louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03740581: Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing
Official title: The Effect of Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing: a Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic foot ulcer
Intensive glycemic control
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2018-11-14
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetic foot ulcer is one of the most serious, most costly and at times life threatening complication of diabetes. The lifetime incidence of foot ulcer occurrence in diabetes is up to 25%. Despite the advent of numerous types of wound dressings and off-loading mechanisms, the ulcer healing rates in diabetes have remained dismally low. Hyperglycemia impairs the inflammatory, proliferative and remodeling phases of an ulcer. There are retrospective studies linking improvement of HbA1c to wound area healing rate. The investigators hypothesised that intensive glycemic control in a patient of diabetic foot ulcer improves the healing process. To explore this hypothesis, the investigators are conducting this randomized control trial with the primary aim of wound healing in patients of diabetic foot ulcer on either intensive glycemic treatment or conventional (pre-existing) glycemic treatment.


Eligibility criteria: Inclusion Criteria:

1. Age \>18 years
2. Patients of DM according to ADA guidelines
3. HbA1c \>8% and/or FBG \>130 on 3 consecutive occasions
4. DFU: Wagner grade 2 \& 3 or UTS 2-3B
5. Duration of ulcer \<12 weeks
6. Wound size: \>1cm2
7. Willingness to sign consent form \& participate in the study
8. Capacity to attend visits at hospital for review

Exclusion Criteria:

1. Diagnosis with unpredictable healing ability e.g. malignancy, depression, HIV, CTD, steroid use
2. Dialysis requiring CKD \& eGFR \<30 ml/min
3. Active Charcot foot
4. PEDIS 4: life threatening DFU
5. Pregnancy
6. ABI \<= 0.7
7. Refusal to give informed consent

Primary outcomes:
measure: Number of participants with complete wound closure (epithelialisation) at 12 weeks in both intensive and conventional treatment groups.
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent reduction in ulcer area (from baseline) at 4 & 12 weeks in both intensive and conventional treatment groups.
timeFrame: 4 and 12 weeks
measure: HbA1c at 4 & 12 weeks in both intensive and conventional groups.
timeFrame: 4 and 12 weeks
measure: Change in ulcer severity- Wagner and UTWSC classification.
timeFrame: 4 and 12 weeks
measure: Incidence of any amputation.
timeFrame: 4 and 12 weeks
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Medical Institute of Medical Education and Research
Study officials:
References:
Clinical trial NCT06250881: Analysis of Ocular Complications of AIDS Patients in Ophthalmic Consultation
Official title: Analysis of Ocular Complications of AIDS Patients in Ophthalmic Consultation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ocular Complications in AIDS Patients, Such as Fundus Opportunistic Infections, Microangiopathy, and Uveitis
Keywords: Ocular complications of AIDS
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV/AIDS patients hospitalized in the infection department at ZhongNan Hospital with ophthalmic consultation during November 19th, 2019 to June 9th ,2023 were included.

Brief summary: Through a cross-sectional descriptive analysis of ophthalmic consultation of AIDS patients in the past 3 years, the basic characteristics of patients were described according to whether there was fundus change, and the clinical characteristics and risk factors of CMVR patients with or without RD were compared.

Detailed description: Patients were divided into normal group, opportunistic infection group, microangiopathopathy group and uveitis group according to the presence of fundus lesions and the types of fundus lesions. The basic information and characteristics of patients in different groups were described. The factors that may be related to ocular fundus disease of AIDS patients were found by statistical analysis.

Eligibility criteria: Inclusion Criteria:

* AIDS inpatient undergoing ophthalmic consultation

Exclusion Criteria:

* Non-hiv infected patients

Primary outcomes:
measure: fundus photo changes
timeFrame: The classification was based on a review of the fundus examination of the patient at the time of the 1 day visit
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital
state: Hubei
Study officials:
References:
citation: Yen M, Chen J, Ausayakhun S, Kunavisarut P, Vichitvejpaisal P, Ausayakhun S, Jirawison C, Shantha J, Holland GN, Heiden D, Margolis TP, Keenan JD. Retinal detachment associated with AIDS-related cytomegalovirus retinitis: risk factors in a resource-limited setting. Am J Ophthalmol. 2015 Jan;159(1):185-92. doi: 10.1016/j.ajo.2014.10.014. Epub 2014 Oct 22.
citation: De Cock KM, Jaffe HW, Curran JW. Reflections on 40 Years of AIDS. Emerg Infect Dis. 2021 Jun;27(6):1553-1560. doi: 10.3201/eid2706.210284.
citation: Landovitz RJ, Scott H, Deeks SG. Prevention, treatment and cure of HIV infection. Nat Rev Microbiol. 2023 Oct;21(10):657-670. doi: 10.1038/s41579-023-00914-1. Epub 2023 Jun 21.
citation: Bekker LG, Beyrer C, Mgodi N, Lewin SR, Delany-Moretlwe S, Taiwo B, Masters MC, Lazarus JV. HIV infection. Nat Rev Dis Primers. 2023 Aug 17;9(1):42. doi: 10.1038/s41572-023-00452-3.
citation: Cohn LB, Chomont N, Deeks SG. The Biology of the HIV-1 Latent Reservoir and Implications for Cure Strategies. Cell Host Microbe. 2020 Apr 8;27(4):519-530. doi: 10.1016/j.chom.2020.03.014.
Clinical trial NCT04735081: Prolonged Bed Rest Versus Early Raising in Vertebral Osteomyelitis
Official title: SPONDYL'UP : Prolonged Bed Rest Versus Early Raising in Vertebral Osteomyelitis - A Restrospective, Monocenter, Before/After Practice Change Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Infectious; Spondylitis
Keywords: Infectious vertebral osteomyelitis
Spondylodiscitis
Bed Rest
Early Raising
Verticalization
Immobilization
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 200
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: Patients with definite infectious spondylodiscitis hospitalised between 2016 and 2022 in Nancy University Hospital

Brief summary: Infectious vertebral osteomyelitis are infectious diseases of the vertebral bone, intervertebral disc and/ or adjacent tissue. Most of cases are due to hematogenous dissemination of pathogen but direct inoculation is an aetiology after surgery. Majority of cases concern adults after 50 years and the annual incidence ranging between 0.5 and 2.4 cases per 100 000 habitants in Europe but seems to increase during last 20 years.

The infectious spondylodiscitis is an important source of morbidity and mortality. The treatment is based on pathogen adapted antimicrobial therapy, which may be associated with bedrest. Surgical act is necessary when neurological complication occurs or when vertebral column instability is too important. The immobilization in bed is use to limit pain and neurological complications. However, the immobilization is based on few literature data and causes important complications especially in elderly.

The of immobilization in Nancy universitity hospital changed in 2019 after institutional recommendations based on expert opinion which recommend an early verticalization of uncomplicated spondylodiscitis. The investigators aimed to evaluate the consequences of this practice change on the hospitalization duration and complication rates due to spondylodiscitis and immobilization.


Eligibility criteria: Inclusion Criteria:

* Infectious spondylodiscitis proven by radiological exam
* Infectious spondylodiscitis with microbiological documentation

Exclusion Criteria:

* Patient included in COROSIVE study
* Vertebral prosthetic device infection
* Infectious spondylodiscitis relapse

Primary outcomes:
measure: Length of hospital stay
timeFrame: when the patient is discharged from hospital (up to 52 weeks)
Secondary outcomes:
measure: Rate of neurological complications
timeFrame: During hospitalisation (up to 52 weeks)
Other outcomes:
measure: Rate of immobilization complications
timeFrame: During hospitalisation (up to 52 weeks)
measure: Mortality
timeFrame: During hospitalisation (up to 52 weeks)
Locations:
Study officials:
References:
Clinical trial NCT03571295: Comparison of Videolaryngoscopy and Direct Laryngoscopy in Pediatric Airway Management
Official title: A Comparison of Direct Laryngoscopy and King Vision® aBlade™ Videolaryngoscopy in Paediatric Airway Management: Success Rate and Learning Curve of Trainee Anaesthetists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Management
Videolaryngoscopy
Keywords: pediatric airway management
learning curve
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 210
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators intended to evaluate first success rate and learning curve of trainee anesthetists performing direct and videolaryngoscopy in pediatric airway management.

Detailed description: After obtaining written informed consent of 10 trainee anesthetists with non less than 24 months and not exceeding 60 months residency, use of the King Vision aBlade videolaryngoscope was demonstrated by presenting a 2 min instruction video. First endotracheal intubation by each trainee anesthetist was randomly allocated to either direct (DL) or King Vision aBlade videolaryngoscopy (KingVL). Then order of laryngoscopy type was alternating at least each trainee anesthetists performed 10 DL and 10 KingVL endotracheal intubations.

Eligibility criteria: Inclusion Criteria:

* ASA 1 to 2
* written informed consent from both legal guardians
* children who were scheduled for nonemergency surgery with requirement of endotracheal intubation

Exclusion Criteria:

* known or predicted difficult airway
* increased risk for pulmonary aspiration

Primary outcomes:
measure: first attempt success rate of endotracheal intubation
timeFrame: operation day
Secondary outcomes:
measure: total time for successful intubation
timeFrame: operation day
Other outcomes:
measure: failure category of the first attempt
timeFrame: operation day
Locations:
city: Mainz
country: Germany
facility: Johannes Gutenberg - Universität
state: Rhineland Palatinate
Study officials:
References:
Clinical trial NCT05688995: COVID-19 Vaccines and the Menstrual Cycle
Official title: COVID-19 Vaccines and the Menstrual Cycle; a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menstrual Irregularity
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 617
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our study included 617 Menstruating females. 74.55% of participants were of the age group between 20-35 years. 59.64% had normal BMI (18.5-24.9 Kg/m2), while 11.99% were underweight (BMI less than 18.5 Kg/m2), 19.77% were overweight (BMI\>24.9 Kg/m2 but less than 30 Kg/m2), and 8.59% were obese (BMI more than 30 Kg/m2). Largest BMI was 39.79 Kg/m2. Most of participants were single ladies (79.25%). 82.01% were nulliparous. 17.83% were multiparous, including 1.62% ladies that had 5 or more children (grand multiparous).

Brief summary: The study aimed to explore the effect of different COVID-19 vaccines on menstrual cycle

Detailed description: This is a descriptive cross-sectional study that took place between September 2021 and December 2021. The study aimed to explore the effect of different COVID-19 vaccines on menstrual cycle. It used an anonymous questionnaire distributed via social media platforms; Facebook, Twitter, and WhatsApp across different cities of Jordan. A total of 732 responses were received with a 59% response rate.

The questionnaire was distributed over four months directed at women who have received at least one dose of the COVID-19 vaccine and who live in Jordan. It took 10 minutes to complete all the questions.

Data collection did not involve direct contact with participants to prevent the spread of COVID-19.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* less than 40 years
* healthy women
* received covid-19 vaccine

Exclusion Criteria:

* women who did not receive the vaccine
* those living outside Jordan (those cannot fill the form) and during analysis.

Primary outcomes:
measure: significant changes in the menstrual cycle after vaccination
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
Study officials:
affiliation: The University of Jordan
name: Naser U Al-Husban
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05471895: Impact of Sexual Violence on the Incidence of Voluntary Termination of Pregnancy in La Réunion
Official title: Impact Des Violences Sexuelles Sur l'Incidence Des Interruptions Volontaires de Grossesses à La Réunion/ Impact of Sexual Violence on the Incidence of Voluntary Termination of Pregnancy in La Réunion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sexual Violence
Abortion
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Each centre receives an average of 15 patients per day for pre-abortion consultations.

Expectation of 7 fully completed questionnaires per day per centre, then approximately 1000 fully completed questionnaires for a total of 8 weeks.

Brief summary: According to the figures for the last three years collected from the Indian Ocean Regional Health Observatory, it appears to be about twice as many voluntary terminations of pregnancy on the island of Reunion compared with France metropolitain region.

Furthermore, the overseas section in 2002, which looked at violence against women of all types in three different spheres of life (the marital sphere, the workplace and public spaces), tends to show a much higher incidence of sexual violence than in metropolitain France.

This trend seems to be confirmed by the overseas section of the VIRAGE survey started in 2018 on the island.

Furthermore, data found in a qualitative study conducted in Ile de France in 2013 seems to demonstrate a more frequent use of abortion among patients who are victims of sexual violence.

Thus, thiçs study will consist in evaluating the impact of sexual violence on the incidence of voluntary termination of pregnancy in Reunion Island.


Eligibility criteria: Inclusion Criteria:

- Adult patient coming for an abortion request at the CHU SUD and NORD, at the GHER and at the CEPS for the CHOR (Reunion Island)

Exclusion Criteria:

* Patient coming to the above-mentioned centres for a "post-abortion" consultation.
* \<18 years
* Patient who does not speak French.
* Illiterate patient.
* Patient who has already completed the questionnaire.
* Patient refusing to participate in the study.

Primary outcomes:
measure: Proportion of women victims of sexual abuse coming for a voluntary termination of pregnancy
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU La Réunion
name: Véronique PERETTI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05079295: Management of Anticoagulants and Antithrombotics in Patients With CSDH
Official title: Thromboembolic and Hemorrhagic Risk Evaluation in Surgically Treated Patients With CSDH Taking Anticoagulants and Antithrombotics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Subdural Hematoma
Anticoagulant-induced Bleeding
Thromboembolic Stroke
Cardiovascular Stroke
Keywords: chronic subdural hematoma
anticoagulants
antithrombotics
thromboembolic disease
cardiovascular risk
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients suffering from CSDH which needs surgery for its evacuation. Study group will be all patients taking anticoagulants or antithrombotics; control group will be all patients who are not taking these drugs.

Brief summary: Primary objective of the study will be to compare, up to 6 months after surgery, number of relapses (post operative re-bleeding) or intracerebral hemorrhage (others than subdural hematomas) and thromboembolic or cardiovascular ischemic events, in patients undergoing surgery for chronic subdural hematoma (CSDH). These data will be correlated to the suspension or not of antithrombotics or anticoagulants before surgery or their re-introduction after surgery.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Informed consent
* Evidence of CSDH which needs surgery
* patients taking antithrombotics or anticoagulants

Exclusion Criteria:

* previous surgery for CSDH

Primary outcomes:
measure: hemorrhagic or thromboembolic events evaluation
timeFrame: up to 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: University Hospital Sant'Anna
state: Emilia-Romagna
Study officials:
References:
Clinical trial NCT01583595: Self Efficacy, Walking Ability, Gait Speed and Physical Activity in People With Chronic Lung Disease
Official title: Determining the Relationships Between Self-efficacy for Walking Ability, Gate Speed and Physical Activity in Patients With Chronic Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lung Disease
Self-efficacy
Keywords: Chronic Lung Disease
Exercise
Self-efficacy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-04-24
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with chronic lung disease

Brief summary: Most patients with chronic lung disease underestimate their actual walking ability due to low confidence. To better understand the relationships between lung function, self-efficacy for walking (confidence in ability to walk a defined distance), actual walking ability for the same distance gait speed and physical activity level-PAL- (total energy expenditure/resting metabolic rate).

Quality of life, self efficacy for activity questionnaires, physical activity level measurement, 4-meter gait speed and 6-minute walk distance will be measured.


Eligibility criteria: Inclusion Criteria:

* Men and women 40 years and older
* Diagnosis of any chronic lung disease as evidenced by pulmonary function testing completed within the prior 12 months
* Able to walk independently and successfully complete the 6-minute walk assessment

Exclusion Criteria:

* Unable to walk without assistance or complete the 6-minute walk assessment
* Patients unable to comprehend and accurately respond to the study questionnaires either by written or spoken communication
* Patients diagnosed with or treated for a lower respiratory tract infection or COPD exacerbation within the prior 30 days

Primary outcomes:
measure: Analyze associations between self-efficacy for walking, gait speed, physical activity level and perceptions of symptoms in patient with chronic lung disease (COPD and Pulmonary Fibrosis)
timeFrame: Day of enrollment.
Secondary outcomes:
measure: Predictive utility of 4-meter gait speed for estimating physical activity level (PAL) as validated by gold standard activity monitor.
timeFrame: 1 week
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Roberto P Benzo, M.D., MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02883595: Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis
Official title: Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sepsis
Keywords: thymosin alpha 1; sepsis; monocyte; pharmacokinetics
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 20
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 determine whether thymosin alpha 1 is effective on improving monocyte function and has the desired pharmacologic activity for sepsis

Detailed description: Part 1: To observe the function of thymosin alpha 1 in sepsis patients via improving phagocytosis, bacteria eradication and antigen-presenting on monocyte Part 2: Pharmacokinetics of thymosin alpha 1 for sepsis

Eligibility criteria: Inclusion Criteria:

1. Written informed consent from the patients or their next of kin for patients unable to consent
2. Age ≥18 yrs
3. Presence of sepsis/ septic shock according to sepsis 3.0

Exclusion Criteria:

1. Pregnant or lactation period.
2. Age \<18 yrs
3. Receiving immunosuppressive therapy such as cyclosporine, azathioprine or cancer chemotherapy within one month.
4. History of bone marrow, lung, liver, kidney, pancreas or small bowel transplantation;
5. Acute pancreatitis with no established source of infection.
6. Not expected to survive 28 days because of end-stage diseases.
7. Participation in another clinical trial.

Primary outcomes:
measure: Ta 1 improving immune function of monocyte for sepsis, used by flow cytometric to measure phagocytosis(CD11b, CD64), antigen presenting(HLA-DR, CD86 and PD-L1), and apoptosis(active caspase 3) on monocyte,
timeFrame: 28days
Secondary outcomes:
measure: Relationship between concentration of Ta 1 and prognosis of sepsis patients, measured by concentration of Ta 1, 28-day all-cause mortality, 28-day clearance rate of pathogenic microorganism, ICU stays and hospital stays
timeFrame: 28 days
measure: Maximum observed serum concentration (Cmax) of Ta 1
timeFrame: 7 days
measure: Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Ta 1
timeFrame: 7 days
measure: Terminal serum half-life (T-HALF) of Ta 1
timeFrame: 7 days
measure: Time of maximum observed serum concentration (Tmax) of Ta 1
timeFrame: 7 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Wu Jianfeng, M. D
role: PRINCIPAL_INVESTIGATOR
References: