louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00519870: Losartan Therapy in Pulmonary Hypertension
Official title: Losartan Decreases Pulmonary Artery Pressure and Improves Exercise Capacity in Patients With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Hypertension
Keywords: Pulmonary hypertension
Angiotensin receptor blocker
Calcium channel blocker
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2007-08-23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In addition to being effective vasodilators, angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) exert neurohumoral inhibitory actions, such as the inhibition of vascular remodeling and smooth muscle cell proliferation and the amelioration of endothelial dysfunction. These beneficial effects, render those agents appropriate for use in the treatment of pulmonary hypertension. However, data regarding the use of ACEIs or ARBs in the treatment of PHT are limited. In this study, efficacy of an ARB, losartan was compared with those of the calcium channel blocker, nifedipine in the treatment of pulmonary hypertension using echocardiographic, 6-minute walk test (6MWT), cardiopulmonary exercise test, and endothelin-1 levels.Losartan is as effective as nifedipine for reducing Doppler echocardiographically measured PAP and improving exercise capacity on 6MWT and CPET. However the short-term use of losartan or nifedipine had no statistically significant effect on endothelin-1 levels in patients with PHT.


Eligibility criteria: Inclusion Criteria:

* Pulmonary hypertension diagnosed by Doppler echocardiographic examination (a mean pulmonary artery pressure of \> 26mmHg)

Exclusion Criteria:

* acute infectious or inflammatory disease,
* exacerbation of chronic obstructive pulmonary disease,
* malignancy,
* acute coronary syndrome in the last 4 weeks,
* uncontrolled arrhythmia and hypertension,
* decompensated heart failure,
* acute pulmonary emboli,
* thrombus in a lower extremity,
* oxygen saturation below 85% at rest,
* failure to cooperate with CPET

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Baskent University Faculty of Medicine, Department of Pulmonary Disease
name: Serife Savas Bozbas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baskent University Faculty of Medicine, Department of Pulmonary Disease
name: Fusun Oner Eyuboglu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06658470: Hand Disability In Systemic Sclerosis - Digital Ulcers
Official title: Investigation of the Turkish Validity and Reliability of Hand Disability In Systemic Sclerosis - Digital Ulcersthe (HDISS-DU) Questionnaire in Individuals With Systemic Sclerosis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Systemic Sclerosis (SSc)
Digital Ulcer
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include individuals aged 18 and older who are receiving treatment for Systemic Sclerosis at two university hospital in Turkey, and meet the inclusion and exclusion criteria.

Brief summary: The aim of this study was to examine the Turkish validity and reliability of the Hand Disability in Systemic Sclerosis - Digital Ulcers Questionnaire (HDISS-DU) in individuals with Systemic Sclerosis.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with SSc by a rheumatologist
* Being 18 years of age or older

Exclusion Criteria:

* Presence of neurological disease
* Presence of any orthopedic problem that would affect functionality
* Presence of a history of orthopedic surgery
* Inability to speak or understand Turkish fluently
* Presence of a psychiatric disease that would affect cooperation
* Severe neurological disease that would affect hand functions (peripheral nerve lesion, trauma, operation, cerebrovascular accident)
* Heart failure and lung pathology that would affect daily living activities

Primary outcomes:
measure: The Hand Disability in Systemic Sclerosis-Digital Ulcers Questionnaire
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Secondary outcomes:
measure: Scleroderma Health Assessment Questionnaire
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
measure: Cochin 17-Item Scleroderma Functional Scale
timeFrame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
state: Malatya
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
References:
Clinical trial NCT03897270: Photoacoustic Imaging of the Breast in Patients With Breast Cancer and Healthy Subjects
Official title: Photoacoustic Imaging of Human Breast
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Carcinoma
Healthy Subject
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
First posted: 2019-04-01
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This trial studies photoacoustic imaging of the breast in patients with breast cancer and healthy subjects. Dense breasts typically reduce the sensitivity of a mammography and also is associated with a higher risk of breast cancer. Photoacoustic tomography combines light and sound to provide more information about breast tissue.

Detailed description: PRIMARY OBJECTIVES:

I. To identify photoacoustic features of breast malignancy and treatment response

OUTLINE:

Participants undergo photoacoustic imaging of the breast over 30 minutes. At subject's discretion, imaging may repeat for a total of 10 studies, each in a separate day.

Eligibility criteria: Inclusion Criteria:

* Women with clinically suspicious or confirmed breast cancer masses (that have not been surgically removed) and will/have already undergo/undergone breast magnetic resonance imaging (MRI).

Exclusion Criteria:

* Pregnant women (there are no known risks to these procedures, but any unforeseen risks are as yet undetermined, so pregnant women will be excluded by means of a verbal confirmation at time of screening).
* Women who have had breast implants in the previous 6 months.
* Women who have had lumpectomy
* Adults unable to consent.
* Individuals who are not yet adults (infants, children, teenagers).
* Pregnant women.
* Prisoners.
* There is no direct benefit of the study to any subject either non-English or English speaker. To facilitate the consent process, we will exclude non-English speaking subjects.

Primary outcomes:
measure: Identify photoacoustic features of breast malignancies
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Ermelinda Bonaccio
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00619736: Study Evaluating the Safety, Tolerability and Pharmacokinetics of NSA-789 in Healthy Japanese Male Subjects
Official title: Ascending Single Dose Study of the Safety, Tolerability and Pharmacokinetics of NSA-789 Administered Orally to Healthy Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 56
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study will provide an initial assessment of the safety, tolerability and pharmacokinetics (PK) of NSA-789 after administration of ascending single oral doses to healthy Japanese male subjects. This is a randomized, double-blind, placebo-controlled, inpatient, sequential-group study conducted under fasting conditions at a single investigational site. Each subject will participate in only 1 dose group and will receive only 1 dose of test article.


Eligibility criteria: Inclusion Criteria:

* Men aged 20 to 45 years inclusive at screening.
* Healthy as determined by the investigator on the basis of screening evaluations.

Exclusion Criteria:

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Use of any investigational drug within 90 days before study day 1 or prescription drug within 30 days before study day 1
* Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results.

Primary outcomes:
measure: Safety and Tolerability
timeFrame: 3 months
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03382236: Evaluating the Effectiveness of Osteopathy in the Management of Pain in Elderly People
Official title: Evaluating the Effectiveness of Osteopathy in the Management of Pain in Elderly People in Residential Care Facilities for the Elderly (EHPAD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteopathy
Lead sponsor: Ecole Supérieur d'Ostéopathie
Sponsor class: OTHER
Collaborators: name: BTP RMS
name: ESO Paris Recherche
First posted: 2017-12-22
Enrollment: 52
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This type of study can have an impact on public health policy and help improve the management of pain in people with EHPAD; Propose better use of drug treatments and non-pharmacological methods such as osteopathy; Help structuring the healthcare sector.

Detailed description: * "Osteopathy" group: 3 osteopathy sessions of 45 min with one session every 3 weeks at S2, S5 and S8. Fascial osteopathic techniques performed will consist of gentle and non-impulsive manipulation
* "Simulated" group: 3 simulated osteopathy sessions lasting 45 minutes, one session every 3 weeks at S2, S5 and S8. The techniques performed will consist of an application of the hands to different anatomical regions than the group "osteopathy" without therapeutic intention, that is to say without tissue tensioning.

The pain will be assessed at inclusion (S0) and at the end of the procedure (S12) by the head physician, the coordinating physician or the psychomotor therapist, ignoring the assignment group of the subject and before each session. osteopathy (at S2, S5 and S8) by a nurse or psychomotor also ignoring the patient's assignment group.

Both groups will continue to benefit from their usual allopathic management and recommendations.

Patients will not be aware of the treatment received (osteopathy or simulated) and will be randomized by a computer server.

Eligibility criteria: Inclusion Criteria:

* Patients older than 75 years
* Patients Residing in Accommodation Facilities for Dependent Old People
* A score measured by the DOLOPLUS 2 Scale at least 7/30 at the start of the study
* For patients in capacity and autonomous: Patients informed and having signed a free and informed consent.

For non-capable patients with a trusted person and / or guardian: Informed patients whose confidant or guardian has been informed and has signed free and informed consent.

- Affiliated to a social security scheme (beneficiary or beneficiary)

Exclusion Criteria:

* Absence of pain
* Medical contraindication known to the practice of osteopathy with fascial aim (advanced degenerative bone disease, metastatic cancer)
* Osteopathic treatment in the last six months
* Patients under curators

Primary outcomes:
measure: DOLOPLUS 2 score
timeFrame: Every week after inclusion during 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Lea Gouaux
state: Ile De France
Study officials:
References:
Clinical trial NCT06714370: Real-World Evidence of Effectiveness and Safety of Tirabrutinib in Patients with Relapsed or Refractory Primary Central Nervous System Lymphoma in Taiwan: a Nationwide Study
Official title: Real-World Evidence of Effectiveness and Safety of Tirabrutinib in Patients with Relapsed or Refractory Primary Central Nervous System Lymphoma in Taiwan: a Nationwide Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Primary Central Nervous System Lymphoma (PCNSL)
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-12-03
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient received Taiwan NHI reimbursement

Brief summary: The goal of this observational study is to describe the real-world effectiveness and safety of tirabrutinib among relapsed or refractory PCNSL patients in Taiwan.


Eligibility criteria: Inclusion Criteria:

1. Patient is ≥ 18 years of age.
2. r/r PCNSL patient, who has newly started NHI public reimbursement tirabrutinib from 01 June 2024 to 30 June 2025.
3. Have provided voluntary written consent, directly from the subject, or through his/her legal representative for a patient who has died or lacks the capacity to give informed consent

Note: The NHI reimbursement criteria are listed below for reference purposes only. Subject enrollment depends on whether reimbursement has been received.

1. Histopathologically confirmed large B-cell PCNSL.
2. Patients with relapsed or refractory PCNSL previously treated at least 2 cycles of HD-MTX.
3. Exclude HIV infection
4. Exclude Burkitt lymphoma
5. Exclude patients using chemotherapy or monoclonal antibodies at the initiation of tirabrutinib treatment.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: At least 9 months for each subject
Secondary outcomes:
measure: Duration of response (DOR)
timeFrame: At least 9 months for each subject
measure: Time-to-treatment response (TTR)
timeFrame: At least 9 months for each subject
measure: Adverse events of special interest (AESIs)
timeFrame: At least 9 months for each subject
measure: Clinical laboratory test
timeFrame: At least 9 months for each subject
measure: Treatment-emergent adverse events (TEAEs)
timeFrame: At least 9 months for each subject
measure: Overall survival (OS)
timeFrame: At least 9 months for each subject
measure: Progression-free survival (PFS)
timeFrame: At least 9 months for each subject
Other outcomes:
measure: ECOG Performance Status Scale
timeFrame: At least 9 months for each subject
measure: Clinical usage and pattern of tirabrutinib
timeFrame: At least 9 months for each subject
measure: Ratio of the premedications for infection and skin-related disorders
timeFrame: At least 9 months for each subject
Locations:
Study officials:
References:
Clinical trial NCT06706570: PIK3CA Mutational Status Assessment
Official title: PIK3CA Mutational Status Assessment: Towards a "Tailored" Diagnostic Approach
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Metastatic
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of n=100 PIK3CA-mutant HR+/HER2- metastatic breast cancer patients will be prospectively collected. The mutational status of PIK3CA will be assessed on patients' FFPE metastasis sample tissues using a NGS panel, which covers the entire length of PIK3CA (full gene coverage). Patients with mutant PIK3CA status will be involved in the study and their FFPE as well as plasma samples will be profiled with all the different techniques (one remaining NGS panel and 2 RT-PCR assays).

Brief summary: Evaluation of PIK3CA mutational status: a route towards a tailored diagnostic approach.

Detailed description: Evaluate the effectiveness and concordance of molecular methods in identifying mutations affecting the PIK3CA gene both on paraffin tissue sections of the tumor and on liquid biopsy of patients with breast cancer treated at the IEO. The molecular test on the liquid biopsy of same patient could bring an important benefit considering that the withdrawal of this biomaterial turns out to be less invasive than a biopsy performed on an organ

Eligibility criteria: Inclusion Criteria:

* • Participant has a histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+ breast cancer by local laboratory.

  * Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing.
  * Participants should be at advanced or metastatic setting prior to treatment.
  * Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
  * Patients must be accessible for follow-up.

Exclusion Criteria:

patients already treated with different treatments like chemotherapy, hormone therapy etc

-

Primary outcomes:
measure: Evaluation of PIK3CA mutational status: a path towards a "tailored" diagnostic approach.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
state: MI
Study officials:
affiliation: Istituto Europeo di Oncologia
name: Nicola Fusco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05309070: The Efficacy of N-acetyl-cysteine in the Treatment of Burning Mouth Syndrome
Official title: The Efficacy of N-acetyl-cysteine in the Treatment of Burning Mouth Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burning Mouth Syndrome
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to examine the efficacy of N-acetyl cysteine in the treatment of burning mouth syndrome. A control group of patients with burning mouth syndrome will receive a placebo. The effect of the therapy will be monitored with the help of the visual-analogue scale (VAS) and the oral health-related quality of life questionnaire (OHIP-14).

Detailed description: The research will include patients who come to the Department of Oral Medicine at the Faculty of Dentistry in Zagreb, and who have been diagnosed with burning mouth syndrome. It is planned to gather a total of 60 patients, 30 patients in the treatment group and 30 in the placebo group.

The purpose and protocol of the research will be explained to the patients. If they are willing to participate, they will sign an informed consent previously approved by the Ethics Committee of the Faculty of Dentistry. They will fill in the OHIP-14 questionnaire and the VAS scale, grading from 0-10, where 0 indicates a condition without symptoms, and 10 the strongest possible intensity of symptoms. They will be randomly assigned to a therapeutic or placebo group and will receive the medicine in an unmarked box. The drug will be taken for two months at a dose of 1200 mg per day. After that, they will come for a check-up and re-complete OHIP-14 and record the intensity of symptoms according to the VAS scale.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of burning mouth syndrome

Exclusion Criteria:

* pregnancy, breastfeeding or pregnancy planning
* anamnestic data about active gastric or duodenal ulcer
* decreased levels of serum iron or B vitamins

Primary outcomes:
measure: Change in quality of life
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Change in subjective symptoms of burning mouth
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: School of Dental Medicine, University of Zagreb
Study officials:
References:
Clinical trial NCT00593970: Influenza Vaccine in Pregnancy Part 2
Official title: Knowledge Possessed by Pregnant Women Regarding Influenza Vaccination During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Pregnancy
Keywords: influenza
vaccine
pregnancy
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 46
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A multi-ethnic group of pregnant women

Brief summary: Pregnant women have limited knowledge regarding influenza, its implications during pregnancy, and recommendations for vaccination during pregnancy. The researchers plan to distribute an information pamphlet to women in a prenatal clinic, offer the vaccine during prenatal visits, and then give a questionnaire on the postpartum floor assessing knowledge.

The researchers hypothesize that with education intervention, knowledge scores on the questionnaire will be higher than those from last year, when no education was provided.


Eligibility criteria: Inclusion Criteria:

* all pregnant women

Exclusion Criteria:

* known hypersensitivity to influenza vaccine

Primary outcomes:
measure: Knowledge scores on our questionnaire
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Mark H Yudin, MD
role: PRINCIPAL_INVESTIGATOR
References: