louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03598348: Evaluate the Efficacy of Maintenance Treatment With Capecitabine Plus Apatinib in Advanced Gastric Cancer
Official title: Maintenance Treatment With Capecitabine Plus Apatinib vs. Apatinib and Observation After First-line XELOX/SOX Chemotherapy for Patients With Advanced Gastric Cancer: a Multicenter, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: advanced gastric cancer, apatinib, capecitabine, maintenance
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 288
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: This is a multicenter, randomized, controlled trial to evaluate the efficacy and safety of Maintenance Treatment with Capecitabine plus Apatinib, Apatinib and Observation after First-line XELOX/SOX chemotherapy for Patients with Advanced Gastric Cancer


Eligibility criteria: Inclusion Criteria:

1. aged 18-75；
2. had histologically confirmed unresectable and/or metastatic (primary or recurrent) adenocarcinoma of the stomach or gastroesophageal junction；
3. received 4-6 cycles of Xelox/SOX regimens as first-line chemotherapy and the response was not progression disease (PD);
4. ECOG 0-2；
5. Patients were tested for tumor HER2 status before treatment, and patients with HER2-negative disease；
6. presence of at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines；
7. Subjects has to voluntarily join the study and sign the Informed Consent Form for the study;
8. Adequate organ function as defined below: Hematologic ANC ≥ 2\*109/L, Platelets ≥ 100\*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN
9. Receiving no form of chemotherapy, targeted therapy or other study medication;

Exclusion Criteria:

1. previous radiotherapy to the abdomen；
2. previous treatment for advanced disease (neoadjuvant chemotherapy was permitted if administered \>6 months before enrollment)；
3. pregnant or lactating women or women of childbearing potential；
4. disease progression during the first-line chemotherapy;
5. active gastrointestinal bleeding, arterial thrombosis or cerebrovascular accident within 6 months before enrollment
6. previous treatment of apatinib and Ramucirumab

Primary outcomes:
measure: PFS
timeFrame: 36 months
Secondary outcomes:
measure: OS
timeFrame: 36 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Xianglin Yuan, PhD,MD
role: STUDY_CHAIR
References:
Clinical trial NCT02328248: Usage of Biological Patch Versus Plastic in the Laparoscopic Repair of Hiatal Hernias
Official title: Randomized Control Trial (RCT) That the Usage With Biological Patch Versus Plastic in the Laparoscopic Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hiatal Hernia
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2014-12-31
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 purpose of this study is to observe the effective and safety in the laparoscopic repair of hiatal hernia using biological patch versus plastic.

Detailed description: observation indicator:

1. incidence rate of complications,
2. postoperative hospital stay
3. readmission rate in 1st month after operation
4. recurrence rate after operation
5. hospitalization costs
6. Self-evaluation of gastroesophageal reflux symptoms and quality of life(QOL) in 6th-month, 1st-year,2nd-year,3rd-year,4th-year and 5th-year after operation

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Hiatal hernia
* Consistent with operation indications throughout the guideline of hiatal hernia by the Chinese Medical Association in 2003
* randomly select patch agreed by patients and family members

Exclusion Criteria:

* Poor general condition
* severe organ dysfunction
* No-tolerate anesthesia
* No-suitable for operation
* Emergency operation needed
* Serious adverse events appeared during the operation
* Sever intraperitoneal adhesion existed
* glucocorticoid with long-term use
* immunocompromised patients
* spirit disease patients
* automatically exit
* women who pregnant

Primary outcomes:
measure: The incidence of complications in all case
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Xijing Hospital
name: Xiaonan Liu, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT02711748: Can Medical Personnel Properly Proceed in the Case of a Patient With Bradycardia?
Official title: Can Medical Personnel Properly Proceed in the Case of a Patient With Bradycardia?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bradycardia
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study aims to assess the regularity of the proceedings in the case of a patient with bradycardia ECG.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* maximum 1 year of work experience in medicine
* paramedics, nurses, physicians

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
* pregnancy

Primary outcomes:
measure: Questionnaire to assess effectiveness of the rhythm recognition and participants' knowledge on life-threatening rhythms
timeFrame: intraoperative
Secondary outcomes:
measure: Time to take proper action
timeFrame: intraoperative
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw, Department of Emergency Medicine
state: Masovia
Study officials:
References:
Clinical trial NCT01427348: Maintaining the Head Extension by an Assistant Decreases Dental Contact
Official title: Maintaining the Head Extension by an Assistant Decreases Dental Contact Between Laryngoscope Blade and Maxillary Incisors During Direct Laryngoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Contact During Direct Laryngoscopy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-09-01
Enrollment: 68
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: PREVENTION

Brief summary: The purpose of this study is to determine whether the head extension by an assistant decreases dental contact between laryngoscope blade and maxillary incisors during direct laryngoscopy


Eligibility criteria: Inclusion Criteria:

* patients undergoing surgery that requires general anesthesia

Exclusion Criteria:

* disease or injury of cervical spine
* dentoalveolar injury
* history of difficult intubation
* anatomical anomaly of face or airway

Primary outcomes:
measure: dental contact
timeFrame: up to 10 minutes
Secondary outcomes:
measure: teeth distance
timeFrame: up to 10 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Kim HJ, Lee JM, Bahk JH. Assisted head extension minimizes the frequency of dental contact with laryngoscopic blade during tracheal intubation. Am J Emerg Med. 2013 Dec;31(12):1629-33. doi: 10.1016/j.ajem.2013.08.019. Epub 2013 Sep 14.
Clinical trial NCT01905748: Acute Phase Reactions and Thrombophilia in Pediatric Patients With Migraine
Official title: Acute Phase Reactions and Thrombophilia in Pediatric Patients With Migraine, Laboratory Investigations in Steady State and During Migraine Attack
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine
Thrombophilia
Keywords: Coagulation
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Acute Migraine attacks can be related to vascular or coagulation activation. Previous studies found relative high incidence of prothrombotic events in Migraine. The present study intends to assess the coagulation system and activation in patients with Migraine during steady state phase and at the beginning of attacks and after 72 hours. A control group of patients with another acute neurologic event like convulsions will be also studied. Patients will be at pediatric age and teenagers.


Eligibility criteria: Inclusion Criteria:

* Patients at the pediatric age (5 to 20 ys old) suffering from Migraine attacks diagnosed by a neurologist.

Exclusion Criteria:

* Patients with other underlying neurological conditions of coagulation diseases

Primary outcomes:
measure: Proportion of patients with activation of the coagulation system.
timeFrame: Two years, each patient will be studied at attack onset and after 72 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Ha'Emek Medical Center
Study officials:
affiliation: Ha'Emek Medical Center, Afula, Israel
name: Ariel Koren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06141148: Clinical Presentation, and Treatment Outcomes in Tuberculous Patients in Sohag Governorate
Official title: Clinical Presentaion, and Treatment Outcomes in Tuberculous Patients in Sohag Governorate
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tuberculosis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: * age above 18ys.
* confirmed diagnosis of tuberculosis.

Brief summary: Tuberculosis (TB) is an infectious disease that commonly affects the lung and is caused by a bacterium called Mycobacterium Tuberculosis. The bacterium mostly affects people with impaired immunity TB becomes the second leading cause of morbidity and mortality among infectious diseases, following the emergence of the human immunodeficiency virus (HIV). HIV is the commonest risk factor for developing a life-threatening tuberculosis disease, on the other hand, HIV related immunodeficiency is worsened by TB infection.TB is among the top 10 causes of death worldwide. In2019, among 8.8 million adults who developed TB disease, 36% were women .TB has become the fifth leading cause of death among women.


Eligibility criteria: Inclusion Criteria:

* age above 18ys.
* confirmed diagnosis of tuberculosis.

Exclusion Criteria:

* childern.
* not confirmed diagnosis of tuberculosis.

Primary outcomes:
measure: percent of cured tuberculous patients
timeFrame: 1 year
measure: percent of treatment failure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: Ali MK, Karanja S, Karama M. Factors associated with tuberculosis treatment outcomes among tuberculosis patients attending tuberculosis treatment centres in 2016-2017 in Mogadishu, Somalia. Pan Afr Med J. 2017 Nov 2;28:197. doi: 10.11604/pamj.2017.28.197.13439. eCollection 2017.
citation: Jalal TMT, Abdullah S, Wahab FA, Dir S, Naing NN. Prevalence and Factors Associated with Tuberculosis Treatment Success among TB/HIV Co-Infection in North-East Malaysia. Malays J Med Sci. 2017 Dec;24(6):75-82. doi: 10.21315/mjms2017.24.6.9. Epub 2017 Dec 29.
citation: Mason PH, Snow K, Asugeni R, Massey PD, Viney K. Tuberculosis and gender in the Asia-Pacific region. Aust N Z J Public Health. 2017 Jun;41(3):227-229. doi: 10.1111/1753-6405.12619. Epub 2016 Dec 13. No abstract available.
citation: Horton KC, MacPherson P, Houben RM, White RG, Corbett EL. Sex Differences in Tuberculosis Burden and Notifications in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis. PLoS Med. 2016 Sep 6;13(9):e1002119. doi: 10.1371/journal.pmed.1002119. eCollection 2016 Sep.
Clinical trial NCT03317548: A Comparison of Clinical Outcomes of Warmed Embryo Vitrified at 2PN Stage and Fresh Embryo Transfers
Official title: Chung Shan Medical University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Female
Reproductive Disorder
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 500
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients underwent in vitro fertilization protocols in Lee Women's Hospital

Brief summary: The aim of this study was to compare the clinical outcomes between fresh embryo and frozen embryo transfer in in vitro fertilization (IVF). All frozen embryo was vitrified at pronuclear stage (2PN) and cultured to cleavage embryos for transfer.

This is a retrospective study. All IVF cycles were included in this study and further divided into fresh and frozen embryo transfer groups. The collection data including: stimulation protocols, medicines, blood test results, pregnancy test and all clinical data. The primary outcome is pregnancy rate and secondary outcome is implantation rate.

Detailed description: Study design

Study progress:

Stage 1: collection of all data from frozen embryo transfer and fresh embryo transfer groups.

Stage 2: selection data and check the delivery outcomes Stage 3: analysis data and presentation. Including criteria: all patients who underwent IVF. Excluding criteria: No. Statistics analysis: chi-test, t-test

Assessment point:

Primary endpoint: pregnancy rate Secondary endpoint: implantation rate Withdraw criteria: not application. Treatments: not application. Collection number: 500 patients. Scheduled trial period: 2017.05.01\~2018.04.30

Expected research results:

The implantation rate in frozen embryo transfer group which vitrified at 2PN stage is higher than fresh embryo transfer.

The pregnancy rate in frozen embryo transfer group which vitrified at 2PN stage is higher than fresh embryo transfer.

This study is only data analysis, no additional collection of samples. This study does not involve vulnerable groups.

Eligibility criteria: Inclusion Criteria:

* all patients with in vitro fertilization protocols

Exclusion Criteria:

* none

Primary outcomes:
measure: pregnancy rate
timeFrame: HCG test at day 15 after embryo transfer or day 18 after oocyte pick up
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
affiliation: Lee Women's Hospital
name: Maw-Shang Lee, Phd
role: STUDY_CHAIR
References:
Clinical trial NCT01091948: GlideScope Video Laryngoscope Versus Fiberoptic Intubation
Official title: GlideScope Video Laryngoscope vs Fiberoptic Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Intubation
Keywords: elective general surgery
orotracheal intubation
Patients would be eligible for inclusion if they were at least 18 years old and scheduled for elective surgery requiring orotracheal intubation.
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2010-03-24
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Following informed consent, patients will be randomly assigned to oral fiberoptic intubation or to oral intubation using the GlideScope Video Laryngoscope. Following the induction of general anesthesia a sealed envelope would be opened to reveal the technique to be used. A stop watch will be started at the beginning of the procedure. At the completion of intubation the stop watch will be stopped and the time recorded along with other data. Based on a sample size estimation process, it is the investigators plan to study fifty patients. The two techniques will be compared in terms of the average time needed to place the endotracheal tube and studied using a two-sided T-Test with a significance level of 0.05. To ensure comparability between the two methods, all intubators will be required to have at experienced at least 10 uses of the GlideScope and 10 uses with fiberoptic intubation.


Eligibility criteria: Inclusion Criteria:

* at least 18 years old
* scheduled for elective surgery requiring orotracheal intubation.

Exclusion Criteria:

* known, difficult airway
* loose teeth
* pregnant
* require a rapid sequence induction,
* Body Mass Index under 30
* unable to give consent
* if special endotracheal tube (ETT) is needed for the case.

Primary outcomes:
measure: Time to Intubation (TTI) as Measured in Seconds
timeFrame: from start of intubation to successfully intubated up to 100 seconds
Secondary outcomes:
measure: Intubation Difficulty Score
timeFrame: from start of intubation to successfully intubated
measure: Successful Intubation on 1st Attempt
timeFrame: from start of first intubation to end of first intubation attempt
measure: Occurrence of Hypoxaemia
timeFrame: at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after
measure: Trace Bleeding
timeFrame: Right after intubation
measure: Sore Throat Grade
timeFrame: On the first postoperative day
measure: Number of Intubation Attempts
timeFrame: from start of intubation to successfully intubated
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03850548: Chronic Infections on Articular Prostheses With C. Acnes Diagnosed by Specific PCR
Official title: Chronic Infections on Articular Prostheses With C. Acnes Diagnosed by Specific PCR : Descriptive Study of 6 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone and Joint Infection
Keywords: bone and joint infection
Propionibacterium acnes
Cutibacterium acnes
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients having had infection prothesis vith C. acnes identified by PCR and managed at the croix rousse hospital

Brief summary: Osteaoarticular infection due to C. acnes are known to be of late onset, causing chronic infection possibly pauci-symptomatic. Osteaoarticular infection due to C. acnes represents a diagnostic challenge, since C. acnes is slow and difficult to grow, and can also be considered a contaminant.A 16S universal PCR bacteriological diagnosis has been proposed but is lacking of sensitivity. A specific C. acnes PCR was developed in 2010, but is not used routinely.


Eligibility criteria: Inclusion Criteria:

* patients having had infection prothesis vith C. acnes identified by PCR

Exclusion Criteria:

* none

Primary outcomes:
measure: Rate of diagnostic delay
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Secondary outcomes:
measure: rate of radiologic signs
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
measure: rate of duration of antibiotherapy
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
measure: rate of use of this diagnostic
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: HCL
name: Tristan Ferry, Md,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00785148: Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid) - Safety
Official title: Safety Dermatological Evaluation: Genital Mucous Irritation - Product Tested: Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-11-05
Enrollment: 31
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To prove the safety of the gynaecological formulation in normal conditions of use.


Eligibility criteria: Inclusion Criteria:

* Integral skin test in the region,
* Use of cosmetic product of the same category

Exclusion Criteria:

* Lactation or gestational risk or gestation
* Use of Anti-inflammatory, immunosuppression or anti-histaminic drugs
* Atopic antecedent or allergic to cosmetic product
* Active cutaneous disease in the evaluation area
* Diseases which cause immunology decrease, such as diabetes and HIV
* Endocrinal pathologies
* Intense solar exposure 15 days before the evaluation
* Treatment until four months before the selection

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.
timeFrame: From treatment start to the end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References: