louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00870181: ADV-TK Improves Outcome of Recurrent High-Grade Glioma
Official title: Adenovirus-Mediated Delivery of Herpes Simplex Virus Thymidine Kinase Administration Improves Outcome of Recurrent High-Grade Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Glioma of Brain
Glioblastoma
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Beijing Chao Yang Hospital
name: Beijing Friendship Hospital
First posted: 2009-03-27
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Malignant gliomas are the most common primary brain tumor in adults, but the prognosis for patients with these tumors remains poor despite advances in diagnosis and standard therapies such as surgery, radiation therapy, and chemotherapy. The advantages of ADV-TK gene therapy highlight its efficacy and safety for glioma patients. This clinical trial was conducted to assess the anti-tumor efficacy and safety of intraarterial cerebral infusion of replication-deficient adenovirus mutant ADV-TK, in combination with systemic intravenous GCV administration in patients with recurrent high-grade glioma.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed WHO grades 3 to 4 malignant glioma
* Diagnosed recurrence or progression by clinical or radiological evidence
* Fit for intraarterial infusion and intravenous chemotherapy
* Adequate hepatic, renal, and hematologic function.
* Legal age ≥18 years
* Life expectancy ≥12 weeks
* Eastern Cooperative Oncology Group performance (ECOG) ≥2
* Chemotherapy completion ≥4 weeks prior and recovery from drug induced toxicities.

Exclusion Criteria:

* Active pregnancy
* Prior gene therapy
* Second primary tumor
* Gravidity, lactation, hypersensitivity to antiviral drugs, immunologic deficit, active uncontrolled infections
* Requiring treatment with warfarin or any other anticoagulants

Primary outcomes:
measure: The primary end point was 6-month progression-free survival rate (PFS-6)
timeFrame: 6 months
Secondary outcomes:
measure: progression-free survival (PFS)
timeFrame: 3 years
measure: overall survival (OS)
timeFrame: 3 years
measure: safety
timeFrame: 1. at the time during treatments; 2. at 6-month; 3. at the end of 1-year following-up; 4. at the end of 2-year following up; 5. at the time the patient censored.
measure: clinical benefit
timeFrame: at the end of 2nd ADK-TK/GCV therapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing YouAn Hospital
state: Beijing
Study officials:
affiliation: Tongji Hospital of HUST
name: Ma Ding, M.D.
role: STUDY_DIRECTOR
References:
citation: Ji N, Weng D, Liu C, Gu Z, Chen S, Guo Y, Fan Z, Wang X, Chen J, Zhao Y, Zhou J, Wang J, Ma D, Li N. Adenovirus-mediated delivery of herpes simplex virus thymidine kinase administration improves outcome of recurrent high-grade glioma. Oncotarget. 2016 Jan 26;7(4):4369-78. doi: 10.18632/oncotarget.6737.
Clinical trial NCT03799081: Use of Fetoscopy in Missed Abortion
Official title: Use of Fetoscopy in Missed Abortion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abortion, Missed
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-01-10
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Women who have undergone a missed abortion in the first trimester who want a surgical treatment option
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the use of hysteroscopic embryoscopy or fetoscopy as a powerful diagnostic tool to provide better counseling for couples having experienced pregnancy loss.


Eligibility criteria: Inclusion Criteria:

* Women diagnosed with missed abortion during the first trimester of pregnancy

Exclusion Criteria:

* Women diagnosed with missed abortion after the first trimester of pregnancy
* Any contraindication for hysteroscopy

Primary outcomes:
measure: Macroscopic anatomic malformations in missed abortions
timeFrame: Two years
Secondary outcomes:
measure: Minimize intrauterine adhesions through observation
timeFrame: Two years
measure: Prevention of retained conception products
timeFrame: Two years
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hille Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Sergio Haimovich, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06453681: Dexmedetomidine As an Adjuvant to Bupivacaine in Bilateral PECs for Pain Control After Cardiac Surgeries
Official title: Dexmedetomidine As an Adjuvant to Bupivacaine in Bilateral Pectoral Nerve Blocks for Postoperative Pain Control After Cardiac Surgeries: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Post Operative Pain
Keywords: PECs
dexameditomedine
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled study
Primary purpose: TREATMENT

Brief summary: the study aims to test the quality of analgesia provided by dexmedetomidine as an adjuvant to bupivacaine bilateral PECs block in patients scheduled for cardiothoracic surgeries with median sternotomy incision.

Detailed description: Background: Good postoperative analgesia in cardiac surgical patients helps in early recovery and ambulation. An alternative to parenteral, paravertebral, and thoracic epidural analgesia can be pectoralis nerve (Pecs) block, which is a novel, less invasive regional analgesic technique.

The study aims to test the quality of analgesia provided by dexmedetomidine as an adjuvant to bupivacaine bilateral PECs block in patients scheduled for cardiothoracic surgeries with median sternotomy incision.

sixty adult patients between the age groups of 25 and 65 years undergoing coronary artery bypass grafting or valve surgeries through midline sternotomy under general anesthesia were enrolled in the study. Patients were randomly allocated into two groups with 30 ineach group. Group 1 patients will receive bilateral Pecs block, whereas Group 2 patients will receive bilateral Pecs block with dexameditomedine postoperatively. Patients will be extubated once they fulfilled extubation criteria. Ventilator duration will be recorded. Patients will be interrogated for pain by visual analog scale (VAS) scoring at rest and cough. Inspiratory flow rate will be assessed using incentive spirometry.

Eligibility criteria: Inclusion Criteria:

* All adult patients between the age groups of 25 and 65 years undergoing either coronary artery bypass grafting (CABG) or valve surgeries through midline sternotomy under general anesthesia

Exclusion Criteria:

* Skin erosions, hematomas or infection at the injection site.
* coagulopathy, ACT more than 150 seconds
* History of hypersensitivity to bupivacaine or Dexametomedine.
* The Patients who are unable to use the pain score.
* patients who will need prolonged post-operative ventilation or inotropic support.

Primary outcomes:
measure: The duration of analgesia
timeFrame: up to 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasralainy school of medicine
city: Cairo
country: Egypt
facility: Kasralaini Faculty of Medicine
Study officials:
References:
Clinical trial NCT03520881: Pediatric ASTHMA-Educator
Official title: The Development and Pilot Testing of a Pediatric Algorithmic Software Tool to Help Manage Asthma (ASTHMA)-Educator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 45
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: There is one group (intervention arm only) in this proof of concept study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project seeks to develop and pilot test the pediatric ASTHMA-Educator mobile application.

Detailed description: This project seeks to develop and pilot test the pediatric ASTHMA-Educator mobile application. The study is being conducted at Montefiore Medical Center among pediatric (7-17 years old) patients with persistent asthma. We are collecting process and clinical outcomes in a longitudinal study design.

Eligibility criteria: Inclusion Criteria:

English-speaking individuals between 7-17 years with:

* Persistent asthma (diagnosis made by a healthcare provider) on a daily controller medication
* Able to give informed consent
* Smartphone (iOS or Android) access

Exclusion Criteria

* Use of oral corticosteroids in the 2 weeks prior to the baseline visit
* Pregnancy
* Severe psychiatric or cognitive problems that would prohibit an individual from understanding and completing the protocol
* Patients that previously received the ASTHMA-Educator application

Primary outcomes:
measure: Change from baseline asthma control to 2, 4, and 6 months
timeFrame: Baseline, 2 months, 4 months, 6 months
Secondary outcomes:
measure: Patient satisfaction measured by the Client Satisfaction Questionnaire-8
timeFrame: Baseline, 2 months, 4 months, 6 months
measure: Change from baseline asthma knowledge to 2 months, 4 months, 6 months
timeFrame: Baseline, 2 months, 4 months, 6 months
measure: Asthma quality of life as measured by the Pediatric Asthma Impact Scale
timeFrame: Baseline, 2 months, 4 months, 6 months
measure: Self-reported medication adherence
timeFrame: Baseline, 2 months, 4 months, 6 months
measure: Asthma emergency department visits
timeFrame: Baseline, 2 months, 4 months, 6 months
measure: Asthma hospitalizations
timeFrame: Baseline, 2 months, 4 months, 6 months
measure: Asthma-related steroid courses
timeFrame: Baseline, 2 months, 4 months, 6 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Sunit Jariwala, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01486381: Long Term Safety of Biphasic Insulin Aspart 30 in Juveniles With Type 1 Diabetes
Official title: A Multi-national, Multi-centre, Open-labelled Extension Study Assessing the Long-term Safety of Biphasic Insulin Aspart 30 (BIAsp 30) in Young Diabetic Subjects With Type 1 Diabetes Mellitus Previously Treated in BIAsp-1240
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-06
Enrollment: 22
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in South Africa. The aim of this trial is to investigate Long term safety of biphasic insulin aspart 30 in juveniles with type 1 diabetes previously treated in trial BIAsp-1240.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent obtained before any trial-related activities according to local requirements. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
* The subject must have completed the trial BIAsp-1240

Primary outcomes:
measure: Number of hypoglycaemic episodes
measure: Occurence of adverse events
measure: Standard safety parameters: Haematology, biochemistry and vital signs
Secondary outcomes:
measure: HbA1c (glycosylated haemoglobin)
measure: Blood glucose level at each time-point in the 8-point glucose profile
measure: BMI (Body Mass Index)
Other outcomes:
Locations:
city: Pretoria
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Cape Town
country: South Africa
facility: Novo Nordisk Investigational Site
state: Western Cape
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06630481: Long-term Survival Outcomes According to the Pathologic Response After Neoadjuvant Treatment in PDAC and the Fate of the Patients with Good CAP Grade
Official title: Long-term Survival Outcomes According to the Pathologic Response After Neoadjuvant Treatment in PDAC and the Fate of the Patients with Good CAP Grade
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Neoadjuvant Therapy
Pathological Complete Response
Keywords: CAP grade
tumor response grading system
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 462
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive adult patients (aged \&gt;18 years) who underwent pancreatic resection after NAT at Seoul National University Hospital between January 2009 and December 2023 were included. Patients were initiated on NAT after confirming PDAC diagnosis based on pathological examination.

Brief summary: 1. Neoadjuvant treatment (NAT) is increasingly used in managing pancreatic ductal adenocarcinoma (PDAC), necessitating dependable methods to evaluate tumor response.
2. Among various pathological tumor regression grading systems, the College of American Pathologists (CAP) system is commonly used to predict chemo-responsiveness and survival.
3. This study aimed to analyze long-term survival outcomes based on pathologic response using the CAP grade after NAT in PDAC and to identify clinicopathologic factors that influence a favorable pathologic response.


Eligibility criteria: Inclusion Criteria:

* Adult patients (aged \&gt;18 years) who underwent pancreatic resection after NAT at a single center between January 2009 and December 2023.
* Patients were initiated on NAT after confirming PDAC diagnosis based on pathological examination.

Exclusion Criteria:

* Patients without a reported CAP grade
* Patients who underwent palliative surgery
* Patients who received NAT outside the specified protocol due to incomplete information.

Primary outcomes:
measure: 5-year overall survival
timeFrame: assessed up to 60months
measure: 5-year disease-free survival
timeFrame: assessed up to 60months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01384981: Effects of Non-invasive Ventilation on Rehabilitation Outcome in COPD-patients
Official title: Effects of Non-invasive Ventilation on Exercise Capacity and Quality of Life in COPD-patients GOLD III/IV
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary rehabilitation
COPD
non invasive ventilation
NIV
exercise capacity
pulmonary rehabilitation
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
Collaborators: name: ResMed
First posted: 2011-06-29
Enrollment: 31
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: TREATMENT

Brief summary: The aim of the study is to find out if nocturnal non-invasive ventilation during pulmonary rehabilitation increases exercise capacity and quality of life more than pulmonary rehabilitation alone.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of COPD in stages GOLD III/ IV
* receiving optimized medical treatment and long term oxygen therapy if needed
* patients consent to participate in this trial
* no treatment with NIV in the last 4 weeks
* treatment with NIV in the last 4 weeks due to an acute exacerbation

Exclusion Criteria:

* treatment with NIV in the last 4 weeks (except due to an acute exacerbation)
* Intolerance to perform NIV
* Acute exacerbation at baseline or during PR
* Hypercapnia \> pCO2 55mmHg
* Inability to perform a 6 minute walking test

Primary outcomes:
measure: change in 6 minute walking distance
timeFrame: day 1 and 25
Secondary outcomes:
measure: change in quality of life (chronic respiratory questionnaire, CRQ)
timeFrame: day 1 and 25
measure: change quality of life (Saint George´s Respiratory Questionnaire, SGRQ)
timeFrame: day 1 and 25
Other outcomes:
Locations:
city: Schönau am Königssee
country: Germany
facility: Schön Klinik Berchtesgadener Land
Study officials:
References:
Clinical trial NCT06662981: The Effect of Preoperative Information and Education in the Clinical Outcome of Total Hip Arthroplasty
Official title: The Effect of Preoperative Information and Education in the Clinical Outcome of Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Arthroplasty
Keywords: preoperative information
preoperative education
total hip arthroplasty
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Preoperative patient information and education is an essential aspect of modern surgical care, particularly for patients undergoing total hip arthroplasty (THA). This prospective, randomized trial aims to assess the effects of structured preoperative education and information on clinical outcomes in patients undergoing THA.

Detailed description: A total of 100 patients will be randomized into two groups: the intervention group (n = 50) receiving standardized preoperative information and education, and the control group (n = 50) receiving standard preoperative care without a formal educational component. Postoperative outcomes, including pain, functionality, mobility, length of hospital stay (LOS), health-related quality of life, anxiety and depression will be compared between the 2 groups.

Eligibility criteria: Exclusion criteria in the study will be patients:

* under 50 years old
* with reduced mental abilities
* with a presence of mental illness
* who have had previous hip surgery

Primary outcomes:
measure: Hip pain and functionality
timeFrame: 30 days postoperatively
measure: Length of Hospital Stay
timeFrame: 30 days postoperatively
measure: Anxiety and Depression
timeFrame: 30 days postoperatively
measure: Health-related quality of life
timeFrame: 30 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Kifissia
country: Greece
facility: KAT Hospital
state: Attica
city: Athens
country: Greece
facility: Sara Eleni Amprachim
Study officials:
References:
citation: Amprachim SE, Vlamis J, Nikolaou VS, Pneumaticos SG. Role of Preoperative Information and Education of Patients Undergoing Total Hip Arthroplasty: A Narrative Review of the Literature. Cureus. 2024 Aug 3;16(8):e66094. doi: 10.7759/cureus.66094. eCollection 2024 Aug.
Clinical trial NCT04612881: Fitostimoline Vaginal Pessaries in Women With Hysterectomy. Randomized, Perspective, Monoscentric Study.
Official title: Clinical Verification of the Activity and Tolerability of Fitostimoline Vaginal Pessaries in Women With Hysterectomy. Randomized, Perspective, Monoscentric Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vaginal Bleeding
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women aged between 30 and 80 years with hysterctomy.

Brief summary: Clinical evaluation of Fitostimoline vaginal pessaries in the treatment of hysterectomy. An observational, randomized, perspective study performed on 60 women where 30 women are treated with fitostimoline pessaries and 30 women are treated with the standard of care.


Eligibility criteria: Inclusion Criteria:

* patient aged between 35 and 80 years
* patient undergoing hysterectomy
* Willingness to understand the procedures and aims of the study

Exclusion Criteria:

* Anamnestic or clinical data of metabolic or endocrine diseases (such as uncontrolled diabetes mellitus) or any other local and / or systemic pathology potentially able to interfere with the study parameters;
* Concomitant treatment with antibiotics / antiseptics, NSAIDs, analgesics (excl. Paracetamol)
* Non-therapeutic use of psychoactive substances;
* Abuse of drugs and / or alcohol / smoking;
* Neurological disorders or psychiatric conditions potentially capable of affecting the validity of the consent and / or compromising the patient's adherence to the study procedures;
* Known allergy, hypersensitivity or intolerance to the constituents of the preparations under study;
* Any condition, medical or otherwise, that could significantly reduce the possibility of obtaining reliable data, achieving the objectives of the study, perfecting its completion;
* Presumption of poor reliability or collaboration;
* Treatment with any preparation in the last 30 days prior to the start of the study;
* Patients already enrolled in this study;
* Center staff directly involved in the study and close relatives

Primary outcomes:
measure: TSS
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Barbara Maglione
Study officials:
References: