louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06620510: Retrospective Study of Long-Term Survival of "Immuncell-LC" in Patients Undergoing Curative Resection for HCC in Korea
Official title: A Multicenter, Retrospective Data Analysis Study on the Long-term Survival Rate of the 'Immuncell-LC Goups' and 'Non-treatment Groups' in Patient Undergo Curative Resection (PEIT, RFA or Operation) for Hepatocellular Carcinoma in Korea
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatocellular Carcinoma
Lead sponsor: GC Cell Corporation
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This long term follow-UP study is observation about the Immuncell-LC Groups' and 'Non-treatment Groups' in patient undergo curative resection (PEIT, RFA or Operation) for Hepatocelluar Carcinoma in Korea.

Brief summary: To observation that long term follow-up study of 'Immuncell-LC groups' and 'Non-treatment groups' in patient undergo curative resection (PEIT, RFA or Operation) for hepatocellular carcinoma in Korea

Detailed description: The purpose of this study is to retrospectively compare the long-term survival of patients who participated in the "Randomized, open-label, multicenter phase 3 clinical trial to evaluate the efficacy and safety of Immunocel-LC treatment and no treatment in Korean patients with hepatocellular carcinoma (HCC) who received potentially curative treatment \[surgical resection, radiofrequency ablation (RFA), or percutaneous ethanol injection (PEI)\] (NCT00699816). HCC was diagnosed by pathological evaluation or radiological imaging studies. Eligibility criteria also included hepatic function of Child-Pugh class A and an Eastern Cooperative Oncology Group performance status score of 0 or 1. Exclusion criteria included autoimmune disease or immunodeficiency, previous or current malignant tumor other than HCC, and severe allergic disorders. Pregnant or breastfeeding women and women planning to become pregnant were also excluded. All eligible participants were randomly assigned to receive adjuvant immunotherapy using a CIK cell agent (the immunotherapy group) or no adjuvant treatment (control group) in a 1:1 ratio.

Eligibility criteria: Inclusion Criteria:

* Patients of participated in the(ClinicalTrials.gov Identifier:NCT00699816)clinical trial.

Exclusion Criteria:

* NA

Primary outcomes:
measure: Recurrence-free Survival(RFS)
timeFrame: up to 9 years
Secondary outcomes:
measure: Overall Survival(OS)
timeFrame: up to 9 years
measure: Cancer-specific Survivals(CSS)
timeFrame: up to 9 years
Other outcomes:
Locations:
Study officials:
affiliation: Global Product Development Division
name: JinHee Kang
role: STUDY_DIRECTOR
References:
Clinical trial NCT01112410: Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Bronchiectasis
Official title: A Randomised Double Blind 13 Week Crossover Trial of Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Patients With Bronchiectasis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bronchiectasis
Keywords: Bronchiectasis
Hypertonic saline
Lead sponsor: Belfast Health and Social Care Trust
Sponsor class: OTHER
First posted: 2010-04-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators hypothesise that nebulised hypertonic saline (6%) will increase the volume of sputum expectorated over a 24 hour period compared to nebulised isotonic saline (0.9%) in patients with mild to severe stable bronchiectasis.


Eligibility criteria: Inclusion Criteria:

* Non CF Bronchiectasis
* 18-80 years
* FEV1 less than 90%
* Chronic sputum production
* Clinical stable

Exclusion Criteria:

* Intolerance to HTS
* Use of HTSaline or antibiotics 14 days prior to study
* Clinically unstable
* Smokers

Primary outcomes:
measure: 24 hour sputum volume
timeFrame: 13 weeks
Secondary outcomes:
measure: Pulmonary Function Testing
timeFrame: 13 weeks
measure: Rheology
timeFrame: 13 weeks
measure: Adherence
timeFrame: 13 weeks
measure: Patient Reported Outcomes RSSQ
timeFrame: 13 weeks
measure: Patient Reported Outcome: Leicester Cough Questionnaire:
timeFrame: 13 weeks
measure: Bronchiectasis Qol Questionnaire
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Belfast HSCT
state: Northern Ireland
Study officials:
References:
Clinical trial NCT01311310: Effect of Remote Ischemic Preconditioning on Children Undergoing Cardiac Surgery
Official title: Effect of Remote Ischemic Preconditioning on Children Undergoing Cardiac Surgery: Implication of Preoperative Cyanosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cyanosis
Keywords: troponin, open heart surgery, children
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-03-09
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study is conducted in order to evaluate the effect of remote ischemic preconditioning on children undergoing cardiac surgery, especially focusing on possible differences according to preoperative cyanosis.


Eligibility criteria: Inclusion Criteria:

* open heart surgery under cardiopulmonary bypass: ventricular septal defect, tetralogy of Fallot

Exclusion Criteria:

* chromosomal defect
* airway and parenchymal lung disease blood disorder
* isolated atrail septal defect
* immunodeficiency

Primary outcomes:
measure: troponin level
timeFrame: within the 1 day after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
References:
Clinical trial NCT02630810: Early Versus Late Hydration After Cesarean Section (CS)
Official title: Early Versus Late Oral Hydration After Cesarean Section: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Motility and Defaecation Conditions
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2015-12-15
Enrollment: 267
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates the effect of early oral hydration on bowel movement after CS, it includes 2 groups: study group participants receive 100 ml water after 1hr from the end of CS, while the others receive water after 6hrs from the end of CS.

Detailed description: Traditionally, oral intake after CS was depend on insurance of intestinal movement, since uncomplicated CS does not affect the intestine and the mother needs to care of her infants, lactates, discharged from hospital, early oral hydration may enhance bowel movement, so the investigators need to evaluate the safety of early oral hydration after CS.

This study compare the effects of introducing water during the 1st hour or after 6 hours on bowel movement after CS.

Eligibility criteria: Inclusion Criteria:

* uncomplicated elective or emergency lower segment Caesarean section
* average blood loss during and after cs
* regional anaesthesia
* primary or recurrent CS

Exclusion Criteria:

* surgical complications esp; intestinal injury
* postpartum hemorrhage
* medical disorder with pregnancy eg. hypertension, diabetes mellitus
* factors that may increase risk of postpartum hemorrhage as twins pregnancy, polyhydramnios and anemia

Primary outcomes:
measure: Time to 1st audible intestinal sound
timeFrame: First 12 hours after Cesarean Section
Secondary outcomes:
measure: Time to passage of first flatus
timeFrame: Up to 48 hours following the Cesarean Section
measure: Time to first bowel motion
timeFrame: Up to 3 days (72 hours) following Cesarean Section
measure: time to 1st breast feed
timeFrame: First 24 hours after the Cesarean Section
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
affiliation: ainshams maternity hospital
name: Amr Yehia, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06097910: Surveillance for Multifocal GGNs
Official title: Active Surveillance for Patients with Multifocal Ground-glass Nodules: a Prospective, Multi-center, Single-arm Trial (ECTOP-1021)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Ground-glass Opacities
Active Surveillance
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients who are willing to particiapte in the study and meet the inclusion and exculsion criteria.

Brief summary: This study is a single-arm, multi-center, phase III trial conducted under the Eastern Cooperative Thoracic Oncoloy Project (ECTOP) with the identification number ECTOP-1021. The primary objective of the study is to assess the overall survival of patients with multifocal ground-glass opacities by employing a active surveillance approach rather than opting for surgical resection.

Detailed description: The trial aims to confirm the hypotheses that delaying surgery until GGO nodules exhibit progression or meet certain criteria offers a prognosis equivalent to those undergoing immediate surgical resection, potentially allowing many of these patients to avoid surgery altogether.

Eligibility criteria: Inclusion criteria Patients eligible for enrollment in the study are required to meet all the following criteria.

1. Demonstrates the following on thin-section computed tomography (TSCT) scan:

   1. Presence of three or more GGNs (bilateral lesions are permitted).
   2. All lesions have remained stable without regression or enlargement for at least 3 months.
   3. The dominant lesion (the lesion with the largest maximum tumor diameter) has a maximum tumor diameter \>=0.6cm and \<=2cm.
   4. CTR \<=0.25 in all lesions.
   5. No lymph node with a diameter \>1cm in the mediastinal view.
   6. Not adjacent to the pleura in dominant lesion and no sign of pleural retraction in any lesions.
2. Aged 18-75 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Has not previously undergo any anti-tumor drug or radiation therapy.
5. Written informed consent.

Exclusion criteria Patients will be excluded if they meet any of the following criteria.

1. History of any prior malignancies within the past 5 years.
2. History of lung surgery.
3. History of interstitial pneumonia, pulmonary fibrosis or other severe pulmonary diseases.
4. Presence of severe or uncontrolled diseases that may possibly reduce the 10-year life expectancy.

Primary outcomes:
measure: 5-year overall survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT04684810: Lay Therapist Effectiveness With Displaced Persons Kurdish Iraq
Official title: Lay Therapist Effectiveness With Displaced Persons Kurdish Iraq: Promising Exploratory Results for Global Mental Health Access
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Health
Therapeutics
Keywords: evidence-based treatments
refugee
lay therapists
global mental health
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were 18-years-or-older Arabic speakers displaced from their homes in either Central/Southern Iraq or Syria and now residing in Kurdish Iraq and seeking treatment for mental health difficulties.

Brief summary: Negative mental health effects of war exposure and displacement are pervasive, but many displaced persons and refugees in low-and-middle income countries lack access to evidence-based treatments. Community lay-therapists are a promising solution for the global mental health field. However, in spite of results from randomized-control trials, no research to-date has examined the external validity of community-led lay-therapist effectiveness. In this exploratory study, longitudinal data at three time points were collected from 28 Arabic-speaking displaced persons (nineteen women and nine men, ages 18-57) seeking mental health services from the Jiyan Foundation: a non-profit founded and based in Kurdish Iraq. Lay therapists trained in evidence-based treatments upon being hired operated largely independently of supervision from foreign clinicians. Participants in weekly psychotherapy completed the Posttraumatic Stress Checklist (PCL-5) and the Psychological Health Questionnaire (PHQ-9) at baseline, one month, and three months, as well as a modified measure assessing traumatic exposure, purpose-in-life, and a modified Afghan Daily Stressors Scale at baseline to assess for moderators of change over time.


Eligibility criteria: Inclusion Criteria:

* Must speak Arabic fluently; must be seeking mental health services at the Jiyan Foundation

Exclusion Criteria:

* No Arabic proficiency; under 18 years

Primary outcomes:
measure: PTSD Symptoms
timeFrame: 3 months
measure: Depression Symptoms
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Jiyan Foundation for Human Rights
Study officials:
References:
Clinical trial NCT06564610: Laparoscopic Transversus Abdominis Plane Block Versus Erector Spinae Plane Block in Bariatric Surgery
Official title: Laparoscopic Transversus Abdominis Plane Block Versus Erector Spinae Plane Block in Obese Patients Undergoing Bariatric Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Obesity
Analgesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 96
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: PREVENTION

Brief summary: The aim of this work is to compare the analgesic efficacy of laparoscopic transversus abdominis plane block, performed by the surgeon to ultrasound-guided erector spinae plane block, performed by the anesthetist, in patients with obesity undergoing bariatric surgery.

Detailed description: This is a randomized controlled trial which will include patients with obesity undergoing bariatric surgery. The patients will be randomly allocated into two groups: transversus abdominis plane block group and erector spinae plane block group. The block will be performed after induction of general anesthesia. Preoperative evaluation and preparation will include history-taking, laboratory investigation, fasting recommendations, and optimization of the medical status. The two groups will receive standard induction and maintenance of anesthesia. After the end of the operation, patients will receive standard care according to the local protocols and the enhanced recovery recommendations. Patients will be monitored according to the pain-related outcomes as well as hemodynamic parameters.

Eligibility criteria: Inclusion Criteria:

* Patients with obesity undergoing laparoscopic bariatric surgery under general anesthesia.

Exclusion Criteria:

* Allergy to local anaesthetic.
* Bleeding disorders.
* Obstructive sleep apnea.
* inability to understand the numerical rating scale for pain assessment.

Primary outcomes:
measure: Numerical rating scale
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Consumption of analgesia
timeFrame: 24 hours after surgery
measure: Heart rate
timeFrame: 24 hours after surgery
measure: Systolic blood pressure
timeFrame: 24 hours after surgery
measure: Vomiting
timeFrame: 24 hours
measure: Diastolic blood pressure
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine, Cairo University.
Study officials:
affiliation: Professor of anesthesia
name: Ahmed Hasanin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00401310: The Efficacy and Safety of MK0724 IV for Improvement of Neurological Damage and Recovery From Middle Cerebral Artery Ischemic Stroke (0724-018)
Official title: A Phase IIa Randomized, Double-Blind, Parallel-Groups, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of MK0724 Intravenous Infusion on the Amelioration of Neurological Damage and Recovery From Middle Cerebral Artery Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Middle Cerebral Artery Stroke
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-11-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The safety and efficacy of MK0724 will be assessed in patients with acute middle cerebral artery stroke using the Action Reach Arm Test (ARAT). This test allows measurement of a specific functional deficit and subsequent recovery correlating with the specific area of stroke in the brain.


Eligibility criteria: Inclusion Criteria:

* 18-80 yrs of age inclusive
* Patient is able to receive IV infusion 8-36 hours after stroke onset
* Baseline NIHSS of 6-18 inclusive

Exclusion Criteria:

* Patient had another stroke within 3 months preceding current stroke, patient's stroke is of origin other than MCA (e.g., non-ischemic, hemorrhage), significant cerebral edema, abnormal liver enzymes and abnormal renal and hepatic functions

Primary outcomes:
measure: Action Research Arm Test score
timeFrame: At 90 days
Secondary outcomes:
measure: Scores on the Stroke Arm Strength question, modified Rankin, and Barthel Index.
timeFrame: At 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04818710: Scalpel Versus Diathermy Skin Incision in Repeated CS
Official title: Comparative Study Between Scalpel and Diathermy Skin Incision in Repeated Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benifits of Using Diathermy in Skin Incision
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
First posted: 2021-03-26
Enrollment: 476
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was performed to compare both methods of skin incisions to determine differences in postoperative pain, hemodynamic changes, incisional time, blood loss during incision, wound healing, and wound complication.

Detailed description: Our study aims to compare the use of diathermy versus scalpel in making skin incision during cesarean section to judge the variations in

1. incision time,
2. incision blood loss,
3. hemodynamic changes,
4. postoperative pain,
5. wound healing
6. wound complications.

Eligibility criteria: Inclusion Criteria:

* women with a history of only one previous cesarean section
* age between 18 and 40 years
* gestational age of 38 to 41 weeks
* body mass index less than 30.

Exclusion Criteria:

* any medical disorder that can affect wound healing as diabetes, chronic anemia, chronic skin conditions, history of allergy, or history of an infected surgical wound.
* Women who conducted primary or emergency cesarean deliveries
* cardiac patients on pacemakers
* patients on anticoagulants
* women refusing to participate in the study

Primary outcomes:
measure: incision time
timeFrame: during surgical operation. the difference between starting skin incision till the rectus sheath was visualized
measure: incision blood loss
timeFrame: during surgery
measure: postoperative pain
timeFrame: during the first day after surgery
Secondary outcomes:
measure: wound healing
timeFrame: during the first week after surgery
measure: wound complications
timeFrame: during the first week after surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Research Centre
Study officials:
References: