louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02028481: Air Tamponade in Macular Holes < 400 μm
Official title: Air Tamponade in Macular Holes < 400 μm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Holes
Keywords: Macular hole
Vitreoretinal surgery
Macular surgery
Air tamponade
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Haukeland University Hospital
First posted: 2014-01-07
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Macular hole is a hole formation which takes place in the center of the retina. Such a hole needs surgical steps in order to close. Closure of the macular hole will lead to a substantially improvement of vision in most cases. Following macular hole surgery a tamponade of intraocular gas is normally injected in order to keep the macula dry for the postoperative period. Postoperative face down position for a week was earlier standard. Several authors report of good closure rates with both air tamponade or lack of face down positioning. In this study standard pars plana vitrectomy with peeling of the internal limiting membrane (ILM) will be performed. The gas tamponade will be replaced by air. Postoperative face down positioning will not be used. Only macular holes less than 400 μm will be included.


Eligibility criteria: Inclusion Criteria:

* Primary macular hole less than 400 μm in diameter
* Duration of symptoms less than 36 months
* Informed consent

Exclusion Criteria:

* Previous vitreomacular surgery
* Myopia more than 6 diopters
* Ocular trauma
* Disease affecting visual function

Primary outcomes:
measure: Closure rate of macular hole
timeFrame: 1 month after enrollment
Secondary outcomes:
Other outcomes:
measure: Visual gain after 6 months of follow up
timeFrame: 6 months after enrollment
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital, Department of Ophthalmology
Study officials:
affiliation: Helse Stavanger HF
name: Vegard Forsaa, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00018681: Regulation of Human Intestinal Bile Acid Transport in Health and Disease
Official title: Regulation of Human Intestinal Bile Acid Transport in Health and Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Diseases
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: This study investigates distribution and regulation of bile acid transport in the human intestine.


Eligibility criteria: Veterans, healthy, scheduled for screening colonoscopy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
References:
Clinical trial NCT02934581: Prevalence Rate, and Clinical Characteristics of Obesity Hypoventilation Syndrome Via Screening Patients Admitted to Medical Intensive Care Units
Official title: Prevalence Rate, and Clinical Characteristics of Obesity Hypoventilation Syndrome Via Screening Patients Admitted to Medical Intensive Care Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity Hypoventilation Syndrome
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-10-17
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult obese (BMI ≥30 kg/m2) patients who were newly admitted to the medical intensive care units and turned out to be diagnosed as obesity hypoventilation syndrome

Brief summary: A prospective observation study to screen adult obese (BMI ≥30 kg/m2) patients who were newly admitted to the medical intensive care units and turned out to be diagnosed as Obesity hypoventilation syndrome(OHS). The investigators purpose is to look into the prevalence, predictive factors, and outcomes of OHS in these critically ill patients.


Eligibility criteria: Inclusion Criteria:

* BMI ≥ 30 kg/m2
* Suspected chronic hypercapnia as following Paco2 ≥ 45 mmHg, HCO3- ≥ 27mEq/L or base excess, BE ≥ 2 mEq/L

Exclusion Criteria:

* Malignancy with lung involvement
* Autoimmune disease with lung involvement
* Moderate to severe obstructive respiratory pattern via spirometry
* Uncontrolled endocrine disease
* Pregnancy
* Pneumonia confirmed by image
* Out-of-hospital cardiac arrest
* Lung edema
* Foreigner of Taiwan

Primary outcomes:
measure: Prevalence of obesity hypoventilation syndrome in Asian critically ill patients
timeFrame: 2-year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT03372681: Comparative Study of Antiperistaltic vs Isoperistaltic Billroth II + Braun Anastomosis for Postoperative Reflux
Official title: A Superiority Study for Postoperative Reflux After Distal Gastrectomy With Antiperistaltic vs Isoperistaltic Billroth II + Braun Anastomosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Postoperative Complications
Keywords: Distal Gastrectomy
Postoperative Reflux Rate
Gastric Cance
Laparoscopic Surgery
Lead sponsor: Shanghai Minimally Invasive Surgery Center
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 214
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: TREATMENT

Brief summary: Postoperative gastroesophageal reflux is one of the most common complications of distal gastrectomy. With more attention paid on it by surgeons, several new operation methods have been practised. Among all these, distal gastrctomy with Billroth II + Braun anastomosis was reported to be an useful method to decrease postoperative reflux rate. Meanwhile, the direction of anastomotic peristalsis has also been reported to affect the anastomosis and thus make difference in reflux rate. We design this study to investigate the potential effect and the superiority of antiperistaltic vs isoperistaltic Billroth II + Braun reconstruction in distal gastrectomy.


Eligibility criteria: Inclusion Criteria:

* Pathologically diagnosed as gastric cancer before surgery
* Clinical staging: cT1-4aN0-3M0
* Postoperative evaluation concluded B-II B anastomosis
* Consent assigned

Exclusion Criteria:

* Diagnosed with other malignancies within 2 years
* Gastric cancer with clinical staging: cT4b or M1
* Women with pregnancy or breast-feeding
* Emergency procedures
* Consent not assigned

Primary outcomes:
measure: Postoperative Reflux Rate
timeFrame: 1 yrs
Secondary outcomes:
measure: Disease-free survival
timeFrame: 3yrs
measure: Overall survival
timeFrame: 3 yrs
measure: Surgery-related reflux gastritis rate
timeFrame: 1yrs
measure: Surgery-related reflux esophagitis rate
timeFrame: 1 yrs
Other outcomes:
Locations:
Study officials:
affiliation: MISC, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
name: Minhua Zheng, M.D. PhD.
role: STUDY_DIRECTOR
References:
citation: Cui LH, Son SY, Shin HJ, Byun C, Hur H, Han SU, Cho YK. Billroth II with Braun Enteroenterostomy Is a Good Alternative Reconstruction to Roux-en-Y Gastrojejunostomy in Laparoscopic Distal Gastrectomy. Gastroenterol Res Pract. 2017;2017:1803851. doi: 10.1155/2017/1803851. Epub 2017 Jan 9.
citation: In Choi C, Baek DH, Lee SH, Hwang SH, Kim DH, Kim KH, Jeon TY, Kim DH. Comparison Between Billroth-II with Braun and Roux-en-Y Reconstruction After Laparoscopic Distal Gastrectomy. J Gastrointest Surg. 2016 Jun;20(6):1083-90. doi: 10.1007/s11605-016-3138-7. Epub 2016 Apr 11.
Clinical trial NCT05336981: Effect of Photobiomodulation for Patients With Xerostomia
Official title: Effect of Photobiomodulation for Patients With Xerostomia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Photobiomodulation
Low-Level Light Therapy
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 60
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: Hyposalivation is a condition represented by a reduced salivary flow and may include symptoms such as mouth dryness (xerostomia), pain, loss of taste,dysphagia, and dysphonia, all of which greatly affect an individual's quality of life.

The aim of the present study was analized the effects of low-level light therapy irradiation (photobiomodulation PBM) on salivary gland function in patients with hyposalivation

Detailed description: Inclusion criteria -the inclusion criteria for participating in the study were: age over 18 years; continuous xerostomia for over three months; and/or altered sialometry findings at baseline (salivary flow \< 0.1 mL/min).

Exclusion criteria. : xerostomia as secondary to radiotherapy; patients with decompensated systemic disorders or cognitive problems

The 60 individuals will be randomized in 2 groups: Group A (30 individuals submitted to treatment with a PBM) and Group B (30 individuals submitted to simulated PBM). A total of 60 patients with xerostomia were enrolled in the study and cited once a week for a period of 6 weeks treatment with diode laser (810nm, 6J/cm2) or sham treatment (according to the group).

Eligibility criteria: Inclusion Criteria:

* the inclusion criteria for participating in the study were: age over 18 years; continuous xerostomia for over three months; and/or altered sialometry findings at baseline (salivary flow \< 0.1 mL/min).

Exclusion Criteria:

* The exclusion criteria were: xerostomia as secondary to radiotherapy; patients with decompensated systemic disorders or cognitive problems

Primary outcomes:
measure: xerostomia
timeFrame: Change (in centimeters measured on a Visual Analogue Scale) determined between day 0 and day 15 and 45 days
measure: SIALOMETRY
timeFrame: before and after 45 days the procedure of laser therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Lopez-Jornet Pia
state: N/A = Not Applicable
city: Murcia
country: Spain
facility: Pia Lopez Jornet
Study officials:
affiliation: Universidad de Murcia
name: Pia Lopez Jornet
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kalhori KAM, Vahdatinia F, Jamalpour MR, Vescovi P, Fornaini C, Merigo E, Fekrazad R. Photobiomodulation in Oral Medicine. Photobiomodul Photomed Laser Surg. 2019 Dec;37(12):837-861. doi: 10.1089/photob.2019.4706.
citation: Brzak BL, Cigic L, Baricevic M, Sabol I, Mravak-Stipetic M, Risovic D. Different Protocols of Photobiomodulation Therapy of Hyposalivation. Photomed Laser Surg. 2018 Feb;36(2):78-82. doi: 10.1089/pho.2017.4325. Epub 2017 Oct 12.
Clinical trial NCT01499381: EMBRACE1: Prostate Biorepository
Official title: Evaluation of a Novel Circulating Microvesicle-Based Multi-analyte Assay for the Detection of Prostate Cancer in Men With Elevated Risk for Prostate Cancer; the EMBRACE1 Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Caris Science, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 1290
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men scheduled for routine prostate biopsy

Brief summary: The objective of this multi-center prospective observational clinical study is to evaluate the clinical performance of the Carisome Prostate assay as an aid in the diagnosis of prostate cancer in men that have been scheduled for a prostate biopsy. Primarily, results of the Carisome Prostate assay will be compared with pathology results of prostate biopsy procedures. Secondarily, the performance of the Carisome Prostate test will be compared to the current standard of care for the detection of prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Men scheduled for a routine prostate biopsy expected to produce a pathology evaluation and report
* Blood draw within 7 days prior to scheduled prostate biopsy procedure
* Blood draw on the day of but prior to biopsy

Exclusion Criteria:

* Any previous diagnosis of cancer with the exception of non-melanoma skin cancer
* Any prior or ongoing treatment for prostate cancer including prostatectomy or hormone therapy
* Prostate biopsy within one month of blood draw
* Previous enrollment in the Caris Life Sciences Biorepository

Primary outcomes:
measure: Carisome Prostate Assay with prostate biopsy outcome
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Caris Science, Inc.
state: Arizona
Study officials:
References:
Clinical trial NCT05140681: Influence of Flap Position Following FibReORS
Official title: Influence of Flap Position on Soft Tissue Regrowth, Keratinized Tissue Increase and Postoperative Discomfort Following Fibre Retention Osseous Resective Surgery (FibReORS): a 6-month Split-mouth RCT With Multilevel Analysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Periodontal Diseases
Keywords: periodontitis
flap position
soft tissue regrowth
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 16
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: There is lack of data in literature on keratinized tissue increase after FibReORS in relation to primary flap position. This study has been designed as a split-mouth randomized trial to assess the influence of flap position after FibReORS. 16 patients were recruited and treated. The placement of the flap 2 mm apically to the bone crest instead at the bone level would be a viable approach to increase KT width without delaying wound healing. The extent of post-operative discomfort/pain was not influenced by primary flap position.


Eligibility criteria: Inclusion Criteria:

1) diagnosis of severe chronic periodontitis (corresponding to grade III or IV according to the actual classification); 2) good general health; 3) full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) \< 20%; 4) at least two contralateral sextants with residual PDs of \> 5 mm and persisting bleeding on probing (BoP) at posterior natural teeth 3 months after the completion of cause-related therapy

Exclusion Criteria:

1) pregnancy and lactation; 2) smoking \> 10 cigarettes/day; 3) intake of antibiotics in the previous 6 months. In addition, teeth with degree II or III mobility, horizontal bone loss higher than 1/3 of the root length or designed as abutment for prosthetic rehabilitation were also excluded from the study.

Primary outcomes:
measure: Amount of soft tissue re-growth after FibReORS
timeFrame: 6 months
Secondary outcomes:
measure: Amount of KT increase after FibReORS
timeFrame: 6 months
Other outcomes:
Locations:
city: Torino
country: Italy
facility: C.I.R. Dental School. Università di Torino
state: TO
Study officials:
References:
Clinical trial NCT05361681: EMI and CIED: Is High Power Charging of Battery Electric Car Safe?
Official title: Assessment of Electromagnetic Interference Between Cardiac Implantable Electronic Devices and High Power Charging Systems for Battery Electric Cars
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pacemaker
ICD
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Exposure of patients with pacemaker or ICD to the electromagnetic fields of high power charging systems
Primary purpose: OTHER

Brief summary: It is not known if the use of high power charging systems for electric vehicles may interfere with the functionality of implanted pacemakers and cardioverter-defibrillators.

Detailed description: The use of electric cars for public and private transport is increasing all over the world. Moreover the charging technique is improving and enables very fast charging with the use of high power. It is not known if the use of high volume charging systems interfere with cardiac implantable electronic devices. The study evaluates different types of high volume charging systems connected to different full electric vehicles with regard to electromagnetic interference with implanted pacemakers or cardioverter-defibrillators.

Eligibility criteria: Inclusion Criteria:

* implanted cardiac implantable electronic device with regular function

Exclusion Criteria:

* implanted cardiac implantable electronic device with irregular function

Primary outcomes:
measure: Electromagnetic interference
timeFrame: during the intervention, i.e. when participants are exposed to the electromagnetic field of the high power charging column
Secondary outcomes:
measure: Electromagnetic fields
timeFrame: during the intervention
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
state: Bayern
Study officials:
References:
Clinical trial NCT05235581: Balance Reactions in a Virtual Environment With Avatar and/or Reinforced Visual Signal Compared to a Real Environment
Official title: Study of the Postural Reactions of Balance Compared Between Real Environment and Virtual Environment With Avatar and Reinforced Visual Signal.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Pôle Saint Hélier
Sponsor class: OTHER
Collaborators: name: Hopital La Musse
First posted: 2022-02-11
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Prospective, multicenter, controlled, randomized study on healthy volunteers.
Primary purpose: SCREENING

Brief summary: The scientific literature shows that there is a degradation of balance in virtual reality. This trial investigates the introduction of a full-body avatar and/or enhanced visual cues on the reduction of the degradation.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer, men and women over 18 years old

Exclusion Criteria:

* Severe visual deficiency not allowing an activity in immersive virtual reality.
* Immobilization of one of the upper limbs (splint restraint splint)
* Orthopedic and painful problems of the inferior limb
* MSSQ greater than 25
* Pregnant woman
* Person under legal protection

Primary outcomes:
measure: Area of CoP (Center of pression) for each test (in cm²)
timeFrame: Immediately after inclusion
measure: Total distance covered by the CoP during the balance test (in cm)
timeFrame: Immediately after inclusion
Secondary outcomes:
measure: Simulator Sickness Quantifying (SSQ)
timeFrame: Immediately after the balance test
Other outcomes:
Locations:
city: Rennes
country: France
facility: Pôle Saint Hélier
state: Bretagne
city: Saint-Sébastien-de-Morsent
country: France
facility: Hôpital la Musse
Study officials:
References:
Clinical trial NCT06665581: Keratinocyte Skin Cancer Surgery in the Elderly, Aged 80 Years and Over, is Effective and Safe
Official title: Keratinocyte Skin Cancer Surgery in the Elderly, Aged 80 Years and Over, is Effective and Safe: a Single Institution Retrospective Study Over One Year
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complication
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 345
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 80 and older having surgery for KC in University Hospital of Zurich between January 1, 2022, and December 31, 2022. All patients included in the study were operated on by the same dermatologic surgery team of University Hospital of Zurich under local anesthe-sia

Brief summary: As a result of a longer life expectancy and a change in UV exposure, physicians will be facing a growing number of elderly patients with keratinocyte cancer (KC) in fair-skinned populations. The purpose of this study is to better characterize KC surgery in patients over 80 years and older with different comorbid conditions and to investigate the incidence of complications associated with KC surgery.

A retrospective monocentric study of patients aged 80 and older, having surgery for KC in University Hospital of Zurich between January 1, 2022, and December 31, 2022, was conducted. Demographics, comorbidities, current medication, treatment type, tumor characteristics, surgical defect size, repair type and complications within 6 months after surgery were analyzed.


Eligibility criteria: Inclusion Criteria:

* Patients aged 80 and older, having surgery for KC in University Hospital of Zurich between January 1, 2022, and December 31, 2022

Exclusion Criteria:

* Presence of a documented rejection.

Primary outcomes:
measure: Incidence of complications associated with KC surgery in individuals aged 80 years and older
timeFrame: From January 1, 2022, to December 31, 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Dermatology Clinic
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References:
Clinical trial NCT00526981: Prone Position for Non-intubated Patients With Acute Respiratory Failure
Official title: Prone Position for Non-intubated Patients With Acute Respiratory Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2007-09-10
Enrollment: 24
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 study will test the hypothesis that the prone position can be used to reduce the need for intubation and mechanical ventilation in patients with acute respiratory failure.


Eligibility criteria: Inclusion Criteria:

* bilateral pulmonary infiltrates or unilateral infiltrates involving more than one lobe on CXR
* PaO2/FIO2 \< 40 kPa
* RR \> 25, or attending intensivist considering likelihood of intubation \> 50%

Exclusion Criteria:

* unsuited for the prone position
* fulfilled inclusion criteria for more than 5 days (120 h)
* immunosuppression
* chronic lung disease
* decision of withdrawal or limitation of therapy
* pulmonary infiltrates of cardiac origin
* decreased GCS level
* PaCO2 \> 10
* attending intensivist considering the patient unsuited for the prone position
* BMI \> 33

Primary outcomes:
measure: Need for intubation and mechanical ventilation
timeFrame: Duration of hospital stay
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
Study officials:
affiliation: Karolinska Institutet
name: Johan Petersson, MD
role: PRINCIPAL_INVESTIGATOR
References: