louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00111046: Pain Relief - Tramadol Versus Ibuprofen
Official title: Post-Operative Pain Relief Following Insertion of Radioactive Plaque for Choroidal Melanoma: Randomised Control Trial of Tramadol Vs Ibuprofen: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Choroidal Melanoma
Melanoma
Eye Neoplasms
Keywords: Pain Relief
Choroidal melanoma
plaque radiotherapy
Lead sponsor: Royal Liverpool University Hospital
Sponsor class: OTHER_GOV
First posted: 2005-05-17
Enrollment: 40
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: The purpose of this study is to assess post operative pain following the insertion of radioactive plaque for choroidal melanoma in patients after receiving either ibuprofen or tramadol.

Detailed description: Patients with choroidal melanomas who are offered ruthenium plaque radiotherapy have their plaque sutured to the sclera under general anaesthesia. The plaque is removed in a few days after delivering the required radioactive dosage to the tumour. While the plaque is in situ, patients require analgesia. The management of post-operative pain is generally not considered a high priority, more importance being given to the regression of the melanoma.

This is indicated by the lack of any study addressing this aspect of care. The failure of patients in general, to complain, may perhaps be due to them having accepted that some degree of pain following 'major surgery for a malignant ocular condition' is the norm.

As per current protocol, ibuprofen is being prescribed, unless contraindicated. Although many are comfortable, others request additional analgesics. Most opioid analgesics provide better pain relief but are associated with nausea, vomiting, constipation and respiratory depression.

Tramadol is an opioid analgesic that is reported to have less of the above mentioned side affects.

Comparisons: To compare the analgesic effect of oral tramadol versus ibuprofen in such patients.

Eligibility criteria: Inclusion Criteria:

* All patients that are admitted for undergoing plaque radiotherapy for choroidal melanoma would be approached to participate in this study.
* They should be adults who are of a sound frame of mind to give an informed consent to participate.

Exclusion Criteria:

* Patients less than 18 years of age
* Patients of unsound mind not capable of giving informed consent
* Active peptic ulcer disease, asthma, renal dysfunction, warfarin therapy, hypothyroidism history of epilepsy, pregnancy, breastfeeding and hypersensitivity to either products.

Primary outcomes:
measure: Compare levels of pain
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
state: Merseyside
Study officials:
affiliation: Royal Liverpool University Hospital
name: Bertil Damato
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04620746: Penicillin Allergy Testing in STD Clinics
Official title: Validate an Easy to Administer Algorithm to Define Penicillin (PCN-B-lactam) Allergy Status in Sexually Transmitted Disease (STD) Clinic Outpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Penicillin Allergy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Indiana University School of Medicine
name: Wake Forest University Health Sciences
name: Louisiana State University Health Sciences Center in New Orleans
name: University of Washington
First posted: 2020-11-09
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Demonstration project to implement penicillin allergy testing in STD outpatients using a questionnaire and pen allergy testing

Detailed description: all subjects receive risk questionnaire For subjects without high risk responses, randomized to direct oral challenge or PCN skin testing followed by oral challenge

Eligibility criteria: Inclusion Criteria:

* Prior history of PCN allergy

Exclusion Criteria:

* No immunodeficiency or contraindication to skin testing

Primary outcomes:
measure: Number of Respondents Who Responded YES to Any Question Defining High Risk Penicillin Allergy Using Questionnaire Developed by the Study
timeFrame: Baseline
measure: Safety of Direct Oral Challenge Defined by Number of Subjects Who Did Not Have Pre-defined Changes in Vital Signs or Pre-defined Emergence of New Respiratory or Skin Symptoms After Oral Challenge
timeFrame: 30 minutes after intervention
Secondary outcomes:
measure: Patient Acceptability of PCN Testing/Oral Challenge Assessed by a Study Team Developed Questionnaire
timeFrame: Immediately after intervention
measure: Provider Assessment of Feasibility of Allergy Evaluation at the End of Study
timeFrame: 18 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: Seattle
country: United States
facility: University of Washington-Harborview Medical Center
state: Washington
Study officials:
affiliation: Johns Hopkins University
name: Jonathan M Zenilman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06614946: Improving Coping to Reduce Suicide Risk Following ED Discharge
Official title: Facilitating Effective Coping to Reduce Suicide Risk Following ED Discharge: A Micro-randomized Trial to Develop an Adaptive Text-based Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicidal
Suicide, Attempted
Suicidal Ideation
Keywords: Emergency Department
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-09-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 2 arms: ESP only and ESP with text-based program. The ESP with text-based program arm includes twice daily (within-person) randomizations.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The researchers hope to learn whether an electronic safety plan (ESP) and a supportive text messaging program are feasible and acceptable to adult patients with recent suicidal thoughts or behavior after emergency department (ED) discharge. From this study, the researchers also hope to learn how to best carry out the ESP and text messaging program to improve outcomes for patients after ED discharge.


Eligibility criteria: Inclusion Criteria:

Individuals presenting to an ED with either:

1. actual, interrupted, or aborted attempt in the last 4 weeks
2. suicidal ideation within the last week

Exclusion Criteria:

* Severe cognitive impairment or altered mental status (psychosis, manic state)
* Severe aggression/agitation,
* Being admitted or transferred into inpatient care,
* Patient not owning a cell phone with text messaging capability

Primary outcomes:
measure: Percentage of eligible individuals who agree to participate
timeFrame: At the time of ED 1 day visit
measure: Completion of the one-month follow-up assessment survey
timeFrame: One month post-discharge from the ED
measure: Completion of the three-month follow-up assessment survey
timeFrame: Three months post-discharge from the ED
measure: Number of withdrawals
timeFrame: Up to 3 months post-discharge from the ED
measure: Percentage of participants who remain active (in text-support condition only)
timeFrame: Up to 28 days post-discharge from the ED
measure: Participant satisfaction with the intervention components
timeFrame: Up to 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Ewa Czyz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01002846: Effects of Acupuncture at ST36 and PC6 on Blood Pressure and Endothelial Dysfunction in Hypertensive Patients
Official title: Effects of Acupuncture at ST36 and PC6 on Blood Pressure and Endothelial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertension
Keywords: Efficacy
Acupuncture
Hypertension
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2009-10-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is randomised, controlled study about effects of acupuncture on blood pressure and endothelial dysfunction in stage I hypertension patient without medication. Subject will receive 8 weeks of either acupuncture or sham acupuncture, measuring FMD and blood test before and after treatment.


Eligibility criteria: Inclusion Criteria:

* Patients age 18-70 diagnosed stage I hypertension ( JNC-7) without taking hypertensive medication

Exclusion Criteria:

* Secondary hypertension
* DM
* History of cardiovascular disease
* Taking hypertensive medication
* Taking hyperlipidemic medication
* Smoking
* Pregnancy or feeding woman
* Cannot follow indication or there is no agreement of patient and conservator
* Investigator decide Inappropriate to trial

Primary outcomes:
measure: To assess effects of acupuncture on endothelial function with FMD variation after 8 weeks treatments.
timeFrame: 8 weeks
Secondary outcomes:
measure: To examine the effects of acupuncture on blood pressure, lipid , hsCRP level variation with ABPM after 8 weeks treatments.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Oriental Medicine of Stroke and Nerologic center
state: South Korea
Study officials:
affiliation: Oriental medicine center of Stroke and Neurology
name: SeongUk Park, OMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00918346: Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation
Official title: Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation in Patients With Open-angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: Ocular hypertension
Lead sponsor: Santen Oy
Sponsor class: INDUSTRY
First posted: 2009-06-11
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the pharmacodynamics (as expressed in intraocular pressure \[IOP\]) of two formulations of tafluprost 0.0015% eyedrops (preserved and unpreserved) in patients with open-angle glaucoma or ocular hypertension.

The primary aim of this study is to show that IOP reduction between the two formulations is equivalent at the end of the 4 week treatment period.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or more
* A diagnosis of open angle glaucoma or ocular hypertension
* Prior use of prostaglandin(s)
* Intra ocular pressure of 22-34 mmHg in at least one eye

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
* Previous participation in any clinical trial in which tafluprost was an investigational drug or use of contact lenses at screening or during the study
* Presence of any abnormality or significant illness that could be expected to interfere with the study

Primary outcomes:
measure: Intraocular Pressures (IOPs) at Baseline
timeFrame: Baseline
measure: Intraocular Pressures (IOPs) at Week 1
timeFrame: Week 1
measure: Intraocular Pressures (IOPs) at Week 4
timeFrame: Week 4
measure: Primary Pharmacodynamic Variable Intention to Treat Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)
timeFrame: Baseline - Week 4
measure: Primary Pharmacodynamic Variable Per Protocol Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)
timeFrame: Baseline - Week 4
Secondary outcomes:
measure: Overall and Time-wise Comparisons of IOP at Week 1
timeFrame: Baseline - Week 1
measure: Change From Baseline in Time-wise IOPs at Week 4
timeFrame: Baseline - Week 4
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Regensburg
country: Germany
facility: Ulrich Richter's surgery
city: Starnberg
country: Germany
facility: Praxis Dr. Hamacher
Study officials:
affiliation: University Hospital of Oulu
name: Juhani Airaksinen, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02842346: Correlation Between Umbilical Resistance Index and Fetal Growth
Official title: Correlation Between Umbilical Resistance Index and Fetal Growth: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Umbilical Doppler
Keywords: Ultrasound; umbilical Doppler; resistance index; fetal growth
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 77
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any pregnant patient with a normally progressing pregnancy and reporting for a prenatal screening ultrasound between 31 and 34 weeks amenorrhea.

Brief summary: The aim of our study was to investigate the correlation between the umbilical resistance index and weight gain during the third trimester of low-risk pregnancies.


Eligibility criteria: Inclusion Criteria:

* Any pregnant patient with a normally progressing pregnancy and reporting for a prenatal screening ultrasound between 31 and 34 weeks amenorrhea.

Exclusion Criteria:

* -The lack of an ultrasound carried out during the first trimester to confirm the term of the pregnancy.
* A medical condition in the mother: diabetes, high blood pressure or a known chronic illness.
* A medical condition in the fetus: suspicion of fetal hypotrophy (fetal biometrics lower than the 10th percentile), a birth defect (a chromosomal abnormality) during the pregnancy.
* Patients with tobacco addiction.
* A body mass index (BMI) ≥ 30 before the pregnancy.
* Multiple pregnancies
* A gap of less than 4 weeks between the date of the ultrasound and the date of delivery.

Primary outcomes:
measure: fetal growth
timeFrame: at birth
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bolz N, Kalache KD, Proquitte H, Slowinski T, Hartung JP, Henrich W, Bamberg C. Value of Doppler sonography near term: can umbilical and uterine artery indices in low-risk pregnancies predict perinatal outcome? J Perinat Med. 2013 Mar;41(2):165-70. doi: 10.1515/jpm-2012-0042.
citation: Salavati N, Sovio U, Mayo RP, Charnock-Jones DS, Smith GC. The relationship between human placental morphometry and ultrasonic measurements of utero-placental blood flow and fetal growth. Placenta. 2016 Feb;38:41-8. doi: 10.1016/j.placenta.2015.12.003. Epub 2015 Dec 12.
Clinical trial NCT00143546: Compassionate Use of Defibrotide for Patients With Veno-occlusive Disease of the Liver
Official title: Compassionate Use of Defibrotide for Patients With Veno-Occlusive Disease
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Hepatic Veno-occlusive Disease
Keywords: Hepatic Veno-occlusive Disease
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2005-09-02
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Veno-occlusive disease (VOD) of the liver is a significant complication for some patients undergoing hematopoietic stem cell transplantation. This disease is thought to be a toxicity secondary to chemotherapy or radiation-induced damage to the epithelial cells of the blood vessels in the liver. VOD is categorized as mild, moderate or severe. Historically, there has been no method to treat the disease. Recently, however, there have been investigations into the use of a new agent called defibrotide.

The primary purpose of this protocol is to provide defibrotide to patients with severe VOD. Because this drug has not been approved by the FDA, use of this medication under the auspices of this IND treatment plan is for compassionate use only.

Detailed description: Secondary objectives of this protocol include the following:

* To describe the toxicities of defibrotide in patients with VOD.
* To describe the response rate of VOD in patients receiving defibrotide.

Eligibility criteria: Inclusion Criteria:

Patients with clinical or pathologic diagnosis of veno-occlusive disease. The following criteria will be used:

1. Hyperbilirubinemia (greater than or equal to 2mg/dl) and two of the following: (hepatomegaly, ascites, or weight gain \[greater than or equal to 5% of baseline\]); OR,
2. Patient who do not fulfill criteria in #1 but who have pathologic or radiographic evidence of VOD.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Wing Leung, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02023346: Prognostic Awareness and Patient-Physician Communication in Malignant Glioma
Official title: Prognostic Awareness and Patient-Physician Communication in Malignant Glioma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Glioma
Keywords: Patient-Physician Communication
Brain cancer
13-253
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2013-12-30
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from the inpatient Neurology service. Caregivers will be recruited from either the inpatient Neurology service (if they are physically present at the hospital at the time of the patient's consent to participate) or via telephone communication (if not physically present at the time of patient consent).

Brief summary: The purpose of this study is to learn more about the understanding patients with brain tumors have of their disease and their communication with their physician. Ultimately, we hope to use these findings to improve communication between patients and their doctors.


Eligibility criteria: Inclusion Criteria:

Patient Inclusion Criteria

* Age greater than or equal to 18
* Diagnosis of any WHO grade III or IV glioma
* Admitted to the inpatient Neurology service
* Has had at least one outpatient visit with a neuro-oncologist at MSKCC Fluent in English

Caregiver Inclusion Criteria

* Age greater than or equal to 18
* Identified by the patient as a relative, friend, or partner with whom he or she has a significant relationship and who provides him or her physical or emotional assistance.
* The patient has himself or herself agreed to participate in this study

Exclusion Criteria:

Patient Exclusion Criteria

* A patient will be excluded if the Glasgow Coma Scale is less than 15. The patient must be oriented to self, age, place, and year, and month.
* Aphasia precluding comprehension and verbalization of consent to participate
* Patients who cannot verbally demonstrate their understanding of the risks, benefits, and alternatives to participating in the study. This evaluation will take place for otherwise eligible and willing participants, and it will be performed by the NP or MD clinician who is obtaining informed consent and will be documented in the medical record.

Caregiver Exclusion Criteria

* No eligible caregivers who can complete the brief assessment in person or via telephone will be excluded

Primary outcomes:
measure: measure prognostic awareness
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memoral Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Eli Diamond, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04805346: Remote Ischemic Conditioning in Oncology
Official title: Remote Ischemic Conditioning for Protection from Treatment-related Cardiotoxicity in Pediatric, Adolescent, and Young Adult Patients Undergoing Anthracycline Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Participants Undergoing Anthracycline Chemotherapy
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 1
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a feasibility study at a single site, Cincinnati Children's Hospital Medical Center. Patients undergoing anthracycline chemotherapy for Hodgkin disease and soft-tissue and bone sarcoma who meet eligibility requirements will be approached to participate in the study. The purpose of the study is to determine if performing remote ischemic conditioning (RIC) is feasible in children and young adults receiving anthracycline chemotherapy. The secondary purpose is to describe differences in markers of myocardial injury and stress in children and young adults that receive RIC prior to anthracycline chemotherapy compared to control subjects that receive sham therapy prior to chemotherapy.


Eligibility criteria: Inclusion Criteria:

1. Pediatric, adolescent, or young adult patients, 11 years of age or above.
2. Able to tolerate upper arm blood pressure inflation.

Exclusion Criteria:

1. Previous diagnosis of cardiomyopathy (dilated, hypertrophic, restrictive, myocarditis) or congenital heart disease other than bicuspid aortic valve.
2. Chronic kidney disease as defined as a pre-transplant GFR \<80
3. Central line in both upper extremities.
4. Known peripheral vascular disease or vasculitis.
5. Platelet count less than 30,000.
6. Known clotting disorder or hypercoagulability
7. Non-English-speaking patients.

Primary outcomes:
measure: Adverse Effects
timeFrame: 18-24 months from start of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Thomas C Ryan
role: PRINCIPAL_INVESTIGATOR
References: