louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04782505: Safety and Pharmacokinetics Evaluation Study According to the Dose of Camostat Mesylate in Healthy Volunteers
Official title: A Open-label, Single-dose, Phase 1 Study to Compare and Evaluate the Safety and Pharmacokinetics According to the Dose of Camostat Mesylate in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2021-03-04
Enrollment: 61
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Part1. Parallel, Part2. Crossover
Primary purpose: TREATMENT

Brief summary: Safety and pharmacokinetics evaluation study according to the dose of camostat mesylate in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged ≥ 19 and ≤ 55 years at screening
* Subjects with body weight of ≥ 55.0 kg and ≤ 90.0 kg, and a body mass index (BMI) of ≥ 18.0 and ≤ 29.9
* Subjects who have no congenital or chronic disease and have no pathological symptoms or findings as a result of an internal examination

Exclusion Criteria:

* Subjects with current or prior history of a clinically significant hepatic, renal, nervous, respiratory, gastrointestinal, endocrine, hematologic and oncologic, urogenital, cardiovascular, musculoskeletal or psychiatric disorder
* Subjects with symptoms of acute disease within 28 days prior to the scheduled first administration date of IP
* Subjects with a history of gastrointestinal diseases (e.g., Crohn's disease, ulcers, etc.) or gastrointestinal resection (except simple appendectomy or hernia surgery) that may affect the absorption of drugs.

Primary outcomes:
measure: Cmax of GBPA
timeFrame: 0-6 hr
measure: AUClast of GBPA
timeFrame: 0-6 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
Study officials:
References:
Clinical trial NCT00778505: Use of Closed-loop Anesthesia in Pediatric Patients
Official title: Target-Controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison in Pediatric Patients Between Manual Perfusion and Automated Perfusion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anesthesia
Keywords: Anesthesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2008-10-23
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during pediatric anesthesia


Eligibility criteria: Inclusion Criteria:

* class ASA I, II or III
* general anesthesia scheduled to last more than one hour
* intraoperative hemorrhage planned to be less than 15% of the blood volume

Exclusion Criteria:

* Combined general and regional anesthesia,
* Patients with a pacemaker or scheduled for a cardiac or brain surgical procedure,
* History of a neurological or a psychiatric disorder, or central brain lesion,
* Patients receiving a psychotropic treatment or a a morphine agonist-antagonist,
* Allergy to latex, propofol, remifentanil, morphine, muscle relaxant, or to a component,
* Hypersensibility to remifentanil or to a derivate of fentanyl,
* Scheduled postoperative ventilation or sedation.

Primary outcomes:
measure: Percentage of time during which the bispectral index is between 40 and 60
timeFrame: anesthesia
Secondary outcomes:
measure: propofol and remifentanil doses
timeFrame: anesthesia
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker Enfants
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hôpital Foch, Suresnes, France
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00912405: Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis
Official title: A Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Sinusitis
Keywords: Patients diagnosed with Chronic Sinusitis undergoing functional endoscopic surgery (FESS)
Lead sponsor: Intersect ENT
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study allows continued access to the Sinexus Intranasal Splint while a marketing application is being prepared. This study will generate additional performance, reimbursement and safety data for the steroid-eluting Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with chronic sinusitis (CS).


Eligibility criteria: Inclusion Criteria:

* Patient is 18 years of age or older
* Patient has a diagnosis of chronic sinusitis
* Patient has a clinical indication for and has consented to FESS
* Patient CT scan confirms CS diagnosis within 6 months of procedure
* CT sacn confirms presence of disease in ethmoid sinus(es)
* Planned FESS includes unilateral or bilateral total ethmoidectomy

Exclusion Criteria:

* Immune deficiency (IGG subclass deficiency or IGA deficiency)
* Oral-steroid dependent COPD, asthma or other condition
* Clinical evidence of acute bacterial sinusitis
* History or diagnosis of glaucoma or ocular hypertension
* Clinical evidence or suspicion of invasive fungal sinusitis
* Evidence of disease or condition expected to compromise survival or ability to complete follow-up
* Known history of allergy or intolerance to corticosteroids
* History of insulin dependent diabetes

Primary outcomes:
measure: Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)
timeFrame: 30 days
measure: Device Placement Success Rate
timeFrame: At the time of procedure
Secondary outcomes:
measure: Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities
timeFrame: Baseline and 30 days
measure: Number of Sinuses With Significant Post-operative Adhesion Formation
timeFrame: 30 days
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Central California Ear, Nose Thraot
state: California
Study officials:
References:
Clinical trial NCT00506805: Safety And Pharmacology Study Of SNX-5422 Mesylate In Subjects With Refractory Solid Tumor Malignancies
Official title: A Phase 1, Open-label, Dose-escalation Study Of The Safety And Pharmacokinetics Of SNX-5422 Mesylate In Subjects With Refractory Solid Tumor Malignancies Or Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: solid tumor malignancy; Hsp90
Lead sponsor: Esanex Inc.
Sponsor class: INDUSTRY
Collaborators: name: Serenex, Inc.
name: Pfizer
First posted: 2007-07-25
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hsp90 is a chemical in the body that is involved in promotion of cancer. SNX-5422 is an experimental drug that blocks Hsp90. It is being evaluated for safety and efficacy in patients with cancer.


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* histologically confirmed solid tumor malignancy
* refractory to available therapy or for which no therapy is available
* adequate organ function

Exclusion Criteria:

* CNS malignancy
* significant GI disease
* at risk for prolonged QT interval

Primary outcomes:
measure: adverse events and other safety assessments
timeFrame: continuous
Secondary outcomes:
measure: tumor response measured by X-rays or scans
timeFrame: after every 2 cycles
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01279005: Risk Taking Behaviour in MSM and the Denial of Sexually Transmitted Diseases and HIV
Official title: Risk Taking Behaviour in MSM and the Denial of Sexually Transmitted Diseases and HIV - Focus Groups, Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: MSM
HIV Infections
Risky Behaviors
Keywords: MSM
focus group
HIV
risk-taking
risk-denial
signature on inform consent, willing to participate, MSM either HIV positive or negative, age 20-50 years old
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: NGO Via Libre
First posted: 2011-01-19
Enrollment: 50
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40-50 years old MSM

Brief summary: Four focus groups , each of 10-15 males, ages 20-50 years old, MSM will be conducted by a medical sociologist. Two groups will be HIV negative participants and two groups of HIV positive MSM. Every group will meet for two hours. The focus group will be recorded and the collected data will be processed further for evaluation and extraction of the relevant information.

The volunteers will sign an inform consent prior to entrance to the study.

Detailed description: The questions that will be discussed during the focus groups: The first sexual contact with a male, what is risk, risk taking behavior, control over your daily life, self esteem and evaluation, risk denial.

Eligibility criteria: Inclusion Criteria:

* Age 20-50
* MSM, willing to participate
* Agree to sign an inform consent

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05310305: PD-1 Antibody and Radiotherapy for Recurrent Cervical Cancer
Official title: Combination of Immune Checkpoint Inhibitors PD-1 Monoclonal Antibody and Radiotherapy for Recurrent, Metastatic and Persistent Advanced Cervical Cancer: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immune Checkpoint Inhibitors
Anti-programmed Death-1 Antibody
Radiotherapy
Recurrent Cervical Carcinoma
Metastatic Cervical Carcinoma
Persistent Advanced Cervical Carcinoma
Objective Remission Rate
Progression-free Survival
Overall Survival
Severe Adverse Events
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with recurrent, metastatic and persistent advanced cervical carcinomas

Brief summary: This study is to investigate retrospectively the effects of combination of immune checkpoint inhibitors anti-programmed death-1 antibody (PD-1 antibody) and radiotherapy for recurrent, metastatic and persistent advanced cervical carcinomas. Patients may or may not accept PD-1 antibody as maintenance therapy. Patients are followed up and the survival outcomes are evaluated. The primary endpoint are objective remission rate. The secondary endpoints are progression-free survival, overall survival and severe adverse events.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Confirmed of recurrent, metastatic, and persistent advanced cervical cancer
* Confirmed of subtypes of cervical squamous carcinoma, adenocarcinoma and adenosquamous carcinoma
* Accepting radiotherapy with concurrent anti PD-1 therapy
* With detailed follow-up outcomes

Exclusion Criteria:

- Not meeting all of the inclusion criteria

Primary outcomes:
measure: Objective remission rate
timeFrame: One year
Secondary outcomes:
measure: Progression-free survival
timeFrame: One year
measure: Overall survival
timeFrame: One year
measure: Severe adverse events
timeFrame: Two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06603805: Optimal Surgical Approach for Early-Stage Breast Cancer in Chinese Patients Aged ≤ 40 Years: a Cohort Study
Official title: Optimal Surgical Approach for Early-Stage Breast Cancer in Chinese Patients Aged ≤ 40 Years: a Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
breast-conserving surgery
radiotherapy
mastectomy
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 974
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient data were extracted from the West China Hospital database at Sichuan University. Records between 1 January 2008 and 31 December 2019 were included.

Brief summary: The optimal surgical treatment option (BCS+RT versus MAST) for young patients with early-stage breast cancer remains debated. The present study aims to explore trends in surgical management and compare survival outcomes between BCS+RT and MAST in young patients with early-stage breast cancer, ultimately providing optimal treatment strategies for Asian populations.

Detailed description: This study is a unique addition to the current research on young women with early-stage breast cancer, aiming to compare the survival outcomes between BCS+RT and MAST, providing valuable insights into their effectiveness for this group of patients. This study enrolled patients at West China Hospital, Sichuan University. Kaplan-Meier analyses with the log-rank test were applied to compare the locoregional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), breast cancer-specific survival (BCSS), and overall survival (OS). Cox multivariate hazard regression was employed to assess hazard ratios (HRs) between the two groups for survival outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-40 years.
* Pathological diagnosis of invasive breast cancer.
* Undergoing Breast-Conserving Surgery (BCS) with Radiotherapy (RT) or Mastectomy (MAST).
* Availability of detailed clinical information, including:

Tumor (T) stage. Node (N) stage. Clinical stage. Hormone receptor status. Endocrine therapy details. Targeted therapy details.

Exclusion Criteria:

* Male patients.
* Patients with distant metastatic disease.
* Patients with bilateral breast cancer.
* Patients not undergoing surgery.
* Follow-up time of less than 1 month.

Primary outcomes:
measure: Breast cancer-specific survival (BCSS)
timeFrame: Jan 1, 2008 to 31 Dec, 2019
measure: LRFS (Locoregional Recurrence-Free Survival)
timeFrame: Jan 1, 2008 to 31 Dec, 2019
measure: DMFS (Distant Metastasis-Free Survival)
timeFrame: Jan 1, 2008 to 31 Dec, 2019
measure: OS (Overall Survival)
timeFrame: Jan 1, 2008 to 31 Dec, 2019
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03286205: A Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.
Official title: A Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Anemia, Iron Deficiency
Lead sponsor: Sutter Gould Medical Foundation
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 0
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: The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia.

Detailed description: The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia. The two dosing regimens under review are a low dose weekly or a larger dose given every three weeks.

Eligibility criteria: Inclusion Criteria:

1. Patients over the age of 18 years old.
2. Being treated by a Sutter Health Physician.
3. Hemoglobin of \< 10mg/dl for Men and Women
4. Ferritin \</= 10ng/ml
5. Patients in whom oral administration is unsatisfactory or impossible.

Exclusion Criteria:

1. Patients with a history of receiving iron or other hematinic in the preceding 3 months, oral iron is allowable.
2. Anemia due to acute blood loss; menorrhagia is allowed.
3. Patients with a current illness known to interact with iron status.
4. Patients unwilling to consent to required blood draws.
5. Patients who are viewed as unable to complete treatment, based on PI recommendation.

Primary outcomes:
measure: superior dosing regimen exists for INfed
timeFrame: 3 years
measure: High Dose Effect
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Modesto
country: United States
facility: Sutter Gould Medical Foundation
state: California
Study officials:
affiliation: Principal Investigator
name: David Adkins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00099905: A Clinical Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes
Official title: A Clinical Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-22
Enrollment: 639
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 assess the safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) in the range 22-45
* Blood glucose criteria must be met
* Not currently on drug therapy for type 2 diabetes

Exclusion Criteria:

* Type 1 diabetes
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular conditions
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in HbA1c at 24 weeks
Secondary outcomes:
measure: Change from baseline in fasting plasma glucose at 24 weeks
measure: Patients with endpoint HbA1c <7% after 24 weeks
measure: Patients with reduction in HbA1c>/=to 0.7% after 24 weeks
measure: Change from baseline in body weight at 24 weeks
measure: Change from baseline in fasting lipids at 24 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Pratley RE, Schweizer A, Rosenstock J, Foley JE, Banerji MA, Pi-Sunyer FX, Mills D, Dejager S. Robust improvements in fasting and prandial measures of beta-cell function with vildagliptin in drug-naive patients: analysis of pooled vildagliptin monotherapy database. Diabetes Obes Metab. 2008 Sep;10(10):931-8. doi: 10.1111/j.1463-1326.2007.00835.x. Epub 2007 Dec 17.
citation: Pratley RE, Rosenstock J, Pi-Sunyer FX, Banerji MA, Schweizer A, Couturier A, Dejager S. Management of type 2 diabetes in treatment-naive elderly patients: benefits and risks of vildagliptin monotherapy. Diabetes Care. 2007 Dec;30(12):3017-22. doi: 10.2337/dc07-1188. Epub 2007 Sep 18.
Clinical trial NCT00150605: Safety of SPD417 Combined With Other Psychotropic Medications in the Treatment of Bipolar I Disorder
Official title: A Phase IIIb, Open Label Observational Study of SPD417 Used in Combination With Other Psychotropic Medications for the Treatment of Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Lead sponsor: Validus Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of SPD417 when given with other psychotropic medications to treat bipolar I disorder.


Eligibility criteria: Inclusion Criteria:

* DSM-IV criteria for Bipolar I disorder
* Screening YMRS score =\>16
* Women of childbearing potential agree to take adequate precautions against contraception
* Currently receiving treatment with antipsychotic therapy or combination therapy of mood stabilizer and antipsychotic

Exclusion Criteria:

* Hospitalization required for treatment of psychiatric symptoms
* Patients who meet DSM-IV for ultra-rapid cycling
* History of serious suicide attempt requiring medical intervention
* Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening

Primary outcomes:
measure: Safety as assessed by treatment-emergent adverse events over 8 weeks of treatment
Secondary outcomes:
measure: YMRS Scale
measure: Clinical Global Impressions Scale - Bipolar Version
measure: HAM-D and MADRS Scales for Depression
Other outcomes:
Locations:
Study officials:
References: