louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01394185: Effects of Dronabinol (Oral THC) on Cannabis Use
Official title: Effects of Dronabinol (Oral THC) on Cannabis Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Marijuana Smoking
Keywords: marijuana
dronabinol
pharmacotherapy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-07-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Study participants received dronabinol (0, 120mg/day and 240mg/day) for 12 consecutive days in a randomized order. During each dronabinol maintenance period they were able to self-administer active or placebo cannabis using either a progressive ratio schedule or choice between cannabis and monetary alternative.


Eligibility criteria: Inclusion Criteria:

* Current use of marijuana
* Able to give informed consent

Exclusion Criteria:

* Daily use of psychoactive medication
* Current Axis I psychiatric disorder other than dependence on cannabis or nicotine, or abuse of drugs or alcohol
* Women who are pregnant, breast feeding, or planning to become pregnant within the next 3 months
* Those seeking treatment for cannabis-related problems or using cannabis under the guidance of a physician for a medical disorder
* Uncontrolled or unstable cardiovascular disease
* Allergy to sesame oil

Primary outcomes:
measure: Marijuana Self-administration - Progressive Ratio
timeFrame: 12-day Dronabinol maintenance period
measure: Marijuana Self-administration - Drug Vs Money Choice
timeFrame: 12-day Dronabinol maintenance period
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University (Bayview Campus)
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ryan Vandrey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03192085: Comparison of SITA-Standard Compared to SITA-Fast Visual Fields.
Official title: Specificity and Patient Perception of SITA-Standard Compared to SITA-Fast Visual Fields in Patients Suspected of Having Glaucoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Lead sponsor: Royal Devon and Exeter NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Exeter
name: University of Plymouth
First posted: 2017-06-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised crossover trial of diagnostic test with assessment of comparative accuracy - feasibility study.
Primary purpose: DIAGNOSTIC

Brief summary: This study will compare SITA-Standard and SITA-Fast tests in patients newly referred to the glaucoma screening clinic at the RD\&E hospital.

Detailed description: This study will compare SITA-Standard and SITA-Fast tests in patients newly referred to the glaucoma screening clinic at the RD\&E hospital. In addition to standard care (SITA-Fast) each person who agrees to take part in the trial will undertake one extra visual field test (SITA-Standard). By comparing the results of the two types of visual field test the investigators aim to provide information on which of the two tests is more specific for glaucoma and which test is better tolerated by patients. The investigators anticipate that this study will generate sufficient data to support a grant application for a longitudinal study to examine the relative merits of different visual field tests in patients with glaucoma and those suspected of developing the disease.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old attending the West of England Eye Unit Glaucoma Service who have been newly referred for suspected glaucoma.

Exclusion Criteria:

* 1. Patients who are unable to perform visual field tests. 2. Patients who are unable to have a full glaucoma assessment. 3. Patients who have undertaken visual field tests in hospital eye departments in the last 2 years.

Primary outcomes:
measure: specificity of the visual field tests
timeFrame: 1 year
Secondary outcomes:
measure: Patients' rating of test difficulty
timeFrame: 1 year
measure: The number of "questions asked" (number of presented stimuli).
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Royal Devon
name: Michael Smith, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05652985: Effect of Inter-professional Collaboration Training Program on Nurses' Collegial Solidarity and Knowledge Sharing
Official title: Effect of Inter-professional Collaboration Training Program on Nurses' Collegial Solidarity and Knowledge Sharing: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nurses Behaviors
Keywords: Inter-professional Collaboration
Collegial Solidarity
Knowledge Sharing
Lead sponsor: Port Said University
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open-label, two-arm Randomized Control Trail (RCT)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Effect of Inter-professional Collaboration Training Program on Nurses' Collegial Solidarity and Knowledge Sharing

Detailed description: the study aims to evulate the effectiveness of inter-professional collaboration training program on nurses' collegial solidarity and knowledge sharing

Hypotheses:

H1: Nurses participating in the inter-professional collaboration training program will report, post intervention, high level of inter-professional collaboration behaviors compared with those nurse nurses in control group.

H2: Nurses participating in the inter-professional collaboration training program will report, post intervention, high level of collegial solidarity compared with those nurse nurses in control group H3: Nurses participating in the inter-professional collaboration training program will report, post intervention, high level of knowledge sharing compared with those nurse nurses in control group this is RCT study among nurses work in EL-Salam hospital, port said, Egypt

Eligibility criteria: Inclusion Criteria:

* licensed nurses who worked in direct contact with patients in their services
* had at least six month of experience in the nursing profession,
* agreed to participate in the study

Exclusion Criteria:

* participating in any intervention program within the last 12 months

Primary outcomes:
measure: Inter-professional collaboration of nurses
timeFrame: 3 monthes
Secondary outcomes:
measure: Colleage solidatory among nurses
timeFrame: 3 months
measure: knoweledge sharing
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03920956: 24-Hour Ambulatory Blood Pressure Monitoring in Community Pharmacies
Official title: Implementation & Evaluation of a 24-Hour Ambulatory Blood Pressure Monitoring Service in Community Pharmacies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is designed to explore the feasibility of providing 24-hour ambulatory blood pressure monitoring in community pharmacies. The investigators hypothesize it will be feasible for community pharmacies to provide the service to assist medical providers in the diagnosing and management of high blood pressure. The investigators will also survey participants regarding their experience with the service as well as conduct interviews with participating pharmacists and medical providers to understand their views and opinions on the feasibility of the service.


Eligibility criteria: Inclusion Criteria:

* Adults greater than or equal to 18 years of age suspected by their physician of having "white coat" or "masked" hypertension (HTN), hypotension symptoms due to antihypertensive therapy, uncontrolled sustained HTN, requiring additional confirmation of an initial diagnosis if HTN, or resistant HTN.

Exclusion Criteria:

* Documented past medical history of persistent atrial fibrillation, on hemodialysis, pregnancy, or dementia.

Primary outcomes:
measure: Patient satisfaction with the pharmacy service and experience wearing the ABPM
timeFrame: up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Dave Dixon, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khaddage SJ, Patterson JA, Sargent LJ, Price ET, Dixon DL. Sex and Age Differences in Ambulatory Blood Pressure Monitoring Tolerability. Am J Hypertens. 2021 Apr 20;34(4):335-338. doi: 10.1093/ajh/hpaa182.
Clinical trial NCT01456156: Study of Postoperative 3D-CRT/IMRT in Hepatocellular Carcinoma
Official title: Phase 2 Study of Postoperative Three-dimensional Conformal Radiation Therapy/Intensive Modulated Radiation Therapy in Hepatocellular Carcinoma: a Single Center Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Cancer
Keywords: hepatocellular carcinoma
postoperative radiotherapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2011-10-20
Enrollment: 76
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: Hepatectomy is difficult when the tumor is adjacent to the big vessels of the liver and some patients can not receive radical resection. Such patients have high risk of recurrence. Tumor resection and postoperative radiation is an option for such patients to achieve radical treatment and radiation may reduce local recurrence.

Detailed description: Patients with risk factors of recurrence receive postoperative radiotherapy using intensive modulated radiation therapy (IMRT) or three-dimensional conformal radiation therapy (3DCRT). The clinical target volume includes tumor bed. The dose will be 50-60Gy/25-30f. Overall survival, local-recurrence free survival, disease free survival and toxicity need be observed.

Eligibility criteria: Inclusion Criteria:

* written informed consent provided
* 18\~75 years old
* patients with histopathological proved hepatocellular carcinoma received hepatectomy and had at least one risk factor of recurrence
* without any lymph node or distant metastasis (any T N0M0)
* liver function: Child-Pugh A or B
* Performance status: Karnofsky (KPS)≥70 or world health organization(WHO) score 0,1
* life expectation\>6 months
* no dysfunction of major organs
* no prior radiotherapy
* negative for human immunodeficiency virus syndrome (HIV)
* Considerable to computed tomography(CT) simulation and 3D-CRT or IMRT

Exclusion Criteria:

* malignant tumors of other sits
* combining severe diseases, such as acute myocardial infarction(AMI), arrhythmias, infection
* surgery performed in other hospitals without details
* pregnant woman or woman need to breast feed or woman with positive chorionic gonadotrophin (HCG)

Primary outcomes:
measure: overall survival
timeFrame: 3 year
Secondary outcomes:
measure: local recurrence free survival
timeFrame: 3 years
measure: disease free survival
timeFrame: 3 years
measure: Number of Participants with Adverse Events
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References:
citation: Chen B, Wu JX, Cheng SH, Wang LM, Rong WQ, Wu F, Wang SL, Jin J, Liu YP, Song YW, Ren H, Fang H, Tang Y, Li N, Li YX, Wang WH. Phase 2 Study of Adjuvant Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC. Hepatology. 2021 Nov;74(5):2595-2604. doi: 10.1002/hep.31993. Epub 2021 Sep 16.
Clinical trial NCT01495156: Study of the Efficacy of Adjunctive Lithium Treatment for the Treatment of Psychotic Mania
Official title: A Randomized, Double-blind, Placebo Controlled Study of the Efficacy of Adjunctive Lithium for the Treatment of Psychotic Mania Followed by an Open Label Long-term Safety Period.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Bipolar I Disorder
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2011-12-19
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed pilot study is a placebo-controlled, parallel group, randomized clinical trial comparing two treatment strategies in adolescents with mania and prominent psychotic features. One group will receive a second generation antipsychotic (SGA) and placebo and the other will receive a SGA and lithium.

The primary double-blind phase of the study will last 8 weeks, followed by a 24-week extension-phase.


Eligibility criteria: Inclusion Criteria:

* Males and females, 12-18 years old, inpatients or outpatients
* meet DSM-IV criteria for Bipolar I disorder - manic or mixed episode
* psychotic symptoms present

Exclusion criteria:

* current serious homicidal/suicidal ideation
* prior non-response or intolerance to an adequate trial of lithium
* prior non-response or intolerance to adequate trials of both aripiprazole and risperidone
* any unstable medical condition or medical contraindication to treatment with lithium, aripiprazole or risperidone
* inability or unwillingness to discontinue concomitant medication that interferes with the pharmacokinetics of either lithium, aripiprazole, or risperidone
* seizure disorder
* pregnant or, if sexually active, not using birth control, such as oral contraceptives, two barrier methods, long-acting depot preparations or an intra-uterine device
* Full Scale IQ less than 70
* meets criteria for a DSM-IV diagnosis of substance-induced mood disorder or mood disorder due to a general medical condition.

Primary outcomes:
measure: Acute phase :Time to partial or full response
timeFrame: 8 weeks
measure: Continuation Phase: time to recurrence of a subsyndromal mood episode
timeFrame: 24 weeks
Secondary outcomes:
measure: Acute phase: number of suicidal events
timeFrame: 8 weeks
measure: Acute phase: positive urine toxicology screens (yes/no variable)
timeFrame: 8 weeks
measure: Acute phase: adherence to medication regimen.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital, North Shore-LIJ Health System
state: New York
Study officials:
References:
Clinical trial NCT04776356: Safety and Effectiveness of the QuickFix Small Staple
Official title: Prospective Study to Evaluate the Continued Safety and Effectiveness of the QuickFix Small Staple to Correct Hallux Valgus Interphalangeus
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hallux Valgus Interphalangeus
Keywords: Staple
Lead sponsor: Arthrex GmbH
Sponsor class: INDUSTRY
First posted: 2021-03-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 45 subjects, male and female, at least 18 years of age from the general population who will be treated with the Arthrex QuickFix Small Staple to correct hallux valgus interphalangeus.

Brief summary: The prospective, post-market, single-center clinical study will include 45 subjects who are candidates for surgery using the Arthrex QuickFix Small Staple for Akin osteotomy to correct hallux valgus interphalangeus. The purpose of the study is to evaluate the continued safety and effectiveness of the device. Device-related adverse events as well as patient reported outcomes (VAS, FFI, FAAM, VR-12) will be collected up to 1 year postoperative.


Eligibility criteria: Inclusion Criteria:

1. Subject requires surgery using the Arthrex QuickFix Small Staple for Akin osteotomy.
2. Subject is 18 years of age or older.
3. Subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state).
4. Subject signed informed consent and is willing and able to comply with all study requirements.

Exclusion Criteria:

1. Insufficient quantity or quality of bone.
2. Blood supply limitations and previous infections which may retard healing.
3. Foreign-body sensitivity.
4. Any active infection or blood supply limitations.
5. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
6. Subjects that are skeletally immature.

Primary outcomes:
measure: Change of Visual Analogue Scale (VAS)
timeFrame: preoperatively, 2 weeks, 6 week, 3 months, 6 months and 12 months postoperative
measure: Change of Foot Function Index (FFI)
timeFrame: preoperatively, 3 months, 6 months and 12 months postoperative
measure: Change of Foot and Ankle Ability Measure (FAAM Sport)
timeFrame: preoperatively, 3 months, 6 months and 12 months postoperative
measure: Change of Veterans RAND 12 Iteam Health Survey (VR-12)
timeFrame: preoperatively, 6 months and 12 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Meissen
country: Germany
facility: Überörtliche Gemeinschaftspraxis für Chirurgie, Unfallchirurgie, Anästhesie und Endoskopie
Study officials:
affiliation: Überörtliche Gemeinschaftspraxis für Chirurgie, Unfallchirurgie, Anästhesie und Endoskopie
name: Tilo Schreiter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01176656: Hypoglycemia: Physician and Patient Perspectives
Official title: Hypoglycemia: Physician and Patient Perspectives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Hypoglycemia
Keywords: Type 2 Diabetes Mellitus
Hypoglycemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2010-08-06
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with T2DM will be identified from a large U.S. administrative claims database using a claims-based algorithm for T2DM. Patients and their associated physicians will be recruited via mail into the survey portion of this study. Survey results will be linked to actual patient care using the claims records.

Brief summary: The purpose of this study is to assess the burden of hypoglycemia and identify unmet need related to the management of hypoglycemia among Type 2Diabetes Mellitus (T2DM) patients on OADs and/or insulin. This is an observational study which will identify patients with T2DM in an administrative claims database and will link claims data with results of patient and physician surveys concerning hypoglycemia.


Eligibility criteria: Inclusion Criteria:

* T2DM claims diagnosis (algorithm-based) with at least 2 pharmacy claims for an antidiabetic drug
* at least 1 HbA1c test recorded during the identification period
* continuous enrollment in the health plan for at least 12 months prior to survey date

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* pregnancy or gestational diabetes

Primary outcomes:
measure: prevalence of hypoglycemia and impact of hypoglycemia
timeFrame: October 2009-October 2010
Secondary outcomes:
measure: Patient Reported Outcomes of Hypoglycemia (including fear, awareness, behavioral modification and recovery from hypoglycemia)
timeFrame: October 2009-October 2010
measure: Treatment adherence and modification related to hypoglycemia, including health status, glycemic control and healthcare utilization
timeFrame: October 2009-October 2010
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Setareh Williams, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06089356: Zolmitriptane as Prophylaxis for Chilhood Migraine
Official title: Zolmitriptane as Prophylactic Therapy Childhood Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Migraine
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: zolmitriptane can be tried as prophylactic therapy of childhood migraine

Detailed description: 90 children with migraine included in the study first group 30 received zolmitriptane second group 30 received topiramate third group 30 received valproate

Eligibility criteria: Inclusion Criteria:

children with migraine -

Exclusion Criteria:

those who suffer from ischemic heart disease , or who have allergy to any of drugs used

-

Primary outcomes:
measure: number and severity of migraine attacks
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Kafrelsheikh University
state: Kafrelsheikh
Study officials:
affiliation: kafrelsheikh university- egypt
name: Abeer Salamah, ass prof
role: PRINCIPAL_INVESTIGATOR
References: