louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02186145: Efficacy and Safety Study of Metronidazole, Nystatin and Dexamethasone Combination Therapy in Bacterial and Fungal Vaginal Infections
Official title: Single Blind Randomized Study of Efficacy and Safety of Vaginal Cream With Association of Metronidazole, Nystatin and Dexamethasone in the Treatment of Bacterial and Fungal Vaginal Infections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bacterial Vaginosis
Fungal Vaginal Infections
Lead sponsor: Marjan Industria e Comercio ltda
Sponsor class: INDUSTRY
First posted: 2014-07-10
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of association of metronidazole, nystatin and dexamethasone in the treatment of bacterial and fungal vaginal infections.


Eligibility criteria: Inclusion Criteria:

* Post-menarche women and premenopausal women, between 18 and 50 years old;
* Diagnosis of bacterial vaginosis (Amsel criteria), fungal (positive KOH test)or mixed vaginal infection;
* Patients who have regular menstrual cycles (patients with regular menstrual cycles with intervals between 21 to 35 days, duration of 1 to 7 days)

Exclusion Criteria:

* Patients who have a known hypersensitivity to components of the formula ;
* Pregnant and lactating women ;
* Patients with other vaginal infections, such as infection by Trichomonas vaginalis , C. trachomatis, Neisseria gonorrhoeae , herpes or HPV.
* Knowledge of positive test result for human immunodeficiency virus ;
* Patients in treatment of cervical intraepithelial neoplasia or carcinoma of the cervix ;
* Patients who have undergone gynecological procedures in the month prior to inclusion (such as cauterization of the cervix , cervical biopsy, high-frequency surgery) ;
* Patients with other vaginal or vulvar conditions that may confound interpretation of clinical response;
* Patients who received intravaginal or systemic antimicrobial or antifungal therapy 14 days before randomization ;
* Patients on immunosuppressive medications (such as corticosteroids , cyclosporine , etc. ) ;
* Known or suspected cancer ;
* Participation in any experimental study or ingestion of any experimental drug 12 months before the start of this study.

Primary outcomes:
measure: Therapeutic cure
timeFrame: Day 21-35
Secondary outcomes:
measure: Evaluation on vulvovaginal inflammation
timeFrame: 21 - 35 days
Other outcomes:
Locations:
city: Santo André
country: Brazil
facility: Faculty of Medicine of ABC (FMABC)
state: SP
Study officials:
References:
Clinical trial NCT06048445: Placement of Biliary Drainage Stent to Prevent Biliary Intestinal Anastomosis After Liver Transplantation in Children
Official title: Placement of Biliary Drainage Stent to Prevent Biliary Intestinal Anastomosis After Liver Transplantation in Children: A Prospective Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Liver Transplant; Complications
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 108
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pediatric patients need liver transplantation

Brief summary: Liver transplantation is an effective method for treating end-stage liver disease and metabolic diseases in children. With the advancement of surgical techniques and the improvement of perioperative management, the survival rates of patients and grafts after liver transplantation have significantly improved. However, the complication of biliary stenosis after transplantation is as high as 7.3% -33.3%, and in severe cases, it can even lead to graft failure and patient death. Therefore, the occurrence of biliary stenosis after liver transplantation seriously affects the quality of life of children, increases the economic burden on families, and urgently needs to find effective methods to reduce the occurrence of this complication.

Based on the clinical practice of our center, we believe that the placement of biliary external drainage stents has the following advantages: 1 Reduce intrahepatic biliary pressure and reduce the occurrence of postoperative biliary fistula; 2. The stent has a supporting effect and can maintain the open state of the bile duct; 3. By external drainage, the quality of bile secretion by the liver can be evaluated; 4. Provide a pathway for cholangiography. However, placing external biliary drainage may also pose certain risks, including increasing surgical procedures, stent detachment causing biliary fistula, and increasing the risk of infection.

This study aims to observe the effect of placing external biliary drainage stents on biliary stricture after liver transplantation in children. The aim is to evaluate the preventive effect of external biliary drainage stents on biliary intestinal anastomotic stenosis after liver transplantation in children, and to provide evidence-based evidence for reducing biliary complications in children.


Eligibility criteria: Inclusion Criteria:

1. The patient underwent liver transplantation surgery at the First Affiliated Hospital of Zhejiang University School of Medicine;
2. Age ≤ 6 years old;
3. First liver transplantation;
4. Willing to sign an informed consent form.

Exclusion Criteria:

- Existence of mental illnesses that can affect cognition and coordination.

Primary outcomes:
measure: duct-jejunum anastomotic stoma stricture
timeFrame: one year
Secondary outcomes:
measure: biliary tract infection
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03815045: Ultrasound Guided Diagnostic Lumbar Puncture in Neurology
Official title: Ultrasound Guided Diagnostic Lumbar Puncture in Neurology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lumbar Puncture
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Subjects who are having a lumbar puncture as part of their clinical care will be randomized to either a traditional landmark based lumbar puncture or ultrasound guided lumbar puncture. The primary objective of study is to compare the success rate of obtaining CSF using Ultrasound guided technique against the Traditional Landmark based approach. Secondary objectives are to evaluate factors influencing the success or failure, patient tolerance, and a safety assessment.

Detailed description: Seventy-two subjects will be randomized into either a traditional landmark-based lumbar puncture or an ultrasound-guided lumbar puncture for obtaining CSF. This study will be conducted in the Neurology clinic. For subjects in the traditional group, the site of needle entry will be determined through palpation of the spine. For subjects in the ultrasound group, site entry will be done using ultrasound guidance. Success and failure of these techniques will be compared along with secondary outcome measures aimed at assessing the safety and efficacy of each of these techniques.

Eligibility criteria: Inclusion Criteria:

* Patient scheduled for LP through Neurology's LP clinic
* 18 years of age or older
* Able to understand the description of procedure and provide informed consent

Exclusion Criteria:

* Any contraindications to doing a standard lumbar puncture; which typically includes risk of bleeding from effects of anticoagulants or bleeding disorders or an infection at the potential site of entry in the back. This includes subjects with spinal cord stimulators.

Primary outcomes:
measure: Success rate of obtaining CSF within 3 attempts
timeFrame: During the baseline visit, approximately 1 hour
Secondary outcomes:
measure: Time to completion of LP, in minutes
timeFrame: Immediately following consent, during baseline visit, approximately 1 hour
measure: Number of attempts to obtain CSF
timeFrame: Immediately following consent, during baseline visit
measure: Incidence of traumatic tap
timeFrame: Time taken to run analysis of CSF RBC count, approximately within 1 day
measure: Pain after the procedure
timeFrame: Immediately post-procedure, approximately 5 minutes
measure: Occurrence of post LP headache
timeFrame: Phone call within 72 hours of procedure
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References:
Clinical trial NCT04400045: Low Dose Treosulfan Based Conditioning Regimen in HSCT for Nijmegen Breakage Syndrome
Official title: Clinical Open-label Phase 2 Study of Low Dose Treosulfan Based Conditioning Regimen Efficacy in Hematopoietic Stem Cell Transplantation for Children With Nijmegen Breakage Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nijmegen Breakage Syndrome
Lead sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to evaluate the safety and efficacy of low dose treosulfan based conditioning regimen in HSCT in Nijmegen breakage syndrome

Detailed description: Nijmegen breakage syndrome (NBS) is a DNA repair disorder. The only curative option for combine immunodeficiency in NBS is allogeneic hematopoietic stem cell transplantation (HSCT). Standard myeloablative conditioning regimens in DNA repair disorders lead to increased morbidity and mortality after HSCT. Low doses of alkylators are used to reduce toxicity rates, which, however, increase the risks of mixed chimerism and graft failure. The data of treosulfan usage in NBS are sparse. To evaluate the safety and efficacy of low dose treosulfan based conditioning regimen in NBS, treosulfan 21g/m2 in combination with fludarabine 150mg/mg, cyclophosphamide 40mg/kg, thymoglobulin (Genzyme) 5mg/kg and rituximab 100mg/m2 will be used from day -6 to -1 day, followed by stem cell infusion. The primary endpoint is event-free survival, where graft failure, death, and malignancies are considered as events.

Eligibility criteria: Inclusion Criteria:

1. Patients aged ≥ 3 months and \< 21 years
2. Patients diagnosed with NBS eligible for an allogeneic HSCT
3. Signed written informed consent signed by a parent or legal guardian

Primary outcomes:
measure: Event-free survival
timeFrame: 3 years after HSCT
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years after HSCT
measure: Cumulative incidence of engraftment
timeFrame: 100 days
measure: Cumulative incidence of graft failure
timeFrame: 3 years
measure: Cumulative incidence of viral infections
timeFrame: 1 year
measure: Cumulative incidence of acute graft versus host disease
timeFrame: 1 year
measure: Cumulative incidence of chronic graft versus host disease
timeFrame: 3 years
measure: Incidence of early organ toxicity
timeFrame: 100 days
measure: Cumulative incidence of transplant related mortality
timeFrame: 3 years
measure: Incidence of long-term toxicity
timeFrame: 3 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: HSCT department
Study officials:
References:
Clinical trial NCT03990545: Vessel Wall MR Imaging to Explore Sex-Differences of Intracranial Arterial Wall Changes After Suspected Stroke
Official title: Vessel Wall MR Imaging to Explore Sex-Differences of Intracranial Arterial Wall Changes After Suspected Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Atherosclerosis
Acute Stroke
Transient Ischemic Attack
Keywords: intracranial atherosclerotic disease
acute stroke
transient ischemic attack
vessel wall imaging
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Suspected stroke patients

Brief summary: Despite advances in stroke care, women continue to face worse outcomes after stroke than men. This disparity in outcomes may be related to biologic sex-differences that manifest in the development and progression of atherosclerosis. Decades of cyclic changes in the hormonal milieu lead to different metabolic profiles in women. These changes may also explain sex-differences in risk factor profiles of atherogenesis and plaque composition. The investigators' objective is to conduct a cross-sectional MR imaging study of suspected stroke patients to compare the burden and composition of intracranial atherosclerosis and risk factors between men and women. Results from this study are expected to show that sex and sex-specific risk factors should be considered at the outset of stroke evaluation for risk-stratification. In the era of precision medicine, the investigators propose the role of sex should be a starting point in the clinical evaluation of stroke.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years
* Suspected stroke patients
* No contraindications for an MRI exam or gadolinium intravenous contrast
* No need for an emergent interventional treatment (e.g., thrombectomy)

Exclusion Criteria:

* Younger than 18 years
* Pregnant

Primary outcomes:
measure: Prevalence of intracranial arterial wall abnormalities by sex.
timeFrame: 1 day (Evaluated at time of clinical presentation).
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jae W Song, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00760045: Clinical Pharmacological Study of AL-43546 Ophthalmic Product in Subjects With Shortened Tear Film Break Up Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Disease
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to observe lacrimal fluid condition (tear film break-up time) chronologically after a single dose of AL-43546 ophthalmic products（0.15%, 0.25% and vehicle）and 0.1% sodium hyaluronate ophthalmic solution and compare lacrimal fluid retention time between them.


Eligibility criteria: Inclusion Criteria:

* Subjects with NIBUT of either eye is 8 seconds or less and other eye is 10 seconds or less at screening test and NIBUT of either eye before instillation in Period I is 10 seconds or less.

Exclusion Criteria:

* Diagnosis of severe Sjogren's syndrome (history of the use of punctal plug one time or more, etc.) in either eye.
* Subjects who will use ophthalmic solutions (excluding the specified artificial tear) or ophthalmic ointment in either eye during the study period.

Primary outcomes:
measure: The change from baseline of non-invasive tear film break up time (ΔNIBUT: seconds).
timeFrame: Up to 180 minutes
Secondary outcomes:
measure: Ocular comfort
timeFrame: After installation
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka Pharmacology Clinical Research Hospital
Study officials:
References:
Clinical trial NCT01300845: Trial Aiming at Assessing the Effect of Humidification on the Comfort of the Patient Receiving an Oxygen Therapy
Official title: Prospective, Randomized, Multi-center Trial Aiming at Assessing the Effect of Humidification on the Comfort of the Patient Receiving an Oxygen Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxygen Inhalation Therapy
Keywords: Oxygen mask
Oxygen cannula
Humidification
Oxygen therapy
Intensive Care Unit
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2011-02-23
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In France, the most used humidifying system during oxygen therapy is a non heated device with weak efficiency and non-proven clinical benefits. This study aims to assess the lack of benefits of non-heated humidification compared to no humidification, as regards to the comfort of the patient receiving oxygen therapy.


Eligibility criteria: Inclusion Criteria:

* Admission in Intensive Care Unit
* Oxygen therapy started for less than two hours in ICU

Exclusion Criteria:

* Age under 18
* Pregnancy
* Participation in other trials with the same endpoints
* absence of registration in french health care system
* patient protected by law
* tracheotomised or intubated patient
* Patient with non invasive ventilation
* Oxygen therapy started for more than two hours in ICU
* moribund

Primary outcomes:
measure: A score of comfort assessed with a detailed and specific questionnaire
timeFrame: This score is assessed between the sixth and the eighth hour after randomization
Secondary outcomes:
measure: The specific scores of comfort for each items
timeFrame: Hour 6-8
measure: Observance level for oxygen therapy
timeFrame: Hour 6-8
measure: Percentage of patients requiring a fibroscopic aspirations during their stay in intensive care unit or USC within the limits of 28 days.
timeFrame: Department discharge limited by day 28
measure: Percentage of patients requiring an intubation during their stay in intensive care unit or USC within the limits of 28 days.
timeFrame: Department discharge limited by day 28
measure: Percentage of patients who had an ear, nose and throat infections during their stay in intensive care unit or USC within the limits of 28 days.
timeFrame: Department discharge limited by day 28
measure: The patients who had a lesion of corneas during their stay in intensive care unit or USC within the limits of 28 days
timeFrame: Department discharge limited by day 28
measure: The length of stay in intensive care unit or USC
timeFrame: Department discharge limited by day 28
measure: mortality in intensive care unit or USC during ongoing stay within the limits of 28 days.
timeFrame: Department discharge limited by day 28
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
References:
Clinical trial NCT03187145: Ultrasound Evaluation of Gastric Emptying in Diabetic Patients
Official title: A Cohort Study of Ultrasound Evaluation of Gastric Emptying in Diabetic Patients: a Comparison With Healthy Controls
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study participants will be diabetic and non-diabetic patients whom are scheduled to undergo elective surgical procedures or heathy control. 150 participants will be recruited in total.

Brief summary: This is a prospective cohort study. The main objective is to compare the frequency of a "full stomach" in the diabetic population compared to healthy controls 2 h after clear liquid and 6h after a light meal, and evaluate the mean gastric emptying time of clear liquid and light meal in diabetic patients.


Eligibility criteria: Inclusion Criteria:

* Diabetic and non-diabetic Patients scheduled for elective surgery aged 18 to 85years American Society of Anesthesia physical status classification I to III Body mass index \< 40 kg/ cm2.

Exclusion Criteria:

* Pregnancy (currently or within the past 3 months) Previous surgery of the upper gastrointestinal tract Achalasia

Primary outcomes:
measure: Number of patients with full stomach
timeFrame: one day
Secondary outcomes:
measure: the mean gastric emptying time of clear liquid and light meal
timeFrame: one day
Other outcomes:
measure: Correlation of diabetes mellitus complications with delayed stomach empty
timeFrame: one day
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT02906345: TPE in Septic Patients and Influence on Organ Failure
Official title: "Analyses on the Effectiveness and Technical Optimization of Therapeutic Plasma Exchange for Patients With Septic Shock, With Special Emphasis on Influencing the Kidney, Liver and Nervous System Through the Extracorporeal Therapy"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Organ Failure
Keywords: Septic shock
Fresh frozen plasma
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 30
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: Therapeutic plasma exchange (TPE) should used for patients with septic shock in a controlled, prospective study focusing on the organ functions of the patients.

Detailed description: Therapeutic plasma exchange (TPE) should used for patients with septic shock in a controlled, prospective study.

Investigators will study three groups:

1. untreated control group;
2. TPE group, plasma separation carried out by filtration;
3. TPE group, plasma separation carried out by centrifugation.

All treated patients should treated two (minimal) to five times by TPE, depending on the need of norephinephrine for the therapy. For each session 40 ml/kg body weight plasma should be exchange. Fluid resuscitation will be done with fresh frozen plasma. The study will focusing on the organ functions of the patients, especially liver-, kidney- and nervous function and also displayed in the SOFA score on study days 3 and 7.

Eligibility criteria: Inclusion Criteria:

* Septic shock, beginning of shock \< 24 hours

Exclusion Criteria:

* Participation in an another clinical trial within the last 30 days
* Participation in this study at an earlier date
* Simultaneous participation in another clinical trial
* Pregnancy
* Unpredictable Bleeding (over 2 erythrocyte concentrates daily)
* Polyneuropathy (known before the beginning of sepsis)

Primary outcomes:
measure: SOFA score ≥ 2 Punkte
timeFrame: day 3
measure: SOFA score ≥ 2 Punkte
timeFrame: day 7
Secondary outcomes:
measure: 28-day survival
timeFrame: day 28
measure: Hospital survival
timeFrame: 1 year
Other outcomes:
measure: number of thrombocytes (DIC)
timeFrame: days 1-7, 14, 21, 28
measure: Haptoglobulin values
timeFrame: days 1-7, 14, 21, 28
Locations:
city: Rostock
country: Germany
facility: Intensive Care Units PIT 1+2, University Hospital Rostock
Study officials:
References: