louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02075112: Soy Isoflavone in Combination With Radiation Therapy and Cisplatin in SCC of the Head and Neck
Official title: A Pilot Study of Soy Isoflavone, Genistein, in Combination With Radiation Therapy and Cisplatin in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer of Head and Neck
Keywords: Soy
Isoflavone
Radiation Therapy
Cisplatin
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Radiation Therapy Oncology Group
First posted: 2014-03-03
Enrollment: 24
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: The purpose of this study is to determine if soy supplementation during chemotherapy and radiation therapy will decrease side effects caused by treatment. Long-lasting dry mouth is a side effect of the standard treatment, and we are testing whether soy supplementation during treatment may reduce this symptom and other side effects of chemoradiation.

Detailed description: Concurrent chemoradiation is the standard of care for locally advanced squamous cell carcinoma of the head and neck (SCCHN). Improving the outcome for patients with this disease remains a major challenge.

Eligibility criteria: Inclusion Criteria:

* Biopsy proven squamous cell carcinoma of the head and neck (SCCHN)
* Primary disease site involving the oropharynx
* Clinical stage III or IV
* Age ≥ 18
* Karnofsky Performance Status (KPS) ≥ 70
* Adequate bone marrow, kidney, and hepatic function (no laboratory value \> 2 times the normal limit)
* Amylase (0-160 U/L) and lipase (0-130 U/L) levels within 1.5 times the range of normal

Exclusion Criteria:

* Prior history of SCCHN
* Prior history of radiation to the head and neck region
* KPS \< 70
* Soy allergy
* Contraindication to cisplatin chemotherapy or plans to alter or reduce cisplatin therapy
* Any head and neck cancer of non-squamous histology
* Any head and neck subsite other than oropharynx (including unknown primary site)
* Patients who are pregnant or lactating
* Patients who may benefit from surgical resection

Primary outcomes:
measure: Percentage of patients with grade 2 or higher xerostomia at 1 year post-treatment
timeFrame: 1 year after treatment completion
Secondary outcomes:
measure: Exploratory biomarker studies: changes in interleukin 6
timeFrame: 3 and 6 months post-treatment
measure: Exploratory biomarker studies: changes in vascular endothelial growth factor
timeFrame: 3 and 6 months post-treatment
measure: Exploratory biomarker studies: changes in isoprostanes levels
timeFrame: 3 and 6 months post-treatment
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University
name: Kristin Higgins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00177112: Impact of Sterilization Technique on Incidence of Urinary Tract Infection After Cystoscopy
Official title: Impact of Sterilization Technique on Incidence of Urinary Tract Infection After Cystoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Tract Infections
Keywords: Cystoscopy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 275
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: The purpose of this study is to verify that the incidence rate of urinary tract infections after a routine outpatient cystoscopy is the same for non-sterile (clean) and sterile procedural techniques.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Patients undergoing routine outpatient flexible cystoscopy

Exclusion Criteria:

* Patients who have had a urinary tract infection within 3 months prior to flexible cystoscopy
* Patients with an indwelling catheter

Primary outcomes:
measure: To verify that the incidence rate of urinary tract infections after a routine outpatient cystoscopy is the same for non-sterile (clean) and sterile procedural techniques
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: VAMC Minneapolis
state: Minnesota
Study officials:
affiliation: VAMC Minneapolis
name: Kyle Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03564912: Prospective Study on the Efficacy and Safety of 2 Week or 3 Week Xelox Regimen for Adjuvant Chemotherapy in CRC
Official title: Prospective Study on the Efficacy and Safety of 2 Week or 3 Week Xelox Regimen for Adjuvant Chemotherapy in Colorectal Patients After Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study select the diagnosis of postoperative colorectal cancer patients with stage II/III to adjuvant chemotherapy, and received 2 weeks and 3 weeks xelox adjuvant treatment process until disease progression or patients died or lost to follow-up. To analyze the difference in efficacy and safety of xelox in 2 weeks and 3 weeks of postoperative adjuvant therapy for colorectal cancer, so as to find a better postoperative adjuvant treatment model.


Eligibility criteria: Inclusion Criteria:

* Carcinoma of the intestine confirmed histologically or cytologically
* Radical surgical resection was performed after diagnosis and the post operative stages were high-risk II or III patients
* The ECOG PS score less than or equal to 2 points
* No chemotherapy of any kind has been performed in the past
* Neutrophils acuity 1.5x10e9/L, platelets more than 100x10e9/L, college blood red protein more than 9g/dL
* liver function transaminase is less than or equal to 2.5 ULN, alkaline phosphatase is less than 2.5 ULN, and total bilirubin is less than 1.5 ULN

Exclusion Criteria:

* Patients with unresectable CRC
* Patients who have any form of chemotherapy before
* Participating in or having participated in clinical studies of other drug
* Patients have second primary malignant tumors of have other malignant tumors in the past five years
* There is evidence of allergic reaction to drugs in this study
* A history of ischemic heart disease in the past 1 year or patients with high risk factors for heart failure, or uncontrolled arrhythmias
* Severe active inflammation, including tuberculosis and HIV
* Long-term immunization or hormone therapy, except hormone replacement therapy at physiological dose
* Drug or alcohol addiction
* Get pregnant or breastfeed
* The investigator considers that the patient is not suitable for this clinical study due to any clinical or laboratory abnormalities or compliance problems

Primary outcomes:
measure: DFS
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First afflicated hospital of zhejiang university
state: Zhejiang
Study officials:
References:
Clinical trial NCT04549012: Determination of Blood Loss After CS
Official title: Tranexamic Acid Plus Oxytocin Versus Oxtocin Only in Reducing Blood Loss After Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Effect of Drug
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 130
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group (A) will receive oxytocin only Group (B)will receive oxytocin plus tranexamic acid
Primary purpose: PREVENTION

Brief summary: Comparing betweeen tranexamic acid plus oxytocin and oxytocin alone in their efficacy in reducing blood loss following CS

Detailed description: tranexamic acid plus oxytocin versus oxytocin only in reducing blood loss following CS

Eligibility criteria: Inclusion Criteria:

1. Age : 20-40 year

   * 2- Gestational age is between 37-41weeks

3- Delivery by uncomplicated elective CS

Exclusion Criteria:

* 1- Risk factors for uterine atony such as polyhydramnios or fetal macrosomia. 2- Grandmultiparity 3- Past history of postpartum hemorrhage either atonic or traumatic 4- Previous history of retained placenta 5- Pre-eclampsia or gestational hypertension/ Maternal DM 6- Abnormal placentation 7- Contraindications to the use of tranexamic acid 8- Hypersensitivity to tranexamic acid. 9- Women receiving anticoagulant therapy. 10- having underlying disease (heart, liver, kidney, pulmonary, etc.),

Primary outcomes:
measure: amount of blood loss
timeFrame: baseline
Secondary outcomes:
measure: maternal and neonatal complication
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00924612: Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation
Official title: Phase II Study of the Effect of Food With Various Levels of Fat on the Pharmacokinetics of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Male Hypogonadism
Keywords: Primary hypogonadism
Secondary hypogonadism
Lead sponsor: Clarus Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-19
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Open-label, five-period, randomized, four-sequence (ABCDE, BDCEA,CBEDA, DBAEC), cross-over study to determine the effect of food containing various amounts of dietary fat on the pharmacokinetics of oral TU.
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.

Detailed description: Pharmacokinetics will be evaluated after the following types of meals: very low fat, low fat, normal diet, high fat, and fasting. Subjects will have one dose of TU administered 30 minutes after the initiation of the meal.

Eligibility criteria: Inclusion Criteria:

* Male
* Age 18-65
* Morning serum testosterone (T) \<300 ng/dL on two occasions

Exclusion Criteria:

* Significant intercurrent disease
* Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score \>15 or history of prostate cancer.
* Serum transaminases \>2 times upper limit of normal
* Serum bilirubin \>2.0 mg/dL
* Hematocrit \<35% or \>50%
* BMI \>36
* Untreated, obstructive sleep apnea.

Primary outcomes:
measure: Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet
timeFrame: 25 hour serial blood draws separated by 4 to 10 days of washout between treatments.
Secondary outcomes:
Other outcomes:
Locations:
city: Torrance
country: United States
facility: LABiomedical Research Institute at Harbor-UCLA Medical Center
state: California
city: Quebec City
country: Canada
facility: Anapharm, Inc.
state: Quebec
Study officials:
affiliation: LABiomedical Research Institute at Harbor-UCLA Medical Center
name: Ronald Swerdloff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00929812: Glucagon Modulation of Ghrelin Secretion
Official title: The Mechanisms Underlying the Glucagon-Induced Suppression of Ghrelin Secretion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Healthy Subjects
Obesity
Diabetes Mellitus, Type 1
Keywords: obesity
food intake
glucagon
ghrelin
glucose
insulin
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2009-06-30
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: As a counterregulatory hormone for insulin, glucagon plays a critical role in maintaining glucose homeostasis in vivo. It is well known that intramuscular glucagon administration stimulates growth hormone (GH), adrenocorticotropic hormone (ACTH) and cortisol release in humans. Recently, it has been shown that glucagon induces a remarkable decrease in ghrelin levels. The mechanisms underlying this effect are unclear and the role of changes in glucose, insulin, glucagon-like peptide-1 (GLP-1) and catecholamines are widely discussed. The aim of the present study is to further evaluate the effect of glucagon on ghrelin secretion and the possible role of the above mentioned factors in mediating this effect.


Eligibility criteria: Inclusion Criteria:

* Subjects \> 18 and \< 60 years old.
* Patients with diabetes type 1 should fulfill the following criteria:

  * ICT Insulin therapy was necessary within the first 3 months after diagnosis;
  * HbA1c-Wert \< 7%.

Exclusion Criteria:

* Diabetes type 1 or 2 (for the healthy group).
* Biochemical evidence of impaired hepatic or renal function.
* History of cardiovascular disease.
* Uncontrolled hypertension.
* Current inflammatory, malignant or psychiatric disease.
* Pregnancy

Primary outcomes:
measure: Changes in satiety scale, total and acylated ghrelin concentrations.
timeFrame: During 240 min after Glucagon/Placebo administration.
Secondary outcomes:
measure: Changes in glucose, insulin and NEFA concentrations.
timeFrame: During 240 min after Glucagon/Placebo administration.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Campus Benjamin Franklin
Study officials:
affiliation: Charite Campus Benjamin Franklin
name: Ayman M Arafat, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arafat AM, Perschel FH, Otto B, Weickert MO, Rochlitz H, Schofl C, Spranger J, Mohlig M, Pfeiffer AF. Glucagon suppression of ghrelin secretion is exerted at hypothalamus-pituitary level. J Clin Endocrinol Metab. 2006 Sep;91(9):3528-33. doi: 10.1210/jc.2006-0225. Epub 2006 Jun 20.
citation: Arafat AM, Weickert MO, Adamidou A, Otto B, Perschel FH, Spranger J, Mohlig M, Pfeiffer AF. The impact of insulin-independent, glucagon-induced suppression of total ghrelin on satiety in obesity and type 1 diabetes mellitus. J Clin Endocrinol Metab. 2013 Oct;98(10):4133-42. doi: 10.1210/jc.2013-1635. Epub 2013 Aug 21.
Clinical trial NCT03615612: Investigation of the Accuracy of a Low-cost, Portable, Autorefractor to Provide Well-tolerated Eyeglass Prescriptions
Official title: Investigation of the Accuracy of a Low-cost, Portable, Autorefractor to Provide Well-tolerated Eyeglass Prescriptions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: PlenOptika, Inc.
name: Aravind Eye Care System
First posted: 2018-08-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: At the Aravind Eye Hospital (AEH) in Madurai, India, patients ages 18-40 receiving treatment for refractive error who choose to enroll in the study will be evaluated using subjective refraction and objective refraction, by way of the QuickSee autorefractor. Patients will then be randomized into one of two treatment plans: receive glasses from objective measure first then subjective measure second, and vice versa. After one week of wearing the first pair of glasses, patient preferences are assessed, and glasses are switched. After a week of wearing the second pair of glasses from the alternate measurement method, patient preferences are again assessed. Patients may then decide which pair patient like best. This is a double blind, case-crossover clinical trial.


Eligibility criteria: Inclusion Criteria: Participants-

1. who visit a Vision Center for their eye check-up
2. who are aged between 18 years and 40 years

Exclusion Criteria: Participants-

1. whose refractive error is not within the detection range of the QuickSee device: -10 to +10 D
2. who have a cylindrical power greater than 3 D
3. who have to travel long distances (beyond 10kms) to the hospital
4. who choose to buy spectacles that are priced more than Rs. 2000/- per pair
5. who have speech or hearing impairment
6. who do not speak the local language, Tamil
7. who do not want to purchase spectacles from AEH

Primary outcomes:
measure: Patient Preference
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madurai
country: India
facility: Aravind Eye Hospital
state: Tamil Nadu
Study officials:
affiliation: Johns Hopkins University
name: David Friedman, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05154812: Yang Yin Fu Zheng Jie Du Therapy in HBV Associated Hepatocellular Carcinoma Based on the Platelet Count/Splenic Length-Diameter Ratio
Official title: Based on the Comprehensive Evaluation System of Platelet Count/Splenic Length-diameter Ratio to Explore the Efficacy of Yang Yin Fu Zheng Jie Du Therapy in Delaying the Progression of HBV Associated Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Hepatocellular Carcinoma
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical research of Yang Yin Fu Zheng Jie Du therapy in HBV associated Hepatocellular Carcinoma based on the platelet count/splenic length-diameter ratio.The purpose of this study is to establish the efficacy evaluation system combined with platelet/splenic length-diameter ratio, and to clarify the effect of this method on relieving hepatitis B cirrhosis and delaying the progression of Hepatocellular Carcinoma.


Eligibility criteria: Inclusion Criteria:

Meet the criteria of hepatocellular carcinoma Patients who tested positive for hepatitis B surface antigen (HBsAg) for \>6 months Liver function grade child-Pugh A/B Patients who have agreed to select local treatment according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2017) TCM syndrome differentiation belongs to deficiency of qi and Yin, stasis and toxin accumulation syndrom Informed consent from the patient.

Exclusion Criteria:

Patient with other hepatitis virus infections or alcoholic liver, autoimmunity liver, primary biliary cirrhosis, genetic metabolic liver disease, and previous liver transplantation; Serious problem of heart, lung, brain, blood and other important organs; Patients with metastatic liver cancer; Pregnant or child breast feeding women; Mental or cognitive disorders; Who are allergic to the study drug.

Primary outcomes:
measure: Tumor progression rate
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival rate
timeFrame: 1 year
measure: Progression-free survival rate
timeFrame: 1 year
measure: Median time to tumor progression
timeFrame: 1 year
measure: Complete response rate
timeFrame: 1 year
measure: the platelet count/splenic length-diameter ratio
timeFrame: 1 year
measure: quality of life (QOL) questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Zhiyun Yang, doctor
state: Beijing
Study officials:
References:
Clinical trial NCT02613312: Chemotherapy Followed by Surgery and Neoadjuvant Hemothoracic Intensity Modified Radiation Therapy (IMRT) for Patients With Malignant Pleural Mesothelioma
Official title: Chemotherapy Followed by Surgery and Neoadjuvant Hemothoracic Intensity Modified Radiation Therapy (IMRT) for Patients With Malignant Pleural Mesothelioma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Mesothelioma
Solitary Fibrous Tumor of the Pleura
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving treatment at the Mayo Clinic Rochester that have been diagnosed with mesothelioma and will undergo chemotherapy followed by surgery and then IMRT as their standard of care.

Brief summary: The purpose of this study is to determine the response rate and overall survival in patients that have been diagnosed with mesothelioma and will undergo chemotherapy, surgery and intensity modified radiation therapy (IMRT) as part of their standard of care.

Detailed description: The investigators will consent patients that have been diagnosed with mesothelioma and will undergo chemotherapy followed by surgery and then IMRT as their standard of care. The investigators will collect data from past and future medical records as well as data regarding their health status for their lifetime by reviewing life status, treatment status and CT scans.

Eligibility criteria: Inclusion Criteria:

* Subject provides informed consent
* Subject is \>18 years of age
* Subject is deemed competent for making medical decisions
* Subject is scheduled to undergo chemotherapy followed by surgery and then IMRT
* Subject is a surgical candidate
* A negative pregnancy test is required in women of child-bearing potential, as standard of care.

Exclusion Criteria:

•Subject is \<18 years old.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 2 years
Secondary outcomes:
measure: Progression free survival (PFS) as evidenced by CT scan review
timeFrame: 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Dennis Wigle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: