louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01706549: Clinical Analysis of Pain After Hysterectomy
Official title: Chronic Pain After Hysterectomy, Qualitative Analysis of Pain and Its Impact on Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: Chronic pain
Hysterectomy
Quality of life
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2012-10-15
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergone hysterectomy for 1-3 years previously and suffering from persistent pain 6 months after surgery. The patients are invited to participate in this study, if they have participated in previous studies "Sevoflurane, Propofol, Postoperative pain" by Yli-Hankala and Pokkinen and study:" Vaginal hysterectomy, laparoscopic hysterectomy, postoperative pain" by Yli-Hankala and Pokkinen.

Brief summary: Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. The aims of the study are:

1. to reveal whether the pain is postsurgical in nature, or if there are any other reasons for the pain.
2. to reveal the type of pain, neuropathic, nociceptive or idiopathic.
3. to reveal the impact of pain on quality of life.

Detailed description: Patients undergone either laparoscopic or vaginal hysterectomy will called for a clinical examination 1-3 years after surgery, if they suffer from pain 6 months after surgery. All patients were treated in Pirkanmaa District Hospital and the anesthesia was either propofol-infusion or sevoflurane gas with remifentanil-infusion.

6months after the surgery, questionnaires about pelvic pain were sent to the patients. Patients still having pain at that time, were invited for detailed sensory and gynecological examinations.

Eligibility criteria: Inclusion Criteria:

* hysterectomy 1-3 years previously
* suffering from pain 6months postsurgically

Exclusion Criteria:

-

Primary outcomes:
measure: Type of Chronic Pain After Hysterectomy
timeFrame: 1-3 years after hysterectomy
Secondary outcomes:
measure: Quality of Life After Hysterectomy
timeFrame: 1-3 years after hysterectomy
measure: Is the Pain Due to Hysterectomy?
timeFrame: 1-3 years
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Satu Pokkinen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Maija-Liisa Kalliomäki, MD, PhD
role: STUDY_DIRECTOR
affiliation: Tampere University Hospital
name: Kari Nieminen, MD, Doc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01252849: Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects
Official title: A Prospective, Randomized, Controlled Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications, Implanted With One, Two, or Three Trabecular Micro-Bypass Stents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma (POAG)
Keywords: Open angle
Glaucoma
surgery
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2010-12-03
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: iStent 1, 2, or 3 stents
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma (POAG)
* Subject on two topical hypotensive medications

Exclusion Criteria:

* Traumatic, uveitic, neovascular, or angle closure glaucoma
* Fellow eye already enrolled

Primary outcomes:
measure: Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs. baseline
timeFrame: 12 Months
Secondary outcomes:
measure: Mean diurnal IOP <18 mmHg at month 12
timeFrame: 12 months
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: S.V. Malayan's Ophthalmology Centre
Study officials:
References:
Clinical trial NCT03026049: Stent Versus Conservative Treatment in Patients With Deep Venous Obstruction
Official title: A Randomized Controlled Trial Comparing Venous Stenting With Conservative Treatment in Patients With Deep Venous Obstruction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Deep-Venous Thrombosis
Deep Venous Stenting
Randomized Clinical Trial
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 65
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: Patients will be randomised between deep venous stenting or conservative management


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Meet criteria for PTS or
* Patients with May Thurner syndrome on additional imaging
* Life expectancy of more than one year
* Deep venous thrombosis \> 1 year
* Signed informed consent

Exclusion Criteria:

* Previous intervention of central veins (inferior vena cava, iliac veins, common femoral vein) on the affected limb
* Known pregnancy
* Inability to answer Dutch QoL questionnaires or limited communication in Dutch (written and spoken)
* Contra-indication for prolonged anticoagulant treatment
* Recent, \<1 year, deep venous thrombosis or pulmonary Embolism
* Known contrast allergy
* Known dialysis or renal insufficiency needing additional preparation for injection of contrast

Primary outcomes:
measure: Quality of Life score
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht university medical center
state: Limburg
Study officials:
References:
citation: van Vuuren TM, van Laanen JHH, de Geus M, Nelemans PJ, de Graaf R, Wittens CHA. A randomised controlled trial comparing venous stenting with conservative treatment in patients with deep venous obstruction: research protocol. BMJ Open. 2017 Sep 11;7(9):e017233. doi: 10.1136/bmjopen-2017-017233.
Clinical trial NCT01697449: An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (RELEVANT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-10-02
Enrollment: 191
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 with metastatic colorectal cancer initiated on Avastin in combination with chemotherapy

Brief summary: This prospective observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in patients with metastatic colorectal cancer. Data will be collected from patients receiving Avastin in combination with chemotherapy according to registered indication in routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Metastatic colorectal cancer
* Prescribed to receive Avastin according to registered indication

Exclusion Criteria:

* Patients not eligible for Avastin treatment according to the Summary of Product Characteristics

Primary outcomes:
measure: Percentage of Participants With At Least One Adverse Event (AE)
timeFrame: Up to 65 months
Secondary outcomes:
measure: Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Up to 65 months
measure: Percentage of Participants Who Were Resectable Postbaseline Among the Participants Who Were Unresectable at Baseline
timeFrame: Up to 65 months
measure: Percentage of Participants With Disease Progression or Death
timeFrame: Up to 65 months
measure: Progression Free Survival (PFS)
timeFrame: Up to 65 months
Other outcomes:
Locations:
city: Belgrade
country: Serbia
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: NIS
country: Serbia
city: Sremska Kamenica
country: Serbia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06048549: The Effect of Obesity in COPD Mechanically Ventilated Patients
Official title: Effect Of Obesity on The Outcome Of Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Effects of Obesity on COPD Mechanically Ventilated Patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients of both genders more than 18 years old admitted at RICU, diagnosed COPD and need mechanical ventilation from August 2023 to August 2024.

Brief summary: Study the relationship between the body mass index and duration of mechanical ventilation \& complications in mechanically ventilated COPD patients.

Study the effect of obesity on mortality rate of COPD mechanically ventilated patients.

Determine prevalence of obesity in mechanically ventilated COPD patients.

Detailed description: Obesity has become a global epidemic with prevalence rising both in developed and developing countries. The percentage of patients with obesity in the intensive care unit (ICU) can be expected to increase concomitantly or even more since obesity increases the risk for a more severe disease course with more need for ICU admission and mechanical ventilation .

Obesity, especially abdominal obesity (android fat distribution) and severe obesity, results in altered respiratory anatomy and physiology and, therefore, complicated airway management and adapted ventilator settings during mechanical ventilation. Obesity appears to be associated with an increased risk of acute respiratory distress syndrome (ARDS) and infection, mainly pneumonia probably related to an imbalanced production of adipokines. In ventilated patients, obesity increases ICU length of stay and the duration of mechanical ventilation .

Obesity is relatively common among individuals with COPD, corresponding to 20%-35% of patients with COPD. Increasing evidence suggests that obesity is a risk factor for impaired quality of life, exercise intolerance, and suboptimal disease control in COPD .

Eligibility criteria: Inclusion Criteria:

* Adult patients of both genders more than 18 years old admitted at RICU, diagnosed COPD and need mechanical ventilation from August 2023 to August 2024.

Exclusion Criteria:

patients less than 18 years old. patients who refused to participate in the research. patients with missing data.

Primary outcomes:
measure: Study the effect of obesity on morbidity and mortality rate of COPD mechanically ventilated patients.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04245449: E-learning+ Rehab Therapy
Official title: A Novel Therapy + E-learning Self-management Program for Stroke Survivors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2020-01-29
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Stroke survivors with arm paresis because of stroke use their "good" arm for daily activities, but in doing so may be self-limiting their own recovery of the "bad" arm. Traditional models of stroke rehabilitation fail to fully engage the survivor and care partner(s) in actively planning post-discharge habits that improve their capacity to live well over their entire lives. This study will test a cutting-edge in-person therapy + online training program designed to progressively transfer the responsibility of driving post-stroke recovery from the therapist to the survivor.


Eligibility criteria: Inclusion Criteria:

* paresis of one arm/hand because of ischemic or hemorrhagic stroke \>2 mo. and \<3 yrs prior
* moderate arm impairment defined as a baseline Fugl-Meyer Assessment of the Upper Extremity score of at least 32±2 points but no more than 47±2 points (out of 60 points)
* Montreal Cognitive Assessment score ≥22
* ability to read English
* ability to communicate as per the therapists' judgement at baseline testing
* 21-90 years of age
* wi-fi connection in the home and either a computer, smartphone or tablet.

Exclusion criteria:

* lesion or injury to brainstem or cerebellum
* other neurological disease that may impair motor or learning skills (e.g., Parkinson's Disease);
* pain interfering with reaching
* uncorrected vision making it difficult to read information on a computer, tablet or phone.

Primary outcomes:
measure: Change in Health Literacy From Baseline to 3 Months
timeFrame: Baseline Visit and 3 months
measure: Change in Self Management Skills From Baseline to 3 Months
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change in Self-Efficacy for Managing Daily Activities From Baseline to 3 Months and 5 Months
timeFrame: Baseline Visit, 3 months and 5 months
measure: Change in Social Isolation From Baseline to 3 Months and 5 Months
timeFrame: Baseline Visit, 3 months & 5 months
measure: Change in Emotional Support From Baseline to 3 Months and 5 Months
timeFrame: Baseline Visit, 3 months (Post Treatment+/- 3 days), & 5 months (Follow up +/- 3 days)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of SC
name: Michelle Woodbury, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00864006: Bioequivalence Study of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions
Official title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Seizures
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-03-18
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the bioequivalence of divalproex sodium 125 MG delayed release tablets.


Eligibility criteria: Inclusion Criteria:

* No clinically significant findings on physical examination, medical history or laboratory tests on screening

Exclusion Criteria:

* Positive test for HIV or Hepatitis B and C
* History of sensitivity to valproic acid or related compounds

Primary outcomes:
measure: Bioequivalence according to US FDA Guidelines
timeFrame: 9 Days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pharma Medica Research, Inc.
name: Xueyu Chen, MD, Ph.D, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00171106: Efficacy and Safety of Valsartan Versus Placebo on Exercise Tolerance in Patients With Heart Failure
Official title: A Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Determine the Effects of Valsartan on Exercise Time in Subjects With Symptomatic Diastolic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diastolic Dysfunction, Symptomatic Heart Failure
Keywords: diastolic dysfunction
heart failure
exercise tolerance
valsartan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the effects of valsartan versus placebo on exercise tolerance in patients with symptoms of heart failure


Eligibility criteria: Inclusion Criteria:

* Symptomatic diastolic heart failure
* Breathlessness with physical exertion

Exclusion Criteria:

* Uncontrolled hypertension
* Asthma, COPD, or abnormal lung function
* History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
* Liver, kidney, or pancreas disease
* Allergy to valsartan

Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change in baseline exercise test after 15-42 days and 14 weeks
Secondary outcomes:
measure: Oxygen consumption during the exercise test
measure: Exercise test blood pressure
measure: Borg score of breathlessness
measure: 6-minute walk test at baseline and after 14 weeks
measure: Quality of life assessment at baseline and after 14 weeks
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Parthasarathy HK, Pieske B, Weisskopf M, Andrews CD, Brunel P, Struthers AD, MacDonald TM. A randomized, double-blind, placebo-controlled study to determine the effects of valsartan on exercise time in patients with symptomatic heart failure with preserved ejection fraction. Eur J Heart Fail. 2009 Oct;11(10):980-9. doi: 10.1093/eurjhf/hfp120.
Clinical trial NCT02648906: A Clinical Trial for an Evaluation of Choline Alfoscerate and Donepezil for Cognitive Improvements of Patients With Cerebrovascular Injury in Alzheimer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Alzheimer Disease
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2016-01-07
Enrollment: 128
Sex: ALL
Minimum age (years): 56
Maximum age (years): 90
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 evaluate efficacy and safety of Choline alfoscerate and Donepezil for cognitive improvements of patients with cerebrovascular injury in Alzheimer patients


Eligibility criteria: Inclusion Criteria:

1. 56\~90 male and female
2. Mini-Mental State Evaluation (MMSE) between 24 and 12
3. Score ≥ 2 at the New Rating Scale for Age-related White Matter Changes (ARWMC), the rating scale of cerebral ischemic injury evaluated with MRI
4. Score 0.5, 1, 2 at CDR
5. presence of at least two of the following vascular risk factors: hypertension, diabetes, obesity, ischemic heart disease, dyslipidemia, hyperhomocysteinemia, smoking, previous cerebrovascular events and familiar history of cardio-cerebrovascular diseases.
6. donepezil 10mg from 3 months ago, dose not changed during clinical trials
7. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints

Exclusion Criteria:

1. Subjects allergic to or sensitive to the Investigational Product or applicable ingredients
2. subject who has taken below medication 1 month before screening 1) Cholinesterase Inhibitors 2) NMDA receptor antagonists 3) blood circulation supplements 4) Acetyl-L-Carnitines 5) Nicergoline 6) Subject who has taken another medication that can affect the result of primary outcome
3. subject that can't be evaluated with ADAS-cog, MMSE, NPI, ADL, CDR, Attention Questionnaire Scale etc.
4. Asthma, COPD
5. Decompensated heart disease
6. Chronic renal failure or chronic liver disease
7. Malignant tumor
8. Subject that cant' be followed up for 12 months after Investigational drug was taken.

9 Subjects who are pregnant, lactating or who plan to be pregnant during the clinical period or females of child bearing years who do not use available contraceptive methods 10. Subject who has taken other clinical or licensed medication from another clinical trial within 30 days prior screening period 11.Other subjects who are deemed not to be appropriate for this clinical study in the discretion of investigator

Primary outcomes:
measure: change of ADAS-cog score compared with Baseline
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sungnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References:
Clinical trial NCT03708406: Otologic and Rhinologic Outcomes in Children With Clef Palate
Official title: Otologic and Rhinologic Outcomes in Children With Cleft Palate at Age 10 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cleft Lip and Palate
Keywords: cleft palate
Eustachian dysfunction
Obstructive ventilation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 60
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutively treated patients affected by a cleft lip and palate or a cleft palate, born between December 2006 and December 2009 and followed in the Montpellier University Hospital, at the age of 10 years.

Brief summary: OBJECTIVE:

To compare otologic and rhinologic outcomes in patients with cleft palate according to surgical protocols and type of cleft.

DESIGN:

Monocentric retrospective and prospective analysis of medical reports.

PATIENTS, PARTICIPANTS:

All consecutively treated patients affected by a cleft palate, born between December 2006 and December 2009 and followed in the Montpellier University Hospital, at the age of 10 years.

INTERVENTIONS:

Results of audiometry, tympanometry, otoscopy, tubomanometry and rhinomanometry and orofacial tomodensitometry done at the age of 10 were evaluated.

MAIN OUTCOME MEASURE(S):

The history of ventilation tubes inserted, and the results at the EDTQ test were analyzed.


Eligibility criteria: Inclusion criteria :

* 10 yo children with operated clefts followed in the universitary hospital of Montpellier
* who went to the ENT check up

Exclusion criteria :

* Thoses who skip the check up

Primary outcomes:
measure: Audiometry
timeFrame: 1 day
Secondary outcomes:
measure: nasal ventilation
timeFrame: 1 day
measure: Eustachian tube function
timeFrame: 1 day
measure: Facial 3D scan
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Lylou Casteil Baume, ENT resident
role: PRINCIPAL_INVESTIGATOR
References: