louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00209495: Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients
Official title: Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Abdominal Hysterectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Abdominal hysterectomy
Pregabalin
Dexamethasone
Multimodal postoperative analgesia
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine. Unfortunately morphine has side-effect: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine.

Detailed description: Combinations of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone is investigated. Primary outcome is 24 hours morphine usage.

Eligibility criteria: Inclusion Criteria:

* Women scheduled for abdominal hysterectomy, between the age of 18 and 75, ASA 1-2
* BMI between 18-32.

Exclusion Criteria:

Patients who:

* Are unable to cooperate
* Has cancer ovarian
* Does not speak Danish
* Has allergy for drugs used in the trial
* Has drug and medicine abuse
* Epilepsy
* Diabetes treated with medicine
* Chronic pain condition
* Daily use of antacids or analgesic
* Known kidney disease
* Use of antidepressive

Primary outcomes:
measure: The total amount of morphine needed postoperatively form 0 - 4 h, and 0 - 24 h, administered by the patient controlled pain treatment. (PCA)
timeFrame: 0 - 24h
Secondary outcomes:
measure: Pain Score (VAS) at rest and at mobilisation.
timeFrame: 0 - 24h
measure: Postoperative nausea and vomiting.
timeFrame: 0 - 24h
measure: Sedation.
timeFrame: 0 - 24h
measure: Dizziness.
timeFrame: 0 - 24h
measure: All measurements are taken at 2, 4 and 24 h postoperatively.
timeFrame: 0 - 24h
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Operations og Anæstesiologisk afd. Y, KAS Glostrup
state: Copenhagen
city: Herning
country: Denmark
facility: Herning Centralsygehus
Study officials:
affiliation: Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
name: Ole Mathiesen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00844181: Racial Differences in Orthostatic Tolerance
Official title: Racial Differences in Orthostatic Tolerance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthostatic Tolerance
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2009-02-16
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample of women of reproductive age

Brief summary: Our central hypothesis is that baroreflex sensitivity is attenuated in black women compared to white women, and that this dysregulation will be apparent during orthostatic challenges. We expect that the cumulative stress index (CSI), a measure of maximal orthostatic tolerance, is higher in Black women (BW) compared to White women (WW).


Eligibility criteria: Inclusion Criteria:

* women between 18-25 yrs of age

Exclusion Criteria:

* history of high blood pressure, uterine fibroids, diabetes, epilepsy

Primary outcomes:
measure: orthostatic tolerance
timeFrame: 1
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: John B. Pierce Laboratory
state: Connecticut
Study officials:
affiliation: Yale University
name: Nina Stachenfeld, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01724281: Outcome of Babies With Asymetry of Lateral Brain Ventricles
Official title: Outcome of Babies With Asymetry of Lateral Brain Ventricles
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lateral Ventricles of Fetuses at Mid Trimester
Keywords: lateral ventricles
Asymetry
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-11-09
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women at 19-30 weeks who attend ultrasound exam and diagnosed with asymetry of lateral brain ventricles.

Brief summary: The investigators will follow up on babies that had prenatal diagnosis at 2nd or 3rd trimester of normal width and asymetry of lateral brain ventricles

Detailed description: Women who will attend 2nd or 3rd ultrasound prenatal scans will be included. Women where the fetus would be diagnosed with lateral ventricles that are normal width (\<10 m"m) but discrepacy of \>3 m"m will be followed up after delivery by head ultrasound and neurologic exam

Eligibility criteria: Inclusion Criteria:

* Healthy pregnant women between 19-30 weeks gestational age and asymetry of lateral ventricles

Exclusion Criteria:

* Lateral ventricles \>10 m"m

Primary outcomes:
measure: Lateral ventricles width after delivery
timeFrame: 2 years
Secondary outcomes:
measure: Neurologic examination of babies with discrepant but normal lateral ventricles
timeFrame: 2 years
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT03874481: The Effect of Sleep Quality on Coronary Artery Disease and In Stent Restenosis
Official title: The Effect of Sleep Quality on Coronary Artery Disease and In Stent Restenosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
In-stent Restenosis
Keywords: sleep duration
sleep quality
coronary artery disease
in stent restenosis
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2019-03-14
Enrollment: 958
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Coronary arter disease

Brief summary: This is a cross-sectional and follow-up study. We analysis the relationship of sleep quality on coronary artery disease(CAD) and in stent restenosis(ISR). Further, we explore the mechanism of relationship between the sleep quality and CAD/ ISR by examining the biomarkers in the pathway of sleep-CAD/ISR.

Detailed description: Background: Coronary artery disease (CAD) is the leading cause of mortality in the world. The important treatment of CAD is Percutaneous coronary intervention(PCI). However, in-stent-restenosis(ISR) is the major issue in the PCI. The factors of ISR include gender, age, diabetes, lipid ,obesity and so on.Recently, studies showed that sleep duration and sleep quality have effect on all of factors and have relationship with coronary artery calcification. We like to explore the relationship between sleep quality and CAD/ISR.

Aims:This is a cross-sectional and follow-up study. We analysis the relationship of sleep quality on coronary artery disease(CAD) and in stent restenosis(ISR). Further, we explore the mechanism of relationship between the sleep quality and CAD/ ISR by examining the biomarkers in the pathway of sleep-CAD/ISR.

Methods: We include patients who were diagnosed as CAD by coronary arteriography. Sleep duration and quality were evaluated from sleep questionnaire. During the 6 months and 9-12months, we follow up the patients who got PCI and get information of Major Adverse Cardiovascular Events (MACE) from follow-up questionnaire. On 9-12 months after PCI, coronary arteriography were produced in PCI patients. Biomarkers were tested during the follow-up.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Coronary artery disease
* PCI patients in the follow-up
* written informed consent

Exclusion Criteria:

* Heart failure; renal failure; secondary hypertension;valvular heart disease ;Cancer;

Primary outcomes:
measure: In-stent restenosis
timeFrame: 9-12 months from PCI
Secondary outcomes:
measure: MACE
timeFrame: 6months, 12months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Hongjian Wang
state: Beijing
Study officials:
References:
Clinical trial NCT03688581: What is the Knowledge and Use of Emergency Contraception
Official title: What is the Knowledge and Use of Emergency Contraception for Women Who Are Seeking Abortion in University Hospitals of Strasbourg
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abortion
Keywords: Abortion
Emergency contraception
Emergency pill
Perception of pregnancy risk
Contraceptive failure
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: woman seeking an abortion at the Orthogeny Center in University Hospitals of Strasbourg

Brief summary: The main objective is to assess the knowledge of women seeking abortion about emergency contraception.

The secondary objectives are to evaluate the use of emergency contraception among women seeking abortion and to identify barriers to the efficacy and use of emergency contraception in these women.


Eligibility criteria: Inclusion Criteria:

* women aged over eighteen years old
* the patient agreed that her questionnaire data should be collected and analyzed for this research.
* women who are able to read and write French
* woman seeking an abortion at the Orthogeny Center in University Hospitals of Strasbourg

Exclusion Criteria:

* refusal to participate in the study

Primary outcomes:
measure: Assessment of women's knowledge of contraceptive methods through a questionnaire
timeFrame: 1 hour after consultation for abortion
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Gynécologie - CMCO
Study officials:
References:
Clinical trial NCT04511481: Deep Learning Magnetic Resonance Imaging Radiomic Predict Platinum-sensitive in Patients With Epithelial Ovarian Cancer
Official title: Deep Learning Magnetic Resonance Imaging Radiomic Predict Platinum-sensitive in Patients With Epithelial Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Predictive Cancer Model
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 93
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients received platinum-based chemotherapy (\>= 4 cycles) and debulking surgery from Sun Yat-sen Memorial Hospital in China from January 2011 to January 2020

Brief summary: Platinum-sensitive is an important basis for the treatment of recurrent epithelial ovarian cancer (EOC) without effective methods to predict.We aimed to develop and validate the EOC deep learning system to predict the platinum-sensitive of EOC patients through analysis of enhanced magnetic resonance imaging (MRI) images before initial treatment.Ninety-three EOC patients received platinum-based chemotherapy (\>= 4 cycles) and debulking surgery from Sun Yat-sen Memorial Hospitalin China from January 2011 to January 2020 were enrolled. This deep-learning EOC signature achieved a high predictive power for platinum-sensitive, and the signature based on MRI whole volume is better than that on primary tumor area only.


Eligibility criteria: Inclusion Criteria:

* (1)Patients with epithelial ovarian cancer (2 )Patients received platinum-based chemotherapy (\>= 4 cycles) and debulking surgery

Exclusion Criteria:

* Patients with epithelial ovarian cancer received less than 4 cycles platinum-based chemotherapy or no debulking surgery

Primary outcomes:
measure: Platinum sensitivity
timeFrame: 9 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT02752581: Efficacy of Peroperative Suction Drain Usage in Arthroscopic Knee Surgery
Official title: Efficacy of Peroperative Suction Drain Usage in Arthroscopic Knee Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chondropathy
Knee Effusion
Knee Hemarthrosis
Keywords: suction drain
knee arthroscopy
knee pain
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 110
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study was designed to investigate efficacy of suction drains in arthroscopic knee surgery, rather than anterior cruciate ligament (ACL) reconstruction. two groups were randomised, and suction drain was applied to one group, and the other group as the control group without a suction drain.

Detailed description: The groups were compared in terms of patellar shock, knee effusion, knee scoring systems, range of motion, loss of labour, hospitalization time. Also different arthroscopic procedures such as meniscectomy, meniscus repair, synovectomy and microfracture were evaluated in terms of need for a suction drain. The controls was at 1st and 15th day, 6th week and 3rd month.

Eligibility criteria: Inclusion Criteria:

* Patients with knee derangement and accepted to enroll to the study

Exclusion Criteria:

* intraarticular fracture, ACL surgery, arthrotomy, bleeding disorder,

Primary outcomes:
measure: Activity Pain
timeFrame: 3 months
measure: Rest Pain
timeFrame: 3 months
measure: Range of Motion
timeFrame: 3 months
Secondary outcomes:
measure: Lysholm
timeFrame: 3 months
measure: International Knee Documentation Committee Score
timeFrame: 3 months
measure: hospitalization time
timeFrame: 1 month
measure: loss of labour time
timeFrame: 1 month
Other outcomes:
measure: Amount of drainage
timeFrame: 1 day
measure: patellar shock
timeFrame: 1.5 months
Locations:
Study officials:
References:
citation: Browett JP, Gibbs AN, Copeland SA, Deliss LJ. The use of suction drainage in the operation of meniscectomy. J Bone Joint Surg Br. 1978 Nov;60-B(4):516-9. doi: 10.1302/0301-620X.60B4.711799.
citation: Alkan K, Unay K, Berkem L, Guven M, Poyanli O. Suction drainage influence on knee effusion following partial meniscectomy with partial fat pad or synovium resection. Acta Orthop Traumatol Turc. 2011;45(4):221-4. doi: 10.3944/AOTT.2011.2545.
citation: Tatari H, Dervisbey M, Muratli K, Ergor A. Report of experience in 190 patients with the use of closed suction drainage in arthroscopic knee procedures. Knee Surg Sports Traumatol Arthrosc. 2005 Sep;13(6):458-62. doi: 10.1007/s00167-004-0537-1. Epub 2004 Nov 13.
Clinical trial NCT02361281: Validation of a Non-invasive Diagnostic Method for Sarcoidosis Using Exhaled Breath
Official title: Validation of a Previously Performed Study on Non-invasive Diagnostic Method for Sarcoidosis Using Exhaled Breath
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcoidosis
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: Gelderse Vallei Hospital
name: Atrium Medical Center
First posted: 2015-02-11
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: sarcoidosis patients with confirmed disease, with a range of disease stages. Average age for all study subjects: +- 50 y/o male/female ratio: approx 15 men vs. 10 women in each group.

Brief summary: Sarcoidosis is a chronic lung disease that is characterized by fatigue, shortness of breath, chest pain and reduced lung function. Suffering from these diseases has a very negative effect on the quality of life. When people are suspected of having sarcoidosis various markers in the blood are measured. Ultimate diagnosis, however, always requires invasive techniques such as bronchoscopy and lung biopsy. Consequently, there is an urgent need for a new diagnostic tool that is easy, quick and most of all non-invasive and thus friendly for the patient.

Such a new diagnostic tool might be found in examining the exhaled air of patients, which contains a complex mixture of so-called volatile organic compounds (VOCs) that are the result of damaging processes that occur in the lung. Determining the VOC profile in the breath can be used as a biomarker, or biological indicator, of those damaging processes. In other words, searching for unique VOC profiles in the breath of sarcoidosis patients might lead to the development of a diagnostic tool that only uses their exhaled breath.

The current study involves 25 sarcoidosis patients and 25 healthy volunteers. The aim of this study is find VOCs in exhaled air that can be used to diagnose sarcoidosis. In a previous study, sarcoidosis-specific VOCs were found, which we intend to validate using the current study.


Eligibility criteria: Inclusion Criteria:

* Patients with confirmed sarcoidosis

Exclusion Criteria:

* (ex-) smokers
* for healthy controls: controls with pulmonary disease excluded

Primary outcomes:
measure: diagnosis by exhaled breath
timeFrame: upon regular visit to clinic, which is expected to occur on average within 4 months after the start of the study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Maastricht University
name: Rianne Fijten, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fijten RRR, Smolinska A, Drent M, Dallinga JW, Mostard R, Pachen DM, van Schooten FJ, Boots AW. The necessity of external validation in exhaled breath research: a case study of sarcoidosis. J Breath Res. 2017 Nov 29;12(1):016004. doi: 10.1088/1752-7163/aa8409.
Clinical trial NCT00140881: A Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children (0476-165)
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 220
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 53-week study to determine the effect of montelukast sodium when given to children (with infrequent episodic asthma) at the earliest symptoms of an acute episode of asthma.


Eligibility criteria: Inclusion Criteria:

* Males or females between the ages of 2 and 14 who have infrequent episodic asthma.

Primary outcomes:
measure: Composite unscheduled acute health care resource utilisation (specific for asthma; unscheduled visits, GP attendance, ED attendance and hospital admission).
Secondary outcomes:
measure: Parent/caregiver QOL endpoints.
measure: The safety and tolerability of montelukast when use as an episode modifier.
measure: The duration and severity of the episode assessed by the parent/caregiver symptom score and the use of b-agonist and oral corticosteroid.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Robertson CF, Price D, Henry R, Mellis C, Glasgow N, Fitzgerald D, Lee AJ, Turner J, Sant M. Short-course montelukast for intermittent asthma in children: a randomized controlled trial. Am J Respir Crit Care Med. 2007 Feb 15;175(4):323-9. doi: 10.1164/rccm.200510-1546OC. Epub 2006 Nov 16.
Clinical trial NCT01245881: Fractional Photothermolysis for Treating Melasma
Official title: A Multicenter Study of Fractional Photothermolysis in the Treatment of Melasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melasma
Keywords: controlled trial
fractional photothermolysis
laser surgery
melasma
pigment disorder
Lead sponsor: Laserklinik Karlsruhe
Sponsor class: OTHER
Collaborators: name: Laser and Skin Centre Potsdam, Potsdam, Germany
First posted: 2010-11-23
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In several observational studies, non-ablative fractional photothermolysis (FP) has been reported to bridge the gap between efficacy and tolerability in the treatment of melasma. While some beneficial effects have been attributed to non-ablative FP in treating melasma, methodological constraints (e.g., a limited number of patients; no control group assignment) impair efficacy assessment; currently published results neither allow researchers and clinicians to draw valid conclusions nor warrant recommendations for therapy. In particular, bias resulting from poorly designed trials may mislead clinicians into making a wrong decision and generate not only unnecessary treatment (i.e., costs), but also a risk of side effects for patients. Therefore, the purpose of this trial was to clarify the efficacy and safety of FP in the treatment of melasma as compared to the lone application of a sun-blocking lotion (SPF \>50).


Eligibility criteria: Inclusion Criteria:

* Adults (female/male) with clinical evidence of melasma;
* Fitzpatrick skin phototype I-III;
* Ability and willingness to comply with the requirements of the protocol.

Exclusion Criteria:

* Pregnancy or nursing;
* Inability to avoid sun exposure for occupational reasons (e.g., gardeners);
* Known history or clinically relevant allergy to components of the sunscreen or topical anaesthetic;
* Use of topical retinoids within 3 months prior to study enrolment;
* Use of topical hydroquinone within 6 months prior to study enrolment;
* Use of topical corticosteroids within 1 month prior to study enrolment;
* Use of topical cosmetic depigmenting agents within 2 weeks prior to study enrolment;
* Laser surgery procedures within the treatment region during the last 12 weeks prior to enrolment;
* Coagulation disorders or anticoagulant treatment;
* Photo-sensitizing medication (e.g., tetracyclines, gold).

Primary outcomes:
measure: Change from Baseline in Melasma Area and Severity Index (MASI) at 12 weeks after final treatment
timeFrame: Pre-treatment and at final follow-up (12 weeks after last treatment session)
Secondary outcomes:
measure: Subjective assessment of treatment outcome (by patients)
timeFrame: Pre-treatment and at final follow-up
measure: Patient satisfaction
timeFrame: Pre-treatment and at final follow-up
measure: Side effects
timeFrame: At each follow-up visit (week 3, 6, 9, 12)
Other outcomes:
Locations:
city: Karlsruhe
country: Germany
facility: Laserklinik Karlsruhe
Study officials:
References: