louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02369926: Endpoint Calibration for a Phase 2 Study of Lisinopril in Multiple Sclerosis
Official title: Phase 2a, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Safety, Tolerability, and Proof-of-Concept Efficacy of Lisinopril in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS), Stage 1
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: multiple sclerosis
telemedicine
remote monitoring
lisinopril
Lead sponsor: Transparency Life Sciences
Sponsor class: INDUSTRY
First posted: 2015-02-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to calibrate the Multiple Sclerosis Functional Composite (MSFC) for home implementation in a phase 2 trial of lisinopril in multiple sclerosis. In this initial stage, participants are required to travel to the study site one day a week for three weeks to complete the MSFC. They are also required to complete the MSFC at home once weekly for three weeks using remote sensing technology and video conferencing.


Eligibility criteria: Inclusion Criteria:

1. Males and females between the ages of 18 and 64.
2. Documented informed consent
3. Documented diagnosis of RRMS via 2010 McDonald Criteria
4. Normal blood pressure at baseline: 90-140 mmHg systolic AND 60-90 mmHg diastolic
5. Baseline score of 0-5.5 on Kurtzke's Expanded Disability Status Scale (EDSS)
6. Availability of a person in the home who is physically able and willing to steady the subject if s/he loses balance during the walk test.

Exclusion Criteria:

1. Hypotensive at baseline: \<90 mmHg systolic or \<60 mmHg diastolic
2. Hypertensive at baseline: \>140 mmHg systolic or \>90 mmHg diastolic
3. Bradycardia at baseline: \< 50 bpm

Primary outcomes:
measure: Safety of mMSFC Tally
timeFrame: Week 6
measure: MSFC Score Comparison
timeFrame: Week 6
measure: Mobile Timed Walk Test Value Comparison
timeFrame: Week 6
measure: Mobile 9-hole Peg Test Time Comparison
timeFrame: Week 6
measure: Mobile Paced Auditory Serial Addition Test Score Comparison
timeFrame: Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Transparency Life Sciences
name: Tomasz Sablinski, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03188926: Surgical Treatment of Long Bone Metastases
Official title: Surgical Treatment for Long Bone Metastases With Intramedullary Nail or Endoprosthetic Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Metastases
Surgery
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with long bone metastases treated surgically with intramedullary nail or endoprosthetic reconstruction

Brief summary: To provide treatment guidelines for patients with long bone metastatic disease based on observational study and to propose an algorithm to guide orthopedic surgeons in decision-making for these patient.

Detailed description: The objectives of this study were to examine clinical outcomes after reconstruction with intramedullary fixation (IMN) or endoprosthetic reconstruction (EPR) with a specific focus on (1) the rate of complication or failure; (2) differences in complication rates by anatomic site; (3) functional results as assessed by the Musculoskeletal Tumor Society System (MSTS); (4) differences in complication rate between patients treated with INM versus EPR; and (5) differences in survival in patients with metastatic bone disease based on disease-specific, laboratory, and demographic information.

Eligibility criteria: Inclusion Criteria:

* bone metastases of the extremity

Exclusion Criteria:

* bone metastases of the spine

Primary outcomes:
measure: Clinical outcomes after treatment of long bone metastases with intramedullary nail versus endoprosthetic reconstruction
timeFrame: 1 year
Secondary outcomes:
measure: Survival in patients undergoing surgery for metastatic bone disease
timeFrame: 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Davide Donati, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02746926: A Study Comparing Amounts of Tafamidis (PF-06291826) in the Blood Without Food in Healthy Volunteers
Official title: A Phase 1, Open-Label, Three-Period Randomized, Single Dose Study To Estimate The Relative Bioavailability Of Pf-06291826 (Tafamidis) Free Acid Capsule Formulation Versus Commercial Capsule In Healthy Subjects Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-04-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 3 different formulations and doses of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 8 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 8 days. After another 14 days, the last formulation will be tested in the same way.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females of non-child bearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).

Exclusion Criteria:

* Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic).
* Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.
* Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.

Primary outcomes:
measure: Area under the concentration-time Curve (AUC)
timeFrame: 168 hours
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 168 hours
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 168 hours
measure: Mean residence time (MRT)
timeFrame: 168 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 168 hours
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 168 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06580626: Various Techniques of Horizontal Ridge Augmentation
Official title: Decompression Technique Versus Ridge Splitting and Ethoss Bone Regeneration in Horizontal Ridge Augmentation With Simultaneous Implant Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Horizontal Ridge Deficiency
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 42 patients will be selected from the Outpatient Clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of missed single tooth or multiple teeth in posterior mandible by dental implant in horizontally atrophic ridge.


Eligibility criteria: Inclusion Criteria:

* Patient's cooperation, motivation and good oral hygiene.
* Patient medically free from systemic diseases that absolutely contraindicate implant surgery.
* Moderately atrophic posterior mandibular alveolar ridge width (more than 4 mm), with minimum 10 mm height.
* Free from history of bruxism / parafunctional habits.

Exclusion Criteria:

* Patients with local pathological disease such as cyst, tumor at the planned surgical site.
* Pregnant patients.
* Heavy smoker patients.

Primary outcomes:
measure: Alveolar ridge width.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Heba Elsheikh
Study officials:
References:
Clinical trial NCT06090526: PSP as Indicator for Urinary Sepsis in ICU
Official title: Pancreatic Stone Protein as Indicator for Urinary Sepsis in Intensive Care Units
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Urinary; Sepsis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who was admitted in intensive care units in Ain Shams University and had risk factors for urosepsis.

Brief summary: Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. For clinical operationalization, organ dysfunction can be represented by an increase in the Sequential Organ Failure Assessment (SOFA) score of 2 points or more, which is associated with an in-hospital mortality greater than 10%. pancreatic stone protein has been studied as biomarker of sepsis and results suggests that it has higher diagnostic performance. The main objective of this study is to identify ability of pancreatic stone protein (PSP) as a new biomarker for diagnosis of urosepsis in Intensive Care Units comparison to other biomarkers and its role as a prognostic marker for mortality


Eligibility criteria: Inclusion Criteria:

* Adult ill patients at the ICU aged more than 18 years old who at risk of urosepsis.
* Both males and females.

Exclusion Criteria:

* - Age less than 18 years.
* Patients with a clinical diagnosis of sepsis at admission.
* Critically ill septic patients with a diagnosis other than urosepsis.
* Critically ill patients who were diagnosed to have urosepsis outside Ain Shams university intensive care and transferred to it.
* Malignant tumor patients.
* Uremic patients undergoing dialysis.

Primary outcomes:
measure: PSP ability to detect urinary sepsis
timeFrame: measurements from admission and patients will be followed until death or discharge from or for 30 days whichever occurred the ICU
Secondary outcomes:
measure: PSP ability to predict prognosis of sepsis in ICU.
timeFrame: measurements from admission and patients will be followed until death or discharge from or for 30 days whichever occurred the ICU
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05002426: Rouviere Sulcus Plane and Hepatic Hilum Plane, Which is Better as a Landmark in Laparoscopic Bile Duct Surgerys
Official title: Rouviere Sulcus Plane and Hepatic Hilum Plane, Which is Better as a Landmark in Laparoscopic Bile Duct Surgerys
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cholelithiasis
Laparoscopic Cholecystectomy
Keywords: anatomy
Lead sponsor: The Second Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: a consecutive patients undergoing elective laparoscopic cholecystectomies at the second affiliated hospital of Anhui medical university

Brief summary: RS and the RS plane are important anatomical markers in laparoscopic cholecystectomy. However, there are many variations in the shape and orientation of the RS, and the RS plane is an imaginary plane, which can be misjudged by different surgeons. The purpose of this study is to introduce a more intuitive anatomical marker and anatomical plane, hilum plane, and discuss the application value of hilum plane in laparoscopic biliary surgery by comparing it with RS and RS plane.

Detailed description: Hepatic hilum plane is the hepatoduodenal serosa plane that extends from the base of the liver IVa segment down to the first segment of the gallbladder triangle.

During the operation, first pulling the gallbladder to the head side, using the separating forceps to slide down horizontally from the hilum (the basement of hepatic segment Ⅳ), and along the serous of hepatoduodenal ligament, that is so called "hilum plane".

It forms a "neck-shoulder" structure when the hilar plane meets the tent-like hepatobiliary triangle. the serosa of hepatobiliary triangle was dissected on the neck area and ventral side of hilar plane, and the serosa of posterior triangle of the gallbladder was also cutted on the same extension line . In this process, the type and orientation of RS, the relationship between the plane of the RS sulcus and the plane of the hilar plane were also recorded and compared with hilum plane.

Eligibility criteria: Inclusion Criteria:

Benign disease of the gallbladder requires surgery

Exclusion Criteria:

Patients with severe cirrhosis or had a history of partial hepatectomy were excluded from the statistics .

patients with unexpected gallbladder carcinoma.

Primary outcomes:
measure: The type of Rouviere sulcus and the "fake RS"
timeFrame: up to 30 days after surgery
measure: The orientation of RS and The relationship between hepatic portal plane and RS plane
timeFrame: up to 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Lei Wang
state: Anhui
Study officials:
affiliation: Second Affiliated Hospital of Anhui Medical University
name: hui hou, master
role: STUDY_CHAIR
References:
Clinical trial NCT05469126: A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants
Official title: A Phase 1, Open-label, Drug Interaction Study to Investigate the Effect of Multiple Doses of Clarithromycin on the Pharmacokinetics of LY3502970 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-07-21
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to determine the levels of study drug called LY3502970 in the blood stream when administered alone and in combination with clarithromycin in healthy participants. This study will last up to approximately 85 days for each participant.


Eligibility criteria: Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Participants with a body weight of 45 kilograms (kg) or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²)
* Participants who have a hemoglobin level of at least 11.4 grams/deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants
* Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

Exclusion Criteria:

* Participants who have a significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Participants who regularly use known drugs of abuse
* Women who are lactating and who are of child-bearing potential
* Participants who have known allergies to LY3502970, related compounds, or any components of the formulation

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970
timeFrame: Predose up to 120 hours postdose
measure: PK: Maximum Observed Concentration (Cmax) of LY3502970
timeFrame: Predose up to 120 hours postdose
Secondary outcomes:
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 NCT01981226: Sonoelastographic Changes After Low Energy Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis
Official title: Sonoelastographic Changes After Low Energy Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Plantar Fasciitis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 30
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: Extracoporeal shock wave therapy(ESWT) was perfomed on the plantar fascia of chornic plantar fasciitis patients. Pre-ESWT and post-ESWT pain intensity, sonography and sonoelastrography of the plantar fascia was checked. Our hypothesis is that the plantar fascia stiffness increased after ESWT as clinical symptom improves.

Detailed description: For patient who met the inclusion criteria, we check sonography and sonoelastography for their plantar fascias and obtain a thorough evulation questionaire for clinical symptom and pain condition and intensity in various conditions, also SF-36 questionaire first. Inform consent was done.

After the ESWT, we follow patient with questionaire and sonography/sonoelastography at 1-week, 1-month, 3-month, 6-month, 9-month, and 12-month post-ESWT time.

The colored sonoelastographic image was analysed by computer software "Image-J" with hue analysis method and relative stiffness of selected area within proximal plantar fascia wasa obtained for statistical analysis.

Eligibility criteria: Inclusion Criteria:

* pain for more than 6 months，poor response to the conservative treatments
* Sonography showed plantar fasciitia\>4.0mm)

Exclusion Criteria:

* Acute infection of soft tissue/bone
* Malignant primary disease
* Blood coagulation disorders
* Pregnancy
* Patients with pacemaker
* foot deformity

Primary outcomes:
measure: Sonoelastographic changes of plantar fascia after ESWT
timeFrame: pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month
Secondary outcomes:
measure: Plantar fascia thickness
timeFrame: pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month
Other outcomes:
measure: Pain intensity(VAS scale)
timeFrame: pre-treatment, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month
Locations:
city: Taipei
country: Taiwan
facility: Natinal Taiwan University Hospital
Study officials:
References:
Clinical trial NCT04365426: Effects of Oral Contraceptives on DNIC in Non-painful Healthy Women
Official title: Effects of Oral Contraceptives on Diffuse Noxious Inhibitory Stimulus (DNIC) in Non-painful Healthy Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraceptive Usage
Diffuse Noxious Inhibitory Control
Lead sponsor: Universidad Vina del Mar
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is tu assess the influence of oral contraceptives (OC) on diffuse noxious inhibitory control (DNIC) in healthy women, tested during high, low endogenous estrogens sessions and ovulatory period.

Detailed description: After being informed about the study and it protocol, all patients giving written informed consent, will undergo to a cephalic (masseter) and extracephalic (finger) mechanical stimulus to evaluate the threshold of mechanical pain, and physiological records of systolic/diastolic pressure and heart rates. After, we will evaluate the threshold response and physiological rates to the same mechanical stimulus under a thermal (cold) conditional pain (TCP) at 3 different moments of menstrual period in No contraceptive group (No OC) versus Contraceptive group (CO). Finally, we will compare the mechanical threshold response, physiological rates and pain perception between both groups.

Eligibility criteria: Inclusion Criteria:

* Healthy women with oral contraceptive treatment (for at least 3 consecutive months), greater than or equal to 15 years old.
* Healthy women without oral contraceptive treatment, greater than or equal to 15 years old.
* Non pregnant women.
* Not under convulsive, chronic pain, antidepresive, antihypertensive, pharmacological treatments
* Without systemic pathologies.

Exclusion Criteria:

* Treatment of a pain, depression, hypertension, convulsion condition with or without medication.
* Regular use of benzodiazepines.
* Systemic pathologies
* Pregnant women
* Menopausal women

Primary outcomes:
measure: Diffuse Noxious Inhibitory Control Efficiency in oral contraceptive healthy women
timeFrame: Baseline phase 1 (2-5 days), phase 2 (14-17 days), and phase 3 (21-27 days) after the beginning of menstrual period
Secondary outcomes:
Other outcomes:
Locations:
city: Viña Del Mar
country: Chile
facility: Universidad Viña del Mar
state: Valparaiso
Study officials:
affiliation: Universidad Vina del Mar
name: Nicolás Pinto-Pardo, DDS, Ms, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: