louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02161653: Metadoxine as a Therapy for Severe Alcoholic Hepatitis
Official title: Impact of Metadoxine in the Oxidative Stress and Early Mortality in Patients With Severe Alcoholic Hepatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Severe Alcoholic Hepatitis
Keywords: Severe alcoholic hepatitis
survival
oxidative stress
Lead sponsor: Hospital General de Mexico
Sponsor class: OTHER_GOV
First posted: 2014-06-12
Enrollment: 135
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: The purpose of this study is to determine whether metadoxine is effective for improve survival and reduced oxidative stress in patients with severe alcoholic hepatitis.


Eligibility criteria: Inclusion Criteria:

* Patients with clinical and biochemical criteria for severe alcoholic hepatitis: Total bilirubin greater than 5 mg/dl in absence of biliary tract obstruction evidenced by ultrasound, history of chronic alcohol intake, leukocytosis, neutrophilia, elevation of transaminases with an aspartate aminotransferase / alanine aminotransferase ratio equal or greater than 2, discriminant function greater than 32.

Exclusion Criteria:

* Diabetes, chronic kidney disease, hepatitis C, hepatitis B and or human immunodeficiency virus infection, asthma or history of atopy or allergic reactions, therapy in the previous two years with steroids, pentoxifylline, metadoxine, S-adenosyl L- methionine, antioxidants or multivitamins.

Primary outcomes:
measure: 30 day-survival
timeFrame: 30 days
measure: Malondialdehyde serum levels
timeFrame: 14 and 30 days
Secondary outcomes:
measure: 3 month-survival
timeFrame: 3 months
measure: 6 month-survival
timeFrame: 6 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital General de Mexico
state: D.f.
Study officials:
References:
citation: Higuera-de la Tijera F, Servin-Caamano AI, Serralde-Zuniga AE, Cruz-Herrera J, Perez-Torres E, Abdo-Francis JM, Salas-Gordillo F, Perez-Hernandez JL. Metadoxine improves the three- and six-month survival rates in patients with severe alcoholic hepatitis. World J Gastroenterol. 2015 Apr 28;21(16):4975-85. doi: 10.3748/wjg.v21.i16.4975.
Clinical trial NCT00379951: A Study to Assess the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-048)
Official title: A Prospective, Multicenter, Noncomparative, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Tract Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-09-25
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem sodium as initial therapy for the treatment of complicated urinary tract infections, including pyelonephritis in indian adults.


Eligibility criteria: Inclusion Criteria:

* Patient has a complicated urinary tract infection
* Patient has acute pyelonephritis with fever, flank pain, pus in the urine, and positive urine culture
* Patient is indian and 18 years of age or greater.

Exclusion Criteria:

* Patient had a kidney transplant
* Patient had been given antibiotic therapy for condition
* Patient had poor liver function
* Patient has complete obstruction of urinary tract
* Patient has history of serious allergy to antibiotics and multivitamins
* Patient is pregnant
* Patient not likely to respond to 10 to 14 days of antibiotic therapy
* Patient not likely to survive 4 week study period

Primary outcomes:
measure: Safety and tolerability
timeFrame: 14 Days
Secondary outcomes:
measure: Compare signs and symptoms of urinary tract infections at 14 days after treatment compared with signs and symptoms before treatment
timeFrame: 14 days after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06203353: Evaluation of the Diaphragm Performance During Weaning From Mechanical Ventilation
Official title: Evaluation of the Diaphragm Tissue Doppler Parameters in Predicting Weaning From Mechanical Ventilation Outcome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mechanical Ventilation Weaning
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2024-01-12
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: Patients undergoing weaning from mechanical ventilation: Pressure support ventilation with the lowest level of support Glasgow coma scale of at least 13 Hemodynamic stability with no vasopressors

Brief summary: Prospective observationnal study, including ICU adult patients with invasive mechanical ventilation for at least 48 hours. Patients are included when performing weaning from mechanical ventilation with pressure support (lowest level of pressure support).

Before separating the patient from the ventilator and performing a T tube spontaneous breathing test, diaphragm ultrasound is performed bilaterally : diaphragm excursion, diaphragm thickening fraction and maximal contraction and relaxation velocities with tissue doppler imaging.

Detailed description: This observationnal study will include patients during weaning from invasive mechanical ventilation: ventilation in pressure support with the lowest level With normal neurological status: glasgow coma scale \> 13 Requiring no vasopressor support

conventionnal diaphragm parameters: diaphram excursion and thickening fraction will be collected bilaterally with the tissue doppler measures: maximal contraction and relaxation velocities, immediately before a T Tube test.

Patients will be divided into 2 groups according to their weaning from mechanicla ventilation outcome, and diaphragm ultrasound patterns will be compared between the 2 groups in order to evaluate the performance of tissue doppler in predicting weaning outcome.

Eligibility criteria: Inclusion Criteria:

* Invasive mechanical ventilation for at least 48 hours

Exclusion Criteria:

* reintubation for extra respiratory failure (neurologic or hemodynamic)
* Patients with chronic repiratory failure

Primary outcomes:
measure: weaning from mechanical ventilation success
timeFrame: Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Mongi Slim hospital
Study officials:
References:
Clinical trial NCT03997253: Optimizing Long-term Survival in Organ Transplantation: From Physiopathology to Optimized Patient Management
Official title: Optimizing Long-term Survival in Organ Transplantation: From Physiopathology to Optimized Patient Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Organ Transplantation
Keywords: organ transplantation, graft, biological collection.
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
Collaborators: name: University Hospital Federation FHU SUPORT
First posted: 2019-06-25
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: various blood and urine samples will be collected from the recipient at D0, D1, D3, D7, D14, M1, M3, M6 and M12 and intraoperative bile collection ancillary studies : stools at D0 D7 M1 and M3 will be collected for liver transplant patient
Primary purpose: OTHER

Brief summary: Increased indications for transplantation continue to worsen the shortage of organs and need the extension of graft sampling criteria and the search for new potential sources of organs. Despite undeniable success in the short term, due to major advances in surgery, medicine and research, transplant recipients continue to face the risk of chronic rejection and long-term complications.

The University Hospital Federation "FHU SUPORT" was created to optimize the chances of success of the organ transplant and improve the quality of life of the transplanted patient. FHU SUPORT 's ambition is based on a translational strategy that presents two priority areas:

Axis 1: Optimization, evaluation, conditioning of the donor, graft, recipient Axis 2: Personalized follow-up of the transplanted patient in the short and long term Identifying factors for long-term graft and patient survival through translational research from a common cohort and biological collection will predict transplant rejection, prolong graft function, or improve the patient's care.


Eligibility criteria: Inclusion Criteria:

* Male or female over 18 (no age limit)
* affiliated to a social security organization
* Recipient (s) of a kidney, liver or heart transplant
* followed by at least one of the FHU SUPORT centers (Tours, Poitiers, Limoges, Rennes)
* having given informed consent to participate in the cohort.

Exclusion Criteria:

* Patient unable to understand the information given by the investigator
* People under the protection of justice

Primary outcomes:
measure: Survival of the graft
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges hospital
city: Poitiers
country: France
facility: Poitiers Hospital
city: Rennes
country: France
facility: Rennes Hospital
city: Tours
country: France
facility: Tours hospital
Study officials:
References:
Clinical trial NCT05258253: Effects of HIA and PCE in Primary Dysmenorrhea
Official title: Effects of High Intensity Aerobics and Pelvic Clock Exercises in Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: high intensity aerobics
primary dysmenorrhea
aerobics
painful menstruation
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 28
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of study is to manage the unpleasant pain suffered by females during Mensturation. The aim of this study is to guide physiotherapist that how to apply these exercises to manage dysmenorrhea.

Detailed description: There are less research on effectiveness of pelvic clock exercises in dysmenorrhea they are very less evidence and less documented in literature.. Although there are many researches on high intensity aerobics.Previous researches only have lierature about aerobics.So to address this literature gap, conduct a prospective randomized controlled trial to investigate the effects of high intensity aerobics and pelvic clock exercises in primary dysmenorrhea.

Eligibility criteria: Inclusion Criteria:

* Girls aged 17-23 years with regular menstrual cycle
* Unmarried girls

Exclusion Criteria:

* Athletes, Married women,
* Girls who were regularly exercising
* Having any pelvic pathology, abnormal menstrual cycle.

Primary outcomes:
measure: Visual analogue scale
timeFrame: last 1 day
Secondary outcomes:
measure: DASS 21
timeFrame: last 1 day
Other outcomes:
Locations:
city: Hafizabad
country: Pakistan
facility: Rasheeda gynae hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sara Aabroo, PPDPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03646851: Aspergillus and Chronic Obstructive Pulmonary Disease Evolution
Official title: Impact of Aspergillus on Chronic Obstructive Pulmonary Disease Evolution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a prospective multicenter cohort study which includes all consecutive COPD patients who come for a visit in one the participating pneumologist. They will have to do a sputum and to complete some questionnaries. Questionnaries will be redone by phone after 1 and 3 months and during the visit after 6 months. We will correlate aspergillus presence in sputum with quality of life (QoL), and COPD symptoms evaluated by questionnaires.

Detailed description: Aspergillosis disease is a growing problem. These diseases are not yet uncommon in chronic obstructive pulmonary disease patients. (COPD).

Aspergillosis disease are very difficult to be diagnosed or treated. Isolation of aspergillus in sputum of patients is not always responsible of a real disease. Need of treatment is discussed. That is why, we will conduct a prospective cohort study to evaluate aspergillus rate in respiratory samples of COPD patients (GOLD stage III or IV)

Eligibility criteria: Inclusion Criteria:

* COPD patients GOLD stage III and IV

Exclusion Criteria:

* Cystic fibrosis
* Pulmonary fibrosis
* hematological malignancy
* known aspergilloma
* allergic bronchopulmonary aspergillosis

Primary outcomes:
measure: presence of aspergillus in sputum or respiratory samples
timeFrame: one year before inclusion
Secondary outcomes:
measure: Dyspnea with MMRC score
timeFrame: day of inclusion
Other outcomes:
Locations:
city: Abbeville
country: France
facility: CH Abbeville
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Amiens
country: France
facility: Clinique de l'Europe
city: Saint-Quentin
country: France
facility: CHU St Quentin
Study officials:
References:
Clinical trial NCT00799851: A Randomized Controlled Trial Comparing Band Ligation and Cyanoacrylate Injection for Esophageal Varices
Official title: Endoscopic Treatment of Esophageal Varices in Advanced Liver Disease Patients: a Randomized Controlled Trial Comparing Band Ligation and Cyanoacrylate Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Disease
Keywords: advanced liver disease
esophageal varices
band ligation
cyanoacrylate injection
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2008-12-01
Enrollment: 38
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: TREATMENT

Brief summary: Compare VBL and cyanoacrylate injection (CI) in the treatment of EV in patients with advanced liver disease regarding eradication, bleeding, mortality, complication and recurrence rates.


Eligibility criteria: Inclusion Criteria:

* advanced liver disease (Child-Pugh ≥ 8 points)
* medium and/or large esophageal varices

Exclusion Criteria:

* prior endoscopic treatment.
* history of shunt operation

Primary outcomes:
measure: Compare VBL and cyanoacrylate injection (CI) in the treatment of EV in patients with advanced liver disease regarding eradication, bleeding, mortality, complication and recurrence rates.
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University Of São Paulo - Gastroenterology
Study officials:
References:
Clinical trial NCT03194451: Dental Stem Cells and Bone Tissue Engineering (CELSORDINO)
Official title: Dental Stem Cells and Bone Tissue Engineering
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tooth, Impacted
Keywords: bone tissue engineering, dental stem cell differentiation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged between 13 and 17 years, who will be operated for wisdom tooth avulsion

Brief summary: The main limitation in bone regeneration is the lack of vascularization of the newly shaped tissue. The main objective of this project is to check if the simultaneous differentiation of dental mesenchymal stem cells toward osteoblastic and endothelial lineage permits to obtain a new pre-vascularized tissue engineered bone construct.

We will then evaluate the boosting effect of the conditionned medium on cell differentiation and production of a prevascularized bone construct.

Detailed description: This project aims to develop a new pre-vascularized tissue engineered bone construct, using human cells of a simple and non invasive tissue source: dental pulp.

We will isolate mesenchymal stem cells from dental tissue of wisdom teeth, extracted from patients aged between 13 and 17 years old.

The objectives are: (i) to assess in combination the endothelial differentiation and osteoblastic differentiation of dental pulp stem cells (immature third molar); (ii) to study the boosting effect of the conditionned medium on cell differentiation and production of a prevascularized bone construct.

The differentiation will be monitored by evaluation of biosynthesized matrix, bone mineralization (immunohistochimie, Westen Blot), histological response (Von Kossa, Alizarin Red) and presence and quantification of pseudo-vascular structures (angiogenesis assay), compared to reference value (commercial differentiation medium).

Eligibility criteria: Inclusion Criteria:

* patients aged between 13 and 17 years, who will come to Dental Service of University Regional Hospital Center of Nancy in order to have a tooth avulsion.
* patient who has received a complete information about research organization and who is not opposed to the use of his own data.
* patient who the representatives of parental authority have received a complete information about research organization and who are not opposed to the use of children's data.

Exclusion Criteria:

* patients with local or general pathology

Primary outcomes:
measure: Bone mineralization
timeFrame: Day 28 of cell culture
Secondary outcomes:
measure: presence and quantification of pseudo-vascular structures
timeFrame: Day 28 of cell culture
Other outcomes:
Locations:
Study officials:
affiliation: IMoPA, UMR-CNRS 7365 CNRS-UL, Medicine Faculty
name: Vanessa MOBY, DD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01783951: Study of S-1 Plus DC-CIK for Patients With Advanced Gastric Cancer
Official title: Autologous Dendritic Cell-cytokine Induced Killer Cell Immunotherapy Combined With S-1 Based Chemotherapy in Patients With Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Gastric Cancer
Keywords: Gastric cancer
S-1
DC-CIK
T cell
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Duke University
name: Geneplus-Beijing Co. Ltd.
First posted: 2013-02-05
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the antitumor effect and safety of clinical effectiveness dendritic cell activated Cytokine induced killer treatment (DC-CIK) plus S-1 based chemotherapy for advanced gastric cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically/cytologically confirmed recurrent or metastatic gastric or esophagogastric junctional adenocarcinoma
* Between 18 and 80 years old
* Capable of oral intake
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Karnofsky Performance Status (KPS) ≥ 70%
* Normal functions of heart, lung and bone marrow
* Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL Absolute granulocyte count ≥ 1,500/mm3 Platelet count ≥ 100,000/mm3
* Adequate hepatic function Total bilirubin level≤ 3.0 times the upper limit of normal (ULN) Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN
* Adequate renal function(normal serum creatinine level)
* A life expectancy≥ 2 months
* Informed consent signed

Exclusion Criteria:

* Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study
* Any radiotherapy or surgery within the previous 4 weeks
* Symptomatic brain metastasis not controlled by corticosteroids
* Bone marrow metastasis
* Active infection
* Serious complications
* Receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: phenytoin, potassium warfarin , flucytosine, cimetidine and folinic acid.
* Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
* Ineligible for the study at the discretion of investigators

Primary outcomes:
measure: Progression free survival（PFS）
timeFrame: 4 years
Secondary outcomes:
measure: Overall survival
timeFrame: 4 years
measure: Response rate
timeFrame: Every 6 weeks
measure: Adverse Events
timeFrame: Every 3 weeks
measure: Quality of life
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University Cancer Center
state: Beijing
Study officials:
References:
Clinical trial NCT04763551: Medically Assisted Procreation and Choice of the Embryo: How Far Would French People Like to go
Official title: Medically Assisted Procreation and Choice of the Embryo: How Far Would French People Like to go - An Opinion Survey Among Patients Resorting to in Vitro Fertilization (IVF) in France.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Keywords: Couple infertility with IVF indication
Genetic indication for PGD in France
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 300
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: Male and female IVF patients in the MAP centers of Montpellier University Hospital, Jeanne de Flandres in Lille, and Foch Hospital in Paris (on request)

Brief summary: In today's context of bioethics laws revision concerning Medically Assisted Procreation, the investigators focus on the opinion of couples resorting to In Vitro Fertilization on a fundamental, much debated issue ; the choice of the embryo.

French lawmakers fear the investigators might be drifting towards embryo selection procedures, but no study allows us to state this is what patients request. This study aims at determining, among the population of patients who resort to Medically Assisted Procreation in France, the ratio of patients who are willing to select the embryo due to its genetic characteristics.


Eligibility criteria: Inclusion criteria:

- Male and female IVF patients in the MAP

Exclusion criteria:

- Patient not fluent in French

Primary outcomes:
measure: Rate of Medically Assisted Procreation
timeFrame: 1 day
Secondary outcomes:
measure: Determine the type of embryo genetic selection
timeFrame: 1 day
measure: Determine, among the population of patients who resort to Medically Assisted Procreation in France
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Noémie Ranisavljevic, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: