louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00133289: ULTRA Study for Pacemaker Patients
Official title: Ventricular Automatic Capture Assessment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bradycardia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-08-23
Enrollment: 950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The ULTRA study will assess the difference in average ventricular voltage output for pacemaker patients randomized to Automatic Capture feature ON versus patients randomized to Automatic Capture feature OFF.


Eligibility criteria: Inclusion Criteria:

* Patients who meet current INSIGNIA® Ultra pacemaker indications
* Patients who will be programmed to a pacing mode of DDD, DDDR, VVI, VVIR, or VDD at the time of implant
* Patients who sign and date a Patient Informed Consent form at or prior to the implant visit
* Patients who remain in the clinical care of the enrolling physician in approved centers

Exclusion Criteria:

* Patients who will receive a single chamber device with an atrial lead only
* Patients who have chronic leads with a ventricular threshold of more than 4.0 V
* Patients whose life expectancy is less than 12 months
* Patients who are expected to receive a heart transplant during the duration of the study
* Patients who have or who are likely to receive a tricuspid valve prosthesis
* Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the ULTRA study.
* Patients who are younger than 18 years of age
* Patients who are pregnant
* Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study

Primary outcomes:
measure: Average ventricular voltage output over time for patients randomized to Automatic Capture feature ON versus patients randomized to Automatic Capture feature OFF
Secondary outcomes:
measure: Compare automatic and manual threshold tests
measure: Project device longevity
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Bruce Koplan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi HY, Noh YH, Jin SJ, Kim YH, Kim MJ, Sung H, Jang SB, Lee SJ, Bae KS, Lim HS. Bioavailability and tolerability of combination treatment with revaprazan 200 mg + itopride 150 mg: a randomized crossover study in healthy male Korean volunteers. Clin Ther. 2012 Sep;34(9):1999-2010. doi: 10.1016/j.clinthera.2012.07.004. Epub 2012 Aug 1.
Clinical trial NCT00640289: Clinical Trial of Factor XIII (FXIII) Concentrate
Official title: Clinical Research Study of Factor XIII Concentrate From Human Plasma Fibrogammin P in Patients With Factor XIII Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia
Factor XIII Deficiency
Keywords: Factor XIII Deficiency
Rare Bleeding Disorder
Hemophilia
Fibrogammin P
Lead sponsor: Children's Hospital of Orange County
Sponsor class: OTHER
Collaborators: name: CSL Behring
First posted: 2008-03-21
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Congenital deficiency of Factor XIII is a rare but potentially life threatening disorder. It is inherited in an autosomal recessive fashion. Infusion of Factor XIII has proved to be useful for prevention and treatment of bleeding episodes, especially of spontaneous intracranial bleedings. In this study, Fibrogammin P will be given to patients with congenital Factor XIII deficiency and congenital/acquired FXIII deficiency to prevent bleeding and to treat established bleeding episodes. For Factor XIII prophylaxis to prevent hemorrhages, the dosage will depend on the weight of the subject. The frequency of Factor XIII administration will be determined by the factor's circulating half-life. During the first month only, a Factor XIII pharmacokinetic study will be determined over a 4-week period. Safety data will include accrual of information on viral safety, liver function, complete blood counts and adverse events. Historical data concerning spontaneous bleeds will be collected whenever possible two years prior to treatment with Fibrogammin P.


Eligibility criteria: Inclusion Criteria:

* Patients may be of either sex or age. Children and newborn infants are specifically included in this study.
* Patient must have documented congenital Factor XIII deficiency
* Patient or legal guardian must sign informed consent
* Patients who have negative serology for hepatitis B should receive Hepatitis B vaccination.

Exclusion Criteria:

* Patient has acquired Factor XIII deficiency

Primary outcomes:
measure: Response to Treatment of Bleeding Events Requiring Additional Factor XIII Infusions
timeFrame: Within 12 hours of FXIII infusion
Secondary outcomes:
measure: Surgical Efficacy Assessments With Factor XIII
timeFrame: During surgical procedure
Other outcomes:
Locations:
city: Orange
country: United States
facility: Children's Hospital of Orange Co.
state: California
Study officials:
affiliation: Children's Hospital of Orange Co.
name: Diane J. Nugent, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04068389: Ultrafine Particles and Fetal Contamination
Official title: Study of the Permeability of Atmospheric Particles Placenta (Fine and Ultrafine Particles): Analysis of Fetal Retention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung; Premature
Pollution; Exposure
Keywords: Atmospheric particles
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 62
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with a medical termination of pregnancy

Brief summary: The objective of this study is to evaluate the transplacental passage of fine and ultrafine particles (nanoparticles) inhaled by the mother.

Detailed description: Epidemiological studies have demonstrated the harmful effects of particulate air pollution on the progress of pregnancy and postnatal health.

Experimental studies have suggested the transplacental passage of asbestos fibers, but despite the strong growth in the use and production of fine and ultrafine particles, no study has examined the permeability of the placenta to these compounds or the exposures fetuses that may result.

The objective of this study is to evaluate the transplacental passage of fine and ultrafine particles (nanoparticles) inhaled by the mother.

Eligibility criteria: Inclusion Criteria:

- All women volunteers for whom a medical termination of pregnancy is proposed for a fetus older than 22 weeks (weight over 500g).

Exclusion Criteria:

* Refusal of participation of the patient.
* Fetus with malformation syndrome affecting pulmonary perfusion.

Primary outcomes:
measure: Presence of fine particles in fetal lung samples yes/no
timeFrame: At the screening
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Olivia OCHRYMCZUK, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02722889: Aortic Elongation and Dissection
Official title: Ascending Aortic Length in Relation to Age and the Occurrence of Type A Aortic Dissection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Aorta
Keywords: Ascending aorta
Elongation of the aorta
Type A dissection
Aortic rupture
Aortic length
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Reference group to assess 'normal' aortic length.

Brief summary: Aim of this study is to measure length of the ascending aorta in adults and to investigate the clinical implication of 'elongation' of the aorta.

Detailed description: Regarding to aortic geometry, attention is often drawn to aortic diameters since an increase in these diameters (e.g. aneurysm) can lead to life-threatening complications such as dissection and/or rupture. In daily practice however (e.g. imaging reports), the investigators often encounter patients with elongation of the ascending aorta. Little is known about the length of the proximal aorta. Furthermore, the clinical implications of an elongated aorta are unknown.

Eligibility criteria: Inclusion Criteria:

* Underwent recent (\<6 years) contrast-enhanced CT scan which allows for segmentation and assessment of aortic geometry.

Exclusion Criteria:

* Age \<18 years old.
* Prior thoracic, cardiac or aortic surgery.
* Genetic disease with cardiac and/or aortic involvement (e.g. Marfan's disease).
* Infectious disease of the aorta.
* Malignant disease with involvement of heart and/or aorta.

Primary outcomes:
measure: Length of the ascending aorta
timeFrame: Up to 72 months
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Head of department of Radiology
name: Joachim Wildberger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04853589: Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis
Official title: Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis - A Double-blind, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alveolar Osteitis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Alveolar osteitis (AO; syn. dry socket) is one of the most frequent complications following tooth removal and it is defined as presence of severe postoperative pain in and around the extraction site, which increases in severity at any time between one and three days after extraction, accompanied by a partially or completely disintegrated blood cloth within the alveolar socket, with or without halitosis, and at the same time excluding any other cause for the pain (Blum 2002). To enhance standard treatment of AO, which consists of curettage of the dry socket, rinsing with saline solution, and inducing bleeding from the exposed alveolar bone walls, numerous products have been tested. One of them is hyaluronic acid (HY). The aim of the present study is to investigate the potential effect of HY gel application in the treatment of AO. Specifically, the application of HY only (HY test group; n = 20) or the combination of HY and an absorbable collagen sponge (HY+C test group; n = 20) will be compared to standard treatment (blood clot; control group, n=20). Clinical and patient related outcome parameters will be recorded for up to 14 days after treatment. A more stable blood clot and thus improved wound healing with faster pain reduction is expected through the use of HY.


Eligibility criteria: Inclusion Criteria:

1. \> 18 years;
2. Untreated AO after extraction of a permanent tooth (excluding wisdom teeth);
3. Diagnosis of AO based on the criteria of Blum (Blum 2002)

   Exclusion Criteria:
4. Patients with chronic diseases and/or taking any medication, influencing hard and soft tissue healing;
5. Pregnancy;
6. History of hypersensitivity or allergy to HY;
7. Inability to attend follow-up appointments; Intake of preoperative antibiotics.

Primary outcomes:
measure: Pain perception by the patient
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University Clinic of Dentistry, Medical University of Vienna
Study officials:
References:
Clinical trial NCT01530789: Paramedical Consultation in Telemedicine
Official title: Evaluation of Paramedical Consultation in Type 1 Diabetic Patients in Telemedicine
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type 1 Diabetic
Keywords: Telemedecine
Telemedecine nurse
Delegation of tasks
Type 1 diabetes
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
First posted: 2012-02-10
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic type 1 patients with the electronic pad

Brief summary: Feasibility monocentrique opened study estimating the use of an electronic personalized educational plan (ePEP) for the follow-up by nurses of 50 patients diabetics type 1 during 6 months having an electronic pad.


Eligibility criteria: Inclusion Criteria:

* patient diabetic type 1
* patient with the electronic pad in a smartphone
* adults
* children between 12 and 17 years 11 months
* patient having signed the consent

Exclusion Criteria:

* patient diabetic type 2
* patient without the electronic pad in a smartphone
* children below 12 years old

Primary outcomes:
measure: Percentage of patient using the system
timeFrame: 6 month
Secondary outcomes:
measure: satisfaction level of the patient and quality of life
timeFrame: 6 month
measure: satisfaction level of physician
timeFrame: 6 month
measure: satisfaction level of the telemedecin nurse
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06326489: Evaluating the Efficacy and Quality of Life Impact of Transitioning to Advanced Hybrid Closed-Loop Insulin Pump Therapy in Romanian Children With Type 1 Diabetes Mellitus
Official title: Evaluating the Efficacy and Quality of Life Impact of Transitioning to Advanced Hybrid Closed-Loop Insulin Pump Therapy in Romanian Children With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 1
Keywords: HbA1c
insulin pumps
closed-loop
Lead sponsor: ELIAS Emergency University Hospital
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will include 30 children with type 1 diabetes aged seven years and older who use a predictive low glucose suspend insulin pump (740G). Patients eligible for the study will receive a 780G insulin pump for three months.
Primary purpose: TREATMENT

Brief summary: The proposed study aims to demonstrate the potential benefits of transitioning T1DM children from predictive low glucose suspend insulin pump therapy to advanced hybrid closed-loop insulin pump therapy in Romania. Primary Outcome: Variations in HbA1c between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G).

Secondary Outcomes: changes in insulin requirements, time in range (TIR) levels, time below range (TBR), coefficient of variation (CV), frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization, and PedsQL SF15 questionnaire scores.


Eligibility criteria: Inclusion Criteria:

* Age 7 years or older at baseline
* Diagnosis of type 1 diabetes
* Current use of a predictive low glucose suspend insulin pump (740G)
* At least 30% of subjects must have an HbA1c \> 7,5% (58 mmol/mol)

Exclusion Criteria:

* Age \< 7 years or ≥ 18 years at baseline
* Diabetes duration \< 1 year at baseline
* HbA1c ≤ 7% (53 mmol/mol)
* Not meeting the Romanian national standards for closed-loop insulin pump therapy
* Other criteria deemed inappropriate by the principal investigator (to be documented)

Primary outcomes:
measure: Variations in HbA1c
timeFrame: Three months
Secondary outcomes:
measure: changes in insulin requirements
timeFrame: Three months
measure: changes in time in range (TIR) levels
timeFrame: Three months
measure: changes in time below range (TBR)
timeFrame: Three months
measure: changes in coefficient of variation (CV)
timeFrame: Three months
measure: changes in frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization
timeFrame: Three months
measure: changes in The Pediatric Quality of Life Inventory™ 4.0 Short Form 15 Generic Core Scales questionnaire scores
timeFrame: Three months
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Elias University Emergency Hospital
state: Sector 1
Study officials:
References:
Clinical trial NCT05331989: Smartphone Addiction and Temporomandibular Joint Dysfunction in Individuals With Nonspecific Neck Pain
Official title: Smartphone Addiction and Temporomandibular Joint Dysfunction in Individuals With Nonspecific Neck Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smartphone Addiction, Temporomandibular Joint Dysfunction
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with nonspecific neck pain, individuals who voluntarily agreed to participate in our study and signed the consent form

Brief summary: It has been reported that excessive use of smartphones increases the stress on the cervical spine, and changes in cervical curvature and pain in the muscles around the neck are associated with the increase in stress. Studies have reported that smartphone users with addictions have neck pain (68%), upper back pain (62%), right shoulder pain (52%), left shoulder pain (46%), and right hand pain (46%). As a result of our study, the frequency of smartphone addiction and temporomandibular joint dysfunction and related factors in individuals with nonspecific neck pain were examined and the results we obtained will contribute to the literature.


Eligibility criteria: Inclusion Criteria:

* Presence of neck pain lasting at least 6 months
* Being between the ages of 18-45
* Individuals with a score between 10-40 points according to the Neck Disability Index
* Individuals who have never had a history of shoulder or neck surgery

Exclusion Criteria:

* Individuals with signs of radicular pain (positive neck distraction test, Spurling's neck compression test, and Adson's test)
* Individuals who get less than 10 points or more than 40 points according to the Neck Disability Index
* Those with a previous history of shoulder and neck surgery
* Individuals with accompanying shoulder pain
* Individuals with spinal cord tumors
* Individuals with meningeal tumors
* Individuals who do not want to participate in the study

Primary outcomes:
measure: Cranio- Cervical Flexion Test
timeFrame: Day 1
measure: Evaluation of cervical mobility
timeFrame: Day 1
measure: Evaluation of Pressure Pain Threshold
timeFrame: Day 1
measure: Functional evaluation of the temporomandibular joint
timeFrame: Day 1
measure: Smartphone Addiction Scale Short Form
timeFrame: Day 1
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: Day 1
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Ayşe Abit Kocaman
Study officials:
affiliation: Kırıkkale University
name: Ayşe Abit Kocaman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Can HB, Tuna F. Relation between endurance of deep cervical flexor muscles and physical activity level, perceived stress, sleep quality, and smartphone addiction. Cranio. 2022 Mar;40(2):126-134. doi: 10.1080/08869634.2020.1724457. Epub 2020 Feb 6.
Clinical trial NCT03357289: Mix Vaccine for Metastatic Kidney Cancer
Official title: Safety and Efficacy Study of Mix Vaccine in Kidney Cancer Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastasis From Malignant Tumor of Kidney (Disorder)
Reaction - Mixed Vaccine
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Jinan University Guangzhou
First posted: 2017-11-29
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of mix vaccine to small metastases of kidney cancer.

Detailed description: By enrolling patients with small metastases of kidney cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of mix vaccine.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree of tumors
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer institute of Fuda cancer hospital
state: Guangdong
Study officials:
References: