louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05933317: A Long-term Follow-up Study of Pulmonary Function Changes Using Phase-resolved Functional Lung MRI in Patients With COVID-19
Official title: A Long-term Follow-up Study of Pulmonary Function Changes Using Phase-resolved Functional Lung MRI in Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Function
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inpatients and outpatients with COVID-19

Brief summary: So far, the number of COVID-19 infections worldwide has exceeded 700 million. Long-term damage to the lungs is a major sequela of COVID infection. Pulmonary function testing is an important means for the evaluation of lung damage. MRI examinations with free breathing and no contrast agent can prevent patients from suffering from ionizing radiation damage caused by multiple CT examinations.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years; Sign the informed consent; Patients diagnosed with COVID-19 by nucleic acid test and survived to be discharged; Complete clinical data during hospitalization.

Exclusion Criteria:

* Patients with bacterial pneumonia; Patients with MRI contraindications.

Primary outcomes:
measure: QDP, VDP
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Tao Ouyang, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT06987617: Pilot Study to Investigate the Impact of an App on the Quality of Life and Symptoms of Individuals Affected by Menopause
Official title: Pilot Study to Investigate the Impact of an App on the Quality of Life and Symptoms of Individuals Affected by Menopause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopausal and Other Perimenopausal Disorders
Keywords: Menopause
Digital Therapeutics
Quality of Life
Lead sponsor: Endo Health GmbH
Sponsor class: INDUSTRY
First posted: 2025-05-23
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study explores the impact of a digital app for the self-management of (peri-)menopausal disorders. A total of 224 participants were randomized into an intervention and a control group. Findings indicate that the app offers beneficial effects on menopausal symptoms and menopause-specific quality-of-life. The study also provided valuable insights for the design of future larger trials and highlights the promising potential of the app to enhance individualized care.


Eligibility criteria: Inclusion Criteria:

* Legal capacity
* Residency in Germany
* Female sex
* Age ≥18 years
* Known and medically confirmed (peri-)menopausal disorder (N95.1, N95.3, N95.8, N95.9)
* Ownership of a smartphone and ability to use it
* Internet access for app usage and questionnaire completion
* Email address for registration
* Willingness to complete questionnaires online
* Motivation for regular app usage
* Sufficient proficiency in the German language
* Absence of exclusion criteria

Exclusion Criteria:

* Changes in hormone therapy within eight weeks before the start of the study and/or planned within the next 12 weeks
* Changes in antidepressant treatment within eight weeks before the start of the study and/or planned within the next 12 weeks
* Previous or current access to the Endo-App or other comparable digital health applications, or current active prescription
* Current participation in other clinical studies
* Failure to meet the inclusion criteria

Primary outcomes:
measure: Menopause-specific Quality of Life Questionnaire (MENQOL)
timeFrame: From enrollment (baseline) to the end of treatment at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chemnitz
country: Germany
facility: Endo Health GmbH
state: Saxony
Study officials:
References:
Clinical trial NCT04643717: Evaluation of pupillometrY for External Ventricular Drains Stop
Official title: Evaluation of pupillometrY for External Ventricular Drains Stop
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: All Indication for External Ventricular Drain Clamping
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who have benefited from an external ventricular bypass, whatever the indication, and for whom the doctor in charge prescribes a clamping test.

Brief summary: Placement of an external ventricular shunt is one of the most common neurosurgical procedures in neuro-resuscitation. However, the modalities of its withdrawal are not, the subject of recommendations but rather of service habits. It has been recently demonstrated that pupillary monitoring by an electronic pupillometer was more reliable than standard clinical monitoring in brain injury patients. This tool provides access to a rich pupillary semiology at the patient's bed.

So the goal is to study the evolution of the various pupillary parameters analyzed by the electronic pupillometer during the external ventricular shunt weaning tests and to highlight the predictive factors of failure.


Eligibility criteria: Inclusion Criteria:

* All patients for whom the doctor orders an external ventricular bypass clamp test
* Neuro-injured patients and non-neuro-injured patients whose state of health requires sedation and mechanical ventilation

Exclusion Criteria:

* Ophthalmological pathology making impossible to carry out measurements by the pupillometer (chemosis, eyelid edema, enucleation, etc.).
* Pregnant woman.

Primary outcomes:
measure: The difference in pupillary contraction speed during the photomotor reflex measured by electronic pupillometer as a function of the outcome of the External ventricular lead clamping test
timeFrame: 48 HOURS
Secondary outcomes:
measure: Comparison of the pupillometry parameters between neuro wronged's patients and not neuro wronged's patients (parameters measured by pupillometer)
timeFrame: 48 HOURS
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital La Timone
city: Saint-Pierre
country: France
facility: CHU de la Réunion
Study officials:
References:
Clinical trial NCT03248817: Phenylephrine Infusion in Cesarean Delivery
Official title: Comparison of Different Protocols of Phenylephrine Infusion for Prophylaxis Against Post-spinal Hypotension During Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cesarean Section Complications
Spinal Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 255
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: the investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop of reactive hypertension occurred) and single shot (1.5 mcg/Kg) phenylephrine

Detailed description: Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Phenylephrine (PE) is the most popular vasopressor for prevention of post-spinal hypotension (PSH) during CD; however, the most appropriate protocol for PE administration is still unknown. The most common PE protocols used for prophylaxis against PSH are: single shot, fixed infusion, and variable infusion. A recent study reported that a dose of 1.5 mcg/Kg is the most suitable single-shot dose for prophylaxis. Another randomized controlled trial compared four doses of PE infusion and reported that 25 mcg/Kg/min and 50 mcg/Kg/min doses were the best doses for fixed infusion with accepted incidence of both PSH as well as reactive hypertension. Using variable infusion rate of PE had been recently introduced in another study with a starting dose of 0.75 mcg/Kg/min. The variable rate infusion showed very good results regarding PSH. In this study, the investigators will compare variable infusion of PE (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop if reactive hypertension occurred) and single shot protocol (1.5 mcg/Kg)

Eligibility criteria: Inclusion Criteria:

* Full term
* Pregnant women
* Scheduled for cesarean delivery

Exclusion Criteria:

* Pre-eclampsia
* Eclampsia
* Hemorrhage
* Cardiac dysfunction
* Baseline low heart rate (below 60 bpm)

Primary outcomes:
measure: Incidence of Post-spinal anesthesia hypotension
timeFrame: 30 minutes after spinal anesthesia
Secondary outcomes:
measure: Incidence of severe Post-spinal anesthesia hypotension
timeFrame: 30 minutes after spinal anesthesia
measure: Incidence of reactive hypertension
timeFrame: 2 hours after spinal anesthesia
measure: systolic blood pressure
timeFrame: 2 hours after spinal anesthesia
measure: diastolic blood pressure
timeFrame: 2 hours after subarachnoid block
measure: heart rate
timeFrame: 2 hours after subarachnoid block
measure: APGAR score
timeFrame: 10 minutes after delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Head of research committee section in anesthesia department
name: Ahmed Mukhtar, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03148717: Preoperative vs. Postoperative Rectal Misoprostol in Cesarean Section
Official title: Preoperative vs. Postoperative Rectal Misoprostol in Cesarean Section: A Randomized, Double Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Neonatal Outcome
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This prospective double-blind placebo-controlled randomized clinical trial will be conducted at Ain-Shams University Maternity Hospital from April 2017 till December 2017. Group 1 women, candidates for cesarean section, will receive preoperative rectal 400 microgram of misoprostol, and Group 2 women will receive postoperative rectal 400 microgram of misoprostol.

2017. 120 women candidate foe elective cesarean section will receive preoperative sublingual 400 microgram of misoprostol, and another 120 women will receive postoperative sublingual 400 microgram of misoprostol.


Eligibility criteria: Inclusion Criteria:

1. Patients candidate for cesarean section.
2. Full term pregnancies (GA 37- 42 Wks).
3. Age (18-40 yrs).
4. body mass index (BMI) (20-30(Kg/m2 .

Exclusion Criteia:

1. Contraindication to spinal anesthesia.
2. Blood dyscrasias.
3. Large fibroids.
4. Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
5. Emergency CS such as fetal distress
6. Extreme of BMI (\<20 or \>30 Kg/m2 ).

Primary outcomes:
measure: Neonatal outcome
timeFrame: 5 minutes
Secondary outcomes:
measure: NICU admission
timeFrame: 24 hours
measure: amount of blood loss
timeFrame: 24 hours
measure: Postpartum hemorrhage
timeFrame: 24 hours
measure: Need for extra uterotonics
timeFrame: 24 hours
Other outcomes:
measure: APGAR score at 1 minute
timeFrame: 1 minute
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT03083717: Application of Nanotechnology and Chemical Sensors for Diagnosis of Decompensated Heart Failure by Respiratory Samples
Official title: Application of Nanotechnology and Chemical Sensors for Diagnosis of Decompensated Heart Failure by Respiratory Samples
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from compensated heart failure (stable) Patients with decompensated acute heart failure Healthy subjects

Brief summary: Application of Nanotechnology and Chemical Sensors for Diagnosis of Decompensated Heart Failure by Respiratory Samples.

Breath testing, which links specific volatile molecular biomarkers in exhaled breath to medical conditions, is becoming increasingly popular as a non-invasive and potentially inexpensive diagnostic method for various diseases. NA-NOSE performs odor detection from exhaled breath, thus producing a distinct fingerprint for each mixture of analytes.

Several studies have been published, stating the advantages of these sensors, leading to promising outcomes in several fields.

The NA-NOSE breath test would be fast (examination and results would be obtained within 5-10 min), inexpensive, eventually portable (smaller than desktop computer), non-invasive and free of any side effects.


Eligibility criteria: Inclusion Criteria:

* signed informed consent
* ≥ 18 years of age, male or female
* Left ventricular Ejection fraction less than 40% or known to suffer from heart failure with preserved ejection fraction
* In decompensated heart failure group: dyspnea with confirmation of pulmonary congestion/edema by chest x-ray

Exclusion Criteria:

* Pericardial diseases, e.g. constrictive pericarditis, tamponade
* Significant congenital heart disease, up to the investigator's opinion
* Life-threatening or uncontrolled arrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter with a resting ventricular rate \>110 beats per minute.
* Acute ST elevation myocardial infarction
* Pregnant women
* Patients with pulmonary embolism
* Probable alternative diagnoses that in the opinion of the investigator could account for patient's HF symptoms (i.e., dyspnea), such as:

  1. significant pulmonary disease
  2. anemia with hemoglobin \<10 g/dl
* participation in another study

Primary outcomes:
measure: Detection of volatile organic compounds in breath samples
timeFrame: Each participant's breath sample will be analysed within one week of collection.
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Attending physician, Cardiology Unit, Rambam Health Care Campus
name: Manhal A Habib, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02852317: Urinary Markers of Detrusor Overactivity in Spina Bifida Patients
Official title: Urinary Markers of Detrusor Overactivity in Spina Bifida Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spina Bifida
Multiple Sclerosis
Spinal Cord Injury
Overactive Bladder
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient with an urodynamic examination scheduled

Brief summary: The purpose of this study is to assess diagnostic performance of urinary markers of detrusor overactivity (Nerve Growth Factor (NGF), Brain-Derived Neurotrophic Factor (BDNF), adenosine triphosphate (ATP), Prostaglandine E2) in detected high pressure bladder un spina bifida patients.


Eligibility criteria: Inclusion Criteria:

Study arm:

* Spina bifida patient
* Seen consecutively in outpatient clinics
* Age \> 18 years-old

Control arm:

* Patients with multiple sclerosis or spinal cord injury or overactive bladder
* Seen consecutively in urodynamics
* with lower urinary tract symptoms
* Age \> 18 years-old

Exclusion Criteria:

* Positive urine culture
* History of urologic neoplasms
* History of interstitial cystitis

Primary outcomes:
measure: Accuracy of urinary markers will be evaluated by area under the curve (AUC)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre hospitalier universitaire de Rennes
Study officials:
References:
Clinical trial NCT06609317: Postpartum pElvic Assisted Recovery With Leva
Official title: Feasibility of Pelvic Floor Muscle Training With a Digital Therapeutic Motion-based Device (Leva Device) in a Postpartum Population
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postpartum Pelvic Floor Function and Symptoms
Keywords: postpartum pelvic muscle training
postpartum pelvic floor
postpartum pelvic floor physical therapy
postpartum urinary incontinence
postpartum bowel incontinence
postpartum pelvic floor recovery
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal of this prospective cohort study is to evaluate the feasibility of postpartum pelvic floor muscle training using an FDA-cleared digital therapeutic motion-based device.

In addition to assessing feasibility, investigators also will evaluate bladder and bowel function, pelvic organ prolapse symptoms, and vaginal and perineal pain in the immediate postpartum period and at 3 and 6 months postpartum. Investigators also will assess sexual function at 3 and 6 months postpartum.

Participants will use the motion-based device for postpartum pelvic floor muscle training and will complete electronically administered surveys at 3 and 6 months postpartum.


Eligibility criteria: Inclusion Criteria:

* Spontaneous vaginal delivery within the last 4-8 weeks
* Age ≥ 18 years
* Ambulatory
* Willing and able to consent to participate.
* English speaking
* Owns a smartphone

Exclusion Criteria:

* Operative or cesarean delivery
* Obstetric delivery at less than 20 weeks gestation
* Third- or fourth-degree perineal laceration
* Episiotomy
* Multiples

Primary outcomes:
measure: Feasibility
timeFrame: From enrollment to 6 months postpartum
measure: Perineal Pain
timeFrame: From enrollment to 6 months postpartum
Secondary outcomes:
measure: Bladder function
timeFrame: From enrollment to 6 months postpartum
measure: Bowel Function
timeFrame: From enrollment to 6 months postpartum
measure: Pelvic Organ Prolapse
timeFrame: From enrollment to 6 months postpartum
measure: Vaginal pain
timeFrame: From enrollment to 6 months postpartum
measure: Sexual function
timeFrame: From enrollment to 6 months postpartum
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00919217: Exploratory Study on the Timing of Multiple Sclerosis (MS) Symptoms
Official title: Exploratory Study on the Timing of MS Symptoms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis
MS
Relapsing-remitting multiple sclerosis
RR-MS
Women
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2009-06-12
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females with relapsing-remitting multiple sclerosis, not menopausal, neither pregnant nor nursing, not treated with steroids in the last 30 days and not on experimental medications

Brief summary: The investigators' overall hypothesis is that appearance or worsening of relapsing-remitting multiple sclerosis (RR-MS) symptoms are affected by various factors including stress, hormonal cycles, illness and missed medications.

Detailed description: Fluctuations in MS symptoms in women with RR-MS might be affected by a variety of factors. To determine which factors are important, we are asking subjects to fill out a diary and calendar on a daily basis for 90 days. After an initial instructional meeting over the phone, the materials are filled out at home and returned monthly via postage-paid envelopes provided by the study. Compensation ($10 gift card) is sent after each monthly diary is received. The diary includes a list of symptoms and a rank scale for the women to show subtle changes in MS symptoms. The calendar allows the subject to denote additional factors such as stress, hormonal cycles, illnesses or immunizations and changed or missed medications. We anticipate that statistical analysis will reveal which of these factors affect women with relapsing-remitting multiple sclerosis.

Eligibility criteria: Inclusion Criteria:

* females
* diagnosed with relapsing-remitting multiple sclerosis

Exclusion Criteria:

* male
* no diagnosis of relapsing-remitting MS
* diagnosis of any other autoimmune disease or fibromyalgia
* peri-, post-, or surgically menopausal
* pregnant within past year or nursing
* history of chemotherapy
* on experimental medications
* treatment with steroids in the last 30 days

Primary outcomes:
measure: number of days with appearance or worsening of symptoms
timeFrame: 3 months
Secondary outcomes:
measure: timing of appearance or worsening of symptoms
timeFrame: 3 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville (recruiting nationwide)
state: Kentucky
Study officials:
affiliation: University of Louisville, Dept. Biology
name: Cynthia Corbitt, PhD
role: PRINCIPAL_INVESTIGATOR
References: