louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02416869: Dexamethasone in Lower Third Molar Surgery
Official title: Effectiveness of Different Application Modalities of Dexamethasone on Clinical Parameters and Quality of Life After Lower Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impacted Third Molar Tooth
Keywords: Dexamethasone
Lower third molar surgery
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2015-04-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this randomized double-blind cross over clinical trial is to investigate effectiveness of different routes of applications (intramuscular and submucous at the site of surgery) and doses (4 mg and 8 mg) of Dexamethasone on swelling, trismus, pain and quality of life after lower third molar surgery.


Eligibility criteria: Inclusion Criteria:

* Healthy patients (ASA I)
* Bilateral symmetrically impacted lower third molars according to Pel-Gregory's and Winter's classification

Exclusion Criteria:

* Heavy tobacco smokers
* Drug and / or alcohol abusers

Primary outcomes:
measure: Facial swelling (using 3 facial measurements (in millimeters)
timeFrame: 1 day, 3 day, 7 day
Secondary outcomes:
measure: Postoperative pain (visual analog scale)
timeFrame: 1 day, 3 day, 7 day
measure: Postoperative trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)
timeFrame: 1 day, 3 day, 7 day
measure: Postoperative discomfort (25-items custom made questionnaire)
timeFrame: 4 day, 7 day
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: School of Dental Medicine
Study officials:
affiliation: University of Zagreb
name: Miroslav M Andric, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01235169: Evaluation of the Proximal Femoral Nail Antirotation With Cement Augmentation in Osteoporotic Femoral Neck Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Proximal Femur Fracture
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-11-05
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open multicenter study, evaluating a new operative technique in femur neck fractures. The treatment consist of augmentated nails in cases of subtrochanteric or inter fracture due to osteoporosis.There two routine surgical techniques in femoral neck fractures:

1. Insertion an intramedullary nail (without augmentation) to the bone.
2. insertion a nail and metal plateto the bone. The major disadvantage of these methods is the relative high rate (4-10 precentages) of failure because of the femur head bone which is very brittle and osteoporotic.

This new approach enables the nail a better grip as a result of the cement augmentation which consists of PMMA (Polymethyl methacrylate).

The investigators main goal is to evaluate the use of this surgical technique


Eligibility criteria: Inclusion Criteria:

* PFNA augmentation is indicated for severe osteoporotic fractures (Subtrochanteric or intertrochanteric) in the proximal femur.
* Men and women above 80 years old that fuffer from fracture in the proximal femur.

Exclusion Criteria:

* Patient can not come to the follow up clinic visits.

Primary outcomes:
measure: Proportion of patients reaching union at the 3-month and 6-month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organizaton
Study officials:
References:
Clinical trial NCT02155569: Extraperitoneal Versus Transperitoneal Cesarean Section
Official title: Extraperitoneal Versus Transperitoneal Cesarean Section: A Prospective Randomized Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean, Extraperitoneal
Keywords: Cesarean, extraperitoneal
Cesarean
Pain
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2014-06-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare post operative morbidity between extra peritoneal cesarian and trans peritoneal cesarean section.


Eligibility criteria: Inclusion Criteria:

* elective cesarean (primary or repeated up to four)

Exclusion Criteria:

* emergent cesarean
* macrosomia (fetal weight \> 4500 g)
* history of major abdominal surgery
* suspected abnormal placentation
* placenta previa

Primary outcomes:
measure: post operative pain
timeFrame: One hour before cesarean and 24 hour postoperatively
Secondary outcomes:
measure: delivery time
timeFrame: 2 minutes after delivery
measure: operation time
timeFrame: 5 minutes postoperatively
measure: hemoglobin differences
timeFrame: one hour before cesarean, 48 hour postoperatively
measure: need for extra analgesic
timeFrame: 48 hour
measure: nausea
timeFrame: 48 hour
measure: vomiting
timeFrame: 48 hour
measure: thoracic and shoulder pain
timeFrame: 48 hour
measure: Urogenital distress measured by Urogenital Distress Inventory
timeFrame: One hour before cesarean and 24 hour postoperatively
measure: Oral intake
timeFrame: 48 hour
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University Hospital
Study officials:
References:
Clinical trial NCT05142969: Chlorhexidine Bathing to Prevent Hospital-acquired Infections: the CLEANS Study
Official title: Effect of Chlorhexidine Bathing on Prevention of Hospital-Acquired Infections in Patients After Surgery in ICU: A Prospective, Single-Center, Single-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chlorhexidine
Hospital-Acquired Infection
Surgery
Intensive Care Unit
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 247
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: Hospital-acquired infections (HAI) have been shown to increase length of hospital stay and mortality. Infections acquired during a hospital stay have been shown to be preventable. The skin of patients is considered a major reservoir for pathogens associated with hospital-acquired infections, and has been suggested as a potential target for interventions to reduce bacterial burden and subsequent risk of infection. The use of daily Chlorhexidine (CHG) bathing in intensive care patients has been advocated to reduce many of the infections in critically ill patients. However, the effectiveness of CHG bathing to reduce ICU infections has varied considerably among published trials, making the effectiveness of CHG bathing in ICU patients uncertain.


Eligibility criteria: Inclusion Criteria:

* adults (≥ 18-years old)
* anticipated SICU stay for 48 hours or more
* APACHE II \>15

Exclusion Criteria:

* Braden Scale for Predicting Pressure Sore Risk score more than 9 (highest risk)
* pregnancy
* skin irritation
* chlorhexidine allergy
* SICU stay of more than 48 hours prior to screening

Primary outcomes:
measure: Incidence of hospital-acquired infections
timeFrame: throughout study completion, an average of 7 days
Secondary outcomes:
measure: Multidrug-resistant bacterial colonization free time
timeFrame: throughout study completion, an average of 7 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT04002869: Innovation in Tuberculosis
Official title: Innovation in Tuberculosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tuberculosis
Lead sponsor: Fundació Institut Germans Trias i Pujol
Sponsor class: OTHER
Collaborators: name: Consorcio Centro de Investigación Biomédica en Red (CIBER)
name: Umeå University
name: North-Western State Medical University named after I.I.Mechnikov
name: INSTITUTUL DE FTIZIOPNEUMOLOGIE CHIRIL DRAGANIUC
name: ODESA SIGNIFICANT DISEASES CENTER
name: Vinnitsa National Medical University
name: SERVICIOS CLINICOS SA
name: Genome Identification Diagnostics GmbH
name: EMPE DIAGNOSTICS AB
name: MAGRITEK GMBH
name: Universidad de La Frontera
First posted: 2019-07-01
Enrollment: 550
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Briefly, subjects from different study groups will be included: (i) patients with suspicion of active TB, (ii) individuals with latent TB infection, (iii) patients with NTM infection, (iv) healthy uninfected controls, and (v) patients with other respiratory diseases such as Acute Respiratory Infections (ARIs) or lung cancer.

Brief summary: Tuberculosis (TB) is one of the major infectious diseases worldwide, and the emergence and spread of drug resistant cases is a public health threat. However, the conventional methods used for diagnosis and drug-susceptibility testing are not enough for controlling the disease. In addition, all TB patients, independently of their age, gender, severity of the disease and type of responsible strain, follow the same treatment duration (up to 20 months in drug resistant cases), which often leads to high frequency of adverse events, suboptimal adherence to treatment, and poor outcome. Therefore, a transition from programmatic to personalized management of TB is needed.

INNOVA4TB proposal will develop innovative technologies and approaches in order to improve the individual risk assessment for TB development, to rapidly diagnose active TB, to detect the drug susceptibility of the strain, to design tailor-made therapies, and to use biomarkers to guide and individualize the duration of antimicrobial therapy. This is of great importance for improving the quality of life of patients and ensuring treatment success, as well as for economic reasons for the healthcare system.


Eligibility criteria: Inclusion Criteria:

* Immunosuppression will not be considered an exclusion criterion

Exclusion Criteria:

* Patients who are not able to give their informed consent to participate in the study will be excluded

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 01/01/2019 to 31/12/2022
Secondary outcomes:
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Institut D'Investigació Germans Trias I Pujol
state: Barcelona
Study officials:
References:
Clinical trial NCT01331369: Intensification of Care to Improve Adherence to Anti-hypertensives
Official title: Intensification of Care to Improve Adherence to Anti-hypertensives in Primary Care: a Pragmatic Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Keywords: adherence
compliance
persistence
drop out
abandon
Lead sponsor: Universidade de Blumenau
Sponsor class: OTHER
Collaborators: name: Fundacao de Apoio a Pesquisa de Santa Catarina
First posted: 2011-04-08
Enrollment: 243
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: The aim of the study is to evaluate the effectiveness of a social-psychological intervention to improve anti-hypertensives adherence in primary care. Its is a pragmatic clinical trial.

Detailed description: We will study two groups of 198 people with hypertension treated in ten health care units. One group will receive usual care dispensed in units (control). The other group (intervention) will be offered six individual assistance with health care worker physician or nurse) during the period of 9 months with a minimum interval of 30 days, plus 9 monthly visits structured by community health agents. Adherence will be measured in both groups at baseline and months 3, 6, 9 and 12, through validated questionnaire and pill count. Also evaluated clinical outcome measures (blood pressure, hospitalizations and deaths). The analysis will be done by intention to treat comparing adherence measures and clinical outcome between groups (Student t test and chi-square test) and within groups over time (paired t test and McNemar). It will be accepted p value \<0.05.

Eligibility criteria: Inclusion Criteria:

* persons with hypertension aged 18 years and older

Exclusion Criteria:

* those with physical or mental impaired that cannot go to health care units or cannot answer a questionnaire
* pregnants

Primary outcomes:
measure: Change in the proportion of people adherent to treatment - MMAS-8
timeFrame: at basal and 3, 6, 9 and 12 months
Secondary outcomes:
measure: Change in the proportion of people adherent to treatment - QAM-Q
timeFrame: at basal and 3, 6, 9 and 12 months
measure: Means difference and/or risk ratio between and within groups of clinical outcomes
timeFrame: at basal and 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Blumenau
country: Brazil
facility: Family Health Units - Unique Health System
state: Santa Catarina
Study officials:
affiliation: Regional University of Blumenau
name: Ernani S Helena, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02942069: Reproducibility of Glucose Fluctuations by Standardized Exercise for Patients With Type 1 Diabetes - a Method Study Based on Continuous Glucose Monitoring
Official title: Reproducibility of Glucose Fluctuations by Standardized Exercise for Patients With Type 1 Diabetes - a Method Study Based on Continuous Glucose Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Exercise
Continuous Glucose Monitoring
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 patients with type 1 diabetes (treated with or without insulin pump) will participate in three identical test sessions on an exercise bike. During the three test sessions, patients will be monitored by heartrate, blood glucose (obtained by lancet) and CGM. The participants will also be using a diary for registration of diet as well as exercise during the study.

Brief summary: The purpose of this project is to investigate whether the glucose response in type 1 diabetes patients measured using Continuous Glucose Monitoring measurement is reproducible in repeated standardized test sessions that include physical activity.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes with a diabetes duration of at least 2 years
* age 18-60 years (inclusive)
* given informed consent
* exercises (at least 30 minutes intentional exercise where participants feel exhausted) one or more times a week
* participants agree to use CGM correctly

Exclusion Criteria:

* pregnancy
* exercising at a high level (five or more times a week with high intensity)
* treatment with prednisolone or less than a month ago contestant has been treated with prednisolone
* treatment with beta blockers
* Abuse of alcohol / drugs

Primary outcomes:
measure: Blood glucose response measured with CGM
timeFrame: 3 identical testing sessions throughout 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hillerod
country: Denmark
facility: Nordsjællands Hospital
Study officials:
affiliation: Senior Researcher
name: Stig Mølsted, Post. doc.
role: STUDY_CHAIR
References:
Clinical trial NCT00462969: Cytologic Analysis of Distention Media as a Screening Test for Endometrial Cancer
Official title: Cytologic Analysis of Distention Media as a Screening Test for Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Keywords: Endometrial cancer
Sonohysterography
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: American College of Obstetricians and Gynecologists
name: National Cancer Institute (NCI)
First posted: 2007-04-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to learn fluid from sonohysterography can be used to diagnose endometrial cancer.

Detailed description: Participants will have a sonohysterography (SHG) performed. Fluid will be collected after instillation of 5mls of saline and again after an adequate SHG is performed. A pathologist will review this fluid to see is cancer cells are present.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed early-stage endometrial cancer

Exclusion Criteria:

* Recurrent or persistent endometrial cancer
* Evidence of distant metastases

Primary outcomes:
measure: Cytology results
timeFrame: At completion of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: David M Kushner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guralp O, Sheridan SM, Harter J, Hinshaw JL, Seo S, Hartenbach EM, Lindheim S, Stewart S, Kushner DM. A new diagnostic test for endometrial cancer?: Cytology analysis of sonohysterography distention media. Int J Gynecol Cancer. 2013 Sep;23(7):1252-7. doi: 10.1097/IGC.0b013e31829fe8f6.
Clinical trial NCT02125669: Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas
Official title: The Role of the 595 nm Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas at Low Risk Anatomical Sites: Outcome of a Double Blind Randomized Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Basal Cell Carcinoma
Keywords: basal cell carcinoma
laser surgery
pulsed dye laser
randomized controlled trial
Lead sponsor: Hautklinik Darmstadt
Sponsor class: OTHER
Collaborators: name: University Medicine Greifswald
First posted: 2014-04-29
Enrollment: 100
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: Pulsed dye laser (PDL) treatments have been suggested to be a safe and effective therapeutic approach for treating basal cell carcinomas. Robust supporting evidence is, however, lacking due to inconsistent design of available studies. The purpose of this study is to evaluate the PDL's efficacy and safety in treating superficial basal cell carcinoma (sBCC) at low risk anatomical sites in an evidence based study setting.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed unpigmented sBCC on the trunk and extremities
* maximal tumour diameter 30 mm

Exclusion Criteria:

* Fitzpatrick skin type \>III
* pregnancy
* previous BCC treatment within 4 weeks
* coagulation disorders
* photo sensitizing medication
* any indication of poor compliance

Primary outcomes:
measure: complete response
timeFrame: 9 months
Secondary outcomes:
measure: patients satisfaction
timeFrame: 9 months
measure: side effects
timeFrame: 9 months
measure: reduction of tumor diameter and tumor thickness
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
affiliation: Hautklinik Darmstadt
name: Maurizio Podda, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hautklinik Darmstadt
name: Syrus Karsai, Dr.
role: STUDY_DIRECTOR
affiliation: Hautklinik Darmstadt
name: Heiko Friedl
role: STUDY_CHAIR
References:
Clinical trial NCT04114669: Behavioral Economics Trial To Enhance Regulation of Blood Pressure (BETTER-BP)
Official title: Behavioral Economics Trial To Enhance Regulation of Blood Pressure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: High Blood Pressure
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-10-03
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: BETTER-BP (Behavioral Economics Trial To Enhance Regulation of Blood Pressure) is a phase II, single-center, prospective, pragmatic randomized clinical trial within the New York City Health and Hospitals (NYC-H+H) system and NYU Langone Family Health Centers. The trial will recruit from 3 NYC-H+H ambulatory clinics as well as NYU Langone Family Health Centers, and will use a lottery incentive program to promote adherence to antihypertensive medication that will be delivered via smartphone for 6 months. The trial will randomize 435 patients with hypertension determined to have poor adherence (\<80% adherence with antihypertensive medication), in a 2:1 (intervention:control) ratio. Baseline enrollment will occur over 36 months with an expected 12 months follow-up per participant.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of hypertension.
* An active prescription for ≥1 antihypertensive medication (any of the following classes: thiazide diuretic, ACE inhibitor, angiotensin receptor blocker, beta blocker, calcium channel blocker, centrally acting alpha agonist, direct vasodilator).

  * 1 ambulatory systolic blood pressure ≥140 mmHg (on therapy).
* Suboptimal adherence (self-report).

Exclusion Criteria:

* Incarcerated
* Pregnant
* Unable to use study software (Way To Health) in English or Spanish
* Unable/unwilling to consent
* Clear barrier to technology use (e.g. visual or hearing impairment)
* Projected life expectancy \<12 months

Primary outcomes:
measure: Change in Systolic Blood Pressure (SBP)
timeFrame: baseline to 12 Months
measure: Adherence
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
measure: Motivation measured with the Treatment Self-Regulation Questionnaire (TSRQ)
timeFrame: Baseline, 6 months, and 12 months
measure: Self-efficacy measured by the Medication Adherence Self Efficacy Scale (MASES)
timeFrame: 12 Months
measure: Comorbidity burden will be evaluated (baseline) using the Charlson Comorbidity Index (CCI)
timeFrame: Baseline
measure: Depression will be measured (baseline) by the PHQ-9
timeFrame: 12 Months
measure: Patient-reported health status will be measured (baseline) using the Short Form 12 (SF-12).
timeFrame: 12 Months
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Health
name: John Dodson
role: PRINCIPAL_INVESTIGATOR
References: