louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02959086: Shanghai Epidemiology Study for Adolescents and Children with Cancer
Official title: Shanghai Epidemiology Study for Adolescents and Children with Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Childhood Cancer
Keywords: Epidemiology
Shanghai
Cancer
Adolescents
Children
Lead sponsor: Children's Cancer Group, China
Sponsor class: NETWORK
Collaborators: name: Shanghai Children's Medical Center
name: Shanghai Municipal Center for Disease Prevention & Control
First posted: 2016-11-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Since January 2002 in Shanghai, 0-19 year-old children and adolescents diagnosed with cancer.

Brief summary: The purpose of this study is to describe the morbidity, mortality, disability and survival rate in Shanghai adolescents and children with cancer diagnosed since January 2002.

Detailed description: The investigators collected information of all the adolescents and children diagnosed cancer in Shanghai since January 2002, including their name, gender, the date of birth, the diagnosis date, disease diagnosis, residence address and the last follow-up time status (survival/death). The type of cancer included all malignant tumors such as Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Non-Hodgkin Lymphoma, Hodgkin Lymphoma, central nervous system tumors, Neuroblastoma, Wilms tumor and so on. Then the investigators would analyze the morbidity, mortality, disability and survival rate.

Eligibility criteria: Inclusion Criteria:

* 0-19 year-old children and adolescents.
* Diagnosed cancer in Shanghai since January 2002.

Exclusion Criteria:

* Patients who were lost of follow-up.
* Patient's death wasn't caused by cancer or complications but by other accidents such as car accident, fell from a great height and so on.

Primary outcomes:
measure: Overall survival for the whole cohort
timeFrame: 5 years
Secondary outcomes:
measure: Mortality for the whole cohort
timeFrame: 5 years
Other outcomes:
measure: Disability rate for the whole cohort
timeFrame: 5 years
Locations:
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Municipal Center of Disease Prevention & Control
state: Shanghai
Study officials:
affiliation: Shanghai Children's Medical Center
name: Yi-Jin Gao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00099086: Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer
Official title: Phase I Trial of Concurrent Taxotere With Radiation Therapy and Hormonal Therapy For Clinically Localized High Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2004-12-09
Enrollment: 20
Sex: MALE
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 phase I trial is studying the side effects and best dose of docetaxel when given with radiation therapy and hormone therapy in patients with locally advanced prostate cancer.

Detailed description: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Docetaxel may also make tumor cells more sensitive to radiation therapy. Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, or bicalutamide, may stop the adrenal glands from making androgens. Giving chemotherapy with radiation therapy and hormone therapy may kill more tumor cells.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate with one of the prognostic factors specified in the protocol. No pelvic lymph node disease that would necessitate pelvic radiotherapy. No radiologic evidence of metastatic disease on bone scan or on CT scan or MRI of the abdomen or pelvis
2. No prior radiation therapy, chemotherapy, immunotherapy or alternative therapy for prostate cancer. Greater than 4 weeks since any major surgery.
3. Performance status 0-2
4. Must meet criteria for acceptable lab values as outlined in the protocol.
5. Peripheral neuropathy must be greater than or equal to 1
6. Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

Exclusion Criteria:

1. No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80

Primary outcomes:
measure: Maximum tolerated dose (MTD) of Taxotere with radiation therapy and hormonal therapy
timeFrame: 57 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: David Marshall, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01830686: Metabolic Effects of Short Term Sugarcane Bagasse Supplementation
Official title: Metabolic Effects of Short Term Sugarcane Bagasse Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: Sugarcane bagasse, glucose tolerance, insulin resistance
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2013-04-12
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to help understand the benefits of eating food supplemented with fiber in the form of sugarcane bagasse (the leftover fiber after cane juice is extracted) on glucose metabolism and body weight.

Detailed description: The investigators will employ a double-blind randomized controlled study design with 3 arms such that obese, insulin resistant adults will be randomly selected to receive food made with 1) sugarcane bagasse, 2) non-caloric, non-fermentable fiber, or 3) a similar product with minimal fiber for 4 weeks. The intervention will be in the form of brownies and cookies and will look and taste nearly identical to each other. Caloric value will be constant with all three delivery systems. Subjects will have blood testing and body composition analysis before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* Males and females age 18-50 years
* Body Mass Index ≥ 30 kg/m2 (a ratio of weight to height)
* Fasting insulin level \>5 µIU/mL, as determined by tests performed during screening

Exclusion Criteria:

* Women who are pregnant
* Past medical history of diabetes
* History of intestinal surgery such as removal of bowel
* History of problems with absorbing food such as celiac disease, inflammatory bowel disease, malabsorption syndrome
* Taking chronic medications for any medical conditions such as diabetes, hypertension, cholesterol, thyroid hormone, etc.
* Any food allergies

Primary outcomes:
measure: The benefit of sugarcane bagasse on glucose tolerance and insulin resistance in adults with established insulin resistance
timeFrame: 4 weeks
Secondary outcomes:
measure: The effect of sugarcane bagasse on body weight/composition
timeFrame: 4 weeks
Other outcomes:
measure: The effect of sugarcane bagasse on incretin profiles as a mechanism to explain its metabolic effects
timeFrame: 4 Weeks
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Daniel Hsia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00691886: Safety and Efficacy of Intravenous (IV) Dexmedetomidine During Flexible Bronchoscopy and Endobronchial Ultrasound
Official title: Safety and Efficacy of Intravenous Dexmedetomidine Infusion During Flexible Bronchoscoy and Endobronchical Ultrasound
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain
Keywords: sedation
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To achieve safe,consistent, continuous sedation using Dexmedetomidine in advaced bronchoscopy procedures that may reduce the need for rapid pain sedative infusion.

Detailed description: Dexmedetomidine hydrochloride as a single agent produces sedation, pain relief, anxiety redution, stable respiratory rates, and predictable cardiovascular responses. Dexmedetomidine facilitates patient comfort, compliance and comprehension by offering sedation with the ability to awaken patients. This study is being done to determine sedation efficacy and dosing; measure reduction or eliminate the need for rapid sedative infusion during bronchoscopy; improvement of patient comfort and safety during complex bronchoscopy; establish a new paradigm for moderate sedation during flexible bronchoscopy

Eligibility criteria: Inclusion Criteria:

* Adults between the age of 18 and 85
* Adults scheduled for flexible brochoscopy using EUBS (Endobronchial Ultrasound)

Exclusion Criteria:

* Sever bradycardia (rate \< 50) and / or related bradydysrhymias (e.g. advanced heart block)
* Impaired ventricular functions (EF \<30%)
* Hypovolemia or hypotension (SBP \<90 or MAP \<a55)
* Have GFR less than 15ml/min 1.73m2 or undergoing hemodialysis
* Endstage liver disease.

Primary outcomes:
measure: Achieve safe, consistent, continous moderate sedation using Dexmedetomidine in advanced bronchoscopy procedures, alleviating the need for rapid sedative infusion.
timeFrame: at conclusion of subject enrollemtn
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
Study officials:
affiliation: Lahey Clinic Medical Center
name: David R Riker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04270786: Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever
Official title: Phase III Randomized Study of Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever in Patients Undergoing Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Safety Issues
Keywords: neutropenic fever, empiric, antibiotics
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized study to evaluate the safety and feasibility of early de-escalation of empirical antibiotics treatment in neutropenic fever patients undergoing hematopoietic stem cell transplantation (HSCT). In case of afebrile for 72 hours with empirical antibiotics treatment, patients will be randomized into 2 groups. In the early de-escalation group, antibiotics treatment will be stopped and prophylaxis with levofloxacin will be resumed. In the control group, the empirical treatment will continue until recovery of neutropenia or at least for 7 days.

Detailed description: This is a randomized study to evaluate the safety and feasibility of early de-escalation treatment of empyrical antibiotics treatment in neutropenic fever patients undergoing hematopoietic stem cell transplantation (HSCT). All patients undergoing HSCT will receive levofloxacin as regular prophylaxis. After patients develop neutropenia fever, the empirical antibiotics protocol will be impenem. In case of persistent for 48 hours, vancomycin will be added. If afebrile is achieved for 72 hours, all patients will randomized into early de-escalating group or control group. In de-escalating group, the empirical antibiotics treatment will be stopped and then levofloxacin prophylaxis will be resumed. In the control group, the empirical antibiotics treatment will be continue until recovery of neutropenia or at least 7 days.

Eligibility criteria: Inclusion Criteria:

* Age ≥18，patients undergo hematopoietic stem cells
* Patients with neutropenic fever: T≥38.5°C once or T≥38°C twice a day with ANC \<0.5x109/L or predicted to be \<0.5x109/L in 24 \~48 hours；
* Patients achieved afebrile （T\<37.5°C）for at least 72 hours；
* Inform consent given

Exclusion Criteria:

* Patients with neutropenic fever with documented blood stream infection, skin and soft tissue infection, pneumonia and catheter associated infection.
* Patients with septic shock
* Levofloaxin allergy or contra-indication

Primary outcomes:
measure: Days of no empirical antibiotics treatment
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Blood & Marrow Transplantation Center, RuiJin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Jiong hu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00439686: Study of ZIO-201 in Advanced Sarcoma
Official title: A Phase IB/IIA Study of the Saftey and Activity of Intravenous Isophosporamide Mustard (ZIO-201) in Patients With Advanced Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Sarcoma
Lead sponsor: Alaunos Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-02-26
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced sarcoma.


Eligibility criteria: Metastatic and /or unresectable disease state after previous standard chemotherapy

Primary outcomes:
measure: toxicities
timeFrame: 6 months
Secondary outcomes:
measure: pharmacokinetics
timeFrame: 6 months
Other outcomes:
Locations:
city: Santa Monica
country: United States
state: California
city: Ann Arbor
country: United States
state: Michigan
Study officials:
affiliation: ZIOPHARM Oncology, Inc
name: Jonathan Lewis, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00965263: Therapeutic Cocaine Vaccine: Human Laboratory Study
Official title: Tests of a Therapeutic Cocaine Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine Dependence
Keywords: Cocaine
immunotherapy
vaccination
antibody
addiction
dependence
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2009-08-25
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical data demonstrate that a cocaine vaccine (TA-CD: Celtic Pharmaceutical) produces selective anti-cocaine antibodies, yet the impact of these antibodies on cocaine's direct effects is unknown. The objective of this human laboratory study was to measure the relationship between antibody titers and the effects of smoked cocaine on ratings of intoxication, craving and cardiovascular effects.

Cocaine-dependent volunteers not seeking drug treatment spend 2 nights per week for 13 weeks inpatient where the effects of cocaine (0, 25, 50 mg) are determined prior to vaccination and at weekly intervals thereafter. Vaccinations occur at weeks 1, 3, 5 and 9.

Detailed description: I do not desire to provide a more extensive description.

Eligibility criteria: Inclusion Criteria:

1. Meets DSM-IV criteria for current cocaine dependence. The volunteer may meet criteria for other substance abuse, but not dependence (other than nicotine).
2. Primary route of cocaine administration is smoking.
3. Age 21-45.
4. Females must be surgically sterilized or post- menopausal
5. Able to give informed consent, and comply with study procedures.

Exclusion Criteria:

1. Dependence on substances other than cocaine or nicotine.
2. Judged to be noncompliant with study protocol.
3. History of autoimmune disease, immune deficiency or hypersensitivity to other vaccines. An HIV test must be negative.
4. Currently uses drugs intravenously
5. Currently taking any psychotropic medication
6. Laboratory tests that are clinically unacceptable to the study physician (BP \> 140/90; BUN, creatinine, LFTs \> 1.5 ULN; hematocrit \< 34 for women, \< 36 for men)
7. Blood or blood products given in the three months prior to vaccination
8. Other vaccines, including flu vaccine, given within 30 days of screening.
9. Ongoing active infection
10. Currently taking immunosuppressives -

Primary outcomes:
measure: Cocaine Intoxication
timeFrame: 13 weeks
Secondary outcomes:
measure: Cocaine Cardiovascular Effects
timeFrame: 13 weeks
measure: Plasma Cocaine
timeFrame: 13 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York-Presbyterian Hospital
state: New York
Study officials:
affiliation: Columbia University
name: Margaret Haney, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haney M, Gunderson EW, Jiang H, Collins ED, Foltin RW. Cocaine-specific antibodies blunt the subjective effects of smoked cocaine in humans. Biol Psychiatry. 2010 Jan 1;67(1):59-65. doi: 10.1016/j.biopsych.2009.08.031.
Clinical trial NCT01129063: Pharmacokinetic Study of Single Doses of Clopidogrel, 75 mg and 300 mg, in Healthy Subjects
Official title: An Open-label, Two-treatment Crossover Pharmacokinetic Study of Clopidogrel Hydrogen Sulfate in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2010-05-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objectives of the study are to:

* Assess the within-subject variability of the pharmacokinetic profiles of the clopidogrel and its active metabolite after a replicated single administration of 75 mg of clopidogrel in healthy male and female subjects
* Assess the pharmacokinetic profiles of the clopidogrel and its active metabolite after single administration of 75 or 300 mg of clopidogrel

Detailed description: The total study duration per subject is 4 - 6 weeks broken down as follows:

* Screening: 2 to 21 days before the first dosing
* Period 1, 2 and 3: 4 days including 1 treatment day each
* Washout between periods: at least 7 days between 2 administrations
* End of study: 7 to 10 days after the last dosing

Eligibility criteria: Inclusion Criteria:

Healthy subjects:

* as determined by medical history and complete physical examination including vital signs and clinical laboratory tests
* with a body weight between 50kg and 95 kg if male, between 40.0 kg and 85.0 kg if female and a Body Mass Index (BMI) between 18 and 28 kg/m2

Exclusion Criteria:

* Evidence of inherited disorder of coagulation/hemostasis functions
* Smoking more than 5 cigarettes or equivalent per day
* Abnormal hemostasis screen
* Any contraindication to clopidogrel
* Unability to abstain from intake of any drug affecting haemostasis throughout the whole study duration.

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

Primary outcomes:
measure: Clopidogrel pharmacokinetic parameters (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC))
timeFrame: Up to 48 hours postdose for each period
measure: Clopidogrel active metabolite pharmacokinetic parameters (Cmax, AUClast and AUC)
timeFrame: Up to 48 hours postdose for each period
Secondary outcomes:
measure: Other clopidogrel pharmacokinetic parameters (first time to reach Cmax (tmax), terminal half-life (t1/2z))
timeFrame: Up to 48 hours postdose for each period
measure: Other clopidogrel active metabolite pharmacokinetic parameters (tmax, t1/2z)
timeFrame: Up to 48 hours postdose for each period
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: International Clinical Development Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05950763: The Causes of Academic Excellence Concentrated in Dormitory
Official title: The Causes of Academic Excellence Concentrated in Dormitory
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Peer Influence
Lead sponsor: Zhejiang Chinese Medical University
Sponsor class: OTHER_GOV
First posted: 2023-07-18
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It refers to two or more members in a dormitory who have achieved outstanding academic performance, have better scientific research results, have better competition awards (meet one or more), and usually study hard and study hard

Brief summary: This research will take the sophomore to senior students of Zhejiang University of Traditional Chinese Medicine as the research object to investigate the influence of dormitory atmosphere on the academic performance, scientific research achievements, and competition awards of dormitory members, analyze the path of straightforward-A student dormitory formation, and find out the current Weak links of college students' ideological and political education in dormitory culture construction, and explore how dormitory culture construction can promote the common progress of dormitory members


Eligibility criteria: Inclusion Criteria:

* Sophomore-senior students of Zhejiang University of Traditional Chinese Medicine

Exclusion Criteria:

* Non-straight-A student dormitory member

Primary outcomes:
measure: Academic Excellence Concentrated in Dormitory
timeFrame: Zhejiang University of Traditional Chinese Medicine sophomore-senior students from admission to September 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Ying Xu
state: Zhe Jiang
Study officials:
References:
Clinical trial NCT03569163: Pulse Oximeter Test
Official title: Accuracy of Pulse Oximeters With Profound Hypoxia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
Lead sponsor: Spry Health
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2018-06-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 11 healthy adults

Brief summary: Assessment of Spry Health's Loop oximetry accuracy in profound hypoxia


Eligibility criteria: Inclusion Criteria:

* Good general health with no evidence of medical problems

Exclusion Criteria:

* Smoking
* Anemia

Primary outcomes:
measure: Oximetry Accuracy
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Hypoxia Lab
state: California
Study officials:
References: