louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02338102: Nasal Saline Irrigation After Radiation Therapy for Oropharyngeal Cancer
Official title: Nasal Saline Irrigation After Radiation Therapy for Oropharyngeal Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Obstruction
Rhinitis, Vasomotor
Epistaxis
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 36
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: The purpose of this study is to learn whether nasal saline irrigation is beneficial to patients undergoing radiation therapy for oropharyngeal cancer.

Detailed description: In this study, subjects are randomized to one of two study arms. They are either randomized to receive nasal saline irrigation treatment (treatment group) or not to receive any nasal irrigation treatment (control group). Subjects randomized to the treatment group will be provided with saline packets to mix with water. All study subjects will be asked to complete questionnaires during the study. If a subject completes all study related activities, their total length of participation in the study will last about 2 months.

Eligibility criteria: Inclusion Criteria:

* All patients seen in the KUMC Ear, Nose and Throat clinic with oropharyngeal cancer that have undergone radiation therapy as the primary treatment

Exclusion Criteria:

* Patients that are at high risk for infection secondary to nasal irrigation
* Patients with autoimmune disease or immune deficiency

Primary outcomes:
measure: Change in quality of life, measured using Sino-Nasal Outcome Test (SNOT-20) summary scores
timeFrame: Change from Baseline to Month 2
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Yelizaveta Shnayder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05192902: Pain Perception Following Computer-Controlled vs. Conventional Dental Anesthesia
Official title: Pain Perception Following Computer-Controlled vs. Conventional Dental Anesthesia: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Perception
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 60
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: This single-blind two-arm randomized control trial (RCT) aims to evaluate the pain perception during and following administration of dental local anaesthesia using two different systems; i.e. computer-controlled (CCLA) and conventional.

Detailed description: The administration of local anaesthesia (LA) is associated with pain, fear and anxiety. Computer-controlled LA (CCLA) aims to control the administration speed and reduce pain, fear and anxiety. This randomised control trial (RCT) aims to compare the pain perception after CCLA and conventional LA, and it uses dental students as both test and operator group versus an experienced dentist as an additional operator of the LA.

Eligibility criteria: Inclusion Criteria:

* Dental students at the Faculty of Medicine, University of Giessen enrolled in the course of Local Anaesthesia.

Primary outcomes:
measure: Pain on Puncture (PoP)
timeFrame: Within 2 hours
measure: Pain during Delivery (PdD)
timeFrame: Within 2 hours
Secondary outcomes:
measure: Dental Anxiety (DA)
timeFrame: Within 2 hours
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: University of Giessen
state: Hessen
Study officials:
References:
Clinical trial NCT00822302: Trial to Evaluate the Ability of a Single Infusion of High-Density Lipoprotein (HDL) to Modulate Markers of Cerebral Ischaemia
Official title: Does recHDL Given i.v. Before CEA Prevent Cerebral Ischaemia? - the Reveal Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: atherosclerosis
stroke
ischaemia
Lead sponsor: St George's, University of London
Sponsor class: OTHER
First posted: 2009-01-14
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The plasma concentration of high-density lipoprotein (HDL) can have anti-inflammatory, anti-oxidative and anti-thrombotic effects in addition to being able to remove cholesterol from peripheral tissues for secretion via the liver.

The investigators hypothesise that elevation of plasma HDLs will reduce the inflammatory response following removal of unstable atherosclerotic plaques in the carotid artery. Such plaques can cause strokes and there is great benefit from early surgical removal, however such surgical procedures involve significant risks to the patient.

The investigators propose infusing HDL into patients prior to removal of their unstable carotid plaque and measuring the changes in inflammatory responses in comparison to a similar placebo controlled group of patients.

Detailed description: Following written informed consent, patients will be randomised to either the placebo or active arm of the study. Bloods will be taken for baseline measurements, and the infusion of either saline (placebo) or rHDL (active agent) will be carried out on the ward. Infusion will take 4 hours, and the active agent infused at 40mg/kg.

Just prior to CAE, bloods will be collected (24 hours post-infusion) and the atherosclerotic tissue collected into RNA stabilising agent for subsequent analysis. Further bloods will then be collected 24 hours post-operatively (48 hours post-infusion).

Patients vital signs will be monitored hourly following infusion and will be reviewed in out-patients at 6 weeks after the operation.

Eligibility criteria: Inclusion Criteria:

* patients listed for elective carotid endarterectomy

Exclusion Criteria:

* pregnant women and women of childbearing age
* patient with impaired renal function or liver function
* patients sectioned under the Mental Health Act

Primary outcomes:
measure: Inflammatory and thrombotic response
timeFrame: baseline, 24 hours after infusion, 48 hours after infusion
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Georges University of London
state: Tooting
Study officials:
References:
Clinical trial NCT03489902: Transvaginal Versus Transobturator Paravaginal Repair
Official title: Transvaginal Versus Transobturator Paravaginal Repair Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystocele
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical trial comparing the new technique for paravaginal repair versus the traditional technique

Detailed description: trial comparing the transobturator paravaginal repair versus the traditional technique

Eligibility criteria: Inclusion Criteria:

paravaginal defect cystocele

midline and paravaginal defect cystocele

Exclusion Criteria:

* uterine descent previous cystocele surgery

Primary outcomes:
measure: Operative data
timeFrame: 1 day
Secondary outcomes:
measure: Pelvic organ prolapse quantification system
timeFrame: 3 month
measure: Operative Details
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams University
name: Hamdy HA Saaid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02572102: Impact of Energy Drinks and Panax Ginseng on Heart Rhythm
Official title: Impact of Energy Drinks and Panax Ginseng on Heart Rhythm in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Electrical Alternation of Heart
Blood Pressure
Keywords: ECG
Blood Pressure
Energy Drinks
Panax Ginseng
Lead sponsor: University of the Pacific
Sponsor class: OTHER
First posted: 2015-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To assess the cardiac effects of an energy drink and Panax Ginseng in healthy volunteers.

Detailed description: Energy drinks are composed of a variety of ingredients such as caffeine, taurine, and panax ginseng amongst others. The safety and efficacy of these ingredients individually and in combination need further exploration. This study is designed to assess the electrocardiographic and blood pressure effects of energy drinks and panax ginseng in healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female adults 18-40 years old.

Exclusion Criteria:

* Baseline corrected QT (QTc) interval greater than 440 milliseconds,
* blood pressure at initial screening appointment greater than 140/90 mmHg,
* concurrent use of prescriptions or OTC medications taken on a daily basis,
* pregnant females,
* patients with any baseline ECG abnormalities.

Primary outcomes:
measure: QTc interval changes
timeFrame: 5.5 hours over 3 visits
measure: Systolic blood pressure changes
timeFrame: 5.5 hours over 3 visits
Secondary outcomes:
measure: QT interval changes
timeFrame: 5.5 hours over 3 visits
measure: PR interval changes
timeFrame: 5.5 hours over 3 visits
measure: QRS duration changes
timeFrame: 5.5 hours over 3 visits
measure: Heart rate changes
timeFrame: 5.5 hours over 3 visits
measure: Diastolic blood pressure changes
timeFrame: 5.5 hours over 3 visits
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03036202: Pharmacokinetics of Epinephrine During Cardiac Arrest
Official title: Pharmacokinetic Study of Epinephrine During Cardiac Arrest Determining T1/2 and Time to Peak Concentration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Keywords: epinephrine
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cardiac arrest of an assumed cardiac origin, treated by the Bergen Emergency Medical Service.

Brief summary: To determine the pharmacokinetics of epinephrine during cardiac arrest.

Detailed description: The aim of out study is to determine the pharmacokinetics in humans during cardiac arrest, following a single dose of epinephrine. Venous samples will be withdrawn every minute the first five minutes following a single dose.

The aim of the study is to determine T1/2 in a clinical setting and to determine time to peak concentration.

Eligibility criteria: Inclusion Criteria:

* Age 18-85 yrs
* Witnessed non-traumatic cardiac arrest.
* Probable cardiac origin
* Treated by Bergen Emergency Medical Services

Exclusion Criteria:

* Terminal illness
* Residents of nursery homes
* Obvious dead
* Hypothermic patients
* Epinephrine administered before arrival of study physician

Primary outcomes:
measure: Concentration of epinephrine (ng/mL) as a function of time the first five minutes following administration
timeFrame: Blood samples will be drawn within minutes, and the survivors transported to hospital. The data according to Utstein-style, will also be collected. Blood samples will be analysed within weeks.Total timeframe for the study is estimated to one year.
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
state: N
Study officials:
affiliation: Haukeland University Hospital
name: Baard E Heradstveit, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05407402: Laughter Yoga on Pain and Comfort in Individuals Diagnosed With Migraine
Official title: Examination of the Effect of Laughter Yoga on Pain and Comfort in Individuals Diagnosed With Migraine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Head
Keywords: laughter yoga,
funny videos,
migraine,
pain,
comfort
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: In individuals diagnosed with migraine, laughter yoga will be performed for 45 minutes, 3 times a week for 1 month. the other application group will watch funny videos for 45 minutes, 3 times a week for 1 month.


Eligibility criteria: Inclusion Criteria:

* Being older than 18 years of age
* Having been diagnosed with migraine for at least one year
* Having no mental disability

Exclusion Criteria:

* individuals using pain relievers
* individuals who have done laughter yoga before

Primary outcomes:
measure: Laughter yoga changes pain
timeFrame: 2 month
measure: Laughter yoga changes comfort.
timeFrame: 2 month
Secondary outcomes:
Other outcomes:
measure: Watching funny videos changes pain
timeFrame: 2 month
measure: Watching funny videos changes comfort.
timeFrame: 2 month
Locations:
city: Aksaray
country: Turkey
facility: Aksaray University
Study officials:
References:
Clinical trial NCT02526602: Preservation of Endopelvic Fascia: Effects on Postoperative Incontinence and Impotence. Randomized Clinical Trial.
Official title: Preservation of Endopelvic Fascia During Radical Prostatectomy: Effects on Postoperative Incontinence and Impotence. Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Urinary Incontinence
Erectile Dysfunction
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2015-08-18
Enrollment: 158
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Urinary incontinence and impotence are typical disturbances after radical prostatectomy. Although, several surgical methods are developed to decrease these disturbances, 8% and 50% of the patients suffer from permanent urinary incontinence and impotence, respectively.

Previously two studies have shown that endopelvic fascia preservation may decrease postoperative incontinence and impotence rates. Unfortunately these studies are retrospective decreasing their reliability.

The present study is prospective and randomized clinical trial. The investigators are going to randomize 180 patient to preservation and opening the endopelvic fascia groups. Functional and oncological results are followed up to 1 year after surgery.

Detailed description: 180 patients going to radical prostatectomy as treatment of prostate cancer will be randomized 1:1 to two study arms: In the other arm endopelvic fascia are preserved during the operation, in the other arm the fascia are opened.

After the operation urinary continence and erection function are compared between the study arms. Additionally the investigators will study oncological outcomes.

Eligibility criteria: Inclusion Criteria:

* Localized prostate cancer
* Planned nerve-sparing robotic radical prostatectomy
* Gleason score 7 or less

Exclusion Criteria:

* Previous prostate surgery (TURP, TUIP, laser...)
* Planned lymphadenectomy
* T3 cancer

Primary outcomes:
measure: Urinary incontinence
timeFrame: 1 year
measure: Erectile function
timeFrame: 1 year
Secondary outcomes:
measure: Complications
timeFrame: 1 year
measure: Oncologic results: positive surgical margin rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Jarno Riikonen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siltari A, Riikonen J, Murtola TJ. Preservation of Endopelvic Fascia: Effects on Postoperative Incontinence and Sexual Function - A Randomized Clinical Trial. J Sex Med. 2021 Feb;18(2):327-338. doi: 10.1016/j.jsxm.2020.11.003. Epub 2020 Dec 23.
Clinical trial NCT01937702: A Trial Investigating the Influence of Injection Speed and Volume on the Perception of Subcutaneous Injection Pain
Official title: A Trial Investigating the Influence of Injection Speed and Volume on the Perception of Subcutaneous Injection Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: Profil Institut für Stoffwechselforschung GmbH
Sponsor class: INDUSTRY
First posted: 2013-09-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A trial, investigating the influence of injection speed and volume on the perception of subcutaneous injection pain.


Eligibility criteria: Inclusion Criteria:

* Subject has signed the informed consent form prior to screening
* Age 18-74 years at screening (both included)

Exclusion Criteria:

* Known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit
* Previous participation in this trial. Participation is defined as having received at least one injection

Primary outcomes:
measure: injection pain
timeFrame: within 24 hours after injection
Secondary outcomes:
measure: variability of injection pain
timeFrame: within the first 24 hours after injection
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Profil Mainz GmbH & Co. KG
state: Rheinland-Pfalz
Study officials:
affiliation: Profil Mainz GmbH & Co KG
name: Thomas Forst, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04012502: De-escalation Protocols in HPV-related Oropharyngeal Carcinoma in Chinese Populations
Official title: De-escalation of Chemoradiotherapy Density in HPV-related Oropharyngeal Carcinoma in Chinese Populations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oropharyngeal Carcinoma
De-escalation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Human papillomavirus (HPV)-related oropharyngeal carcinoma are exquisitely radiosensitive. Several studies attempted to reduce the toxicities of treatments through reduced-dose radiation and showed promising results, but all data were collected from non-Chinese areas. Like nasopharyngeal carcinoma, oropharyngeal carcinoma may have different biological behavior and relationship with HPV infection. So the investigators studied whether toxicities reducing treatment with reduced radiation dose and omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with HPV-positive oropharyngeal carcinoma.


Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of squamous cell carcinoma of oropharynx with IHC p16 positive or PCR HPV16 positive
* T1-2/N1-3M0（except T1N1M0 and single LN\<3cm）or T3-4N0-3M0 according to UICC/AJCC 8th staging system
* Age ≥18
* No prior anti-tumor treatment
* Karnofsky Performance Score (KPS)≥70
* Adequate blood supply
* Informed consent obtained

Exclusion Criteria:

* cannot take contrast-MRI imaging
* Pregnant
* Combined with other malignant tumor (except basal cell carcinoma of skin)

Primary outcomes:
measure: PFS
timeFrame: 2 year
Secondary outcomes:
measure: OS
timeFrame: 2 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan Universtiy Shanghai Cancer Centre
state: Shanghai
Study officials:
affiliation: Fudan University Shanghai cancer centre
name: Chaosu Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06223802: Biodex Training in Hemodialysis Females With Osteopenia
Official title: Balance Response to Biodex Training in Hemodialysis Females With Osteopenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemolysis
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 58
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: imbalance is a common problem in hemodialysis patients with osteopneia, biodex training is a good device that treat imbalance

Detailed description: 58 women with osteopenia problem and dialysis will be divided to trained women group with a number of 29 women receiving 3-time biodex training per week, every time will be 10 minutes for 12 weeks or nontrained women group that will act as a control group (n = 29 women)

Eligibility criteria: Inclusion Criteria:

* osteopneia women
* hemodialysis women

Exclusion Criteria:

* pregnancy
* autoimmune disorders
* lower limb orthopedic problems
* psychological manifestaion

Primary outcomes:
measure: bone mineral density of femur bone
timeFrame: it will be measured after 12 weeks
Secondary outcomes:
measure: overall stability index
timeFrame: it will be measured after 12 weeks
measure: Antero posterior stability index
timeFrame: it will be measured after 12 weeks
measure: Mediolateral stability index
timeFrame: it will be measured after 12 weeks
measure: six minute walk test
timeFrame: it will be measured after 12 weeks
measure: Short physical performance battery
timeFrame: it will be measured after 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahram canadian university
Study officials:
affiliation: Ahram Canadian University
name: hagar El-Hadidy, lecturer
role: PRINCIPAL_INVESTIGATOR
References: