louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05520242: Use of Animations Movies to Increase Response in a National Health Survey
Official title: Use of Small Animations Movies to Increase Response in a National Health Survey. A Random-ised Controlled Trial. A Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Response
Non-response
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Region Capital Denmark
name: North Denmark Region
name: Region Zealand
First posted: 2022-08-29
Enrollment: 201200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to examine the potential for animation movies to improve response rates and sample composition in an embedded randomized controlled trial in the Danish National Health Survey 2021. The overall research question is whether cover letters including an animation movie can perform better than generic letters.

Detailed description: The aim of this study is to examine the potential of animation videos to improve response rates and sample composition in an embedded randomized controlled trial in the Danish National Health Survey 2021 (DNHS-2021). The overall research question is whether digital cover letters including an animation video can perform better than digital letters without animations. The proposition is that such letters should increase the willingness of some sample members to participate by means of increased motivation and reduced complexity, and that this will be reflected in higher response rates. In addition to examining whether it can be advantageous for overall response rates to use cover letters including animation videos, this study also examines the effect of different versions of the animation videos across sample subgroups in order to identify how to best target potential non-respondents in future surveys.

Eligibility criteria: Inclusion Criteria:

* Aged 16 years or older and living in Denmark at January 1th 2021.
* Able to receive an invitation through a secure electronical mail service (Digital Post).

Primary outcomes:
measure: The number of invited individuals who respond to the survey
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: National Institute of Public health, University of Southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Anne I Christensen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03645642: To Study the Safety and Efficacy of Midodrine With Albumin Versus Albumin Alone in Hepatic Hydrothorax
Official title: To Study the Safety and Efficacy of Midodrine With Albumin Versus Albumin Alone in Hepatic Hydrothorax- A Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Hydrothorax
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hepatic hydrothorax is defined with accumulation of transudate fluid (500 ml) in the pleural cavity in patients with decompensated liver cirrhosis but without cardiopulmonary and pleural diseases. The Prevalence is 5-12% The treatment for hydrothorax is diuretics, repeated thoracocentensis, TIPS and liver transplant.. Midodrine increases effective arterial blood volume and also increases renal perfusion.It has also been used in Refractory ascitis .It has been shown to mobilise ascitis. In patients who are ineligible for TIPS and Liver transplant there is no data on Midodrine and its effects on Hydrothorax in cirrhotics.There are also no guidelines on the use of albumin during Pleural fluid tapping and the dose to be used. This study is being done to assess the safety and efficacy of Midodrine in hydrothorax.


Eligibility criteria: Inclusion Criteria:

* Patients with hepatic hydrothorax
* Patients with age from 18-75 years
* No evidence of Cardiac and pulmonary disease

Exclusion Criteria:

* Renal failure ( Creatinine\>2.5mg/dl)
* Gastrointestinal bleeding
* Spontaneous bacterial empyema/ Peritonitis
* Patients with urinary retention
* Intrinsic advanced pulmonary disease (CXR, HRCT thorax)
* Cardiovascular disease (Electrocardiogram, 2D Echo)
* Systemic arterial hypertension
* Presence of hepatocellular carcinoma or portal vein thrombosis, Budd chiari syndrome
* Patients with active untreated sepsis
* Pregnancy
* Patients with hepatic encephalopathy
* Patients eligible for TIPS
* No use of drugs affecting systemic hemodynamics prior to 7 day of enrollment

Primary outcomes:
measure: Change in frequency of thoracentesis.
timeFrame: 3 months
Secondary outcomes:
measure: Partial or complete resolution of hepatic hydrothorax
timeFrame: 3 months
measure: Development of Spontaneous Bacterial Empyema
timeFrame: 3 Months
measure: Development of Thorocacocentesis Induced circulatory dysfunction
timeFrame: 3 Months
measure: Drug related adverse events in both arms
timeFrame: 3 Months
measure: Transplant free survival in both groups
timeFrame: 3 Months
measure: Predictors and mechanisms of repeated development of hepatic hydrothorax
timeFrame: 3 Months
measure: Number of patients going for TIPS(Transintrahepatic Portosystemic Shunts)
timeFrame: 3 Months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT05414942: Opioid Reduction Program for Total Knee Replacement Patients
Official title: Opioid Reduction Program for Total Knee Replacement Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Injuries
Knee Injuries and Disorders
Opioid Use
Keywords: Opioid
Total Knee Replacement
Knee Arthroplasty
Knee Injuries
Prevention
Analgesics, Opioid
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: Campbell Clinic
First posted: 2022-06-10
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the context of prescribed opioids, research suggests that increased exposure is associated with long-term opioid use. Orthopedic surgeries are associated with the prescribing of more opioid narcotics than any other surgical specialty, particularly for Total Knee Replacement surgery, which is associated with severe post-operative pain. The proposed project is a randomized clinical trial to explore the efficacy of our Total Knee Replacement Opioid Reduction Program (ORP) vs. Treatment As Usual (TAU) in the reduction of opioid use following total knee replacement surgery.

Detailed description: The purpose of the study is to build upon our existing research to: (1) explore the efficacy of a disseminable Opioid Reduction Program (ORP) to reduce long-term use of prescribed opioids following TKR surgery, (2) assess whether lower opioid use following surgery is related to better functional recovery, and (3) model opioid use trajectories following TKR surgery (i.e., MMEs/week for 12 weeks), which will allow us to examine the factors that characterize at-risk groups.

There will be one control arm (Treatment as Usual or TAU) and one experimental arm (Opioid Reduction Program or ORP). The experimental arm will receive the intervention material twice. The first session is pre-surgery, and the second session is a shortened "booster" session approximately 2-weeks post-op.

Eligibility criteria: Inclusion Criteria:

* 18 years or older.
* Presenting for a total knee replacement (TKR) surgery at Campbell Clinic which will result in an opioid prescription.
* Access to a telephone.
* Able to consent in English.

Exclusion Criteria:

* Under the age of 18.
* Contraindications to use of opioid medication.
* No access to a telephone.
* Unable to understand consent materials in English.

Primary outcomes:
measure: Opioid pills (dose and type) prescribed by Campbell Clinic.
timeFrame: 12-weeks post-op.
measure: Opioid pills prescribed outside of Campbell Clinic.
timeFrame: 12-weeks post-op.
measure: Opioid pill count questionnaire.
timeFrame: 12-weeks post-op.
Secondary outcomes:
measure: KOOS Jr.
timeFrame: 12-weeks post-op.
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Karen Derefinko, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03314142: Effects of Bran Size on Glycemic Responses
Official title: Short-term Effects of Bran Size on Glycemic Responses in Normal Weight Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Potential Abnormality of Glucose Tolerance
Appetitive Behavior
Keywords: blood glucose
bran particle size
glucemic index
Lead sponsor: Agricultural University of Athens
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study investigated the effects of bran's particle size on glycemic responses

Detailed description: This study aimed at 1. to determine the GI and GL of three breads and 2. to investigate the effects of bran's particle size on postprandial glycemic response in healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking, non-diabetic men and women, individuals with normal body mass index (BMI; between 18.5 and 24.9 kg/m2)

Exclusion Criteria:

* severe chronic disease (e.g. coronary heart disease, diabetes mellitus, kidney or liver conditions, endocrine conditions)
* gastrointestinal disorders
* pregnancy
* lactation
* competitive sports
* alcohol or drug dependency

Primary outcomes:
measure: Capillary blood glucose responses
timeFrame: 2 hours
Secondary outcomes:
measure: Subjective appetite ratings
timeFrame: 2 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Agricultural University of Athens
Study officials:
affiliation: Agricultural University of Athens
name: Emilia Papakonstantinou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06326242: What Unmet Need for the Patients?A Focus on the Social Determinants of Health in Phase 1 Clinical Trials
Official title: Toward a Patient-centered Early Drug Development in Oncology: What Unmet Need for the Patients? A Focus on the Social Determinants of Health in Phase 1 Clinical Trials
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Solid Tumor
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 100
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: Patient enrolled in a phase 1 and early phase 2 study at our institution.

Brief summary: An observational prospective study of patients enrolled and treated with experimental drugs in Phase I studies.

Detailed description: The study focuses on defining the problem of geographical accessibility of patients to the Phase 1 facility of the European Institute of Oncology, based on an anonymized extraction of data from the enrolled patient database, to assess national territorial disparities in access to innovative experimental therapies, in relation to various socioeconomic determinants. Finally, information on relevant psychological factors for participation in clinical trials will also be collected.

Eligibility criteria: Inclusion Criteria :

* Patient with a histological or cytological diagnosis of solid or hematological tumor.
* Age ≥ 18 years.
* Patient enrolled in a phase 1 and early phase 2 study at our institution.
* The patient has received at least 1 administration of the experimental drug under study in the early phase trial.

Exclusion Criteria :

- Patients treated in phase 1 trials at other institutions, even if referred to our division or receiving standard therapies at IEO but outside of clinical trials, are not included.

Primary outcomes:
measure: The geographical accessibility of patients attending the Phase 1 facility of the European Institute of Oncology (IEO).
timeFrame: 1 year
Secondary outcomes:
measure: The characterization of enrolled patients involves assessing their participation in clinical trials
timeFrame: 1 year
measure: The characterization of enrolled patients based on therapeutic compliance.
timeFrame: 1 year
measure: The protocol prescriptions in relation to socioeconomic and geographical determinants.
timeFrame: 1 year
Other outcomes:
Locations:
city: Milano
country: Italy
facility: European Institute of oncology
Study officials:
affiliation: European Institute of Oncology
name: Teresa Profeta
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04904770: Time Performance of Scoop Stretcher Versus Vacuum Mattress for Prehospital Spinal Stabilization
Official title: Time Performance of Scoop Stretcher Versus Vacuum Mattress for Prehospital Spinal Stabilization: Open-Label Simulation-based Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immobilization
Keywords: Spinal stabilization
Prehospital
Emergency Medical Services
Scoop stretcher
Vacuum mattress
Spinal cord injury
Prehospital emergency care
Lead sponsor: Geneve TEAM Ambulances
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: A simulation-based randomized controlled trial was designed with the objective to assess the time needed to achieve spinal stabilization using a scoop stretcher compared to a vacuum mattress.

Detailed description: A simulation-based randomized controlled trial was designed with the objective to assess the time needed to achieve spinal stabilization using a scoop stretcher compared to a vacuum mattress. The participants will be recruited among healthcare workers from one Emergency Medical Service. Then, the participants will first act as patient and undergo spinal stabilization from an other team, afterwards they will have to complete a spinal stabilization either using a scoop stretcher or a vacuum mattress, depending on allocation regarding randomization. The sessions will be video recorded to allow subsequent assessment.

Eligibility criteria: Inclusion Criteria:

* registered paramedics or emergency medical technician (EMT) actually working in the ambulance service.

Exclusion Criteria:

* member of study investigators

Primary outcomes:
measure: Change in time to perform the procedure
timeFrame: At study session (real-time assessment), in July or August
Secondary outcomes:
measure: Quality of stabilization
timeFrame: At study session (real-time assessment), in July or August
measure: Level of anxiety
timeFrame: 5 minutes after spinal stabilization, on a questionnaire
measure: Level of comfort
timeFrame: 5 minutes after spinal stabilization, on a questionnaire
measure: Degree of induced dyspnoea or shortness of breath
timeFrame: 5 minutes after spinal stabilization, on a questionnaire
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Genève TEAM Ambulances
Study officials:
affiliation: Geneve TEAM Ambulances
name: Loric Stuby
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01691170: Comparison of Two Protocols for Patellofemoral Pain Syndrome
Official title: Quadriceps Femoris Strengthening Versus Hamstring Stretching for Patellofemoral Pain Syndrome: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Patellofemoral Pain Syndrome
Keywords: Pattelofemoral pain syndrome
Stretching
Strengthening
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The patellofemoral pain syndrome (PFPS) is defined as a painful complaint in the anterior aspect of the knee, although peripatellar pain and / or retropatellar are also common. In general, conservative treatment is the initial option of choice for patients with PFPS, however, the lack of a specific causal factor makes it difficult to choose the best treatment so early. This way, the purpose of this study is investigate the effects of the quadriceps femoris strengthening versus hamstring stretching in patients with pattellofemoral pain.


Eligibility criteria: Inclusion Criteria:

* Symptoms of anterior knee pain for at least 1 moth;
* Average pain level of 3 or more on a 10-cm visual analogue scale during stepping up and down a 25-cm height;
* Anterior or retropatellar knee pain on at least 2 of the following activities: prolonged sitting, climbing stairs, squatting, running, kneeling, and hopping/jumping;
* Presence of 2 of the following clinical criteria on assessment: pain during apprehension test, pain during the patellar compression test, and crepitation during the compression test.

Exclusion Criteria:

* Previous knee surgery or arthritis;
* History of patellar dislocation or subluxation, malalignment, or ligament laxity;
* Patellar tendon pathology or chondral damage;
* Spinal referred pain;
* History of other abnormalities such as leg length inequalities (\>2 cm);
* Medication as a part of the treatment;
* Previous physical therapy or acupuncture treatment for the knee within the previous 30 days.

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: Participants will be followed for the duration of 8 weeks.
Secondary outcomes:
measure: Lysholm Scale
timeFrame: Participants will be followed for the duration of 8 weeks.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Physical Therapy, Speech and Occupational Therapy Department, University of São Paulo.
Study officials:
References:
Clinical trial NCT01986270: Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo
Official title: A Multicenter, Double-blind, Placebo Controlled, Parallel Group, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels of of Oral Sumatriptan Given for the Acute Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine With or Without Aura
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-11-18
Enrollment: 1141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to compare the efficacy, toleration and safety of eletriptan 40mg and 80mg, with sumatriptan 25mg and 50mg, and placebo when given orally to subjects with an acute migraine.


Eligibility criteria: Inclusion Criteria:

* Subjects who expected to suffer at least one acute attack of migraine, with or without aura, each 6 weeks (The diagnosis of migraine was to comply with the criteria proposed by the International Headache Society (IHS))
* Subjects capable of taking medication as outpatients, and recording the effects of such medication.

Exclusion Criteria:

* Pregnant or breast-feeding women
* Migraine subjects who also suffered from concomitant frequent (non-migrainous) headache, defined as more than six attacks per month on average.

Primary outcomes:
measure: Headache response at 1 hour after the first dose for the first attack.
timeFrame: 1 hour
Secondary outcomes:
measure: Pain-free response at 1 hour after the first dose for the first attack.
timeFrame: 1 hour
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01853670: Adaptive Radiation Therapy for Head & Neck Cancer Patients
Official title: Kilovoltage Conebeam Imaging Based Adaptive Radiation Therapy for Head & Neck Patients Treated With Intensity Modulated Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Head and Neck
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the utility of kilovoltage (kV) cone beam CT imaging to track the dose delivered in head and neck cancer patients, to assess the benefit of cone beam CT to patients set-up for radiation treatment, to determine how shifts based on kV cone beam CT compare to the standard approach (orthogonal pair), and to develop remote access tools (preferably internet-based) so that the MD can approve these plans in real time.

Detailed description: The investigators' secondary objectives for this study are to assess the possibility of using kV cone beam for treatment replanning as compared to standard the treatment planning, to determine the need and feasibility of adaptive radiation therapy, to develop concept of establishing cumulative DVH (C-DVH) with daily updates and compare it to planned DVH (P-DVH), to identify tolerance margins, to evaluate local control, locoregional control, distant metastasis, and overall survival, to assess patient quality of life,and to develop predictors of patients which may benefit from ART.

Eligibility criteria: Inclusion Criteria:

* Patients should have an ECOG (Eastern Clinical Oncology Group) performance status of 0-2
* Patients should meet at least one of the following criteria:

  1. Locally advanced cancer (T3-T4 and/or N2-N3)
  2. Tumors wrapping around critical structures such as the optic nerves, optic chiasm, or brainstem
  3. Significant expected weight loss.

Exclusion Criteria:

* Previous surgical procedure more significant than a biopsy to the primary tumor or regional lymph nodes.
* Poor renal function (inability to undergo a CT with IV contrast)
* Previous radiation therapy to the head and neck.
* Inability to tolerate prolonged immobilization.
* Children and women who are pregnant or decline to use contraception.

Primary outcomes:
measure: Clinical patient response
timeFrame: From the date of initiation of radiation therapy, until date of first progression or until date of death (approximately 5 years).
Secondary outcomes:
measure: Patient quality of life
timeFrame: During radiation therapy (7-9 weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
Study officials:
affiliation: Beth Israel Medical Center
name: Ken Hu, MD
role: PRINCIPAL_INVESTIGATOR
References: