louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00397956: To Evaluate the Treatment Effect of an Anti-Infective Agent for Complicated Infections (0826-053)
Official title: An Open-Label, Single-Arm, Non-Comparative Study to Evaluate the Efficacy, Tolerability & Convenience of Invanz(TM) (Ertapenem Sodium) In the Treatment of Community-Acquired Sepsis in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sepsis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-11-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To collect clinical response data with the use of ertapenem in community acquired sepsis.


Eligibility criteria: Inclusion Criteria:

* Male or female patients, 18 years of age or older
* Patients present with at least two of the following signs and symptom:
* fever (temperature\> 38c or \< 36c)
* heart rate \> 90 beats/min)
* respiratory rate\> 20 breaths/min)
* high white blood cell count \> 12,000/ul or \>10% bands)

Exclusion Criteria:

* Patient has a history of allergy or hypersensitivity (anaphylaxis) or serious adverse reaction to ertapenem or any carbapenem
* Patient has a poor chance of survival for more than 14 days.
* Patient has an apache ii score \> 15 (see attachment 3.
* Patient has an infection caused by pathogens resistant to ertapenem
* The patient requires antibiotics other than ertapenem (such as: glycopeptides, macrolides or antifungal agents)

Primary outcomes:
measure: Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment
Secondary outcomes:
measure: Safety and Tolerability
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03308656: Uterocervical Angle in Induction of Labor
Official title: Uterocervical Angle in Success of Induction of Labor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor Induction, Third Trimester
Keywords: uterocervical angle, labor induction
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant population undergoing labor induction in the third trimester

Brief summary: To evaluate the performance of uterocervical angle (UCA) in the prediction of labor induction.

Detailed description: Induction of labor is a common procedure in obstetrics. In recent years, uterocervical angle (UCA) emerged as a new ultrasound parameter in the prediction of labor. Dziadosz et al concluded that the performance of UCA was even better than the cervical length in their cohort. A wide UCA during second trimester shown to have an increased risk of preterm labor and narrow angle was less likely to have labor.

The investigators are aimed to investigate predictive role of both cervical length and UCA in the labor induction in third trimester of pregnancy.The investigators focused on nulliparous women who are taking dinoproston for the cervical preparation and aim to measure their UCA.

Eligibility criteria: Inclusion Criteria:

* Nulliparous singleton pregnancy
* no previous systemic illnesses

Exclusion Criteria:

* abnormal Pap smear
* previous cesarean section
* history of dilatation and curettage (D\&C)
* history of LEEP and cervical conization

Primary outcomes:
measure: uterocervical angle
timeFrame: once at the beginning of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kanuni SSTRH
Study officials:
affiliation: Kanuni SSTRH
name: Alev Aydin, MD,ObGyn
role: STUDY_DIRECTOR
References:
Clinical trial NCT07001956: The Clinical Study on the Treatment of Refractory RA With UTAA91 Injection
Official title: Clinical Study on the Treatment of Refractory Moderate - to - Severe Active Rheumatoid Arthritis With UTAA91 Injection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Rheumatoid Arthritis (RA)
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: UTAA91 injection
Primary purpose: TREATMENT

Brief summary: This clinical trial is designed as a single - arm, open - label, single - center, investigator - initiated early - phase clinical study. The primary objective is to evaluate the safety of UTAA91 injection in treating subjects with refractory moderate - to - severe active rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years (inclusive of the boundary value), with no restriction on gender.
* Expected survival time of at least 3 months.
* Subjects with refractory moderate - to - severe active rheumatoid arthritis who have failed standard treatment or lack effective therapeutic options.
* Meet the requirements for liver and kidney function, as well as cardiopulmonary function.
* Free from severe psychiatric disorders.
* Able to understand the trial and have signed the informed consent form.

Exclusion Criteria:

* A history of malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years prior to screening.
* Subjects with positive results in virus/syphilis tests.
* Severe cardiac diseases or unstable systemic diseases.
* Active or uncontrollable infections requiring systemic treatment within 7 days before administration; evidence of central nervous system invasion at screening.
* Pregnant or breastfeeding women, female subjects planning to become pregnant within 2 years after cell infusion, or male subjects whose partners plan to become pregnant within 2 years after their cell infusion.
* Subjects who have received CAR - T therapy or other gene - modified cell therapies before screening.
* Subjects who participated in other clinical studies within 1 month before screening.
* Other conditions deemed unsuitable for enrollment by the investigator.

Primary outcomes:
measure: Adverse events
timeFrame: About 1 year
Secondary outcomes:
measure: Cmax
timeFrame: About 1 year
measure: Tmax
timeFrame: About 1 year
measure: Disease remission rate
timeFrame: About 3 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT05709756: Prevalence and Predictors of Esophageal Thermal Lesions in High-power-Short-duration Ablation of Atrial Fibrillation
Official title: Prevalence and Predictors of Esophageal Thermal Lesions in High-Power-Short-Duration Ablation of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophagus Injury
Atrial Fibrillation
Keywords: Atrial Fibrillation
Esophagus Injury
Pulmonary vein isolation
Esophagoscopy
Lead sponsor: Helios Health Institute GmbH
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with documented atrial fibrillation who were referred to our clinic for pulomary vein isolation

Brief summary: Patients with documented atrial fibrillation who were referred to our clinic for catheter ablation will undergo standard HPSD ablation and subsequent esophagoscopy.

After esophagoscopy patients will be followed up for one month in the form of a telephone follow-up.

The primary endpoint of the study assessed by esophagoscopy performed on the day after the index catheter ablaton is the incidence of esophageal thermal lesions.

Secondary endpoints include:

1. The size of the esophageal thermal lesions.
2. The severity of esophageal thermal lesions.


Eligibility criteria: Inclusion Criteria:

* Atrial fibrillation documented in the 12-lead ECG
* Indication for catheter ablation in accordance with currentn ESC guidelines

Exclusion Criteria:

* Pregnancy
* Women of childbearing potential without a negative pregnancy test within 48 hours prior to ablation procedure
* Known intracardiac or other thrombi
* Contraindication to anticoagulation
* Contraindication to esophagoscopy: diseases and deformities of the cervical spine, esophageal varices

Primary outcomes:
measure: Prevalence of ablation-related esophageal thermal lesions
timeFrame: One day after Catheter ablation
Secondary outcomes:
measure: Size of ablation-related esophageal thermal lesions
timeFrame: One day after Catheter ablation
measure: Severity of ablation-related esophageal thermal lesions
timeFrame: One day after Catheter ablation
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Arash Arya
state: Saxony
city: Leipzig
country: Germany
facility: Department of Electrophysiology, Leipzig Heart Center at University of Leipzig
state: Saxony
Study officials:
affiliation: Leipzig Heart Center at University of Leipzig
name: Gerhard Hindricks, MD
role: STUDY_CHAIR
affiliation: Leipzig Heart Center at University of Leipzig
name: Arash Arya, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00303056: Efficacy and Safety Study of Intra-articular Multiple Doses of Icatibant in Patients With Painful Knee Osteoarthritis
Official title: Efficacy and Safety of Intra-articular Multiple Doses of 500 µg Icatibant Including 40 mg Triamcinolone as Calibrator in a Randomized, Double-blind, Parallel-group, Placebo-controlled 13-week Multi-centre Study in Patients With Symptomatic Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Joint Disease
Keywords: Osteoarthritis
knee
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-03-15
Enrollment: 590
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 primary objective is to compare the overall treatment effect on pain relief between icatibant and placebo. The secondary objectives are to assess the efficacy of icatibant in term of onset, extent and duration of pain relief relative to triamcinolone, to evaluate the safety of icatibant, to evaluate overall conditions of daily life after treatment with icatibant, to assess systemic exposure of icatibant following intra-articular injection.

Detailed description: This is a multinational, randomized, placebo-controlled study to be conducted in Europe and the US. Study medication will be administered by intra-articular injection 3 times in weekly intervals, being followed by an observation period of further 11 weeks.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects with painful osteoarthritis of the knee.

Exclusion Criteria:

* Subjects presenting with diagnosis of OA \< 3 months and an OA grading \< K\&L grade II, with any condition with impact on on the target indication, any test-compound-related condition, any study-related condition (all those conditions detailled in the CSP).

Primary outcomes:
measure: Pain during activity, at rest and at night will be measured daily via an electronic patient diary (EPD) using a 100-unit visual analog scale (VAS).
Secondary outcomes:
measure: Patient global assessment assessed daily as well as WOMAC scores at each visit and intake of rescue medication daily via EPD recording. Safety assessed at each visit and pharmacokinetics at visits 2, 3 & 4.
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Administrative Office
state: New Jersey
city: Vienna
country: Austria
facility: Administrative Office
city: Praha
country: Czech Republic
facility: Administrative Office
city: Berlin
country: Germany
facility: Administrative Office
city: Warszawa
country: Poland
facility: Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT01322256: PET/CT Scanning for the Follow-up of Antibiotic Treatment of Infectious Osteoarthritis in the Diabetic Foot
Official title: Positron Emission Tomography - Computed Tomography (PET/CT) Scanning for the Follow-up of Antibiotic Treatment of Infectious Osteoarthritis in the Diabetic Foot
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Foot
Osteoarthritis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators' primary objective is to assess the predictive power of PET/CT scanning in the evolution of infectious osteoarthritis of the diabetic diabetic after antibiotic therapy prescribed by national and international recommendations.


Eligibility criteria: Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Patient has type I or type II diabetes
* Patient consulting in the department of Metabolic and Endocrine Diseases (Caremeau Hospital) or the department of Nutritional Diseases and Diabetology (Grau de Roi Medical Center) at the Nîmes University Hospital
* Patient has infected osteoarthritis of the foot according to the International Working Group on the Diabetic Foot with a probability \> 50% (score \>= 2).

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding
* Patient has severe sepsis or a stage 4 infection according to the international consensus on the diabetic foot
* Patient has severe renal insufficiency as defined by glomerular filtration rate \< 30ml/min/1.73 m\^2, calculated according to the MDRD equation, and is not undergoing dialysis
* Patient has a contra-indication for an MRI
* pacemaker
* intracranial clips
* metallic inclusions
* severe claustrophobia

Primary outcomes:
measure: The difference between AUCs for PET/CT scan and scintigraphy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
city: Le Grau du Roi
country: France
facility: CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Sophie Schuldiner, MD
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Nathalie Jourdan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04613856: Water Bolus Volumes During Continuous Exercise in Heat
Official title: Water Bolus Volumes During Continuous Exercise in Heat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration (Physiology)
Hyperthermia
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, counterbalanced, crossover study
Primary purpose: PREVENTION

Brief summary: Hydration is important to all individuals including occupational workers who complete physical activity in the heat. Current best practice guidelines suggest drinking a cup of water every 15-20 minutes during activity in a hot environment, but research shows this may not be ideal for best maintaining hydration. The goal of this study is to determine if larger, more frequent water boluses better maintain hydration than smaller, less frequent water boluses during moderate intensity physical activity in the heat.


Eligibility criteria: Inclusion Criteria:

* Male
* 18-39 y old
* Self-reported to be healthy

Exclusion Criteria:

* Female
* Not within defined age range
* History of any cardiovascular, neurologic, or metabolic disease
* Current tobacco use or regular use within the last 2 years.
* Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
* Inability to follow the rules of the protocols or understand the consent form

Primary outcomes:
measure: Percent body mass loss
timeFrame: 2 hours
measure: Core temperature
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Center for Research and Exercise in Special Environments
state: New York
Study officials:
References:
Clinical trial NCT06172556: Early Brain Damage Assessment in Aneurysmal Subarachnoid Haemorrhage in Predicting Cognitive Impairment
Official title: The Role of Early Cerebral Edema and Hematoma Assessment in Aneurysmal Subarachnoid Hemorrhage (a-SAH) in Predicting Structural Brain Abnormalities in Cognitive Impairments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysmal Subarachnoid Hemorrhage
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Han Chinese emergency call

Brief summary: the goal of this type of study : observation study is to learn about cerebral edema and hematoma in aneurysmal subarachnoid hemorrhage the main questions it aims to answer are current clinical practices lack predictive models to identify early structural brain abnormalities affecting cognition.

Detailed description: the development of a predictive model termed the a-SAH Early Brain Edema/Hematoma Compression Neural (Structural Brain) Networks Score System (SEBE-HCNNSS).

Eligibility criteria: Inclusion Criteria: first-ever stroke, diagnosed with SAH via CT scan within 24 - 48 hours or lumbar puncture; 2) age between 18 and 70 years; 3) Confirmation of cerebral aneurysm by digital subtraction angiography (DSA) and/or CT angiography (CTA); 4) absence of neurological or psychiatric disease history and each unruptured intracranial aneurysm patient must be admitted to the hospital in excellent preoperative and pre-interventional condition; 5) Informed consent is signed by the patient and/or family. 6)Clinical diagnosis of Alzheimer's Disease Must be able to swallow tablets.

-

Exclusion Criteria: 1) patients over 70 years old; 2) presence of neurological focal deficits or severe aphasia; 3) cognitive dysfunction or history of cognitive decline including craniotomy, antipsychotics, neurodegenerative diseases, and chronic subdural hematoma; 4) concurrent acute or chronic infections, corneal or pupillary abnormalities, severe autoimmune or systemic diseases such as rheumatic illnesses of the musculoskeletal system; 5) concurrent severe organic dysfunction; 6) patients with recurrent aneurysms or aneurysms not first diagnosed in our hospital; 7) diagnosis of major psychosis according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition criteria 8)Insulin dependent diabetes,9)Thyroid disease

Primary outcomes:
measure: Description of subarachnoid blood on cranial CT
timeFrame: 24 - 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: The First Hospital of Hebei Medical University
name: Mingdong Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03049956: OVEMP in Myasthenia
Official title: Diagnostic Accuracy of Repetitive Ocular Vestibular Evoked Myogenic Potentials in Myasthenia Gravis (OMG Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myasthenia Gravis, Ocular
Keywords: Ocular Vestibular Evoked Myogenic Potentials
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-02-10
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Myasthenia gravis is an autoimmune disorder of neuromuscular transmission, characterized by fluctuating muscle weakness and fatigability. In isolated ocular myasthenia, when only the extraocular muscles are involved, most common ancillary tests, such as acetylcholine receptor autoantibodies and repetitive nerve stimulation, are often negative.

A simple, quick and non-invasive test for ocular myasthenia based on ocular vestibular evoked myogenic potentials (oVEMP) was recently developed.

The main goal of the study is to validate repetitive oVEMP stimulation in a blinded diagnostic accuracy study in order to facilitate early and accurate diagnosis of ocular myasthenia.


Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature
* Patients with diplopia and/or ptosis suspicious for myasthenia gravis.

Exclusion Criteria:

* Vestibular disorders
* Significant systemic myasthenia symptoms (respiration or swallowing difficulties) unable to undergo oVEMP testing.
* Patients with significant cardiac or respiratory disease will be excluded from the Tensilon test as part of the reference standard.
* Women who are pregnant or breast feeding.

Primary outcomes:
measure: Decrement (as quantified in %) of repetitive 20 Hz ocular vestibular-evoked myogenic potentials (oVEMP)
timeFrame: The primary outcome measure (index test oVEMP) will be assessed at baseline, in conjunction with reference standard/standard clinical workup (including blood analysis, neurological exam, edrophonium test, electromyography, single-fiber electromyography).
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Ophthalmology/Neurology Department
Study officials:
References:
citation: Valko Y, Rosengren SM, Jung HH, Straumann D, Landau K, Weber KP. Ocular vestibular evoked myogenic potentials as a test for myasthenia gravis. Neurology. 2016 Feb 16;86(7):660-8. doi: 10.1212/WNL.0000000000002383. Epub 2016 Jan 20.