louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04923269: A Study of LY3532226 in Healthy Participants
Official title: A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3532226 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-06-11
Enrollment: 41
Sex: ALL
Minimum age (years): 21
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 main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in healthy participants. Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it. This study will last approximately 8 weeks including screening period.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy males or females not of childbearing potential.
* Body mass index (BMI) within the range of 18.5 to 40 kilograms per meter squared (kg/m²), inclusive

Exclusion Criteria:

* Have a significant history of or current CV (e.g., myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk while taking the study intervention; or of interfering with the interpretation of data
* Have a history of malignancy within 5 years prior to screening
* Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis
* Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2X the upper limit of normal (ULN) or total bilirubin level (TBL) \>1.5X ULN
* Have serum triglyceride level ≥5 mmol/L (442.5 mg/dL)
* Have undergone any form of bariatric surgery
* Have received systemic or inhaled glucocorticoid therapy (excluding topical, intraarticular, and intraocular preparations); for more than 14 consecutive days within 4 weeks before screening

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline up to Week 8
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226
timeFrame: Day 1 through Day 43
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226
timeFrame: Day 1 through Day 43
measure: PK: Time to Maximum Concentration (Tmax) of LY3532226
timeFrame: Day 1 through Day 43
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Lilly Centre for Clinical Pharmacology
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 NCT06134869: Open Membrane Technique as an Innovative Minimally Invasive Technique
Official title: Open Membrane Technique as an Innovative Minimally Invasive Technique for Hard and Soft Tissue Augmentation: a Prospective Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Graft
Keratinized Tissue
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Sixteen patients with horizontal deficiencies in the posterior mandible were treated with "the Open Membrane Technique" (OMT). Dense PTFE membranes covering an allograft biomaterial were used without any attempt to passivate the flap. Flap closure with an open wound (membrane exposure) was monitored weekly for up to 6w at the time of membrane removal. At implant placement, soft and hard tissue gains were assessed clinically and radiographically. Bone cores were harvested for histological analysis from the implant preparation sites


Eligibility criteria: Inclusion Criteria:

* Healthy adults
* Free of any systemic disease affecting bone metabolism
* Highly compliant
* Good oral hygiene
* Willing to sign informed consents prior to their inclusion

Exclusion Criteria:

* Untreated periodontal disease
* Heavy smokers
* Excessive alcohol consumption
* Uncontrolled systemic conditions

Primary outcomes:
measure: Hard tissue gain
timeFrame: 5 months
Secondary outcomes:
measure: Soft tissue gain
timeFrame: 5 months
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Clinic 506
state: Ashrafieh
Study officials:
References:
Clinical trial NCT00388869: Renal Artery Calcium and Hypertension
Official title: Calcifications of the Renal Arteries and Renal Artery Stenosis in Patients With and Without Hypertension?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Atherosclerosis
Keywords: renal artery
calcium
CT
hypertension
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-10-17
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: CT of the abdomen is a very common examination performed for various indications.One of the common findings is vascular calcifications including calcifications of the renal arteries.Calcifications in the carotid arteries and coronary arteries are good predictor for obstructive atherosclerotic disease.Stenosis of the renal arteries can cause symptomatic or asymptomatic hypertension with subsequent clinical sequelae. Therefore early diagnosis of this condition is imperative.

The goal of our study is to investigate the correlation between incidental calcifications of the renal arteries in CT examinations and the presence of actual stenosis of these vessels in patients with and without hypertension.

Detailed description: Every patient aged 30-100 referred for abdominal CT examination with IV contrast injection will be included in this study (total 300 patients.Prior to the examination relevant clinical data including history of hypertension and predisposing conditions for atherosclerotic disease, will be investigated. The patient will undergo conventional CT with no special procedures. The images will be review by the radiologist for the presence of renal arteries calcifications, renal arteries stenosis,plaque location, plaque burden and characterization and secondary renal pathology.

This study will not change the examination technique and is not associated with any inconvenience to the patients.

Eligibility criteria: Inclusion Criteria:

* Every patient referred fo abdominal CT aged 30-100

Exclusion Criteria:

* Contraindication for IV contrast injection failure to demonstrate renal arteries with contrast refusal to sign an informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Nurith Hiller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05542069: Measurement of the Diaphragm Loading During the Training With a IMT Device
Official title: Measurement of the Diaphragm Loading During the Training With a Inspiratory Muscle Trainer Device
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sports Physical Therapy
Lead sponsor: Clínica Basilea
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy adult volunteers

Brief summary: It is well known that the the training with the IMT device increases the Maximal Inspiratory Pressure. Nonetheless, there are doubts about which muscles are involved during this training. The aim of this study is to determine the diaphragm loading of healthy subjects during the training with a IMT device from a low . Therefore, each subject will be monitored using esophageal and gastric manometry.

Detailed description: This study has a quasi-experimental design. The investigators will recruit ten healthy adult volunteers without anticoagulation or esophageal lesions, after signing a consent form.

After checking the appropriate correct position of each catheter, each subject will use the IMT device throughout different randomized loads (percentages of the maximal inspiratory pressure, counting by tens from 10% to 100%). FluxMed® GrT MBMed respiratory mechanic monitor will be used. Each percentage of resistive load will be maintained for 5 inspirations. Meanwhile, an operator will register the esophageal pressure,the gastric pressure and the transdiaphragmatic pressure. Diaphragm collaboration in each percentage of resistive load will be determine by calculating the relation between the gastric pressure and the transdiaphragmatic pressure (∆Pgas/∆Pdi).

Eligibility criteria: Inclusion Criteria:

* older than 18 years
* healthy subjects

Exclusion Criteria:

* without anticoagulation
* without esophageal lesions
* without airway lesions
* without spirometry alterations

Primary outcomes:
measure: Diaphragm intervention during a certain percentage of resistive load with a IMT device
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Clinica Basilea
Study officials:
affiliation: Clinica Basilea
name: Dario Villalba, PT
role: STUDY_DIRECTOR
References:
Clinical trial NCT00176969: Response of Topical Capsaicin in Alopecia Areata
Official title: Perifollicular Nerves in Alopecia Areata: Response to Topical Capsaicin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alopecia Areata
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: It has been postulated that Alopecia Areata (AA) is, at least in part, a neurologically mediated disease. Research supporting this theory includes the finding that nerves surrounding the hair follicles are collapsed. We want to take this research a step further and show that not only are these perifollicular nerves collapsed, but that their function is also impaired.

Detailed description: To assess the function of perifollicular scalp nerves in AA we will look at the response of these nerves to the topical medication capsaicin. Under normal circumstances topical capsaicin is known to target nerves in the peripheral nervous system causing short-term release of the neuropeptide Substance P (SP) as well as long-term transient depletion of SP. We expect the AA patients will respond abnormally to topical capsaicin treatment.

Eligibility criteria: Inclusion Criteria:

* Must have alopecia totalis or universalis.
* Be in good health.
* Not be taking any medications including topical medications
* Be 18 years or older.
* Be willing to apply study medication or vehicle as directed, comply with instructions and commit to follow-up visits.
* Not have had hair chemically treated (including colored hair, permed hair, etc) within the month prior to the study.

Exclusion Criteria:

* Absence of extensive alopecia areata.
* People not in good health.
* People taking medications.
* Allergies to capsaicin.
* Presence of irritated or visibly inflamed scalp.
* Having had hair chemically treated (including colored hair, permed hair, etc.) within the month prior to study.

Primary outcomes:
measure: Topical capsaicin will quantitatively decrease the amount of Substance P in the scalp of AA patients.
Secondary outcomes:
measure: The scalps of AA patients may be less sensitive to stimuli.
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Maria Hordinsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Marna Ericson, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02152969: Drug-drug Interaction Study (Telmisartan, Amlodipine, Chlorthalidone)
Official title: An Open-label, Multiple-dose, Two-arm Clinical Study to Evaluate the Drug-drug Interaction and Safety of Telmisartan, Amlodipine and/or Chlorthalidone in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2014-06-02
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate Drug-drug interaction

Detailed description: The purpose of this study is to evaluate the Drug-Drug(telmisartan, amlodipine and/ or chlorthalidone) interaction and safety in healthy adult volunteers.

Eligibility criteria: Inclusion Criteria:

1. Participant who has a body weight that is ≥55kg(male) or ≥50kg(female) with ideal body weight of 80-120% (ideal body weight)
2. Who has not suffered from clinically significant disease
3. Provision of signed written informed consent

Exclusion Criteria:

1. History of and clinically significant disease psychiatric, or malignancy.
2. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
3. Administration of other investigational products within 3 months prior to the first dosing.
4. Administration of herbal medicine within 2 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
5. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.

Primary outcomes:
measure: AUCt ss, Cmax ss of telmisartan/amlodipine/chlorthalidone
timeFrame: Totally 28points for 24 hours
Secondary outcomes:
measure: Cmin ss, tmax ss, t1/2 of telmisartan/amlodipine/chlorthalidone
timeFrame: Totally 28points for 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St.Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Dong Seok Yim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00969969: A Study to Evaluate the Effectiveness and Safety of an Implant in the Treatment of Osteoarthritis of the Great Toe
Official title: A Study to Evaluate the Effectiveness and Safety of an Implant in the Treatment of Osteoarthritis of the Great Toe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of First Metatarsalphalangeal Joint
Keywords: First MTP Joint
Hallux Rigidus
Hallux Limitus
Cartilage Replacement
Osteoarthritis
First MTP Joint Osteoarthritis
Big Toe Pain
Lead sponsor: Cartiva, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-02
Enrollment: 236
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: This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the great toe.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Osteoarthritis of the first metatarsophalangeal joint and is a candidate for arthrodesis
* Presence of good bone stock
* Capable of completing self-administered questionnaires

Exclusion Criteria:

* \< 18 years of age
* Osteoarthritis of the first metatarsophalangeal joint, though is not a candidate for arthrodesis
* Active bacterial infection of the foot
* Additional ipsilateral limb (hip, knee, ankle, or foot) pathology that requires active treatment (surgery or brace)

Primary outcomes:
measure: VAS, FAAM, Safety
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Fredericton
country: Canada
facility: Horizon Health Network
state: New Brunswick
city: Halifax
country: Canada
facility: Queen Elizabeth Science Centre
state: Nova Scotia
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital - Surrey Foot and Ankle Clinic
state: Camberley
city: Tooting
country: United Kingdom
facility: St. George's Hospital
state: London
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital - Stanmore Foot & Ankle Clinic
state: Middlesex
city: Sheffield
country: United Kingdom
facility: Northern General Hospital NHS Trusts - Sheffield Orthopaedics
state: South Yorkshire
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
state: Surrey
city: South Devon
country: United Kingdom
facility: Torbay Hospital
state: Torquay
Study officials:
affiliation: University of Rochester
name: Judith Baumhauer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02892669: Predictive Value of Heart Rate Variability on Outcome in Patients Admitted to the Intensive Care Department
Official title: Predictive Value of Heart Rate Variability on Outcome in Patients Admitted to the Intensive Care Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the intensive care department

Brief summary: This study is designed to evaluate the predictive value of heart rate variability on medial outcome in patients admitted to the intensive care department


Eligibility criteria: Inclusion Criteria:

* adults admitted to ICU

Exclusion Criteria:

* rhythm other then sinus
* presence of cardiac pacemaker

Primary outcomes:
measure: Mortality
timeFrame: 6 months
Secondary outcomes:
measure: ICU stay
timeFrame: 6 months
measure: Hospital stay
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02936869: Incentives for Postnatal Care Demand
Official title: Incentives for Postnatal Care Demand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Death
Neonatal Death
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to identify the causal impact of performance-based monetary incentives in increasing postnatal care (PNC) referrals by traditional birth attendants (TBAs), via a randomized controlled trial (RCT).


Eligibility criteria: Inclusion Criteria:

* community-based providers of antenatal and/or delivery care, and who are non-formally trained
* must be resident within the community
* must not plan to relocate over the intervention duration
* identified in partnership with community leadership
* be willing to participate fully in the study, including having their clients contacted for verification

Exclusion Criteria:

* plan to relocate over the intervention duration
* refusal to provide informed consent for the entire study protocol including agreeing to have their delivery clients contacted for verification

Primary outcomes:
measure: Maternal Postnatal Care Referral
timeFrame: Within 48 hours of delivery
Secondary outcomes:
measure: Neonatal Postnatal Care Referral
timeFrame: Within 48 hours of delivery
Other outcomes:
Locations:
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Adanna Chukwuma, MBBS, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Margaret McConnell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Jessica Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Health Policy Research Group
name: Chinyere Mbachu, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Itina SM. Characteristics of traditional birth attendants and their beliefs and practices in the Offot Clan, Nigeria. Bull World Health Organ. 1997;75(6):563-7.
citation: Sibley LM, Sipe TA, Barry D. Traditional birth attendant training for improving health behaviours and pregnancy outcomes. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD005460. doi: 10.1002/14651858.CD005460.pub3.
citation: Oyebola, B. C., Muhammad, F., Otunomeruke, A., & Galadima, A. (2014). Effect of Performance-Based Incentives for Traditional Birth Attendants on Access to Maternal and Newborn Health-care Facilities in Gombe State, Nigeria: A Pilot Study. Meeting Abstract. Lancet.
citation: WHO. (2004). Making Pregnancy Safer: The Critical Role of the Skilled Attendant - A Joint Statement by WHO, ICM, and FIGO. Geneva: World Health Organization.
citation: Chukwuma A, Mbachu C, McConnell M, Bossert TJ, Cohen J. The impact of monetary incentives on referrals by traditional birth attendants for postnatal care in Nigeria. BMC Pregnancy Childbirth. 2019 May 20;19(1):150. doi: 10.1186/s12884-019-2313-8.