louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01758562: Caphosol® Versus State-of-the-art Mouthcare in Patients With Allogeneic Stem Cell Transplantation: a Randomized Controlled Study About the Efficacy of the Mouth Rinse Caphosol®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allogeneic Stem Cell Transplantation
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomized controlled study about the efficacy of the mouth rinse Caphosol in patients with allogeneic stem cell transplantation. 85% of the patients receive a severe oral mucositis due to their treatment.

70 patients will be randomized in the intervention (Caphosol) or in the standard (state-of-the-art) group. Primary endpoint is the duration of the mucositis, secondary endpoints are the occurence of oral mucositis measured with the WHO-scale and the occurence of pain measured with the NRS-scale (Numeric Rating Scale).

* Trial with medical device


Eligibility criteria: Inclusion criteria:

* Allogeneic stem cell transplantation
* Male and female patients age 18-80
* Signed informed consent after information

Exclusion criteria:

* Contra-indications due to ethical reasons
* Unable to read or write
* Unable to speak or understand the german language
* Low-salt diet

Primary outcomes:
measure: Duration of oral mucositis
timeFrame: 20-30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Centre of Clinical Nursing Science
state: ZH
Study officials:
affiliation: University Hospital Zurich, Centre of Clinical Nursing Science
name: Rebecca Spirig, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00935662: A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses
Official title: A Randomised, Single-blind, Placebo-controlled, Two-centre Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD8329 After Single Ascending Oral Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Men
Keywords: First time in man
Safety study
AZD8329
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-07-09
Enrollment: 119
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective for this study is to assess the safety and tolerability of AZD8329 when given as a single dose in increasing dose strength, and also to identify the highest tolerated dose for future studies.


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

Primary outcomes:
measure: Safety measurements (ECG's, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)
timeFrame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.
Secondary outcomes:
measure: PK samples for AZD8329
timeFrame: Intense PK-sampling during the 24 hours following administration of investigational product and additional samples up to 72 hours after dose.
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: Quintiles AB, Phase I Services, Uppsala, Sweden
name: Wolfgang Kühn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00682162: Impact of Acupuncture on Vasomotor Rhinitis
Official title: Impact of Acupuncture on Vasomotor Rhinitis: a Randomised Placebo Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vasomotor Rhinitis
Acupuncture
Keywords: acupuncture
randomised controlled trial
placebo
sham laser
vasomotor rhinitis
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic rhinitis without an allergic or infectious aetiology (vasomotor rhinitis) is a common disease for which there are only poor therapeutic treatment options. The current placebo controlled partially double blinded pilot study evaluated the effects of acupuncture on the symptoms of vasomotor rhinitis.


Eligibility criteria: Inclusion Criteria:

* term of sickness \> 3 month
* negative allergic testing

Exclusion Criteria:

* term of sickness \< 3 month
* previous nasal surgeries
* polyposis nasi
* contraindications regarding acupuncture (such as: risk of bleeding, pregnancy)
* psychologic disorders
* drug addiction
* autoimmune disease
* other severe disease

Primary outcomes:
measure: The main outcome measure was the alteration of the nasal sickness score (NSS; scoremax 27).
timeFrame: 5 weeks
Secondary outcomes:
measure: Secondary outcome measures were the evaluation of a subjective symptoms score by patients' diaries and of their quality of life (SF-12 health survey).
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of otorhinolaryngology of the University of Munich
city: Munich
country: Germany
facility: Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich,
Study officials:
affiliation: Multidisciplinary Pain Centre, Department of Anaesthesiology, University of Munich, Germany
name: Dominik Irnich, PD. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fleckenstein J, Raab C, Gleditsch J, Ostertag P, Rasp G, Stor W, Irnich D. Impact of acupuncture on vasomotor rhinitis: a randomized placebo-controlled pilot study. J Altern Complement Med. 2009 Apr;15(4):391-8. doi: 10.1089/acm.2008.0471.
Clinical trial NCT05342662: Light Sleep: Screen Use and Sleep Health
Official title: Evaluating the Consequences of Mistimed Light-emitting Device Use on Cardiac Activity and Sleep Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glasses
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomly assigned to wear either blue light-blocking glasses or glasses with clear lenses during the second week of the study. During the third week, participants will be assigned to wear the opposite pair of glasses. Sleep and wake behaviors are the primary study outcome.
Primary purpose: OTHER

Brief summary: The Phone Sleep Study is being done to find out whether wearing blue light-blocking glasses in the evening improves subsequent sleep. This is a 21-day study and participants will be asked to wear a sleep-monitoring "actiwatch", a heart tracker, and an activity monitor, as well as to provide screenshots of participants' smartphone's screen time app for three weeks. Participants will also be asked to wear a blood pressure cuff on their arm for three days during each week, for a total of nine days.


Eligibility criteria: Inclusion Criteria:

1. Fluent English speaker and reader
2. Capable of providing one's own informed consent
3. Age 18 to 29 years old
4. Healthy, sighted individuals
5. Own an iOS smartphone (iPhone)
6. Willingness to update smartphone to access the current version of the Screen Time or StayFree application, depending on smartphone operating system
7. Willingness to participate in surveys, wear health monitoring devices, and provide screenshots of their smartphone's screentime application throughout the entire study

Exclusion Criteria:

1. Younger than 18 or older than 29 years
2. Individuals who are blind or wear corrective lenses
3. Taking prescribed medications that affect sleep
4. Recent shift work
5. Sleep disorder diagnosis or any cardiovascular disease

Primary outcomes:
measure: Sleep onset
timeFrame: Throughout the duration of the study (~3 weeks)
measure: Sleep midpoint
timeFrame: Throughout the duration of the study (~3 weeks)
measure: Total sleep time at night
timeFrame: Throughout the duration of the study (~3 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: University Park
country: United States
facility: Biobehavioral Health Building
state: Pennsylvania
Study officials:
affiliation: Department of Biobehavioral Health
name: David Reichenberger, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06827262: Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain
Official title: Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Low-back Pain
Vertebrogenic Pain Syndrome
Keywords: Intraosseous basivertebral nerve ablation
Axial low back pain
Low Back Pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2025-02-14
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are established patients in a medical practice who will receive intraosseous nerve ablation to treat vertebrogenic pain utilizing a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use according to standard of care.

Brief summary: Compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.

Detailed description: The objective of this study is to compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.

Eligibility criteria: Inclusion Criteria:

* Study candidate is scheduled to be treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use (IFU).
* Signed a valid, IRB/EC-approved informed consent form.

Exclusion Criteria:

* Meets any contraindications per locally applicable Instructions for Use (IFU).

Primary outcomes:
measure: Change in Disability (Oswestry Disability Index (ODI) from Baseline
timeFrame: 60-months post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Larkspur
country: United States
facility: MarinHealth Spine Institute
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Post Falls
country: United States
facility: North Idaho Day Surgery, LLC
state: Idaho
city: Eugene
country: United States
facility: Pacific Sports and Spine
state: Oregon
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
Study officials:
affiliation: Boston Scientific Corporation
name: Natalie Bloom Lyons, M.A.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01167062: Efficacy of Tamsulosin Oral-controlled Absorption System (OCAS) in the Treatment of Distal Ureteral Stones
Official title: Efficacy of Tamsulosin OCAS in the Conjunctive Medical Treatment of Distal Ureteral Stones.A Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ureteral Calculi
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2010-07-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized double blind placebo-controlled study that will assess the efficacy of Tamsulosin oral-controlled absorption system (OCAS) 0.4 mg in the conjunctive medical treatment of distal ureteral stones with a size of 4-10 mm compared to placebo in control group.

Detailed description: * patient will be randomized to receive placebo or Tamsulosin OCAS 0.4 mg 1 tablet OD for a maximum of 28 days or until the ureteral stone is passed and sodium diclofenac 50 mg twice a day, for 10 days.
* All patients will receive 75 mg sodium diclofenac via intramuscular on demand

Eligibility criteria: Inclusion Criteria:

* Male or female patient aged =\> 18 years.
* Patients who have distal ureteral stones with a size of 4-10 mm
* Written informed consent has been obtained.

Exclusion Criteria:

* Patients with history of ureteral surgery
* Patients with urinary tract infection
* Patient with diabetes and peptic ulcer
* Patient with renal dysfunction (elevated of serum creatinine level)
* Patients with severe hydronephrosis
* Patients with history of passing stones
* Pregnancy
* Patients who desire to withdraw from the study

Primary outcomes:
measure: Stone expulsion rate and time.
timeFrame: 28 days
Secondary outcomes:
measure: Number of diclofenac injection used
timeFrame: 28 days
measure: Rate of occurrence of adverse events
timeFrame: 28 days
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Maharat Nakhon Chiangmai Hospital
state: Chiangmai
Study officials:
References:
Clinical trial NCT02728362: Suprapatellar Nailing of Tibial Shaft Fractures
Official title: Suprapatellar Nailing of Tibial Shaft Fractures: Long Term Follow Up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Broken Leg
Keywords: tibial shaft fractures
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with tibial shaft fractures.

Brief summary: To investigate the functional outcomes and prevalence and severity of knee pain for patients undergoing suprapatellar nailing of tibial shaft fractures.

Detailed description: Suprapatellar nailing...

Participants will be followed for 10 years prospectively. Follow up visits will occur at 2 weeks, 6weeks, 3 months, 6 months, 12 months, 3 years, 5 years, 7 years and 10 years.

Interim analysis will be done at 1, 3, 5, and 7 years with final analysis occuring at 10 years.

Primary and secondary endpoints in patients undergoing suprapatellar nailing of tibial shaft fractures are:

1. To evaluate the long term presence of knee pain
2. To evaluate the long term functional outcomes

Eligibility criteria: Inclusion Criteria:

* Isolated, unilateral tibial shaft fractures
* Orthopaedic Trauma Association (OTA) classification of 42 and may extend to 43A or 43B
* age 18-65, including pregnant women
* open or closed fractures
* able to sign consent
* english speaking

Exclusion Criteria:

* compartment syndrome
* other lower extremity injuries that will affect functional outcomes
* problems maintaining follow up (homeless, not willing to return for follow up)
* pathological fractures
* prisoners
* previous retained hardware in the injured leg
* injuries requiring vascular repair

Primary outcomes:
measure: Long term presence of knee pain
timeFrame: 10 years
Secondary outcomes:
measure: Long term functional outcomes
timeFrame: 10 years
measure: Knee Range of Motion (ROM)
timeFrame: 10 years
measure: Fracture Healing
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
affiliation: Spectrum Health Hospitals
name: Blake W Miller, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04456062: Using Caring Contacts to Reduce Psychiatric Morbidity Following Hospitalization During the COVID-19 Pandemic
Official title: Using Caring Contacts to Reduce Psychiatric Morbidity Following Hospitalization During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychiatric Hospitalization
Keywords: Caring Contacts
Suicide Prevention
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Subjects will be recently discharged patients from Sunnybrook Inpatient Psychiatry Unit. Subjects will be randomized in a 1:1 ratio to either the Caring Contact intervention or usual care. 75 subjects will be enrolled in each arm. In additional to usual discharge-related care, subjects in the caring contact group will receive brief emails that convey a message of hope and provide resources. These emails will be sent on days 4, 21, and 56 post-discharge. The specific content of these emails will be pre-determined varying slightly by time point. In contrast, the control group will only receive usual discharge-related care, including discharge planning and also a sheet of resources normally provided to patients. A widely used and validated measure will be employed to assess depression and anxiety symptoms. The 25-item self-report Hopkins Symptom Checklist will be emailed to all subjects at baseline, day 4, 21, and 56 post-discharge, along with the Caring Contact communication. It is hypothesized that there will be a significantly greater reduction in mental health symptoms among patients receiving Caring Contacts compared to those who receive usual care.


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent
* Inpatient status in Sunnybrook Inpatient Psychiatry Unit at time of recruitment
* Have an email or mailing address
* Ability to read and understand English
* The ability to understand and comply with the requirements of the study and capable of providing informed consent

Exclusion Criteria:

* A primary Major Neurocognitive Disorder diagnosis

Primary outcomes:
measure: Hopkins Symptom Checklist-25 (HSCL-25)
timeFrame: Baseline, day 4, day 21, day 56 post-discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Ayal Schaffer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Rosalie Steinberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holman S, Steinberg R, Sinyor M, Lane H, Starritt K, Kennedy SH, Niederkrotenthaler T, Zaretsky A, Castel S, Schaffer A. Caring Contacts to Reduce Psychiatric Morbidity Following Hospitalization During the COVID-19 Pandemic: A Pilot Randomized Controlled Trial. Can J Psychiatry. 2023 Mar;68(3):152-162. doi: 10.1177/07067437221121111. Epub 2022 Aug 22.
Clinical trial NCT05083962: Healthy Lifestyle Program: A Novel Group-based Training
Official title: Healthy Lifestyle Program: A Novel Group-based Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Healthy Lifestyle Program involves twelve, 2-hour seminars during which participants will learn how to build healthy behaviors through a combination of individual and group exercises. Participants will use lessons from the seminars to pursue health goals and learn the basics of physical fitness, nutrition, sleep \& recovery, stress management, and weight management for optimal health. Throughout the program, participants will be supported by a behavior coach along with dedicated fitness training, dietary strategy, and stress management support. As part of this next installment of the program, we are conducting a study of the Healthy Lifestyle Program to capture outcome data, including weight/BMI, blood pressure, hemoglobin A1c, and lipid profile.


Eligibility criteria: Inclusion Criteria:

* Preferential access to the HLP is provided folks who live in the neighborhoods of Roxbury, Dorchester, and Mattapan. However, this is certainly not exclusive and we continue to have participants from all around the greater Boston area, especially now that the program is being delivered virtually.

Exclusion Criteria:

* There are no groups of people who are excluded from participating in the program, except for the specified by the age cut offs.

Primary outcomes:
measure: BMI
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: