louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00499850: Phase I FOLFOX Combination
Official title: A Phase I,Open Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as First and Second Line Therapy in Patients With Advanced Colorectal Adenocarcinoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Colorectal Carcinoma
Keywords: ZD6474
FOLFOX
colorectal
adenocarcinoma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-07-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase I,open label study to assess the safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as first and second line therapy in patients with advanced colorectal adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed locally advanced, recurrent or metastatic colorectal adenocarcinoma (Stage IV)
2. WHO performance status 0-1
3. one or more measurable lesions min 10mm by spiral CT or min 20mm by conventional techniques

Exclusion Criteria:

1. Brain metastasis or spinal cord compression unless irradiated at least 4 weeks before entry and stable
2. last dose of prior chemotherapy discontinued at least 4 weeks before start study treatment
3. prior unanticipated severe reaction to oxaliplatin

Primary outcomes:
measure: Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin
timeFrame: Assessed at each visit
Secondary outcomes:
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: Research Site
city: Footscray
country: Australia
facility: Research Site
city: Heidelberg
country: Australia
facility: Research Site
city: Parkville
country: Australia
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT01958450: Comparison of the Efficacy of Fractional Er:YAG Laser for Acne Scar
Official title: Comparitive Study of Efficacy and Safety Between Fractional Er:YAG Laser and Bipolar Radiofrequency Treatment for Acne Scar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scar
Keywords: acne scar
Laser therapy
wound healing
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 27
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Compare the efficacy of frational Er:YAG laser and that of bipolar frequency with diode laser treatment.

Detailed description: In acne scar treatment, ablational laser would be superior to nonablative laser treatment. Frational Er:YAG laser treatment is a effective treatment plan for acne scar without severe adverse effects.

Eligibility criteria: Inclusion Criteria:

* moderate acne scar

Exclusion Criteria:

* taking steroids, nonsteroidal antiinflammatory drug, and isotretinoin
* anyone who received acne scar procedures within 6 months
* underlying diabetes mellitus, keloid, or malignancy

Primary outcomes:
measure: Global asessment of acne scar
timeFrame: 12 weeks
Secondary outcomes:
measure: ECCA
timeFrame: 12 weeks
measure: adverse effect assessment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Dermatology, Seoul National University College of Medicine
Study officials:
affiliation: Department of Dermatology, Seoul National University College of Medicine
name: Dae Hun Suh, PhD
role: STUDY_CHAIR
affiliation: Department of Dermatology, Seoul National University College of Medicine
name: Seonguk Min, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kutlubay Z, Gokdemir G. Treatment of atrophic facial acne scars with the Er:YAG laser: a Turkish experience. J Cosmet Laser Ther. 2010 Apr;12(2):65-72. doi: 10.3109/14764171003706141.
Clinical trial NCT01967550: Efficacy and Safety of Diclofenac DDEA 2.32 % in Patient Suffering From Knee Osteoarthritis (OA)
Official title: A 4-week, Randomized, Double-blind, Multi-center, Vehicle-controlled, Parallel Group Study to Assess the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel for the Relief of Signs and Symptoms in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Keywords: Symptomatic knee OA Kellgren-Lawrence grade 1-3
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-10-23
Enrollment: 304
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of diclofenac DDEA 2.32 % in patient suffering from knee osteoarthritis (OA).


Eligibility criteria: Inclusion Criteria:

* 1. Male or female ≥ 50 years old; 2. Symptomatic OA of one or both knees, according to ACR criteria, diagnosed at least 6 months previously; 3. Pain in either knee originates in the knee (not referred pain from other sites, such as hip or back) and no other cause of pain than knee OA; 4. Have used oral NSAIDs or COXIBs for the knee OA pain (including aspirin if ≥ 500 mg and used in this indication), at least one dose per day, for not less than 10 days out of the 14 days preceding the screening visit and also within the 24 hours preceding the screening visit; 5. Be able to tolerate rescue medication with only 500 mg paracetamol (APAP) taken in doses of 1-2 tablets up to a maximum of 6 tablets (3 grams) per day for the duration of the study

Exclusion Criteria:

- 1. Partial or total replacement of either knee joint, past or planned/expected during study duration.

2. OA of the knee due to other underlying conditions, such as gout, chondrocalcinosis, hemochromatosis, joint infections, neuropathia, or severe traumatic joint damage (however, common risk factors, such as obesity and past meniscectomy or ligament rupture and repair, are allowed); 3. History of systemic inflammatory (autoimmune) disease (rheumatoid arthritis, systemic psoriasis, systemic lupus erythematosus, systemic sclerosis, etc.) or laboratory values indicative of such disease with subsequent diagnosis by a physician; 4. Fibromyalgia within the previous year; 5. Allergy or asthma to diclofenac, APAP, aspirin, other NSAIDs or any of the ingredients in the gel (i.e. isopropyl alcohol, propylene glycol, or butylhydroxytoluene), or any other contraindication for the study drug or the rescue medication

Primary outcomes:
measure: Measure: Pain On Movement (POM)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Hersfeld
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Munich
country: Germany
city: Stockach
country: Germany
Study officials:
References:
Clinical trial NCT01325350: Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alopecia
Baldness
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-03-29
Enrollment: 306
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 2% solution in women with female pattern hair loss. All treatments will be provided in a double-blinded fashion except for minoxidil 2% solution which will be provided open-label.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate female pattern hair loss with ongoing hair loss for at least 1 year
* Willingness to have micro-dot-tattoo applied to scalp
* Willingness to maintain same hair style, length and hair color during study

Exclusion Criteria:

* Drug or alcohol abuse within 12 months
* HIV positive
* Received hair transplants or had scalp reductions
* Use of hair weaves, hair extensions or wigs within 3 months
* Oral or topical minoxidil treatment within 6 months
* Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks

Primary outcomes:
measure: Change From Baseline in Target Area Hair Count (TAHC)
timeFrame: Baseline, Month 6
measure: Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
timeFrame: Baseline, Month 6
measure: Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
timeFrame: Baseline, Month 6
measure: Change From Baseline in Target Area Hair Width (TAHW)
timeFrame: Baseline, Month 6
measure: Change From Baseline in Target Area Hair Darkness (TAHD)
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Portland
country: United States
state: Oregon
city: Berlin
country: Germany
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02547350: Prophylactic Intravesical Chemotherapy to Prevent Bladder Tumors After Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Upper Tract Urothelial Carcinoma
Bladder Recurrence
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2015-09-11
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy of prophylactic intravesical chemotherapy (different chemotherapy drugs and dosage regimen) in the prevention of bladder recurrence after nephroureterectomy for upper tract urothelial carcinoma (UTUC).


Eligibility criteria: Inclusion Criteria:

1. Patients who were clinically diagnosed with UTUC
2. Treated with radical nephroureterectomy

Exclusion Criteria:

1. Distant metastasis
2. Prior history of bladder or synchronous bladder cancer
3. Administration of neoadjuvant chemotherapy
4. Presence of severe complications.

Primary outcomes:
measure: intravesical recurrence-free survival
timeFrame: two years after surgery
Secondary outcomes:
measure: cancer-specific survival
timeFrame: two years after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05084950: Informing the Population of Their Level of Protection Against COVID-19 in Monaco: a Prospective Study (MonaVacc)
Official title: Informing the Population of Their Level of Protection Against COVID-19 in Monaco: a Prospective Study (MonaVacc)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2
COVID-19
Vaccines
Antibody
Lead sponsor: Centre Scientifique de Monaco
Sponsor class: OTHER
Collaborators: name: Department of Health Affairs, Monaco
First posted: 2021-10-20
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a single-centre prospective observational study in the general population of the Principality of Monaco, attending the community public health center of Monaco, for Covid testing and/or vaccination.

Brief summary: Vaccines against the coronavirus type 2 causing severe acute respiratory syndrome Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) have been created in a short period of time due to the rapid spread of the virus. These vaccines use different and sometimes innovative technologies, such as the use of ribonucleic acid (RNA), or a non-replicating viral vector. Efficacy ranging from 70-90% in the first weeks after the second injection of these vaccines has been reported, with side effects whose causality remains to be determined.

Detailed description: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Eligibility criteria: Inclusion Criteria:

* Participant must live in the Principality of Monaco
* Deliver a written consent to participate to the study
* And/Or Have been infected with SARS-CoV-2
* And/Or Have been, or are about to be, vaccinated against SARS-CoV-2

Exclusion Criteria:

- None of the above

Primary outcomes:
measure: Covid-19 Neutralizing Antibodies Measurment
timeFrame: 24-month period
Secondary outcomes:
Other outcomes:
Locations:
city: Monaco
country: Monaco
facility: Centre National de Depistage - Espace Leo Ferre
Study officials:
References:
Clinical trial NCT01620450: Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese
Official title: A Single-centre, Randomised, Double Blind, Cross-over Trial Demonstrating the Bioequivalence Between NN2000-Mix30 and NN-X14Mix30 (NovoRapid® 30 Mix) in Healthy Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-06-15
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process in healthy Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* Japanese
* Considered generally healthy based on medical history and physical examination
* Body Mass Index (BMI) between 18 and 27 kg/m\^2 (both inclusive)
* Fasting plasma glucose between 3.8 mmol/L (68.4 mg/dL) and 6.0 mmol/L (108.0 mg/dL)

Exclusion Criteria:

* Clinically significant abnormal values in clinical laboratory tests of haematology, biochemistry, fasting plasma glucose and urinalysis
* Any serious systemic infectious disease that occurred during the last 4 weeks before trial
* Any inter-current illness that may affect blood glucose
* Subject with a first degree relative with diabetes mellitus
* Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 4 weeks

Primary outcomes:
measure: Area under the curve of insulin aspart concentration (AUC IAsp, 0-16h)
timeFrame: From 0 to 16 hours after injection
measure: Maximum insulin aspart concentration (Cmax IAsp)
Secondary outcomes:
measure: Area under the curve of insulin aspart concentration (AUC IAsp)
measure: Time to maximum insulin aspart concentration (tmax IAsp)
measure: Terminal elimination half life (t½)
measure: Body weight
measure: Adverse events
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00519350: Towards a High-fat Feeding Intervention Study: Identification of Markers for Inflammation and Organ Damage
Official title: Towards a High-fat Feeding Intervention Study: Identification of Markers for Inflammation and Organ Damage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Inflammatory Response Syndrome
Sepsis
Keywords: SIRS, sepsis and related syndromes
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2007-08-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in Maastricht University Hospital area undergoing one of selected types of surgery

Brief summary: Patients undergoing major surgery, trauma or burns are prone to develop an exacerbated inflammatory response, which is potentially lethal to the individual. Recently, the researchers' group showed in a rodent model of hemorrhagic shock that high-fat feeding administered before shock attenuates inflammation and reduces intestinal and hepatic damage. In the mechanism that underlies this protective effect, the release of cholecystokinin in gut wall and activation of efferent vagus bundles are crucial events. Before investigating the effect of high-fat nutrition in clinical setting, suitable markers of inflammation and organ damage need to be selected. In this study, blood will be collected in patients undergoing different types of operations. Consequently several markers for inflammation and organ damage will be determined. Hence, suitable parameters for a future high-fat intervention study will be selected.


Eligibility criteria: Inclusion Criteria:

* \> 18 years
* elective liver / colon / femur surgery

Exclusion Criteria:

* Acute inflammation
* Chronic Obstructive Respiratory Disease
* Recent history of abdominal pain or diarrhea
* BMI \< 18.5
* Alcohol or Drugs abuses
* Recent intake of antibiotics

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Hospital
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Jan-Willem Greve, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05279950: Full Mouth Ultrasonic Debridement Carried Out Either by Piezoelectric or Magnetostrictive Device
Official title: Clinical and Patient Centred Outcome Performance of Full Mouth Ultrasonic Debridement Carried Out for the Treatment of Periodontitis Performed Either by Piezoelectric or Magnetostrictive Device. A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis, Adult
Keywords: periodontitis
patient centred outcomes
magnetostrictive
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of periodontitis requires removal of dental biofilm both through professional mechanical plaque removal and domiciliar oral hygiene procedures. This study aims to compare biometric and psychological results after professional treatment of periodontitis carried out by piezoelectric or magnetostrictive ultrasonic devices.

Detailed description: Patients diagnosed with periodontitis will be assessed for eligibility criteria. Full-mouth periodontal assessment will be performed by an examiner to detect severity and extension of the disease. Thereafter, patient will receive oral hygiene instruction and a closed envelope with patient allocation will be opened. After the allocation to the intervention group, full-mouth ultrasonic debridement will be delivered to the patient by an operator and information about patient perception will be collected. Three months later, patients will be recalled for a new periodontal assessment.

Eligibility criteria: Inclusion Criteria:

* \>18 years
* periodontitis of stage 1 and 2
* absence of systemic chronic disease

Exclusion Criteria:

* anticoagulants treatment
* antibiotic treatment 3 months before the screening visit

Primary outcomes:
measure: Pain perception
timeFrame: through study completition, 1 year
measure: noise
timeFrame: through study completition, 1 year
measure: vibration
timeFrame: through study completition, 1 year
Secondary outcomes:
measure: pocket closure
timeFrame: through study completition, 1 year
Other outcomes:
Locations:
city: Siena
country: Italy
facility: AOUS
Study officials:
References:
Clinical trial NCT04984850: Oncology - Bolstering Oral Agent Reporting Related to Distress
Official title: Feasibility, Acceptability, and Potential Effects of a Comprehensive Oral Chemotherapy Intervention on Medication Adherence Self-efficacy, Medication Adherence, and Symptom Distress: A Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Chemotherapy
Keywords: Oral chemotherapy
medication adherence
self-efficacy
pilot randomized control trial
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Rossy Cancer Network
First posted: 2021-08-02
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Individuals on oral chemotherapy (OC) often face many challenges requiring adequate informational support, monitoring, and management. This pilot randomized control trial (RCT) aims to assess the feasibility, acceptability, and preliminary effects of a comprehensive OC intervention on medication adherence self-efficacy, medication adherence, and symptom distress.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Diagnosis of cancer, any stage
* Being followed by a care team at the affiliated hospital centre
* About to start or within the first cycle of oral anticancer treatment (traditional cytotoxic, targeted therapy, hormonal therapy as active ongoing treatment for cancer with the aim of killing cancer cells/shrinking tumor size)
* Has a computer/tablet/smartphone device with internet
* The ability to communicate, read, and write in English or French

Exclusion Criteria:

* Receiving IV chemotherapy, immunotherapy, and/or oral hormonal therapy as long-term maintenance treatment for prevention of cancer's return/growth of cancer cells after initial treatment
* Significant physical or cognitive limitations that would prevent ability to participate in study as reported by patient, primary healthcare provider, or research staff
* At imminent "end-of-life"
* Participating in an ongoing clinical trial

Primary outcomes:
measure: Feasibility and acceptability
timeFrame: Five months
Secondary outcomes:
measure: Potential effects of intervention via medication adherence self-efficacy, medication adherence and symptom distress
timeFrame: Five months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CIUSSS du Centre-Ouest-de-l'Île-de-Montréal
state: Quebec
Study officials:
References: