louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02013102: A Phase Ⅳ Study of Decitabine in Myelodysplastic Syndrome
Official title: A Randomized, Controlled, Multi-center Collaborative Phase Ⅳ Study to Evaluate the Safety and Efficacy of Decitabine in Myelodysplastic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myelodysplastic Syndrome
Lead sponsor: Cttq
Sponsor class: INDUSTRY
First posted: 2013-12-17
Enrollment: 240
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: The purpose of this study is to evaluate of the safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.

Detailed description: Total subjects: 240, doseⅠgroup of 120 patients, doseⅡgroup of 120 patients. Subjects are stratified randomize. If necessary, participants accepted best supportive therapy.

Eligibility criteria: Inclusion Criteria:

* Age≥18;
* The diagnosis of MDS patients comply WHO2008 standards;
* IPSS score≥0.5;
* WHO classification for patients RCUD, RARS and transfusion-dependent RCMD;
* ECOG PS score: 0-2;
* Expected survival≥3 months;
* Serum bilirubin≤1.5\*ULN, serum ALT and AST≤2.5\*ULN, serum Cr≤1.5\*ULN;
* Subjects signed informed consent form in line with GCP requirements.

Exclusion Criteria:

* Can not marrow biopsy;
* Previously diagnosed AML;
* Received azacitidine or decitabine treatment any time before;
* Being diagnosed with other malignancies in the prior 12 months;
* Pregnant or lactating women;
* Failure to control systemic fungal, bacterial or viral infection;
* Known or suspected allergy to decitabine;
* Known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection;
* Have a history of neurological or psychiatric disorders, including epilepsy or dementia;
* CTCAE 3 or 4 degree peripheral neuropathy;
* According to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the patients completed the study in patients;
* Using other experimental drugs or participating in other clinical trials in the prior one months.

Primary outcomes:
measure: The safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.
timeFrame: 2-4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University General Hospital
name: Shao Zonghong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03931902: The Comparison of Laryngeal Mask Airway and Endotracheal Tube in General Anesthesia for Premature Neonates
Official title: The Comparison of Laryngeal Mask Airway and Endotracheal Tube in Premature Neonates Undergoing General Anesthesia for Inguinal Hernia Repair Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infant
Anesthesia
Respiratory Complication
Keywords: pediatric airway management
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 43
Sex: ALL
Maximum age (years): 52
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: To compare the perioperative respiratory adverse events between using laryngeal mask airway and endotracheal tube in preterm neonates receiving general anesthesia for hernia surgery.

Detailed description: The participant patients will be randomly allocated into two groups: the laryngeal mask airway group (LMA group) and endotracheal tube group (ETT group). Masking ventilation with sevoflurane will be used for anesthesia induction till the adequate anesthetic depth. Intubation with laryngeal mask airway (LMA) or endotracheal tube (ETT) will be done as allocated group. After the surgery completed and the patient wakened up, the anesthesiologist will remove the LMA or ETT according to the clinical criteria for extubation.

Eligibility criteria: Inclusion Criteria:

* preterm neonates (gestational age \< 37 weeks) in our neonatal ward scheduled to receive unilateral or bilateral inguinal hernia repair surgery, and whose body weight \> 2000g at surgery

Exclusion Criteria:

* emergent surgery, infants who was intubated before surgery, long-term oxygen or mechanical ventilation dependence, severe congenital cardiopulmonary disease, lacking of birth history, combination with other major surgery, postmenstrual age \> 52 weeks at surgery

Primary outcomes:
measure: Perioperative respiratory complication
timeFrame: from induction of anesthesia to postoperative 24 hours
measure: postoperative hospital stays
timeFrame: from postoperative day 1 up to postoperative day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
affiliation: Kaohsiung Medical University
name: Miaopei Su, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05333302: Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma
Official title: Pilot Study of CD19 CAR-T Cells Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma in Children/Young Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: B-cell Acute Lymphoblastic Leukemia
Lymphoblastic B-Cell Lymphoma
Keywords: immunotherapy
CAR-T cells
CD19
Lead sponsor: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to estimate the safety and the efficacy of CAR- T cells immunotherapy for children/young adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.

Detailed description: Locally manufactured second generation autologous CD19 CAR-T cells are used for immunotherapy. Protocol treatment includes lymphodepleting conditioning (fludarabine + cyclophosphamide) followed by one CAR-T cells intravenous infusion with tocilizumab premedication.

Eligibility criteria: Inclusion Criteria:

* CD19+ relapsed or refractory lymphoblastic leukemia/lymphoma;
* Karnofsky or Lansky performance scale greater or equal to 70;
* T-cells count in peripheral blood \>150 cells/µL;
* Written informed consent.

Exclusion Criteria:

* primary immunodeficiencies or genetic syndromes;
* neurologic diseases;
* autoimmune diseases or polyallergie;
* transfusion of donor lymphocyte less than 6 week before CAR-T cells infusion;
* GvHD grade 2-4;
* uncontrolled systemic infection;
* hypoxia (Sp02\<90%)
* severe hepatic dysfunction: ALT or AST \>=3x upper limit of normal for age;
* renal dysfunction: serum creatinine level \>=3x upper limit of normal for age;
* positive serology for human immunodeficiency virus (HIV), active hepatite C or B;
* pregnancy.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 1 month
Secondary outcomes:
measure: Objective Response Rate (ORR) (CR+CRi+CRm)
timeFrame: 28 days after CAR-T cells infusion
measure: Overall survival (OS)
timeFrame: 1 year
measure: Events free survival (EFS)
timeFrame: 1 year
measure: Leukemia free survival (LFS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
state: Minsk Region
Study officials:
affiliation: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
name: Olga Aleinikova, MD, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT06578702: Evaluation of Intermittent Triple Therapies in Real Life
Official title: Evaluation of Intermittent Triple Therapies in Real Life
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Infections
Keywords: HIV Infections
Intermittent Triple Therapy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subject (≥ 18 years old) living with HIV monitored at the Trait d'Union/Infectious Diseases department in Strasbourg and having benefited from intermittent triple therapy

Brief summary: The strategy of intermittent triple therapy for people living with HIV was validated in France following the randomized clinical trial QUATUOR. There is little data in real life, as shown in the meta-analysis of Parienti JJ et al.

Currently this strategy is proposed by some teams in France, but is not recommended internationally.

The research hypothesis is that intermittent treatment is an effective and safe option in a therapeutic lightening strategy in people living with HIV People living with HIV adults followed in Strasbourg who have benefited from intermittent treatment The expected results will consist of an improvement in knowledge on the efficacy and tolerance of this therapeutic strategy.


Eligibility criteria: Inclusion criteria:

* Adult subject (≥ 18 years old)
* Living with HIV monitored at the Trait d'Union/Infectious Diseases department in Strasbourg
* Having benefited from intermittent triple therapy between 01/01/2017 and 31/01/2024

Exclusion criteria:

* Subject (and/or their legal representative if applicable) having expressed their opposition to the reuse of their data for scientific research purposes.

Primary outcomes:
measure: Evaluation of HIV viral load
timeFrame: 48 weeks after reduction of the HIV viral load
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Le Trait d'Union - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT03882502: Electrical Stimulation in Traumatic Brain Injury (TBI) Induced Aphasia
Official title: The Effect of Transcranial Direct Current Stimulation (tDCS) on Naming Ability in Patients With Traumatic Brain Injury Induced Aphasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aphasia
TBI (Traumatic Brain Injury)
tDCS
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: P.A.N.-Zentrum
name: Unfallkrankenhaus Berlin
name: Kliniken Beelitz GmbH
First posted: 2019-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to investigate whether a tDCS-accompanied intensive naming therapy leads to a performance improvement in patients with chronic aphasia induced by a moderate TBI


Eligibility criteria: Inclusion Criteria:

* aphasia assessed by Aachener Aphasie Test (AAT) \> 6 month after moderate TBI
* Age: 18 - 80 years
* right handedness

Exclusion Criteria:

* dementia or other neurological diseases
* History of severe alcoholism or use of drugs
* Severe psychiatric disorders such as depression, psychosis (if not in remission)
* Severe untreated medical problems such as cancer

Primary outcomes:
measure: Naming ability assessed by
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University medicine Greifswald
Study officials:
affiliation: University Medicine Greifswald
name: Agnes Floeel, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06538402: Ileal Reservoir Length and Functional Outcome in Ileal Pouch-anal Anastomosis: An Assessor-blinded, Randomized Controlled Trial
Official title: Ileal Reservoir Length and Functional Outcome in Ileal Pouch-anal Anastomosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ulcerative Colitis
Familial Adenomatous Polyposis
Keywords: ileal pouch-anal anastomosis
ulcerative colitis
familial adenomatous polyposis
randomized controlled trial
pouch function
quality of life
complications
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled trial is to compare outcome after construction of an ileal (J-shaped) reservoir of 10 versus 15 centimeters in primary ileal pouch-anal anastomosis surgery.

Detailed description: The primary aim of this randomized controlled trial is to compare functional outcome in terms of bowel function correlated with quality of life for patients who undergo primary ileal pouch-anal anastomosis surgery with an ileal (J-shaped) reservoir length of either 10 cm or 15 cm.

Secondary aims include health-related quality of life measures and postoperative complications.

Eligibility criteria: Inclusion Criteria:

* Undergoing ileal pouch-anal anastomosis (IPAA) for ulcerative colitis or familial adenomatous polyposis (FAP) (implying a normal sphincter function as judged by history and clinical examination)
* Signed informed consent
* Able to perform both a small (10 cm) and medium-size (15 cm) pouch with adequate reach and no tension as determined subjectively by the surgeon intraoperatively

Primary outcomes:
measure: Pouch dysfunction score
timeFrame: 1, 3, 5 and 10 years after surgery
Secondary outcomes:
measure: Short Inflammatory Bowel Disease Questionnaire
timeFrame: 1, 3, 5 and 10 years after surgery
measure: Short-form (SF)-36
timeFrame: 1, 3, 5 and 10 years after surgery
measure: Postoperative complications using the Comprehensive Complication Index (CCI)
timeFrame: 90 days after surgery
measure: Pouch failure
timeFrame: 1, 3 and 5 years after surgery
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
References:
Clinical trial NCT01506102: Thromboelastography During and After Delivery
Official title: Determination of Thromboelastography Values in Pregnancy and After Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delivery Uterine
Lead sponsor: Città di Roma Hospital
Sponsor class: OTHER
First posted: 2012-01-09
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to establish reference values for thromboelastography (TEM-A) in healthy pregnant women during labor and 2 hours and 24 hours after delivery.

Detailed description: Previous, preliminary investigations by using thromboelastography, confirmed that pregnancy is a hypercoaguable state which remains in the first 24 hours postdelivery. Unfortunately results obtained by the existing studies that attempted to establish reference values for TEG suffer considerable bias.

The aim of this study will be to determine the range values for thomboelastography in pregnant women. Since there is no available information on the expected distribution of the outcome, a sequential design will be used. The main endpoint of the analysis will be a reliable estimate for the outcome expected in healthy women after labor. The investigators will state their target estimate as being reliable when the ratio between the estimate and its standard error is smaller than 2.

During labor, 2 hours after delivery and 24 hours postpartum, a venous blood sample will be taken from eligible women for thromboelastographic determination. Whole blood nonadditive TEM will be performed on the TEM-A automated thromboelastometer (Framar Biomedica,Rome, Italy) to obtain the four classical TEM parameters: reaction (R) time, k time, alpha angle and maximum amplitude (MA).

Inclusion criteria Healthy parturients in labor Exclusion criteria parturients who will eventually had: operative or instrumental vaginal delivery, estimated blood loss greater than 500 mL, the occurrence of II and III degree perineal lacerations, any coagulation disorder or anticoagulant therapy

Eligibility criteria: Inclusion Criteria:

* healthy parturients in labor

Exclusion Criteria:

* parturients with coagulation defects or anticoagulant therapy

Primary outcomes:
measure: TEM-A automated thromboelastometer, Framar Biomedica,Rome, Italy
timeFrame: 24 hours postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Città di Roma Hospital
Study officials:
affiliation: Città di Roma Hospital
name: Silvia Stirparo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04672902: Treatment of Mirizzi Syndrome
Official title: Single-operator Cholangioscopy and Electrohydraulic Lithotripsy for the Treatment of Mirizzi Syndrome: A Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mirizzi Syndrome
Cholelithiasis
Acute Cholecystitis
Lead sponsor: Tecnologico de Monterrey
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 3
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A 34-year-old female, A 54-year-old male, A 40-year-old female. with diagnosed Mirizzi Syndrome by an image study, with a concomitant common bile duct dilatation.

Brief summary: Mirizzi syndrome is an infrequent complication of long-standing cholelithiasis. Extrinsic compression of the common hepatic duct is usually caused by an impacted stone in Hartmann's pouch or cystic duct resulting in the development of cholecystobiliary fistula. This syndrome is classified based on the presence and severity of cholecystobiliary fistula. Mirizzi syndrome is challenging to diagnose preoperatively and may require complex biliary surgical procedures for resolution. Endoscopic treatment is a safe alternative with a high success rate. Single-operator cholangioscopy combined with lithotripsy has been shown to have a 90-100% success rate in the treatment of biliary stones. Herein, A single center experience treating Mirizzi syndrome with single-operator cholangioscopy guided electrohydraulic lithotripsy is presented. Difficult management of Mirizzi syndrome has led to research of new treatment options to minimize the risk of high rate complications. Single-operator cholangioscopy in combination with laser lithotripsy is an adequate and safe alternative for the treatment of this condition.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old
* Patients with a preoperative diagnosis of Mirizzi Syndrome
* Patients with a common bile duct dilatation

Exclusion Criteria:

* Patients younger than 18 years old
* Patients with an inconclusive biliary diagnosis
* Patients without a diagnosis of Mirrizi Syndrome
* Patients without common bile duct dilatation

Primary outcomes:
measure: Resolution of the common bile duct compression by an extrinsic gallbladder stone, with minimally invasive procedure such as single operator cholangioscopy, combined with lithotripsy
timeFrame: 2019-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Escuela Nacional de Medicina, Tecnologico de Monterrey
state: Nuevo Leon
Study officials:
References:
Clinical trial NCT05637502: Graded Motor Imagery in Women Diagnosed With Genito-Pelvic Pain Penetration Disorder
Official title: Graded Motor Imagery in Women Diagnosed With Genito-Pelvic Pain Penetration Disorder. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genito-Pelvic Pain/Penetration Disorder
Keywords: Genito-Pelvic Pain/Penetration Disorder
Pelvic pain
Dyspareunia
Graded Motor Imagery
Physical Therapy
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess the effects of a Graded Motor Imagery (GMI) programme in women diagnosed with Genito-Pelvic Pain Penetration (GPPD) Disorder.

The main questions it aims to answer are:

Does a GMI programme reduce pain intensity levels in women diagnosed with GPPPD? Does a GMI programme have an effect on sexual function in women diagnosed with GPPPD?

Participants will undergo a GMI programme and will be tested prior to and after the intervention to assess if the programme has a significant effect with regards to pain intensity and other pain-related outcome

Detailed description: Graded Motor Imagery has been extensively used in several populations suffering pain-related disorders. It triggers cortical stimulation gradually in order to have an effect on the alterations that might have occured due to pain

Women suffering from Genito-Pelvic Pain Penetration Disorder deal with persistent pelvic pain that is no longer responding to a noxious stimulus, therefore this clinical presentation could have several cortical alterations implicated.

The main goal of this study is to assess if a Graded Motor Imagery programme is able to reduce pain intensity and improve sexual function in women diagnosed with Genito-Pelvic Pain Penetration Disorder.

Eligibility criteria: Inclusion Criteria:

* Women diagnosed with persistent pelvic pain
* Pain suffered for a period of a minimum of 3 months
* Adult (\>18 years) women

Exclusion Criteria:

* Medical condition that logically explains the presence of pain
* Pain suffered for a period of less than 3 months

Primary outcomes:
measure: Pain Intensity
timeFrame: 6 weeks
measure: Sexual function
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
References:
Clinical trial NCT00284102: PEEP Test and Gas Exchange in ALI/ARDS Patients
Official title: Positive End Expiratory Pressure (PEEP) Test and Gas Exchange in ALI/ARDS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: gas exchange
dead space
respiratory failure
ALI/ARDS patients
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2006-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators aim to study the effect of different levels of PEEP in ALI/ARDS patients on gas exchange.

Detailed description: In a population of ALI/ARDS patients during mechanical ventilation we will evaluate the effect of different levels of PEEP on gas exchange and dead space.

Eligibility criteria: Inclusion Criteria:

* ALI/ARDS patients requiring mechanical ventilation

Exclusion Criteria:

* Hemodynamic instability
* Barotrauma

Primary outcomes:
measure: Gas exchange, dead space, respiratory mechanics
timeFrame: 5, 15, 30, 60 minutes from PEEP change
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Policlinico Hospital
Study officials:
affiliation: Policlinico Hospital
name: Davide Chiumello, MD
role: PRINCIPAL_INVESTIGATOR
References: