louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00798759: Examination of Ocular Surface Effects With Administration of Travatan Z and XALATAN
Official title: Examination of Ocular Surface Effects With Administration of TRAVATAN Z® and XALATAN®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-angle Glaucoma
Ocular Hypertension
Keywords: Open-angle glaucoma
Ocular hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-11-26
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* 18 years or older.
* Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
* Intraocular pressure (IOP) controlled with BAK (benzalkonium chloride) preserved IOP-lowering medication for 1 year, with last 6 months on XALATAN® monotherapy.
* Best corrected visual acuity of -0.6 logMAR or better in each eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Treatment with BAK preserved artificial tears within 30 days of Visit 1.
* Known or suspected Sjogren's disease.
* Uncontrolled IOP.
* History or evidence of infectious or inflammatory ocular conditions.
* Progressive retinal or optic nerve disease.
* Ocular laser surgery within 3 months of Visit 1.
* Keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface within 1 year of Visit 1.
* Current use of punctal plugs or punctal cautery.
* Use of systemic medications that has not been stable for 30 days prior to Visit 1.
* Use of contact lens within 30 days of Visit 1.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT)
timeFrame: Day 0, Day 84
Secondary outcomes:
measure: Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score
timeFrame: Day 0, Day 84
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00534300: Intravenous n-3 Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)-Pacemaker
Official title: Intravenous Infusion of n-3 Polyunsaturated Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ventricular Tachycardia
Sudden Cardiac Death
Keywords: ICD-pacemaker
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2007-09-24
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The long-chain n-3 polyunsaturated fatty acids (PUFA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), appear to offer protection against sudden cardiac death and ventricular arrhythmias. EPA and DHA are essential fatty acids which are incorporated into cellular membranes after regular ingestion of fatty fish or fish oil.

This study investigates a possible acute effect of intravenous infusion of n-3 PUFA on inducibility of ventricular tachycardia (VT) in patients with an ICD-pacemaker.

The hypothesis is that an acute rise in the concentration of n-3 PUFA in plasma will increase the electric stability of the myocardial cells, so that VT is more difficult to induce.

In a randomized, placebo-controlled, double-blind, crossover study, a lipid emulsion with a high content of n-3 PUFA (or placebo: isotonic saline) will be administered intravenously before a non-invasive electrophysiologic examination performed via the ICD and following a predefined protocol.

The main outcome is inducibility of VT. If sustained VT is induced in a patient after both n-3 PUFA and placebo, the strength of the required stimulus after n-3 PUFA and after placebo is compared.


Eligibility criteria: Inclusion Criteria:

* Sustained ventricular tachycardia (VT) inducible during primary electrophysiological study (before ICD implantation) and one of the following

  * Latest VT episode terminated by anti-tachycardia pacing (ATP)
  * VT induced during primary electrophysiological study terminated by ATP

Exclusion Criteria:

* Premenopausal women
* Allergy to fish or egg protein
* Blood pressure \> 160/90 (treated or untreated)
* MI, PCI or CABG within the previous 6 months
* HbA1c \> 10%
* ALT \> 150 U/L
* INR \> 3.5
* Plasma-potassium \< 3.5 mmol/L
* Fasting triglycerides \> 3 mmol/L
* Other serious illness
* Inability to sign informed consent

Primary outcomes:
measure: Inducibility of ventricular tachycardia
timeFrame: Hours
Secondary outcomes:
measure: Heart rate variability
timeFrame: Hours
measure: Ventricular repolarization parameters
timeFrame: Hours
measure: Concentration of n-3 fatty acids in plasma and platelet membranes
timeFrame: Hours
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Cardiology, Aalborg Hospital
Study officials:
affiliation: Aalborg Hospital, Aarhus University Hospital, Denmark
name: Trine Madsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00614900: Prevalence of Pulmonary Hypertension in COPD Patients
Official title: Prevalence and Influence of Pulmonary Hypertension in COPD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Pulmonary Hypertension
Keywords: COPD
pulmonary hypertension
NT-proBNP
6 minutes walk test
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2008-02-13
Enrollment: 117
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients have been admitted to hospital with an exacerbation in COPD in 2006.

Brief summary: The prevalence of an increased pulmonary blood pressure amongst patients with chronic obstructive pulmonary disease (COPD)is unclear. So is the impact of abnormal pulmonary blood pressure on symptoms. The aim of this study is to determine the prevalence of an increased pulmonary blood pressure in 200 patients with COPD. Furthermore we will investigate if lung function test results and blood tests can predict an increased pulmonary blood pressure, and explore whether COPD patients with a high pulmonary blood pressure have more symptoms that their co-patients.

Detailed description: The prevalence of pulmonary hypertension in patients with chronic obstructive pulmonary disease (COPD) is unclear. The presence of an abnormally increased pulmonary blood pressure worsens the prognosis of COPD, but the patients are not currently diagnosed or treated for pulmonary hypertension. The aim of this study is to determine the prevalence of pulmonary hypertension in 200 patients with COPD and explore whether it worsens functional capacity and symptoms. Furthermore we will look into whether blood gas values, NT-proBNP, CRP and lung function test result can predict which patients are at risk of having pulmonary hypertension.

Methods: All patients will be screened by echocardiography. Those with signs of pulmonary hypertension will be admitted to right heart catheterization for direct measurements of pulmonary haemodynamics.

All patients will perform a 6 minutes walk test and spirometry. Blood levels of NT-proBNP and CRP will be measured. Life quality by the St. George Questionnaire and contacts to the health care system is also assessed. Differences in these parameters are analyzed among patients with no, moderate or severe pulmonary hypertension.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD
* Prior admittance to hospital with exacerbation in COPD
* Informed consent

Exclusion Criteria:

* Exacerbation in COPD less than 6 weeks before examination

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Århus
country: Denmark
facility: Department of pulmonary diseases, Aarhus Sygehus
Study officials:
affiliation: Aarhus Universitetshospital, Aarhus Sygehus
name: Ole Hilberg, Md, Dr.med.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01248000: The Use of FDG-PET in Patient With Hodgkin Lymphoma: a Population Based Study From Northern Italy
Official title: The Use of FDG Positron Emission Tomography (PET)in Patient With Hodgkin Lymphoma (HL) in the "Real World": a Population Based Study From Northern Italy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Histologically Confirmed Classical Hodgkin Lymphoma According to the Current World Health Organisation Classification
Keywords: Hodgkin lymphoma
FDG-PET
prognostic factor
clinical trial
Lead sponsor: Gruppo Italiano Studio Linfomi
Sponsor class: OTHER
Collaborators: name: Registro Tumori di Modena
name: Registro Tumori di Reggio Emilia
name: Registro Tumori di Parma
name: registro Tumori di Ferrara
First posted: 2010-11-25
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cases of classical Hodgkin lymphoma diagnosed between 2006 and 2008 in the province of Modena, Reggio Emilia, Parma and Ferrara will be considered eligible for this study.

Brief summary: Positron Emission Tomography (PET) represents a step forward in the definition of response to therapy in patients with Hodgkin Lymphoma (HL). In particular the use of PET for the early assessment of response has been described as the most important tool for predicting the risk of disease progression. As no data are available to support the use of early assessment of response for adapting and modifying subsequent treatment, the use of PET should be limited only to patients enrolled in clinical trials. Irrespective of recommendations PET scanning is included in the current management of patients with HL at baseline, mid treatment, end of treatment, and follow-up. So far no study has been performed to verify how PET is currently used in the clinical setting and to assess if and how results of PET scanning are used for supporting treatment and clinical decisions.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed classical Hodgkin lymphoma according to the current World Health Organisation Classification (nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte depleted).
2. Clinical stage I-IV.
3. No previous chemotherapy, radiotherapy or other investigational drug for HL.

Exclusion Criteria:

1. None.

Primary outcomes:
measure: Progression-free survival
timeFrame: within 1 month after end of treatment
measure: Overall survival
timeFrame: within 1 month after end of treatment
measure: Disease-free survival
timeFrame: within 1 month after end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Registro Tumori di Modena
Study officials:
affiliation: Università di Modena e Reggio Emilia
name: Massimo Federico, MD
role: STUDY_CHAIR
References:
Clinical trial NCT07014800: Tomoelastography in Predicting Postoperative Pancreatic Fistula
Official title: Multi-frequency MR Elastography Based Tomoelastography: Additional New Imaging Tool for Postoperative Pancreatic Fistula Risk Stratification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatectomy
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 157
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who underwent both preoperative multi-frequency MRE and pancreaticoenteric anastomosis were included in the study.

Brief summary: Postoperative pancreatic fistula (POPF) is a prevalent and severe complication of pancreaticoenteric anastomosis; however, its accurate preoperative prediction is challenging. Multi-frequency MR elastography-based tomoelastography can quantify pancreatic mechanical properties (stiffness and fluidity), thus further improving the predictive performance of conventional MRI for postoperative pancreatic fistulas.


Eligibility criteria: Inclusion Criteria: Participants diagnosed with postoperative pancreatic fistula who underwent both preoperative multi-frequency MRE and pancreaticoenteric anastomosis were included in the study.

-

Exclusion Criteria:

without appropriate image quality； without available pathological data

-

Primary outcomes:
measure: Postoperative pancreatic fistula
timeFrame: The participants were routinely examined on days 1, 3, 5, and 7 after surgery to determine fluid volumes and serum amylase levels.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Shi Siya
state: Guangdong
Study officials:
References:
Clinical trial NCT02636400: Immediate Intra Uterine Isemination (IUI) Versus Expectant Management in Postoperative Endometriosis Patients
Official title: Is Postoperative IUI Better Than Expectant Management in Infertile Endometriosis Patients With Good Prognosis Based on EFI Score?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Endometriosis
Infertility
Keywords: Infertility
endometriosis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-12-21
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Is postoperative IUI better than expectant management in infertile endometriosis patients with good prognosis based on their EFI score? (A single centre randomised controlled trial).


Eligibility criteria: Inclusion Criteria:

* recent (\<6months) complete laparoscopic endometriosis resection
* endometriosis fertility index (EFI) at least 7/10
* Regular menstrual cycles (min 24days - max 38days) with proven ovulation
* At least one functional tube at surgery, normal uterus
* Sperm sample of partner: normal or mild male factor

Exclusion Criteria:

* frozen (donor or partner) sperm
* clinical and/or imaging evidence of endometriosis recurrence/persistence at randomization
* FSH \> 20 IU/L

Primary outcomes:
measure: cumulative clinical pregnancy rate
timeFrame: participants will be followed for the duration of 7 menstrual cycles and in case of pregnancy, they will be followed until the pregnancy outcome is known, implying an average time frame of 1.5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Thomas D'Hooghe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05678400: Comparison of the Immediate Effects of a Hypopressive Abdominal Exercise Program Versus a Proprioceptive Neuromuscular Facilitation Stretching Program on Hamstring Flexibility in Adults With Short Hamstring Syndrome
Official title: Comparison of the Immediate Effects of a Hypopressive Abdominal Exercise Program Versus a Proprioceptive Neuromuscular Facilitation Stretching Program on Hamstring Flexibility in Adults With Short Hamstring Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Therapy
Physical Therapy Modalities
Hamstring Muscles
Lead sponsor: University of Vigo
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 19
Sex: ALL
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: A Randomised Controlled Trial was conducted to assess increases in hamstring flexibility using two different methods, one group of participants who were stretched with PNF techniques and the other group who performed Hypopressive Abdominal Techniques (HAT). Flexibility scores of both groups were obtained and compared using pre and post measurements of a single intervention.


Eligibility criteria: Inclusion Criteria:

* Participants with less than 75° in the straight leg raise test.

Exclusion Criteria:

* History of hamstring injury within the last year.
* Pharmacological treatment or history of neurological, orthopaedic, growth or autoimmune disorders.
* Training to improve flexibility in the week prior to the intervention.
* Hypertension.
* Pregnant women.
* Inability to perform hypopressive abdominal techniques.

Primary outcomes:
measure: Straight leg raise test.
timeFrame: Baseline changes at the end of the intervention (approximately one hour).
Secondary outcomes:
measure: The Toe-Floor Distance test
timeFrame: Baseline changes at the end of the intervention (approximately one hour).
Other outcomes:
Locations:
city: Pontevedra
country: Spain
facility: Facultade de fisioterapia
Study officials:
References:
Clinical trial NCT04491500: Retinal and Choroidal Circulation Changes Following Rapid Ascent to a High Altitude Environment
Official title: Retinal and Choroidal Circulation Changes Following Rapid Ascent to a High Altitude Environment Evaluated by OCT Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Altitude Retinopathy
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the staff will go to Yushu on the 2020 preventive blindness project.

Brief summary: This is a prospective observational study. The purpose is to explore the effect of high altitude hypobaric hypoxia on retinal microcirculation and the change of the thickness of the retina and choroid by optical coherence tomography angiography (OCTA).

Detailed description: Yushu is in Qinghai-Tibet plateau, an average altitude of 4000 m. The medical staff is limited in Yushu. Zhongshan ophthalmic center, sun yat-sen university in Yushu blindness project has lasted many years. Some medical staff who arrived at Yushu will have a plateau response. The high altitude hypoxia on retinal microcirculation evaluated by OCTA has not been reported. The aim of the study is to observe the microcirculation changes after exploring a hypobaric and hypoxia environment using OCTA, and relation with the plateau response. OCTA is a non-invasive examination and could see the microcirculation of the fundus directly and quickly.

Eligibility criteria: Inclusion Criteria:

1. The subjects who plan to go to Yushu within one month.
2. Did not live on the high altitude of more than 1000 meters within 6 months.

Exclusion Criteria:

1. Unable and unwilling to provide informed consent.
2. Any ocular disease may influence the retinal and choroidal circulation.

Primary outcomes:
measure: retinal microcirculation changes
timeFrame: 1 month
Secondary outcomes:
measure: Retinal thickness changes
timeFrame: 1 month
measure: Choroidal thickness changes
timeFrame: 1 month
measure: The correlation of retinal microcirculation with the altitude illness
timeFrame: 1 month
measure: The changes of intraocular pressure
timeFrame: 1 month
measure: The changes of blood pressure including systolic and diastolic Blood Pressure
timeFrame: 1 month
measure: The changes of blood oxygen
timeFrame: 1 month
measure: the degree of altitude illness
timeFrame: 1 month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Liang xiaoling
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Xiaoling Liang, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06773000: Nutritional Supplementation in Geriatric Hip Fractures
Official title: Can Complex Carbohydrates and Essential Amino Acid Supplementation Improve Outcomes Following Geriatric Hip Fractures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Geriatric Hip Fracture
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 118
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized controlled trial comparing outcomes between geriatric hip fractures who received a commercially available (XR RecoveryTM, Salt Lake City Utah) peri-operative nutritional supplement for three weeks post-operatively to those who receive standard nutritional counseling. The main question it aims to answer is:

- Does supplementation decrease muscle loss via ultrasound measurements of the cross-sectional area of the rectus femoris of the uninjured leg?


Eligibility criteria: Inclusion Criteria:

1. Male or female, aged 65 years or older.
2. Presenting with a geriatric hip fracture (femoral neck, intertrochanteric, or subtrochanteric) requiring surgical intervention.
3. Able to provide informed consent.
4. Expected to survive at least 6 months after surgery, with no terminal illness.

Exclusion Criteria:

1. Pre-existing conditions that significantly impair mobility prior to injury.
2. Severe renal or liver impairment.
3. Active treatment with investigational drugs or participation in another clinical trial within the last 30 days.
4. Inability to tolerate oral nutritional supplementation due to gastrointestinal disorders.
5. Allergies to any components of the nutritional supplement being tested.

Primary outcomes:
measure: Percentage change in muscle loss, as measured by the cross-sectional area of the rectus femoris muscle
timeFrame: Baseline, Visit 7 (1 year post operation)
Secondary outcomes:
measure: Number of inpatient complications related to the surgical procedure for hip fractures
timeFrame: From admission (visit 1) until discharge (~72 hours post-operation)
measure: Number of wound complications
timeFrame: Visit 5, up to 6 months
measure: Length of hospital stay
timeFrame: From admission (visit 1) until discharge (~72 hours post-operation)
measure: Rate of readmission
timeFrame: Visit 7 (1 year post operation)
measure: Mortality Rate
timeFrame: Visit 7 (1 year post operation)
measure: Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
timeFrame: Baseline, Visit 7 (1 year post operation)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Abhishek Ganta, MD
role: PRINCIPAL_INVESTIGATOR
References: