louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04751448: COLON-MD: Colon Cancer Longitudinal Study
Official title: COLON MD: Colon Cancer Longitudinal Study of the Microbial Metabolites and Dietary Factors That Influence Response to Treatment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colon Cancer
Keywords: FOLFOX Treatment
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: Baylor University
First posted: 2021-02-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Colon cancer patient, prior to surgery or prior to treatment start

Brief summary: The goal of this proposal is to identify how the composition of the gut microbiome and diet interact to impact chemotherapy-induced diarrhea incidence and severity.

Detailed description: In this longitudinal observational study patients will supply samples of their gut microbiome prior to scheduled colonoscopy or surgery along with dietary intake and blood samples; the relative abundance of microbes from those samples along with dietary data will be used to predict the presence or absence and severity of chemotherapy-induced diarrhea. Microbiome and diet based predictions from blinded samples will be combined to map the diet-microbiome changes during treatment to the changes in immune markers and risk of chemotherapy-induced diarrhea.

Eligibility criteria: Inclusion Criteria:

* Colon cancer diagnosis
* Age \>18 and \< or equal to 79.
* Ability to perform informed consent
* FOLFOX treatment expected

Exclusion Criteria:

* Not Pregnant
* Does not have Lynch syndrome or FAP diagnosis.
* Inability to perform inform consent
* inability to comply with follow up program
* history of prior colon cancer diagnosis
* previous treatment with antibiotics in the last month.
* previous bowel resection.

Primary outcomes:
measure: Microbiome-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer
timeFrame: 3 years
Secondary outcomes:
measure: Dietary-Based Prediction of Chemotherapy-induced Diarrhea in Colon Cancer
timeFrame: 3 years
Other outcomes:
Locations:
city: Temple
country: United States
facility: Baylor Research Institute
state: Texas
Study officials:
References:
Clinical trial NCT07008248: Real-World Clinical Study for Malignant Tumor-Induced Cachexia
Official title: Real-World Clinical Study for Malignant Tumor-Induced Cachexia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clinical Characteristics and Treatment Outcomes of Malignant Tumor Cachexia
Multicenter Observational Study
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Xuzhou Central Hospital
First posted: 2025-06-06
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Cachexia patients with malignant tumors

Brief summary: This study is a non-interventional, multicenter observational study, aiming to assess the clinical characteristics and treatment outcomes of malignant tumor cachexia. The study is mainly divided into two cohorts:

Retrospective Cohort: This cohort focuses on patients who have already been diagnosed with cachexia before the initiation of this study. It involves the retrospective collection and analysis of clinical data.

Prospective Cohort: This cohort includes patients who are diagnosed with cachexia after the start of this study. Data will be prospectively collected and analyzed during their subsequent diagnosis and treatment process.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older (including 18 years).
* Malignant tumor confirmed by histology or cytology (both malignant solid tumors and malignant hematologic tumors are eligible for enrollment).
* Meeting the Fearon diagnostic criteria for cachexia.
* Life expectancy of ≥2 months (for the prospective cohort only).
* Able to sign the informed consent form (waiver of informed consent for the retrospective cohort).

Exclusion Criteria:

Retrospective Cohort:

* Missing gender information.
* Missing date of birth or age information.
* Lack of any treatment or follow-up information after the date of meeting the diagnostic criteria for cachexia.

Prospective Cohort: (Patients with any of the following are not eligible for enrollment in this study)

* Patients who are unable to receive any treatment for any reason.
* Patients who cannot undergo at least one follow-up.
* Patients whom the investigator deems unsuitable for participation in this study.

Primary outcomes:
measure: The value of weight increase compared to the baseline
timeFrame: through the observation period，an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Xuzhou Central Hospital, Xuzhou Clinical School of Xuzhou Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT01877330: Optimal Location of Local Anesthetic Injection for Ultrasound Guided Interscalene Block
Official title: Intraplexus vs Extraplexus Injection of Local Anesthetic for Interscalene Block for Patients Undergoing Arthroscopic Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Arthroscopy
Ultrasound-guided Interscalene Nerve Block
Keywords: shoulder arthroscopy
ultrasound guided nerve block
interscalene nerve block
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-06-13
Enrollment: 208
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: This is a prospective randomized clinical trial to determine where is the optimal location for local anesthetic injection for ultrasound guided interscalene nerve blocks. The investigators are investigating if local anesthetic deposited between the nerve roots is more effective than local anesthetic deposited in the interscalene groove.


Eligibility criteria: Inclusion Criteria:

ASA I-II patients who are 18 years and older and who are scheduled for shoulder arthroscopy are eligible for enrollment provided they do not have any of the following exclusion criteria.

Exclusion Criteria:

* chronic pain
* high preoperative opioid requirement
* age \< 18 years old
* non-English speaking
* contraindication to regional anesthesia (allergy to local anesthetics, coagulopathy, severe thrombocytopenia, pre-existing neuropathy in operative limb, infection at puncture site)
* need for postoperative nerve function monitoring
* patient refusal
* dementia
* pulmonary disease or low baseline oxygen saturation

Primary outcomes:
measure: Onset of motor blockade
timeFrame: 1 hour from time of injection
Secondary outcomes:
measure: Patient Satisfaction Score
timeFrame: 24 hours
measure: Opioid consumption
timeFrame: 24 hours
measure: Quality of Nerve block
timeFrame: 24 hours
measure: Incidence of post-operative nausea/vomiting
timeFrame: 24 hours
measure: Duration of nerve block
timeFrame: 24 hours
measure: Number of needle passes
timeFrame: 1 hour
measure: Number of paresthesias
timeFrame: 1 hour
measure: Residual paresthesia
timeFrame: 24 hour
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Orthopedic Institute
state: California
Study officials:
affiliation: University of California, San Francisco
name: Pedram Aleshi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Monica W Harbell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02815748: The Metabolite Identification and Material Balance Study of SP2086
Official title: A Single-center, Randomized, Open, Single Dose Phase I Study to Access the Metabolite Identification and Material Balance in Health Volunteer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: SP2086
Metabolite identification
Material balance
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-06-28
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the Metabolite identification and material balance of SP2086 in healthy adult volunteers.

Detailed description: All subjects were given SP2086 100mg only one time, and blood sample should be collected before and 96 hours after medicine taken.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers with a body mass index(BMI) between 19 and 25 Kg/m2,and weight ≥50kg.
* Lab and other examination results were normal or mildly abnormal without clinical significance, clinical doctors had considered eligible.
* Had signed the informed consent himself or herself voluntarily.

Exclusion Criteria:

* Has a history of severe system disease, or family history (including the cardiovascular system, digestive system, urinary system, etc.).
* Has a history of allergy or intolerance to SP2086 OR other DPP-IV.
* The subjects participated 3 times or more than 3 times drug clinical subjects in nearly a year;participate any drug clinical trial prior to the test 3 months, or had blood donor, or plan to blood donors three months before the test;or had a transfusion in 4 weeks.
* Did not take effective contraceptive measures or planning of the subjects in half a year.
* Researchers considered the patient adherence is poor, or has any unfavorable factors that not suit to participate the test.

Primary outcomes:
measure: The maximum plasma concentration (Cmax) of SP2086
timeFrame: up to 96 hours
measure: The maximum plasma concentration (Cmax) of SP2086 acid
timeFrame: up to 96 hours
measure: The area under the plasma concentration-time curve (AUC) of SP2086
timeFrame: up to 96 hours
measure: The area under the plasma concentration-time curve (AUC) of SP2086 acid
timeFrame: up to 96 hours
Secondary outcomes:
measure: The number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: up to 96 hours
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Shijitan Hospital Affiliated to Capital Medical University
name: XingHe Wang, P.H.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02156648: A Feasibility Study for Women Receiving Anthracycline Chemotherapy With or Without Radiation for HER2-neu Positive Invasive Ductal Carcinoma
Official title: A Feasibility Study for Women Receiving Adjuvant or Neo-adjuvant Anthracycline Chemotherapy With or Without Radiation for HER2-neu Positive Invasive Ductal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Invasive ductal
HER2-neu positive
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this project is to assess the feasibility of collecting plasma samples for cardiac biomarker assessment, and to identify if there is an associations between the biomarkers, echocardiographic features and the cardiac PET scan results (in patients receiving radiation therapy). This is the first step in a research program that has an overall goal of being able to predict early-treatment induced cardiotoxicity in patients with breast cancer.


Eligibility criteria: Inclusion Criteria:

1. Stage I-III, HER2-neu positive invasive ductal carcinoma
2. Scheduled to receive adjuvant/neo-adjuvant 5-Fluorouracil, Epirubicin, Cyclophosphamide and Docetaxel (FEC-D) chemotherapy
3. Scheduled to receive adjuvant Trastuzumab
4. ECOG Performance status 0-2
5. Adequate baseline imaging on transthoracic echocardiography, and baseline cardiac ejection fraction of ≥ 55%. Additionally, breast cancer patients≥45 years of age and scheduled to receive whole breast radiation therapy will receive two cardiac PET scans.

Exclusion Criteria:

1. Prior anthracycline chemotherapy
2. History of dilated cardiomyopathy, congestive heart failure, or coronary artery disease
3. Life expectancy less than 15 months
4. Pregnant or lactating women
5. Use of beta receptor antagonists, calcium channel antagonists, angiotensin converting enzyme inhibitors, or angiotensin receptor inhibitors at baseline.
6. Previous chest wall/breast or nodal radiation.

Primary outcomes:
measure: Recruitment rates
timeFrame: every 4 weeks up to 2 years
Secondary outcomes:
measure: Cardiotoxicity
timeFrame: Once when the last participant completes week 57
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
Study officials:
affiliation: The Ottawa Hospital Cancer Centre
name: Susan Dent, Oncologist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02425748: Safety and Efficiency of γδ T Cell Against Non Small Lung Cancer ( Without EGFR Mutation)
Official title: γδ T Cell Immunotherapy for Treatment of
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lung Cancer
Keywords: γδ T Cell, non small lung cancer, Without EGFR Mutation
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Jinan University Guangzhou
First posted: 2015-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, effects of γδT cells on human non small lung cancer ( without EGFR mutation) in combination with tumor reducing surgery, for example cryosurgery going to be investigated.

Detailed description: Non small lung cancer will be removed using tumor reducing surgery such as cryosurgery. PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and DC-CIK, they will be infused to the patients as immunotherapy.

Eligibility criteria: Inclusion Criteria:

1. Age:18-75
2. Karnofsky performance status \>50
3. Diagnosis with non small lung tumors based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, gd Tcells/ DC-CIK.
5. Life expectancy: Greater than 3 months
6. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other kinds of cancer
2. History of coagulation disorders or anemia
3. Patients with heart disease and diabetes

Primary outcomes:
measure: Reduced size of the tumor.
timeFrame: Up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biological treatment center in Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT03202030: Immediate Dentoalveolar Restoration Compared to Bio-oss
Official title: Immediate Dentoalveolar Restoration Compared to Demineralized Bovine Bone in Immediate Implants Placed in Fresh Sockets With Buccal Bone Resorption: 18-months Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fresh Sockets With Buccal Resorption
Keywords: immediate dentoalveolar restoration
bio-oss
immediate dental implant
bovine bone
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: University of the Republic, Uruguay
First posted: 2017-06-28
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomised controlled trial compares the immediate dentoalveolar restoration and bovine demineralised bone in immediate implants placed in fresh sockets with buccal resorption. A total of 34 patients will be included and followed clinically and radiographically for 18 months. Patient centred outcomes will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Tooth extraction indicated for teeth in anterior area between second premolars

Exclusion Criteria:

* Diabetes and other systemic conditions that may affect osseointegration

Primary outcomes:
measure: Buccal-palatal thickness
timeFrame: 18 months
Secondary outcomes:
measure: Oral-health related quality of life
timeFrame: 18 months
Other outcomes:
Locations:
city: Montevideo
country: Uruguay
facility: Universidad de La Republica del Uruguay
Study officials:
References:
Clinical trial NCT01970930: Tissue Banking Study - Polycythemia Vera or Essential Thrombocythemia (PV & ET) Patients
Official title: Treatment Strategies for Myeloproliferative Neoplasms by Targeting the Tumor Suppressor P53
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycythemia Vera
Essential Thrombocythemia
Keywords: Tissue banking
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: The Leukemia and Lymphoma Society
First posted: 2013-10-28
Enrollment: 131
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have polycythemia vera or essential thrombocythemia

Brief summary: The purpose of the study is to isolate and characterize stem cells of patients with Polycythemia Vera (PV) and Essential Thrombocythemia (ET) to find out why these cells are not working the way they should be and why they seem to be sensitive to regulatory factors in the blood, such as clotting.

Detailed description: Specific Aim 1: Assess the effects of RG7112 on MPN HSC/HPC p53 levels and study how it affects MPN stem cell function.

Specific Aim 2. Assess the effects of a combination of low doses of IFNα and RG7112 on MPN HSC/HPC.

Eligibility criteria: Inclusion Criteria:

* polycythemia vera or essential thrombocythemia
* agree to give blood for study

Exclusion Criteria:

* none

Primary outcomes:
measure: Stem cell function
timeFrame: at one time study visit
Secondary outcomes:
measure: CD34+ cells assays
timeFrame: at one time study visit
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ronald Hoffman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02189330: A Study To Estimate How Much Tafamidis Created In Different Ways Can Be Measured in Blood Samples
Official title: A Phase 1, Open-Label, Randomized, 2-Cohort, Crossover, Single Dose Study to Estimate the Relative Bioavailability of PF 06291826 (Tafamidis) Following Administration of Two Oral Formulations Versus Commercial Capsule in Healthy Subjects Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-07-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: All subjects in this study will be given tafamidis. After swallowing a single pill of tafamidis, measurements including blood samples will be compared to see if tafamidis made in different ways is about the same. After approximately 28 days subjects will be given another pill of tafamidis and the study measurements will be repeated.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females of non-child bearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).

Exclusion Criteria:

* Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic).
* Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 168 hours
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 168 hours
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 168 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 6
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02420730: Safety, Tolerability and Systemic Pharmacokinetics of AGN-232411 in Healthy Participants and Participants With Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-04-20
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the safety, tolerability, and systemic pharmacokinetics of up to 3 different concentrations of AGN-232411 topical ophthalmic solution in healthy participants and participants with dry eye.


Eligibility criteria: Inclusion criteria:

Stage 1

-Healthy participants.

Stage 2 -Participants with the symptoms of dry eye disease.

Exclusion criteria:

Stage 1

-Known allergies or sensitivities to study medications, fluorescein, or lissamine green

Stage 2

* Known allergies or sensitivities to study medications, fluorescein, or lissamine green
* Allergic ocular disease, ocular trauma, corneal erosions or ulcers, or uveitis within the previous 12 months
* History of any ocular surgery within the previous 12 months.

Primary outcomes:
measure: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 56 days
Secondary outcomes:
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Sall Research Center
state: California
city: Glendale
country: United States
facility: Lugene Eye Institute
state: California
city: Montebello
country: United States
facility: Montebello Medical Center, Inc.
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: