louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02362516: Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809
Official title: Non-randomised, Open Label, Sequential-group Study to Assess the Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-02-13
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the exposure of BI 425809 in cerebrospinal fluid relative to plasma as well as safety and tolerability, and to evaluate the effect of different doses of BI 425809 on biomarkers levels in cerebrospinal fluid.


Eligibility criteria: Inclusion criteria:

* Healthy male according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), puls rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (incl.)
* Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation

Exclusion criteria:

* Any finding in the medical examination (including blood pressure (BP), puls rate (PR) or electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range and considered as clinical relevant by investigator
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders Further exclusion criteria may apply

Primary outcomes:
measure: AUC0-14 (area under the concentration-time curve of the analyte in plasma and CSF over the time interval from 0 to 14h)
timeFrame: 17 days
measure: Cmax (maximum measured concentration of the analyte in plasma and CSF)
timeFrame: 17 days
measure: C312 (concentration of the analyte in plasma and CSF at the time point 312h)
timeFrame: 17 days
Secondary outcomes:
measure: frequency [N(%)] of subjects with drug-related adverse events (AEs)
timeFrame: 30 days
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: 1346.3.32001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT05741216: Evaluation of Comfort of Ocular Lubricants in Symptomatic Contact Lens Wearers
Official title: Evaluation of Comfort of Ocular Lubricants in Symptomatic Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-02-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the ocular comfort of 3 ocular lubricants and a comparator.

Detailed description: The expected duration of subject participation is at least 7 days. This study will be conducted in Australia and Canada.

Eligibility criteria: Key Inclusion Criteria:

* Is able to understand and sign an approved information consent letter;
* Habitually wears daily disposable soft contact lenses in both eyes
* Uses rewetting drops on a regular basis;
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Routinely sleeps in habitual contact lenses;
* Has any known active ocular disease and/or infection;
* Is pregnant or lactating;
* Other protocol specified exclusion criteria may apply.

Primary outcomes:
measure: Ocular comfort
timeFrame: Up to Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: School of Optometry and Vision
state: New South Wales
city: Waurn Ponds
country: Australia
facility: Deakin Collaborative Eye Care Clinic, Deakin University
state: Victoria
city: Waterloo
country: Canada
facility: School of Optometry and Vision Science, University of Waterloo
state: Ontario
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Dry Eye
role: STUDY_DIRECTOR
References:
Clinical trial NCT06037616: Teaching Simple Skin Sutures to Medical Students
Official title: Comparison of Methods for Teaching Simple Skin Sutures to Medical Students: a Randomized Blinded Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Medical Students
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Learning the simple skin suture is part of the surgical basics required for all medical students, including future general practitioners.

However, there is no data in the educational literature to help choose the best learning technique.

Several teams have offered video learning showing the correct technique. Level n+1 peer learning was also proposed, without and with supervision by an expert.

The investigators propose to carry out a prospective study comparing the quality of sutures and knowledge according to the chosen learning method.

Detailed description: Send to medical student a teaching package two weeks before simulation session to practice skin suture. There are 4 teaching packages related to 4 interventional groups The skin suture performed by medical students are recorded on video. 1 video per medical student.

The skin sutures recorded in these video are rated by two blinded expert with evaluation grid.

After the simulation session, the students complete knowledge, self-confidence, satisfaction and mental load questionnaires

Eligibility criteria: Inclusion Criteria:

* Medical student of the faculty of Clermont-Ferrand

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: quality of skin suture
timeFrame: 15 days after simulation session
Secondary outcomes:
measure: knowledge of student
timeFrame: 15 days after simulation session
measure: self-confidence of student
timeFrame: 15 days after simulation session
measure: mental load of student
timeFrame: 15 days after simulation session
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Alexandre Lautrette
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Clermont-Ferrand
name: Nicolas D'Ostrevy
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Jean Perrin
name: geraud galvaing
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06444516: Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease
Official title: A Single-Arm Study to Evaluate and Demonstrate Safety and Performance of a Novel Ocular Lubricant in Adult Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Disease
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-06-05
Enrollment: 161
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: The purpose of this study is to evaluate and demonstrate the efficacy and safety of an investigational ocular lubricant formulation in patients with mild to moderate dry eye disease (DED).

Detailed description: The study will consist of a Screening visit, a Baseline visit on Day 1, a remote Compliance Check on Day 14, and an Exit visit on Day 30. The expected study duration of participation for each subject is 37 days, with 30 ± 5 days of exposure to the investigational product.

Eligibility criteria: Key Inclusion Criteria:

* Willing and able to understand and sign an approved informed consent form.
* Exhibit symptoms of dry eye at the Screening visit.
* Best Corrected Visual Acuity equal to or better than 20/80 Snellen in each eye at the Screening visit.
* Willing to discontinue use of all artificial tear supplements and use only the study product as directed starting at Visit 2/Day 1.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Pregnant, breastfeeding, or planning to become pregnant during the study.
* Ocular abnormalities that could adversely affect the safety or efficacy outcome.
* Uncontrolled active systemic diseases.
* Use of systemic medications known to cause dry eye.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change from Baseline in Impact of Dry Eye on Everyday Life - Symptom Bother (IDEEL-SB) Questionnaire Score at Day 30
timeFrame: Baseline (Day 1); Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Kindred Optics at Maitland Vision Center
state: Florida
city: Orlando
country: United States
facility: Vision Health Institute
state: Florida
city: Franklin Park
country: United States
facility: Franklin Park Eye Center, PC
state: Illinois
city: Pittsburg
country: United States
facility: Kannarr Eye Care, LLC
state: Kansas
city: New York
country: United States
facility: SUNY College of Optometry Clinical Vision Research Center
state: New York
city: Granville
country: United States
facility: ProCare Vision Center
state: Ohio
city: Wyomissing
country: United States
facility: Wyomissing Optometric Center
state: Pennsylvania
city: Memphis
country: United States
facility: Optometry Group, PLLC
state: Tennessee
city: Wichita Falls
country: United States
facility: Clarke Eyecare Center
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT00868816: Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles Versus 12 Cycles
Official title: A Prospective, Randomized, Control Trial of Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles vs 12 Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Cancer
Keywords: oxaliplatine
colorectal cancer
chemotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2009-03-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 investigate which oxaliplatie based adjuvant method (8 cycles or 12 cycles) is better for patients receiving curative colorectal cancer resection.

Detailed description: We administered 5-FU, lv and Oxaliplatin as adjuvant chemotherapy (3 weeks per cycle) to patients with Stage II or Stage III colorectal cancer. The study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.

Eligibility criteria: Inclusion Criteria:

* age \< 75 years with histologically proven adenocarcinoma of the colon or rectum
* no severe major organ dysfunction
* WHO performance status of 0 or 1
* Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system)

Exclusion Criteria:

* age \>= 75
* severe major organ dysfunction
* WHO performance status of \>1
* Stage I or Stage IV

Primary outcomes:
measure: disease-free survival
timeFrame: 5 years after operation
Secondary outcomes:
measure: overall survival liver metastasis-free survival
timeFrame: 5 years after operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: department of general surgery, zhongshan hospital, fudan university
name: jianmin xu, MD, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02764216: Elective Mucosal Irradiation in Head-and-Neck Cancer of Unknown Primary
Official title: Elective Mucosal Irradiation in Head-and Neck Cancer of Unknown Primary, A Single Arm Phase II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Head-and-neck Cancer
Carcinoma of Unknown Primary
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
Collaborators: name: Shanghai Jiao Tong University School of Medicine
First posted: 2016-05-06
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 optimal treatment of HNCUP remains controversial and lacks evidence from prospective randomized trials. The management of these patients relies primarily on surgery and radiotherapy. The role of radiotherapy in sterilizing putative mucosal sites remains controversial. The main debate concerns the extent of the radiation field. Although pan-mucosal irradiation from the nasopharynx to the hypopharynx and bilateral neck nodes reduces the risk of emergence of a mucosal primary or a nodal relapse, it has been associated with significant toxicity and long-term morbidity (mostly xerostomia and dysphagia). Most single institution retrospective studies have not shown any advantage for more extensive irradiation.Therefore, elective mucosal irradiation may might be appropriate only for these patients.


Eligibility criteria: Inclusion Criteria:

1. Carcinomas metastatic to cervical lymph node with unknown primary
2. Squamous cell carcinoma, poorly differentiated carcinoma, or undifferentiated carcinoma
3. All patients must be suitable to attend regular follow-up and undergo toxicity assessment.
4. Stage T0, N1-3, M0 disease
5. Karnofsky score over 60
6. No significant cardiac, chest, gastrointestinal or renal morbidities

Exclusion Criteria:

1. Previous radiotherapy to the head and neck region
2. Previous malignancy except non-melanoma skin cancer
3. Previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up

Primary outcomes:
measure: Mucosal recurrence free survival
timeFrame: 3 years
Secondary outcomes:
measure: Disease-free survival
timeFrame: 3 years
measure: Neck control rate
timeFrame: 3 years
measure: overall survival rate
timeFrame: 3 years
measure: Acute toxicities(gastrointestinal toxicities,hematologic toxicities, dysphagia,oral mucositis)
timeFrame: 2 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai ninth people's hospital
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
citation: Dou S, Li R, Zhang L, Wang Z, Xie L, Zhang C, Zhu G. Long-term results of elective mucosal irradiation for head and neck cancer of unknown primary in Chinese population: The EMICUP study. Cancer Med. 2020 Mar;9(5):1712-1720. doi: 10.1002/cam4.2856. Epub 2020 Jan 17.
Clinical trial NCT02010216: A Study of RoActemra/Actemra (Tocilizumab) in Adult Patients With Rheumatoid Arthritis (SVOBODA Programme)
Official title: Non-Randomized Phase IV Trial on Efficacy and Safety of Actemra in the Treatment of Adult Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-12-12
Enrollment: 23
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: This open-label, single arm study evaluated the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients received RoActemra/Actemra 8 mg/kg intravenously every 4 weeks, alone or in combination with standard anti-rheumatic therapy, for 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, ≥ 18 years of age
* Confirmed moderate or severe rheumatoid arthritis
* Intolerability or absence of effect or decrease in effect of rheumatoid arthritis treatment with disease modifying antirheumatic drugs (DMARDs)

Exclusion Criteria:

* Presence of infectious diseases \[tuberculosis (Tb), human immunodeficiency virus (HIV), virus hepatitis A/B/C\]
* Inadequate hematologic, renal or liver function
* Peptic ulcer disease (in acute phase)
* Pregnant and lactating women

Primary outcomes:
measure: Change From Baseline in Disease Activity 28 (DAS28) Score
timeFrame: Baseline, Week 12
measure: Percentage of Participants Achieving ACR20/50/70 Responses After the Third Infusion Categorized by Highest Response Achieved
timeFrame: Baseline, Week 12
measure: Safety: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
city: Astana
country: Kazakhstan
city: Astana
country: Kazakhstan
city: Shymkent
country: Kazakhstan
city: Shymkent
country: Kazakhstan
city: Ust-kamenogorsk
country: Kazakhstan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01699516: Non-invasive Contrast Enhanced Ultrasound Sonography in Intestinal Acute Graft-vs-Host Disease
Official title: A Prospective Study on Qualitative and Quantitative Non-invasive Evaluation of Intestinal Acute Graft-vs-host Disease by Contrast Enhanced Ultrasound Sonography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intestinal GVHD
Neutropenic Enterocolitis
Keywords: allogeneic transplantation; intestinal graft-vs.-host disease; contrast enhanced ultrasound sonography
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 32
Sex: ALL
Minimum age (years): 22
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In the setting of allogenic transplant: intestinal acute graft vs host disease (GVHD), stomach GVHD, neutropenic enterocolitis.

Brief summary: Intestinal acute graft-vs-host disease (GVHD) is a life-threatening complication after allogeneic hematopoietic cell transplantation. Non-invasive diagnostic procedures are still lacking and diagnosis is difficult. We hypothesized that contrast-enhanced ultrasound sonography (CEUS) could detect microcirculation changes of the bowel walls during intestinal GVHD and help to detect and monitor treatment response. We employed CEUS to prospectively evaluate intestinal GVHD in 83 consecutive transplant patients between 2008 and 2011. Fourteen /83 patients with biopsy-proven intestinal GVHD were selected as study group. Fourteen patients with biopsy-proven stomach GVHD without intestinal symptoms (N=16), normal volunteers (N=6) and patients with neutropenic enterocolitis (N=4), were chosen as control group. All patients were evaluated with both standard transabdominal ultrasonography (US) and CEUS at the onset of intestinal symptoms, during clinical follow up and at flare of symptoms. Standard US revealed non-specific bowel wall thickening, and simultaneous involvement of multiple intestinal segments in 9/14 patients. CEUS showed three distinct patterns of microcirculation changes that correlated with GVHD activity. These findings were not observed in the control group. Moreover, CEUS findings correlated with treatment response and predicted flare of intestinal symptoms. CEUS is a non-invasive, easily reproducible bed-side tool to detect and monitor intestinal GVHD.


Eligibility criteria: Inclusion Criteria:

* Bone Marrow Transplant
* intestinal acute graft versus host disease
* stomach GVHD
* neutropenic enterocolitis

Exclusion Criteria:

no biopsy proven intestinal or stomach GVHD no neutropenic enterocolitis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Santa Chiara Hospital University of Pisa
Study officials:
References:
Clinical trial NCT00619216: Myfortic Conversion Trial in OLT Recipients With GI Intolerance
Official title: A Three-Month, Open-Label, Two Cohort Study to Investigate the Safety and Tolerability of Myfortic in Combination With Neoral (Cyclosporin) or Prograf (Tacrolimus) in Liver Transplant Recipients With GI Intolerance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GI Disturbance
Keywords: Orthotopic Liver Transplant Recipients with GI disturbance
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2008-02-20
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recipients of Orthotopic Liver Transplants

Brief summary: Liver transplant patients often require multimodal immunosuppressive therapy to minimize their risk for rejection. In our regimen, MMF (mycophenolate mofetil) is often added to lower the side effects of the calcineurin inhibitors. Unfortunately the literature reports 20% up to as many as 40% of patients have GI intolerance to MMF. At our Center, approximately 30% of patients have intolerance to MMF, thereby mitigating our ability to use this agent. The primary objective of this study is to assess the tolerability of myfortic in combination with Neoral or Tacrolimus as determined by the GSRS (Gastrointestinal Symptom Rating Scale) after conversion from MMF in maintenance liver transplant patients with GI intolerance within 3 months.


Eligibility criteria: Inclusion Criteria:

* Recipients of orthotopic liver transplant at least 8 weeks post transplant
* Mild and/or moderate GI complaints directly related to MMF

Exclusion Criteria:

* Multi-organ transplant recipients
* Evidence of graft rejection within 14 days prior to Baseline visit

Primary outcomes:
measure: Evaluation of GI symptoms using GSRS, GIQLi, and SF-12 after conversion to Myfortic
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina-Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill Department of Surgery
name: David Gerber, MD
role: PRINCIPAL_INVESTIGATOR
References: