louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02869373: Spinal Stabilization Exercise Effects in Hypermobility
Official title: Assistant Professor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypermobility Syndrome
Lead sponsor: Ataturk Training and Research Hospital
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of an 8-week lumbar spinal stabilization exercise program on pain, trunk muscle endurance and postural stability in women with benign joint hypermobility syndrome


Eligibility criteria: Inclusion Criteria:

* volunteers in an age range of 18 to 30,
* being women,
* having benign joint hypermobility syndrome diagnosed according to the Brighton criteria,
* having no contraindication to join an exercise program.

Exclusion Criteria:

* having rheumatologic or neurologic diseases,
* any other pathology involving the musculoskeletal system-history of fractures, joint dislocations, sprains and strains,
* associated connective tissue disorders including Marfan syndrome, Ehlers-Danlos syndrome, osteogenesis imperfecta,
* severe psychological disorders,
* being pregnant,
* intervention including exercise or physical therapy in the last 3 months.

Primary outcomes:
measure: Change in musculoskeletal pain intensity as measured by Visual Analog Scale
timeFrame: Change from baseline musculoskeletal pain intensity at 8 weeks
Secondary outcomes:
measure: Change in trunk muscle endurance as measued with McGill's trunk muscle endurance tests
timeFrame: Change from baseline trunk muscle endurance at 8 weeks
measure: Change in postural stability as measured with Biodex Balance System SD
timeFrame: Change from baseline postural stability at 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Yildirim Beyazit University
name: Seyda TOPRAK CELENAY
role: STUDY_DIRECTOR
affiliation: Izmir Katip Celebi University
name: Derya OZER KAYA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03646773: Microvascular Effects of Intravenous Esmolol During Postoperative Atrial Fibrillation
Official title: Microvascular Effects of Intravenous Esmolol in Patients With Normal Cardiac Function Undergoing Postoperative Atrial Fibrillation: a Prospective Pilot Study in Cardiothoracic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Atrial Fibrillation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 25
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: Adult patients scheduled for conventional cardiac or thoracic surgery who experienced in-hospital postoperative atrial fibrillation within the first seven postoperative days

Brief summary: Background: Postoperative atrial fibrillation (POAF) is commonplace after cardiothoracic surgery. A rate control strategy by using short-acting beta blockers is recommended as a first-line therapy in patients without hemodynamic instability. Microcirculatory effects of POAF and esmolol have not been yet investigated. The investigators made the hypothesis that POAF without hemodynamic instability would induce microvascular dysfunction which could be reversed by intravenous esmolol.


Eligibility criteria: Inclusion Criteria:

* conventional cardiac surgery
* thoracic surgery

Exclusion Criteria:

* Postoperative atrial fibrillation leading to hemodynamic instability

Primary outcomes:
measure: effects of POAF without hemodynamic instability on near infrared spectroscopy (NIRS) parameters in combination with a vascular occlusion test
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00030173: A Trial to Evaluate Epothilone D in Patients With Advanced Solid Tumors
Official title: A Phase 1, Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Epothilone D in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Epothilone D
tubulin polymerization
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2002-02-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Epothilone D represents one of a class of cytotoxic macrolides capable of causing mitotic arrest by stabilizing tubulin polymerization. Since microtubules are essential for mitosis, motility, secretion and proliferation, the observed antitumor effects of epothilones have been attributed to their ability to initiate cell death by inhibiting such processes. Epothilone D has demonstrated in vitro cytotoxic activity in a panel of human cell lines, equipotent to that of paclitaxel. In vivo, Epothilone D has also shown significant antitumor activity in a range of xenograft models, including paclitaxel-resistant xenografts. Epothilone D is more potent than paclitaxel in cell lines that demonstrate multiple drug resistant activity overexpressing p-glycoprotein.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of histologically documented, advanced stage, primary or metastatic adult solid tumors that are refractory to standard therapy or for which no curative standard therapy exists. This includes but is not limited to cancers of the breast, ovary, head and neck, esophagus, lung, gastrointestinal tract, and sarcomas.
2. Evidence of radiographically measurable or evaluable disease.

Exclusion Criteria:

1. Pre-existing peripheral neuropathy of CTC Grade \> 2 due to any cause.
2. Documented hypersensitivity reaction (CTC Grade \> 2) to prior paclitaxel or other therapy containing Cremophor.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01692873: Prognostic and Predictive Biomarkers of Therapeutic Response in Pancreatic Tumors
Official title: Research for Prognostic and Predictive Biomarkers of Therapeutic Response in Pancreatic Tumors - PACAomics / IPC 2011-004
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Tumor
Keywords: pancreatic tumor
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Pancreatic cancer is among the most serious human neoplasia and the most difficult to treat.

Most patients present at diagnosis a non resectable, locally advanced or metastatic disease, with a median survival of 12 month.

The aim of this study is the identification of diagnosis biomarkers, predictive of the therapeutic response.

This project investigate the use of molecular analyses applied to pancreatic tumor cells collected by microbiopsy under ultrasound-endoscopy, and blood cells.


Eligibility criteria: Inclusion Criteria:

* Suspicion of pancreatic adenocarcinoma
* Patient \> 18 years old
* Social Security affiliation
* Signed informed consent

Exclusion Criteria:

* Patient in emergency situation
* Major person being the object of a legal protective measure or unable to express its consent

Primary outcomes:
measure: Biomarkers
timeFrame: within twenty four hours
Secondary outcomes:
measure: Histology
timeFrame: within twenty four hours
Other outcomes:
Locations:
city: Marseille
country: France
facility: Marine GILABERT, MD
Study officials:
affiliation: Institut Paoli-Calmettes
name: Marine GILABERT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fraunhoffer NA, Abuelafia AM, Chanez B, Bigonnet M, Gayet O, Roques J, Chuluyan E, Dusetti N, Iovanna J. Inhibition of glucuronidation in pancreatic cancer improves gemcitabine anticancer activity. Cancer Commun (Lond). 2022 Nov;42(11):1212-1216. doi: 10.1002/cac2.12365. Epub 2022 Sep 30. No abstract available.
citation: Fraunhoffer NA, Abuelafia AM, Dusetti N, Iovanna J. Limitation and challenges in using pancreatic cancer-derived organoids as a preclinical tool. Cancer Commun (Lond). 2022 Oct;42(10):1028-1031. doi: 10.1002/cac2.12335. Epub 2022 Jul 18. No abstract available.
Clinical trial NCT00699673: Evaluation of the Brain Natriuretic Peptide as a Predictor of Morbidity and Mortality in Cardiac Surgery
Official title: Evaluation of the Brain Natriuretic Peptide as a Predictor of Morbidity and Mortality in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Valvular Disease
Keywords: Brain natriuretic peptide
EuroScore
Cardiac surgery
Cardiopulmonary bypass
Coronary artery disease
Valvular disease
Risk stratification in cardiac surgery
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2008-06-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who need cardiac surgery and age \> 18 years

Brief summary: Objective: The purpose of the present study is to assess if perioperative variation of Brain Natriuretic Peptide (BNP) levels is a predictor of mortality and morbidity after cardiac surgery.Material and Methods: 500 consecutive patients will be enrolled prospectively in this study before cardiac surgery under cardiopulmonary bypass. BNP levels will be measured prior to surgery and at postoperative day 1. Variations of BNP levels will be analyzed to determine if it is a predictor of mortality and morbidity after cardiac surgery. This dynamic evaluation will be compared to other tools of risk stratification in cardiac surgery as the EuroScore. All patients will be followed 3 years after the procedure.

Hypothesis: Perioperative BNP variations may be more sensitive than pre- or postoperative BNP levels alone. Furthermore the perioperative homeostasis will be measured to assess its impact on BNP secretion during the perioperative period.


Eligibility criteria: Inclusion Criteria:

* Patient who need cardiac surgery
* Age \> 18 years

Exclusion Criteria:

* Patient on mechanic ventilation before surgery
* Aortic dissection-Congenital disease

Primary outcomes:
measure: BNP levels; hospital and long-term morbidity and mortality
timeFrame: BNP levels prior to surgery and at postoperative day 1; Hospital and long-term morbidity and mortality (1, 2 and 3 years)
Secondary outcomes:
measure: EuroScoreCardiac markers; inflammation markers; echocardiography
timeFrame: EuroScoreCardiac markers at day 1, 2, 5; Inflammation markers at day 1, 2, 5; Echocardiography (day 5, and 1, 2 and 3 years)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Cardio-Vasculaire au NHC, Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Michel KINDO, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kindo M, Minh TH, Perrier S, Petit-Eisenmann H, Bentz J, Cristinar M, Ajob G, Collange O, Mazzucotelli JP. Impact of prosthesis-patient mismatch on early haemodynamic status after aortic valve replacement. Interact Cardiovasc Thorac Surg. 2017 Jan;24(1):48-54. doi: 10.1093/icvts/ivw303. Epub 2016 Sep 13.
Clinical trial NCT05100173: Clinical Evaluation of Genetron IDH1 PCR Kit in Glioma Patients
Official title: Clinical Evaluation of Genetron IDH1 PCR Kit in Glioma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioma, Malignant
Glioma, Mixed
Lead sponsor: Genetron Health
Sponsor class: INDUSTRY
Collaborators: name: Huashan Hospital
name: Zhejiang University
name: West China Hospital
name: The First Hospital of Jilin University
First posted: 2021-10-29
Enrollment: 1192
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital sample

Brief summary: The purpose of this trail is to evaluate the performance of Genetron IDH1 PCR Kit in Glioma patients using real-time PCR method.

Detailed description: This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron IDH1 PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method. Combined with the results of clinicopathological classification, the incidence of IDH1 gene R132H mutation in different subtypes was counted to evaluate the clinical performance of the Genetron IDH1 PCR Kit.

Eligibility criteria: Inclusion Criteria:

1. Enroll cases in strict accordance with the requirements of the study
2. The remaining samples after routine clinical testing
3. The collection and processing of samples meet the requirements of standard laboratory operations and product instructions
4. The relevant information of the sample is complete, including sample number, gender, age, and possible clinical diagnosis information
5. Each sample must have HE staining results (hematoxylin-eosin staining)
6. Pathological examination diagnosed as glioma, other brain tumors or normal tissues
7. Number of samples: 10 pieces of each sample with a thickness of 10μm, and the tumor content is not less than 50%

Exclusion Criteria:

1. Incomplete sample information
2. Severely contaminated samples
3. Samples that do not meet the requirements of sample collection and processing

Primary outcomes:
measure: Efficacy of the Genetron IDH1 PCR Kit
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jilin
country: China
facility: The First Hospital of Jilin University
city: Shanghai
country: China
facility: Huashan Hospital of Fudan University
city: Sichuan
country: China
facility: West China Hospital of Sichuan University
city: Zhejiang
country: China
facility: The Second Affiliated Hospital of Zhejiang University
Study officials:
References:
Clinical trial NCT05327673: Impact of the Use of Allogeneic Hematopoietic Stem Cell Transplantation in Reunion Island Patients: Quality of Life, Determinants of Choices and Financial Repercussions
Official title: Impact of the Use of Allogeneic Hematopoietic Stem Cell Transplantation in Reunion Island Patients: Quality of Life, Determinants of Choices and Financial Repercussions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Allogeneic Hematopoietic Stem Cell Transplantation
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
Collaborators: name: Institut Paoli-Calmettes
First posted: 2022-04-14
Enrollment: 100
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 diagnosed with myeloid acute leukemia, lymphoid acute leukemia, non-hodgkin lymphoma, Hodgkin disease, or myelodysplasic syndrome candidate to an allogeneic hematopoietic stem cell transplantation in mainland

Brief summary: This project aims to document and analyse - with a three-fold anthropological, psychosocial and economical approach - the consequences of the geographical distance from mainland France on the alloSCT on both patients, their caregivers and the healthcare system. It is organised in 3 working packages (WP).


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with hematological malignancy (myeloid acute leukemia, lymphoid acute leukemia, non-hodgkin lymphoma, Hodgkin disease, or myelodysplasic syndrome
* candidate to an allogeneic hematopoietic stem cell transplantation in mainland France ;
* Residing in Reunion Island
* Age \>18 year old;
* who accept or not allogeneic hematopoietic
* Able to complete a questionnaire

Exclusion Criteria:

* Opposition to participation and collection of their data
* Person deprived of liberty by judicial or administrative decision, and person subject to legal protection (guardianship or curators)

Primary outcomes:
measure: Quality of life Functional Assessment of Cancer Therapy - Bone Marrow Transplantation questionnaire. (FACT-BMT questionnaire)
timeFrame: 24 months
Secondary outcomes:
measure: satisfaction with decision questionnaire
timeFrame: 24 months
measure: decision regret scale
timeFrame: 24 months
measure: fear of recurrence questionnaire
timeFrame: 24 months
measure: preferences of patients questionnaire
timeFrame: 24 months
measure: cost of treatment
timeFrame: 24 months
Other outcomes:
Locations:
city: Saint-Pierre
country: France
facility: CHU de la Réunion
Study officials:
References:
Clinical trial NCT03016273: Bladder Flap Technique In Elective Cesarean Section
Official title: Bladder Flap Versus Non Bladder Flap Technique In Women Undergoing Elective Cesarean Section A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Delivery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cesarean section is a surgical procedure used to deliver one or more babies. cesarean section is usually performed when vaginal delivery will put the mother or child's health or life at risk. In recent years, the number of cesarean section has risen worldwide.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing elective primary cesarean section
2. previous cesarean section
3. gestational age 32 or more.

Exclusion Criteria:

1. Patients undergoing emergent cesarean section
2. Patients undergoing planned vertical uterine incision.
3. Patients undergone previous laparotomies.
4. Gestational age less than 32 weeks .
5. Patient refusing to participate in the study
6. Women with body mass index \>35

Primary outcomes:
measure: the skin - delivery time
timeFrame: duration of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Assuit university
Study officials:
References:
Clinical trial NCT00418873: Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward
Official title: A Multi-centre Comparative Study to Evaluate the Anti-aggression Effect and Safety of Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: schizophrenia
zotepine
risperidone
second generation antipsychotic
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Taiwan, Inc.
First posted: 2007-01-05
Enrollment: 39
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 compare the efficacy and tolerability of zotepine versus Risperidone in aggressive schizophrenic patients.


Eligibility criteria: Inclusion Criteria:

* Aged 18 to 65 years, male or female
* In-patients suffering from schizophrenia according to DSM-IV diagnostic criteria with PANSS total score of greater than or equal to 60.
* Patients with PANSS-EC total score of greater than or equal to 14 and with at least one PANSS-EC symptom score greater than or equal to 4

Exclusion Criteria:

* Patients with history of seizure or with alcohol or substance abuse in the last 6 months
* Diabetes, Parkinson's disease or phaeochromocytoma
* Patients with hypertension and current use of antihypertensive agents
* Women who are pregnant, lactating or intend to become pregnant during the study period
* Poor response to two different antipsychotics in full dose and full course or use of clozapine previously
* Renal, hepatic, haematologic disease or other conditions may not suitable for the study based on investigator's evaluation

Primary outcomes:
measure: Change from baseline in aggression behavior assessed using the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) score.
timeFrame: 6 Weeks
Secondary outcomes:
measure: Change from baseline on the total score of Positive and Negative Syndrome Scale
timeFrame: 6 Weeks
measure: Change from baseline on Clinical Global Impression (CGI)
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Bali
country: Taiwan
state: Taipei county
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
Study officials:
affiliation: Taipei City Hospital
name: Chang-Jer Tsai
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan HY, Lin AS, Chen KP, Cheng JS, Chen YY, Tsai CJ. An open-label, randomized, controlled trial of zotepine and risperidone for acutely ill, hospitalized, schizophrenic patients with symptoms of agitation. J Clin Psychopharmacol. 2013 Dec;33(6):747-52. doi: 10.1097/JCP.0b013e31829e8168.