louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04196816: Surgery for Pancreatic Cancer With Oligo-Metastasis
Official title: Surgery/Destruction for Stage IV Pancreatic Cancer With Oligo-Metastatic Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Pancreatic Surgery
Keywords: Surgery
Metastasis surgery
Survival
Multimodal treatment
Stage IV
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Université Montpellier
name: Association de Chirurgie hepato-bilio-pancreatique et transplantation (ACHBT)
name: Federation de recherche en chirurgie digestive (FRENCH)
name: Club Français du Pancreas (CFP)
First posted: 2019-12-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had resection or destruction of one or more synchronous or metachronous metastases or local recurrence of pancreatic adenocarcinoma

Brief summary: Pancreatic cancer is increasing in incidence and will be the second leading cause of cancer-related deaths in 2030 in the West. Only 10 to 15% of patients are eligible for curative resection with long-term survival rarely exceeding 20% at 5 years. The management of metastatic or recurrent diseases can not, unfortunately, be recommended to date because of limited data available (INCA 2019).

However, recent, low-strength publications have reported encouraging results on the long-term survival of stage IV or recurrent patients.

The aim of the present retrospective cohort study is to analyze results of surgery/destruction of metastatic synchronous or metachronous disease or local recurrence in patients with stage IV pancreatic cancer


Eligibility criteria: Inclusion criteria:

- Patients who had resection or destruction of one or more synchronous or metachronous metastases or local recurrence of pancreatic adenocarcinoma

Details:

* synchronous lesions, metachrones can be included
* all distant lesions (hepatic, pulmonary) can be included
* documented lymph node involvement after analysis of the specimen (hepatic hilum, mesenteric root, retroperitoneal or inter-aortic-cellar) can be included
* patients with local recurrence who underwent surgical treatment

Exclusion Criteria:

- Patient who reject the study protocol

Primary outcomes:
measure: Overall survival
timeFrame: 3 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: REGIS SOUCHE
role: STUDY_DIRECTOR
References:
Clinical trial NCT03195816: A Computer-based Cognitive Stimulation in Mild Cognitive Impairment With White Matter Hyperintensities
Official title: Effects of a Computer-based Cognitive Stimulation on the Verbal Learning and the Progression of White Matter Hyperintensities in Mild Cognitive Impairment: A Protocol for a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
white matter hyperintensities
computerized cognitive training
brain plasticity
Lead sponsor: Broca Hospital
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison between experimental group and control group.
Primary purpose: PREVENTION

Brief summary: This is a non-pharmacological study evaluating the impact of a computerized cognitive stimulation program on verbal learning and on the progression white matter hyperintensities in elderly with mild cognitive impairment.

Detailed description: White matter hyperintensities (WMH) can appear in Mild Cognitive Impairment (MCI) and have been associated to executive, attention and processing speed deficits. Some findings indicate that the presence of WMH may contribute to Alzheimer's disease (AD) in addition to ß-amyloid, suggesting a greater vulnerability of MCI. One important challenge is to prevent or slowing down the progression of WMH. Few studies investigated the effects of computerized cognitive interventions in MCI with WMH, which deserve special attention. This study aim to investigate the effects of an intensive computer-based cognitive stimulation (CCS) program on the verbal learning in episodic memory in MCI with WMH and to explore the effects on the progression of WMH at 1-year interval.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Mild Cognitive Impairment
* With and without with matter hyperintensities
* MRI data available or accept to perform one
* No engagement in other cognitive intervention program

Exclusion Criteria:

* Psychiatric and neurological disorders
* History of alcohol or other substance consumption
* Sensory and or motor deficit that could interfere with the use of computer tool
* Refusal MRI.

Primary outcomes:
measure: Change on Rey Auditory Verbal Learning test
timeFrame: Baseline assessment in 3-weeks period before intervention, change from baseline at 6-months immediately after the end intervention, and after 3-months follow-up
Secondary outcomes:
measure: Change on Fazekas scale
timeFrame: Baseline assessment of WMH severity and evolution at 12 months immediately after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Broca University Hospital
name: Anne-Sophie AR RIGAUD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02636816: Cardiovascular Effects of Carbetocin Given During Elective Cesarean
Official title: Cardiovascular Effects of Carbetocin During Elective Caesarean Delivery: A Randomized Controlled Trial Comparing Infusion Versus Bolus Administration Using Nexfin™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Effect of Carbetocin on Cardiovascular System
Pregnancy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2015-12-22
Enrollment: 57
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators are investigating whether slow administration of carbetocin is tolerated by patients better than if it is administered quickly, with respect to side effects such as headache, nausea, vomiting and facial flushing.

Detailed description: Patients undergoing elective cesarean under spinal are included in the study. These patients are treated with carbetocin to reduce blood loss from the lining of the womb after delivery of the baby. The study is a randomised double blind controlled trial with 2 groups. One group will receive carbetocin quickly, the second group will receive carbetocin slowly. The investigators will compare the difference between groups with respect to side effects and the effect of carbetocin on the cardiovascular system.

Eligibility criteria: Inclusion Criteria:

* elective cesarean delivery under spinal,
* low risk for post partum hemorrhage,
* able to understand english

Exclusion Criteria:

* cesarean under general anesthesia,
* bleeding condition,
* placenta previa,
* unable to understand english

Primary outcomes:
measure: percent change in cardiac output parameters as measured by non-invasive cardiac output monitor
timeFrame: 10 minutes
Secondary outcomes:
measure: incidence of side effects occurring within timeframe below
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Vit Gunka, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02492516: Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS
Official title: Evaluation the Safety of Intravenous Injection of Adipose Derived Mesenchymal Stem Cell in Patients With ALS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Amyotrophic Lateral Sclerosis
Keywords: adipose tissue mesenchymal stem cell intravenous injection ALS
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2015-07-08
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Amyotrophic lateral sclerosis (ALS) is a lethal degenerative disorder that upper motor and lower motor neurons are destroyed in brain stem and spinal cord. Riluzole is the only therapeutic option now. Recently several studies have shown that stem cell transplantation is safe and can be effective in reduction of disease progression and increase of quality of life.

Detailed description: the study is perform with 8 patients who has sporadic form of ALS with(ALS-Functional Rating Test) ALS-FRS\> 24 and (Forced Vital Capacity) FVC\>40% . The adipose sample is provide from healthy donors with abdominal lipoaspiration. After isolation and culture of mesenchymal stem cells, the cells are injected intravenously (2 million cells/kg). All the patients will be followed for 12 months at 72hours, 2months, 4 months, 6 months and 12 months after transplantation to find the adverse events. During follow up the assessments including: ALS-FRS, FVC and electromyography and serologic tests.

Eligibility criteria: Inclusion Criteria:

* Both gender
* Age: 18-55
* Sporadic form of disease
* ALS-FRS\> = 24
* FVC \>= 40%

Exclusion Criteria:

* Familial form of ALS
* Malignancy
* Autoimmune disease
* Diagnosis of other motor neuron diseases

Primary outcomes:
measure: fever
timeFrame: 72hours
measure: Unconsciousness
timeFrame: 72hours
Secondary outcomes:
measure: The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)
timeFrame: 2 months
measure: FVC
timeFrame: 2 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Head of department of Regenerative Medicine,Royasn Institute
name: Nasser Aghdami, MD,PhD
role: STUDY_DIRECTOR
affiliation: Professor associated of neurology, Shahed University
name: Masood Nabavi, MD
role: STUDY_DIRECTOR
affiliation: Department of Regenerative Medicine, Royan Institute
name: Leila Arab, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00331916: AL-15469A for the Treatment of Bacterial Conjunctivitis
Official title: AL-15469A for the Treatment of Bacterial Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Conjunctivitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-05-31
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether AL-15469A is safe and effective in the treatment of bacterial conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Signs \& Symptoms of conjunctivitis

Exclusion Criteria:

* Under 1 mo. age

Primary outcomes:
measure: Clinical cure and microbiological success
Secondary outcomes:
measure: Individual signs and symptoms of bacterial conjunctivitis at each visit
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: US
state: Texas
Study officials:
affiliation: Study Director
name: Stella Robertson, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01303016: Improving Nutrition and Health Outcomes in Intibuca, Honduras
Official title: Improving Nutrition and Health Outcomes in Intibuca, Honduras
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malnutrition
Undernutrition
Lead sponsor: Shoulder to Shoulder
Sponsor class: OTHER
Collaborators: name: The Mathile Institute for the Advancement of Human Nutrition
First posted: 2011-02-24
Enrollment: 639
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to better understand how to prevent malnutrition in children under age 5 years in Intibuca, Honduras. A randomized community trial design was used to implement a nutrition program, including a complementary nutrition supplement, educational sessions, and growth and health monitoring integrated into the basic primary care package, to participants living in communities in the intervention group. Participants living in the control group communities will receive the nutrition supplement for one year following the study.


Eligibility criteria: Inclusion Criteria:

* Children between the ages of 6 months and under 5 years at the time enrollment who reside in Concepcion.

Exclusion Criteria:

* Children with congenital anomalies, mental retardation, severe physical handicap, undernutrition caused by medical conditions that contribute to undernutrition such as heart disease, kidney failure, face and throat problems that interfere with swallowing, medical problems interfering with the absorption of food, and chronic diseases such as tuberculosis, etc.
* Plans to move or change place of residence outside the intervention region in the next 2 months.
* Children whose weight for age z score falls below - 3.
* Children whose weight for age z score is above 3.

Primary outcomes:
measure: Height and weight
timeFrame: Every other month for 12 months
measure: Hemoglobin
timeFrame: Baseline, month 6, and month 12
measure: Retinol binding protein, transferrin receptor, and C-Reactive Protein
timeFrame: Baseline, month 6, and month 12
Secondary outcomes:
measure: Food insecurity
timeFrame: Baseline, month 6, and month 12
measure: Health outcomes
timeFrame: Baseline, month 6, and month 12
measure: Acceptability/Sustainability of nutrition supplement
timeFrame: Baseline, month 3, and month 8
Other outcomes:
Locations:
Study officials:
affiliation: Shoulder to Shoulder
name: Jeff Heck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03687216: HVPG-Guided Therapy Versus EVL Plus NSBB in Second Prophylaxis of Esophageal Variceal Bleeding
Official title: A Single-center Randomized Controlled Study of Secondary Prophylaxis of Cirrhosis Related Esophagogastric Variceal Hemorrhage Treated With HVPG-guided Therapy or Standard Esophageal Variceal Ligation Plus Beta-blocker
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Varices in Cirrhosis of the Liver
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A single-center randomized controlled study comparing endoscopic or interventional therapy guided by the hepatic venous pressure gradient (HVPG) , to standard endosopic variceal ligation plus nonselective beta-blocker therapy (NSBB) in patients with esophageal varices due to liver cirrhosis with a history of esophageal variceal hemorrhage.Primary study outcome of the study is variceal rebleeding episodes occurring within the first years after interventions. Second study outcomes of the study are hepatic encephalopathy occurrence, mortality occurrence, liver transplantation or other cirrhosis-related complications.


Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis diagnosed by clinical examination, imaging or biopsy;
* A previous history of variceal hemorrhage;
* Written informed consent.

Exclusion Criteria:

* Previous history of secondary prophylactic treatment;
* Contraindications to treatment of endoscopy, surgery and TIPS
* Severe cardiac, pulmonary or renal dysfunction;
* Lactating or pregnant;
* Malignancies;

Primary outcomes:
measure: Variceal rebleeding rate
timeFrame: One year of follow-up
Secondary outcomes:
measure: Hepatic encephalopathy: The incidence of hepatic encephalopathy
timeFrame: One year of follow-up
measure: Ascites: The incidence of ascites detected by ultrasound
timeFrame: One year of follow-up
measure: Cirrhotic complications
timeFrame: One year of follow-up
measure: Liver transplant-free survivial
timeFrame: One year of follow-up
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT04239716: Regional Anesthesia for Modified Radical Mastectomy With Axillary Lymph Node Dissection
Official title: Feasibility of Combined Ultrasound Guided Interscalene Brachial Plexus Block and Erector Spinae Plane Block for Anesthesia in Modified Radical Mastectomy With Axillary Lymph Node Dissection: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Dr. Mohamed Elsayed Afandy
First posted: 2020-01-27
Enrollment: 13
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: local and regional anesthesia have been introduced with the goal of reducing the side effects associated with general anesthesia and IV opioid analgesia.our hypothesis is that ultrasound-guided interscalene brachial plexus block and erector spinae plane block will provide efficient surgical anesthesia and postoperative analgesia after modified radical mastectomy.

Detailed description: inadequate analgesia after modified radical mastectomy with axillary lymph node dissection may occur with most of regional anesthesia. pain in the axilla and upper limb is related to ineffective block of medial and lateral pectoral nerves as long thoracic and thoracodorsal nerves, leading to inadequate analgesia.The aim of this study is to evaluate the efficacy and safety of ultrasound-guided interscalene brachial plexus block and erector spinae plane block for providing surgical anesthesia and postoperative analgesia after modified radical mastectomy.

Eligibility criteria: Inclusion Criteria:

* Female patients aged 40-85 years old
* American Society of Anesthesiologists' physical status III and IV
* Planned for modified radical mastectomy with axillary lymph node dissection

Exclusion Criteria:

* Patient refusal
* Neurological or psychiatric disorders
* Local infection at injection site
* Spine or chest wall deformity
* Allergy or any contraindication to any of the study drugs
* Opioid or alcoholic addiction
* Chronic pain of any cause
* Uncooperative patients.

Primary outcomes:
measure: Success rate of the regional blocks
timeFrame: from the start to the end of the operation
Secondary outcomes:
measure: duration of the blocks
timeFrame: 24- hours in the postoperative period
measure: Patients' satisfaction
timeFrame: 24-hours postoperative
measure: Any adverse events
timeFrame: 24-hours postoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University, Faculty of Medicine
Study officials:
affiliation: Tanta University, Faculty of Medicine
name: Mona R Elghamry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University, Faculty of Medicine
name: Mohamed E Afandy, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04358016: Terlipression Prevent Developing of Acute Kidney Injury During Upper-gastroentestinal Bleeding
Official title: The Protection of Telipression on Developing of Acute Kidney Injury in Cirrhotic Patients With Upper-gastroentestinal Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cirrhosis, Liver
Upper Gastrointestinal Bleeding
Keywords: liver cirrhosis
upper gastrointestinal bleeding
acute kidney injury
urinary IL-18
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators studied the renal function index level in terlipressin treated cirrhotic patients with upper-gastrointestinal bleeding at different time point.

Detailed description: 54 cirrhotic patients with uppre-gastrointestinal bleeding were entrolled and were distributed into terlipressin group and control group at 1:1 rate. Patients in Terlipressin group received 1mg/6h of terlipressin intravenously for 5 days, and patients in control group recerved 1mg/12h of Somatostatin intravenously for 5 days.

At enrollment, 24h,48h,72,and 1week, the renal function index level( serum creatinine,urine biochemistry and Urinary tubule injury index etc) were tested.

Eligibility criteria: Inclusion Criteria:

* Diagnosied as cirrhosis with upper gastrointestinal bleeding 18≤age≤70 Varicose vein rupture occurred within 24 hours, Without drug, endoscopy or interventional therapy Can read, understand and sign informed consent

Exclusion Criteria:

* Pregnant women, lactating women; Serious cardiovascular disease: history of acute cardiac infarction, heart block, heart failure, arterial hypertension(（SBP\>170mmHg and/ or DBP\>100mmHg） Occlusive lower extremity venous disease Asthma, chronic obstructive pulmonary disease Have serious or unable to control other organ diseases; Cerebrovascular disease; Age ≥70 years old Known to be allergic to therapeutic drugs Chronic kidney disease Weight ≤40kg

Primary outcomes:
measure: incidence of acute kidney injure
timeFrame: 48 hours
Secondary outcomes:
measure: hemostasis rate
timeFrame: 48 hours
measure: incidence of hepatic encephalopathy
timeFrame: 48 hours
measure: The incidence of spontaneous bacterial peritonitis;
timeFrame: 48 hours
measure: The incidence of hyponatremia
timeFrame: 48 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai hospital
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Xuesong Liang, Dr
role: PRINCIPAL_INVESTIGATOR
References: