louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03555630: Thromboelastogram in Postdelivery Preeclamptic Patients
Official title: Effect of Age on Reference Values for Thromboelastography in Pregnant Women With Pre-eclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Coagulation Disorder
Pregnancy Complications
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Term pregnant patients with preeclampsia

Brief summary: There are no studies evaluating the effect of aging on hemostasis of preeclamptic patients. Additionally, although there are some studies that establish normal reference values for TEG profiles in healthy term pregnant patients, conflicting results have been found in preeclampsia. Reference values are important to establish baseline parameters in cases of pre-eclampsia complicated by postpartum hemorrhage. The investigators will evaluate reference values for TEG in postdelivery preeclamptic patients and the difference between vaginal delivery and cesarean section.

Detailed description: After approval by the Institutional Review Board and informed consent from participants, the investigators are obtaining blood samples for TEG processing, from pregnant patients admitted to the maternity unit of Augusta University Medical Center. Patients are being classified in 2 groups: term pregnant patients with diagnosis of pre-eclampsia who undergo cesarean section and those having spontaneous vaginal delivery. Each group will be divided into subgroups according to maternal age: 18-25 years, 26-35 years, \>36 years. Pre-eclampsia is defined and classified according to the definitions of the American College of Obstetricians and Gynecologists published in 2013.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years Mental competence Gestational age \> 37-week Informed consent Diagnosis of preeclampsia (with or without features of severity)

Exclusion Criteria:

Gestational age \< 37-week Known bleeding or thrombotic diathesis Use of aspirin or unfractionated or low-molecular weight heparin within the last 48 hours BMI \> 35 Maternal comorbid conditions other than preeclampsia

Primary outcomes:
measure: R time
timeFrame: 10 minutes
Secondary outcomes:
measure: K time
timeFrame: 10 minutes
measure: Maximum amplitude
timeFrame: 10 minutes
measure: LY-30
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
Study officials:
References:
Clinical trial NCT05522530: Cross-cultural Adaptation and Validity of Mini Bestest in Balance Disorders in the Autonomous City of Buenos Aires: Validation Study Protocol
Official title: Cross-cultural Adaptation, Reliability, Validity and Viability of the Mini Bestest in Balance Disorders Upon Admission or Readmission to Vestibular Rehabilitation in the Autonomous City of Buenos Aires: Validation Study Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vestibular Disease
Peripheral Vestibular Disorder
Lead sponsor: Hospital de Rehabilitacion Manuel Rocca
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with peripheral vestibular disorders

Brief summary: The objective of this study is to carry out the cross-cultural adaptation of the Mini BESTest (a balance assessment scale) into Argentine Spanish, as well as to study its validation in patients with peripheral vestibular disorders in the autonomous city of Buenos Aires.


Eligibility criteria: Inclusion Criteria:

* Subjects \>18 years of age,
* With vestibular alterations of peripheral etiology, within the second year of evolution
* Time of evolution of symptoms ≤ 2 years
* Independent walking with or without walking assistance device
* Who are at the beginning of a VR program
* No diagnoses of psychiatric disorders or cognitive impairment,
* Sign the informed consent

Exclusion Criteria:

* Who have suffered amputation in one of their lower limbs,
* History of neurological pathologies (stroke, multiple sclerosis, neuromuscular disease)

Primary outcomes:
measure: Mini BESTest
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Almagro
country: Argentina
facility: Marcos Ceferino Gabriel Valdez
state: Autonomous City Of Buenos Aires
Study officials:
References:
Clinical trial NCT03619330: Testosterone Replacement Therapy and Liraglutide Effects on Weight Loss in Hypogonadism.
Official title: Effects of Liraglutide and Testosterone Replacement Therapy on Features of Hypogonadism and Weight Loss in Obese Men With Persistent Features of Hypogonadism.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypogonadism
Obesity
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the effects of liraglutide and testosterone replacement therapy on features of hypogonadism and weight loss in obese men with persistent features of hypogonadism after unsuccessful lifestyle measures.



Primary outcomes:
measure: The main outcome was improvements of symptoms related to hypogonadism
timeFrame: Patients were screened and asked for symptoms at the beginning and every 4 weeks for 16 weeks of the study.
measure: The main outcome was change testosterone level.
timeFrame: Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial.
measure: the main outcome was change in gonadotropin levels.
timeFrame: Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial.
Secondary outcomes:
measure: The secondary outcome was change in body weight.
timeFrame: Patient's body weight in kilograms were measured at the base point and every four weeks during the 16 weeks of clinical trial.
measure: The secondary outcome was change in waist circumference.
timeFrame: Patient's waist circumference was measured at the basepoint and every four weeks during 16 weeks of clinical trial.
Other outcomes:
measure: The other outcomes was changes changes in fasting concentrations of glucose.
timeFrame: Patient's fasting blood was drawn at the basepoint and and the end of the 16 weeks of clinical trial.
measure: Other outcome was change in fasting concentration of insulin.
timeFrame: Patient's fasting blood was drawn at the basepoint and and the end of the 16 weeks of clinical trial.
measure: Other outcome was change in HOMA IR index for insulin resistance.
timeFrame: Patient's fasting blood was drawn at the basepoint and and the end of the 16 weeks of clinical trial.
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Andrej Janez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04128930: Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea
Official title: Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2019-10-16
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: The aim of this trial is to compare two different ways of CPAP titration:

CAP titration with fixed pressure vs. auto-titrating CPAP.

Detailed description: Continuous positive airway pressure (CPAP) for the treatment of moderate obstructive sleep apnea (OSA) is only reimbursed in Belgium after in-laboratory overnight titration. Nevertheless, in a recent clinical practice guideline of the AASM, it is recommended that PAP therapy can be initiated using either in-laboratory titration or auto-titrating CPAP (APAP) at home in OSA patients without significant comorbidities. Indeed, several studies evaluated the impact of titration with APAP at home in these patients and showed that the outcome is comparable with in-hospital titration. Up to now, evidence for home titration with fixed CPAP (and follow-up via telemonitoring) is very limited. The use of sleep laboratory space is costly and limits access for diagnostic studies. This study aims to evaluate whether CPAP titration at home with fixed CPAP produces outcomes equal to those following APAP titration.

Eligibility criteria: Inclusion Criteria:

* moderate OSA (obstructive AHI 15-30/u on initial PSG)

Exclusion Criteria:

* Presence of hypoventilation
* Presence of central sleep apnea (central AHI ≥ 15)

Primary outcomes:
measure: CPAP adherence
timeFrame: 3 months
Secondary outcomes:
measure: Effective pressure level
timeFrame: 2 weeks
measure: Residual apnea/hypopnea index
timeFrame: 2 weeks
measure: Mask leaks
timeFrame: 2 weeks
measure: Proportion of good titration
timeFrame: 2 weeks
measure: Residual device AHI
timeFrame: 3 months
measure: Epworth Sleepiness Scale
timeFrame: 3 months
measure: Blood pressure
timeFrame: 3 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 3 months
measure: 36-Item Short Form Health Survey
timeFrame: 3 months
measure: Hospital contacts
timeFrame: 3 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Dries Testelmans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04490330: Screening for Alcohol-related Cognitive Impairments in Cirrhotic Patients
Official title: Screening for Alcohol-related Cognitive Impairments in Cirrhotic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alcohol Dependence
Dependence
Cognitive Impairments
Cirrhosis
Liver Diseases
Keywords: Alcohol Dependence
Dependence
Cognitive Impairments
Cirrhosis
Liver Diseases
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with alcoholic cirrhosis will be evaluated with BEARNI tool in order to detect alcohol-related cognitive problems.

Brief summary: 80% of patients with alcohol use disorders (AUD) present cognitive impairments, such as memory and executive functions. These disorders may have repercussions in addiction treatment by altering the patient's adherence to care. The level of impairment is dependent on the onset of addiction, and also the duration of abstinence.

A complete neuropsychological evaluation is necessary to highlight cognitive impairments. In practice, the evaluation of these disorders by practitioners, is done with the help of tools of screening like the MoCa (Montreal cognitive assesment) and the BEARNI (Brief evaluation of alcohol related neuropsychological impairment).

However, none of these tools have been evaluated in patients with alcoholic cirrhosis. Indeed, some studies have suggested that liver disorders including cirrhosis may be a factor aggravating cognitive disorders.

The purpose of this study is to evaluate the ability of the BEARNI tool to detect alcohol-related cognitive problems in patients with alcohol-related cirrhosis.


Eligibility criteria: Inclusion Criteria:

* Patient with cirrhosis
* patients with cirrhosis diagnosed by clinical examination
* patients with cirrhosis diagnosed by biological and / or morphological and / or noninvasive tests and / or liver biopsy
* CHILD A, B or C

Exclusion Criteria:

* hepatitis encephalopathy less than 6 months old
* complicated cirrhosis with hepatocellular carcinoma
* Acute alcoholic hepatitis
* viral cirrhosis

Primary outcomes:
measure: number of alcoholic cirrhosis patients with presence of alcohol-related cognitive disorders
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT03515525: Analysis of Hematoma Following Breast Surgery
Official title: Retrospective Review of Patient Records for Analysis of Postoperative Bleeding Following Breast Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematoma
Postoperative Bleeding
Keywords: Breast surgery
Closed-suction drains
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2018-05-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We enrolled 20 subjects who developed unilateral hematoma requiring evacuation following bilateral breast surgery between January 2008 and January 2018 at our institution. Gender, age, breast surgery subtype, preoperative and postoperative hemoglobin values as well as perioperative heparinization were recorded.

Brief summary: A retrospective review of patients who developed hematoma following breast surgery from 2003 to 2018 in a single institution was performed. The study investigated the value of closed-suction drains regarding the quantity and quality of fluid secretion for the prediction of subcutaneous hematoma in patients undergoing breast surgery procedures.


Eligibility criteria: Inclusion Criteria:

* Patients who developed hematoma requiring revision following bilateral breast surgery including augmentation mammoplasty, subcutaneous mastectomy and breast reduction.

Exclusion Criteria:

* Patients who developed hematoma requiring revision following unilateral breast surgery.
* Breast surgery in absence of hematoma.
* Patients with known coagulation disorders.

Primary outcomes:
measure: Drain fluid volume
timeFrame: 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Department of Plastic Surgery, University Hospital of Regensburg
Study officials:
References:
Clinical trial NCT01959230: Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Participants With Ocular Redness
Official title: A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in a Population of Adult and Geriatric Subjects With Ocular Redness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperemia
Keywords: Ocular redness
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2013-10-09
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: To compare the efficacy and safety of brimonidine tartrate ophthalmic solution 0.025% with its vehicle for the treatment of ocular redness in a population of adult and geriatric participants with ocular redness.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age.
* Have a history of redness relief drops use or expressed a desire to use drops for redness relief, within the last 6 months.
* Have ocular health within normal limits including a calculated best-corrected visual acuity of 0.3 logarithm of the minimum angle of resolution (logMAR) or better in each eye, as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart.

Exclusion Criteria:

* Any ocular/systemic health problems.
* Use of any disallowed medications.

Primary outcomes:
measure: Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale
timeFrame: 0 (predose), 5, 15, 30, 60, 90, 120, 180, and 240 minutes postdose on Day 1
Secondary outcomes:
measure: Ocular Redness as Measured by the Participant
timeFrame: Day 1 to Day 15; Day 15 to Day 29; Day 29 to Day 36
measure: Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale
timeFrame: 0 (predose), 1, 360, and 480 minutes (min) postdose on Day 1 and 0 (predose), 1, and 5 min postdose on Days 15 and 29
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Bausch & Lomb Incorporated
state: Tennessee
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Heleen DeCory
role: STUDY_DIRECTOR
References:
citation: McLaurin E, Cavet ME, Gomes PJ, Ciolino JB. Brimonidine Ophthalmic Solution 0.025% for Reduction of Ocular Redness: A Randomized Clinical Trial. Optom Vis Sci. 2018 Mar;95(3):264-271. doi: 10.1097/OPX.0000000000001182.
Clinical trial NCT00841230: Deanxit and Rivotril in Tinnitus Patients
Official title: Additional Value of Deanxit in Tinnitus Patients Treated With Rivotril
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tinnitus
Keywords: Tinnitus
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2009-02-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether increased tinnitus reduction can be obtained with Deanxit in patients already receiving Rivotril.


Eligibility criteria: Inclusion Criteria:

* pure tone, narrow band noise or polyphonic tinnitus
* unilateral or bilateral tinnitus
* VAS ≥ 4

  * cochleair origin tinnitus
  * tinnitus present 3 months or more
  * age 18y or more
  * intake Rivotril 1mg/d
  * patient 'able to cooperate'
  * patient able to fill in TQ en VAS
  * No pontine angle pathology on MRI

Exclusion Criteria:

* pulsatile tinnitus
* pregnancy or breast feeding
* contra-indications Deanxit
* recovery myocard infarct
* conduction disorder His
* untreated glaucoma
* MAO inhibitors: 15d stop
* otosclerosis
* middle ear pathologies
* Ménière
* somatic tinnitus

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 3 weeks, 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
Study officials:
affiliation: University Hospital, Antwerp
name: Olivier Meeus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00540930: Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy
Official title: A Randomized Control Trial of Intravitreal Ranibizumab (Lucentis) for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy for Choroidal Melanoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Uveal Melanoma
Radiation Retinopathy
Radiation Maculopathy
Lead sponsor: Shields, Shields and Associates
Sponsor class: OTHER
First posted: 2007-10-08
Enrollment: 400
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: Uveal Melanoma is the most common primary intraocular malignancy in adulthood. Eye preserving treatments can deliver equivalent life prognosis in the management of small and medium sized uveal melanomas, as compared to enucleation. Plaque radiotherapy has emerged as the most common eye-preserving treatment in the current management of uveal melanoma, but is complicated by visual loss in approximately 70% of patients at 10 years follow-up. Strategies for the prevention and early treatment of radiation retinopathy/maculopathy need to be developed to improve visual outcomes following plaque treatment. Ranibizumab (Lucentis) is the antigen binding fragment of a recombinant, humanized monoclonal antibody, which inhibits the activity of vascular endothelial growth factor A, a mediator in the development of choroidal neovascularization. Lucentis is commonly used in the eye for eye conditions such as age related macular degeneration. This study will investigate the possible benefit of Anti-VEGF therapy (Lucentis) in reducing the incidence of radiation complications following plaque radiation for uveal melanoma.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* new diagnosis of choroidal melanoma
* scheduled for plaque radiotherapy at Wills Eye Health System

Exclusion Criteria:

* Pre-existing retinal disorders (i.e. age-related macular degeneration, diabetic maculopathy, retinal vascular occlusion, macular hole, surface wrinkling retinopathy)
* prior retinal detachment
* media opacities precluding accurate OCT imaging
* history of glaucoma
* pregnancy
* age \<18 years.

Primary outcomes:
measure: Presence or absence of optical coherence (OCT) evidence of macular edema.
timeFrame: 4 months
Secondary outcomes:
measure: Grade of macular edema on OCT, visual acuity (LogMAR), and foveal thickness measurement on OCT at follow-up.
timeFrame: 4 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Institute
state: Pennsylvania
Study officials:
affiliation: Wills Eye Institute
name: Carol L Shields, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02829125: Influence of Postoperative Rehabilitation and Pre- and Postoperative Physical Activity in Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Injuries
Keywords: Early rehabilitation
abdominal surgery
ERAS
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 400
Sex: ALL
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: patients undergoing abdominal surgery

Brief summary: The concept of early rehabilitation (ERAS: enhanced after-surgery recovery) was introduced by Kehlet et al. in 1995, as part of the colon surgery. This program is a support for patients combining laparoscopic surgery, epidural analgesia, early refeeding and rapid mobilization of patients. This strategy targets multiple elements (20 items) to support pre-, intra- and postoperative patients. This reduces the pain and the different organ dysfunction induced by surgical stress significantly decreasing length of hospital stay, postoperative morbidity and costs.

Furthermore, early mobilization of patients is fundamental to the ERAS method. Few studies have analyzed the influence of preoperative exercise on postoperative rehabilitation.


Eligibility criteria: Inclusion criteria

1. non-cancerous and cancerous pathology
2. signed Consent
3. Every patient operated on a scheduled or emergency abdominal surgery

Exclusion criteria

1. inability to give informed about information
2. minor Patient

Primary outcomes:
measure: quality of life questionnaire
timeFrame: before and after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive - Hôpital de Hautepierre
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Jean-Philippe STEINMETZ, MD
role: STUDY_DIRECTOR
affiliation: University Hospital, Strasbourg, France
name: Benoît ROMAIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Strasbourg, France
name: Serge ROHR, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: