louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05169112: Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy
Official title: The Impact of Adjuvant Androgen Deprivation Following Radical Prostatectomy on Prostate Cancer Recurrence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Tolmar Pharmaceuticals
First posted: 2021-12-23
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prostate cancer is the most common cancer in men and radical prostatectomy is the most frequent treatment for this disease. Unfortunately, approximately 40% of patients will develop recurrence after surgery, requiring additional salvage radiation. Salvage radiation after recurrence is successful in less than half of these men and most of those die from their disease. Measures to prevent recurrence are an important research priority for prostate cancer patients and their families. Hormonal therapy (androgen deprivation therapy; ADT) is routinely used to treat patients with metastases, but few clinical trials have examined if adjuvant ADT after surgery will prevent cancer recurrence. We aim to address this research oversight and test the hypothesis that for men at high risk of cancer recurrence, 1 year of ADT immediately after surgery will be safe and will significantly improve cancer outcomes.


Eligibility criteria: Inclusion Criteria:

1. undetectable PSA (\<0.02 ng/ml) within 16 weeks post-operative;
2. ≥25% predicted risk of PSA recurrence within 5 years of surgery (based on the Kattan nomogram)

Exclusion Criteria:

1. Unwilling to receive ADT;
2. previously received ADT;
3. lymph node metastases
4. allergy to any form of ADT

Primary outcomes:
measure: Rate of enrolment
timeFrame: 1 year
Secondary outcomes:
measure: Rate of enrolment per site
timeFrame: 1 year
measure: Proportion of patients completing study intervention per-protocol
timeFrame: 1 year
measure: Time to study start-up
timeFrame: 1 year
measure: Completeness of study assessments
timeFrame: 1 year
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health
state: Nova Scotia
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre universitaire de santé McGill - McGill University Health Centre
state: Quebec
Study officials:
References:
Clinical trial NCT06872112: A Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension
Official title: Phase I Study: A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Pulmonary Arterial Hypertension (PAH)
Keywords: Pulmonary Arterial Hypertension
Artesunate
PAH
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a 20-week, Phase 1, single-center, open-label, dose-escalation study evaluating the safety and tolerability of daily oral artesunate in patients with PAH.


Eligibility criteria: Inclusion Criteria

* Each participant must meet the following criteria to be enrolled in this study:
* Adults aged 18 to 75 years.
* WHO functional class I, II/III despite treatment with maximally tolerated doses of 2 or more treatment modalities including PDE5 inhibitors, guanylate cyclase stimulators, endothelin receptor antagonists, and prostanoids when appropriate.

Exclusion Criteria

* Participants who meet any of the following criteria will be excluded from the study.
* Participants with serious concomitant morbidity per investigator assessment.

Primary outcomes:
measure: Number of Participants with treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Roham Zamanian, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05729412: Prescription Audit in OPD of NABH & JCI Approved Hospital in Capital Territory of India
Official title: A Prescription Audit In The Outpatient Department Of Nabh & Jci Approved Super Speciality Hospital In The Capital Territory Of India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Keywords: Medical Audit
Prescription Audit
Gender difference
Lead sponsor: Kakatiya University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient prescription which is randomly picked during study period

Brief summary: Aim of the study: The aim of the study is to evaluate the quality of the prescription provided to the outpatient.

Need of study:

For the promotion of the good clinical practice To improve the efficiency of the multidisciplinary team in the healthcare To utilize resources to provide better patient care To improve quality standards and quality of care For implication of professional practices To identify and eliminate deficient practice

Objectives:

1. To study the quality of good prescription
2. In minimization of prescription errors and medication errors
3. Also to comply with good clinical practice
4. Enhancement of patient safety
5. In the maintenance of rational prescribing
6. To study the quality of care provided by the hospital to the patient

Plan of study:

* To select the patient based on inclusion and exclusion criteria
* To collect the information from OP's prescription
* To identify prescribing errors and medication error
* To study the management of good prescription

Study Sites: Max Super Speciality Hospital, Saket, New Delhi (INDIA) Study Design: Observational cohort study Study Duration: 1 month (November 2022)

Detailed description: Source of the data: Review of out-patient prescription Sample size: 100 prescription

Possible outcomes:

Minimization of prescribing errors It improves the quality of care Enhancement of patient safety Compliance with good clinical practice In the maintenance of rational prescribing

Eligibility criteria: Inclusion Criteria:

* Participants who are willing to participate.
* Participants who are attending in the out-patient department.
* Participants reported during the study period.
* Participants who have a prescription which is legible and complete.

Exclusion Criteria:

* Participants who are unwilling to provide the required information.
* Participants who are not attending the out-patient department.
* Participants whose prescription is not legible and competent

Primary outcomes:
measure: Percentage of prescription
timeFrame: November 01, 2022 to November 30, 2022
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Max Super Speciality Hospital
state: Delhi
Study officials:
References:
Clinical trial NCT06268912: Cryoanalgesia for Irreversible Pulpitis
Official title: Cryoanalgesia: Temperature Modulation for Pain Management in Irreversible Pulpitis a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulpitis - Irreversible
Keywords: Cryoanalgesia
Irreversible Pulpitis
Pain Management
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to evaluate the effectiveness of pulpal anesthesia in pain control during endodontic treatment by lowering the temperature of the injected plain 3% cold Mepivacaine (5ºC) compared to 3% Mepivacaine at room temperature in teeth with irreversible pulpitis.

Detailed description: Mepivacaine has some advantages over other anesthetics. The investigators wanted to compare whether changing temperature could improve its effectiveness in cases of irreversible pulpitis.

Eligibility criteria: Inclusion Criteria:

All Patients within the age group of 18-100 years old,

* Patients diagnosed of irreversible pulpitis.

Exclusion Criteria:

* Moderate to pulp necrosis,
* Previous initiated treatment.
* Pregnancy or lactation.
* Allergy or problems to any substances used in the study,
* Acute apical abscess.
* Chronic apical abscess.
* Unrestorable teeth.
* Unsuccessful anesthesia technique (no lip numbness for lower molars or positive response to cold test).

Primary outcomes:
measure: Assessment of Pain and Anxiety
timeFrame: 1 visit of 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Gonzalo Gomez
Study officials:
affiliation: UIC
name: gonzalo gomez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04989712: MOReS Freestyle Libre Validation Study
Official title: The Impact of Different Exercise Timings on Blood Glucose Control and Cognition in Children and Adolescents Using the Freestyle Libre Continuous Glucose Monitoring System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Glucose
Executive Function
Cognitive Change
Keywords: MVPA
Glucose
Cognition
Children
Adolescents
Lead sponsor: Oxford Brookes University
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 10
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised cross over design. Participants act as own controls.
Primary purpose: OTHER

Brief summary: To measure the effects of interrupting prolonged sitting with brief standing physical activity interventions on physical and cognitive performance, health and wellbeing in young people.

Detailed description: Cross over randomised exposure response experimental study in 10 healthy children and adolescents, to measure the effects of interrupting prolonged sitting with brief standing physical activity interventions on their physical and cognitive performance, mobility, health and wellbeing. The study will assess the extent of the immediate and short-term effects of interrupting sitting with brief moderate-vigorous physical activity (MVPA) breaks compared to a sitting only condition.

Dietary analysis and metabolic and cognitive tests after acute exercise will be performed on the participants to compare the FreeStyle Libre responses between those with and without disabilities.

Eligibility criteria: Inclusion Criteria:

* Young people aged 9-18 years old
* No significant current or previous medical history
* Are able to participate safely in the study's assessments and brief interrupted sitting moderate to vigorous physical activity (MVPA)

Exclusion Criteria:

* Those with uncontrolled epilepsy/seizures (stable epilepsy/on medication \> 12 weeks)
* Those who have Type 1 and Type 2 diabetes or other glucose intolerance or on medication for such conditions
* Those who experience contraindications to physical training
* Those who are on any form of steroids, anti-anxiety/depression drugs, birth control, beta-blockers, statin, adrenaline, HIV or Hepatitis C medications (these medications can affect the readings during the oral glucose tolerance test)
* Those with known allergies to plasters

Primary outcomes:
measure: Executive Functioning - Eriksen Flanker Task
timeFrame: Maximum of two weeks
measure: Working Memory - WISC Digit Span
timeFrame: Maximum of two weeks
Secondary outcomes:
measure: Oral Glucose Tolerance Test (OGTT)
timeFrame: Maximum of two weeks
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Brookes University
state: Oxfordshire
Study officials:
affiliation: Oxford Brookes University
name: Helen Dawes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03956212: Inflammatory Mediators in Erythema Migrans
Official title: Inflammatory Proteins, Gene Polymorphisms, and Transcriptome Profiles in Patients With Erythema Migrans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erythema Migrans
Keywords: Lyme Borreliosis
Inflammation
Outcome
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University of Ljubljana School of Medicine, Slovenia
First posted: 2019-05-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective of this study is to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with erythema migrans to gain better insight into pathogenesis of early Lyme borreliosis and to define new immune modulators that could serve as biomarkers of disease activity.


Eligibility criteria: Inclusion Criteria:

* erythema migrans in patients \> 18 years

Exclusion Criteria:

* pregnancy or immunocompromising conditions
* taking antibiotic with antiborrelial activity within 10 days

Primary outcomes:
measure: inflammatory proteins in erythema migrans patients
timeFrame: up to 12 months follow-up
Secondary outcomes:
measure: gene polymorphisms in erythema migrans patients
timeFrame: at enrollment
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Daša Stupica, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05348512: Laboratory Study for the Acquisition of Spectral and Photoplethysmographic Data
Official title: Laborstudie Zur Aufnahme Spektraler Und Photoplethysmographischer Daten
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Volunteers
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers \>= 18 years

Brief summary: Laboratory study on healthy volunteers to acquire spectral video data from the tongue and fingers as well as photoplethysmographic data from the forehead, fingers, and earlobes to evaluate and optimize algorithms for imaging photoplethysmography (iPPG) and multispectral imaging (MSI)


Eligibility criteria: Inclusion Criteria:

* healthy volunteers \>= 18 years old

Exclusion Criteria:

* pregnant and nursing women
* persons unable to consent
* persons with tattoos or diseases on the tongue, finger, ear, or forehead
* narcoleptics
* epileptics
* persons with arterial hypertension, peripheral arterial disease, anemia, Raynaud syndrome, autoimmune vasculitides, Takayasu arteritis, venous insuffiencies, microangiopathy, diabetic vasculopathy, scleroderma

Primary outcomes:
measure: RGB video data
timeFrame: 16 minutes
measure: hyperspectral data
timeFrame: 16 minutes
measure: multispectral video data
timeFrame: 16 minutes
measure: plethysmographic wave
timeFrame: 5 minutes
measure: pulse
timeFrame: 5 minutes
measure: pulsation index
timeFrame: 5 minutes
measure: SpO2
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Department of Visceral, Transplantation, Vascular and Thoracic Surgery
Study officials:
affiliation: University of Leipzig
name: Ines Gockel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01721512: The Growth and Development of Breast and Formula Fed Term Asian Infants
Official title: The Growth and Development of Breast and Formula Fed (Containing Synbiotics and LCPUFA) Term Asian Infants.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth
Keywords: Prospective observational study
Breast feeding
Infant formula
Infant
Indonesia
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Fonterra Brands (Singapore) PTE LTD
First posted: 2012-11-04
Enrollment: 160
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy infants recruited from Jati Padang, Pasar Minggu District, South Jakarta, Indonesia

Brief summary: Prospective cohort study of breast and formula fed infants in a suburban setting in Jakarta, Indonesia


Eligibility criteria: Inclusion Criteria:

* Breast-fed: 1. Mother intends to exclusively breast-feed from birth to at least 4 months; 2. A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg.
* Formula-fed: 1. Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding; 2. A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg; 3. Mother consents to her infant receiving trial infant formula for 12 months.

Exclusion Criteria:

* 1. Severe congenital or metabolic disease likely to affect infant feeding or infant growth.
* 2. Multiple birth

Primary outcomes:
measure: Infant weight, body length head circumference
timeFrame: 12 months
Secondary outcomes:
measure: Gastrointestinal tolerance
timeFrame: 6 months
measure: Indicators or formula tolerance
timeFrame: 12 months
measure: General health
timeFrame: 12 months
measure: Gut integrity
timeFrame: 3 months
measure: Gut microflora
timeFrame: 3 months
measure: Developmental progress
timeFrame: 12 months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Universitas Indonesia
Study officials:
affiliation: Indonesia University
name: Agus Firmansyah, Professor, MD, PhD, SpA(K)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dwipoerwantoro PG, Mansyur M, Oswari H, Makrides M, Cleghorn G, Firmansyah A. Growth of Indonesian Infants Compared With World Health Organization Growth Standards. J Pediatr Gastroenterol Nutr. 2015 Aug;61(2):248-52. doi: 10.1097/MPG.0000000000000770.
Clinical trial NCT04551612: Level of Middle Cranial Fossa Dura in Patients With Cholesteatoma
Official title: Evaluation of the Level of Middle Cranial Fossa Dura in Patients With Cholesteatoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cholesteatoma, Middle Ear
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cholesteatoma in one ear

Brief summary: Cholesteatoma is a destructive lesion that progressively expands in the middle ear, mastoid or petrous bone and leads to destruction of the nearby structures. Erosion, which is caused by bone resorption of the ossicular chain and otic capsule, may cause hearing loss, vestibular dysfunction, facial paralysis and intracranial manifestations

Detailed description: Cholesteatoma has three Classical forms: (1) Congenital, primary or genuine cholesteatoma: occurs behind an intact tympanic membrane. Primary acquired cholesteatoma: looks like a limited diverticulum of the pars flaccida with little or no history of otorrhea. Secondary acquired cholesteatoma: develops with posterosuperior perforations in eardrum and expansion of the disease process into the antrum, mastoid, attic and middle ear. Granulation tissue, polyps and foul- smelling otorrhea are common findings in this type

Eligibility criteria: Inclusion Criteria:

* All adults above the age of 18 presented to the Assiut university Clinic with

cholesteatoma will be included in the study.

Exclusion Criteria:

1. Patients with previous mastoid surgery
2. Patients with Craniofacial anomalies or cleft lip and palate
3. Pediatric populations ≤ 18 years old
4. Patients with congenital ear anomalies

Primary outcomes:
measure: Evaluation of the Level of Middle Cranial Fossa Dura in Patients with Cholesteatoma by multislice computed tomography.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06980012: Evaluation of the Impact of the Clinical Pharmacist in Oral Therapies in Oncology.
Official title: Evaluation of the Impact of the Clinical Pharmacist in the Initiation and Follow-up of Oral Therapies in Oncology.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neoplasm
Lead sponsor: Polyclinique Lyon Nord
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The hospital pharmacist plays a vital role at the time of the patient's first prescription in a healthcare facility, to inform the patient about his or her new therapy and create a link between the hospital and the patient's home pharmacy, so that the patient can continue to receive care at home. It is also essential that the hospital pharmacy and the patient's local pharmacy work together within a reasonable timeframe. This will help improve patient care and treatment follow-up, detect any undesirable effects and optimize their management..

The aim of this prospective interventional study is to measure the benefits of pharmaceutical monitoring in healthcare institutions at the initiation of oral therapy on patient compliance, side-effect management and adherence, in comparison with patients without this monitoring.

The primary endpoint is compliance with the Girerd questionnaire.


Eligibility criteria: Inclusion Criteria:

* Patient suffering from an oncological pathology (excluding hematological malignancies)
* Initiation of a specific treatment in the context of an oncological pathology: oral therapy treatment taken at home in oncology (which may follow surgery, radiotherapy or other in-patient treatments).
* Patient who has not yet started treatment or who has started treatment less than 30 days
* Patient with continuation of oral therapy dispensed in pharmacies

Exclusion Criteria:

* Patients suffering from hematological malignancies
* Patient living in an institution or hospital
* Patient under treatment for more than 30 days
* Patient undergoing treatment other than oral therapy (venous or subcutaneous anticancer treatment)
* Patient whose treatment after initiation is not dispensed in a pharmacy

Primary outcomes:
measure: Observance
timeFrame: 3 months and 6 months after treatment initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Rillieux-la-Pape
country: France
facility: Polyclinique Lyon Nord
Study officials:
References: