louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03136731: Evidence-based Screening Strategies for Celiac Disease
Official title: Improving Case-finding Strategies for Celiac Disease in Family Members: a Follow-up Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Celiac Disease
Keywords: Celiac disease, Gluten, Microbiome, Genetic
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 3517
Sex: ALL
Minimum age (years): 6
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers; cohort 1, 3217 genetically predisposed healthy family members of celiac disease patients (high risk group for celiac disease), Cohort 2, 200 new celiac disease index cases will be enrolled

Brief summary: Main aim: To find evidence-based screening strategies for celiac disease in high risk groups and to find new biomarkers or biomarker combinations for celiac disease diagnostics and follow-up.

Detailed description: The current project will result in the identification of genetic, environmental or downstream biomedical markers that predict the development of celiac disease at the individual level. Moreover, the markers can be exploited in prediction of specific disease risks, manifestations, comorbidities and complications.

Eligibility criteria: Inclusion Criteria:

* Cohort 1: Family member of celiac disease patient
* Cohort 2: Previously diagnosed celiac disease

Exclusion Criteria:

* Cohort 1: No previous celiac disease
* Cohort 2: Celiac disease diagnosis not confirmed

Primary outcomes:
measure: Forthcoming celiac disease diagnosed by current diagnostic criteria
timeFrame: With in 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital / Tampere University
Study officials:
References:
citation: Paavola S, Kurppa K, Huhtala H, Saavalainen P, Lindfors K, Kaukinen K. Coeliac disease re-screening among once seronegative at-risk relatives: A long-term follow-up study. United European Gastroenterol J. 2022 Jul;10(6):585-593. doi: 10.1002/ueg2.12255. Epub 2022 May 25.
citation: Paavola S, Lindfors K, Kivela L, Cerqueira J, Huhtala H, Saavalainen P, Tauschi R, Kaukinen K, Kurppa K. Presence of high-risk HLA genotype is the most important individual risk factor for coeliac disease among at-risk relatives. Aliment Pharmacol Ther. 2021 Sep;54(6):805-813. doi: 10.1111/apt.16534. Epub 2021 Jul 18.
Clinical trial NCT06921031: Stroke Patients' Preferences for an Exoskeleton for Lower Limb Rehabilitation Using the DCE Method (EXOPREF)
Official title: Stroke Patients' Preferences for an Exoskeleton for Lower Limb Rehabilitation Using the DCE Method.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Stroke Patients
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic stroke patients without any specific characteristics

Brief summary: The main aim of this study is to investigate the preferences of individual stroke patients for key features of an exoskeleton, intended for lower limb rehabilitation, with a view to its potential integration into the design of future exoskeletons. This will be a multicenter study. Patients will be presented different scenarios of choices about the attributes about gait exoskeleton.

Conditional logistic regression models will be used to define the preferences of the subjects.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* informed consent to participate in the study
* motor impairment secondary to stroke
* ability to answer the questionnaire with or without assistance from a relative or interviewer

Exclusion Criteria:

- history of lower-limb exoskeleton use

Primary outcomes:
measure: Choices of the participants
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
city: Ploemeur
country: France
facility: Centre de rééducation Kerpape
Study officials:
References:
Clinical trial NCT01636531: A Study of A High Concentration Liquid Formulation Versus A Lyophilized Formulation of Gantenerumab in Healthy Volunteers
Official title: A Multi-center, Randomized Open-label, Single-dose, Parallel Group Investigation of the Relative Bioavailability, Tolerability and Dose-exposure Relationship of a High Concentration Liquid Formulation (HCLF) Versus a Lyophilized Formulation (LyoF) of RO4909832 (Gantenerumab) When Administered by su
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-07-10
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This multi-center, randomized, open-label, single-dose, parallel group study will assess the relative bioavailability, tolerability and dose-exposure relationship of a high concentration liquid formulation (HCLF) versus a lyophilized formulation (LyoF) of gantenerumab (RO4909832) in healthy volunteers. Subjects will be randomized to receive single subcutaneous doses of either HCLF or LyoF. Anticipated time for treatment period and follow-up will be 13 weeks.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects, 40 to 70 years of age. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
* Body mass index 18.0 to 30.0 kg/m2 inclusive
* Female subjects who are either surgically sterilized or post-menopausal
* Agree not to donate blood or blood products for transfusion for the duration of the study and for one year after their dosing

Exclusion Criteria:

* Suspicion of alcohol or drugs of abuse addiction
* Positive for hepatitis B, hepatitis C or HIV 1 or 2 infection
* Participation in an investigational drug or device study within three months before dosing
* Concomitant disease or condition or treatment which could interfere with the conduct of the study or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
* Any clinically relevant history of hypersensitivity or allergic reactions, either spontaneous or following drug administration or exposure to food or environmental agents
* Any familial history of early onset Alzheimer's disease
* Claustrophobia, presence of pacemakers, aneurism clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would contraindicate an MRI scan

Primary outcomes:
measure: Relative bioavailability: Area under the concentration-time curve
timeFrame: Pre-dose and up to 85 days post-dose
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 8 months
measure: Dose-exposure relationship
timeFrame: approximately 8 months
Other outcomes:
Locations:
city: Rennes
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04817631: Management of Tubo-ovarian Abscess: a Single Center Experience
Official title: Management of Tuba-ovarian Abscess: a 10 Year Single-center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tubo-ovarian Abscess
Keywords: abscess drainage
abscess size
medical treatment
surgical treatment
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women over 18 years of age who presented to our clinic with symptoms of infection and where tuboovarian abscess was suspected with physical and ultrasonographic examination are included in this study

Brief summary: Electronic database of our tertiary obstetrics and gynecology clinic was searched for patients who were treated for tub-ovarian abscess during the last 10 years (January 2010- November 2020). Patients' biometric data, admission date and duration, medical and surgical treatment modalities were recorded using an Excel sheet. Patients will be evaluated on the basis of the treatment they receive, length of treatment, if surgically treatment the type of surgery performed. Hospitalization length, readmission, recurrence will be compared between treatment modalities.

Detailed description: This retrospective study is conducted at Health Sciences University Turkey, Sisli Hamidiye Etfal Training and Research Hospital Department of Obstetrics and Gynecology. Electronic database was searched for patients who were treated for tub-ovarian abscess during the last 10 years (January 2010- November 2020). Patients' biometric data, admission date and duration, medical and surgical treatment modalities were recorded using an Excel sheet. Patients will be evaluated on the basis of the treatment they receive, length of treatment, if surgically treatment the type of surgery performed. Hospitalization length, readmission, recurrence will be compared between treatment modalities. A change in management strategy over the years if any will be reported.

Eligibility criteria: Inclusion Criteria:

* presence of a pelvic mass \> 3 cm with transvaginal ultrasound or magnetic resonance imaging indication abscess
* cervical and uterine tenderness
* abdominal rebound-defense under physical examination indication peritoneal irritation
* presence of symptoms such as fever, pelvic pain and increase in laboratory infection parameters

Exclusion Criteria:

* Patients with known malignities
* Patients with incomplete data in the clinic's electronic database
* Patients who continued their treatment at other centers

Primary outcomes:
measure: Evaluating the management of tuboovarian abscess on the basis of surgical or medical modalities by assessing hospitalization duration and recurrence
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Hamidiye Etfal Training and Research Hospital
Study officials:
References:
Clinical trial NCT00963573: Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428)
Official title: Efficacy and Safety of Loratadine-Betamethasone Oral Solution (1 mg/0.05 mg/1 mL) for Initial Treatment of Severe Perennial Allergic Rhinitis in School Age Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rhinitis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study attempts to document the therapeutic value of combining loratadine antihistamine action (no sedative) with anti-inflammatory effects of betamethasone at low doses, which may facilitate treatment adherence by patients whereas providing an effective and rapid perennial allergic rhinitis (PAR) symptoms relief.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of perennial allergic rhinitis.
* Age \>= 6 years old and \<= 12 years old.
* Patients in good general conditions, without any other relevant clinical condition except for perennial allergic rhinitis.
* Symptoms total score at admission \>= 8 (out of 15 possible). Individual symptoms (score 0 to 3 points) were: Sneezing or nasal pruritus, eye reddening or pruritus, nasal congestion, wet nose or with secretion (sniffing), secretion sensation at pharynx (post-nasal dripping).
* Number of symptoms: At least three.

Exclusion Criteria:

* Age \< 6 years old or \> 12 years old.
* Co-existence of acute sinusitis or some chronic condition different from asthma or atopic dermatitis.
* Presence of systemic fungal infections.
* Conscience or behavioral disturbances.
* Current oral or parenteral steroid treatment.
* Concomitant use of Phenobarbital, rifampicin, diphenylhydantoin or ephedrine.
* Known hypersensitivity to any of the study pharmacological combination components.

Primary outcomes:
measure: To evaluate efficacy and safety of loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg, respectively, as an initial treatment for severe perennial allergic rhinitis in school age children
timeFrame: Day 6 (Final visit)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Mendoza de Morales T, Sanchez F. Clinical efficacy and safety of a combined loratadine-betamethasone oral solution in the treatment of severe pediatric perennial allergic rhinitis. World Allergy Organ J. 2009 Apr;2(4):49-53. doi: 10.1097/WOX.0b013e31819f2105.
Clinical trial NCT01761773: A Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal Function
Official title: A Phase 1, Open-Label, Parallel-Cohort, Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Renal Impairment
Lead sponsor: Exelixis
Sponsor class: INDUSTRY
First posted: 2013-01-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the trial is to compare the pharmacokinetics of a 60 mg dose of cabozantinib in adult subjects with impaired renal function compared with healthy adult subjects. Another objective is to assess the safety and tolerability of cabozantinib in these adult subjects.


Eligibility criteria: Inclusion Criteria:

* Body weight must be ≥ 50 kg and \< 130 kg with a BMI ≤ 38.0 (kg/m2).
* Must use acceptable form of birth control during the course of the study and for 3 months following the single dose of study drug.
* Female subjects of childbearing potential must have a negative pregnancy test at screening and check-in.
* Negative test for HIV; hepatitis A, B, and C.
* Must have adequate vital sign reads at screening and check-in.
* Must be able to comply with dietary and fluid restrictions required for the study.

Exclusion Criteria:

* History of medical or surgical conditions that would interfere with GI absorption, distribution, metabolism, or excretion of the study drug.
* Recent clinical evidence of pancreatic injury.
* Recent use of drugs known to significantly inhibit or induce P450 CYP3A4 enzymes.
* Previous diagnosis of malignancy.
* Unwilling to forgo use of any over-the-counter or non-prescription preparations.

Primary outcomes:
measure: Pharmacokinetics
timeFrame: Days 1 - 8 as well as the morning of Days 11, 13, 15, 18, 21, 22.
Secondary outcomes:
measure: Safety and Tolerability
timeFrame: Days 1 - 8 and Days 11, 13, 15, 18, 21, 22.
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Neptune
country: United States
state: New Jersey
Study officials:
References:
Clinical trial NCT05260073: Patient and Clinician Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis
Official title: A Prospective Cohort Study of Patients With Actinic Keratosis (AK) in the Face or Scalp Treated With Tirbanibulin and Followed for 24 Weeks Post Treatment-initiation. Patient Reported Outcomes (PROs) and Clinical Profile of Patients Will be Gathered for Descriptive Analyses of Patient Outcomes Over the 24-week Study Observation Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratosis, Actinic
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be participants diagnosed with AK on the face or scalp, and aged 18 years or above at the time of initiation of treatment. The study cohort will be drawn from dermatology clinics from across the U.S.

Brief summary: The purpose of the study is to evaluate patient reported outcomes (PROs) in terms of health-related quality of life (HRQoL) among subjects with actinic keratosis (AK).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with AK of the face or scalp
* Has clinically typical, visible, and discrete AK lesions
* Considered as a potential candidate for tirbanibulin (Klisyri®) treatment to manage their AK
* Willing to avoid excessive sun or ultraviolet (UV) exposure, and/or use relevant sunscreen protection and protective clothing during the study duration
* Able to read and write English
* Provide consent to participate in the study
* Willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

* Participants with any dermatological condition of the face or scalp that could interfere with the clinical evaluations.
* Hypertrophic AK lesions, open wounds or suspected skin cancers within close proximity of the treatment area.
* Anticipated need for in-patient hospitalization or in-patient surgery within the next 2 months.
* Participants unable to comply with the requirements of the study or participants who in the opinion of the study physician should not participate in the study.
* Participants for whom medical chart is inaccessible to physicians to complete baseline data collection.

Primary outcomes:
measure: Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Percentage of Participants With Investigator Global Assement (IGA) Success at Week 8
timeFrame: At Week 8
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Almirall Investigational Site 1
state: South Carolina
Study officials:
References:
Clinical trial NCT05304273: Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages
Official title: COMPARATIVE STUDY OF EFFECTS BETWEEN LETROZOLE PLUS MISOPROSTOL AND MIFEPRISTONE PLUS MISOPROSTOL IN TERMINATING NON-VIABLE FIRST TRIMESTER PREGNANCIES
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Miscarriage
Lead sponsor: Calcutta National Medical College and Hospital
Sponsor class: OTHER_GOV
First posted: 2022-03-31
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective interventional study where participants with non-viable pregnancy at 1st trimester will be randomized into two arms, one group will receive conventional treatment with oral mifepristone followed by misoprostol vaginally and another group will receive letrozole for three consecutive days followed by misoprostol vaginally in an attempt to terminate the pregnancy medically. Mean duration of induction to expulsion of product of conception and rate of complete abortion will be compared in two groups.


Eligibility criteria: INCLUSION CRITERIA :

* Women older than 18years who will give consent regarding medical management of missed abortion
* First trimester pregnancy (gestational age less than equal to 12weeks) with missed abortion confirmed by ultrasonography
* Hemoglobin level more than 12mg/dl

EXCLUSION CRITERIA :

* Hemodynamically unstable patient
* Abnormalities in blood tests including complete blood count (CBC), prothrombin time(PT), internationalised normalized ratio(INR) and fibrinogen
* History or clinical evidence of any thromboembolic impairment or deep venous thrombosis
* Having intra-uterine device
* Present or previous use of corticosteroids
* History of any malignancy
* Existing cardiovascular disease contraindicating misoprostol

Primary outcomes:
measure: Expulsion of product of conception
timeFrame: 24 hours since administration of misoprostol
measure: Requirement of surgical evacuation
timeFrame: beyond 24 hours since misoprostol administration
Secondary outcomes:
Other outcomes:
Locations:
city: Kolkata
country: India
facility: Calcutta National Medical College and Hospital
state: West Bengal
Study officials:
References:
Clinical trial NCT03811873: Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates
Official title: Assessment of Vertebral Fracture Risk Using VFA and Vertebral Strength Assessment With DXA-Finite Element Analysis in Liver Transplant Recipients in Pretransplant Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Bone Disease
Transplant-Related Disorder
Secondary Osteoporosis
Keywords: transplant related disorders
liver transplant
transplant related bone disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Testing a single group of participants who are first time liver transplant candidates.
Primary purpose: PREVENTION

Brief summary: The researchers are trying to compare the effectiveness of Vertebral Fracture Assessment (VFA) in addition to the current standard of care spine x-ray in evaluation pre-liver transplant patients.


Eligibility criteria: Inclusion criteria

* First time liver transplant candidates deemed too early for liver transplant
* 24 hour urine Creatinine clearance of \> 40 mg/dl. However bone turnover markers (beta CTx and P1NP) will be measured only in those with creatinine clearance \>60mg/dl

Exclusion criteria

* Patients with prior solid organ transplantation
* Liver/kidney combination will be excluded
* Patients with 24 hr. urine creatinine clearance \< 40mL/minute
* Patients who have been on osteoporosis medications - Bisphosphonates \[Fosamax (Alendronate), Actonel (Risedronate), Boniva (Ibandronate), or Reclast (Zoledronic acid)\] Teriparatide (Forteo), Abaloparatide (Tymlos), Denosumab (Prolia), within the past 5 years
* Use of other systemic medications that can effect bone remodeling including sex hormone replacement therapy (estrogen or testosterone), calcitonin, androgen deprivation therapy, aromatase inhibitors, or SERMS in the past 6 months
* Underlying disease that significantly impacts bone metabolism such as primary hyperparathyroidism, hyperthyroidism, Paget's disease of bone, fibrous dysplasia, or malignancies with skeletal metastases

Primary outcomes:
measure: Incident of clinical fractures validated by spine x-ray or other imaging (vertebral fracture assessment -VFA)
timeFrame: 24 months
Secondary outcomes:
measure: Changes in bone mineral density by dual x-ray absorptiometry
timeFrame: 24 months
measure: Percent changes from baseline to 12 months estimation of bone strength derived from finite element analysis
timeFrame: 24 months
measure: Changes in bone turnover markers in end stage liver disease
timeFrame: 24 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Ejigayehu G Abate, M.D
role: PRINCIPAL_INVESTIGATOR
References: