louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03717766: Application of New Technologies in the Resection of Intracranial Tumors
Official title: Application of New Technologies in the Resection of Intracranial Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Neoplasm
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with intraaxial brain tumors that are tributary to surgical treatment.

Brief summary: Main Outcome: To assess the effectiveness of new intraoperative technologies in the resection of intracranial tumors.

Design: Prospective observational study.

Method: Prospective observational study of the use and effectiveness of intraoperative neuronavigation ultrasound, intraoperative tractography, intraoperative fluorescence, advanced neuronavigation and intraoperative neurophysiology in the resection of intracranial supratentorial tumors.

Number of patients: 70 - 100.

Duration of the study: 3 years.

Ethical considerations: The study will be carried out following the international ethical recommendations for medical research in humans. Before beginning the study, the Ethical Committee of the Hospital of Santa Creu i Sant Pau approved the study protocol. It is about the study of surgical techniques that we use in our usual clinical practice.

Fundings: There are no funding sources.


Eligibility criteria: Inclusion Criteria:

* intraaxial brain tumors that are tributary to surgical treatment.

Exclusion Criteria:

* extra-axial brain tumors.

Primary outcomes:
measure: Percentage of intracranial tumor resection
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00812266: Topotecan and Cisplatin Versus Etoposide and Carboplatin in 1st Line Treatment of Patients With Small Cell Lung Cancer and Extensive Disease (SCLC-ED)
Official title: Randomized Phase III Trial of Topotecan and Cisplatin Versus Etoposide and Carboplatin in the Treatment of Patients With Previously Untreated Small Cell Lung Cancer and Extensive Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Extensive Disease
First-Line
Small Cell Lung Cancer
Keywords: SCLC
Extensive disease
topotecan
Lead sponsor: Danish Oncological Lung Cancer Group
Sponsor class: OTHER
First posted: 2008-12-22
Enrollment: 281
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: Randomised trial comparing standard chemotherapy with carboplatin and etoposide with a combination of topotecan and cisplatin in patients with inoperable lung cancer of small cell type.

Detailed description: Fase III, multicenter randomised trial comparing up to six cycles of carboplatin and etoposide with up to six cycles of topotecan and cisplatin in patients with extensive stage small cell lung cancer and PS 0-3

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed SCLC
* Extensive stage
* No prior chemotherapy
* WHO PS 0-3
* Adequate organ function (liver, kidney)
* Adequate hematology (bone marrow)
* Informed consent

Exclusion Criteria:

* PS 4
* Inadequate organ function
* Uncontrolled infection
* Concomitant major medical contraindications

Primary outcomes:
measure: 2 years survival
timeFrame: 2 years
Secondary outcomes:
measure: Response rates
timeFrame: 2 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. Oncology, Rigshospitalet
Study officials:
affiliation: Dept. of Oncology, Rigshospitalet, Copenhagen
name: Seppo W Langer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00524966: Randomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy
Official title: Randomized Controlled Trial of Bipolar Versus Ultrasonic Hemostasis Techniques in Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-09-05
Enrollment: 100
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: RATIONALE: The use of bipolar energy sealing system or ultrasonic coagulation for hemostasis during thyroidectomy may reduce blood loss and hypocalcemia and may be more cost-effective.

Detailed description: PURPOSE: This clinical trial is studying how well bipolar energy sealing system and ultrasonic coagulation for hemostasis during thyroidectomy reduce blood loss and hypocalcemia, as well as which device is the most cost-effective approach for thyroidectomy.

Eligibility criteria: Inclusion Criteria:

* Patients requiring thyroidectomy

Exclusion Criteria:

* Patients unwilling or unable to provide informed consent
* Age less than 18 years old
* Reoperative case
* Patients who use pacemakers

Primary outcomes:
measure: Blood loss and hypocalcemia
timeFrame: one week
Secondary outcomes:
measure: Cost of thyroidectomy
timeFrame: one week
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Electron Kebebew, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02931266: PASS MIS® Post-market Clinical Follow-up
Official title: Evaluation of the Efficacy and Safety of the PASS MIS® System in the Treatment of Spinal Thoracolumbar Fractures
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Spinal Fractures
Lead sponsor: Medicrea International
Sponsor class: INDUSTRY
First posted: 2016-10-13
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient suffering from thoraco-lumbar spinal fracture and receiving a posterior osteosynthesis through a mini-invasive approach

Brief summary: Prospective, multicenter non comparative and observational study (post-market clinical follow-up).

Detailed description: Patients operated with PASS MIS® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.

The inclusion period will be 12 months and the follow-up 24 months

Eligibility criteria: Inclusion Criteria:

* Patient which need to be operated to treat a fracture at the lumbar and/or thoracic spine with the PASS MIS® device from MEDICREA®
* Patient \> 18years
* Patient with a mature skeleton
* Patient able to understand the protocol and the planning visit
* Patient able to complete a self-administered questionnaire
* Patient who have signed the informed consent form

Exclusion Criteria:

* Patient presenting other medical indication than thoracolumbar fracture
* Patient unable or who refuse to sign an informed consent form
* Patient unable to complete a self-administered questionnaire
* Patient judged as non-compliant by the investigator or not able to come back for follow-up visits
* Patient who need to receive or who received an open procedure
* Patient who has been not implanted with the PASS MIS® system
* Pregnant women or intending to get pregnant within the next 2 years after the surgery
* Patient with contra-indications to do radiographies
* Local infectious state
* Allergy or intolerance to the materials, suspected or known
* Any contra-indications present in the notice of the product

Primary outcomes:
measure: Spinal stability
timeFrame: 12 months postoperatively
measure: Spinal fusion
timeFrame: 12 months postoperatively
Secondary outcomes:
measure: Adverse events
timeFrame: During surgery, 1-6 months, 12 months, 24 months postoperatively
measure: Disability
timeFrame: 1-6 months, 12 months, 24 months postoperatively
measure: Patient satisfaction index
timeFrame: 1-6 months, 12 months, 24 months postoperatively
measure: Pain
timeFrame: 1-6 months, 12 months, 24 months postoperatively
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital la Timone
Study officials:
affiliation: Hopital la Timone, Marseille
name: Stephane Fuentes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01493466: Serum Proteomics Analysis for Sepsis
Official title: Serum Proteomics Analysis for Dynamic Changes of Differential Proteins in Sepsis Patient With iTRAQ Labeling and LC-MS/MS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SIRS
Sepsis
Severe Sepsis
Death
Keywords: proteomics,
serum,
sepsis,
potential biomarkers,
dynamic changes
normal
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2011-12-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects were selected from among inpatients who were hospitalized between May 2010 and Mar 2012 in the Respiratory ICU, Surgical ICU, and Emergency ICU, Chinese People's Liberation Army (CPLA) General Hospital.

Brief summary: Serum proteomics is a very useful tool to identify various disease. The purpose of the present study was to find differential proteins among patient with normal, SIRS, sepsis, severe sepsis, death and to screen potential biomarkers for their dynamic changes. Serum proteins were identified by iTRAQ labeling and LC-MS/MS. The bioinformatics analysis was performed with the Mascot software and the International Protein Index (IPI) and the Gene Ontology (GO) Database and KEGG pathway Database. The differentially expressed proteins were verified by Western blot by another sample collected from clinical.


Eligibility criteria: Inclusion Criteria:

* Male and female aged 18 years old and over;
* clinically confirmed infection;
* fulfilled at least two criteria of systemic inflammatory response syndrome
* (a) core temperature higher than 38 °C or lower than 36 °C
* (b)respiratory rate above 20/min, or PCO2 below 32 mmHg
* (c) pulse rate above 90/min, and
* (d) white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands.

Exclusion Criteria:

* younger than 18 years of age;
* acquired immunodeficiency syndrome;
* reduced polymorphonuclear granulocyte counts (\< 500 μL-1);
* died within 24h after admission into the ICU, or refused to participate in the study, or declined treatment during the period of observation.

Primary outcomes:
measure: Survival status
timeFrame: 28 days after admission to ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Beijin
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Department of Respiratory Diseases, Chinese PLA General Hospital
name: Lixin Xie, MD
role: STUDY_DIRECTOR
References:
citation: Su L, Pan P, Yan P, Long Y, Zhou X, Wang X, Zhou R, Wen B, Xie L, Liu D. Role of vimentin in modulating immune cell apoptosis and inflammatory responses in sepsis. Sci Rep. 2019 Apr 5;9(1):5747. doi: 10.1038/s41598-019-42287-7.
Clinical trial NCT03795766: Nausea and Vomiting After Gynecologic Surgery
Official title: Prevalence and Predictors of Nausea and Vomiting After Gynecologic Surgery: a Cross-section Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Nausea and Vomiting
Gynecologic Surgery
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients accept elective surgeries for gynecologic disease with good performance status.

Brief summary: In this cross-section study, all patients in the gynecologic ward of Peking Union Medical College Hospital will accepted a survey about the prevalence and severity of nausea and vomiting according to visual analogue scale and WHO classification. Epidemiological, surgical, anaesthetic characteristics and post-operative treatment are considered as predictors for the post-operative nausea and vomiting. The primary objective is the incidence of nausea and vomiting. The secondary objective is the possible predictors of nausea and vomiting.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Elective surgeries for gynecologic disease
* Good performance status
* Signed an approved informed consents
* Post-operative stay 72 hours or longer

Exclusion Criteria:

* Emergency surgeries
* Not meeting all of the inclusion criteria

Primary outcomes:
measure: Incidence of post-operative nausea and vomiting
timeFrame: 72 hours post-operative
Secondary outcomes:
measure: Severity of post-operative nausea and vomiting by visual analogue scale
timeFrame: 72 hours post-operative
measure: Severity of post-operative nausea and vomiting by World Health Organization classification
timeFrame: 72 hours post-operative
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01057966: Bioavailability of Nutrients Contained in Softgel Capsules vs Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vision
Keywords: Bioavailability
Ocular Vitamins
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-01-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a comparison of the bioavailability of nutrients contained in softgel capsules vs tablets.


Eligibility criteria: Inclusion Criteria:

1. Age 18 to 35
2. Body Mass Index (BMI) 21-27 kg/m2
3. Must be able to give written informed consent
4. Subjects must be willing to comply with all study requirements.
5. Subjects must understand, sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

1. Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria
2. Subjects who are pregnant, lactating or planning to be pregnant during the course of the study
3. Subjects with known sensitivity to planned study concomitant medications
4. Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.
5. Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication

Primary outcomes:
measure: Bioavailability of nutrients
timeFrame: 1 week for each treatment cross-over period
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center For Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT06530966: Phase I Study of ICP-332 in Healthy Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-332 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: InnoCare Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A multiple ascending dose phase I study of ICP-332 in healthy subjects


Eligibility criteria: Inclusion Criteria:

1. Voluntarily sign the informed consent form
2. Body mass index (BMI) of ≥ 18.5 kg/m2 and \< 30 kg/m2
3. Male or infertile female subjects who are between 18-55 years old (inclusive)

Exclusion Criteria:

1. Significant current or past acute or chronic disease or condition.
2. A history of tuberculosis or current active/latent infection.
3. With a history of drug or food allergy, or allergy to any of the composition components of the study drug, or allergic disease.
4. Subjects with clinically significant abnormalities in the screening examinations.

Primary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to Day 28
measure: Number of Participants With Clinically Significant Change in Vital Signs
timeFrame: Up to Day 28
measure: Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)
timeFrame: Up to Day 28
measure: Number of Participants With Clinically Significant Change in Physical Examination
timeFrame: Up to Day 28
measure: Number of Participants With Clinically Significant Change in Clinical Laboratory Values
timeFrame: Up to Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Pharmaron CPC Inc.
state: Maryland
Study officials:
References:
Clinical trial NCT01732666: Effect of Nefopam on Remifentanil Induced Postoperative Hyperalgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Undergoing Laparoscopic Gastrectomy
Keywords: Opioid-induced hyperalgesia (OIH)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-11-26
Enrollment: 25
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: SUPPORTIVE_CARE

Brief summary: Opioids has been reported to cause hyperalgesia. Opioid induced hyperalgesia (OIH) is defined as paradoxically lowering the threshold of pain after the exposure of opioid. Remifentanil is a short acting opioid that is commonly used during anesthesia and surgery. However, OIH was reported to occur after surgery when large amount of remifentanil was administered. On the other hand, nefopam is a centrally acting, non-opioid analgesic. Nefopam has been reported to have analgesic and anti-hyperalgesic effect.

The investigators hypothesized that nefopam administration could prevent OIH or reduce the severity of OIH. Therefore, the objective of the study is to find out the effect of nefopam on remifentanil induced hyperalgesia in patients undergoing laparoscopic abdominal surgery.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing laparoscopic gastrectomy
2. American Society of Anesthesiologists physical status I or II
3. aged from 20 to 65 years

Exclusion Criteria:

1. Past history of chronic pain
2. Drug or alcohol abuse
3. Psychotic disorder
4. Taking analgesics, anti-epileptics, and anti-depressants.
5. Taking opioids within 24 hrs
6. Renal disease
7. Neuromuscular disease.
8. Moderate to severe cardiovascular disease
9. Pregnant or breast-feeding

Primary outcomes:
measure: Hyperalgesic extent around surgical incision
timeFrame: Postoperative 24 hr and 48 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT06625866: Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use
Official title: Design, Implementation, and Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Episiotomy
Episiotomy Extended by Laceration
Episiotomy Infection
Episiotomy Wound
Lead sponsor: Universidad Panamericana
Sponsor class: OTHER
Collaborators: name: Universidad de la Salud - UNISA
name: IMSS-Bienestar
name: Secretaría de Educación, Ciencia, Tecnología e Innovación de la Ciudad de México
First posted: 2024-10-03
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two hospitals (clusters) will be assigned to intervention and standard of care.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This pilot study seeks to analyze the impact of interventions based on behavioral economics theory (e.g., feedback and information) on episiotomy use.


Eligibility criteria: Inclusion Criteria:

* Healthcare personnel involved in decision-making associated with performing episiotomies who work in the hospital selected to pilot the proposed intervention.

Exclusion Criteria:

* Healthcare personnel who are not involved in the decision-making process over performing episiotomy during delivery.

Primary outcomes:
measure: Number of episiotomies performed
timeFrame: During spontaneous or assisted vaginal delivery
Secondary outcomes:
measure: Episiotomy indication documented in the medical record
timeFrame: During spontaneous or assisted vaginal delivery
measure: Number of assisted vaginal deliveries
timeFrame: At the time of vaginal delivery
measure: Number of perineal and cervical lacerations (composite outcome)
timeFrame: At the time of spontaneous or assisted vaginal delivery
measure: Rate of transfusion of blood products (composite outcome)
timeFrame: Administered in the first 24 hours after delivery
measure: Blood loss at the time of delivery
timeFrame: Within the first hour after spontaneous or assisted vaginal delivery
measure: Hematocrit after delivery
timeFrame: Within 24 hours after delivery
measure: Pain management after delivery
timeFrame: Administered in the first 24 hours after vaginal delivery
measure: Patient satisfaction with the inpatient care received during and after vaginal delivery
timeFrame: Within the first 24 hours after delivery.
measure: Rate of surgical site infection
timeFrame: In the first 6 weeks after vaginal delivery
measure: Rate of surgical site dehiscence
timeFrame: In the first 6 weeks after vaginal delivery
measure: Five-minute Apgar
timeFrame: Neonatal assessment 5 minutes after spontaneous or assisted vaginal delivery
measure: Rate of NICU Admission
timeFrame: In the first 24 hours after delivery.
measure: Rate of Neonatal death
timeFrame: Within the first 28 days of life
Other outcomes:
Locations:
Study officials:
References: