louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03726502: Comparing Uretersocopy With Versus Without Use of Guide-wire in Treatment of Ureteral Stone
Official title: Comparing Uretersocopy With Versus Without Use of Guide-wire in Treatment of Ureteral Stone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureteral Calculi
Keywords: Ureteral Calculi
safety guide-wire
ureteroscopy
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone

Detailed description: While there are some retrospective studies compared ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone, there is not randomized clinical trial in this regard. This study was designed to compare the efficacy and safety of ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone

Eligibility criteria: Inclusion Criteria:

* ureteral stone who underwent ureteroscopy

Exclusion Criteria:

* transplant kidney
* coagulopathy disorders
* history of ureteral stenosis
* skeletal disorders

Primary outcomes:
measure: stone free rate
timeFrame: 3 months after surgery
Secondary outcomes:
measure: operation time
timeFrame: at time of surgery
measure: grade of kidney hydronephrosis
timeFrame: 3 months after surgery
measure: ureteral injury
timeFrame: at time of surgery
Other outcomes:
Locations:
city: Tehrān
country: Iran, Islamic Republic of
facility: Shahid beheshty university of medical sciences
Study officials:
affiliation: Shahid beheshty university of medical sciences
name: Abbas Basiri, prof
role: STUDY_CHAIR
References:
Clinical trial NCT02483221: Postoperative Pain Therapy With Hydromorphone TCI-PCA vs. Morphine PCA
Official title: Phase 4 Study of Postoperative Pain Therapy With Hydromorphone Using Patient-Controlled Target-Controlled Infusion (TCI-PCA) vs. Patient-Controlled Analgesia (PCA) With Morphine After Elective Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Postoperative Pain
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2015-06-26
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of postoperative pain with hydromorphone (a strong analgesic) using patient-controlled analgesia with target-controlled infusion compared to conventional patient-controlled analgesia with morphine after elective cardiac surgery


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Scheduled for elective cardiac surgery involving thoracotomy and subsequent ICU stay

Exclusion Criteria:

* Administration of other analgesics or sedatives, if not administered in stable dosages for at least 14 days or if not used for premedication and surgery
* Administration of hydromorphone or morphine in the period between screening and surgery
* Severe hepatic or renal impairment in medical history
* BMI\>= 35 ASA\>= 4

Primary outcomes:
measure: Numerical Rating Score
timeFrame: up to 17 hours after extubation
Secondary outcomes:
measure: Modified Observer's Assessment of Alertness/Sedation Scale
timeFrame: up to 17 hours after extubation
measure: Postoperative Nausea and Vomiting
timeFrame: day of surgery
measure: Respiratory Frequency
timeFrame: up to 17 hours after extubation
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Anesthesiology, University Hospital Erlangen
state: Bavaria
Study officials:
affiliation: Department of Anesthesiology, University Hospital Erlangen
name: Christian Jeleazcov, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ihmsen H, Schuttler J, Jeleazcov C. Pharmacokinetics of Morphine and Morphine-6-Glucuronide During Postoperative Pain Therapy in Cardiac Surgery Patients. Eur J Drug Metab Pharmacokinet. 2021 Mar;46(2):249-263. doi: 10.1007/s13318-020-00663-z. Epub 2021 Feb 5.
Clinical trial NCT03989921: Ovarian Reserve and Embryo Implantation
Official title: Ovarian Reserve and Embryo Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Reserve
IVF
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 598
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population concerned is all young patients, defined as being under 35 years old, who have benefited from IVF in the 2 inclusion centres (Centres d'Aide Médicale à la Procréation des CHU de Nîmes and the Saint Roch clinic in Montpellier) between 01/01/2014 and 30/06/2015.

Brief summary: Compare, in young patients with In vitro fertilization (IVF), the rate of embryo implantation by early culture transfer (J2-J3) between 2 groups of patients: "normo responders" vs. "poor responders".


Eligibility criteria: Inclusion Criteria:

* IVF patient managed with or without ICSI between 01/01/2014 and 30/06/2015 in one of the two study centres
* Age \< 35 years old
* Fresh transfer of at least one embryo between D2 and D6
* patients who have already received one or more transfer attempts.

Exclusion Criteria:

* No fresh transfer (Freeze All, segmentation failure, stimulation failure)
* Double successive embryo transfer (e. g. J3-J5). We did not retain these cases because if only one of the 2 embryos is implanted, it is not possible to know which transfer it corresponds to.
* Maternal serum FSH determination \< 4 IU/ml at D3 in the baseline balance sheet (hypogonadotropic hypogonadism)

Primary outcomes:
measure: The embryo implantation rate at 5 weeks after transfer is defined by the presence of an embryo with objective cardiac activity by ultrasound
timeFrame: 5weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHUNimes
Study officials:
References:
Clinical trial NCT00156221: MR Scanning of Very Young Children With Severe Developmental Disorders
Official title: MR Scanning of Very Young Children With Severe Developmental Disorders (Autistic Spectrum Disorders and/or Mental Retardation and/or Language Disorders)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism
Mental Retardation
Language Disorder
Keywords: Autism
MRI
Developmental Disorders
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Netherlands Organisation for Scientific Research
name: The Dutch Brain Foundation
First posted: 2005-09-12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY
Time perspective: OTHER

Brief summary: The specific is to study the MR morphologic and spectroscopic brain correlates and predictors of development in children with severe developmental disorders (autistic spectrum disorders and/or mental retardation and/or language disorders). Given the frequently observed association of autism with known medical conditions, particularly in cases with comorbid mental retardation and in cases with atypical autism (Rutter et al., 1994; Gillberg, 1995), children with suspected autism or related developmental disorders will be asked to participate in an extensive state of the art laboratory work-up which includes T1 and T2 weighted MRI of the brain. MRI data will be analyzed both qualitatively, looking for focal abnormalities and degree of myelination, and quantitatively, measuring volumes of total brain, cerebellum, ventricles and grey and white matter. For research purposes, the work-up will be supplied with proton Magnetic Resonance Spectroscopy (MRS) of the brain. This data set provides the opportunity to chart brain-behavior relationships in young children with suspected autism and related PDD cross-sectionally.


Eligibility criteria: Inclusion Criteria:

* Age 18 months to 7 years
* Diagnosis of autism spectrum disorder, a language disorder or mental retardation

Exclusion Criteria:

* Significant motor or sensory impairment
* Major physical abnormalities
* History of serious head injury
* Identifiable neurologic disorder
* Metal implants
* Contraindication for MRI

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Herman van Engeland, PhD, MD
role: STUDY_CHAIR
affiliation: UMC Utrecht
name: Mijke Zeegers, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05734521: Avalglucosidase Alfa Pregnancy Study
Official title: A Descriptive Safety Study Based on Data Collected From Women and Their Offspring Exposed to Nexviazyme/Nexviadyme (Avalglucosidase Alfa-ngpt/Avalglucosidase Alfa) During Pregnancy and/or Lactation in the Postmarketing Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pompe Disease
Pregnancy
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women and their offspring exposed to avalglucosidase alfa during pregnancy and/or lactation

Brief summary: This is a worldwide, descriptive safety study collecting data on women and their offspring exposed to avalglucosidase alfa during pregnancy and/or lactation, to assess the risks of avalglucsodiase alfa on pregnancy and maternal complications and adverse effects in the developing fetus, neonate, and infant.

* Outcomes in exposed infants, including growth and development, will be assessed through at least the first year of life.
* Data will be collected for approximately 10 years.

Detailed description: Study Design Time Perspective: Retrospective and Prospective

Eligibility criteria: Inclusion Criteria:

* Women and their offspring exposed to avalglucosidase alfa during pregnancy and/or lactation for whom an Individual Case Safety Report (ICSR) has been submitted to the Sanofi Global Pharmacovigilance (PV) department, and/or,
* Women exposed to avalglucosidase alfa during pregnancy and/or lactation who have provided informed consent to enroll in the Pompe Pregnancy Sub-registry.

Exclusion Criteria:

There are no exclusion criteria in this study.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Primary outcomes:
measure: Maternal complications
timeFrame: through study completion, an average of 10 years
measure: Pregnancy outcome
timeFrame: through study completion, an average of 10 years
measure: Infant outcome
timeFrame: through study completion, an average of 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Investigational site worldwide
state: New Jersey
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT03434821: Hyperoxemia and Ventilator-associated Pneumonia
Official title: Impact of Hyperoxemia on Incidence of Ventilator-associated Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation
Keywords: Hyperoxemia
ventilator-associated
pneumonia
critical illness
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients hospitalized in intensive care unit requiring invasive mechanical ventilation (IV) for more than 48 hours.

Brief summary: The aim of this prospective cohort single-center observational study is to determine the impact of hyperoxemia on ventilator-associated pneumonia (VAP) occurrence.

* SpO2 will be continuously recorded in order to determine the percentage of time spent with hyperoxemia.
* Patients with VAP will be prospectively identified.
* Patient characteristics and risk factors for VAP will be prospectively collected.
* Oxidant stress will be prospectively investigated in study patients: glutathion peroxidase (GPX), plasmatic superoxyde dismutase (SOD), total plasmatic antioxidant status (SAT) and urinary 8-isoprostanes will be performed at ICU admission, once a week, and at VAP occurrence.

Patients with VAP will be compared with those with no VAP


Eligibility criteria: Inclusion Criteria:

* Adult patients admitted to the ICU
* Expected duration of mechanical ventilation \> 48h
* Signed informed consent
* Social insurance

Exclusion Criteria:

* Pregnancy or breast feeding
* No informed consent
* Hyperbaric oxygen treatment
* Prisoners and patients under guardianship

Primary outcomes:
measure: VAP occurrence
timeFrame: 28 days after ICU admission
Secondary outcomes:
measure: percentage of time spent with hyperoxemia during ICU stay
timeFrame: 28 days after ICU admission
measure: relationship between hyperoxemia at ICU admission and the presence of acute lung injury (ALI)
timeFrame: 28 days after ICU admission
measure: percentage of time spent with hyperoxemia during ICU stay, and the presence of acute lung injury
timeFrame: 28 days after ICU admission
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU de Lille
Study officials:
affiliation: University Hospital, Lille
name: Saad Nseir, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03765021: Tranexamic Acid vs Fractional CO2 Laser in Post-acne Hyperpigmentation
Official title: Tranexamic Acid Versus Fractional CO2 Laser in Post-inflammatory Hyperpigmentation in Acne Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Inflammatory Hyperpigmentation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 25
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: comparing between the effect of intradermal injection of TXA and low power low density fractional CO2 lasers on post acne hyperpigmentation

Detailed description: Randomized controlled split-face study. One side of the face will be assigned to TXA intradermal microinjection using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will be prepared under sterile conditions. Injections will be applied intradermally on hyperpigmented areas at 1cm intervals. The injection will be repeated every two weeks for three months. The other side of the face will be randomly assigned to low power fractional CO2 laser with a power of 12 watts, spacing 700 micrometers (low density), and dwell time 300 microsecond every four weeks for three months.

Eligibility criteria: Inclusion Criteria:

* Egyptians of both sexes.
* Age \> 18.
* Patients who can avoid sun exposure one week after sessions.
* Patients who stopped taking systemic isotretinoin for more than six months.

Exclusion Criteria:

* Pregnancy and lactation.
* Concomitant use of anticoagulants.
* Bleeding disorders.
* Personal or family history of DVT or thromboembolic events.
* Scarring and keloid tendency.
* Active skin infection, active HSV.
* History of photosensitivity or photosensitizing medication.
* Occupational sun exposure.

Primary outcomes:
measure: Measurement of melanin index to assess change of post-acne hyperpigmentation
timeFrame: 3 months
measure: Measurement of erythema index to assess change of post-acne hyperpigmentation
timeFrame: 3 months
measure: Measurement of post-acne hyperpigmentation index to assess change of post-acne hyperpigmentation
timeFrame: 3 months
measure: Patient satisfaction score to assess change of post-acne hyperpigmentation
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Tawfic SO, Abdel Hay R, Salim H, Elmasry MF. Tranexamic acid versus fractional carbon dioxide laser in post-acne hyperpigmentation. Dermatol Ther. 2021 Nov;34(6):e15103. doi: 10.1111/dth.15103. Epub 2021 Sep 6.
Clinical trial NCT00131521: Comparison of Different Mucoactive Agents for the Care of the Intubated Patient in a Surgical Trauma Intensive Care Unit
Official title: Comparison of Different Mucoactive Agents for the Care of the Intubated Patient in a Surgical Trauma Intensive Care Unit: A Randomized, Double Blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mucus Obstruction
Intubation
Keywords: mucus obstruction, ventilator management
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2005-08-18
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study compares N-acetylcysteine (mucomyst) and sodium chloride to determine their efficacy in the prevention of pulmonary mucus obstruction and retention in intubated patients admitted to the surgical trauma intensive care unit (STICU).


Eligibility criteria: Inclusion Criteria:

* Intubated and admitted to the Surgical Trauma Intensive Care Unit (STICU)
* Subjects must be eligible to start treatment within 24 hours of their initial intubation

Exclusion Criteria:

* Patient anticipated to be extubated within 24 hours following STICU admission
* Hypersensitivity to acetylcysteine.
* Pregnancy

Primary outcomes:
measure: prevention of pulmonary mucus obstruction
Secondary outcomes:
measure: days of mechanical ventilation
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Univesity Hospital
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: John G. Myers, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00559221: FLAG+Ida With G-CSF Priming for Patients Younger Than 60 Years With Resistant AML
Official title: Fludarabine and Cytarabine as Continuous Infusion Plus Idarubicin With Granulocyte-Colony Stimulating Factor (G-CSF) Priming for Patients Younger Than 60 Years With Resistant Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: AML
Lead sponsor: Cooperative Study Group A for Hematology
Sponsor class: NETWORK
First posted: 2007-11-16
Enrollment: 37
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: - To determine the feasibility of fludarabine and cytarabine as continuous infusion plus idarubicin with granulocyte-colony stimulating factor priming for patients with resistant acute myeloid leukemia other than acute promyelocytic leukemia

Detailed description: - The feasibility will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.

Eligibility criteria: Inclusion Criteria:

* Failure to achieve CR after initial induction chemotherapy including standard dose cytarabine.
* Early relapse, occurring after a first CR lasting less than 12 months.
* Patients with multiple relapses will be included.
* Written informed consent must be given.
* 15 and 60 years of age.
* 2 or less by ECOG performance scale.

Exclusion Criteria:

* acute promyelocytic leukemia
* pregnant or lactating

Primary outcomes:
measure: Complete remission rate, duration of complete remission, toxicities
timeFrame: 06/2008
Secondary outcomes:
measure: progression-free survival, overall survival
timeFrame: 06/2008
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Ulsan Universtity Hospital, ROK
name: Hawk Kim, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim H, Lee JH, Joo YD, Bae SH, Lee JH, Kim DY, Lee WS, Ryoo HM, Jo JC, Choi Y, Lee KH; CoOperative Study Group A for Hematology (COSAH). A prospective, multicenter phase II study of continuous infusion of FLAG for patients older than 60 yr with resistant acute myeloid leukemia: a comparison with intensive younger patients' trial. Eur J Haematol. 2016 Feb;96(2):188-97. doi: 10.1111/ejh.12568. Epub 2015 May 6.
Clinical trial NCT05383521: Safety and Efficacy of Two Oral Tinidazole Regimens for Refractory Trichomonas Vaginitis
Official title: Oral Tinidazole Treatment of Refractory Trichomonas Vaginitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trichomonas Vaginitis
Keywords: Refractory Trichomonas Vaginitis
Tinidazole
Lead sponsor: Peking University Shenzhen Hospital
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: For patients who failed to conventional treatment (recommended by the guidelines including tinidazole, 2g once daily for 5-7 days), the following regimens were selected: Tinidazole , 2g twice daily for 14 days. At the same time, metronidazole, 400 mg, daily, vaginal administration for 14 days.

Tinidazole , 1g three times daily for 14 days. At the same time, metronidazole, 400 mg, daily, vaginal administration for 14 days.
Primary purpose: TREATMENT

Brief summary: We compare two oral tinidazole regimens for refractory trichomonas vaginitis.

Detailed description: Refractory trichomonas vaginitis has become a clinical problem, which has a direct impact on the health and life of patients. Refractory trichomonas vaginitis is mainly caused by drug resistance of trichomonas. Drug resistant trichomonas has appeared China. Increasing the dosage of anti trichomonal drugs is the main treatment method at present. The aim of this study was to evaluate the efficacy and safety of two oral tinidazole regimens for refractory trichomonas vaginitis.

Eligibility criteria: Inclusion Criteria:

* Women be at least 18 years of age
* Failure of conventional treatment (recommended by guidelines including tinidazole, 2g once daily for 5-7 days)

Exclusion Criteria:

* Allergy to metronidazole or tinidazol
* Pregnant or nursing
* HIV or other chronic disease

Primary outcomes:
measure: Cure rate of refractory trichomoniasis
timeFrame: 24 weeks
Secondary outcomes:
measure: Safety of tinidazole tablets
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Peking
country: China
facility: Beijing Obstetrics and Gynecology Hospital,Capital Medical University
city: Peking
country: China
facility: Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
city: Peking
country: China
facility: Peking University First Hospital
Study officials:
affiliation: Peking University Shenzhen Hospital
name: Shangrong Fan Fan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: