louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02945137: Optimal Site for Rapid Urease Test in the Stomach
Official title: Comparison of Rapid Urease Test Between the Gastric Body and Antrum in Helicobacter Pylori-Infected Stomach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori Infection
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects who underwent an upper gastrointestinal endoscopy were enrolled in this study at a single, tertiary-care, academic medical center. During endoscopy, rapid urease tests would be performed in the body and antrum.

Brief summary: The accurate diagnosis of H. pylori infection is an important step for establishing the strategy for gastric cancer prevention. During endoscopy, rapid urease test (RUT) is the first of biopsy-based H. pylori tests. Despite indirect test for H. pylori detection, RUT shows rapid result with good sensitivity and specificity. Several study reported that H. pylori density was related to positive reaction time of RUT. However, there was no study comparing the positive reaction times of RUT according to biopsy site, degree of gastric atrophy, and intestinal metaplasia.

Detailed description: The aims of this study were to: (1) assess the positive reaction times of RUT in the body and antrum, (2) investigate the association between the difference of RUT results (body and antrum) and gastric atrophy, and intestinal metaplasia, and (3) evaluate the optimal biopsy site for RUT according to degree of gastric atrophy in Korean population.

Eligibility criteria: Inclusion Criteria:

* Subjects who underwent upper endoscopy and rapid urease test

Exclusion Criteria:

* : age \< 20 or \> 70 years; anemia (serum hemoglobin level \< 10 g/dL); severe systemic disease or advanced chronic liver disease; use of certain medications, including proton pump inhibitors, H2-receptor antagonists, or antibiotics; a history of H. pylori eradication; a history of gastric surgery; a recent history of upper gastrointestinal bleeding.

Primary outcomes:
measure: Positive reaction time of urease test
timeFrame: within 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Digestive Disease Center, Soonchunhyang University Hospital
Study officials:
affiliation: Assistant Professor
name: Jun-Hyung Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04623437: Responsible Side Effects Management in Oncology
Official title: Comprehensive Antineoplastic Therapy Adverse Events Monitoring and Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pharmacovigilance
Oncology
Antineoplastic Treatment
Keywords: pharmacovigilance in oncology
antineoplastic treatment
adverse events
Lead sponsor: University Hospital Sestre Milosrdnice
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 267
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: all cancer patients actively receiving systemic antineoplastic treatment, ECOG 0-2

Brief summary: Study of pharmacovigilance in oncology. Monitoring and management of AEs during antineoplastic treatment.

Detailed description: Monitoring and management of AE's during antineoplastic treatment. Comparison of AE's reported by patient with the ones recognised by the oncologist, and vice versa, during antineoplastic treatment.

Eligibility criteria: Inclusion Criteria:

all cancer patients receiving systemic antineoplastic treatment, ECOG 0-2

Exclusion Criteria:

age \<18, \>75; other active and severe comorbidities; no solid cancer; IUC patients

Primary outcomes:
measure: comparison of perspectives
timeFrame: may 2016 until october 2016
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: UHC Sestre milorsdnice
state: Croatia, Europe
Study officials:
References:
Clinical trial NCT00128037: Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors (JCOG 9806)
Official title: A Phase II Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors: Initial Report of Japan Clinical Oncology Group Trial (JCOG 9806)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Neoplasm
Keywords: pulmonary neoplasm
preoperative chemoradiotherapy
surgical resection
superior sulcus tumor
chest wall invasion
mytomicin C
vindesine
cisplatin
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-08-09
Enrollment: 75
Sex: ALL
Minimum age (years): 15
Maximum age (years): 74
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of the trimodality (concurrent chemoradiotherapy followed by surgical resection) approach in superior sulcus tumors.

Detailed description: Pre-operative radiotherapy has long been the community standard in Pancoast, or superior sulcus tumor. However, both complete resection rate (-50%) and long-term survival (-30%) are poor and unchanged for 40 years. Concurrent chemoradiotherapy has been shown to be beneficial in unresectable stage III non-small cell cancer. Surgery after induction chemoradiotherapy thus is a promising treatment strategy, and in fact, SWOG reported favorable results of this trimodality approach in superior sulcus tumor. The current trial is a Japanese, cooperative, multi-center, prospective one to evaluate its safety and efficacy.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed, pathologically documented non-small cell lung cancer (NSCLC)
* Invasion to the first rib or more superior chest wall
* Age: 15-74 years old
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Ample organ function
* No prior chemo- or radiotherapy
* Signed informed consent

Exclusion Criteria:

* Metastasis to, or involvement of, mediastinal node (N2)
* Distant metastasis or dissemination to pleura/pericardium
* Active concomitant malignancy
* Unstable angina, recent myocardial infarction, heart failure
* Uncontrolled diabetes or hypertension
* Pregnant or lactating women
* Other severe complications

Primary outcomes:
measure: 3-year survival rate
Secondary outcomes:
measure: complete resection rate
measure: post-surgical morbidity/mortality
measure: local control rate
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
facility: National Cancer Center
state: Tokyo
Study officials:
affiliation: Tokyo Medical University
name: Harubumi Kato, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01486537: Acidity Level of Blood From Primary Molar's Pulp While Undergoing Pulpotomy or Pulpectomy Procedure
Official title: Characterization of Blood Drawn From the Pulp of Primary Molar Undergoing Pulpotomy or Pulpectomy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: samples
children
the age group 3-13 years
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-12-06
Enrollment: 87
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy children undergoing dental treatment by residents in Hadassah hospital Jerusalem.

Ages between 3-13 years old.

Brief summary: The aim of this study is to evaluate the level of acidity of blood samples that are been taken from pulp chambers of primary molars undergoing pulpotomy or pulpectomy procedures. Our hypothesis is that samples from teeth undergoing pulpectomy would be acidic while samples from teeth undergoing pulpotomy would bo neutral.

Detailed description: The samples will be collected by 1 m"l syringe that is pre-washed with Heparin.than the samples will be analyzed in an Astrop machine of neonates.

Eligibility criteria: Inclusion Criteria:

* no systemic disease
* teeth that are undergoing pulpotomy or pulpectomy

Exclusion Criteria:

* systemic disease
* pulp necrosis
* permanent teeth

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
affiliation: Hadassah Medical Organization
name: Moti Moskovitz, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06357637: Abdominal Circumference Measure in Caesarian Section
Official title: Preoperative Measurement of Abdominal Circumference as a Predictor of Difficult Spinal Anesthesia and Maternal Hypotension During Caesarian Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Spinal
Cesarean Section
Keywords: Preoperative evaluation
Abdominal circumference
Difficult spinal anesthesia
Maternal hypotension
Cesarean Section
Lead sponsor: CHU Mohammed VI Marrakech
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 124
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: Parturients scheduled for elective cesarean section or admitted for emergency cesarean section in the maternal operating theater of Mohammed VI University Hospital during the period of the study

Brief summary: The goal of this observational study is to evaluate preoperative measures of abdominal circumference in patients admitted for a cesarean section. The main questions it aims to answer are:

* Can preoperative abdominal circumference predict patients with difficult spinal anesthesia
* Can preoperative abdominal circumference predict the occurrence of maternal hypotension during cesarean section Participants will be examined preoperatively in terms of visibility and palpation of spinous processes, abdominal circumference will be measured in the supine and sitting positions with other clinical parameters. Spinal anesthesia will be performed by the same experienced anesthesiologist with a standardized procedure. The number of skin punctures, needle reorientations, traumatic Cerebrospinal fluid, need for a paramedian approach or failure will be recorded. Maternal blood pressure and vasopressor requirements will also be monitored.


Eligibility criteria: Inclusion Criteria:

* Parturients admitted for elective or emergency cesarean section

Exclusion Criteria:

* Acute fetal distress
* Umbilical cord prolapse
* Scoliosis
* Contraindication to spinal anesthesia
* Medical history of spinal surgery American Society of Anesthesia Status 4 or 5

Primary outcomes:
measure: Number of patients with difficult spinal anesthesia
timeFrame: During surgery
Secondary outcomes:
measure: Rate of Maternal hypotension
timeFrame: The first hour after spinal anesthesia is performed
Other outcomes:
Locations:
city: Marrakech
country: Morocco
facility: CHU Mohammed VI
Study officials:
References:
citation: Yu C, Gu J, Liao Z, Feng S. Prediction of spinal anesthesia-induced hypotension during elective cesarean section: a systematic review of prospective observational studies. Int J Obstet Anesth. 2021 Aug;47:103175. doi: 10.1016/j.ijoa.2021.103175. Epub 2021 May 1.
citation: Merveille OC, Childers MK, Kreimid MM, George WD. Weaning from mechanical ventilation in a general rehabilitation center: a commentary. Am J Phys Med Rehabil. 1999 Jan-Feb;78(1):85-6. doi: 10.1097/00002060-199901000-00022. No abstract available.
Clinical trial NCT04216537: Survival Significance of Molecular Pathology and Genetic Variation in Brain Gliomas
Official title: Survival Significance and Clinical Characteristics of Molecular Pathology and Genetic Variation in Brain Gliomas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioma
Molecular Sequence Variation
Genetic Change
Keywords: Survival
Subgroup
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 3000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects are all received tumor resection in the First Affiliated Hospital of Zhengzhou University.

Brief summary: This study aims to collect clinical, radiological, pathological, molecular and genetic data including detailed clinical parameters, MR and histopathology images, molecular pathology and genetic data. This study seeks to find the prognostic and clinical significance based on molecular and genetic biomarkers/subgroups of gliomas.

Detailed description: Precise classification based on molecular and genetic biomarkers/subgroups for gliomas is challenging. This study aims to collect clinical, radiological, pathological, molecular and genetic data including detailed clinical parameters, MR and histopathology images, molecular pathology (1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations, etc) and genetic data (Whole exome sequencing, RNA sequencing, proteomics, etc). This study seeks to find the prognostic and clinical significance based on molecular and genetic biomarkers/subgroups of gliomas.

Eligibility criteria: Inclusion Criteria:

* Patients must have radiologically and histologically confirmed diagnosis of primary glioma
* Life expectancy of greater than 3 months
* Must receive tumor resection
* Must have sufficient fresh frozen tissues for NGS
* Signed informed consent

Exclusion Criteria:

* No gliomas
* No sufficient amount of tumor tissues for detection of molecular pathology
* Patients who are pregnant or breast feeding
* Patients who are suffered from severe systematic malfunctions
* Do not have sufficient fresh frozen tissues for NGS

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From enrollment to death of patients. Estimated about 5 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References:
Clinical trial NCT00000337: Infusion Laboratory: Protocol 1 - Selegeline - 2
Official title: Infusion Laboratory: Protocol 1 - Selegeline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 31
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of selegiline on the subjective and physiological effects of cocaine challenge in chronic crack abusers, and to evaluate clinical safety issues pertaining to selegeline, to cocaine and their interaction in a chronic crack dependent population.

Detailed description: To develop a medication for the treatment of cocaine addiction using a medical human physio-neuro-psycho-immunology laboratory setting. To characterize this cocaine abusing population on a variety of psychological and physicologically measures over time from withdrawal through pere and post cocaine administration. To determine the effects of selegeline on the subjective and physiological effects of cocaine challenge in chronic crack abusers. To evaluate clinical safety issues pertaining to selegeline, to cocaine and their interaction in a chronic crack dependent population.

Eligibility criteria: Inclusion Criteria:

M/F, ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Primary outcomes:
measure: Degree of drug craving
measure: History, incidence and amount of drug use
measure: Type and severity of stimulant withdrawal symptoms
measure: Population incidence of symptoms of depression, possible organic brain syndrome deficits
measure: Frequency and intensity of drug use and sexual behaviors at risk for HIV
measure: Evidence of change in neurophysiology and brain activity
measure: Evidence of change in subjective responses to cocaine challenge
measure: Clinical physiological response to cocaine challenge - especially adverse effects measures
measure: Degree to which study medication influences changes in #6, 7 & 8 above (possible efficacy measure)
measure: Characterization of study population
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 1996 CPDD: "Acute cocaine administration reverses EEG signs of cocaine withdrawal.". 1996 CPDD: "Acute cocaine administration reverses EEG signs of cocaine withdrawal."
Clinical trial NCT01490437: Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma
Official title: A Prospective Phase 2 Study of PEmetrexed in Combination With Cisplatin in Patients With Advanced UrotheLIal CAnceR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urothelial Carcinoma
Keywords: Advanced urothelial carcinoma
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2011-12-13
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pemetrexed has demonstrated a favorable response with minimal toxicity when used as single agent as first-line and second-line treatment for advanced urothelial carcinoma. The response rates were 32% and 28% for the first-line and second-line setting, respectively. Cisplatin is one the most active chemotherapeutic agents in urothelial cancer, frequently used as combination chemotherapy such as GP (gemcitabine plus cisplatin) or MVAC (methotrexate, vinblastine, adriamycin, and cisplatin).

Pemetrexed and cisplatin showed favorable activity profile in advanced non-small cell lung cancer with highly favorable toxicity profile.

This study is to assess the efficacy and safety of pemetrexed plus cisplatin in advanced urothelial carcinoma.


Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic diagnosis of urothelial (transitional cell) carcinoma with the exception of micropapillary subtype
* Patients must have recurrent disease (locally advanced or metastatic) that is not amenable to local therapy or newly diagnosed distant metastatic disease
* Measurable disease defined by RECIST v.1.0
* ECOG performance status of 2 or better
* Adequate organ and bone marrow function defined as

Exclusion Criteria:

* Other tumor type than urothelial carcinoma
* Presence or history of CNS metastasis
* Prior systemic chemotherapy or immunotherapy (but prior local intravesical chemotherapy or immunotherapy was allowed. And recurrent disease after adjuvant or neoadjuvant cisplatin-based systemic chemotherapy is allowed if the last chemotherapy was administered 1 year or more before the patient enrollment.)
* Presence of second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
* Peripheral sensory neuropathy grade 2 or worse
* Other serious illness or medical conditions

Primary outcomes:
measure: Response rate
timeFrame: 12 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: 12 months
measure: Overall survival
timeFrame: 12 months
measure: Safety
timeFrame: 8 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
citation: Choi YJ, Lee SH, Lee JL, Ahn JH, Lee KH, You D, Hong B, Hong JH, Ahn H. Phase II study of pemetrexed in combination with cisplatin in patients with advanced urothelial cancer: the PECULIAR study (KCSG 10-17). Br J Cancer. 2015 Jan 20;112(2):260-5. doi: 10.1038/bjc.2014.591. Epub 2014 Nov 27.
Clinical trial NCT00347737: The Effects of Therapy With Teriparatide on Vascular Compliance and Osteoprotegerin/RANKL
Official title: The Effects of Therapy With Teriparatide (Recombinant Parathyroid Hormone (1-34) on Vascular Compliance and Osteoprotegerin/RANKL
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoporosis
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: University of Kansas
First posted: 2006-07-04
Enrollment: 0
Sex: ALL
Minimum age (years): 40
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 is to determine what effect teriparatide will have on vascular (blood vessel) compliance and osteoprotegerin (bone fluid)and RANKL levels (bone cells).

Detailed description: Research subjects participation is about 6 months. Subjects will give themselves daily injections of teriparatide after instruction on technique.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women and men over the age of 40 who are starting therapy with teriparatide

Exclusion Criteria:

* Patients with diabetes mellitus
* current smokers
* patients with a history of organ transplantation
* Patients currently of previously on glucocorticoid therapy within the past year
* Patients with serum creatinine above 1.5 mg/dl, patients with uncontrolled hypertension (BP 140/90 or greater)
* Patients ineligible for teriparatide therapy: History of metabolic bone disease other than osteoporosis
* History of radiation therapy
* Patients pregnant or nursing
* History of bone metastasis or skeletal malignancies
* History of hypercalcemia

Primary outcomes:
measure: The study measures changes in vascular compliance with teriparatide 1 hour, 3 months, and 6 months after initiating teriparatide. Osteoprotegerin and RANKL levels
timeFrame: baseline, 3, and 6 months
Secondary outcomes:
measure: CRP levels
timeFrame: Baseline and at 6 months of therapy
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Leland Graves, III, MD
role: PRINCIPAL_INVESTIGATOR
References: