louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03339414: Blood microRNA Depression Change After DHCA
Official title: Blood microRNA Depression Change After DHCA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm
Lead sponsor: China International Neuroscience Institution
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20-100

Brief summary: Collect the blood sample per-operation experience deep hypothermia cardiac arrest for aorta artery replacement surgery Collect the blood from the CPB machine and from intravenous injection tube which already set at different time point.

Detailed description: Collect the blood sample per-operation experience deep hypothermia cardiac arrest for aorta artery replacement surgery Collect the blood from the CPB machine and from intravenous injection tube which already set at different time point Test the blood sample of DHCA, analysis the correlation between miR-194 and temperature.

Eligibility criteria: Inclusion Criteria:

* aortic dissection patients

Exclusion Criteria:

* other organ disorder

Primary outcomes:
measure: microRNA express change
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Xiaohua Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05602714: Real World Data Collection and Analysis on the Anterior Cervical Spine Surgery
Official title: Efficacy and Safety of Anterior Cervical Spine Surgery in Patients With Cervical Degenerative Disc Disease - a Real World Data Collection and Analysis Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Disc Degeneration
Keywords: Cervical Degenerative Disease
Cervical Myelopathy
Cervical Radiculopathy
Anterior Cervical Spine Surgery
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2022-11-02
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cervical degenerative disc disease

Brief summary: This observational study aims to evaluate the efficacy and safety of anterior cervical spine surgery in patients with cervical degenerative disc disease

Detailed description: This observational study is an ambispective cohort designed. Patients who are diagnosed cervical degenerative disc disease will be selected to join in this study. Visual Analogue Scale, Japanese Orthopaedic Association Scale, Neck Disability Index, SF-36, and device related or procedure related adverse events will be recorded and compared to evaluate the efficacy and safety of anterior cervical spine surgery in patients with cervical degenerative disc disease

Eligibility criteria: Inclusion Criteria:

1. Patients over 18 years old
2. Clinical symptoms and imaging support cervical degenerative disc disease；
3. Failed a minimum of 3months conservative treatment
4. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) anterior cervical spine surgery
5. Written informed consent given by subject

Exclusion Criteria:

1. Patients with non-degenerative (e.g., trauma, tumor, and infection) or neuromuscular diseases (e.g., motor neuron disease) were excluded
2. Patients with cervical spine X-ray film and CT scan contraindications
3. Women who are lactating and pregnant

Primary outcomes:
measure: Japanese Orthopaedic Association Scale
timeFrame: 1st year
Secondary outcomes:
measure: Neck Disability Index
timeFrame: 1st year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT05207514: Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer
Official title: Open-label, Randomized, Active-controlled, Multicenter, Phase III Clinical Trial to Compare the Efficacy and the Safety of Taxotere and Nanoxel M as Neoadjuvant Chemotherapy in Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2022-01-26
Enrollment: 26
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase III Clinical Trial to Compare the Efficacy and the Safety of AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Taxotere Versus AC(Doxorubicin, Cyclophosphamide) Followed by 4 Cycles Nanoxel M as Neoadjuvant Chemotherapy in Patients With Breast Cancer

Detailed description: The purpose of this study is to evaluate efficacy and safety of AC followed by Taxotere versus AC followed by Nanoxel M as neoadjuvant chemotherapy in breast caner patients.

Eligibility criteria: Inclusion Criteria:

1. Patients who were diagnosed with primary breast cancer by core biopsy
2. Patients who have been identified as HER2 negative in the tissue obtained through core needle biopsy and have confirmed the positive / negative status of ER (Estrogen receptor) and Progesterone receptor (PR)

   * HER2 positive is defined as IHC 3+ or FISH +
3. Patinets whose TNM stage confirmed by CT or MRI (T2-T3, anyN, M0 or T1-3, N1-3, M0)

Exclusion criteria:

1. Patients who have distant metastasis
2. Patients who have cystitis or urinary obstruction
3. Patients who have history of thromboembolism or coagulation disorder
4. Patients who have Interstitial lung disease ans liver cirrhosis ( \> Child-Pugh class B)
5. Patients who have Insulin-Dependent Type II diabete mellitus

Primary outcomes:
measure: Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0
timeFrame: at the time of definitive surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sevrance Hospital
Study officials:
affiliation: Severance Hospital
name: Joohyuk Sohn, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01977014: NIMS- New Implantable Pump in Pulmonary Arterial Hypertension, a Safety Follow up
Official title: NIMS- New Implantable Pump in Pulmonary Arterial Hypertension, a Safety Follow up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension Group 1 and 4 According to Nice Classification
Lead sponsor: NordicInfu Care AB
Sponsor class: INDUSTRY
First posted: 2013-11-06
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in Scandinavia who received a LenusPro pump

Brief summary: This observational study aims to chart patients which get their prostacyclin treatment via the subcutaneous LenusPro pump. How the surgical procedure is performed and the clinical follow-up of these patients. And by this also charting complications that might occur in relation to treatment.

Participating centres are located in Denmark, Norway and Sweden.


Eligibility criteria: Inclusion Criteria:

* The patient should have been diagnosed with Pulmonary Arterial Hypertension
* The patient has received or will receive treatment with the implanted pump LenusPro

Exclusion Criteria:

* The patient is participating in another study which means treatment of the patient no longer follows the normal clinical practice

Primary outcomes:
measure: Number and severity of events reported for the Lenus Pro in a clinical environment.
timeFrame: Up to 3,5 years
measure: Changes in baseline variables during follow-up on quality of life.
timeFrame: Up to 3,5 years
Secondary outcomes:
measure: Description of baseline and follow-up of hemodynamic and functional capacity.
timeFrame: Up to 3,5 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Cardiology, Aarhus University Hospital, Skejby
city: Copenhagen
country: Denmark
facility: Department of Cardiology Rigshospitalet University Hospital
city: Oslo
country: Norway
facility: Department of Cardiology Oslo University Hospital, Rikshospitalet
city: Trondheim
country: Norway
facility: Department of Cardiology, St Olav University Hospital
city: Linköping
country: Sweden
facility: Department of Cardiology University Hospital in Linköping
city: Lund
country: Sweden
facility: Skane Univerity Hospital, Lund
city: Stockholm
country: Sweden
facility: Karolinska Univerity Hospital, Solna
city: Uppsala
country: Sweden
facility: Department of Cardiology Uppsala Akademiska University Hospital
Study officials:
affiliation: Department of Cardiology, Rigshospitalet in Copenhagen
name: Jorn Carlsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, Uppsala Akademiska University Hospital
name: Gerhard Vikstrom, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, Oslo University Hospital
name: Arne Andreassen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01548014: The Effect of a Probiotic Preparation (VSL#3) Plus Infliximab in Children With Crohn's Disease
Official title: Reduction in Frequency of Infliximab Administration From q 8 Weeks to q 12 Weeks in Children With Crohn's Disease Receiving Probiotic VSL#3 Supplementation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Crohn's disease
VSL #3
infliximab
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 1
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose was to evaluate as to whether administration of infliximab of 12 week interval with supplementary VSL#3 is more effective or at least of similar efficacy when compared to conventional administration of infliximab only of 8 week interval.

Detailed description: The purpose of our study was to evaluate if supplementation of VSL#3 can improve treatment outcome for those pediatric Crohn's patients treated with infliximab every 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients who were diagnosed with severe Crohn's disease who require infliximab treatment
* confirmed diagnostic of Crohn's disease in clinical, endoscopic and histological findings

Exclusion Criteria:

* patients who has proven to have infliximab antibody

Primary outcomes:
measure: Reduction in Frequency of Infliximab Administration from q 8 Weeks to q 12 Weeks in Children with Crohn's Disease Receiving Probiotic VSL#3 Supplementation
timeFrame: 1-year treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT01342614: The Effect of Metformin on the Correlation Between Hyperinsulinemia and Hypertension
Official title: The Effect of Metformin on the Correlation Between Hyperinsulinemia and Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Essential Hypertension
Keywords: Hypertension
Insulin Resistance
Hyperinsulinemia
Metformin
Fosinopril
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2011-04-27
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the effect of metformin on the correlation between hyperinsulinemia and hypertension.


Eligibility criteria: Inclusion Criteria:

* 20 to 65 years of age, regardless of sex
* duration of hypertension was \<5 years
* overweight or obesity, mild to moderate hypertension, receive no euglycemic agent or antiobesity drug

Primary outcomes:
measure: Blood pressure measurement
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04076514: The Role of Central Neck Dissection in Stage N0 Papillary Thyroid Carcinoma
Official title: The Role of Central Neck Dissection in Stage N0 Papillary Thyroid Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Papillary Thyroid Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with papillary thyroid carcinoma with clinically negative lymph node who undergo total thyroidectomy and central neck dissetion in assiut university hospital, department of general surgery.

Brief summary: The benefits of prophylactic central neck dissection (pCND) remain controversial in clinically node-negative (cN0) papillary thyroid carcinoma (PTC). This study main goal is to investigate benefits of prophylactic central neck dissection in clinically node-negative papillary thyroid carcinoma.

Detailed description: Papillary thyroid carcinoma (PTC) is the most common type of differentiated thyroid carcinoma. Recurrence rate is still high. The standard management is total thyroidectomy. regional lymph node metastasis is noted in recurrent cases. Some studies stated benefits of central neck dissection in orevention of recurrence and others said there is no benefits. so prophylactic central neck dissection (pCND) remain controversial in clinically node-negative (cN0) papillary thyroid carcinoma (PTC).

Eligibility criteria: Inclusion Criteria:

* patients with papillary thyroid cancer with clinically node negative.

Exclusion Criteria:

* patients with clinical evidence of nodal metastases.
* patients with a previous history of thyroidectomy.
* patients with mixed-type papillary thyroid cancer.

Primary outcomes:
measure: the incidence metastatic lymph node in patients with clinically node-negative thyroid carcinoma who underwent total thyroidectomy with central neck dissection
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Asyūţ
country: Egypt
facility: Ahmed Kamel
state: Asyut
Study officials:
References:
Clinical trial NCT02876614: Value of Radionuclide Cisternography
Official title: VALUE OF RADIONUCLIDE CISTERNOGRAPHY IN PATIENTS WITH CEREBROSPINAL FLUID LEAK
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CSF Leak
Fistula
Keywords: radionuclide cisternography
CSF leak
imaging
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 113
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who received a convocation for realization of RC

Brief summary: Radionuclide cisternography (RC) is a nuclear medicine examination based on intrathecal injection of \[111In\]diethylenetriaminepentaacetic acid (\[111In\]DTPA). It is prescribed for two recommendations: detection of cerebrospinal fluid (CSF) leak/fistula and diagnosis of normal pressure hydrocephalus.

In the search part of CSF leak/fistula, RC offers the benefit of a 24-hour study of CSF unlike other reference tests.

In addition to SPECT/CT imaging, the radiopharmacist performs sampling in nasal cavities and throat of the patient to collect a possible flow of CSF.

These samples are analysed by radioactivity measurements and bring an added value to the exam.

The interest of this examination for management of CSF leak/fistula remains unclear.

The aim of this study is to identify and analyse results of all RC examinations performed since 2005 in the Nuclear Medicine department of the Neurological Hospital.

The full analysis of patients will allow discussing the role of RC in management of CSF leak/fistulae in clinical practice.


Eligibility criteria: Inclusion Criteria:

* patients who received a convocation for realization of RC (extraction with GERA, software of Nuclear Medicine)

Exclusion Criteria:

* patients who received a convocation for realization of RC with "valve" protocol

Primary outcomes:
measure: RC /SPECT/CT imaging
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon
name: Elise LEVIGOUREUX, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03036514: Sublingual Sufentanil Tablet System (SSTS) Versus Intravenous Patient Controlled Analgesia After Back Surgery.
Official title: Sublingual Sufentanil Tablet System (SSTS) Versus Intravenous Patient Controlled Analgesia (PCIA) With Morphine for Postoperative Pain After Back Surgery. A Single Center Case-control Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: numeric rating scale
opioid side effects
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2017-01-30
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Single center case-control study design
Primary purpose: DEVICE_FEASIBILITY

Brief summary: In this study, numeric rating scale (NRS) and side effects are measured after usage of a sublingual sufentanil tablet system (SSTS) in comparison to intravenous patient controlled analgesia (PCIA).

Detailed description: Sublingual sufentanil tablet system (SSTS) is compared in pain relief and side effect profile with the routinely used intravenous patient controlled analgesia (PCIA) with morphine in the postoperative phase after back surgery. The common use of PCIA with morphine is associated with a rather slow onset-time and active metabolites, with occurrence of potential harmful side effects as sedation and desaturation.

This mono-centric project involving American Society of Anesthesiologists (ASA) classification I-II patients undergoing elective neurosurgery (laminectomy) are recruited. Enrolled patients undergo numeric rating scale (NRS) and side effect questionnaire during the first 72h postoperatively.

Eligibility criteria: Inclusion Criteria:

* scheduled elective laminectomy or spinal fusion
* American Society Anesthesiology Classification system (ASA) I-III

Exclusion Criteria:

* chronic opioid use (\>3 months)
* pregnancy
* obstructive sleep apnea syndrome
* supplemental oxygen therapy at home
* postoperative use of non-steroidal anti-inflammatory or anti-neuropathic drugs

Primary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: 72 hours postoperatively
Secondary outcomes:
measure: Evaluation of side effect
timeFrame: 72 hours postoperatively
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University hospital Antwerp
state: Antwerp
Study officials:
affiliation: Universiteit Antwerpen
name: Davina Wildemeersch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02241395: Cell Therapy as Treatment for Cerebral Palsy
Official title: Autologous Bone Marrow Mononuclear Cell Therapy in Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
autologous bone marrow mononuclear cells
stem cell
Lead sponsor: Neurogen Brain and Spine Institute
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to study the effect of autologous bone marrow mononuclear cells on common symptoms of cerebral palsy patients.


Eligibility criteria: Inclusion Criteria:

* diagnosed cases of any type of Cerebral Palsy
* age above 6 months.

Exclusion Criteria:

* presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/ Hepatitis C Virus
* malignancies
* bleeding tendencies
* pneumonia
* renal failure
* severe liver dysfunction
* severe anemia \[Hemoglobin \< 8\]
* any bone marrow disorder
* space occupying lesion in brain
* other acute medical conditions such as respiratory infection and pyrexia.

Primary outcomes:
measure: change in clinical symptoms over a period of 2 years
timeFrame: 2 years
Secondary outcomes:
measure: Change in GMFM score
timeFrame: 1 year
measure: Change in Gross Motor Function Measure
timeFrame: 1 year
Other outcomes:
Locations:
city: Navi Mumbai
country: India
facility: Neurogen brain and spine institute
state: Maharashtra
Study officials:
References: