louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01999634: Monitoring by Microdialysis of Postoperative Complications After Proctectomy
Official title: Evaluation of Microdialysis to Monitor Postoperative Outcomes After Proctectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rectal Cancer
Keywords: rectum
microdialysis
anastomotic leaks
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2013-12-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to monitor by microdialysis the postoperative outcomes in order to identify anastomotic leaks after rectal surgery.


Eligibility criteria: Inclusion Criteria:

* rectal disease requiring proctectomy with anastomosis and stomy
* proctectomy by laparoscopy or laparotomy
* written consent

Exclusion Criteria:

* history of colorectal surgery
* rectal surgery without anastomosis
* breastfeeding or pregnancy
* ASA score IV

Primary outcomes:
measure: anastomotic leaks rate
timeFrame: postoperative day 30
Secondary outcomes:
measure: superficial surgical site infection rate
timeFrame: postoperative day 30
measure: functional success of microdialysis
timeFrame: postoperative day 5
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens university hospital
Study officials:
affiliation: CHU Amiens
name: jean marc regimbeau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Solligard E, Juel IS, Spigset O, Romundstad P, Gronbech JE, Aadahl P. Gut luminal lactate measured by microdialysis mirrors permeability of the intestinal mucosa after ischemia. Shock. 2008 Feb;29(2):245-51. doi: 10.1097/SHK.0b013e3180cab3ce.
citation: Cibicek N, Zivna H, Zadak Z, Kulir J, Cermakova E, Palicka V. Colon submucosal microdialysis: a novel in vivo approach in barrier function assessment - a pilot study in rats. Physiol Res. 2007;56(5):611-617. doi: 10.33549/physiolres.931004. Epub 2006 Dec 19.
citation: Krejci V, Hiltebrand L, Buchi C, Ali SZ, Contaldo C, Takala J, Sigurdsson GH, Jakob SM. Decreasing gut wall glucose as an early marker of impaired intestinal perfusion. Crit Care Med. 2006 Sep;34(9):2406-14. doi: 10.1097/01.CCM.0000233855.34344.29.
Clinical trial NCT00927134: Gene Therapy for X-linked Chronic Granulomatous Disease (CGD) in Children
Official title: Phase I/II Gene Therapy Study for X-linked Chronic Granulomatous Disease in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Granulomatous Disease
Keywords: Chronic Granulomatous Disease in children (=or< 18 years)
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Goethe University
First posted: 2009-06-24
Enrollment: 2
Sex: MALE
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the side effects and risks after infusion of retroviral gene corrected autologous CD34+ cells of the peripheral blood of chemotherapy conditioned (busulphan) children with chronic granulomatous disease (CGD). Also gene corrected and functional active granulocytes in the peripheral blood and the engraftment in the bone marrow of the patients will be monitored an documented.


Eligibility criteria: Inclusion Criteria:

* x-linked Chronic Granulomatous Disease
* history of life-threatening severe infections
* no HLA-matched related or unrelated donor
* therapy resistent life threatening infections/organ dysfunction
* no other treatment options e.g. HSCT

Exclusion Criteria:

* \> 18 years of age
* HIV infection
* life expectancy \> 2 years
* infections treatable by conventional therapy (antibiotics, antimycotics, allogeneic granulocytes)

Primary outcomes:
measure: eradication of pre-existing therapy refractory bacterial and/or fungal infections
timeFrame: 6 months
Secondary outcomes:
measure: Reconstitution of ROS production by peripheral blood cells
timeFrame: 1 month
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Children's Hospital
Study officials:
affiliation: University Children's Hospital, Zurich
name: Reinhard Seger, Prof Dr med
role: PRINCIPAL_INVESTIGATOR
affiliation: University Children's Hospital, Zurich
name: Janine Reichenbach, PD Dr med
role: STUDY_CHAIR
affiliation: University Children's Hospital, Zurich
name: Ulrich Siler, Dr rer nat
role: STUDY_CHAIR
affiliation: Georg Speyer Research Institute, Frankfurt a.M.
name: Manuel Grez, Dr rer nat
role: STUDY_CHAIR
References:
citation: Ott MG, Schmidt M, Schwarzwaelder K, Stein S, Siler U, Koehl U, Glimm H, Kuhlcke K, Schilz A, Kunkel H, Naundorf S, Brinkmann A, Deichmann A, Fischer M, Ball C, Pilz I, Dunbar C, Du Y, Jenkins NA, Copeland NG, Luthi U, Hassan M, Thrasher AJ, Hoelzer D, von Kalle C, Seger R, Grez M. Correction of X-linked chronic granulomatous disease by gene therapy, augmented by insertional activation of MDS1-EVI1, PRDM16 or SETBP1. Nat Med. 2006 Apr;12(4):401-9. doi: 10.1038/nm1393. Epub 2006 Apr 2.
Clinical trial NCT05863234: Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia
Official title: Multicenter, Open-label, Dose-escalation Phase I/II Study to Evaluate the Tolerability, Safety, Efficacy and Pharmacokinetics of Repeated Continuous Intravenous PPMX-T003 in Patients With Aggressive NK Cell Leukaemia (ANKL) (Physician-initiated Clinical Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Aggressive NK Cell Leukemia
Keywords: neoplasms
Lead sponsor: Hiroshima University Hospital
Sponsor class: OTHER
Collaborators: name: Kyoto University Hospital
name: Hokkaido University Hospital
name: Okayama University
name: Tokai University
name: Kyushu University
name: Tohoku University
name: Nagoya University
name: Komagome Hospital
First posted: 2023-05-17
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is Phase I/II Dose-Escalation Study to evaluate the tolerability, safety, efficacy and pharmacokinetics of PPMX-T003 in aggressive NK-cell leukemia.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with ANKL (regardless of whether the disease is first or recurrent) based on diagnostic criteria developed with reference to the World Health Organization (WHO) 4th edition (2017) criteria.

Exclusion Criteria:

* Patients eligible to receive chemotherapy as treatment for ANKL

Primary outcomes:
measure: Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the first course)
timeFrame: 7days after the administration
Secondary outcomes:
measure: Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the second course or later)
timeFrame: From the second course to the final course (Max. 35days after the first administration)
measure: Efficacy of PPMX-T003 repeated continuous intravenous administration (1) Liver volume evaluated by CT scan
timeFrame: 35 days
measure: Efficacy of PPMX-T003 repeated continuous intravenous administration (2) improvement in liver function as assessed by the Model for End-stage Liver Disease (MELD and MELD-Na)
timeFrame: 35 days
measure: Efficacy of PPMX-T003 repeated continuous intravenous administration (3) Survival duration at 6 months
timeFrame: 6 months
measure: Efficacy of PPMX-T003 repeated continuous intravenous administration (4) Percentage of subjects who were able to transition to chemotherapy
timeFrame: 35days after the treatment
measure: Serum drug concentration during repeated continuous intravenous PPMX-T003 administration
timeFrame: 35 days
measure: Anti-drug antibody production (Immunogenicity)
timeFrame: 35 days
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
Study officials:
References:
Clinical trial NCT01720134: The Impact of Legally Enforced Embryo Transfer Policy (Belgian Law 2003) on Cumulative Delivery Rate.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Impact of Legislation on Cumulative Delivery Rate
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2012-11-02
Enrollment: 1258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing IVF/ICSI cycles

Brief summary: Multiple pregnancy (MP) is associated with significant fetomaternal complications and a high cost. The multiple pregnancy rate per cycle (MPR) of treatment with Assisted Reproductive Technology (ART) is 25 % or higher even in countries where ART is reimbursed, much higher than the 1% after natural conception, related to the number of embryos transferred, and preventable by single embryo transfer (SET). In Belgium, the laboratory costs for 6 fresh ART cycles are reimbursed for female patients younger than 43 with a Belgian insurance number since July 2003, but only if a limited number of embryos is transferred depending on female age and cycle rank. Although this policy has resulted in a significant reduction in the MPR after ART in Belgium from 24 % to 13 %, available data are cycle based and it is unknown if the cumulative delivery rate per patient is affected by this legislation. The aim of this study was to test the hypothesis that Belgian ART legislation since 2003, coupling lab reimbursement to restriced embryo transfer policy, has resulted in a reduced CDR when compared to the situation before 2003.


Eligibility criteria: Inclusion Criteria:

* patients with their first IVF/ICSI cycle

Exclusion Criteria:

* cycles without oocytes or sperm, oocyte reception cycles, embryo reception cycles, cycles with preimplantation genetic diagnosis/screening

Primary outcomes:
measure: cumulative delivery rate
timeFrame: 1999-2006
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Leuven University Fertility Center
Study officials:
References:
Clinical trial NCT04370717: Chronic Pain Management During a Pandemic
Official title: Chronic Pain Management During a Pandemic: Will Telemedicine Replace In-person Consultation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: chronic pain, telehealth
Lead sponsor: Unika Medical Centre
Sponsor class: NETWORK
First posted: 2020-05-01
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive community patients referred to the interdisciplinary clinic

Brief summary: This is an open-label cohort study of chronic pain patients referred to an interdisciplinary community outpatient clinic. The aim of this study is to determine whether video consultations are non-inferior to regular consultations in diagnosing and planning subsequent interventions. The null hypothesis is that there is no difference in the International Statistical Classification of Diseases 10th edition (ICD-10) codes established via telehealth and subsequent clinic visits. The patients will complete standard health questionnaires online and undergo a structured and detailed interview to clarify the diagnosis and establish appropriate treatment. A limited telehealth physical examination based on direct observation will be conducted.

At the subsequent clinic visit, the accuracy of diagnosis and adherence to the plan of care will be evaluated.

The primary and secondary endpoints will be gathered from the electronic charts and from the recruited participants by questionnaires completed online one week after the telemedicine consultation. The diagnosis and plan of care semi-structured match will be performed during the in-person follow-up visit.


Eligibility criteria: Inclusion Criteria:

all patients referred for consultation

Exclusion Criteria:

1. Not English-speakers
2. Patients who do not have any compatible telecommunication devices
3. Patients illiterate in basic telecommunication and have no one in their household to help
4. Patients unable to complete online self-assessment forms and study questionnaires
5. Patients unable to make a follow-up visit
6. Individuals with unstable pain complaints

Primary outcomes:
measure: Percentage of patients with a matching diagnosis between telehealth and in-person consultation
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of patients with a matching plan of care/recommendations between telehealth and in-person visit
timeFrame: 6 months
measure: Patient satisfaction from telehealth encountered measured on 7-point Likert scale
timeFrame: 6 months
measure: feasibility of telehealth visits
timeFrame: 6 months
measure: cost-saving
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Silver Centre for Pain Care
state: Ontario
Study officials:
References:
Clinical trial NCT00308217: Single Ventricle Outcome
Official title: The Examination of Outcome in Children With Single Ventricle Physiology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Disease, Congenital
Single Ventricle
Hypoplastic Left Heart Syndrome
Keywords: Heart Disease, Congenital
Single Ventricle
Hypoplastic Left Heart Syndrome
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2006-03-29
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The objective of this research proposal is to perform an ongoing single institution prospective clinical trial examining the overall clinical outcome of children with single ventricle physiology.

Detailed description: Congenital disease is the most common cause for infant death from a birth defect. Approximately 30,000 infants are born each year with congenital heart defects.Over one-third of those babies will require cardiac surgery. A particularly lethal cardiac defect is one with single ventricle physiology. The objective of this research proposal is to perform an ongoing single institution prospective clinical trial examining the overall clinical outcome of children with single ventricle physiology.

Eligibility criteria: Inclusion Criteria:

* All patients with single ventricle physiology scheduled for ultimate Fontan surgical palliation at Children's Healthcare of Atlanta will be eligible.
* All subjects must sign informed consent prior to enrollment in study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Associate Professor, Emory University School of Medicine
name: Robert M Campbell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04525417: Rapid Screening Test for Covid-19 Antibodies in Healthcare Workers
Official title: Use of Rapid Covid-19 Antibody Test Marketed by AAZ Laboratories in Healthcare Workers Presumably Being Infected by SARS-CoV-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid-19 Immune Status of Healthcare Workers
Lead sponsor: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
Sponsor class: NETWORK
First posted: 2020-08-25
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric, open-label, prospective, non-randomized study
Primary purpose: DIAGNOSTIC

Brief summary: The study objectives were to assess 1/the immune status of healthcare professionals with suggestive symptomatology of Covid-19 infection and 2/the sensitivity and specificity of AAZ rapid test by comparing it with a serological ELISA test.

An open-label, monocentric, prospective, non-randomized study, is conducted, including 50 hospital healthcare professionals and 50 private health professionals.

Knowledge of serostatus will achieve the implementation of a strategy of management of patients according to specific immunity of health professionals


Eligibility criteria: Inclusion Criteria:

* Healthcare professionals with symptoms suggestive of Covid-19 infection

Exclusion Criteria:

* any other subject
* pregnant women
* protected adult

Primary outcomes:
measure: To assess the predictive value of Covid-19 rapid test
timeFrame: One week
measure: Compare the results of rapid tests on serum and capillary samples
timeFrame: one week
Secondary outcomes:
measure: A posteriori diagnosis of a covid-19 recent infection with suggestive symptomatology
timeFrame: one week
measure: Analysis of factors associated with negativity of PCR test on oropharyngeal swabs and positive serology
timeFrame: One week
Other outcomes:
Locations:
city: Paris
country: France
facility: Bichat University Hospital
Study officials:
affiliation: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
name: Elisabeth Bouvet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00503217: GnRH Agonist and Intrauterine Insemination
Official title: Effect of GnRH Agonist Administration at the Time of Implantation in Intrauterine Insemination Cycles: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intrauterine Insemination
Keywords: intrauterine insemination
GnRH agonist
implantation
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2007-07-18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study is to assess whether GnRH agonist administration in the luteal phase improves pregnancy outcome in intrauterine insemination (IUI) cycles.


Eligibility criteria: Inclusion Criteria:

* Women \< 38 years old
* Bilateral tubal patency confirmed by hysterosonography
* Normal ultrasound scan of uterus and ovaries
* Normal day 3 basal hormones
* Motile sperm count after capacitation ≥ 3 mill/ml

Exclusion Criteria:

* Endometriosis
* Polycystic ovary syndrome
* Uterine disease (polyps, myomas and müllerian diseases)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Instituto Valenciano de Infertilidad Spain
Study officials:
affiliation: Instituto Valenciano de la Infertilidad
name: Jose Bellver, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Valenciano de Infertilidad
name: Elena Labarta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01595217: MRCP Diagnoses EHCC Better When Combined DWI
Official title: The Incremental Value of 3T Diffusion-Weighted MRI in Diagnosing Extrahepatic Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Tract Neoplasm
Cholangiocarcinoma
Keywords: Biliary Tract Neoplasm
Cholangiocarcinoma
Diffusion magnetic resonance imaging
Magnetic resonance imaging
Magnetic resonance Cholangiopancreatography
Lead sponsor: China Medical University, China
Sponsor class: OTHER
Collaborators: name: First Hospital of China Medical University
First posted: 2012-05-09
Enrollment: 99
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Researching the diagnostic significance of Biliary Tract Neoplasm under combining DWI sequence with MRCP versus MRCP only separately.

Detailed description: The purpose of the study is to evaluate the usefulness of diffusion weighted imaging(DWI) combined with MRCP of 3.0T magnetic resonance imaging (MRI) in the evaluation of suspected malignant bile duct diseases. People with suspected Biliary Tract Neoplasm based on clinical symptoms (such as jaundice and thinness with unknown reasons) and CA-199 value raises are included.Diagnosis divided into two steps: the first one，only provide conventional MR sequences and MRCP images to make a diagnosis; the second step,provide the DWI images additionally, combining the image data before to make a diagnosis. Hypothesis is that DWI sequence should be regularly added into MRCP examination for improving diagnosis rate of Biliary Tract Neoplasm.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Suspected Biliary Tract Neoplasm based on clinical symptoms(such as jaundice and thinness with unknown reasons)and CA-199 raises（\>37U/mL）
* No evidence of clinical symptoms or CA-199 increase by non-bile duct cancerous factors(hepatitis,cholangeitis,stones)
* Age ≥ 16

Exclusion Criteria:

* Previous Biliary Tract Neoplasm surgery
* Contraindication for MRI (such as pacemaker or inner ear implant)
* Claustrophobia
* Age \< 16

Primary outcomes:
measure: EHCC performance on DWI, ADC map and MRCP
timeFrame: at the end of the study
Secondary outcomes:
measure: ADC, SNR, CNR and SIR for EHCC lesion under different b values
timeFrame: at the end of the study
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Room of 3.0TMR in the FAH of CMU
state: Liaoning
Study officials:
affiliation: First Affiliated Hospital of China Medical University
name: Xiaoping yang, MD
role: PRINCIPAL_INVESTIGATOR
References: