louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03857763: A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma
Official title: A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of apatinib plus concurrent neoadjuvant chemoradiotherapy in patients with esophageal squamous cell carcinoma.


Eligibility criteria: Inclusion Criteria:

1. Age:18 to 70 years old (man or female);
2. Pathologically diagnosed with esophageal squamous cell carcinoma;
3. Patients with Stage for Ⅱ-Ⅲ(T2-4N0/+M0) (According to transesophageal ultrasonography;
4. Patients with measurable lesions(According to the criteria in RECIST1.1);
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
6. Life expectancy greater than or equal to 3 months;
7. Major organ function has to meet the following certeria:

(1) For results of blood routine test

1. HB≥80g/L;
2. ANC≥1.5×109/L;
3. PLT≥90×109/L; (2) For results of blood biochemical test

a) ALT and AST≤2.5×ULN; b) TBIL\<1.5×ULN; c) Serum creatinine ≤1.5×ULN; 8. Doctors believe that treatment can bring benefits to patients; 9. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion Criteria:

1. Have received prior treatment with chemotherapy or radiotherapy；
2. Have high blood pressure and antihypertensive drug treatment can not control;
3. Patients with severe cardiovascular disease ;
4. Accompanied by esophageal perforation and esophagotracheal fistula;
5. Patients with active bleeding or bleeding tendency;
6. Pregnant or lactating women;
7. The researchers think inappropriate.

Primary outcomes:
measure: The pathological complete response rate(pCR)
timeFrame: within 3 weeks after surgery
Secondary outcomes:
measure: R0-resection rate
timeFrame: within 3 weeks after surgery
measure: Disease-free survival(DFS)
timeFrame: 3 years
measure: Overall survival (OS)
timeFrame: 1year
measure: Adverse events Toxicity
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04818463: Characterization and Verification of the Intensive Care Standard Operating Procedure (SOP) Adherence of the Treated COVID-19 Patients
Official title: Characterization and Verification of the Intensive Care Standard Operating Procedure (SOP) Adherence of the Treated COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: During the intensive care stay with SARS-CoV-2 infected intensive care adult patients

Brief summary: As part of the internal quality management (QM project), this retrospective cohort study examines the adherence to Standard Operating Procedures (SOP) of the COVID-19 patients treated since January 1st, 2020 to February 28th, 2021 in intensive care units of the Clinic for Anesthesiology m.S. operative intensive care medicine CCM / CVK.


Eligibility criteria: Inclusion Criteria:

* During the intensive care stay with SARS-CoV-2 infected intensive care patients of the Charité - Universitätsmedizin Berlin, admitted to the intensive care units of the Department of Anesthesiology and operative intensive care medicine (CCM / CVK)
* Treatment period: 01/01/2020 to 02/28/2021
* At least 18 years old

Exclusion Criteria:

• Incomplete electronic documentation

Primary outcomes:
measure: SOP "Analgesia, sedation, delirium and pain therapy"
timeFrame: 01.01.2020 - 28.02.2021
Secondary outcomes:
measure: SOP "Treatment of acute respiratory distress syndrome (ARDS)"
timeFrame: 01.01.2020 - 28.02.2021
measure: SOP "Infectious treatment"
timeFrame: 01.01.2020 - 28.02.2021
measure: SOP "Weaning"
timeFrame: 01.01.2020 - 28.02.2021
measure: SOP "Nutrition"
timeFrame: 01.01.2020 - 28.02.2021
measure: SOP "Sepsis"
timeFrame: 01.01.2020 - 28.02.2021
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Campus Virchow-Klinikum
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02696863: Plan for Systematic Identification of Lung Cancers of Occupational Origin: Implementation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Broncho Pulmonary Cancer
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Saint Etienne
First posted: 2016-03-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primitive CBP Patients

Brief summary: The main objective is to identify obstacles and elements facilitating the implementation of a tracking device Broncho Pulmonary Cancer during the course of care.

The secondary objective is to assess patient knowledge and information received on their previous occupational exposure during their professional activity.

This is a prospective multicenter study of qualitative methodology through in-depth interviews conducted with patients treated at ICLN and CHU Saint-Etienne


Eligibility criteria: Inclusion Criteria:

* primitive CBP Patients;
* Patients employees or have been employees of the general scheme and / or the agricultural social security system;
* Patients understand French.

Exclusion Criteria:

* Patients recognized occupational disease for CBP;
* recognized disability in patients for CBP by the social security system;
* Patients who have never been employees of the General or the agricultural social security system plan
* Patients already included in phase 1 of the study;
* Refusal of participation, signed consent major patients protected under guardianship;
* Patients unable to understand the course of the study.

Primary outcomes:
measure: Interview
timeFrame: 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
city: St-Priest-en-Jarez
country: France
facility: ICLN
Study officials:
References:
Clinical trial NCT00880763: A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016)
Official title: A Phase II Randomized Placebo-controlled Study to Evaluate the Safety and Efficacy of MK-7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Japanese Treatment-Experienced Patients With Chronic Hepatitis C Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-04-14
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluates safety and efficacy of vaniprevir (MK7009), when administered with Pegylated-Interferon (peg-IFN) and Ribavirin, in Japanese patients with Hepatitis C infection. The primary hypotheses are that 1.) the proportion of patients achieving rapid viral response (RVR) in one or more of the vaniprevir treatment groups is superior to that in the placebo group, when each is administered concomitantly with pegylated interferon (peg-IFN) α-2a and ribavirin; and 2.) vaniprevir at the studied doses is well tolerated compared with placebo, when each is administered concomitantly with peg-IFN α-2a and ribavirin for 28 days.


Eligibility criteria: Inclusion Criteria:

* Has chronic genotype 1 Hepatitis C infection

Exclusion Criteria:

* Has not tolerated previous course of peg-IFN and ribavirin
* Has HIV
* Has Hepatitis B
* Has a history of clinically significant medical condition that may interfere with the study (e.g., stroke or chronic seizures or major neurological disorder) or is contraindicated for treatment with peg-IFN and ribavirin

Primary outcomes:
measure: Percentage of Participants Achieving Rapid Viral Response
timeFrame: Week 4
Secondary outcomes:
measure: Percentage of Participants Achieving a > or = 2-log10 Decrease in HCV RNA From Baseline to Week 4
timeFrame: Baseline and Week 4
measure: Percentage of Participants Achieving a > or = 3-log10 Decrease in HCV RNA From Baseline to Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in HCV RNA in log10 at Week 4
timeFrame: Baseline and Week 4
measure: Number of Participants Who Experienced at Least One Adverse Event
timeFrame: Up to 6 weeks
measure: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Hayashi N, Mobashery N, Izumi N. Vaniprevir plus peginterferon alfa-2a and ribavirin in treatment-experienced Japanese patients with hepatitis C virus genotype 1 infection: a randomized phase II study. J Gastroenterol. 2015 Feb;50(2):238-48. doi: 10.1007/s00535-014-0979-2. Epub 2014 Aug 13.
Clinical trial NCT06901063: Research of Brachial Plexus Anatomy
Official title: Research of the Sonographic Anatomy of Interscalene Brachial Plexus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brachial Plexus Injury
Ultrasound
Keywords: Brachial plexus
Nerve block
Ultrasound
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospectively collect ultrasound video of interscalene brachial plexus from existed departmental database.

Brief summary: The research aims at analyzing the sonographic anatomy characteristics of the interscalene brachial plexus.


Eligibility criteria: Inclusion Criteria:

* ASA physical status class I or II
* Scheduled for elective surgery

Exclusion Criteria:

* Skin lesion or infection of neck
* Any known peripheral neuropathy
* Brachial nerve plexus injury
* Previous injury or operation on neck
* Pregnancy or breast feeding
* Allergic to ultrasound gel

Primary outcomes:
measure: The distribution of the number of visible bundles in C6 nerve root
timeFrame: immediately after the procedure
Secondary outcomes:
measure: The distribution of the number of visible bundles in C5 nerve root
timeFrame: immediately after the procedure
measure: The distribution of the number of visible bundles in C7 nerve root
timeFrame: immediately after the procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT00193063: Weekly Gemcitabine and Trastuzumab in the Treatment of Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer
Official title: Phase II Trial of Weekly Gemcitabine and Herceptin in the Treatment of Patients With HER-2 Overexpressing Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: Genentech, Inc.
First posted: 2005-09-19
Enrollment: 41
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: Due to its remarkable activity as salvage treatment in women with metastatic breast cancer as well as the additive activity observed for gemcitabine administered in combination with trastuzumab, the clinical activity of the combination of gemcitabine administered with trastuzumab represents an exciting and ideal combination to further evaluate in Her 2 over-expressing metastatic breast cancer patients.

Detailed description: Upon determination of eligibility, all patients will be receive:

Gemcitabine + Trastuzumab

Eligibility criteria: Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Her-2 positive metastatic breast cancer confirmed by biopsy
* Measurable disease
* Able to perform activities of daily living without considerable
* No previous chemotherapy with gemcitabine
* No more than one prior chemotherapy regimen for metastatic breast cancer
* Adequate bone marrow, liver and renal function
* Normal heart function
* Give written informed consent prior to entering this study.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Received previous treatment with gemcitabine
* History of brain metastases
* Serious underlying medical conditions

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 18 Months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 21 Months
measure: Overall Survival (OS)
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Denise A. Yardley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yardley DA, Burris HA 3rd, Hanson S, Greco FA, Spigel DR, Barton J, Hainsworth JD. Weekly gemcitabine and trastuzumab in the treatment of patients with HER2-overexpressing metastatic breast cancer. Clin Breast Cancer. 2009 Aug;9(3):178-83. doi: 10.3816/CBC.2009.n.029.
Clinical trial NCT06737263: Comparison of BioHPP (High Performance Polymer) - vs Titanium- vs Zirconia Abutments
Official title: Comparison of BioHPP (High Performance Polymer) - vs Titanium- vs Zirconia Abutments A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peri-implant Soft Tissue Healing
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The project is a prospective, randomized, controlled study. The material BioHPP (High Performance Polymer) is compared with the gold-standard abutment materials titanium and zirconia in terms of peri-implant soft tissue healing.

Detailed description: A total of 60 participants are divided into three groups of 20 persons each. One group receives BioHPP abutments, while the two control groups receive titanium or zirconia abutments.

The patients are provided with closed healing dental implants. After 3 months, following implant exposure and optical impression, the implants are restored with individual abutments.

Follow-up appointments are scheduled at 3, 6, 12, 24, and 36 months after implantation. During these visits, implant healing is assessed based on clinical parameters such as probing depth, plaque index, mean bone level, and bleeding on probing.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* The patients must be between 18 and 99 years old.
* non-smokers, former smokers, or light smokers (fewer than 10 cigarettes per day).
* ASA ( American Society of Anesthesiologists) Class I or II.
* There must be no pregnancy or breastfeeding period.
* the patients must have an edentulous section of up to 3 teeth in the maxillary or mandibular region, where it is possible to place an implant
* no allergy to any of the study-related materials

Exclusion Criteria:

* Patients under 18 or over 99 years old.
* Heavy smokers or former heavy smokers who quit less than five years ago
* Existing pregnancy or breastfeeding period.
* Individuals classified as ASA Class III to V.
* Presence of a polymer allergy.
* Patients with severe systemic diseases, immune deficiencies, or on corticosteroid medication.
* Patients undergoing local radiation or bisphosphonate therapy.
* Patients requiring sinus augmentation or soft tissue augmentation.
* Participation in another dental study

Primary outcomes:
measure: Mean Bone level
timeFrame: 36 months after implantation
Secondary outcomes:
measure: Plaque index
timeFrame: 36 months after implantation
measure: Bleeding on probing
timeFrame: 36 months after implantation
measure: Probing depth
timeFrame: 36 months after implantation
measure: Occurrence of complications
timeFrame: 36 months after implantation
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Oral Surgery and Radiology
Study officials:
References:
Clinical trial NCT03082963: Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation
Official title: Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
ablation
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-03-17
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall goal of this project is to test the feasibility of performing real-time electrogram morphology recurrence (EMR) mapping in patients with persistent atrial fibrillation (AF) to locate areas of high electrogram morphology recurrence rate. The Investigator believe that the EMR mapping can be integrated into cardiac mapping and used to identify potential sites for ablation. Furthermore, this study could help demonstrate the efficacy of this technology's ability to terminate or slow AF.

The Investigator will test this technology on ten subjects undergoing a second ablation procedure. The Investigator will map the AF utilizing the EMR to indicate locations of stable activity and ablate the area. The Investigator believes that the study could produce acute AF termination or AF cycle length slowing. In addition to testing the real-time electrogram morphology recurrence mapping, the study would also like to determine the acute effects of radiofrequency ablation of areas of high recurrence rates and determine long term freedom from AF following ablation of areas of high recurrence rates.


Eligibility criteria: Inclusion Criteria:

* Male and female at least 21 years of age
* persistent Afib with one prior failed ablation for persistent or long standing persistent Afib

Exclusion Criteria:

* Inability to sign consent
* Patients with a life expectancy less than one (1) year
* Patients with chronic kidney disease with sufficiently low GFR that precludes either CT angiogram of the heart or contrast MRI study
* Pregnant women and women that are breast feeding
* Patients with multiple (2 or more) prior failed ablations
* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

Primary outcomes:
measure: Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility
timeFrame: 2 hours
Secondary outcomes:
measure: Ablation Acute Effects
timeFrame: 2 hours
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: 30 days
measure: Ablation Acute Effects
timeFrame: 2 hours
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Raul Mitrani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06050863: Local Delivery of Silk Fibroin and Chlorhexidine
Official title: A Comparative Evaluation of Subgingivally Delivered Chlorhexidine, Silk Fibroin and Combination of Fibroin and Chlorhexidine as Local Drug Delivery in Periodontitis - A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Periodontal Pocket
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study is a prospective randomised split mouth study to evaluate the effect of Silk fibroin as drug delivery system while simultaneously assessing the efficacy of silk fibroin in comparison to chlorhexidine.

Detailed description: Fifteen healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, procedure involved, potential benefits and risks associated with procedure and written informed consent were obtained from all patients.All the patients underwent scaling and root planing.

Following randomization, the site will be assigned to one of the three study groups.

1. Group I (SRP+ Silk Fibroin)
2. Group II (SRP+ Chlorhexidine)
3. Group III (SRP+ Combination of Fibroin and Chlorhexidine) Periodotal pack was placed and patient was recalled after 21days, 1 month and 3 month for the follow up.

Eligibility criteria: Inclusion Criteria:

1. Patient with age between 30-50 years.
2. Patients with stage I/ II with Grade A/ B periodontitis according to 2017 World workshop classification of periodontal disease will be considered.
3. Patients with localized periodontal pockets.
4. Patients willing to participate in the study.

Exclusion Criteria:

1. Patients with known systemic diseases.
2. Non complaint patients.
3. Patients who received any surgical or nonsurgical therapy 6 months before the start of the study.
4. Pregnant or lactating females.
5. Use of systemic antibiotics in the past 6 months.

Primary outcomes:
measure: Probing pocket Depth (PPD)
timeFrame: 3 months
measure: Relative attachment level (RAL)
timeFrame: 3 months
Secondary outcomes:
measure: Plaque Index
timeFrame: 3 months
measure: Gingival index
timeFrame: 3 month
measure: Modified Sulcus Bleeding Index
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: