louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04763070: Ciprofloxacin in Drug-resistant Epilepsy
Official title: Effect of Ciprofloxacin on Seizure Frequency in Patients With Drug-resistant Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy Intractable
Lead sponsor: Mazandaran University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 23
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effect of a short-term prescription of ciprofloxacin on intestinal microbial pattern and seizure frequency of patients with drug-resistant epilepsy.


Eligibility criteria: Inclusion Criteria:

* Drug-resistant epilepsy with frequency of at least 2 seizure/Week
* Acceptance of patients or his/her guardian (Signing informed consent)

Exclusion Criteria:

* Hypersensitivity to ciprofloxacin or other fluoroquinolones
* History of tendon, renal, hepatic or cerebrovascular disease, organ transplantation or myasthenia gravis
* Usage of medications with interaction to ciprofloxacin
* No reliable contraception
* Pregnancy or breastfeeding
* Being under treatment with corticosteroid
* Usage of antibiotics in recent 2 months or need to use it during the study
* Patients who are candidate for epilepsy surgery or other nonmedical treatments
* Change in anti-seizure medications (ASMs) during recent month
* Patients who will need changes in ASMs dose during study

Primary outcomes:
measure: Changes in seizure frequency registered in questionnaire
timeFrame: 4 weeks
measure: Changes in quantity of microbial DNA extracted from stool samples by AccuPrep Stool DNA extraction Kit
timeFrame: 7 days
measure: Changes in microbial burden of stool samples using Absolute real time polymerase chain reaction (PCR)
timeFrame: 7 days
Secondary outcomes:
measure: Changes in seizure frequency registered in questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sari
country: Iran, Islamic Republic of
facility: Bu Ali Sina hospital
state: Mazandaran
Study officials:
References:
Clinical trial NCT02498470: Prospective Registry to Assess the Cath Lab Percutaneous Coronary Intervention Long-term Outcomes: a Single Center
Official title: Prospective Registry to Assess the Cath Lab Percutaneous Coronary Intervention Long-term Outcomes: a Single Center
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 10000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients receiving coronal artery angiography or percutaneous coronary intervention therapy in the first affiliated hospital of sun yat-sen university

Brief summary: The registry study is to obtain the state of the percutaneous coronary intervention state treatment for coronary heart disease in the center of the first hospital of sun yat-sen unversity in a real world.

Detailed description: The registry study is to obtain the long-term outcomes of the percutaneous coronary intervention state treatment for coronary heart disease patients in the center of the first hospital of sun yat-sen unversity in a real world. The data are collected using an uploading system through internet.

Eligibility criteria: Inclusion Criteria:

* Patients receiving coronal artery angiography or percutaneous coronary intervention therapy

Exclusion Criteria:

* none

Primary outcomes:
measure: Composite Major Adverse Cardiac Events (MACE)
timeFrame: 5 years
Secondary outcomes:
measure: Target Lesion Failure
timeFrame: 5 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Xiaodong Zhaung
state: Guangdong
Study officials:
affiliation: first affiliated hospital of sun yat-sen university
name: zhimin du, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02142270: Epidemiology of Sudden Cardiac Arrest in Sub-Saharan Africa: Rationale and Design
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Lead sponsor: Cameroon Resuscitation Council
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 250000
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All residents of districts of interest will be surveyed during 3 years. premature deaths occurring in residents of districts of interest will be checked for past medical history, circumstances of death, and autopsy report (if possible). Investigators will also analyze the employment of resuscitation attempts during the timeframe of sudden cardiac arrest (SCA) in various patient populations throughout African countries.

The arm group of the study is every resident of the district of interest

Brief summary: Background The burden of sudden cardiac death (SCD) in Africa is unknown. Our aim is to assess the epidemiology of SCD in Africa. Methods The sub-Saharan Africa SCD study is a prospective, multicenter, community-based registry monitoring all cases of cardiac arrest occurring in victims \> 15 years old. Investigators will use the definition of established SCD if an unexpected death without obvious extracardiac cause, occurred with a rapid witnessed collapse, or if unwitnessed, occurred within 1 hour after the onset of symptoms; probable SCD if an unexpected death without obvious extracardiac cause occurred within the previous 24 hours. After approval from institutional boards, Investigators will record demographic, clinical, electrocardiographic and biological variables of SCD victims (including survivors of cardiac arrest) in several sub-Saharan African cities. All deaths occurring in residents of districts of interest will be checked for past medical history, circumstances of death, and autopsy report (if possible). Investigators will also analyze the employment of resuscitation attempts during the timeframe of sudden cardiac arrest (SCA) in various patient populations throughout countries. Conclusion This study will provide comprehensive, contemporary data on the epidemiology of SCD in sub-Saharan Africa and will help in the development of strategies to prevent and manage cardiac arrest in this region of the world.


Eligibility criteria: Inclusion Criteria:

* Victims of cardiac arrest, either SCD or aborted SCA

Exclusion Criteria:

* Age ≤ 15 years.
* Refusal of consent (by the family).

Primary outcomes:
measure: Sudden Cardiac Death
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Douala
country: Cameroon
facility: Bonny
Study officials:
References:
Clinical trial NCT04565470: Strategies of Self-management of Endometriosis Symptoms
Official title: Strategies of Self-management of Endometriosis Symptoms: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients consulting at a specialised centre

Brief summary: To determine the prevalence and perceived utility of self-management strategies amongst patients with endometriosis and who consult the endometriosis clinic of the Geneva University Hospital, information about these strategies will be obtained via a web-based questionnaire.


Eligibility criteria: Inclusion Criteria:

* patients consulting at the endometriosis clinic of the HUG
* minimum 18 years
* capacity to answer the questions of the questionnaire

Exclusion Criteria:

* minor patients

Primary outcomes:
measure: frequency of use of any self-management strategy
timeFrame: during the last 6 months prior to the questionnaire
Secondary outcomes:
measure: frequency of use of the pre-specified strategies: gymnastics, rest, hypnosis, meditation, exercise, osteopathy, cold/warm, acupuncture, CBD, cannabis, alcohol, TENS, phytotherapy, curcuma, essential oils, diet
timeFrame: during the last 6 months prior to the questionnaire
Other outcomes:
measure: perceived efficacy of the different strategies of self-management
timeFrame: during the last 6 months prior to the questionnaire
measure: perceived reduction of analgesic use by the different strategies of self-management
timeFrame: during the last 6 months prior to the questionnaire
measure: side effects of the different strategies of self-management
timeFrame: during the last 6 months prior to the questionnaire
Locations:
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève HUG
Study officials:
affiliation: University Hospital, Geneva
name: Benno Rehberg-Klug, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04215770: Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin
Official title: Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin in Children With Severe Tonsillitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tonsillitis Streptococcal
Keywords: Co-amoxiclav
Benzyl Penicilli
Tonsillitis
Lead sponsor: Combined Military Hospital, Pakistan
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 310
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single blinded clinical trial
Primary purpose: TREATMENT

Brief summary: To compare intravenous Co-amoxiclav versus Benzyl penicillin in children with severe streptococcal tonsillitis in terms of efficacy, safety and cost effectiveness.

Detailed description: Efficacy was measured through improvement (decrease in fever, settling lymphadenopathy and disappearance of tonsillar exudate) in Centor Criteria score on daily basis. Improvement i.e reduction in Centor Criteria score was recorded for all children till full recovery.

Safety was measured by frequency of hypersensitivity reactions or severe side effects of antibiotics necessitating stoppage of the drug. All the children in both Groups were given test dose of the antibiotic before giving full dose of antibiotic prescribed.

Cost effectiveness was compared in terms of total cost of injections (Co-amoxiclav versus Benzyl penicillin) which were administered to children in both groups.

Eligibility criteria: Inclusion Criteria:

1. Children who had 3 or 4 score according to Centor Criteria for tonsillitis/pharyngotonsillitis, were included in study
2. Children between ages of 5 to 15 years
3. Children with positive Rapid Antigen detection Test (RADT) for Streptococcus Pyogenes

Exclusion Criteria:

1. Immunocompromised children
2. Children with known hypersensitivity to Penicillins (esp Coamoxiclav and Benzyl penicillin)
3. Children with liver or renal failure
4. Children who were already using any oral or parenteral antibiotics

Primary outcomes:
measure: treatment efficacy
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mardan
country: Pakistan
facility: CMH Mradan
state: KPK
Study officials:
affiliation: CMH Mardan
name: Ahmed Khan, MBBS, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05323370: Lymphangioleiomyomatosis, a Study on Cathepsin K
Official title: Study of New Potential Biomarkers of Lymphangioleiomyomatosis: Determination of Cathepsin K, Cystatin C, Collagen Telopeptides and Chondroitin Sulfates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphangioleiomyomatosis
Tuberous Sclerosis Complex
Keywords: urine
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female patients with lymphangioleiomyomatosis or with tuberous sclerosis complexwithout AML or healthy volunteers

Brief summary: This is a physiopathological case-control, non-interventional, monocentric study of adult patients with lymphangioleiomyomatosis. The controls are patients followed in neurology at the CHU of Tours for a tuberous sclerosis complex without lymphangioleiomyomatosis, the healthy volunteers are women with neither pulmonary nor renal pathology and recruited at the clinical investigation centre of the CHU of Tours.


Eligibility criteria: Inclusion criteria for patients with lymphangioleiomyomatosis

* Age ≥ 18 years
* Female carrier of lymphangioleiomyomatosis according to ERS criteria

Inclusion criteria for healthy female volunteers

* Age ≥ 18 years
* Women with no history of lymphangioleiomyomatosis, pulmonary, renal or osteoporotic disease

Inclusion criteria for tuberous sclerosis complex patients without lymphangioleiomyomatosis

* Age ≥ 18 years
* Woman followed for tuberous sclerosis complex for whom a chest CT scan less than 3 years old does not objectify a pulmonary cyst. (= without lymphangioleiomyomatosis)

Non-inclusion criteria

* Woman under judicial protection
* Woman with a urinary tract infection within 15 days
* Person who objected to the data processing

Primary outcomes:
measure: urine cathepsin K proteins levels
timeFrame: inclusion visit
measure: urine cathepsin K activity
timeFrame: inclusion visit
Secondary outcomes:
measure: urinary quantity of cystatin C
timeFrame: inclusion visit
measure: urinary quantity C and N-telopeptides of type 1 collagen
timeFrame: inclusion visit
measure: serum level of chondroitin sulphates
timeFrame: inclusion visit
measure: renal angiolipomas
timeFrame: inclusion visit
measure: FEV1 measurement
timeFrame: inclusion visit
measure: VEGF-D measurement
timeFrame: inclusion visit
measure: T-score measurement
timeFrame: inclusion visit
Other outcomes:
Locations:
city: Tours
country: France
facility: University hospital
Study officials:
affiliation: University Hospital, Tours
name: Sylvain MARCHAND-ADAM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00219570: Dalacin-T Gel Post Approval Study
Official title: Phase IV Clinical Study Of Clindamycin Phosphate Topical Gel In The Treatment Of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Parexel
name: SACT INTERNATIONAL Co., LTD.
name: Acronet
name: Bellsystem24 , Inc.
name: Mitsubishi Kagaku Bio-Clinical Laboratories, inc
name: SATO Pharmaceutical Co., Ltd.
First posted: 2005-09-22
Enrollment: 134
Sex: ALL
Minimum age (years): 13
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate, in a comparison vs. Acuatim cream (nadifloxacin cream), the efficacy and safety of Dalacin T Gel (clindamycin phosphate gel) as a therapeutic medication for acne vulgaris in acne vulgaris patients, including children ages 13 and up, in order to clarify the clinical positioning of Dalacin T Gel.


Eligibility criteria: Inclusion Criteria:

* Acne vulgaris patients found by a investigator to have at least 10 inflammatory lesions (papules, pustules) on a portion of either a cheeks or the forehead, with an inflammation severity of moderate or worse.

Exclusion Criteria:

* Patients with, for example, acne elastosis, steroidal acne, necrotizing acne, or occupational acne.

Primary outcomes:
measure: To verify the non-inferiority to Acuatim cream of Dalacin T Gel in terms of the percent reduction in the inflammatory lesion count (the assessments of investigator) at Treatment Week 4 or EOT (discontinuation)
Secondary outcomes:
measure: To verify the non-inferiority to Acuatim cream of Dalacin T Gel in terms of the percent reduction in the inflammatory lesion count (the assessments of the Data Review Committee based on photographs) at Treatment Week 4 or EOT (discontinuation) According
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01741870: A Need-based Nutritional Intervention in Nursing Home Residents
Official title: The Effectiveness of a Need-based Nutritional Intervention Strategy to Improve the Nutritional Status of Elderly Nursing Home Residents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Nutritional supplement
Nutritional status
Physical functional activity
Nursing home elderly
Lead sponsor: Asia University
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 92
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To examine the effectiveness of a "need-based nutritional intervention" strategy in improving the nutritional and physical functional status of nursing home elderly.

Detailed description: Ninety-two nursing home residents aged 65 years or older and BMI \<25 were randomly assigned to the intervention or control groups. Subjects in the treatment group received a soy-protein-based nutritional supplement, if his/her BMI was \<24kg/m2 and nutritional score was \<24 according to the Mini Nutritional Assessment. The supplementation would be suspended if both conditions were not met. At baseline and every 4 weeks up to 24 weeks, thereafter, all subjects were measured for anthropometric parameters. At baseline, 12 weeks and 24 weeks subjects were measured for blood biochemical indicators, handgrip strength and Barthel's index.

Eligibility criteria: Inclusion Criteria:

1. ≥ 65 years of age
2. BMI ≤ 25 (kg/m2)
3. ≥1 month of residency
4. Able to self-feed or receive oral-feeding
5. Non-bed-ridden
6. Cognitively able to answer the questionnaire

Exclusion Criteria:

1.Hospitalized or having acute infection/diseases

Primary outcomes:
measure: Assessment of nutritional status with the Mini nutritional Assessment (MNA)
timeFrame: Baseline and every 4 weeks, up to 24 weeks
Secondary outcomes:
measure: Biochemical indicators
timeFrame: Baseline, 12, and 24 weeks
Other outcomes:
measure: Physical functional status
timeFrame: Baseline, 12 and 24 weeks
measure: Hospital admissions
timeFrame: Baseline, and 24 weeks
Locations:
city: Taichung
country: Taiwan
facility: Asia University
Study officials:
affiliation: Professor, Dept. of Healthcare Adm., Asia University, 500 liufeng Road, Wufeng, Taichung, Taiwan 41354
name: Alan C Tsai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weatherall M. Protein-energy oral supplementation in malnourished nursing-home residents. Age Ageing. 2001 Jan;30(1):85. doi: 10.1093/ageing/30.1.85. No abstract available.
citation: Lee LC, Tsai AC, Wang JY, Hurng BS, Hsu HC, Tsai HJ. Need-based intervention is an effective strategy for improving the nutritional status of older people living in a nursing home: a randomized controlled trial. Int J Nurs Stud. 2013 Dec;50(12):1580-8. doi: 10.1016/j.ijnurstu.2013.04.004. Epub 2013 May 3.
Clinical trial NCT01007370: Comparison of LMA-Fastrach and I-gel for Blind Tracheal Intubation.
Official title: Comparison of LMA-Fastrach and I-gel for Blind Tracheal Intubation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Keywords: tracheal intubation
supraglottic airway devices
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2009-11-04
Enrollment: 160
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 investigators aim to compare two different types of supraglottic devices for tracheal intubation in patients undergoing elective surgery under general anesthesia.

Our hypothesis is that the use of the I-gel supraglottic airway will result in a higher first attempt success rate of blind tracheal intubation.

Detailed description: Supraglottic airway devices such as LMA-Fastrach and I-gel provide patent airways during general anesthesia.

The LMA-Fastrach is designed to provide a conduit for blind or fiberoptically guided tracheal intubations. However, the success rate of tracheal intubation on the first attempt through this device varies between 50 and 87%.

The I-gel is a newer device for airway management which, with its wide bore, allows direct passage of a tracheal tube. Recent studies suggest that the I-gel is easy to insert and that limited experience is needed before a high success insertion rate is obtained.

In this prospective and randomized study, we will evaluate the performance of both devices for tracheal intubation in patients undergoing elective surgery under general anesthesia.

Eligibility criteria: Inclusion Criteria:

* Age 18 and older
* ASA physical status 1-3
* Patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation

Exclusion Criteria:

* ASA physical status 4-5
* Contraindications to muscle relaxation
* Anticipated or known difficult intubation or ventilation
* Patients with limited mouth opening (less than 2 cm)
* Patients at increased risk of aspiration, or having an history of symptomatic gastroesophageal reflux or hiatal hernia.

Primary outcomes:
measure: First attempt success rate of tracheal intubation.
timeFrame: After successful insertion of tracheal tube
Secondary outcomes:
measure: Time needed for successful insertion of a supraglottic device.
timeFrame: After insertion
measure: First and total attempt success rate of supraglottic device insertion.
timeFrame: After insertion
measure: Total time and number of attempts needed to obtain successful tracheal intubation.
timeFrame: After tracheal intubation
measure: Fiberoptic view following the supraglottic device insertion.
timeFrame: After insertion of the device
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Nathalie Massicotte, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: