louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02365558: A Study to Evaluate the Effect of Increased Stomach pH on Evacetrapib in Healthy Participants
Official title: Evaluation of the Impact of Increased Gastric pH Following Omeprazole Administration on the Pharmacokinetics of Evacetrapib in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-02-19
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the effect of increased stomach pH on how much evacetrapib is found in the blood stream and how long the body takes to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected.

There are two parts to the study. Participation in both parts will be required.

The study will last approximately 30 days, not including screening.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy participants, as determined by medical history and physical examination
* Females must be of non-child-bearing potential
* Have a body mass index of 18 to 32 kilograms per square meter (kg/m\^2)

Exclusion Criteria:

* Have known allergies to evacetrapib, omeprazole, related compounds, or any components of the evacetrapib or omeprazole formulations

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib
timeFrame: Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8,12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose
measure: Pharmacokinetics (PK): Time of Maximum Observed Concentration (Tmax) of Evacetrapib
timeFrame: Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])
timeFrame: Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Madison
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00689858: Study to Assess the Effect of Pharmacokinetics/Pharmacodynamics (PK/PD) Interaction After co-Administration of Cilostazol With Ginkgo Biloba or Placebo
Official title: Clinical Trial to Assessment the PK/PD Characteristics and Safety After co-Administration of Cilostazol With Ginkgo Biloba or Placebo in Healthy Subject.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteers
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-06-04
Enrollment: 40
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: TO assess the PK/PD effect of co-administerd Cilostazol with Ginkgo biloba or placebo, Phase I study in healthy Volunteers were designed


Eligibility criteria: Inclusion Criteria:

* healthy male adult volunteer between 19 and 45 years of age and within 15% of ideal body weight by broca's formula.
* the subjects who doesn't have any congenital or chronic diseases and symptoms or signs of diseases after physical examinations.\]

Exclusion Criteria:

* the subject who has abnornal lab. ( In particular, AST or ALT \> 1.25 times of upper limit / Total bilirubin \> 1.5 times of upper limit/170,000 \< Platelet \< 360,000 / PT or aPTT or BT\> \>upper limit
* the subject who receive any metabolic enzyme inducing or inhibiting drugs like barbiturates or drink excess alcohol within 1 month prior to the study.

Primary outcomes:
measure: Maximum plasma concetration of Cilostazol at steady state
timeFrame: within 12hrs after cilostazol
Secondary outcomes:
measure: PD parameter: change from baseline after administration (change value of aggregation %)
timeFrame: within 12hrs after cilostazol
Other outcomes:
Locations:
city: Pusan
country: Korea, Republic of
facility: INJE University Pusan Paik Hospital
city: Seoul
country: Korea, Republic of
facility: SK chemicals
city: Seoul
country: Korea, Republic of
facility: SKChemicals
Study officials:
affiliation: Inje University
name: Jae Gook Shin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02971358: Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer
Official title: Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer - a Prospective Single Center Phase I/II Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Locally Advanced and Metastatic Prostate Cancer
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prostate cancer is the most common non-skin cancer diagnosed among men and the second leading cause of male cancer deaths in the United States. In 2013, it is estimated that 29,270 men have died from prostate cancer. Although radiation and surgery are quite effective for localized disease, there is no effective cure for men who present with metastatic prostate cancer as the 5-year relative survival rate is only 28%.

Currently, androgen deprivation therapy (ADT) via medical or surgical castration is the standard first-line therapy in men with metastatic disease but castration-recurrent prostate cancer (CRPC) eventually emerges with a median time of 18-24 months. Once CRPC develops, secondary hormonal manipulation, chemotherapy, and immunotherapy are marginally effective.

Given the dismal prognosis of metastatic prostate cancer, new ideas and novel approaches must be explored to improve the clinical outcome. In this regard, recently emerging data suggest that local tumor control may enhance the effectiveness of subsequent systemic therapies. Therefore, in this proposal, the investigators have designed a Phase I/II study in which they will prospectively evaluate the safety and feasibility of cytoreductive prostatectomy in men with newly diagnosed mPCa.


Eligibility criteria: Inclusion Criteria:

* Adenocarcinoma of the prostate
* Very high risk PCA (PSA ≥ 20 oder Gleason Score ≥ 8 oder ≥ cT3) and/or oligometastasierte PCA (T any N positive M any, oder T any N any M positive)
* ≤5 bone metastasis
* ≤75 years
* Ability for informed consent
* Clinically no infiltration into the rectum or pelvic wall
* Clinically no visceral metastasis
* Male, \>18 Jahre
* Fit for surgery
* ECOG Performance Status 0 oder 1

Exclusion Criteria:

* Male, \< 18 Jahre
* \> 5 bone metastasis
* \> 75 years
* No ability for informed consent
* Clinically infiltration into the rectum or pelvic wall
* Not fit for surgery
* Clinically visceral metastasis

Primary outcomes:
measure: The rate of perioperative complications within 90 days after surgery (Clavien-Dindo-classification)
timeFrame: 90
Secondary outcomes:
measure: Time to start androgen deprivation therapy
timeFrame: 2 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT04270058: TEGSEDI Pregnancy Surveillance Program
Official title: Pregnancy Surveillance Program of Women and Infants Exposed to TEGSEDI During Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy
Pregnancy
Keywords: Hereditary transthyretin amyloidosis with polyneuropathy
Hereditary transthyretin amyloidosis
hATTR
hATTR-PN
Rare disease
Lead sponsor: Akcea Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-02-17
Enrollment: 20
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There will be 2 cohorts:

Cohort 1 will be pregnant patients who have been exposed to at least 1 dose of TEGSEDI within 25 weeks prior to conception or during pregnancy.

Cohort 2 will be pregnant patients who have hATTR-PN, who were not exposed to TEGSEDI or have not received TEGSEDI within the previous 25 weeks prior to conception.

The exposed cohort will include pregnant patients from any country where TEGSEDI is marketed and/or clinical trials, post-market studies and registries are being conducted or expanded access programs are available.

Brief summary: This is a worldwide safety surveillance study of pregnancy outcomes in women with hATTR-PN who may have been exposed or were not exposed to TEGSEDI prior to or during the pregnancy and of pediatric outcomes up to 1 year of age.


Eligibility criteria: Inclusion Criteria:

TEGSEDI exposed patients (Cohort 1) meeting the following criteria will be eligible for study entry:

1. Pregnancies exposed to at least 1 dose of TEGSEDI within 25 weeks prior to conception or during pregnancy.
2. Able and willing to provide informed consent.

Unexposed patients (Cohort 2) meeting the following criteria will be eligible for study entry:

1. Have a diagnosis of hATTR-PN during pregnancy.
2. Have not been exposed to TEGSEDI within 25 weeks prior to conception or during pregnancy.
3. Able and willing to provide informed consent.

Exclusion Criteria:

None

Primary outcomes:
measure: Frequency of Selected Pregnancy and Fetal/Neonatal Outcomes
timeFrame: 10 years or 12 months after the last live birth whichever is later
measure: Frequency of Selected Pregnancy Complications
timeFrame: 10 years or 12 months after the last live birth whichever is later
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: TEGSEDI Pregnancy Coordinating Center
state: West Virginia
Study officials:
References:
Clinical trial NCT01348958: Evaluation of Orthopedic Knee Measurement Using Lunar iDXA
Official title: Evaluation of Orthopedic Knee Measurement Using Lunar iDXA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemi Knee Arthroplasty
Patello-femoral Osteoarthritis
Keywords: Patello femoral
osteoarthritis
arthroplasty
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2011-05-06
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is to compare scans of the knee performed using new software designed specifically to look at the knee joint with those performed using approved software designed for scans of the hip.


Eligibility criteria: Inclusion Criteria:

1. Adult (\>30 years) males and females.
2. Have had a hemi knee replacement of one knee at least 8 weeks ago.
3. Patello-femoral osteoarthritis is not a contraindication if person does not have symptoms from the patello-femoral joint.
4. Able to provide informed consent.
5. In good general health.

Exclusion Criteria:

1. Neuromuscular or vascular disease in the affected leg.
2. Found to be unsuitable for hemi knee arthroplasty (KA) before or at surgery.
3. Preoperative extensions defect greater than 15 degrees.
4. Preoperative maximal flexion of less than 100 degrees.
5. Symptomatic patello-femoral osteoarthritis.
6. Insufficiency of anterior cruciate ligament (ACL)
7. Fracture sequalae (Intraarticular fracture and all tibial condyle fractures).
8. Previous osteotomy.
9. Previous extensive knee surgery.
10. Metabolic bone disease including osteoporosis with a T score of \<-2.5.
11. Rheumatoid arthritis.
12. Postmenopausal women on systemic hormone replacement therapy (HRT).
13. Long-term treatment with oral corticosteroids and/or bisphosphonates.
14. Inability to consent (such as Alzheimer's Disease).
15. Misuse of drugs or alcohol.
16. Serious psychiatric disease.
17. Disseminated malignant disease and treatment with radiotherapy or chemotherapy.

Primary outcomes:
measure: Efficacy of Lunar orthopedic knee software.
timeFrame: 5 months from starting study.
Secondary outcomes:
Other outcomes:
Locations:
city: Cashmere
country: New Zealand
facility: CGM Research Trust - Princess Margaret Hospital
state: Christchurch
Study officials:
affiliation: CGM Reseach Trust - Princess Margaret Hospital
name: Nigel Gilchrist, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04644458: Use of Ulna Length to Predict Tidal Volume in Adult Egyptians
Official title: Use of Ulna Length to Predict Protective Lung Tidal Volume in Adult Egyptians
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tidal Volume
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult Egyptian volunteers

Brief summary: The aim of the study is to evaluate the ability of ulna length to predict accurate protective lung tidal volume in Egyptian people in reference to their standing height.

Detailed description: After approval of local ethical committee and informed consent, one hundred healthy volunteers will be rnrolled in this study. Height of each subject will be measured while standing upright against a wall. Then, the left ulna will be measured with a measure tape from the olecranon to mid point of styloid process. From ulna length, height is estimated as advised by Malnutrition Advisory Group, British Association of Parenteral and Enteral Nutrition. October 2008. Malnutrition Universal Screening Tool.Protective lung tidal volume is calculated as 6 ml/kg predicted body weight (PBW) as follow:

PBW= 50\*0.91 (centimetres of height - 152.4) in males and 45.5\*0.91(centimetres of height - 152.4) in females.

Each measurement will be performed only once for each subject. Agreement between measurements will be expressed by the Bland-Altman method.

Eligibility criteria: Inclusion Criteria:

- Healthy adult Egyptian

Exclusion Criteria:

- Deformity or previous surgery in the left arm

Primary outcomes:
measure: Protective lung tidal volume
timeFrame: measurement of left ulna while standing for each volunteer throught the study completion, average 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university hospital
Study officials:
affiliation: Consultant of anesthesia and ICU Elhelal insurance hospital
name: Hosam eldeen M Marie, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02885558: Role of Calcium Channels in Vascular Function
Official title: Role of T-type Calcium Channels in Vascular Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelium, Vascular
Keywords: Receptors, Calcium Channel Blocker
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the role of T-type calcium channels in endothelial dysfunction observed with ageing.


Eligibility criteria: Inclusion Criteria:

* age 20 - 30 and 60-70
* BMI \< 30

Exclusion Criteria:

* Hypertension (\>150/90 mmHg)
* Smoking
* Physical activity \>2 hours/week
* Known chronic diseases
* Pregnancy or birth within 3 month
* Alcohol misuse

Primary outcomes:
measure: Vascular function
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Centre for Phsical Activity Research
city: Odense
country: Denmark
facility: Cardiovascular and Renal Research
Study officials:
References:
Clinical trial NCT02149758: EFFECT OF SELECTIVE COX-2 INHIBITOR (ETORICOXIB) ALONG WITH SCALING AND ROOT PLANING (SRP) ON CLINICAL PARAMETERS AND SALIVARY LEVEL OF SUPEROXIDE DISMUTASE IN CHRONIC GENERALIZED PERIODONTITIS A DOUBLE-BLIND, PLACEBO-CONTROLLED, DOUBLE-MASKED RANDOMIZED CONTROLLED TRIAL (RCT).
Official title: EFFECT OF SELECTIVE COX-2 INHIBITOR (ETORICOXIB) ALONG WITH SCALING AND ROOT PLANING (SRP) ON CLINICAL PARAMETERS AND SALIVARY LEVEL OF SUPEROXIDE DISMUTASE IN CHRONIC GENERALIZED PERIODONTITIS A DOUBLE-BLIND, PLACEBO-CONTROLLED, DOUBLE-MASKED RANDOMIZED CONTROLLED TRIAL (RCT).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cyclooxygenase Two Inhibitors
Etoricoxib
Periodontitis
Superoxide Dismutase
Saliva
Keywords: Cyclooxygenase two inhibitors
Etoricoxib
Periodontitis
Superoxide dismutase
Saliva
Lead sponsor: Tatyasaheb Kore Dental College
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The hypothesis is that Etoricoxib act as an adjuvant to SRP in alleviating periodontal inflammation by:

1. improving clinical periodontal parameters and,
2. improving the salivary SOD levels.


Eligibility criteria: Inclusion Criteria:Forty patients with chronic generalized periodontitis

-

Exclusion Criteria:with system illnesses, allergies, pregnancy, history of any drug intake and periodontal treatment in past 6 months.

Primary outcomes:
measure: change from baseline in salivary SOD level
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kolhapur
country: India
facility: Tatyasaheb kore Dental College And Research Centre
state: Maharashtra
Study officials:
affiliation: Tatyasaheb Kore Dental College And Research Centre
name: Dr.Sumit S. Shetgar, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02583958: Assessment of Efficacy & Safety for a New Wound Dressing Urgo 310 3166 in the Local Treatment of VLU or Mixed Leg Ulcers
Official title: Assessment of Efficacy and Safety for a New Wound Dressing URGO 310 3166 in the Local Treatment of Venous or Mixed Leg Ulcers: A European, Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leg Ulcers
Lead sponsor: Laboratoires URGO
Sponsor class: INDUSTRY
First posted: 2015-10-22
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: Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local treatment of venous or mixed leg ulcers: a European, randomised clinical trial.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old who has provided his/her written informed consent,
* Patient who can be monitored by the same investigation team throughout the whole duration of the study,
* Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing,
* Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3,
* Ulcer area \> or equal to 5cm2,
* Ulcer duration \> or equal to 6 months,
* Ulcer presenting a the surface wound bed covered with 50% or more by sloughy tissue,
* Moderately or heavily exudative ulcers.

Exclusion Criteria:

* Clinical infection on the wound bed.

Primary outcomes:
measure: Relative regression of wound surface area
timeFrame: week 20
Secondary outcomes:
measure: Percentage of debrided wounds
timeFrame: at each clinical evaluation up to 20 weeks
measure: Occurrence of adverse events as assessed by the investigator according to a classification MedDRA
timeFrame: between inclusion and week 20
measure: Patient's Quality of Life
timeFrame: at inclusion visit and at week 20 or at the end of study treatment
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital Rothschild
Study officials:
affiliation: Hospital Rothschild - Paris - France
name: Sylvie Meaume, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00862758: Request for Single Patient IND for Compassionate/Emergency Use of Tocilizumab
Official title: Emergency IND for Provision of Tocilizumab
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Juvenile Idiopathic Arthritis
Keywords: juvenile idiopathic arthritis
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2009-03-17
Sex: MALE
Minimum age (years): 11
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: Application for Compassionate Use of Tocilizumab in a Boy with Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) Unresponsive to All Licensed Medications.

Detailed description: This trial is for a single subject with juvenile idiopathic arthritis unresponsive to all licensed treatments for JIA, and some licensed only for rheumatoid arthritis. He is currently wheelchair bound and completely dependent for activities of daily living and self-care. He is in constant pain, has abundant warmth and swelling of nearly all joints including TMJs, neck, shoulders, elbows, wrists, MCP and finger joints (even some DIP joints), hips, knees, ankles, subtalar and intertarsal joints, MTP and IP joints of the toes.

Drug at a dose of 8 mg/kg would be administered IV every 2 weeks, with close safety and monitoring studies.

Treatment would be monitored every 2 weeks. Efficacy will be measured using the ACR Pedi 30, 50 and 90 definitions as previously published, based on: 1) physician global assessment of disease activity; 2) parent/patient assessment of overall well-being; 3) functional ability; 4) number of joints with active arthritis; 5) number of joints with limited range of motion; and 6) erythrocyte sedimentation rate.

Eligibility criteria: Inclusion Criteria:

* Subject X, polyarticular JIA, not responding to any other drug

Exclusion Criteria:

* Not identified subject

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma CIty
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Kathleen O'Neil, M.D.
role: PRINCIPAL_INVESTIGATOR
References: