louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02010879: The Impact of Platelet Functions on Spontaneous Ductal Closure in Preterm Infants
Official title: The Impact of Platelet Count, Platelet Mass Index and Platelet Function Evaluated by Platelet Function Analyzer (PFA-100) on Spontaneous Ductal Closure in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patent Ductus Arterioses
Keywords: patent ductus arterioses
ductal closure
thrombocyte
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: preterm infants with gestational age below 30 weeks and birth weght lower than 1500 g

Brief summary: Although thrombocytopenia has been reported as a risk factor for patent ductus arterioses, there is lack of data on the function of platelets in ductal closure. Information on functions of platelets in ductal closure may change the known model for ductus arterioses and may affect the treatment modalities.

Detailed description: Patent ductus arterioses is a common problem which involves both pulmonary and cardiac outcomes in preterm infants. Although thrombocytopenia has been reported as a risk factor for patent ductus arterioses, there is lack of data on the function of platelets in ductal closure.

The investigators aim to investigate the relation between thrombocytopenia and platelet functions in pathogenesis of spontaneous ductal closure. The investigators hypothesize that Information on functions of platelets in ductal closure may change the known model for ductus arterioses and may affect the treatment modalities.

Eligibility criteria: Inclusion Criteria:

* gestational age lower than 30 weeks and birth weight lower than 1500 g
* obtained informed consent

Exclusion Criteria:

* any received medical treatment in first 2 days of life
* death in first 2 days
* patients who received any thrombocyte or fresh frozen plasma suspensions
* any known genetic thrombocyte disorder in the family

Primary outcomes:
measure: spontaneous ductal closure
timeFrame: 8 weeks
Secondary outcomes:
measure: need for treatment
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Children's Hospital
Study officials:
affiliation: Ankara University
name: Omer Erdeve, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01880879: A Prospective Multicenter Trial Evaluating Helios Biodegradable Polymer SES Safety and Effectiveness in CAD Treatment
Official title: A Prospective Multicenter Trial Evaluating Helios Biodegradable Polymer Sirolimus-eluting Stent Safety and Effectiveness in Treatment of Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
PCI
stent
Lead sponsor: Kinhely Bio-tech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: RenJi Hospital
name: Peking University
First posted: 2013-06-19
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: research topic:helios After registration of clinical research bidders:kinhely bio-tech Co.Ltd study design:A prospective single treatment group multicenter clinical study Number of patients:Included in the subjects of 800 cases Main research purpose:Evaluation of safety and effectiveness Mainly studies the finish:1 year target lesion of the failure

Inclusion criteria :

one:Gender not limited at the age of 18 to 80 two:myocardial ischemia or angina symptoms of coronary artery disease three:A narrow is less than 50% treated with stents four:Comply with the instructions five:Voluntarily signed the informed consent form exclusion criteria: one:Pregnant women two:cardiac shock three:Against a suppository medicines or allergies four:Participated in other test research in the first 6 months five:Within 6 months after PCI plans to accept non cardiac surgery six:Non-compliant patient Follow-up time:A month for 6 months and 9 months to 1 year to 2 years follow-up progress plan:All center within 6 months after start of complete into the group

Detailed description: no desired

Eligibility criteria: Inclusion Criteria:

* Any age 18 to 80 sex Myocardial ischemia or angina pectoris of coronary artery disease An application stents diameter stenosis greater than 50% Comply with the instructions Voluntarily signed the informed consent form

Exclusion Criteria:

* Pregnant women cardiac shock Intolerance to antithrombotic therapy or allergies 6 months prior to the start of the study involved in other studies Within 6 months after PCI plans to accept non cardiac surgery Non-compliant patient

Primary outcomes:
measure: 1 year incidence of target lesion
timeFrame: 1year
Secondary outcomes:
measure: cardiac death Target blood vessels caused by myocardial infarction Ischemia driven target lesion revascularization of 1 year and 2 years,MACE, Stent thrombosis events,clinical success.
timeFrame: 2 years
measure: 2 years, the incidence of various combination of the pathological changes of failure
timeFrame: 2 years
Other outcomes:
measure: Rehospitalization rate
timeFrame: 2 years
Locations:
city: Shanghai
country: China
facility: Yan chai hospital affiliated to Shanghai jiaotong university school of medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT01520779: Recurrence of Hepatocellular Carcinoma
Official title: Risk Factors for Recurrence of Hepatocellular Carcinoma After Radiofrequency Ablation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular cacinoma
Radiofrequancy ablation
Intrahepatic recurrence
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2012-01-30
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hepatocellular carcinoma (HCC) who underwent radiofrequency ablation (RFA) from 1/2006 till 12/2010in Tropical medicine department and hepatocellular carcinoma clinic, Ain Shams university

Brief summary: analysis of the risk factors of intra-hepatic distant recurrence (IDR) of hepatocellular carcinoma within 1 year after radiofrequency ablation.


Eligibility criteria: Inclusion Criteria:

1. Proved diagnosis of HCC according to AASLD practice guidelines (Bruix and Sherman, 2005).
2. Patients underwent RFA for HCC with BCLC (The Barcelona-Clinic- Liver-Cancer staging system) stage A (Bruix and Sherman, 2005) with no eligibility or ability to do transplantation or resection.
3. Patients should be followed-up for more than 12 months to exclude early recurrence i.e. recurrence within 1 year.
4. Patients with INR \< 1.5 or prothrombin concentration \> 50%.
5. Platelet count \> 50000 cell/mm3.

Exclusion Criteria:

1. Presence of extra-hepatic metastasis or gross vascular invasion.
2. Child class C patients.
3. Follow up period of less than 12 months.

Primary outcomes:
measure: Recurrence of hepatocellular carcinoma
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Tropical medicine department
Study officials:
References:
Clinical trial NCT06290479: A Three-Group Study to Examine the Efficacy of the Air up® Drinking System at Improving Hydration and Associated Health Outcomes
Official title: A Three-Group Study to Examine the Efficacy of the Air up® Drinking System at Improving Hydration and Associated Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Water Intake
Keywords: Hydration
Drinking habits
Flavored water
Lead sponsor: air up GmbH
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-03-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: OTHER

Brief summary: A randomized, controlled trial evaluating the air up® drinking system's impact on hydration and health outcomes. Participants will use air up® with Peach, Orangeade, or unscented pods and their effects on drinking habits, and health outcomes will be assessed over 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Willingness to use the system
* Generally healthy
* Enjoys the smell of peach or orangeade.

Exclusion Criteria:

* Silicone allergy
* IBS, bariatric surgery,
* pregnancy
* participation in another clinical study.

Primary outcomes:
measure: Change in Hydration Habits and Health Outcomes as Measured by the Water Intake Questionnaire and the Hydration-Related Quality of Life Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Blood Biomarkers
timeFrame: Measured at baseline and at the end of the 12-week study period
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT04896879: Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals Regarding LARS
Official title: Rectal Cancer Survivorship, the Struggle of the Low Anterior Resection Syndrome (LARS). Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Anterior Resection Syndrome
Rectal Cancer
Keywords: low anterior resection syndrome
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Kom Op Tegen Kanker
name: AZ Sint-Jan AV
name: AZ Delta
name: AZ Sint-Lucas Gent
First posted: 2021-05-21
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants will be patients with major LARS, their informal caregivers and healthcare professionals

Brief summary: Exploration of the experiences and needs of patients with the low anterior resection syndrome, their informal caregiver and health care professionals. This is a qualitative study where semi-structured interviews will be conducted with patients and informal caregivers. next to that focus groups will be performed with healthcare professionals from different professions.


Eligibility criteria: PATIENTS

Inclusion Criteria:

* adult patients (18+)
* confronted with major low anterior resection syndrome after rectal cancer surgery

Exclusion Criteria:

* stoma at time interview
* abdominal perineal resection

INFORMAL CAREGIVERS Inclusion criteria

* Adults (18+)
* Nominated by the participating patient as their principal caregiver Exclusion criteria None

HEALTHCARE PROFESSIONALS inclusion criteria

* Adults (18+)
* Caring for patients with LARS Exclusion criteria None

Primary outcomes:
measure: needs and experiences of patients with major lars and their informal caregiver through individual semistructered interviews
timeFrame: Interview will last about 60 minutes
measure: Needs and experiences of healthcare professionals caring for patients with LARS through focus groups
timeFrame: Focus group will last about 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Pape E, Decoene E, Debrauwere M, Van Nieuwenhove Y, Pattyn P, Feryn T, Pattyn PRL, Verhaeghe S, Van Hecke A; Belgian LARS collaborative group. Information and counselling needs of patients with major low anterior resection syndrome: A qualitative study. J Clin Nurs. 2023 Apr;32(7-8):1240-1250. doi: 10.1111/jocn.16277. Epub 2022 Mar 6.
Clinical trial NCT01700179: Evaluation of Safety, Tolerability, and Antiviral Activity of ACH-0143102 Plus Ribavirin In Treatment-naive Hepatitis C Virus Infection Genotype 1b Participants
Official title: A Phase 1b, Open-label, Pilot Study to Evaluate the Safety, Tolerability, and Antiviral Activity of Oral ACH-0143102 Administered in Combination With Ribavirin for 12 Weeks in Treatment-naive Subjects With Chronic Hepatitis C Virus Infection Genotype 1b
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C Infection
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Achillion, a wholly owned subsidiary of Alexion
First posted: 2012-10-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the safety, tolerability, and efficacy of 12 weeks of treatment with ACH-0143102 and ribavirin in genotype 1b (GT1b), treatment-naive, hepatitis C virus (HCV) participants.

Detailed description: A Phase 1b, pilot study that evaluated the safety, tolerability, and antiviral activity of oral ACH-0143102 administered in combination with ribavirin for 12 weeks in treatment-naive participants with chronic HCV GT1b.

Eligibility criteria: Inclusion Criteria:

* Males and females aged 18 years and older.
* Clinical diagnosis of hepatitis C with GT1b.
* Chronic hepatitis C treatment-naive participants.
* Interleukin 28B genotype CC.
* HCV ribonucleic acid \> 10,000 international units/milliliter at screening.
* Female participants must be willing to use 2 effective methods of contraception during the dosing period and for 6 months after the last dose of ribavirin.
* Male participants must be willing to use an effective barrier method of contraception throughout the dosing period and for 6 months after the last dose of ribavirin. Male participants must agree not to donate sperm while enrolled in the study and for 6 months after the last dose of ribavirin.
* Willing to participate in all study activities and all study requirements.

Exclusion Criteria:

* Body mass index \> 36 kilograms/meter squared.
* Pregnant or nursing females.
* Clinically significant laboratory abnormalities at screening.
* Previous participation in a clinical trial with protease inhibitor and/or non-structural protein 5A inhibitor.
* Human immunodeficiency virus infection or other liver diseases.
* Positive hepatitis B surface antigen.
* Liver cirrhosis.
* Uncontrolled psychiatric disease.
* Clinical evidence of chronic cardiac disease.
* History of malignancy of any organ system within 5 years.

Primary outcomes:
measure: Sustained Virologic Response At 12 Weeks (SVR12)
timeFrame: 12 weeks following the last dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02799979: 3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension
Official title: 3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pulmonary hypertension diagnosed

Brief summary: Pulmonary hypertension is a rare and severe disease, affecting a young population. Survival is very poor and has been closely related to right ventricular dysfunction. Current prognostic equations rely mostly on right heart catheterization data. The identification of simple echocardiographic prognostic factor is urgently needed. It could help identifying with a non invasive method, high risk patients who could benefit from an intensive specific therapy. 3D right ventricular imaging is a new echocardiographic tool which provides RV volumic analysis, RV ejection fraction, overcoming the classical limits of 2D ultrasound.

The aim of this study is to validate a new software for 3D analysis of the right ventricle and assess its prognostic role in pulmonary hypertension.

To do so, the investigators will realize a prospective monocentric longitudinal cohort study, including 100 pulmonary hypertension patients. Echocardiographic data will be collected at baseline and after 6 months.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years old
* Pulmonary hypertension diagnosed by right heart catheterization
* Informed consent obtained
* Affiliation to the French national health insurance

Exclusion Criteria:

* Associated significant left heart disease
* Sub-optimal acoustic windows
* Patient unable to attend follow-up visits

Primary outcomes:
measure: Number of death from any cause
timeFrame: Baseline to 24 months
Secondary outcomes:
measure: Number of Hospitalisation
timeFrame: Baseline to 24 months
measure: 3D right ventricular imaging echocardiographic
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Hopital Pasteur - Chu Nice
Study officials:
affiliation: CHU NICE
name: PAMELA MOCERI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moceri P, Duchateau N, Baudouy D, Squara F, Bun SS, Ferrari E, Sermesant M. Additional prognostic value of echocardiographic follow-up in pulmonary hypertension-role of 3D right ventricular area strain. Eur Heart J Cardiovasc Imaging. 2022 Oct 20;23(11):1562-1572. doi: 10.1093/ehjci/jeab240.
Clinical trial NCT01873079: PPI for Prevention of Post-sphincterotomy Bleeding
Official title: Prevention of Delayed Post-sphincterotomy Bleeding by High Dose Proton Pump Inhibitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bleeding
ERCP
Keywords: ERCP
sphincterotomy
proton pump inhibitor
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Endoscopic biliary sphincterotomy is a common and important procedure for biliary access and therapy during endoscopic retrograde cholangiopancreatography (ERCP). Bleeding is one of the important complications related to sphincterotomy. This study determines the role of proton pump inhibitor (PPI) in preventing post-sphincterotomy bleeding in patients undergoing ERCP and sphincterotomy.

Detailed description: Eligible patients will be randomized to receive either high dose PPI or standard care. PPI will be given before ERCP and continue for one week after the sphincterotomy.

Both overt and occult bleeding will be documented up to 10 days after the sphincterotomy. Bleeding rates of the two groups will be compared.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients undergoing ERCP who will require sphincterotomy

Exclusion Criteria:

* Previous sphincterotomy/papillotomy
* Previous Polya gastrectomy
* Patients on maintenance PPI
* Pregnant and lactating women
* Age \<18 years
* Previous liver transplant
* unable to consent for study

Primary outcomes:
measure: Proportion of patients with bleeding after sphincterotomy
timeFrame: 10 days
Secondary outcomes:
measure: Proportion of patients who require transfusion, endoscopic hemostasis and other intervention to control bleeding
timeFrame: 10 days
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Wai K Leung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04518579: Epidural-inhalational Versus Epidural-intravenous Anaesthesia on Anti-tumor Immunity in Patients With Cancer Colon
Official title: Effect of Epidural-inhalational Versus Epidural-intravenous Anaesthesia on Anti-tumor Immunity in Patients Undergoing Open Surgery for Cancer Colon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunity Factors in Cancer Colon Patients
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group (EP) received epidural - propofol based anesthetic technique and postoperative analgesia through patient controlled epidural analgesia and Group (EH) received epidural- inhalational based anesthetic technique and postoperative analgesia through patient controlled epidural analgesia
Primary purpose: PREVENTION

Brief summary: Surgery is the primary treatment for colon cancer. However, the rate of recurrence or metastasis in colon cancer can be as high as 30%, even in stages 1 and 2 . Most colon cancer-related deaths are caused by metastatic disease . Many patients with colon cancer harbour micrometastases and disseminated tumour cells at the time of surgery . Whether the micrometastases develop into clinically significant metastases depends on the immune system's ability to eradicate them.The aim of the study is to declare the effect of epidural-intravenous based anesthetic technique on anti-tumor immunity and in comparison to epidural inhalational based anesthetic technique in patients undergoing open surgical resection of colon cancer.


Eligibility criteria: Inclusion Criteria:

* Age 20-70 yrs.
* ASA class I and II
* Elective open surgery for non-metastatic cancer colon stage I,II

Exclusion Criteria:

* Patient refusal
* Known allergy to the study medications
* Patients with compromised immune function ( associated blood diseases, immunosuppressive drugs, chemotherapeutic agents, corticosteroids)
* Contraindications to epidural insertion e.g. infection at insertion site and coagulopathy

Primary outcomes:
measure: anti tumour immunity
timeFrame: preoperative and Day 1 postoperatively
Secondary outcomes:
measure: change in pain intensity
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: South Egypt Cancer Institute
Study officials:
affiliation: dean of SECI
name: samy ab amr, professor
role: STUDY_CHAIR
References: