louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03118804: Weaning From Mechanical Ventilation Guide by Assessment of Lung Tidal Distribution With EIT
Official title: Weaning From Mechanical Ventilation Guide by Assessment of Lung Tidal Distribution With EIT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation
Keywords: Weaning
Mechanical ventilation
Electrical impedance tomography
Tidal distribution
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with mechanical ventilation admitted to ICU of Zhongda hospital

Brief summary: To evaluate whether EELI, RVD, GI were good predictor for weaning from mechanical ventilation

Detailed description: 53 patients who ready to wean from mechanical ventilation were included in this study. The changes of lung tidal distribution during SBT with mechanical ventilation by EIT were recorded. Whether EELI, RVD, GI were good predictor for weaning from mechanical ventilation?

Eligibility criteria: Inclusion Criteria:

1. Intubated patients age between 18 years old and 80 years old
2. Duration of controlled mechanical ventilation≥ 24 h
3. Patients ready to wean from mechanical ventilation
4. Informed consent

Exclusion Criteria:

1. Pregnant women
2. Patients with malignant tumor
3. High paraplegia, neuromuscular lesions
4. Thoracic deformity, diaphragmatic hernia
5. Patients with ECMO
6. Patient participated in another interventional trial before enrollment

Primary outcomes:
measure: Weaning duration
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: Southeast University
name: Liu Songqiao, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03554304: Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers
Official title: A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: QT/QTc Interval in Healthy Volunteers
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
First posted: 2018-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers


Eligibility criteria: Inclusion Criteria:

1. Body mass index ≥18 to ≤33 kg/m2, inclusive.
2. Stable health based on a medical history without any major pathology/surgery in the 6 months

Exclusion Criteria:

1. An uninterpretable or abnormal screening electrocardiogram (ECG) indicating a second- or third-degree atrioventricular block
2. History of risk factors for torsades de pointes, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypocalcemia, or hypomagnesemia.
3. A sustained supine systolic blood pressure \>150 mm Hg or \<90 mm Hg or a supine diastolic blood pressure \>95 mm Hg or \<50 mm Hg at Screening or Check-in (Day -1).

Primary outcomes:
measure: Incidence of delay in cardiac repolarization induced by WCK 5222
timeFrame: 0-4 days
Secondary outcomes:
measure: Incidence of adverse events to assess tolerability at the supratherapeutic dose to be used in the thorough QT evaluation
timeFrame: 0-4 days
measure: Incidence of AEs to assess the safety of high doses of single-dose administration of FEP-ZID
timeFrame: 0-4 days
Other outcomes:
Locations:
city: West Bend
country: United States
facility: Spaulding Clinical Research
state: Wisconsin
Study officials:
References:
Clinical trial NCT03592004: Radiomics of Mp-MRI Assessing NAC Outcome in Breast Cancer
Official title: Radiomics of Multiparametric MRI for Neoadjuvant Chemotherapy Outcomes Assessment in Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Radiomics
Neoadjuvant Chemotherapy
Multi-parametric MRI
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Guangdong Provincial People's Hospital
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Beijing Friendship Hospital
name: Yunnan Cancer Hospital
name: Liaoning Cancer Hospital & Institute
name: First Hospital of China Medical University
name: Affiliated Hospital of Hebei University
First posted: 2018-07-19
Enrollment: 500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese

Brief summary: This is a single-arm, multicentre study that aims to assess whether Radiomics combining multiparametric MRI and clinical data could be a good predictor of the responses to neoadjuvant chemotherapy in Breast Cancer.

Detailed description: Patients undergo multiparametric MRI (including T2WI, DWI and DCE-MRI) at baseline, after 2 courses of neoadjuvant chemotherapy, and prior to the surgery at least 8 weeks after the treatment procedure. Patients undergo biopsy test in one week after the baseline MRI scan to detect the biomarkers including ER, PR, Her-2 and Ki-67, which can be used to select the treatment plan referring to the NCCN clinical guidelines. After the surgery, responses to neoadjuvant chemotherapy are determined according to the histopathologically examination of the surgically resected specimens.

After completion of treatment procedure, patients are followed up for 5 years.

Eligibility criteria: Inclusion Criteria:

* biopsy-proven invasive breast cancer;
* received complete neoadjuvant chemotherapy and no treatment has been done before;
* surgery was performed after completion of neoadjuvant chemotherapy, after which pCR was confirmed by postoperative pathological examination;
* pretreatment MRI data within a month before the start of the treatment was eligible, including T2WI, DWI and DCE-MRI.

Exclusion Criteria:

* not completing neoadjuvant chemoradiotherapy;
* not undergoing surgery at our hospital, or pCR was not assessed;
* lack of T2WI, or DWI or DCE-MRI data;
* insufficient MRI quality to obtain measurements (e.g., owing to motion artifacts);
* had unilateral multifocal cancers, and the correlation between the tumor in MR images and postoperative pathological examination was uncertain.

Primary outcomes:
measure: predicting pathological complete response (pCR) or no response (NR)
timeFrame: 20 weeks
measure: 5 years for Disease free survival
timeFrame: 5 years
measure: 5 years for Overall survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Zhenyu Liu
Study officials:
affiliation: Chinese Academy of Sciences
name: Jie Tian, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00568204: Study of Effectiveness of Mexyn-A
Official title: Proof of Concept of MEXYN-A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pruritus
Keywords: pruritus, itching, mexyn-a, clearitch, magicool-plus
Lead sponsor: Evangelical Synod Medical Centre
Sponsor class: OTHER
First posted: 2007-12-05
Enrollment: 279
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Atomised Methoxymethane-in-Aqua (MEXYN-A) a new topical self-chilled, non-steroidal, non-flammable, pressurised spray which embodies in one simultaneous application, most of the currently recognised and effective chemical, mechanical and thermal anti-pruritic therapies and hydrotherapy.

Detailed description: The primary clinical endpoint was to establish MEXYN-A efficacy and safety in abolishing or reducing pruritus related to cutaneous diseases, insect bites and poison ivy, within few seconds of the application. The secondary endpoint was to measure the itch free period as a result of the new intervention.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from severe itching due to : Atopic Dermatitis, contact dermatitis, psoriasis, urticaria, xerosis, prickly heat, genital pruritus, chicken pox, aquagenic pruritus, lichen planus, poison ivey, insect bites.
* Past experience with the use of at least one conventional medication for pruritus or conventional medication for the same disorder patients suffered.

Exclusion Criteria:

* Patients who have taken any anti-pruritic drug during the month prior to participation.
* Patients who have taken drugs for any reason for 2 days prior to participating in the study.

Primary outcomes:
measure: Treating Pruritus
timeFrame: three days
Secondary outcomes:
measure: measuring itch-free period after applying the new treatment, effect on sleep disturbance
timeFrame: three days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Evangelical Synod Medical Centre
Study officials:
affiliation: Evangelical Synod Medical Centre
name: Ihab Akhnoukh
role: PRINCIPAL_INVESTIGATOR
affiliation: Harpur Memorial Hospital
name: Ashraf Khella
role: STUDY_DIRECTOR
References:
Clinical trial NCT02463604: Renal PRotection Against Contrast mEdium-induced nephroPathy in High Risk Patients undErgoing Coronary Angiography
Official title: Renal PRotection Against Contrast mEdium-induced nephroPathy in High Risk Patients undErgoing Coronary Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency
Contrast Medium-induced Renal Insufficiency
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2015-06-04
Enrollment: 220
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the efficacy of remote ischemic preconditioning on preventing contrast medium-induced nephropathy in a population of high risk patients undergoing coronary angiography. Half of participants will receive a preconditioning procedure while the other half will receive a sham procedure.

Detailed description: Contrast medium-induced nephropathy has a big impact on clinical outcomes in patients suffering from renal insufficiency who undergo percutaneous coronary interventions.

Remote ischemic preconditioning is proved to protect myocardium in patients undergoing percutaneous coronary angiography.

We will evaluate the effect of remote preconditioning on renal protection.

Eligibility criteria: Inclusion Criteria:

1. Patient headed to coronary angiography
2. Glomerular filtration rate :

   * ≤ 40ml/min/1,73m² (MDRD equation)
   * or ≤ 60ml/min/1,73m² (MDRD equation) with 1 additional risk factor : age \> 75 years, NYHA ≥ III/IV, diabetes mellitus
3. Signed informed consent

Exclusion Criteria:

1. Preoperative assessment / dilated cardiomyopathy assessment
2. Acute ST-segment elevation myocardial infarction
3. Cardiogenic shock requiring pressor amine or systolic blood pressure \<80mmHg
4. Resuscitation after cardiac arrest
5. Intra-aortic balloon pump
6. Contraindication for the repeted use of an upper-arm pressure cuff
7. Extra-renal epuration
8. No health insurance coverage
9. Legal incapacity (patients under tutorship, curatorship or judicial protection)
10. Patient enrolled in another interventional trial or being in a washout period
11. Incapacity/impossibility to undergo 12-month follow-up
12. Patient refusal

Primary outcomes:
measure: Increase in serum creatinin level (≥25% or 0,5mg/dL)
timeFrame: 48h after coronary angiography
Secondary outcomes:
measure: Serum creatinin level is measured 12 months after coronary angiography and major adverse events are collected to assess long-term effects of remote ischemic preconditioning on renal function
timeFrame: 12 months after coronary angiography
Other outcomes:
Locations:
city: Angers
country: France
facility: UH Angers - Cardiology ward
Study officials:
affiliation: UH Angers, Cardiology
name: Fabrice Prunier, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00384904: Drug Interaction Study of Famotidine and Atazanavir With Ritonavir in HIV-Infected Patients
Official title: Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Famotidine With or Without Tenofovir on the Pharmacokinetics of Atazanavir When Given With Ritonavir in HIV-Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-10-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this clinical research study is to assess the effect of Famotidine given twice daily on Atazanavir administered with Ritonavir in HIV-Infected subjects.


Eligibility criteria: Inclusion Criteria:

* HIV-infected male and female subjects between the ages of 18 to 65 years old with a BMI 18 to 35 kg/m²
* Prior to enrollment subjects must be currently receiving Atazanavir/Ritonavir plus at least 2 NRTIs, must have plasma HIV RNA \<400 copies/mL and have CD4 count \>200 cells/mm³

Primary outcomes:
measure: Atazanavir plasma drug concentrations
timeFrame: on days 10, 11, 17, 18, 24 and 25
Secondary outcomes:
measure: Ritonavir plasma drug concentrations
timeFrame: on days 10, 11, 17, 18, 24 and 25
measure: Safety measures: Physical examinations
measure: ECGs
timeFrame: entry and discharge
measure: laboratory tests including, liver and renal function
timeFrame: entry, discharge and days 11, 18
measure: CD4 count
timeFrame: discharge
measure: HIV viral load
timeFrame: entry and discharge
Other outcomes:
Locations:
city: Voorhees
country: United States
facility: Garden State Infectious Disease Associates, Pa
state: New Jersey
city: Chapel-Hill
country: United States
facility: Unc Center For Aids Research
state: North Carolina
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05096104: Patient Satisfaction During Artificial Induction of Labor by Cervical Ripening
Official title: Patient Satisfaction During Artificial Induction of Labor by Cervical Ripening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Ripening
Keywords: Cervical Ripening
PREGNANCY
LABOR INDUCED
Artificial induction
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult woman who underwent induction of labor between February 1, 2020 and February 29, 2021

Brief summary: 20% of deliveries take place following an artificial induction of labor. The latter sometimes requires prior cervical ripening, of which the two most widely used methods in France are oral misoprostol and the balloon catheter, left to the discretion of clinicians.

The objective of this study is to observe which cervical maturation method patients choose when an artificial induction of labor with an unfavorable cervical status must be carried out, and to observe the patient's criteria as to the choice made, as well as their experience and their satisfaction with artificial induction of labor, in order to improve our clinical practices, the experience of childbirth, and promote patient autonomy.


Eligibility criteria: Inclusion Criteria:

* Adult woman (≥18 years old)
* Patient who underwent induction of labor between February 1, 2020 and February 29, 2021
* Patient not having expressed her opposition, after information, to the reuse of her data for the purposes of this research.

Exclusion Criteria:

* Patient who expressed her opposition to participating in the study
* Absence of prior cervical maturation (Bishop score greater than or equal to 6 on the day of initiation)
* Gestational age less than 37 weeks, multiple pregnancy, scarred uterus, non-cephalic presentation, death in utero and severe fetal malformation (requiring neonatal resuscitation or with a palliative care plan)
* Patient for whom the triggering method was chosen by the practitioner
* Patient under guardianship, curatorship or safeguard of justice

Primary outcomes:
measure: Retrospective study of the cervical ripening method that patients choose when artificial induction of labor with unfavorable cervical status must be performed
timeFrame: Files analysed retrospectively from JFebruary 01, 2020 to February 29, 2021 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
name: Nicolas SANANES, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03889704: Neuromuscular Electrical Stimulation for Jaw-closing Dystonia
Official title: Neuromuscular Electrical Stimulation for Jaw-closing Dystonia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Muscle Dystonia
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 6 patients with jaw-closing dystonia will be treated with neuromuscular electrical stimulation over 8 weeks. The distance the mouth can be opened voluntarily and the oro-mandibular dystonia questionnaire (OMDQ-25) will be employed to determine whether there is any objective change in jaw opening or evidence of functional improvement.


Eligibility criteria: Inclusion Criteria:

* Jaw-closing dystonia, which may be primary or secondary to a neurodegenerative disease or medications.
* Unable to voluntarily open jaw fully on examination.
* Evidence of functional impairment resulting from dystonia including inability to completely open the jaw during speaking or eating to such an extent that it interferes with these tasks.
* Patient interested in participating, and willing to attend multiple treatment sessions in the neurology clinic.

Exclusion Criteria:

* Presence of a cardiac pacemaker, implanted defibrillator, or other implanted electronic device.
* Inability to provide consent (either by the patient, spouse, or an identified power of attorney).
* Age under 18 years.
* Pregnancy.

Primary outcomes:
measure: Jaw Opening
timeFrame: Change from before starting first treatment to after completing last treatment, usually completed over 8 weeks.
measure: Jaw Opening
timeFrame: Average change from before to after each 20-minute treatment session.
measure: Oromandibular Dystonia Questionnaire
timeFrame: Change from before the first treatment to after the last treatment, usually over 8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Edward Burton, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06955104: Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0108+C2407 in Patients With Dyslipidemia
Official title: A Multi-center, Randomized, Double-blind, Parallel, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0108+C2407 in Patients With Dyslipidemia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Dyslipidemia
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2025-05-02
Enrollment: 106
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: A Multi-center, Randomized, Double-blind, Parallel, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0108+C2407 in Patients with Dyslipidemia

Detailed description: To evaluate the efficacy and safety of JW0108+C2407 in dyslipidemia patients

Eligibility criteria: Inclusion Criteria:

* Age of 19 years old at the time of written informed consent
* Patients with dyslipidemia

Exclusion Criteria:

* Secondary dyslipidemia
* Patient who does not meet the specified TG, LDL-C level

Primary outcomes:
measure: Percent change from baseline in LDL-C
timeFrame: Week 8
Secondary outcomes:
measure: Efficacy and Safety: Change from baseline in LDL-C (mg/dL)
timeFrame: Week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT03530904: Comparison Between Early and Late Mobilization After Cardiac Device Implantation
Official title: Comparison Between Early and Late Post-operative Mobilization Following Implantation of Cardiac Pacemaker or Defibrillator
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pacemaker, Artificial
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Mobilization after cardiac implantable electronic devices (CIED) implantation is highly variable between centers, some discharging home after 3-4 hours while others request bed restriction for 24 hours. Concern about lead dislodgements due to early mobilization are probably not justified. Bed restriction may result in considerable inconvenience to the patients.

Detailed description: Mobilization after cardiac implantable electronic devices (CIED) implantation is highly variable between centers, some discharging home after 3-4 hours while others request bed restriction for 24 hours. Concern about lead dislodgements due to early mobilization are probably not justified. Bed restriction may result in considerable inconvinience to the patients.

Patients will be randomally assigned to early mobilization (after 4 hours) or bed restriction till the morning after the procedure.

Primary outcome: lead malfunction, patients' satisfaction

Eligibility criteria: Inclusion Criteria:

All patients undergoing device implantation and are hemodynamically stable

Exclusion Criteria:

* hemodincamically unstable
* patient's request

Primary outcomes:
measure: Lead dislodgement
timeFrame: one month
Secondary outcomes:
measure: Patients' comfort level
timeFrame: one month
Other outcomes:
Locations:
Study officials:
References: