such as caesarean section, hysterectomy, appendicectomy and various laparoscopic surgeries. this study is conducted to analyse the effect of addition of dexmedetomidine to bupivacaine in Transversus Abdominis Plane (TAP) block.

Detailed description: Peripheral nerve block is becoming increasingly popular technique for postoperative pain relief and is also established as a part of multimodal analgesia and enhanced recovery program. Transversus abdominis plane (TAP) block is a regional technique for providing analgesia of the anterolateral abdominal wall. TAP block are commonly given in patients who have undergone various abdominal as well as pelvic surgeries such as caesarean section, hysterectomy, appendicectomy and various laparoscopic surgeries.The Purpose of a TAP block is to infiltrate local anaesthetic agents in the plane between the internal oblique and transversus abdominis muscles thereby providing effective postoperative analgesia. Earlier the blind TAP block (through lumbar triangle of Petit) was commonly given but with widespread use of ultrasound nowadays it is almost always given under ultrasound guidance. Accuracy and efficacy of TAP block is significantly improved under ultrasound guidance because under ultrasound guidance the anesthetic agent can be properly deposited in the neurovascular plane. Ultrasound provides real time and direct visualisation of needle during infiltration of local anaesthetic drug.

Eligibility criteria: Inclusion Criteria:

* pregnant female elected for cesarean section
* ASAll

Exclusion Criteria:

* coagulopathy
* BMI\>35

  * heart Diseases
  * diabets

Primary outcomes:
measure: Post operative pain
timeFrame: 24 hours
Secondary outcomes:
measure: Sedation
timeFrame: 24 hours
measure: Heart rate
timeFrame: 24 hours
measure: Total analgesic consumption
timeFrame: 24 hours
measure: Side effects
timeFrame: 24hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Menoufia University
state: Governorate
Study officials:
affiliation: Menoufia University
name: rabab M habeeb
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02335073: Effect of 4 Liver Fibrosis Tests (PIIINP, CIV, LN, and HA) on the Prognosis of Liver Cirrhosis
Official title: Effect of 4 Liver Fibrosis Tests (PIIINP, CIV, LN, and HA) on the Prognosis of Liver Cirrhosis: A Single-center, Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Keywords: Prognosis
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2015-01-09
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population should be patients with a diagnosis of liver cirrhosis who were admitted to the Department of Gastroenterology of the General Hospital of Shenyang Military Area.

Brief summary: Liver biopsy is the reference method for the measurement of liver fibrosis. But it has many limitations, such as sampling error and individual variation in interpreting the results. Currently, serum liver fibrosis markers have been employed as non-invasive diagnosis of liver fibrosis and evaluation of the severity of liver fibrosis. They include laminin (LN), hyaluronic acid (HA), collagen type IV (CIV), and N-terminal propeptide of collagen III (PIIINP). However, few study was conducted to explore the role of these liver fibrosis markers in evaluating the prognosis of liver cirrhosis. Our hypothesis is that LN, HA, CIV, and PIIINP in combination or alone can predict the prognosis of liver cirrhosis.


Eligibility criteria: Inclusion Criteria:

1. Patients were admitted to our department.
2. Patients were diagnosed with liver cirrhosis.
3. Patients signed the informed consent and agreed to test serum liver fibrosis markers (PIIINP, CIV, LN, and HA).

Exclusion Criteria:

1. Non-cirrhotic patients.
2. Malignancy.
3. Severe cardiopulmonary diseases.
4. Severe infectious diseases.
5. Other diseases with a shortened lifespan.
6. Pregnant and breastfeeding.
7. Poor adherence.

Primary outcomes:
measure: Death
timeFrame: 6-12 months
Secondary outcomes:
measure: Hepatic decompensation events
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Department of Gastroenterology, General Hospital of Shenyang Military Area
state: Liaoning
Study officials:
References:
Clinical trial NCT01111773: Study Evaluating a Heated Lidocaine and Tetracaine Topical Patch in the Treatment of Patients With Patellar Tendinopathy
Official title: An Open-label Pilot Study Evaluating Synera® in the Treatment of Patients With Patellar Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Patellar Tendinopathy
Keywords: Patellar tendonitis
Lead sponsor: ZARS Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-28
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to explore the potential usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with patellar tendinopathy.

Detailed description: The purpose of this pilot study is to explore the potential usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with patellar tendinopathy. A number of efficacy variables will be employed to evaluate their utility for assessing painful responses in this population. The study will be a 2-week, open-label study conducted at a single study site in patients with pain associated with patellar tendinopathy in a single knee. During this out-patient study, patients will apply one study patch to the affected tendon twice daily for approximately 14 days. Patches will be applied morning and evening (applications separated by approximately 8-10 hours) and removed after 2-4 hours.

Eligibility criteria: Inclusion Criteria:

* be at least 18 years of age
* have pain associated with patellar tendinopathy in a single knee (minimum 2-week duration)
* have tenderness at the proximal insertion of the patellar tendon in the affected knee

Exclusion Criteria:

* have any history of surgery in the target knee
* have used any topically applied pain medication on the target treatment area within 3 days preceding the Screening/Baseline Visit
* have had any injected steroids in the target knee within 3 months of the Screening/Baseline Visit
* have used any injected pain medication within 14 days preceding the Screening/Baseline Visit
* are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.)

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Victorian Institute of Sport Assessment (VISA) score
timeFrame: Two weeks
Secondary outcomes:
measure: Pain intensity
timeFrame: Two weeks
measure: Patient Global Assessment of Treatment Satisfaction (PGAS)
timeFrame: Two weeks
Other outcomes:
Locations:
city: Warren
country: United States
facility: Sports Medicine Clinic
state: Michigan
Study officials:
affiliation: Detroit Medical Center, Sports Medicine Clinic
name: Henry Goitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04745273: Interaction Between Tramadol and Ondansetron
Official title: The Effect of Ondansetron on the Efficacy of Tramadol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cholecystectomy, Laparoscopic
Keywords: tramadol
ondansetron
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In the postoperative period; pain, nausea, and vomiting are undesirable side effects that reduce the patient's comfort and may lead to various complications. Ondansetron is frequently used as an antiemetic and tramadol hydrochloride is used for postoperative analgesia in laparoscopic cholecystectomy. However, some studies have reported that there is a drug interaction between these two drugs and they reduce each other's effects, thus requiring more analgesics in the postoperative period.

The aim of this study is; To evaluate whether ondansetron reduces the analgesic efficacy of tramadol hydrochloride in laparoscopic cholecystectomies.

Detailed description: During the operation, 4 mg iv ondansetron (2mL) will be administered to the ondansetron group and 2mL iv 09% saline will be administered to the placebo group. The patients' heart rate, blood pressure, oxygen saturation, sedation score (with Ramsey Seading Score), amount of pain (with NRS), degree of nausea (with NRS), whether there is vomiting, whether analgesic or antiemetic treatment is required, and the amount of tramadol use will be recorded at 1, 2, 4, 8, 12 and 24 hours in the postoperative period.

Eligibility criteria: Inclusion Criteria:

60 patients over the age of 18, ASA I-II, undergoing laparoscopic cholecystectomy

Exclusion Criteria:

1. Patients under 18 years of age
2. Patients with known allergies to the drugs to be used
3. Pregnant and breastfeeding mothers
4. Patients who received antiemetic or cortisone within 24 hours before surgery
5. Patients with mental illness or epilepsy
6. Patients with alcohol or substance abuse

Primary outcomes:
measure: Interaction
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Kozyatagi Hastanesi
Study officials:
affiliation: Anethesiologist
name: Sevgi Bilgen, Assoc. Prof.
role: STUDY_CHAIR
References:
citation: Bilgen S, Erdogan Ari D, Ozveri E. The Effect of Ondansetron on the Analgesic Efficacy of Tramadol in Patients Undergoing Laparoscopic Cholecystectomy. Int J Clin Pract. 2022 Mar 8;2022:7387600. doi: 10.1155/2022/7387600. eCollection 2022.