louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02850432: Clinical and MRI Cardiac Biomarkers on Peripheral Arterial Disease in Patients With Long Term DM
Official title: The Evolution and Impact of Clinical and MRI Cardiac Biomarkers on Peripheral Arterial Disease in Patients With Long Term DM
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Magnetic resonance imaging
Extracellular volume matrix fraction
Peripheral artery disease
Blood-oxygen level dependent
Cardiac function
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to establish a clinically feasible simultaneous evaluation of heart and lower limb using MRI and to assess the combined benefit of clinical and cardiac MRI imaging markers in the evaluation of PAD and prediction of treatment outcome.

Detailed description: We expect to enroll about 60 long-term DM patients (\>10 years) from main study. Patient will receive evaluation of the perfusion in the lower limb by using blood oxygenation-level dependent (BOLD) sequence with measurement of the extracellular volume fraction (ECV) as an indicator of fibrosis severity in calf muscles. All patients will receive cardiac MRI (cardiac function, ischemia and fibrosis) and MR angiography (severity of PAD). The baseline studies will be completed within 2 years and 3 additional follow-up studies will be performed by the end of 4th year.

Eligibility criteria: The inclusion criteria include:

1. Able to understand and provide signed informed consent
2. DM history of 10 years and above
3. Willing to receive 3 MRI follow-up and serum hematocrit examinations within 2 years, if applicable
4. Willing to receive standard therapy such as surgery or medication
5. Age between 18-80 years old

The exclusion criteria include:

1. Pregnant or breast-feeding women
2. Allergic MRI contrast medium
3. Absolute contraindications to contrast MRI (e.g., metallic hazards, hemodynamic instability, pregnancy, known allergy to contrast medium).
4. Contraindicated to MRI study: cardiac pacemaker, cochlear implantation, metallic object within eyeball
5. Patients that refuse to, or has poor ability of understanding and comply study conditions, such as severe dementia or difficulty in mobility
6. Patients having dialysis

Primary outcomes:
measure: Post-treatment improvement of peripheral artery disease
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gueishan
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Taoyuan
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yu-Hsiang Juan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06171932: Comparison Of Efficacy Of Hydrocortisone And Methyl Prednisolone In Acute Severe Asthma
Official title: Comparison Of Efficacy Of Hydrocortisone And Methyl Prednisolone In Acute Severe Asthma
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Asthma Acute
Lead sponsor: University of Karachi
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 30 in each group

Brief summary: COMPARISON OF EFFICACY OF HYDROCORTISONE AND METHYLPREDNISOLONE IN ACUTE SEVERE ASTHMA

In this study Investigator will compare the efficacy of hydrocortisone and methyl prednisolone in acute severe asthma that will lead to final result and beneficial effects that will help in early resoloution of symptoms and help in preventing recurrence

Detailed description: investigator will compare the efficacy of hydrocortisone v/s methylprednisolone in management of patients presented with acute severe asthma in emergency.

A local study was conducted in 2009, after that there is a big research gap exists at national level although international literature is available on the same but it can not be generalized to our population due to socio, geographic and economic differences so there is dire need to conduct this study this gives a strong rationale to implement in our settings

Eligibility criteria: Inclusion Criteria:

* Either Gender (18 to 50 years old)
* Patient presenting to emergency department with acute severe asthma

Exclusion Criteria:

* Patients with critical illness or pregnant females. .Patient treated other than hydrocortisone and methylprednisolone. .Patients not willing to participate in study.
* Life threatening asthma
* Near fatal asthm

Primary outcomes:
measure: Spirometry
timeFrame: 24 hours
measure: Blood pressures
timeFrame: 24 hours
measure: Respiratory rate
timeFrame: 24 hours
measure: Heart rate
timeFrame: 24 hours
measure: PEAK EXPIRATORY FLOW RATE
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Zia ud din hospital university
state: Sindh
city: Karachi
country: Pakistan
facility: Zia ud din university hospital
state: Sindh
city: Karachi
country: Pakistan
facility: Zia ud din university hospitals
state: Sindh
city: Karachi
country: Pakistan
facility: Zia ud din university
state: Sindh
Study officials:
affiliation: zia ud din university karachi
name: Inayat ur Rehman, MD ER
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aggarwal P, Bhoi S. Comparing the efficacy and safety of two regimens of sequential systemic corticosteroids in the treatment of acute exacerbation of bronchial asthma. J Emerg Trauma Shock. 2010 Jul;3(3):231-7. doi: 10.4103/0974-2700.66522.
Clinical trial NCT04250532: Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN.
Official title: Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drowning
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lifeguards working on the Girondine Atlantic coast

Brief summary: Drowning is the 3rd leading cause of accidental death in the world. One of the tools used by lifeguards to help ER assess gravity, is pulse oximetry. Its measure is variable even in optimal condition and its accuracy can be altered by factors specific to the patient and by environmental factors. The conditions gathered during a drowning rescue are thus propitious to a misleading evaluation. Assessing its reliability and looking for influencing factors of the measure of pulse oximetry could help for pre-hospital care management.

Detailed description: The research focuses on the measurement of pulse oximetry among lifeguard on the Atlantic coast of Gironde, France, before and after their daily training, using a standardized measurement protocol.

The follow-up will be done during the beach monitoring period during the summer of 2020. A total of 3 months of measurement collection is expected.

Eligibility criteria: Inclusion Criteria:

* Lifeguard working on the Girondine Atlantic coast
* up to 18 years old,
* no smoker,
* No chronic pathology.

Exclusion Criteria:

* Chronic cardiac pathology,
* Chronic respiratory pathology,
* Acrosyndrome,
* Smoker.

Primary outcomes:
measure: Proportion of abnormal pulse oximetry measure
timeFrame: 3 months after inclusion day
Secondary outcomes:
measure: Variation of pulse oximetry according to individuals factors
timeFrame: 3 months after inclusion day
measure: Variation of pulse oximetry according to environnementals factors
timeFrame: 3 months after inclusion day
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hopital Pellegrin
Study officials:
References:
Clinical trial NCT03542552: Nifedipine Versus Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa
Official title: Oral Nifedipine Versus Intravenous Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa: Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Placenta Previa
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 176
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Antepartum hemorrhage is defined as bleeding from or within the female genital tract, occurring from 28+0 weeks of pregnancy and till delivery of the fetus. it occurs in 3-5% of pregnancies and is an important cause of perinatal and maternal morbidity and mortality worldwide

Detailed description: There are many tocolytic agents may have a role in conservative management of placenta previa such as magnesium sulfate, calcium channel blockers and β-sympathormimetics. In 2004 Sharma suggests that ritodrine hydrochloride in patients with symptomatic placenta previa tends to prolong the pregnancy and result in an increase in birth weight of the babies without causing any adverse effect on the mother and fetus

Eligibility criteria: Inclusion Criteria:

* Estimated gestational age : between 28 weeks and 37 week's gestation
* Confirmed Placenta previa; either major or minor degrees.
* Placenta previa with preterm uterine contractions

Exclusion Criteria:

* Severe attack of bleeding requiring an immediate intervention.
* Fetal heart rates instability or non-reassuring tracing
* Intrauterine fetal death or major fetal anomalies.
* If associated with abruptio placentae
* Patients with known bleeding disorders or on anticoagulant therapy
* Patients with severe medical disorders as myasthenia gravis documented magnesium toxicity.

Primary outcomes:
measure: The duration of prolongation of gestation
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
citation: Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
Clinical trial NCT00178152: Erythema Toxicum Neonatorum in Newborns and the Development of Asthma
Official title: The Implication of Erythema Toxicum Neonatorum in Newborns on the Development of Future Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Erythema Toxicum Neonatorum
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 334
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Case studies will include subjects between the ages of 3-9 years who have had at least 2 asthma diagnoses within the last 2 years. Patients will be selected based upon their ICD9 codes for asthma. Control subjects will be age matched and without an asthma diagnosis.

Brief summary: Erythema Toxicum Neonatorum (ETN) is a common skin finding that affects healthy full-term babies. Several authors have commented on the possible relationship between ETN and the development of atopic conditions, such as atopic dermatitis or respiratory disease later in life. There is a paucity of research addressing this issue.


Eligibility criteria: Inclusion Criteria:

* Children between the ages of 3-9 years who have had at least 2 asthma diagnoses within the last 2 years.
* Control subjects will be age matched and without an asthma diagnosis.

Exclusion Criteria:

* Children without accessible medical records

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Department of Pediatrics, University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Jill S Halterman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: West Penn Allegheny Health System
name: Ritu Pabby, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01344252: Topical Jelly and Intracameral Anesthesia Versus Subtenon Anesthesia, in Cataract Surgery
Official title: Topical Jelly and Intracameral Anesthesia Versus Subtenon Anesthesia, in Cataract Surgery: Preference and Surgical Conditions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cataract Surgery Anesthesia
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The options for anesthesia in cataract surgery described are: general, regional or local. The local strategy, it may be by periocular blocking(subtenon, peribulbar or retrobulbar), subconjunctival or topical. The risks faced by subconjunctival, peribulbar or retrobulbar, have made subtenon and topical strategies the most used. Likewise, to improve the effectiveness of the topical strategy was added gel topical lidocaine and intracameral dose of lidocaine.

Subtenon and topical anesthesia are two safe strategies and there were performed multiple studies showing that both are effective in controlling pain, but showing a slight superiority of subtenon. This difference does not appear to be clinically significant. In turn, the addition of gel and intracameral anesthesia, improved pain control. However, lack evidence to compare patient preference when using topical gel and intracameral anesthesia versus sub-Tenon anesthesia.

Multiple advantages has the topical anesthesia. Besides being a safe strategy for the patient, offers a rapid visual recovery, no generates blepharoptosis or diplopia postoperatively, subconjunctival hemorrhage and chemosis.

Because of this the investigators plan to conduct a study comparing the efficacy of gel topical and intracameral anesthesia versus subtenon anesthesia in cataract surgery with scleral incision, assessing the patient's preference Hypothesis: Topical administration of lidocaine in gel and intracameral anesthesia is a better strategy that subtenon anesthesia in cataract surgery


Eligibility criteria: Inclusion Criteria:

* bilateral cataract

Exclusion Criteria:

* refuse to participate, high surgical risk (ASA 4 or 5), allergy to lidocaine or other amide local anesthesics, inability to understand the informed consent, coagulation abnormalities, prior ophthalmologic surgery, small pupil, Fuchs dystrophy, lens luxation, uveitis

Primary outcomes:
measure: number of subjects who prefer topical anesthesia.
timeFrame: 1 month
Secondary outcomes:
measure: intraoperative pain
timeFrame: 1 hour
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Hospitalitaliano de buenos aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
References:
Clinical trial NCT00791752: Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017
Official title: A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase 1Study in Healthy Volunteers to Assess the Safety, Tolerability andPharmacokinetics of AZD4017 After Single Ascending Oral Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety and Tolerability
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-11-14
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when given as single oral ascending doses to healthy volunters. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distrubution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected. The future indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.


Eligibility criteria: Inclusion Criteria:

* Provision of signed written and dated informed consent
* BMI between 19 and 30 kg/m2
* Subjects must be willing to use barrier methods of contraception

Exclusion Criteria:

* History of any clinical significant disease
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Laboratory blood sample result showing elevated liverenzymes (ASAT, ALAT) and muscle enzymes (CK).

Primary outcomes:
measure: Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratoryvariables
timeFrame: The variables will be measure predose and the repeatedly during the following 47 hours after dosing
Secondary outcomes:
measure: Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal half-life, area under the plasma concentration-time curve and the apparent oral plasma clearance (CL/F)
timeFrame: Blood samples for determination of AZD4017 concenration will be taken predose and repeatedly during the 47 hours post dose
Other outcomes:
Locations:
city: Gotteborg
country: Sweden
facility: Research Site
Study officials:
affiliation: Sahlgrenska University Sweden
name: Marianne Hartford, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06630052: Incidence of Tenderness Opposite to Adductor Canal in Patients Suffering From Osteoarthritis Knee Pain. A Cohort Study.
Official title: Incidence of Tenderness Opposite to Adductor Canal in Patients Suffering From Osteoarthritis Knee Pain. A Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Arthritis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with confirmed KOA by symptomatic (rated knee pain \> four on a 10-point numeric rating pain scale (NRP scale)) and radiologically (Kellgren-Lawrence grades I, II ) findings

Brief summary: Knee osteoarthritis (KOA) is a common knee disorder. The pathological changes affecting the knee are typically examined by using X-ray imaging to assess the narrowing of the joint space and the presence of osteophytes. However, some previous clinical trials have revealed a discrepancy between the severity of joint pain and the image finding even with the use of knee MRI. Some studies have revealed that there are age-related changes in the type of fibers with the formation of a network of transverse fiber bands, and this may cause some compression or traction on the neurovascular content of the adductor canal. Other studies noted the presence of excessive yellow-colored adipose tissue that stretches or entangles some nerve fibers. The primary outcome of this study will be the incidence rate of tenderness over the midthigh corresponding to the AC in patients with KOA who are complaining of severe pain that is discordant with the radiological finding.


Eligibility criteria: Inclusion Criteria:

* Adult patients with confirmed KOA by symptomatic (rated knee pain \> four on a 10-point numeric rating pain scale (NRP scale)) and radiologically (Kellgren-Lawrence grades I, II ) findings

Exclusion Criteria:

* Post-traumatic knee osteoarthritis, oncological diseases, endocrine diseases (gout, diabetes), autoimmune diseases (rheumatoid arthritis), infectious diseases and patients with a history of previous knee surgeries or endoscopies

Primary outcomes:
measure: incidence of tenderness corresponding to the AC in patients complaining of severe pain with discordant with the radiological finding
timeFrame: time of clinical examination at the date of the visit to the pain clinic till the knee interventions up to 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Maadi
country: Egypt
facility: Abeer Ahmed Mohamed
state: Cairo
city: Cairo
country: Egypt
facility: Anesthesia department - Faculty of medicine- Cairo University
Study officials:
References:
Clinical trial NCT05031832: Chemsex Engagement and HIV Biomedical Prevention in MSM
Official title: The Interrelationship Between Chemsex Engagement and HIV Biomedical Prevention in MSM
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recreational Drug Use
Keywords: Chemsex engagement
Pre-exposure prophylaxis
Antiretroviral therapy
men who have sex with men
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 733
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: sexually active adult men who have sex with men living in Hong Kong, and able to complete the questionnaire

Brief summary: HIV biomedical prevention through treatment-as-prevention (TasP) and pre-exposure prophylaxis (PrEP) is highly efficacious for reducing HIV transmission risk. The benefits could be undermined by the rising HIV transmission risks in men who have sex with men (MSM) who engaged in chemsex. This project aims to assess the impacts of chemsex on the growth of the HIV epidemic by exploring the complex relationships between chemsex engagement and usage of HIV biomedical prevention in MSM in Hong Kong. Participants would be recruited from the community and clinics in 2 cross-sectional studies (500 HIV-negative and 500 HIV-positive MSM), for HIV self-testing and completing an electronic questionnaire. The association of chemsex would be examined between PrEP-naïve and PrEP experienced HIV-negative MSM, and between good and poor adherence to antiretroviral therapy (ART) among HIV-positive subjects in case-control analyses using logistic regression and multilevel models. The main outcomes include coverage of biomedical prevention in MSM, and their drug use patterns.


Eligibility criteria: Inclusion Criteria:

* aged 18 or above
* male
* have had sex with men since 2019
* could be communicated in English or Chinese

Exclusion Criteria:

* failed to provide consent

Primary outcomes:
measure: pre-exposure prophylaxis coverage
timeFrame: 6 months
measure: Good antiretroviral therapy adherence
timeFrame: 2 years
measure: Drug use pattern
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: