louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00991016: Single and Multiple Dose Safety, Tolerability, and Pharmacokinetics Study of PF-04805712 in Healthy Volunteers
Official title: A Phase 1 Randomized, Double Blind (3rd Party Open), Placebo Controlled Combined Single And Multiple Dose Safety, Tolerability And Pharmacokinetics Study Of Orally Administered PF-04805712 In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-07
Enrollment: 61
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To assess the safety and tolerability of escalating single and multiple doses of the compound in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy males and females of non-childbearing potential.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Primary outcomes:
measure: Safety: Adverse events, vital signs measurements, telemetry, 12 lead ECGs, blood and urine safety tests.
timeFrame: 12 weeks
measure: Pharmacokinetics: PK parameters will be determined after single dose, fasted and (at one dose) fed, and at steady state (fasted or fed depending on single dose data).
timeFrame: 12 weeks
Secondary outcomes:
measure: Pharmacodynamics: Urinary LTE4
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06907316: Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis
Official title: Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis - a Randomized, Multicentre, Non-inferiority, Open Label Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Syphilis
Keywords: syphilis
treatment
cefixime
Lead sponsor: Bulovka Hospital
Sponsor class: OTHER
Collaborators: name: Všeobecná fakultní nemocnice Praha
name: Národní referenční laboratoř pro syfilis, Státní zdravotní ústav
name: Örebro University, Sweden
First posted: 2025-04-02
Enrollment: 61
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 evaluates the efficacy (non-inferiority) and safety of a new antibiotic treatment (cefixime), which has been previously used for single dose therapy of gonorrhoea in many years , in the treatment of early syphilis. Participants will be randomized to one of two study arms and will receive either expirimental regimen (cefixime) or the current standard antibiotic regimen (benzathine penicillin G). New treatment alternatives for syphilis could ensure that people are appropriately treated during periods or in settings of benzathine penicillin G stock out, penicillin allergy, or other intolerance to penicillin injection. This study may also identify an oral regimen for settings in which injections are not feasible.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Non-pregnant, non breastfeeding
3. Able to provide informed consent
4. Clinically or laboratory-confirmed primary, secondary or early latent syphilis with a positive rapid treponemal test and an RPR/VDRL titer equal to or greater than 1:8
5. Non-cephalosporin allergic
6. Non-penicillin allergic
7. Agree to be occasionally called by study staff to be reminded to take study drug
8. Willing to attend follow-up visits

Exclusion Criteria:

1. Under 18 years of age
2. Pregnancy, breastfeeding
3. Prior history of syphilis in last two years
4. Allergy or contraindication to penicillin or cephalosporins (including allergy to cefixime)
5. Systemic antibiotic therapy in last two weeks
6. Previous enrollment in the study
7. Presenting a situation or condition that would not allow reliable study follow up (For example: frequent travel, alcohol abuse or substance misuse)

Primary outcomes:
measure: Serological cure
timeFrame: from baseline (treatment) to 3 months after treatment
Secondary outcomes:
measure: Secondary serological cure
timeFrame: from baseline (treatment) to 6 and 12 months after treatment
measure: Treatment safety
timeFrame: from baseline till the end of follow-up (12 months from baseline)
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Fakultní nemocnice Bulovka
city: Praha
country: Czech Republic
facility: Národní referenční laboratoř pro syfilis, Státní zdravotní ústav
Study officials:
References:
Clinical trial NCT00980616: Use of Local Analgesia With Epinephrine During Total Hip Arthroplasty (THA)
Official title: Effect of the Injection of Local Analgesia With Epinephrine During Total Hip Arthroplasty on the Blood Losses Per and Operatively.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthroplasty, Replacement, Hip
Keywords: Arthroplasty, hip
blood losses
pain
local analgesia
epinephrine
Primary total hip arthroplasty
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2009-09-21
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to determine if the use of infiltration with an adrenalin solution in the operative field of Total Hip Arthroplasty (THA), allays a significant reduction of the cumulated volume of bleeding (pre and post operative) without increasing the per and post operative risks. At the same time, the effect on the post operational pains is evaluated.

Detailed description: This prospective randomized study compares a population receiving a local anaesthetic (ropivacaine, adrenalin and physiological serum) in the operative field to a population undergoing a standard protocol.

The cumulated volume of bleeding per and post operative are recorded and complete blood count (CBC).

Eligibility criteria: Inclusion Criteria:

* Primary total hip arthroplasty
* Age between 50 and 85

Exclusion Criteria:

* fracture of the femoral neck
* patients with contraindications for local anaesthesia

Primary outcomes:
measure: measuring volume of cumulated bleeding per and post operative and analyse of complete blood count (CBC)
timeFrame: pre and post operative
Secondary outcomes:
measure: Womac score pre operative, at 3 months and at 12 months
timeFrame: at 3 months and 12 months
measure: Visual analogue pain score (VAS) during hospitalisation
timeFrame: at 3 months and 12 months
measure: Consumption of analgesics
timeFrame: at 3 months and 12 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand (orthopaedic surgery)
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Stephane Descamps, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05473416: Comparing the Effects of Pilates and McKenzie in Power Looms Workers Having Nonspecific Chronic Low Back Pain
Official title: Comparing the Effects of Pilates (Pelvic Tilt) and McKenzie Back Extension Exercises in Power Loom Workers Having Non-specific Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonspecific Chronic Low Back Pain
Pain
Disability Physical
Keywords: Pilates pelvic tilt exercise & McKenzie back exercise
Lead sponsor: University of Faisalabad
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 46
Sex: MALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was based on the research design of a randomized clinical trial. The single-blind study, in which participants were blind. The sample size of this study was 46. Patient was divided into 2 groups, 23 in each group.
Primary purpose: TREATMENT

Brief summary: to check the effects of Mckenzie intervention \& Pilates intervention on power looms workers having nonspecific chronic low back pain

Detailed description: The purpose of this study is to check and compare the effects of McKenzie back extension exercise and Pilates pelvic tilt exercise on power looms workers having nonspecific chronic low back pain. To check the effects of these interventions on pain, disability, and anterior pelvic tilt angle.

In this study pain intensity of the subjects will be noted via a numeric pain rating scale. Pain will be measured at baseline, after 2 weeks and 4 weeks of intervention.

In this study disability of the patients will be measured via Quebec back pain disability scale. Disability will be measured at baseline, after 2 weeks and 4 weeks of intervention.

In this study, a goniometer will be used to measure the anterior pelvic tilt angle. Anterior pelvic tilt angle will be measured at baseline, after 2 weeks and 4 weeks of intervention.

Eligibility criteria: Inclusion Criteria:

* Age of the participants between 35-45 years.
* Only male workers diagnosed with nonspecific chronic low back pain.
* Power looms workers; Operator of power looms, working 12 hours per day.
* Low back pain for more than three months.
* Power looms workers with pain intensity on NPRS ranges from mild to moderate.
* Anterior pelvic tilt angle more than normal 13º±4.9º, anteriorly tilt to 18º to 25º.

Exclusion Criteria:

* Serious spinal pathology like tumors.
* Any inflammatory diseases.
* History of spinal surgery.
* Neurological disorder.
* Pain due to any systemic diseases.

Primary outcomes:
measure: Pain intensity
timeFrame: one month
measure: Disability index
timeFrame: one month
Secondary outcomes:
measure: Anterior pelvic tilt angle abnormailty
timeFrame: one month
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Dr Hafiz Almas PT
state: Punjab
Study officials:
affiliation: The University of Faisalabad
name: Hafiz Muhammad Almas Sabir Muhammad Sabir Ali, MS OMPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06421116: Validation of a Preclinical Model Based on Patient-derived Organoids for the Study of the Gut-joint Axis in Spondyloarthritis
Official title: Validation of a Preclinical Model Based on Patient-derived Organoids for the Study of the Gut-joint Axis in Spondyloarthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spondyloarthritis
Inflammatory Bowel Diseases
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by Spondyloarthtitis. Controls with inflammatory or non-inflammatory conditions.

Brief summary: This project aims to develop and validate a model of human organoids derived from patients with Spondyloarthritis, focusing on synovial and intestinal tissues as targets of the gut-joint axis. The tissue marker profile of patient-derived organoids studied by gene expression, immunohistochemistry, and cytokine production profile will be compared with that of controls in order to test for the presence of specific biomarkers.


Eligibility criteria: Inclusion Criteria:

* More than 18 years of age;
* Ability to understand and sign an informed consent form;
* Clinical indication for intestinal and/or synovial biopsy;
* Only for SpA patients group: meeting ASAS classification criteria.

Exclusion Criteria:

* Actively treated cancer;
* Severe comorbidities that, in the investigator\&#39;s opinion, may affect the quality of samples for planned experimental applications;
* Only for patients undergoing ileal-colic biopsy: history of colorectal cancer disease, celiac disease;
* Only for patients undergoing a synovial biopsy: septic arthritis.

Primary outcomes:
measure: Viability assessment
timeFrame: 24 months
Secondary outcomes:
measure: Production of pro-inflammatory cytokines
timeFrame: 24 months
Other outcomes:
measure: Invasion capacity assessment (synovial organoids)
timeFrame: 24 months
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
References:
Clinical trial NCT00731016: Treatment of the Hutchinson-Gilford Progeria Syndrome With a Combination of Pravastatin and Zoledronic Acid
Official title: Treatment of the Hutchinson-Gilford Progeria Syndrome With a Combination of Pravastatin and Zoledronic Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hutchinson-Gilford Progeria Syndrome
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2008-08-08
Enrollment: 15
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We suggest treating the Hutchinson-Gilford Progeria Syndrome by two molecules (zoledronic acid and pravastatin).The therapeutic approach which we propose has for objectives to reduce, to prevent or to delay the gravest infringements of the disease, to prolong the life of the children, and in a more general way, aim at improving their living conditions.


Eligibility criteria: Inclusion Criteria:

* Molecularly characterised patients with a known mutation of their LMNA gene leading to the production of a farnesylated prelamin A, whether truncated or not
* Patients must be able to travel and consult in Marseille, France for necessary explorations planned at the inclusion step, then following the protocol flow
* chart for zoledronic acid injections and follow-up visits
* Patient older than 3 years
* Patients affiliated or beneficiary of a legal medical insurance
* Adult patients certifying they have been properly informed about the protocol, and they signed a written consent form. Children and/or disabled patients whose parents/legal tutor have been informed and have signed a written consent form

Exclusion Criteria:

* Known hypersensitivity to pravastatin or zoledronic acid
* Seric transaminase levels higher than 3 times of normal value
* CPK level higher than 5 times of normal value
* Creatininemia higher than 0.5mg/dl or 44mM, or creatinin clearance lower than 70ml/min/1.73m3
* Presence of dental troubles, or recent dental trouble
* Maxillary osteonecrosis or bone nakedness antecedent
* Congenital galacosemia, glucose or galactose maladsorption syndrome, lactase deficiency
* Every other pathology thought to be incompatible with proposed treatment by the investigator
* Under treatment that can interfere with pravastatin and/or zoledronate metabolisms

Primary outcomes:
measure: To evaluate the tolerance and efficacy of pravastatin and zoledronic acid in combination on the patient's weight, height and bone metabolism in Progeria treatment
timeFrame: 48 months
Secondary outcomes:
measure: To evaluate the tolerance and efficacy of the treatment on other clinical and biological symptoms
timeFrame: 48 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Laboratoire de Génétique Moléculaire - Hopital de la Timone
Study officials:
affiliation: Assistance Publique des Hopitaux de Marseille
name: Nicolas LEVY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00845416: Newborn Screening for Severe Combined Immunodeficiency (SCID) in a High-Risk Population
Official title: Newborn Screening for SCID in a High-Risk Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Combined Immunodeficiency
T Cell Lymphocytopenia
Keywords: TREC
T cell
Primary Immunodeficiency
PID
Navajo
SCID
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 1800
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Navajo Indians

Brief summary: The goal of the proposed research is to establish the validity of a newborn screening method for severe combined immunodeficiency (SCID). The assay to be used is developed on the basis of PCR quantification of T-cell receptor excision circles (TRECs) that is absent in SCID patients, thus correlating with the disease

Detailed description: To show that early diagnosis of SCID with a TREC screening assay can warrant timely treatment of the disease and avoid life-threatening infections on patients. Babies with SCID are unable to fight infections. They become severely ill in their first months of life and do not survive unless their immune systems can be restored. SCID can be treated by bone marrow transplant if recognized early. The newborn screening test to be employed in this study is designed to diagnose SCID before infections occur. By conducting a pilot testing program in a high-risk population on the Navajo Indian Reservation, where one in 2,000 infants is born with SCID, we hope to confirm the benefits of newborn screening for early diagnosis of SCID

Eligibility criteria: Inclusion Criteria:

* Birth in a study hospital on the Navajo Reservation

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chinle
country: United States
facility: Chinle Hospital
state: Arizona
city: Tuba City
country: United States
facility: Tuba City Hospital
state: Arizona
Study officials:
References:
Clinical trial NCT04936516: McGrath vs. C-MAC Video Laryngoscopy Comparison in Endotracheal Tube Insertion
Official title: Effectiveness Comparison Between McGrath and C-MAC Video Laryngoscope in Endotracheal Tube Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult or Failed
Lead sponsor: Udayana University
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Tracheal intubation is commonly performed using a standard Macintosh blade, but recently there has been advanced technology using video laryngoscopy (VL).In this modern era, there are various types of available VL to make it easier for anesthesiologists to perform intubation, especially in patients with difficult airway anatomy.

Various studies showed different results regarding the effectiveness of both C-MAC® and McGrath®, by assessing the comparison of the effectiveness, valuable information will be obtained for further consideration by experts in choosing the best tools in the future.


Eligibility criteria: Inclusion Criteria:

1. Elective surgery patients without neck and face trauma
2. Undergo surgery requiring general anesthesia with endotracheal intubation
3. Patients with physical status ASA I-III
4. Patients aged 18-65 years
5. Nutritional status (BMI \< 35 Kg/m2)

Exclusion Criteria:

1. Patients refusal to be included in the study
2. Patients with cervical spine instability
3. Anatomical and structural abnormalities of the maxillary teeth
4. Thyromental distance \<6 cm and inter-incisor distance \<3.5 cm
5. History of difficult intubation
6. LEMON criteria ≥ 3

Primary outcomes:
measure: Intubation time
timeFrame: From first intubation attempt until successful intubation, an average of one minute
measure: Ease of intubation
timeFrame: From first intubation attempt until successful intubation, an average of two minutes
Secondary outcomes:
measure: Number of intubation attempts
timeFrame: From first intubation attempt until successful intubation, an average of one minute
measure: Glottic visualization
timeFrame: During first intubation attempt, an average of 30 seconds
measure: Complications of intubation
timeFrame: From first intubation attempt until successful intubation, an average of one minute
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Sanglah General Hospital
state: Bali
Study officials:
affiliation: Udayana University
name: Tjokorda GA Senapathi, Dr
role: STUDY_CHAIR
affiliation: Udayana University
name: Jhoni P Pasaribu
role: STUDY_DIRECTOR
affiliation: Udayana University
name: Christopher Ryalino
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00443716: Determination of Adipocyte Parameters in Iliac Crest Biopsies From Post Menopausal Women
Official title: Determination of Adipocyte Parameters in Iliac Crest Biopsies From Post Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Postmenopausal
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2007-03-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of estrogen treatment on adipocytic and osteoblastic parameters by histomorphometrically measuring adipocyte volume (AV/TV) and adipocyte numbers in goldner's stained iliac crest bone biopsy specimens collected from subjects recruited in the study (IRB number 21B85). The adipocytic parameters will be then correlated with osteoblastic parameters obtained previously during the course of the initai study involving the effect of transdermal estrogen on bone turnover in postmenopausal osteoporotic women.


Eligibility criteria: Post-menopausal osteoporotic women

Primary outcomes:
measure: efficacy of estraderm treatment on osteoporotic women
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: B. Lawrence Riggs, M.D.
role: PRINCIPAL_INVESTIGATOR
References: