louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06149065: Factors Associated With the Acne Severity Among Transmen Population: a Cross-sectional Study
Official title: Factors Associated With the Acne Severity Among Transmen Population: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne
Transgenderism
Keywords: Diet, Female-to-male transgender, Masculinizing hormone therapy, Risk factors
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 247
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All transmen who visited the Gender Variation (GenV) Clinic (outpatient clinic) of Ramathibodi Hospital

Brief summary: The goal of this observational cross-sectional study is to identify factors associated with severity of acne in Thai transmen receiving masculinizing hormone therapy. The main questions it aims to answer are:

* What are the factors associated with severity of acne in transmen?
* Does masculinizing hormone therapy associate with the severity of acne in transmen? Participants will be asked to complete an online questionnaire and allow to take pictures of their face for acne assessment purpose.


Eligibility criteria: Inclusion Criteria:

* Transmen who visited the Gender Variation (GenV) Clinic of Ramathibodi Hospital
* Transmen who received masculinizing hormone therapy (testosterone)
* Transmen who completed an online questionnaire and intentional submit their facial photographs

Exclusion Criteria:

* Refusal to participate
* Incomplete questionnaire
* Missing photos
* Diagnosis of any disorders of sexual differentiation which may have peculiar hormonal effect

Primary outcomes:
measure: The severity of acne
timeFrame: 1 day (At the time of answering an online questionnaire)
Secondary outcomes:
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Division of Dermatology, Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University
state: Bangkok
Study officials:
References:
Clinical trial NCT00302965: Effectiveness of Plasma Transfusions in Critical Care Patients
Official title: Effectiveness of Fresh Frozen Plasma in Critical Care (EPICC) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Coagulation
Keywords: Plasma
Trauma
Critical Care
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2006-03-15
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Measuring the effectiveness of plasma transfusions in critical care

Detailed description: Measuring the effectiveness of plasma transfusions in critical care

Eligibility criteria: Inclusion Criteria:

* ICU Admission
* INR \> 1.2
* Require FFP for active bleeding and/or prior to an invasive procedure
* Are able to provide consent or proxy consent

Exclusion Criteria:

* Congenital or acquired coagulation factor deficiency
* Platelet count \< 50 x 109 /L and have NOT received subsequent platelet transfusion
* Consumptive coagulopathy (bleeding ≥ 3 sites and ↓ plts, ↓ fib, ↑ d dimer)
* Uncontrolled bleeding (6 or more units of blood in the last 6 hours)
* Receiving therapeutic doses of heparin/heparinoid (must be off for at least 6 hours)
* Have received clotting factor concentrates in the previous 24 hours
* Are expected to require surgery in the next 48 hours
* Survival expected to be less than 48 hours
* Currently enrolled in another study with a similar outcome
* Previous enrollment in this study

Primary outcomes:
measure: the proportion of patients with a correction of the INR (Determined by the treating physician)
measure: Secondary outcomes include changes in coagulation tests (INR, aPTT and individual coagulation factor levels
measure: bleeding and complications from FFP (fluid overload, transfusion reactions).
Secondary outcomes:
measure: Secondary outcomes include changes in coagulation tests (INR, aPTT and individual coagulation factor levels
measure: bleeding and complications from FFP (fluid overload, transfusion reactions).
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
Study officials:
affiliation: OHRI
name: Alan Tinmouth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00976365: Evaluation of the Safety and Efficacy of THL-P in Metastatic Breast Cancer
Official title: Phase IIa Study of Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Taiwan THL Co.LTd.
Sponsor class: INDUSTRY
Collaborators: name: National Taiwan University Hospital
First posted: 2009-09-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to obtain evidence from test article with efficacy in Metastatic Breast Cancer patients. The average of all changes from baseline to post-treatment evaluations in global health/quality of life (QoL) subscale assessed by self-administered European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30).

Detailed description: The test article is extracted from many natural herbals, in which most or their components have been shown to have anti-tumor activity. A study in 2004 showed the test article could have strong immunomodulatory effect on the antigen-stimulated proliferation response (PR) of peripheral blood mononuclear cells (PBMC) and T-cells from recurrent aphthous ulcerations (RAU) patients and suggested that it might be a potential immunoceutical agent for treatment of RAU. Subsequent study in 2005 also suggested the test article as a potential immunoceutical agent for treatment of RAU because the result showed it could modulate the antigen-stimulated cytokine production by T-cells isolated from RAU patients. Another study in 2005 showed the test article also had a broad-range tumor killing function and provided a molecular basis underlying therapeutic activity. It was also suggested in this study will could be a potential and promising cancer therapeutic or preventive agent.

The aim of this current study is to explore the safety and efficacy of the investigational product with 20 ml, 3 times per day (daily dose: 60 ml) for a total of 24 weeks in the patients with metastatic breast cancer refractory to conventional treatment modalities.

Eligibility criteria: Inclusion Criteria:

* Confirmed breast cancer with clinical evidence.
* Life expectancy of at least 4 weeks.

Exclusion Criteria:

* Any Uncontrolled infection.
* Lupus erythematosus.
* Malignant tumor.

Primary outcomes:
measure: QOL
timeFrame: 6 months measure
Secondary outcomes:
measure: CBC with platelet and differential counts. AST, ALT, total bilirubin, BUN, uric acid and Creatinine
timeFrame: 6 months measure
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: King-Jen Chang, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02922465: Drug-Drug Interaction Study to Assess the Effects of Multi Dose Clopidogrel on the Pharmacokinetics of Single-Dose K-877 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The primary objective of this study is to assess the effects of clopidogrel on the PK of K-877 in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Subject provides written informed consent before any study-specific evaluation is performed;
* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive at screening;
* Subject has a BMI of 18 to 30 kg/m², inclusive;
* Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges, or results that do not show clinically significant abnormalities, as judged by the Investigator at screening and check-in;

Exclusion Criteria:

* Subject is a woman who is pregnant or breastfeeding;
* Subject has clinically significant abnormalities in the screening or check-in assessments;
* Subject has current or history of clinically significant coagulation, bleeding, or platelet disorders;
* Subject or a family member of the subject has a history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations, including aneurysms;

Primary outcomes:
measure: Plasma exposure of K-877 by measuring Cmax when administered alone or with Clopidogrel
timeFrame: Up to 72 hours after dosing
measure: Plasma exposure of K-877 by measuring AUC when administered alone or with Clopidogrel
timeFrame: Up to 72 hours after dosing
Secondary outcomes:
measure: Evaluation of 20 participants with treatment emergent adverse events as assessed by the principle investigator
timeFrame: Through study completion up to 17 days.
Other outcomes:
Locations:
city: Cincinnati
country: United States
state: Ohio
Study officials:
References:
Clinical trial NCT06232265: An Observational Study on Predicting the Efficacy of Immunotherapy for NSCLC Based on LIRAscore
Official title: An Observational Study on Predicting the Efficacy of Immunotherapy for Non-small-cell Lung Cancer Based on LIRAscore
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Keywords: immunotherapy
LIRA score
biomarker
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects of this study were patients with previously untreated, locally advanced or metastatic non-small-cell lung cancer (stage IIIB/IIIC or stage IV) without driver gene mutation.

Brief summary: This is a multi-center, observational clinical study to explore the role of LIRAscore in predicting immunotherapy monotherapy and combination with chemotherapy efficacy and prognosis in locally advanced or metastatic non-small-cell lung cancer. The study plans to enroll 108 patients. The primary endpoint of this study was ORR, and secondary endpoints were PFS, OS, DoR, DCR, and safety.


Eligibility criteria: Inclusion Criteria:

1. Patients voluntarily participated in the study, signed the informed consent, and had good compliance;
2. Histologically and/or cytologically confirmed previously untreated, locally advanced or metastatic non-small-cell lung cancer (stage IIIB/IIIC or stage IV) without driver gene mutation;
3. Patients are willing to receive immunotherapy monotherapy or immunotherapy combined with chemotherapy;
4. The patient agrees to provide the remaining tissue samples after clinical routine diagnosis during the baseline period for LIRA score and PD-L1 immunohistochemical testing;
5. The Eastern Organization for Oncology (ECOG) physical fitness score is 0 or 1;
6. The patient has at least one measurable or unmeasurable but evaluable lesion.

Exclusion Criteria:

1. According to clinical routine, patients do not meet the criteria for receiving standard anti-tumor treatment;
2. Patients with known EGFR mutations, ALK rearrangements or ROS1 rearrangements are not eligible to participate in this study;
3. According to the researcher's judgment, the patient is not suitable to participate in this study.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 3 years
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: 3 years
measure: Overall Survival (OS)
timeFrame: 3 years
measure: Duration of response (DoR)
timeFrame: 3 years
measure: Disease Control Rate (DCR)
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Wangjun Liao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06566365: Effect of Hormonal Cahanges During Menstrual Cycle on Subcostal Transversus Abdominis Plane Block
Official title: Effect of Hormonal Cahanges During Menstrual Cycle on Subcostal Transversus Abdominis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Menstrual Cycle
Subcostal Transversus Abdominis Plane Block
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fascial plane blocks are traditionally considered regional anesthesia techniques, where a mixture of local anesthetic (LA) is injected into a plane between two fascial layers, with the aim of spreading along this anatomical plane to block the nerves lying within or passing through it . Various pathophysiological processes that alter the structure and characteristics of fasciae can affect the spread of the local anesthetic and the success of the block. Diabetes, hormonal changes, and cannabinoid use are among these factors. This study aims to investigate the effects of hormonal changes during the menstrual cycle on subcostal TAP block.

Detailed description: Female patients scheduled for laparoscopic cholecystectomy at Adıyaman University Training and Research Hospital, who have been informed about the study and have provided written consent to participate, will be included in the study. The patients who agree to participate will be divided into groups based on the phases of their menstrual cycles. After ensuring airway safety under general anesthesia, a bilateral TAP block using 20 cc of 0.25% bupivacaine with a subcostal approach under ultrasound guidance will be administered to both groups. The study aims to compare the hemodynamic values (arterial blood pressure, heart rate, peripheral oxygen saturation) during the perioperative period, the visual analog scale (VAS) scores postoperatively, and the Quality of Recovery-15 (QoR-15) scores at 24 hours postoperatively between the two groups. This will allow for the investigation of the effects of hormonal changes during the menstrual cycle on the efficacy and success of subcostal TAP blocks.

Eligibility criteria: Inclusion Criteria:

* ASA I-II, female, Laparoscopic cholecyctectomy, Subcostal TAP , 18-65 years old patient

Exclusion Criteria:

* ASA III-IV
* \<18 , \>65 years old patients
* menstrual disorders

Primary outcomes:
measure: visual analogue scale (VAS)
timeFrame: postoperative 1st,2nd, 6.- 12.-24. hour
Secondary outcomes:
measure: Quality of Recovery - 15
timeFrame: postoperative 24. hour
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Adıyaman Training and Research Hospital
Study officials:
References:
Clinical trial NCT06403865: Patient-Reported Outcomes in Real-life of Cabotegravir and Rilpivirine
Official title: Evaluation en Vie réelle de la qualité de Vie de Personnes Vivant Avec le VIH traité Par cabotégravir et Rilpivirine Par Patient-Reported Outcomes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Quality of Life
Keywords: Long-Acting Injectable Regimen
HIV
Patient-reported Outcomes
Treatment switch
Lead sponsor: University Paris 7 - Denis Diderot
Sponsor class: OTHER
Collaborators: name: Hopital Foch
First posted: 2024-05-08
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People living with HIV-1 whose ARV treatment has been changed to an injectable CAB+RPV LA treatment

Brief summary: Context The introduction of the long-acting injectable antiretroviral treatment cabotegravir and rilpivirine into the therapeutic armamentarium for people living with HIV represents a potentially significant evolution in patients' experience of their treatment and pathology. Its effects on the quality of life of PLHIV are explored in this research. In addition, the two-monthly intra-muscular injection regimen also raises questions about the city-to-hospital transition of care for PLHIV, as well as compliance with the therapeutic window.

Main objective To evaluate the effect of switching HIV treatment to CAB+RPV LA on health-related quality of life on the "Treatment Impact" dimension of the PROQOL-HIV questionnaire, 15 months after switching treatment.

Population People living with HIV-1 whose ARV treatment has been changed to an injectable CAB+RPV LA treatment

Study Design Observational study. Inclusion at HIV medical follow-up visit for change of ARV treatment to CAB/RPV.

Self-administered questionnaires at M3, M9 and M15 after change of treatment (first CAB/RPV injection).


Eligibility criteria: Inclusion Criteria:

* HIV-1 carriers
* Patients who changed treatment (as part of routine care) to injectable CAB+RPV at the same visit as the inclusion visit
* HIV-RNA less than or equal to 50 copies/mL for at least 6 months prior to inclusion visit
* Patient 18 years of age or older
* Patient able to read, understand and answer self-questionnaires in French

Exclusion Criteria:

* Pregnant or breast-feeding women
* Known hypersensitivity to cabotegravir or rilpivirine
* Documented resistance to cabotegravir or rilpivirine
* Chronically active hepatitis B (HBsAg+)
* Any pathology or history of treatment which, in the investigator's judgment, would contraindicate the patient's inclusion in the study or prevent him/her from following the constraints of the protocol.

Primary outcomes:
measure: Treatment Impact - PROQOL-HIV
timeFrame: between D0 (baseline) and 15 months after the first injection of CAB+RPV LA
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04637165: Exploring the Immunology of Sarcoidosis
Official title: Exploring the Immunology of Sarcoidosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
Keywords: macrophage
lymphocyte
cytokine
immunology
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of York
First posted: 2020-11-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sarcoidosis

Brief summary: In sarcoidosis, over activity of parts of the immune system drives the accumulation of granulomas (collections of immune cells) in affected parts of the body. To facilitate development of effective and safe treatment options in the future it will be vital to understand how and why the immune system becomes over active. The aim of this research is to work towards this goal by studying cells of the immune system and the molecular pathways inside these cells that control how they behave. This will be achieved by analysing patterns of proteins and RNA (the code used to tell cells which proteins to produce) in immune cells present in blood samples and tissue biopsies from people with sarcoidosis.


Eligibility criteria: Inclusion Criteria:

1. Males or females, of any race, between 18 and 85 years of age, inclusive
2. Able to provide written informed consent
3. Clinician diagnosis of sarcoidosis
4. Treatment-naïve or receiving immunomodulatory therapy.

Exclusion Criteria:

1. Evidence of acute bacterial infection or other condition likely in the opinion of the investigator to significantly impact results of blood assays.

Primary outcomes:
measure: Transcriptomics (RNA) -tissue
timeFrame: 3 years
Secondary outcomes:
measure: Protein - tissue
timeFrame: 3 years
measure: Transcriptomics (RNA) - blood
timeFrame: 3 years
measure: Cytokines - blood
timeFrame: 3 years
Other outcomes:
measure: Antibodies - blood
timeFrame: 3 years
Locations:
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
state: East Yorkshire
Study officials:
References:
Clinical trial NCT06142565: Treatment of Postviral Olfactory Dysfunction
Official title: Treatment of Postviral Olfactory Dysfunction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hyposmia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Skane
First posted: 2023-11-21
Enrollment: 120
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: TREATMENT

Brief summary: A decreased sense of smell (hyposmia) is often caused by viral infections, such as COVID-19. Today, the only recommended treatment for hyposmia is olfactory training, a time consuming method with limitations in terms of both compliance and effect. The aim of this study is therefore to evaluate, as well as optimize, a new treatment method for olfactory loss.

Hyposmic participants will be recruited and randomized into two different treatment conditions. One group will do regular olfactory training and the other will do passive olfactory training with scented nose plugs. The training will be conducted in the home of the individual monday through friday for two consecutive months. Subjective and objectvie measures of olfactory problems will be assessed before and after treatment, as well as subjective measures related to quality of live and genereal wellbeing.


Eligibility criteria: Inclusion Criteria:

* 18 - 65 years old
* Physically and cognitively capable of participating in the study
* Having appropriate olfactory screening test scores (hyposmic)

Exclusion Criteria:

* Anosmics
* Individuals with other diagnoses that could affect the study results

Primary outcomes:
measure: Objective olfactory function
timeFrame: 2 months
measure: Subjective symptoms and social/emotional consequences
timeFrame: 2 months
measure: Subjective health
timeFrame: 2 months
measure: Subjective olfactory function
timeFrame: 2 months
measure: Subjective degree of suffering from olfactory impairment
timeFrame: 2 months
measure: Subjective parosmia
timeFrame: 2 months
measure: Subjective depressive symptoms
timeFrame: 2 months
measure: Subjective general wellbeing
timeFrame: 2 months
measure: Compliance
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Solna
country: Sweden
facility: Karolinska Institutet
state: Stockholm
Study officials:
affiliation: Karolinska Institutet
name: Johan N Lundstrom
role: PRINCIPAL_INVESTIGATOR
References: