louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02703090: Assessing the Cortical Response to Noxious and Auditory Stimuli Using Near Infrared Spectroscopy in Subjects Under General Anesthesia
Official title: Assessing the Cortical Response to Noxious and Auditory Stimuli Using Near Infrared Spectroscopy in Subjects Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Pain
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 54
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The primary aim is to utilize near-infrared spectroscopy (NIRS) in patients under general anesthesia to measure changes in brain blood flow in the bilateral somatosensory cortices and the prefrontal cortices in response to noxious stimulation.


Eligibility criteria: Inclusion Criteria:

* 12-30 years of age
* Structurally normal heart
* Right-handed
* English-speaking

Exclusion Criteria:

* Unable to cooperate or understand the study
* Neurologic disease
* Diabetes mellitus
* Syndrome of greater than minor severity.
* Smoker
* Scalp or hair does not permit sufficient optical light detection
* Unable to keep his/her head still for a period of 200 consecutive seconds

Primary outcomes:
measure: Utilization of NIRS to measure changes in oxyhemoglobin and deoxyhemoglobin in the somatosensory and prefrontal cortices in response to noxious stimulation, and whether these changes are reduced or eliminated by remifentanil.
timeFrame: During surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Barry D Kussman, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karunakaran KD, Kussman BD, Peng K, Becerra L, Labadie R, Bernier R, Berry D, Green S, Zurakowski D, Alexander ME, Borsook D. Brain-based measures of nociception during general anesthesia with remifentanil: A randomized controlled trial. PLoS Med. 2022 Apr 22;19(4):e1003965. doi: 10.1371/journal.pmed.1003965. eCollection 2022 Apr.
Clinical trial NCT00594490: Evaluating the Effectiveness and Outcomes of Silicone Breast Prosthetics
Official title: Adjunct Study for Silicone Gel-Filled Mammary Prosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast, reconstruction, silicone
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Mentor Worldwide, LLC
First posted: 2008-01-15
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women undergoing breast reconstruction

Brief summary: This trial will evaluate the outcome of placement of silicone breast prosthetics.

Detailed description: Patients will be evaluated for complications following placement of silicone breast prostheses.

Eligibility criteria: Inclusion Criteria:

* over 18 undergoing breast reconstruction

Exclusion Criteria:

* patients with collagen vascular diseases, rheumatoid arthritis, scleroderma, etc.

Study Closed

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: The University of California, Irvine
state: California
Study officials:
affiliation: The University of California, Irvine
name: Gregory Evans
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06224790: Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy
Official title: Effectiveness & Safety of Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Nephropathies
Type 2 Diabetes
Keywords: Type 2 Diabetes Mellitus
Diabetic Nephropathy
Perfenidone
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness \& safety of pirfenidone in type 2 diabetic patients with diabetic nephropathy


Eligibility criteria: Inclusion Criteria:

* Diabetic Nephropathy Stage 3 (eGFR 30-59 mL/min/1.73m2) Type 2 Diabetes HbA1c \<7.5% Patient taking ACEi/ARB for at least 3 months BP \<140/90

Exclusion Criteria:

* History of photosensitivity rash History of decompensated liver or cardiac disease History of urinary tract infection Pregnancy or lactation History of nephrotoxic drugs or hakeem medication Polycystic kidney disease History of autoimmune disease History of hypersensitivity to study drugs

Primary outcomes:
measure: 15% improvement in eGFR
timeFrame: 6 months
Secondary outcomes:
measure: Safety - Adverse Effects of Drugs
timeFrame: 6 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: King Edward Medical University
state: Punjab
Study officials:
References:
Clinical trial NCT05950490: Construction of Diagnosis and Treatment System for Primary Vitreoretinal Lymphoma
Official title: Construction of Diagnosis and Treatment System for Primary Vitreoretinal Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Vitreoretinal Lymphoma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tongren Hospital
name: Southern Medical University
First posted: 2023-07-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly diagnosed PVRL patients admitted to the Ophthalmology or Hematology departments of Peking Union Medical College Hospital from 2022 to 2024.

Brief summary: This study intends to apply for the establishment of research beds, establish a Chinese PVRL research cohort, and carry out a to achieve the following research objectives:

The goal of this prospective observational study is to construct the diagnosis and treatment system for primary vitreoretinal lymphoma（PVRL）. The study is to achieve the following research objectives:

1. To establish a comprehensive diagnostic criteria for PVRL with high diagnostic efficiency and strengthen the PVRL diagnostic system;
2. To establish a standardized treatment pathway for PVRL and evaluate the efficacy and safety of treatment;
3. To screen the prognosis evaluation indicators, and to establish the follow-up process and prognosis evaluation system of PVRL；
4. To explore the pathogenesis of PVRL, specific tumor markers and drug therapeutic targets.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed PVRL patients admitted to the Ophthalmology or Hematology departments of Peking Union Medical College Hospital from 2022 to 2024;
* 18-75 years old;
* The diagnosis was confirmed by pathology, aqueous humor/vitreous IL-10/IL-6, vitreous flow cytometry and gene rearrangement.;
* HIV-Ab negative;
* Creatinine clearance \> 50ml/min;
* Sign informed consent.

Exclusion Criteria:

* Combined with other tumors;
* Uncontrolled active infections;
* Pregnant or lactating women;
* Antitumor therapy other than the protocol of this study was used.

Primary outcomes:
measure: Interleukin-10/Interleukin-6（IL-10/IL-6）
timeFrame: 1 year
measure: Interleukin-10/Interleukin-6（IL-10/IL-6）
timeFrame: 2.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Meifen Zhang
role: STUDY_CHAIR
References:
Clinical trial NCT03440190: Bariatric Surgery and Pharmacokinetics of Methylphenidate
Official title: Bariatric Surgery and Pharmacokinetics Methylphenidate: BAR-MEDS Methylphenidate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Methylphenidate
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-02-22
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on methylphenidate.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Methylphenidate concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02362490: Efficacy of Peginterferon Alpha 2a Therapy in Chronic Hepatitis B Patients Being Treated With Nucleoside(Acid) Analogues
Official title: HBsAg Clearance of Peginterferon Treatment in Patients Who Had Chronic Hepatitis B and Were on the Treatment of Nucleoside(Acid) Analogues
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis B
Keywords: chronic hepatitis B
interferon
Nucleotide analogues
HBsAg
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Antiviral therapy is the most important method to slow and stop the progress of the disease in patients with chronic hepatitis B (CHB). Nucleoside (acid) analogues (NA) can Effectively suppress HBV replication, but it should be continue used and relapse would happen in most patients after withdrawal of therapy. However, long-term use of NA could induce viral resistance mutation lead to loss of efficacy. Interferon treatment can enhance specific and non-specific immune function in chronic hepatitis B patients, make patients get immune control to HBV infection and obtain sustained response after treatment. Thus the CHB patients on the treatment of NA should be stop NA treatment after interferon treatment. In this study, the effects of interferon treatment in CHB patients who were on the NA treatment and obtained HBsAg level≤250 IU/ml.

Detailed description: In this trial, patients who were CHB and treated with NA more than 6 months, still on the treatment and achieved HBsAg level ≤250 IU/ml with HBV DNA undetectable will be randomized enrolled into group A (Intervention group), in which patients switch to interferon therapy for 72 weeks, group B(control group), patients continue treated with NA for 72 weeks. Serum HBV DNA load, HBsAg/anti-HBs level, HBeAg/anti-HBe will be tested at enrollment and every 3 months during the treatment course. Parameters of Liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. The efficacies of interferon treatment were devalued by the rate of HBsAg clearance and decline of HBsAg levels on the 72 weeks of interferon treatment compared with control group.

Eligibility criteria: Inclusion Criteria:

* patients who were chronic hepatitis B and had achieved HBsAg level ≤250 IU/ml on treatment of Nucleoside (acid) Analogues

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver

Primary outcomes:
measure: rate of HBsAg loss
timeFrame: 72 weeks
Secondary outcomes:
measure: decline of HBsAg level
timeFrame: 72 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan hospital,Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT04274790: Impact of 5-Fluorouracil (5-FU) on Cancer Cells From Liver Metastases of Colon Cancer
Official title: Analysis of the Impact of 5-Fluorouracil on the Translational Control and Plasticity of Cancer Cells From Liver Metastases of Colon Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cancer of Colon
Metastasis to Liver
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with metastatic colon cancer in the hepatic phase.

Brief summary: Analyze the dynamics of incorporation of 5-fluorouracil into cancer cell ribosomes from liver metastases of patient with metastatic colon cancer.

Detailed description: This is a monocentric, prospective, non-interventional cohort study in adult patients with metastatic colon cancer with hepatics metastasis.

Tumour samples collected for this study include:

* A fragment of the previously operated primary tumor: FFIP block and/or archived frozen tumor if available.
* A fragment of the liver metastasis(s) performed as part of standard metastasis surgery, this fragment will include a tumor area and a healthy area within the margin of excision. These samples collected in a fresh state will be analyzed immediately.

Eligibility criteria: Inclusion Criteria:

* Patient with metastatic colon cancer operated on and followed up at the Centre Leon Berard for liver metastasis.
* Patient affiliated to social security

Exclusion Criteria:

* Other pathologies that may interfere with biological evaluation, in particular known hepatic cirrhosis, whatever its origin, other liver overload diseases (hemochromatosis, Wilson's disease), but excluding steatosis (which can be chemo-induced).

Primary outcomes:
measure: 5-FU in ribosome
timeFrame: Up to 24 months
Secondary outcomes:
measure: Methylation profile of ribosomal RNAs
timeFrame: Up to 24 months
measure: Transcriptomic and proteomic profile
timeFrame: Up to 24 months
measure: Specific molecular signature
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Leon Berard
name: Philippe CASSIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04147390: Immunosuppression After Repeat Keratoplasty
Official title: Topical 0.03% Tacrolimus Versus Systemic Mycophenolate Mofetil for Preventing Graft Rejection After Repeat Keratoplasty: One-year Results of a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Keratopathy
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Purpose: To compare the efficacy of topical 0.03% tacrolimus with systemic mycophenolate mofetil (MMF) in preventing corneal allograft rejection after repeat keratoplasty.

Design: Prospective, randomized clinical trial Introduction: Repeat keratoplasty continues to be an important indication for corneal transplantation in many centers, and it accounts for up to 41% (varying from 6% to 41%) of all keraptoplasty cases performed.

Methods: This study will enroll all patients who are candidate for repeat keratoplasty after a failed penetrating keratoplasty. Group 1 will receive MMF orally 1 g twice daily for the first 6 months and then 1 g daily for the next 6 months, and group 2 will receive topical 0.03 % tacrolimus 3 times a day for 12 months. All patients are treated with topical and oral corticosteroids postoperatively. The participants are observed closely for signs of graft rejection, and the rates of rejection-free graft survival are calculated and compared between the two groups at postoperative month 12


Eligibility criteria: Inclusion Criteria:

* all patients who are scheduled for repeat corneal transplantation following failed primary penetrating keratoplasty (PK )

Exclusion Criteria:

* uncontrolled increase in intraocular pressure
* active herpetic keratitis and corneal ulcer
* limbal stem cell deficiency
* a history of limbal stem cell transplantation
* age less than 18 years
* pregnancy, a history of malignant disorders
* abnormal liver or kidney function
* the presence of poorly controlled systemic hypertension
* diabetes mellitus
* systemic infections
* active peptic ulcer disease
* any gastrointestinal disorders led to patient exclusion

Primary outcomes:
measure: graft rejection
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT01661790: Intrapleural Bevacizumab and Cisplatin Therapy for Malignant Pleural Effusion Caused by Non-small Cell Lung Cancer
Official title: Open-labeled, Randomized, Multicenter Phase III Study of Adjuvant Chemotherapy Comparing Bevacizumab Plus Cisplatin With Cisplatin Regimen in Malignant Pleural Effusion of Advanced Stage Non-Small-Cell Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malignant Pleural Effusion
Keywords: Bevacizumab;
non-small cell lung cancer;
malignant pleural effusion;
intrapleural administration
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2012-08-10
Enrollment: 72
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: TREATMENT

Brief summary: To determine the efficacy and Safety of intrapleural Bevacizumab and cisplatin as a treatment for malignant pleural effusions (MPE) in patients with non-small cell lung cancer (NSCLC).


Eligibility criteria: Inclusion Criteria:

* Patients with advanced recurrent or progressive NSCLC proven cytohistologically
* Karnofsky performance status (KPS) ≥60
* Life expectancy ≥ 2 months
* No history of severe diseases of major organs including liver, heart, and kidney
* No previous intrapleural therapy
* Written informed consent

Exclusion Criteria:

* Active thoracic cavity or systemic bleeding
* Active pleural or systemic infection.
* Known sensitivity to Bevacizumab or Cisplatin
* Refusal to participate in the study.

Primary outcomes:
measure: Number of Participants With "Complete Response" and "Partial Response"
timeFrame: from randomization, This treatment was given every two weeks,responses were made by biweekly
Secondary outcomes:
measure: Median Progression Free Survival (PFS)
timeFrame: baseline to biweekly,until disease progression
measure: Overall Survival (OS)
timeFrame: randomization to four weeks,until death
measure: Adverse Reactions
timeFrame: Up to 1 month after the last treatment
measure: Qualify of Life (QoL)
timeFrame: baseline to biweekly,until death
Other outcomes:
measure: Quantitative RT-PCR(Reverse Transcription-Polymerase Chain Reaction) for VEGF-A(Vascular Endothelial Growth Factor A)
timeFrame: before intrapleural administration
Locations:
city: Beijing
country: China
facility: PLA 304 hospital
state: Beijing
Study officials:
affiliation: PLA 304 hospital
name: Nan Du
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04723290: COVID-19 Seroconversion Study Among GHdC Staff Members - Summer 2020
Official title: SARS-CoV-2 Seroconversion Study Among GHdC Staff Members
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Grand Hôpital de Charleroi
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 2817
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: The management of the Grand Hôpital de Charleroi hospital authorized the performance of a serology for each member of the establishment's staff in order to better characterize the proportion of its employees who have already been in contact with the SARS CoV-2 virus for organizational and evaluation purposes symptoms.

Detailed description: At the start of the SARS-CoV-2 pandemic, several workers had symptoms compatible with COVID-19 at a time when PCR (smear) testing was only allowed for hospitalized people. In addition, the PCR test has a fairly low sensitivity. In this context, serology can make it possible to determine whether the symptoms are indeed linked to exposure to SARS-CoV-2.

As a hospital, and in order to prepare for a possible second epidemic wave, it is also useful to know the proportion of staff members who have already been in contact with the virus for organizational purposes and symptom assessment.

.

Eligibility criteria: Inclusion Criteria:

* Be a member of the staff of the Grand Hôpital de Charleroi who wishes to participate in order to know their immunity related to SARS CoV-2 after the first wave of pandemic.

Exclusion Criteria:

* Not be part of the staff of the Grand Hôpital de Charleroi.

Primary outcomes:
measure: Serological tests to know the level of antibodies against SARS CoV-2
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
state: Hainaut
Study officials:
affiliation: Grand Hôpital de Charleroi
name: Nathalie de Visscher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Visscher N, Holemans X, Gillain A, Kornreich A, Lagasse R, Piette P, Ventura M, Thys F. SARS-CoV-2 Seroprevalence among Healthcare Workers after the First and Second Pandemic Waves. Viruses. 2022 Jul 14;14(7):1535. doi: 10.3390/v14071535.