louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02299622: Personalized Sequence for Thoracic, Esophageal, and H&N Cancer
Official title: Establishment of Personalized Cancer Medicine Using Samsung Cancer Sequencing Platform in Lung Cancer/Mediastinal Tumor/ Head & Neck/Esophageal Cancer/Rare Cancer (PerSeq: Personalized Sequence)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: metastatic, histologically confirmed NSCLC, head \& Neck Cancer, Esophageal cancer

Brief summary: The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. The genome analysis needs systematic infra and database based on personal genetic information Therefore, a big data of genome-clinical information is important.

Detailed description: To determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(PFS, duration of response and overall survival) of patients with advanced cancer, the investigators are going to take a fresh tissue of patients and process molecular profiling.

Eligibility criteria: Inclusion Criteria:

* metastatic, histologically confirmed NSCLC, head \& Neck Cancer, Esophageal cancer

Exclusion Criteria:

-

Primary outcomes:
measure: the spectrum of targetable genetic mutation in evaluated cancer specimens (for example, % of EGFR T790M mutation, BRAF mutation, or ALK mutation)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Keunchil Park
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04183322: PCV13 in Non-pregnant Papua New Guinean Women
Official title: Reactogenicity and Immunogenicity of Pneumococcal Conjugate Vaccination in Non-pregnant Papua New Guinean Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumococcal Infections
Keywords: Pneumococcal conjugate vaccine
PCV
Reactogenicity
Immunogenicity
Women childbearing age
Lead sponsor: Telethon Kids Institute
Sponsor class: OTHER
Collaborators: name: Papua New Guinea Institute of Medical Research
First posted: 2019-12-03
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 healthy non-pregnant women aged between 18-45 years old living in Goroka, Papua New Guinea.

Brief summary: This is an observational study to determine the reactogenicity and immunogenicity of pneumococcal conjugate vaccine in non-pregnant women of reproductive age in Papua New Guinea.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Non-pregnant
* 18-45 years old

Exclusion Criteria:

* Known hypersensitivity to any vaccine component
* Known/suspected to be immunocompromised
* Receipt of corticosteroids ≤30 days before
* Pregnant (pregnancy tests will be performed)
* Not being well at the time of vaccination
* Plan to travel out of the area in the month post-vaccination

Primary outcomes:
measure: Immunogenicity
timeFrame: 28 days
Secondary outcomes:
measure: Reactogenicity
timeFrame: 24-48 hours after vaccination
measure: Adverse events
timeFrame: 28 days
Other outcomes:
Locations:
city: Goroka
country: Papua New Guinea
facility: Papua New Guinea Institute of Medical Research
state: Eastern Hghlands Province
Study officials:
References:
citation: Javati S, Masiria G, Elizah A, Matlam JP, Ford R, Richmond PC, Lehmann D, Pomat WS, van den Biggelaar AHJ. An observational study of the reactogenicity and immunogenicity of 13-valent pneumococcal conjugate vaccine in women of childbearing age in Papua New Guinea. Pneumonia (Nathan). 2020 Nov 25;12(1):13. doi: 10.1186/s41479-020-00076-1.
Clinical trial NCT01069822: A Study in Healthy Volunteers to Assess Effect of AZD6765 on Midazolam Blood Levels
Official title: A Phase I Open-label, Fixed Sequence Study to Determine the Effect of Multiple Intravenous Doses of AZD6765 on the Pharmacokinetics of Oral Midazolam (CYP3A4 Substrate) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Midazolam
Pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The main purpose of this study is to evaluate the effect repeated doses of AZD6765 (a drug being developed for the treatment of patients with severe major depressive disorder) has on the PK (pharmacokinetic) profile of Midazolam. (The PK profile is how the drug leaves your body and acts in the body.)


Eligibility criteria: Inclusion Criteria:

* BMI between 19-30

Exclusion Criteria:

* Significant result for C-SSRS at screening or baseline
* Single arm preference for IV procedures

Primary outcomes:
measure: Pharmacokinetic parameters to be calculated from midazolam and AZD6765 plasma concentrations
timeFrame: on Day -1 and Day 6
Secondary outcomes:
measure: Safety variables (adverse events, vital signs, physical and neurological examinations, clinical laboratory assessments, 12-lead ECG, C-SSRS, CADSS, and VAS scales)
timeFrame: will be collected from the time of informed consent (Visit 1) until completion of the follow-up visit.
measure: Optional Genetic sampling
timeFrame: at admission Day -2
measure: Exploratory - renal biomarkers in urine
timeFrame: At admission Day -2 until follow up visit
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: AstraZeneca
name: Willie Earley, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Brendan Smyth, MD, Ph.D
role: STUDY_DIRECTOR
affiliation: Quintiles, Inc.
name: Phil Leese, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00235222: Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY
Official title: Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV
Keywords: Stavudine
Reduced dose of stavudine
Viral load
Peripheral neuropathy
Treatment Experienced
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-10-10
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Lipodystrophie, peripheral neuropathy and mitochondrial toxicity has been associated to stavudine at standard doses The aim of this study is to evaluate the efficacy of reduced doses of stavudine (30 mg b.i.d.) in HIV patients with controlled viral load and body weight \> 60 kg, receiving an antiretroviral therapy containing stavudine 40 mg b.i.d.

Detailed description: Stavudine is a nucleoside inhibitor larged used in HIV treatments and has been associated to mithocondrial toxicity. As it is still largely used in developping countries,the evaluation of reducing dose is of importance.

A single-arm open pilot 48 weeks study to evaluate the capacity of a switch from d4T 40 mg to 30 mg bid in patients with body weight \> 60kg to maintain full viral load suppression. Clinical and biological evaluations were carried out at baseline, W24 and W48. Primary end-point is viral load suppression (\<400 coies/ml) at W24.

Secondary end-points are : Evolution of CD4 count at W24 and W48, neurological examination at Baseline, W24 and W48, metabolic parameters and stavudine PK at W24.

Eligibility criteria: Inclusion Criteria:

* HIV patients
* Patients with an antiretroviral treatment containing stavudine at standard doses (40mg BID) for at least 3 months
* Patients with viral load \< 400 copies/ml for at least 3 months

Exclusion Criteria:

* Patients receiving an antiretroviral therapy containing stavudine at 30mg BID
* Current Opportunistic Infection
* Current chemotherapy or under cytokines treatment (PEG, INF, IL2)
* Pregnant or feeding Women

Primary outcomes:
measure: Proportion of patients with viral load < 400 copies/ml at week S24
Secondary outcomes:
measure: Clinical and biological safety of the reduced doses of stavudine at week 24. Percentage of patients with viral load < 400 copies/ml at week 48, evolution of Cd4 count from baseline to W24 and 48. Evolution of metabolic parameters from baseline to W24 and
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Maladies Infectieuses Hôpital Pitié-Salpêtrière
Study officials:
affiliation: Service de médecine Interne Hôpital Pitié Salpêtrière
name: Manuela BONMARCHAND, MD
role: STUDY_CHAIR
affiliation: Service de Maladies Infectieuses Hôpital Pitié Salpêtrière
name: Hocine AIT-MOHAND, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04170322: Comparing Pvc or Silicone Gastric Calibration Tube During Sleeve Gastrectomy
Official title: Randomized Controlled Trial Comparing Introduction Time of Thin Pvc Versus Thick Silicone Gastric Calibration Tubes for Sleeve Gastrectomy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery
Calibration Tube
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Time from 40 Fr gastric calibration tube introduction on surgical request till first stapling is measured as introduction time.

Problems to advance are noted A note is made If change to other type of gastric tube is needed

Detailed description: when ready to perform sleeve gastrectomy anesthesiologist is asked to introduce 40 Fr gastric calibration tube. A clock is running till first staple is fired as a measure of time to introduce.

If problems to position 40 Fr gastric calibration tube correctly, if resistance to advance, change to other type of gastric tube and check again difficulties. Make a note of problems and reason to change.

Eligibility criteria: Inclusion Criteria: only primary sleeve gastrectomy

-

Exclusion Criteria:

* revision procedure
* known eosophageal or gastric anatomical abnormalities

Primary outcomes:
measure: introduction time
timeFrame: intraoperative
Secondary outcomes:
measure: rate of changing tube
timeFrame: intraoperative
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Azsintjan
Study officials:
affiliation: AZ Sint-Jan AV
name: Jan Paul Mulier
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03145922: Epigenetic Regulation of Altered T-cell Immunity in Sarcoidosis
Official title: Epigenetic Regulation of Altered T-cell Immunity in Sarcoidosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcoidosis
Sarcoidosis, Pulmonary
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: University of Iowa
First posted: 2017-05-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People living with Sarcoidosis.

Brief summary: Sarcoidosis is a multi-system granulomatous disorder that is triggered and influenced by gene-environment interactions. Although sarcoidosis predominantly affects the lungs in most cases, the clinical disease course is highly variable and any organ can be affected leading to end organ damage despite currently available therapeutics that unfortunately also have numerous and potentially devastating side effects. The environmental triggers of sarcoidosis are unknown but several occupational, environmental and infectious agents have been associated with sarcoidosis in susceptible hosts. Exposure to these triggers result in inflammation, characterized by activation of CD4+ T-cells, cytokine production, subsequent recruitment of other immune cells, and granuloma formation. Although several genetic markers have been associated with sarcoidosis, none fully explain individual susceptibility or clinical course variability, strongly implicating the environment and epigenetics. We have the ability to generate a map of the epigenetic histone modifications in immune cells via Chromatin Immuno-Precipitation coupled with next generation sequencing (ChIP-seq) and a map of transcriptome profiles via RNA-seq. The availability of histone and transcriptional signatures defining T cell activity in sarcoidosis will help identify the specific molecular programs affected by disease processes and can become the basis for future discovery of novel biomarker diagnostics in a clinical setting.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 85
* Diagnosis of sarcoidosis confirmed by either biopsy or by manifestations consistent with acute sarcoidosis in absence of other known diagnosis.
* Have a suspected diagnosis of sarcoidosis and is scheduled to undergo a biopsy procedure to confirm a diagnosis of sarcoidosis.
* Able to tolerate and willing to undergo study procedures

Exclusion Criteria:

* Current cigarette smoking or smoking within six months prior to the study
* Currently or recently (\<6months) on immunosuppressive therapy
* Pregnancy
* Patient inability to participate in the study, such as undergo venipuncture and or BAL

Primary outcomes:
measure: Epigenomic Signature of Sarcoidosis
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco (Parnassus)
state: California
Study officials:
References:
Clinical trial NCT04880122: Dried Blood Spots for SARS-CoV-2 Serology (COVID-19).
Official title: Comparison of Dried Blood Spots and Venous Blood for the Detection of SARS-CoV-2 2 Antibodies in a Population of Nursing Home Residents.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV-2 Acute Respiratory Disease
Keywords: serology
dried blood spot
elderly
nursing home residents
COVID-19
antibodies
immunoglobins
serosurveillance
vaccination
enzyme-linked immunosorbent assay (ELISA)
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to validate dried blood spots (DBS) for SARS-CoV-2 (Severe Acute Respiratory Syndrome 2) antibody detection in elderly individuals.

Detailed description: In the current SARS-CoV-2 pandemic, testing for SARS-CoV-2 specific antibodies is paramount to monitor immune responses in post-authorization vaccination and sero-epidemiology studies. However, large scale and iterative serological testing by venipuncture in older persons can be challenging. Capillary blood sampled using a finger prick and collected on protein saver cards, i.e., dried blood spots (DBS), has already proven to be a promising alternative. However, elderly persons have a reduced cutaneous microvasculature, which may affect DBS-based antibody testing. Therefore, we aimed to evaluate the performance of DBS for the detection of SARS-CoV-2 antibodies in nursing homes residents. We collected venous blood and paired Whatman and EUROIMMUN DBS from nursing home residents, and from staff as a reference population. Venous blood samples were analyzed for the presence of SARS-CoV-2 IgG antibodies using the Abbot chemiluminescent microparticle immunoassay (CMIA). DBS were analyzed by the EUROIMMUN enzyme-linked immuno sorbent assay (ELISA) for SARS-CoV-2 IgG antibodies.

Eligibility criteria: Inclusion Criteria:

* nursing home staff and residents

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Sensitivity and specificity of DBS for SARS-CoV-2 antibody detection
timeFrame: baseline (single timepoint)
measure: Optimization of the cut-off for seropositivity.
timeFrame: baseline (single timepoint)
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
state: Oost-Vlaanderen
Study officials:
affiliation: University Ghent
name: Piet Cools
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03708822: Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Official title: Open-Label, Multicenter, Phase Ⅱ Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 48
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 single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of docetaxel and cisplatin combined with Nimotuzumab in the treatment of recurrent and metastatic nasopharyngeal carcinoma


Eligibility criteria: Inclusion Criteria:

* biopsy proved nasopharyngeal carcinoma;
* stage IVB according to the eighth edition American Joint Committee on Cancer/Union for International Cancer Control staging system, or recurrent disease beyond more than 6 months after curative chemotherapy and/or radiotherapy;
* 18-70 years;
* without other malignancy;
* had at least one measurable disease;
* had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
* estimated life expectancy exceeding 3 months;
* adequate functions of the major organs.

Exclusion Criteria:

* allergic to docetaxel or cisplatin or nimotuzumab;
* pregnant or lactating female;
* patients received other clinical trails within 3 months;
* had serious infections, comorbidities or vital organs dysfunction.

Primary outcomes:
measure: overall response rate
timeFrame: up to 18 weeks
Secondary outcomes:
measure: disease control rate
timeFrame: up to 18 weeks
measure: duration of response
timeFrame: From date of documented response until the date of progressive disease [PD] or death, whichever came first, assessed up to 12 months
measure: progression-free survival
timeFrame: From date of the enrollment until the date of the documented PD or death, whichever came first, assessed up to 12 months
measure: overall survival
timeFrame: From date of the enrollment until the date of the documented death, assessed up to 72 months
measure: adverse events
timeFrame: up to 18 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,
Study officials:
References:
Clinical trial NCT05210322: Percutaneous Cholangiopancreatoscopy Registry
Official title: The Percutaneous Cholangiopancreatoscopy Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Biliary Stones
Cholangiocarcinoma, Intrahepatic
Biliary Stricture
Cholelithiasis
Choledocholithiasis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes patients with clinical indication for the cholangiopancreatoscopy procedure.

Brief summary: The Percutaneous Cholangiopancreatoscopy (PCPS) registry is an observational, multicentric, prospective, and retrospective registry of patients undergoing the percutaneous cholangiopancreatoscopy procedure at sites across the United States. In the retrospective component of the study, clinical and procedural data regarding patients who have undergone clinical indicated percutaneous cholangiopancreatoscopy procedure in the past will be collected from all the registry sites and stored in a secure database. The prospective component of the registry will run for three years at each site where patients undergoing the clinically indicated percutaneous cholangiopancreatoscopy procedure will be enrolled in the study, and the patients' data will be collected whenever the patients present to interventional radiology (IR) for a procedure or clinic visit.


Eligibility criteria: Inclusion Criteria:

* Male or female adults
* 18 years of age and older
* Patients undergoing clinically indicated percutaneous cholangiopancreatoscopy procedure at the Johns Hopkins Hospital or one of the registry sites.
* Willing and able to understand and sign a written informed consent document for the prospective component of the study.

Exclusion Criteria:

* Pregnant women
* Children (\< 18 years of age)

Primary outcomes:
measure: Tube free survival
timeFrame: Up to 3 years
Secondary outcomes:
measure: Technical success
timeFrame: At the time of the procedure
measure: Procedural success
timeFrame: At the time of the procedure
measure: Clinical success
timeFrame: At the time of the procedure
measure: Complication rate
timeFrame: At the time of the procedure
measure: Complication rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Harjit Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: