louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06866652: Evaluating Dyspnea in Autoimmune Myasthenia Gravis "why Am I Short of Breath?"
Official title: Evaluating Dyspnea in Autoimmune Myasthenia Gravis "why Am I Short of Breath?"
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myasthenia Gravis
Dyspnea
Keywords: dyspnea
breathlessness
respiratory
Lead sponsor: Institut de Myologie, France
Sponsor class: OTHER
Collaborators: name: APHP
First posted: 2025-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age ≥18 Confirmed diagnosis of autoimmune MG Shortness of breath in daily life: score 1 or 2 on the respiration item on the MG- activities of daily living score

Brief summary: Individuals with MG (IwMG) experience shortness of breath that may be activity-related, occur at rest and even happen during sleep. Dyspnea is a complex, multidimensional and multifactorial symptom involving sensory perception, cognition and emotion. Identifying the cause(s) of dyspnea in MG may assist in finding therapeutic strategies, reducing discomfort, improving QoL and potentially limiting respiratory deterioration and incidence of MG crisis.

Detailed description: MYaResp is a prospective observational, cross-sectional study to evaluate dyspnea in adults with autoimmune myasthenia gravis.

Study aims include to:

* Describe the characteristics of dyspnea in IwMG
* Understand contributing factors and factors associated with dyspnea in IwMG including the relationship between patient-reported dyspnea, disease severity and functional limitations.
* Determine the most effective tests to identify the causes and contributing factors of dyspnea

Eligibility criteria: Inclusion Criteria:

* Age ≥18
* Confirmed diagnosis of autoimmune MG
* Shortness of breath in daily life: score 1 or 2 on the respiration item on the MG- activities of daily living score
* Signed consent form
* Affiliated to or beneficiary of a social security scheme

Exclusion Criteria:

* Known Pregnancy
* Known respiratory disorder (other than MG)
* Recent (within past 4 weeks) respiratory infection
* Current MG crisis or exacerbation (necessitating increase in MG medication \&/or hospital admission)
* No dyspnea - score 0 or 3 on the respiration item on the MG- activities of daily living score
* Severe cognitive impairment/guardianship

Primary outcomes:
measure: Dyspnea questionnaires
timeFrame: baseline
Secondary outcomes:
measure: cardiopulmonary exercise test
timeFrame: baseline
measure: Polysomnography
timeFrame: baseline
measure: Functional measures
timeFrame: baseline
measure: Quality of life questionnaires
timeFrame: baseline
measure: Anxiety and depression
timeFrame: baseline
Other outcomes:
measure: impact of myasthenia in daily living
timeFrame: baseline
measure: Respiratory pressures
timeFrame: baseline
Locations:
city: Paris
country: France
facility: Institute of Myology
Study officials:
References:
Clinical trial NCT06072352: Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline
Official title: A Multicenter Randomized Controlled Trial Comparing Routine Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline to Decrease Maternal and Neonatal Infection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Maternal Infection During Pregnancy
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 3500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Maternal infection during pregnancy is one of the leading causes of maternal mortality, accounting for 10.7% of maternal deaths worldwide (\~37,000 annually). Majority of maternal infection occurs during intrapartum (36%) and postpartum (47%) period, of which the genital tract is the source of infection in 89% of intrapartum and 54% of postpartum sepsis.

Introduction of skin flora into the genital tract during vaginal examination in women with rupture of membranes or active labour may cause intrapartum and puerperal sepsis. We hypothesize intrapartum vulval and perineal cleansing before vaginal examination could reduce the chance of peripartum infection caused by introducing the skin flora to intrauterine environment.

We plan to carry out a randomized controlled trial of intrapartum vulval and perineal cleansing using chlorhexidine, compared sterile water, prior to vaginal examination during labour and its effect on maternal and neonatal sepsis.


Eligibility criteria: Inclusion Criteria:

* All women age ≥ 18 years old
* Live singleton pregnancy
* Planned vaginal delivery
* Term in labour (after 37+0 weeks of gestation)
* Availability of GBS result at 35-37 weeks

Exclusion Criteria:

* Preterm delivery (between 24+0 to 36+6 weeks of gestation)
* Multiple pregnancy
* Presence of fever before onset of labour
* History of antibiotics use 7 days before onset of labour
* History of adverse reaction to chlorhexidine
* Planned Caesarean delivery
* Planned delivery in other units
* Women with autoimmune disease, immunodeficiency, human immunodeficiency virus or on long term steroids
* Stillbirth
* Known genital herpes
* Genital wart during pregnancy

Primary outcomes:
measure: A composite of endometritis, wound infection, or other infection
timeFrame: delivery to within six weeks of delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02219152: Topical Instillation of Tranexamic Aacid in Bronchoscopy to Decrease Bleeding During Entobronchial & Transbronchial Biopsiy: a Prospective Double Blind Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bronchoscopy Biopsy
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Bleeding during transbronchial ro endobronchial biopsy is rather a common complication.

Mostly this is an insignificant bleeding, but in 3% of the biopsies there is a substantial amount of bleeding that requires a special treatment or follow up.

The goal of this study is to examine whether submission of tranexamic acid during the biopsy could diminish the amount of bleeding.


Eligibility criteria: Inclusion Criteria:

* Patient that are candidates to endobronchial or transcronchial biopsy

Exclusion Criteria:

* S/P MI or CVA or PE or DVT .
* S/P thrombophilia.
* Patients under coagulation therpay
* Chronic Renal Failure
* Pregnancy

Primary outcomes:
measure: amount of bleeding
timeFrame: participants will be followed for the duration of hospital stay, an expected average of one day
Secondary outcomes:
measure: amount of erythrocytes
timeFrame: participants will be followed for the duration of hospital stay, an expected average of one day
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Neville Berkman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05705752: Balance Training Vs Pilates Training
Official title: Effects on Balance of a Specific Training in Balance and Pilates: a Quasi-randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance Training
Keywords: Pilates
Balance training
Physiotherapy
Prevention
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Many pathologies present balance disturbances, however, other types of therapies such as Pilates are increasingly used within the Physiotherapy profession. It is therefore necessary to know the effects that this type of exercise has compared to the traditional method of balance training in order to make good use of this type of therapy.

The objective of the study will be to know if there are differences between both types of training on the balance of the participants.


Eligibility criteria: Inclusion Criteria:

* University students between 18 and 35 years.

Exclusion Criteria:

* Diseases or patologies that affect balance.
* Professional sportmen.
* Having suffered an injury 6 months prior to the intervention.

Primary outcomes:
measure: Y Balance Test
timeFrame: 0 week
measure: Y Balance Test
timeFrame: 5 week
Secondary outcomes:
measure: Emery test
timeFrame: 0 week, 5 week
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Faculty of Physiotherapy of the University of Valencia
Study officials:
affiliation: University of Valencia
name: David Hernández-Guillén, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02649452: Acute Effects of Vibration on Shoulder Flexibility - Experimental Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Whole body Vibration
Lead sponsor: Universiti Tunku Abdul Rahman
Sponsor class: OTHER
Collaborators: name: Universiti Tunku Abdul Rahman
First posted: 2016-01-07
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Whole body vibration (WBV) can help to improve muscle flexibility by stimulating the neuromuscular functions. But there is a dearth in the literature to prove its effectiveness in improving the flexibility of the upper limb muscles. Therefore the purpose of the study is to determine the effects of vibration on improving upper limb flexibility. This experimental research will be conducted by recruiting participants at the age of 19 to 27 with no histories of injuries on the upper limb. They will be randomly assigned into two groups; experimental (with vibration) and control (no vibration) group. The WBV machine will be used to provide vibration to the upper extremities by placing both palms on the vibration platform. The outcome measure of active chest flexibility and shoulder reach flexibility will be performed pre and post vibration.


Eligibility criteria: Inclusion Criteria:

* ages of 19 to 28
* no athletic background

Exclusion Criteria:

* shoulder pain and injury within 12 months, recent back pain and neck pain, recent fever and high blood pressure.

Primary outcomes:
measure: Active Chest Flexibility test
timeFrame: one minute
measure: Shoulder Reach Flexibility test
timeFrame: one minute
Secondary outcomes:
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Universiti Tunku Abdul Rahman
state: Selangor
Study officials:
References:
Clinical trial NCT02745652: Carpel Tunnel Syndrome and Physical Therapy Modalities
Official title: Pulsed Magnetic Field Versus Ultrasound in Treatment of Postnatal Carpal Tunnel Syndrome: Randomized Control Trial on Female Egyptian Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: median nerve
wrist joint
carpal tunnel
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 55
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Carpel tunnel syndrome (CTS) is very common complain during pregnancy with high percentage to continue postnatal. Conservative treatment is more recommended in these cases. There are many physical therapy modalities proposed to treat CTS without knowing which modality is better than the other. So the aim of this study to compare the effect of two modalities in treating CTS in postnatal females.

Detailed description: Carpal tunnel syndrome (CTS) is one of the most common peripheral nerve entrapment disorders in the upper limb. CTS is common during pregnancy especially in the third trimester as well, a significant percentage of females postnatal may still have some complaints up to at least 3 years postnatal.

Purpose: To compare the effect of pulsed magnetic field (PEMF) versus ultrasound (US) in treating patients with CTS. Forty postnatal female patients with idiopathic CTS were assigned randomly into two equal groups. One group received PEMF with nerve and tendon gliding exercises for the wrist 3 times for week for 4 weeks. The other group received US plus the same exercises. Pain level, sensory and motor distal latencies of the median nerve (MSDL and MMDL), sensory and motor conduction velocities of the median nerve (MSCV and MMCV), functional status scale and hand grip strength were assessed pre and post treatment

Eligibility criteria: Inclusion Criteria:

* Mild to moderate CTS
* Positive electro diagnostic findings: prolonged median motor distal latency (MMDL) above 4 ms, and below 6ms.
* Prolonged median sensory distal latency above 3.5 ms .
* Positive Phalen and Tinel test.
* Subjects scored pain intensity more than 5 in visual analogue scale (VAS).

Exclusion Criteria:

* severe cases with delayed motor distal latency \> 6ms.
* Orthopedic or neurological disorders of neck or the upper limb as cervical radiculopathy.
* Pronator teres syndrome or double crush syndrome.
* Pre- existing CTS before their last pregnancy, current pregnancy.
* Diabetic neuropathy and Thoracic outlet syndrome.
* Wasting of thenar muscles, ulnar neuropathy.
* Rheumatoid arthritis, previous fractured carpal bone and previous surgery in the forearm especially transverse ligament release

Primary outcomes:
measure: Pain intensity
timeFrame: 4 weeks change from the baseline scores
Secondary outcomes:
measure: Functional status scale
timeFrame: 4 weeks change from the baseline scores
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04605432: FFI and PR Could Improve Bowel Cleansing.
Official title: Face-to-face Instructions and Personalized Bowel Cleansing Regimens for Inpatients Could Improve Bowel Preparation Quality.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Preparation
Keywords: bowel preparation; face-to-face instruction; personalized intervention
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 320
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: background:The use of enhanced instruction can improve the efficiency of education for bowel preparation regimens. Researchers hypothesized that face-to-face instruction and personalized intervention for inpatient could improve successful bowel preparation rate and patient's compliance with regimens.

Methods:This was an endoscopist-blind,randomized controlled trial. 320inpatients were randomized 1:1 in one of the two study groups. The intervention group received face-to-face instruction and personalized intervention for bowel preparation protocol, while control group received the standard bowel preparation protocol. Patients'demographics, bowel preparation quality, colonoscopy completion and attendance were recorded. Logistic regression was performed to identify predictors of bowel preparation failure.


Eligibility criteria: Inclusion Criteria:

* Inpatients undergoing colonoscopy.
* patients older than 18 years.

Exclusion Criteria:

* prior surgery of colorectal resection;
* suspected colonic stricture or perforation;
* incomplete or complete bowel obstruction;
* use of prokinetic agents or purgatives within 7 days;
* Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis and toxic megacolon;;
* pregnancy or lactation;
* Inability to prepare bowel;
* unable to give informed consent.

Primary outcomes:
measure: Quality of Bowel Preparation
timeFrame: 1 Day of colonoscopy
Secondary outcomes:
measure: adverse events
timeFrame: The day of colonoscopy and the day before
measure: cecal intubation rate
timeFrame: 1 Day of colonoscopy
measure: polyp detection rate
timeFrame: 1 Day of colonoscopy
measure: cecal intubation time
timeFrame: 1 Day of colonoscopy
measure: withdrawal time
timeFrame: 1 Day of colonoscopy
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo No. 1 Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT03061032: Treatment of Hepatitis C Virus Infection With Generic Sofosbuvir/Ledipasvir in Iranian Patients
Official title: Open-label Study of Efficacy and Safety of Generic Sofosbuvir/Ledipasvir±Ribavirin in Iranian Patients With Hepatitis C Virus Genotype 1 Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatitis C
Lead sponsor: Iran Hepatitis Network
Sponsor class: OTHER
Collaborators: name: Baqiyatallah Research Center for Gastroenterology and Liver Diseases
First posted: 2017-02-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hepatitis C virus (HCV) infection with around 0.5% and 2.2% prevalence in Iran and world is one of the public health problems resulting in chronic liver disease, cirrhosis and hepatocellular carcinoma. All cases of chronic HCV infections are candidates of treatment to prevent advanced liver diseases. The previous Pegylated-interferon and Ribavirin therapy was not efficient in all cases and results in numerous number of side-effects. Introduction of direct acting antiviral agents (DAAs) such as Sofosbuvir and Ledipasvir make the eradication of HCV possible however these regimens are not affordable and available in developing countries. The generic DAAs are manufactured in many of these countries such as Iran to provide the treatment with reasonable price.


Eligibility criteria: Inclusion Criteria:

* Chronic HCV infection
* \>18 years old

Exclusion Criteria:

* HIV co-infected
* Liver transplanted
* Receiving drugs with suspected interactions

Primary outcomes:
measure: Sustained Virologic Response
timeFrame: 12 weeks after completion of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Iran Hepatitis Network
name: Seyed Moayed Alavian, MD
role: STUDY_CHAIR
affiliation: Iran Hepatitis Network
name: Heidar Sharafi, PhD
role: STUDY_DIRECTOR
affiliation: Iran Hepatitis Network
name: Bita Behnava, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Iran Hepatitis Network
name: Mohammad Saeid Rezaee-Zavareh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01144832: Irritable Bowel Syndrome (IBS) Treatment With H1-receptor Antagonists
Official title: IBS Treatment With H1-receptor Antagonists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Keywords: visceral hypersensitivity
mast cells
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2010-06-16
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose:

To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the H1-receptor antagonist ebastine.

Design:

Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment with ebastine 20mg once daily or placebo (1:1 randomization).

End points:

End point is the effect of treatment on clinical symptoms and visceral hypersensitivity which will be evaluated with a barostat test.


Eligibility criteria: Inclusion Criteria:

* Irritable Bowel Syndrome (ROME III criteria)
* age 18-65 years

Exclusion Criteria:

* medication: antidepressants or H1-receptor antagonists
* pregnancy, breast feeding
* co-morbidity: severe kidney- and/or liver disease

Primary outcomes:
measure: Effect of treatment on visceral sensitivity measured with rectal barostat.
timeFrame: after 12 weeks treatment
Secondary outcomes:
measure: Effect of treatment on IBS symptoms.
timeFrame: after 12 weeks treatment
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University hospitals Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Catholic University Leuven
name: Guy Boeckxstaens, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wouters MM, Balemans D, Van Wanrooy S, Dooley J, Cibert-Goton V, Alpizar YA, Valdez-Morales EE, Nasser Y, Van Veldhoven PP, Vanbrabant W, Van der Merwe S, Mols R, Ghesquiere B, Cirillo C, Kortekaas I, Carmeliet P, Peetermans WE, Vermeire S, Rutgeerts P, Augustijns P, Hellings PW, Belmans A, Vanner S, Bulmer DC, Talavera K, Vanden Berghe P, Liston A, Boeckxstaens GE. Histamine Receptor H1-Mediated Sensitization of TRPV1 Mediates Visceral Hypersensitivity and Symptoms in Patients With Irritable Bowel Syndrome. Gastroenterology. 2016 Apr;150(4):875-87.e9. doi: 10.1053/j.gastro.2015.12.034. Epub 2016 Jan 2.
Clinical trial NCT07013032: Diagnostic and Prognostic Value of Reticulated Platelet Fraction in Ventilator-Associated Pneumonia (REPLAY-VAP)
Official title: Diagnostic and Prognostic Value of Reticulated Platelet Fraction in Patients With Ventilator-Associated Pneumonia: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ventilator-Associated Pneumonia
Lead sponsor: Konya City Hospital
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill adult patients (aged 18 years and older) who are mechanically ventilated for more than 48 hours in the intensive care unit and diagnosed with ventilator-associated pneumonia (VAP).

Brief summary: Ventilator-associated pneumonia (VAP) is a serious infection that occurs in patients who have been on mechanical ventilation for more than 48 hours in the intensive care unit (ICU). Early and accurate diagnosis is critical to reduce complications and improve outcomes. This prospective observational study aims to evaluate the diagnostic and prognostic value of reticulated platelet fraction (RP%) in patients diagnosed with VAP. Blood samples will be taken as part of routine care, and RP% levels will be analyzed using a standard hematology analyzer. The study will investigate whether RP% can help identify VAP earlier and predict outcomes such as mortality and response to antibiotics.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Receiving mechanical ventilation for more than 48 hours
* Diagnosed with ventilator-associated pneumonia (VAP) according to clinical, radiologic, and laboratory criteria

Exclusion Criteria:

* Diagnosis of pneumonia upon ICU admission
* Pneumonia as the primary reason for initiation of mechanical ventilation
* Mechanical ventilation duration less than 48 hours
* Pregnant or breastfeeding patients
* Presence of chronic inflammatory conditions, hematologic disorders, malignancy, autoimmune disease, or immunosuppressive/chemotherapy/radiotherapy treatment within the past 4 weeks

Primary outcomes:
measure: Diagnostic accuracy of reticulated platelet fraction (RP%) in diagnosing ventilator-associated pneumonia (VAP)
timeFrame: Within 48 hours of VAP diagnosis
Secondary outcomes:
measure: Correlation between baseline RP% and 28-day all-cause mortality
timeFrame: 28 days from VAP diagnosis
Other outcomes:
Locations:
Study officials:
References: