louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00681005: A Comparative Study of Proton-pump Inhibitor Tests for Chinese Reflux Patients in Relation to the CYP2C19 Genotypes
Official title: A Comparative Study of Proton-pump Inhibitor Tests for Chinese Reflux Patients in Relation to the CYP2C19 Genotypes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GERD
Keywords: PPI test
gastroesophageal reflux disease
CYP2C19
rabeprazole
pantoprazole
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-05-20
Enrollment: 178
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Backgrounds \& Aims: Proton-pump inhibitor (PPI) test has been proposed as a valuable tool in the diagnosis of gastroesophageal reflux disease (GERD) in Western populations. We assumed that a higher prevalence of poor metabolizers in Chinese population might affect the diagnostic accuracy of a PPI test.

Methods: In this open-label, randomized trial, patients with symptoms suggestive of GERD were randomly assigned to receive a 2-week test with daily rabeprazole 40-mg or daily pantoprazole 80-mg after diagnostic endoscopy. Therapeutic response was assessed with a five-grade daily record. Genotypes of cytochrome P450 (CYP) 2C19 polymorphism were determined.

Detailed description: As described above

Eligibility criteria: Inclusion Criteria:

* Consecutive patients with symptoms suggesting GERD will be enrolled from gastroenterology outpatient clinics in our academic institute. The typical GERD symptom was defined as heartburn and/or regurgitation at least 3 episodes per week in recent 3 months.

Exclusion Criteria:

* Those who were under maintenance PPI treatment, have a medical contraindication to PPI therapy, report a history of peptic ulcer disease or gastrointestinal surgery, malignancy proven by endoscopy, or unwilling or unable to provide informed consent.

Primary outcomes:
measure: at least 50% reduction of symptoms
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Ming-Shiang Wu, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03211377: Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma
Official title: Non-interventional Study to Evaluate Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophagogastric Junction Cancer
Lead sponsor: Anyang Tumor Hospital
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: For this study patients had to be at least 18 years old with histologically or cytologically confirmed locally advanced esophagogastric junction cancer

Brief summary: This is a non-interventional study to observe the safety and efficiency of chemotherapy for potentially resectable locally advanced esophagogastric junction


Eligibility criteria: Inclusion Criteria:

* Histologically or cytological proved locally advanced esophagogastric junction cancer
* ECOG performance status ≦2
* Stage IIa-IIIc
* No distant metastasis (M0)
* Sign in Informed Consent Form

Exclusion Criteria:

* History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
* Pregnancy or lactation women,
* Inadequate hematopoietic function： WBC≦3,500/mm3; ANC≦1,500/mm3; Platelet≦80,000/mm3
* Inadequate organ function which is defined as below:

Total bilirubin \>2 pper limit of normal range (ULN); ALT / AST \> 2.5 upper limit of normal range (ULN); serum creatinine \> 1.5 mg/dL, and Ccr \> 60 ml/min (estimated by Cockcroft-Gault formulation);

* Symptomatic peripheral neuropathy
* Receiving a concomitant treatment with other fluoropyrimidines
* Fluoropyrimidines (DPD) congenital absence

Primary outcomes:
measure: disease free survival(DFS)
timeFrame: up to 3 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: up to 5 years
measure: Adverse events(AE)
timeFrame: through study completion, up to 1 year
Other outcomes:
Locations:
city: Anyang
country: China
facility: Department of science and education
state: Henan
Study officials:
References:
Clinical trial NCT06866977: A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Advanced Pancreatic Cancer
Official title: A Single-arm, Open-label Clinical Study to Evaluate the Efficacy and Safety of VRT106 in Combination With Chemotherapy for Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer
Keywords: Advanced pancreatic cancer
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: Guangzhou Virotech Pharmaceutical Co., Ltd.
First posted: 2025-03-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-center, single-arm, open label investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of advanced pancreatic cancer.

Detailed description: This is a single-center, single-arm, open label investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of advanced pancreatic cancer.

The study is planned to enroll 10 subjects. The entire study consists of a screening period of up to 28 days, treatment period, and a follow-up period (safety follow-up 28 days after the final study dose and survival follow-up once every 3 months).

Eligibility criteria: Inclusion Criteria:

* Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.
* Males and females≥18 years of age, inclusive, at the Screening Visit.
* Have unresectable pancreatic cancer as determined by imaging or surgical exploration and locally advanced or metastatic pancreatic ductal adenocarcinoma (including adenosquamous carcinoma) as confirmed by histology or cytology.
* No prior systemic therapy for unresectable locally advanced and metastatic pancreatic cancer.
* Have at least one measurable lesion according to RECIST v1.1 criteria.
* An Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
* Expected survival time of≥3 months.
* No serious hematologic and cardiac abnormalities of the liver, kidneys, or coagulation functions.

Exclusion Criteria:

* Have suffered from other malignant tumors in the past 5 years, except for cured basal cell skin cancer, non-melanoma skin cancer, and cervical cancer in situ.
* Previous treatment with other oncolytic viruses.
* Immunocompromised patients.
* Known alcohol or drug dependency.
* Women who are pregnant or breastfeeding.

Primary outcomes:
measure: Safety and tolerability
timeFrame: About 3 years
Secondary outcomes:
measure: Overall survival rate
timeFrame: About 3 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT01206777: Feasibility Study of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-cell Malignancies
Official title: Assessment of Hypersensitivity Reactions and Feasibility of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-Cell Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) at a Comprehensive Cancer Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Indolent or Intermediate Grade B-cell Malignancy
Keywords: Hypersensitivity Reactions
B-cell malignancies
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2010-09-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
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 assess the feasibility of a 60 minute rapid infusion rituximab protocol in the institution's outpatient infusion center.


Eligibility criteria: Inclusion Criteria:

* Age 18-89
* Diagnosis of indolent or intermediate grade B-cell malignancy
* Patients receiving rituximab-based therapy at a dose of 375mg/m2, regardless of weight
* First dose given within 3 months of the second dose
* Infusion scheduled for outpatient administration at The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute

Exclusion Criteria:

* Diagnosis of aggressive lymphoma
* Absolute lymphocyte count \> 10 x 103 cells/µL
* New York Heart Association (NYHA) classification Grade II or greater congestive heart failure
* Enrolled on another clinical trial
* Allergy to murine-containing medications
* Grade III or IV hypersensitivity reaction during the initial infusion of rituximab
* Prisoners
* Pregnant women
* Mentally or physically unable to give consent

Primary outcomes:
measure: Incidence of Grade III and IV Hypersensitivity Reactions
timeFrame: Every 15 minutes from start of infusion until completion, for up to 1 hour
Secondary outcomes:
measure: Time Savings of a 60 Minute Infusion Versus Predicted Infusion Time Using Standard Second Dose Titration Schedule
timeFrame: Determined from difference in expected time by package insert administration and actual time on day of treatment
measure: Demonstrate Nursing Satisfaction for Administration of Rapid Infusion Over Standard Titration Practice
timeFrame: 6 months, as a before and after infusion survey
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jeffrey Jones, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dotson E, Crawford B, Phillips G, Jones J. Sixty-minute infusion rituximab protocol allows for safe and efficient workflow. Support Care Cancer. 2016 Mar;24(3):1125-9. doi: 10.1007/s00520-015-2869-4. Epub 2015 Aug 14.
Clinical trial NCT01725477: Laparoscopic Tubal Patency Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methylene Blue
Laparoscopy
Tubal Patency
Lead sponsor: Pourmatroud, Elham, M.D.
Sponsor class: INDIV
First posted: 2012-11-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 1. Methylene blue in laparoscopy use for tubal patency assessment
2. Methylene blue could have negative effect on sperm motility, oocyte granulosa cell and fertility.
3. tubal washing after Methylene blue administration could be effective in pregnancy rate after operation.

Detailed description: women with unexplained infertility and without any problem during laparoscopy and hysteroscopy entered in the study.After randomization in one group after dye test,washing with normal saline was done until all of visible Methylene blue removed.In second group washing with normal saline did not done. pregnancy rate until three months after operation was followed without any intervention.

Eligibility criteria: Inclusion Criteria:

* women with unexplained infertility

Exclusion Criteria:

* any intervention during operation like ovarian drilling or septum resection

Primary outcomes:
measure: Pregnancy rate
timeFrame: up to 12 weeks
Secondary outcomes:
measure: complications rate in two group
timeFrame: Up to 12 weeks
Other outcomes:
measure: Abortion rate
timeFrame: Up to 12 weeks
Locations:
city: Ahvaz
country: Iran, Islamic Republic of
facility: Ahvaz Jundishapur university of medical science
Study officials:
References:
citation: Galili Y, Ben-Abraham R, Rabau M, Klausner J, Kluger Y. Reduction of surgery-induced peritoneal adhesions by methylene blue. Am J Surg. 1998 Jan;175(1):30-2. doi: 10.1016/s0002-9610(97)00232-8.
Clinical trial NCT00001377: Familial Prostate Cancer
Official title: Familial Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplastic Syndromes, Hereditary
Prostatic Neoplasms
Keywords: Familial
Inherited Prostate Cancer
Linkage
Prostate Cancer
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to identify affected individuals in families with prostate cancer and to use this information to identify genetic markers closely-linked to the disease gene.

Detailed description: The purpose of this study is to identify affected individuals in families with prostate cancer and to use this information to identify genetic markers closely-linked to the disease gene.

Eligibility criteria: Families will be identified with two or more first degree relatives affected with prostate cancer or with one male with prostate cancer that developed before age 55.

Must have clinical evidence of prostate cancer in the family.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI)
state: Maryland
Study officials:
References:
citation: Vocke CD, Pozzatti RO, Bostwick DG, Florence CD, Jennings SB, Strup SE, Duray PH, Liotta LA, Emmert-Buck MR, Linehan WM. Analysis of 99 microdissected prostate carcinomas reveals a high frequency of allelic loss on chromosome 8p12-21. Cancer Res. 1996 May 15;56(10):2411-6.
citation: Bright RK, Vocke CD, Emmert-Buck MR, Duray PH, Solomon D, Fetsch P, Rhim JS, Linehan WM, Topalian SL. Generation and genetic characterization of immortal human prostate epithelial cell lines derived from primary cancer specimens. Cancer Res. 1997 Mar 1;57(5):995-1002.
citation: Emmert-Buck MR, Vocke CD, Pozzatti RO, Duray PH, Jennings SB, Florence CD, Zhuang Z, Bostwick DG, Liotta LA, Linehan WM. Allelic loss on chromosome 8p12-21 in microdissected prostatic intraepithelial neoplasia. Cancer Res. 1995 Jul 15;55(14):2959-62.
Clinical trial NCT05902377: 68Ga-NY104 PET/CT Imaging in Renal Cell Carcinoma
Official title: 68Ga-NY104 PET/CT Imaging in Patients With Confirmed or Suspicious Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Keywords: 68Ga-NY104
carbonic anhydrase IX
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective, single-center study in patients with renal cell carcinoma. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in the detection of clear cell renal cell carcinoma.

Detailed description: Two types of patients will be recruited in this study. Type 1, patients with renal masses scheduled for surgery, type 2, patients with confirmed or suspicious recurrent/metastatic ccRCC. Each patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. Imaging interpretations and reference standards will be used to estimate the sensitivity and specificity of 68G-NY104 PET/CT.

46 patients will be recruited in Peking Union Medical College Hospital. This study will be conducted according to local regulations and laws, the ethical principles that have their origin in the Declaration of Helsinki, and the principles of Good Clinical Practice.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent provided for participation in the trial
2. Age ≥ 18 y
3. at least one of the following indications should be applied

   1. Scheduled for surgical resection of renal mass
   2. confirmed recurrent/metastatic clear cell renal cell carcinoma
   3. suspicion for recurrent/metastatic clear cell renal cell carcinoma

Exclusion Criteria:

1. On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT.
2. Pregnancy or lactation
3. Severe claustrophobia.

Primary outcomes:
measure: Binary reading of focal lesions identified on 68Ga-NY104 PET/CT
timeFrame: From study completion to 1 month after completion
Secondary outcomes:
measure: SUVmax of focal lesions identified on 68Ga-NY104 PET/CT
timeFrame: From study completion to 1 month after completion
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Uion Medical College Hospital
name: Huo Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03488277: Leg Elevation for Prevention of Post Spinal Hypotension in Cesarean Section
Official title: Evaluation of the Efficiency of Leg Elevation for Preventing Post Spinal Hypotension in Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2018-04-04
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: Prospective trial including full term parturients scheduled for a cesarean section under spinal anesthesia. patients are being randomly assigned into 2 groups:

LE group: will be positioned in 15° left tilt with leg elevation with a 30cm height pillow under the heels, this position will be hold after spinal anesthesia until fetal extraction.

Control group: will be positioned in supine with 15° left tilt. the 2 groups will receive a 10ml/kg of crystalloid co-load intravenously, and the spinal anesthesia will be performed in sitting position with the same dose of Bupivacain, morphine and sufentanil.

Detailed description: Prospective trial including full term parturients scheduled for a cesarean section under spinal anesthesia. patients are being randomly assigned into 2 groups:

LE group: will be positioned in 15° left tilt with leg elevation with a 30cm height pillow under the heels, this position will be hold after spinal anesthesia until fetal extraction.

Control group: will be positioned in supine with 15° left tilt. the 2 groups will receive a 10ml/kg of crystalloid co-load intravenously, and the spinal anesthesia will be performed in sitting position with the same dose of Bupivacain, morphine and sufentanil. we will record the demographic data, pre and intraoperative hemodynamic parameters, the dose of ephedrine required to treat post spinal hypotension and fetal parameters: pH and blood lactates

Eligibility criteria: Inclusion Criteria:

* full term parturients
* age\> 18 Y
* scheduled of elective or urgent cesarean section under spinal anesthesia

Exclusion Criteria:

* patients who had general anesthesia

Primary outcomes:
measure: Incidence of post spinal hypotension
timeFrame: during the first 30minutes after the spinal anesthesia
Secondary outcomes:
measure: Lowest systolic blood pressure
timeFrame: during the first 30 minutes following spinal anesthesia
measure: ephedrine consumption
timeFrame: during the first 30 minutes following the spinal anesthesia
measure: Fetal ph
timeFrame: 30 minutes after spinal anesthesia
measure: Fetal blood lactates
timeFrame: 30 minutes after spinal anesthesia
Other outcomes:
Locations:
city: La Marsa
country: Tunisia
facility: Mongi Slim Hospital
state: Tunis
Study officials:
affiliation: Mongi Slim Hospital
name: Mhamed Sami Mebazaa, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01315977: Dietary Antioxidants, Redox Tone and Health Promotion: an Orthomolecular Study of Interactions
Official title: Orthomolecular Mechanisms of Health Effects of Antioxidant Rich Diets, With Focus on Green Tea (Camellia Sinensis), DNA Protection and Key Biochemical Products/Effects of the Antioxidant Response Element
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Antioxidant oxidant balance
Activation of Antioxidant Response Element
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Our Lady of Maryknoll Hospital
First posted: 2011-03-16
Enrollment: 60
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Aging is associated with increased risk of various diseases, and much attention is given to the use of natural products (like herbs) and 'functional food', such as teas, for healthy aging.

The body is continuously exposed to potentially damaging agents (known as free radicals). The imbalance between the amount of free radicals and that of antioxidants in the body is known as oxidative stress. It is known that Type 2 DM is a state of increased oxidative stress, which is thought to lead to many long term complications of Type 2 DM, such as heart disease, vision problems and kidney failure. Antioxidant therapy, including increased consumption of antioxidant rich foods and beverages such as green tea, has been suggested as possibly beneficial in lowering the risk of these complications.

The purpose of this study is to examine the effects of regular intake of green tea on indices of oxidative stress and antioxidant defense within cells, plasma and urine so as to investigate if regular intake of green tea can be recommended for health promotion.


Eligibility criteria: Inclusion Criteria:

* Type 2 DM subjects
* Genotyped for polymorphism in the heme-oxygenase gene promoter region to be homozygous for long (\> 26) or short (\< 24) GT repeats

Exclusion Criteria:

* smokers
* have suffered DM related complication
* already taking antioxidant or herbal supplements

Primary outcomes:
measure: Activation of Antioxidant Response Element After Consumption of Green Tea
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kowloon
country: China
facility: Our Lady of Maryknoll Hospital
state: Hong Kong
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Iris BENZIE, DPhil
role: STUDY_CHAIR
References: