louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03977220: Nab-paclitaxel Combined With S-1 Treating Diffuse Type of Stage Ⅲ Gastric Cancer
Official title: Phase I Study: Nab-paclitaxel Combined With S-1 Treating Diffuse Type of Stage Ⅲ Gastric Cancer as Adjuvant Setting (NORDICA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Gastric Cancer
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigators assessed the effectiveness of Nab-paclitaxel combined with S-1 treating diffuse type of stage Ⅲ gastric cancer as adjuvant setting

Detailed description: Adjuvant chemotherapy is still the standard of care for stage Ⅲ gastric cancer. Till now, oxaliplatin with capecitabine or S1 still the standard chemotherapy regimen. Howerver, the prognosis of diffuse type gastric cancer patients is still poor even after adjuvant chemotherapy of XELOX or S1 regimen. Several retrospective, single institutional studies have shown that the addition of Nab-paclitaxel to S1 can prolong the survival of advanced gastric cancer with diffuse type.However, the effection of Nab-paclitaxel and S1 is unknown in diffuse gastric cancer patients after radical surgery. We assessed the effectiveness of radical surgery following docetaxel, nab-pacitaxel and S1 therapy for gastric cancer with diffuse type.

Eligibility criteria: Inclusion Criteria:

* gastric cancer patients after radical resection
* diffuse type gastric cancer stage III

Exclusion Criteria:

* Patients who have metastasis disease
* Patients who can not tolerate chemotherapy

Primary outcomes:
measure: Recommended dose for Phase II study
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00228020: Study of Safety and Efficacy of a Basiliximab, Mycophenolate Mofetil, Cyclosporine Microemulsion and Prednisone Combination Treatment Regimen in Pediatric Renal Allograft Recipients
Official title: A Randomized, Placebo-controlled, Double-blind, Multicenter Study Investigating Basiliximab in Combination With MMF, Cyclosporine Microemulsion and Prednisone in the Prevention of Acute Rejection in Pediatric Renal Allograft Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pediatric Kidney Transplantation
Keywords: pediatric, kidney transplantation, basiliximab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-28
Enrollment: 212
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is assess the safety and efficacy of the treatment regimen of basiliximab ,cyclosporine microemulsion, MMF, and prednisone combined compared to cyclosporine microemulsion, MMF and prednisone in the time to first biopsy proven acute rejection episode or treatment failure during the first 6 months post-transplantation in pediatric renal allograft recipients.


Eligibility criteria: Inclusion Criteria:

* Patients who are recipients of primary or secondary renal allograft.
* Patients who are single-organ recipients (kidney only).

Exclusion Criteria:

•Patients who are recipients of HLA-identical renal transplants. Patients whose donor kidney cold ischemia time (CIT) is greater than 36 hours. Patients whose transplant kidney is obtained from a non-heart beating donor Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Time to first BPAR episode or treatment failure
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Offner G, Toenshoff B, Hocker B, Krauss M, Bulla M, Cochat P, Fehrenbach H, Fischer W, Foulard M, Hoppe B, Hoyer PF, Jungraithmayr TC, Klaus G, Latta K, Leichter H, Mihatsch MJ, Misselwitz J, Montoya C, Muller-Wiefel DE, Neuhaus TJ, Pape L, Querfeld U, Plank C, Schwarke D, Wygoda S, Zimmerhackl LB. Efficacy and safety of basiliximab in pediatric renal transplant patients receiving cyclosporine, mycophenolate mofetil, and steroids. Transplantation. 2008 Nov 15;86(9):1241-8. doi: 10.1097/TP.0b013e318188af15.
citation: Hocker B, Kovarik JM, Daniel V, Opelz G, Fehrenbach H, Holder M, Hoppe B, Hoyer P, Jungraithmayr TC, Kopf-Shakib S, Laube GF, Muller-Wiefel DE, Offner G, Plank C, Schroder M, Weber LT, Zimmerhackl LB, Tonshoff B. Pharmacokinetics and immunodynamics of basiliximab in pediatric renal transplant recipients on mycophenolate mofetil comedication. Transplantation. 2008 Nov 15;86(9):1234-40. doi: 10.1097/TP.0b013e318188ae18.
Clinical trial NCT00316420: Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer
Official title: Phase I Trial of Gemcitabine and Capecitabine (Xeloda) in Patients With Advanced Pancreatic Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Cancer
Lead sponsor: Swedish Medical Center
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2006-04-20
Enrollment: 20
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 test the effectiveness and safety of the drug combination of gemcitabine and capecitabine (Xeloda) in patients with advanced pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

* Metastatic or unresectable pancreatic cancer
* No prior chemotherapy except radiation-sensitizing doses of 5-FU
* No radiotherapy less than 4 weeks prior to the start of the study

Exclusion Criteria:

* Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-FU
* Moderate to severe renal impairment
* Uncontrolled diabetes
* Inability to swallow tablets

Primary outcomes:
measure: MTD and DLT for the combination therapy of gemcitabine and capecitabine
timeFrame: January 2010
Secondary outcomes:
measure: Tumor Response
timeFrame: January 2010
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Swedish Medical Center Cancer Institute
state: Washington
Study officials:
affiliation: Swedish Medical Center Cancer Institute
name: Philip Gold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Swedish Medical Center Cancer Institute
name: Henry Kaplan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00391820: Evaluate the Safety and Efficacy of a 5-HT4 Agonist in Chronic Constipation (ACCORD Trial)
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of TD-5108 for the Treatment of Chronic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Constipation
Keywords: constipation
chronic
bowel function
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2006-10-24
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study 0038 compares the safety and effectiveness of an investigational drug, TD-5108 with placebo (a sugar pill) for the treatment of chronic constipation.


Eligibility criteria: Inclusion Criteria:

* Meet ROME III Criteria

Exclusion Criteria:

* Constipation caused by:colonic etiology, pelvic floor dysfunction, metabolic disturbances, neurologic disturbances,concomitant medications affecting bowel function
* Chronic treatment with anticholinergics, narcotic analgesics
* Irritable Bowel Syndrome

Primary outcomes:
measure: - Clinical response
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Breco Research
state: Texas
Study officials:
References:
citation: Goldberg M, Li YP, Johanson JF, Mangel AW, Kitt M, Beattie DT, Kersey K, Daniels O. Clinical trial: the efficacy and tolerability of velusetrag, a selective 5-HT4 agonist with high intrinsic activity, in chronic idiopathic constipation - a 4-week, randomized, double-blind, placebo-controlled, dose-response study. Aliment Pharmacol Ther. 2010 Nov;32(9):1102-12. doi: 10.1111/j.1365-2036.2010.04456.x. Epub 2010 Sep 22.
Clinical trial NCT03153020: Determinants of Adherence to Post-stroke/Transient Ischemic Attack Secondary Prevention Treatment: Cohort Study in the Rhône
Official title: Determinants of Adherence to Post-stroke/Transient Ischemic Attack Secondary Prevention Treatment: Cohort Study in the Rhône
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Transient Ischemic Attack
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 633
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 with stroke or transient ischemic attack of the Rhone area

Brief summary: The effectiveness of emergency management of acute ischemic stroke has improved considerably in recent years with thrombolysis and more recently thrombectomy. This improvement is accompanied by an increase in the number of stroke survivors. One of the major issues for these ever-increasing survivors is the prevention of recurrence. According to data from the 3 French registries, more than 20% of patients have at least one recurrence. Secondary prevention treatment has demonstrated his efficacy to prevent stroke recurrence.

This evolution justifies identifying factors associated with adherence to secondary prevention treatment, measured at 1 year post-stroke / transient ischemic attack (TIA), in patients included in the STROKE 69 cohort.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients treated for a stroke suspicion at the acute phase,
* with symptom onset (the last time the patient was seen without deficit ) less than 24 hours,
* Managed by the Rhône's emergency medical help service (SAMU), in one of the emergency unit or stroke unit of the Rhône area
* Having given their written consent for the extraction of their healthcare consumption data from the Health Insurance databases

Exclusion Criteria:

* Hemorrhagic stroke,
* Patient institutionalized in the year following the stroke / transient ischemic attack,
* Patient unable to take treatment alone.

Primary outcomes:
measure: Compliance to secondary prevention treatment 1 year post a stroke or transient ischemic attack
timeFrame: 1 year post a stroke or transient ischemic attack
measure: Determination of factors influencing compliance with secondary prevention treatment 1 year post a stroke or transient ischemic attack
timeFrame: 1 year post a stroke or transient ischemic attack
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche
Study officials:
References:
Clinical trial NCT00213720: Treatment of Subclinical Hyperthyroidism
Official title: Place de l'Iode RadioActif Dans l'HyperThyroïdiE Sub-clinique (PIRHATES)/ Evaluation of the Interest of Subclinical Hyperthyroidism Treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Subclinical Hyperthyroidism
Atrial Fibrillation
Keywords: Hyperthyroidism
atrial fibrillation
quality of life
radioiodine treatment
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 145
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients referred to tertiary hospitals for advice on thyroïd disease

Brief summary: Objective: To determine if the treatment of subclinical hyperthyroidism will reduce the rate of atrial fibrillation, the main complication of this condition.

Detailed description: Randomized open-labelled multicentre study comparing radioiodine vs medical supervision without treatment

Eligibility criteria: Inclusion Criteria:

* Men and women aged 50 and greater
* Isolated decreased thyroid-stimulating hormone (TSH) with normal FT4 and FT3 levels

Exclusion Criteria:

* Iodide overload
* Non sinusal heart rhythm
* Severe heart disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Patrick Roger
city: Clermont-Ferrand
country: France
facility: Philippe Thiéblot
city: Dijon
country: France
facility: Jean-Marcel Brun
city: Lille
country: France
facility: Jean-Louis Wemeau
city: Limoges
country: France
facility: Marie-Pierre Teissier
city: Lyon
country: France
facility: Jacques Orgiazzi
city: Marseille
country: France
facility: Bernard Conte-Delvox
city: Montbrison
country: France
facility: CH de Montbrison
city: Montpellier
country: France
facility: Jacques Bringer
city: Nancy
country: France
facility: Marc Klein
city: Nimes
country: France
facility: Michel Rodier
city: Paris
country: France
facility: Laurence Leenhardt
city: Poitiers
country: France
facility: Richard Marechaud
city: Reims
country: France
facility: Brigitte Delemer
city: Reims
country: France
facility: Claire Schvartz
city: Rouen
country: France
facility: Jean-Marc Kuhn
city: Saint-Etienne
country: France
facility: Bruno Estour
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg
city: Toulouse
country: France
facility: Philippe Caron
city: Tours
country: France
facility: Pierre Lecomte
Study officials:
affiliation: Hopitaux Universitaires de Strasbourg
name: Bernard Goichot, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00161720: Retrospective Study to Capture Dosing and Treatment Outcome Data in Participants With Severe Congenital Protein C Deficiency Who Were Treated With Protein C Concentrate Under an Emergency Use IND
Official title: A Retrospective Study to Capture Dosing and Treatment Outcome Data in Subjects With Severe Congenital Protein C Deficiency Who Were Treated With Protein C Concentrate Under an Emergency Use IND
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Protein C Deficiency
Keywords: Severe Congenital Protein C Deficiency
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE

Brief summary: This is a data collection study with the purpose of capturing dosing and treatment outcome data in participants with severe congenital protein C deficiency who were treated with protein C concentrate under an Emergency Use Investigational New Drug Application (IND).


Eligibility criteria: Inclusion Criteria:

* Participant treated with protein C concentrate under a Baxter Healthcare Corporation Emergency Use IND.
* Participant with diagnosis of severe congenital protein C deficiency.
* Participant or parent/legally authorized representative has provided written informed consent.

Primary outcomes:
measure: Number of Participants who Received a Dose of Protein C in Retrospective Study
timeFrame: Throughout the study period (up to 6 months)
measure: Number of Participants with Prophylactic Treatment Outcome
timeFrame: Throughout the study period (up to 6 months)
measure: Number of Participants with Acute Episode Treatment Outcome
timeFrame: Throughout the study period (up to 6 months)
measure: Number of Participants with Adverse Experiences (AEs) Related to Protein C Concentrate Treatment
timeFrame: Throughout the study period (up to 6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children´s Hospital of Los Angeles
state: California
city: Denver
country: United States
facility: Children´s Hospital Denver
state: Colorado
city: Fort Carson
country: United States
facility: Evans Army Hospital
state: Colorado
city: Boston
country: United States
facility: Children´s Hospital Boston
state: Massachusetts
city: Cleveland
country: United States
facility: Rainbow Babies & Children´s Hospital
state: Ohio
city: Dayton
country: United States
facility: The Children´s Medical Center - Dayton
state: Ohio
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Fort Worth
country: United States
facility: Cook Children´s Medical Center
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Texas Children´s Hospital
state: Texas
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01984320: Cabergoline and Coasting to Prevent OHSS
Official title: Combining Cabergoline and Coasting in Gonadotropin Releasing Hormone(GnRH)Agonist Protocol in Intracytoplasmic Sperm Injection (ICSI) to Prevent Ovarian Hyperstimulation Syndrome (OHSS): a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OHSS
Keywords: OHSS
ICSI
Coasting
Cabergoline
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The effectiveness of cabergoline to prevent moderate-severe OHSS to coasting.

Detailed description: To randomly compare three study groups under a high risk of developing OHSS to one of three arms of management, either coasting for 1 to 3 days or receiving cabergoline for 8 days or coasting for 1 day plus receiving cabergoline for 8 days in ICSI patients following the long luteal GnRH agonist protocol.

Eligibility criteria: Inclusion Criteria:

1. Age \<or= 35, BMI \<or= 30
2. Long protocol GnRH agonist cycles
3. Estradiol level on day of HCG \>or= 3500 pg/ml
4. Retrieving more than 15 oocytes

Exclusion Criteria:

1. Male factor
2. Uterine factor

Primary outcomes:
measure: Rate and degree of OHSS (composite outcome)
timeFrame: 14 days
Secondary outcomes:
measure: Number of oocytes
timeFrame: 1 day
Other outcomes:
measure: Number of Metaphase II (MII) oocytes
timeFrame: 1 day
measure: Fertilization rate
timeFrame: 2 days
measure: Number of embryos
timeFrame: 3 to 5 days
measure: Implantation rate
timeFrame: 5 weeks
measure: Chemical pregnancy rate
timeFrame: 14 days
measure: Clinical pregnancy rate
timeFrame: 28 days
measure: Early miscarriage rate
timeFrame: 12 weeks
measure: Ongoing pregnancy rate
timeFrame: 12 weeks
measure: Live birth rate
timeFrame: 40 weeks
Locations:
city: Cairo
country: Egypt
facility: IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)
Study officials:
affiliation: Cairo University
name: Mohamed Roushdy, MD
role: STUDY_CHAIR
References:
citation: Esinler I, Bozdag G, Karakocsokmensuer L. Preventing ovarian hyperstimulation syndrome: cabergoline versus coasting. Arch Gynecol Obstet. 2013 Nov;288(5):1159-63. doi: 10.1007/s00404-013-2875-z. Epub 2013 May 16.
citation: Bassiouny YA, Dakhly DMR, Bayoumi YA, Salaheldin NM, Gouda HM, Hassan AA. Randomized trial of combined cabergoline and coasting in preventing ovarian hyperstimulation syndrome during in vitro fertilization/intracytoplasmic sperm injection cycles. Int J Gynaecol Obstet. 2018 Feb;140(2):217-222. doi: 10.1002/ijgo.12360. Epub 2017 Nov 9.
Clinical trial NCT04781920: Follow-up of Anterior Cruciate Ligament Reconstruction
Official title: Follow-up of Anterior Cruciate Ligament Reconstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anterior Cruciate Ligament Rupture
Keywords: Anterior Cruciate Ligament
reconstruction
Operative report
Consultation report
Isokinetic tests
Clinical surveys
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 200
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 having undergone an Anterior Cruciate Ligament (ACL) reconstruction will be included.

Brief summary: Rupture of Anterior Cruciate Ligament (ACL) is a common pathology, but is subject to variability of associated lesions, surgical management and rehabilitation.

Detailed description: In this study, a collect data of patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction in order to evaluate the clinical, functional and morphological results of this intervention, in order to improve the management of the patient.

Eligibility criteria: Inclusion Criteria:

* Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction

Exclusion Criteria:

* None

Primary outcomes:
measure: Analysis of Magnetic Resonance Imaging (MRI) results
timeFrame: Pre-operative and Month: 12
Secondary outcomes:
measure: Analysis of operative report results
timeFrame: Month: 12
measure: Analysis of consultation report
timeFrame: pre-operative and Months: 1,5 , 3, 6, 12
measure: Analysis of isokinetic tests
timeFrame: Months: 9, 12
measure: Analysis of clinical surveys
timeFrame: pre-operative and Months: 3, 6, 12
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Thomas NERI, MD
role: PRINCIPAL_INVESTIGATOR
References: