louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00197379: The Effect of 0.5% Roxithromycin Lotion for Androgenetic Alopecia
Official title: The Study for New Effect of Roxithromycin on Androgenetic Alopecia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alopecia
Keywords: androgenetic alopecia
roxitromycin
apoptosis
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is exploiting the new drugs for androgenetic alopecia because there are still no effective and safe topical drug for androgenetic alopecia. Roxithomycin is one of the macrolide antibiotics that has immunomodulatory effects. We firstly found that roxithromycin increases the rate of murine and human hair follicle elongation in vitro. Therefore, we apply this drug on this disease therapy.

Detailed description: The topical therapy for androgenetic alopecia is still not enough to improve cosmetically. Thereforem we try to find new effective and safe topical therapy for this disease. Roxithromycin has not only antibacterial action but also immunomodulatory and anti-inflamatory potency. For example, roxitromycin inhibits T cell responces to mitogens and production of cytokines, IL-2 and IL-5. We firstly found that roxitromycin increased human and murine hair elongation in vitro to inhibit apoptosis of hair bulb. Then, we wish to apply roxithromycin on the therapy for androgenetic alopecia.

Eligibility criteria: Inclusion Criteria:

* Androgenetic alopecia

Exclusion Criteria:

* Cicatricial alopecia
* Allergy to roxitromycin
* Children (19years old or younger)
* Pregnant female

Primary outcomes:
Secondary outcomes:
measure: Pathological study taken from lesional scalp skin.
timeFrame: One year
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: Department of Dermatology, Hamamatsu University School of Medicine
Study officials:
affiliation: Hamamatsu University
name: Masahiro Takigawa, M.D.
role: STUDY_CHAIR
References:
citation: Ohshima A, Tokura Y, Wakita H, Furukawa F, Takigawa M. Roxithromycin down-modulates antigen-presenting and interleukin-1 beta-producing abilities of murine Langerhans cells. J Dermatol Sci. 1998 Jul;17(3):214-22. doi: 10.1016/s0923-1811(98)00017-6.
citation: Ito T, Ito N, Saathoff M, Bettermann A, Takigawa M, Paus R. Interferon-gamma is a potent inducer of catagen-like changes in cultured human anagen hair follicles. Br J Dermatol. 2005 Apr;152(4):623-31. doi: 10.1111/j.1365-2133.2005.06453.x.
citation: Lindner G, Botchkarev VA, Botchkareva NV, Ling G, van der Veen C, Paus R. Analysis of apoptosis during hair follicle regression (catagen). Am J Pathol. 1997 Dec;151(6):1601-17.
Clinical trial NCT04603079: Nurse Leadership for Hospital Infection Control
Official title: A Randomized Control Trial to Change Nurse Leadership in Maintaining Minimum Service Delivery Standards for Hospital Infection Control in the Era of COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse's Role
Infection
Keywords: Randomized Control Trial
Nurse leadership
Hospital Infection Control
COVID-19
Lead sponsor: Forman Christian College, Pakistan
Sponsor class: OTHER
Collaborators: name: King Edward Medical University
First posted: 2020-10-26
Enrollment: 344
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 200 nurses will be sampled. A 100 nurses each will be randomly assigned to the control and experiment group each.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim is to deliver an intervention to promote nurse leadership and decision-making in the hospital setting, by providing them with training for maintaining minimum service delivery standards for hospital infection control with respect to COVID-19; but also other infectious disease burden management.

Detailed description: Nurses are frontline practitioners in the fight against COVID-19. Empowering nurses through training for infection prevention for COVID-19 is an essential step to facilitate nurse leadership and safety in the hospital. There is immense reliance on nurses with regard to patient safety, yet very little effort is made to invest in interventions for their leadership roles in developing countries, including Pakistan. In this study the aim is to deliver an intervention for COVID-19 preventive protocols to nurses and assess the impact of the intervention through a pre and post-test survey. A total of 200 nurses will be sampled. A 100 nurses each will be part of the control and experiment group each.

The data will be analyzed using SPSS. Pre and post test results will be presented using descriptive data and bivariate regression will be used to present higher odds of confidence in preventive and awareness literacy for COVID-19 in nurses after intervention delivery. Through this research the aim is to improve nurse leadership in maintaining minimum service delivery standards for hospital infection control with respect to COVID-19; but also other infectious disease burden management.

Eligibility criteria: Inclusion Criteria:

* The selection criteria will be all currently working staff nurses.

Exclusion Criteria:

* Student nurses or nurses not part of clinical rounds.

Primary outcomes:
measure: Core competencies in nurses for infection control and prevention (Min and Sil 2014)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Online sampling of nurses from public and private hospitals (confidential data)
state: Punjab
Study officials:
References:
Clinical trial NCT05730179: Pain Inhibitory Effects of a Single Painful Mechanical Stimulus Compared to Multiple and Multiple at Different Locations
Official title: Conditioned Pain Modulation Induced by Mechanical Stimulation: A Mechanism of Manual Therapy Analgesia - Study 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Conditioned Pain Modulation
Manual Therapy
Physiotherapy
Physical therapy
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective is to estimate the effects on pain thresholds of a single painful mechanical stimulus compared to multiple and multiple stimuli at different locations.

Detailed description: The mechanical stimulus produced in manual therapy (MT) techniques elicits neurophysiological responses within the peripheral and central nervous system responsible for pain inhibition. Almost all types of MT elicit a neurophysiological response that is associated with the descending pain modulation circuit. But it has not been demonstrated whether this inhibition occurs through a conditioned pain modulation mechanism induced by painful mechanical stimulation that is carried out with manual therapy techniques.

Eligibility criteria: Inclusion Criteria:

* healthy male or female between 18 and 65 years
* Free of pain and with no history of chronic pain

Exclusion Criteria:

* Pregnant or having given birth within the last year

Primary outcomes:
measure: Change from Baseline in Tibialis Anterior Pressure Pain Threshold (PPT) to immediate post-conditioning stimulus
timeFrame: At baseline and immediately after the conditioning stimulus
Secondary outcomes:
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Josué Fernández Carnero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06616779: DigiDiab Evaluation Domiciliary Nursing Care
Official title: An Open, Single-centre, Non-interventional Study of the CE-marked Medical Device GlucoTab, According to Intended Use Without Additional Invasive and Stressful Measures
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM)
Type 2 Diabetes, Insulin Requiring
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 40
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: Non-critically ill patients with type 2 diabetes receiving domiciliary nursing care who require s.c. insulin therapy

Brief summary: GlucoTab is a stand-alone software system to support healthcare professionals in the care of patients with diabetes mellitus or newly diagnosed hyperglycaemia who are treated with insulin and/or other glucose-lowering drugs or of patients only requiring glucose monitoring.

It provides a therapy algorithm for subcutaneous basal insulin therapy of patients with type 2 diabetes, which will be used in this study.

Detailed description: GlucoTab: The CE-marked medical device GlucoTab is a system designed to support healthcare personnel in managing insulin therapy for patients with diabetes.

In this study, only the GlucoTab algorithm supported basal therapy will be used, which is intended for patients with Type 2 diabetes in domiciliary nursing care requiring insulin therapy.

GlucoTab has a CE certificate, will be used according to its intended purpose and no additional burdensome or invasive interventions are planned

Eligibility criteria: Inclusion Criteria:

* Informed consent obtained after being advised of the nature of the study
* Male or female aged ≥ 18 years
* Type 2 diabetes (treated with insulin therapy)
* Receiving domiciliary nursing care

Exclusion Criteria:

* type 1 diabetes mellitus
* intravenous insulin therapy
* hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy
* continuous subcutaneous insulin infusion
* gestational diabetes or pregnancy
* known or suspected allergy to insulin
* total parenteral nutrition
* any mental condition rendering the patient incapable of giving his/her consent
* any disease or condition which according to the investigator would interfere with the trial or the safety of the patient

Primary outcomes:
measure: Efficacy - mean percentage of Fasting Blood Glucose
timeFrame: ≥ 24 hours after start of the therapy by using the GlucoTab system
Secondary outcomes:
measure: Safety - number of hypoglycaemic events
timeFrame: at the end of the study, on average three months
measure: Efficacy
timeFrame: at the end of the study, on average three months
measure: Usability
timeFrame: at the end of the study, on average three months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02549079: Soluble Factors in the Serum of Severely Burned Patients
Official title: Soluble Factors in the Serum of Severely Burned Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burn Patients
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 23
Sex: ALL
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: Patients with burn injuries treated in the burn intensive care unit

Brief summary: The present study investigates the levels of certain soluble factors in the blood of patients with severe burn injury. Serum levels of different soluble factors will be correlated with the clinical outcome, presence of sepsis, the area of burn, and other clinical parameters in order to make a statement regarding their use as biomarkers in the prediction and monitoring of burn patients.

Detailed description: Burn patients still represent a critical patient collective with a high mortality rate although treatment technologies have improved over the years. One problem healthcare professionals face is the fact that reliable biomarker which predict the clinical outcome, the onset of sepsis, and monitor the severity of disease in burn patients are still missing. These biomarkers would allow an early adoption of treatment modalities to improve the outcome and prevent life-threatening complications.

Blood samples from severely burned patients will be collected over a period of five days and different cytokines (for example the macrophage migration inhibitory factor protein family) will be measured in the serum. Clinical data of the patients (sepsis, total body surface area of burns, abbreviated burn severity index, sepsis-related organ failure assessment, etc.) will be documented and correlated to the levels of soluble factors.

Eligibility criteria: Inclusion Criteria:

* 18 years of age
* minimum of 10% total body surface area burn
* needing ICU treatment

Exclusion Criteria:

* younger than 18 years of age
* immunosuppression (e.g. HIV)
* undergone surgery 2 weeks prior to burn injury
* malignancies
* severe diseases (myocardial infarction, lung embolism)
* declining to participate in the study

Primary outcomes:
measure: Survival of a total of 23 burn patients during their treatment in the ICU
timeFrame: five days
Secondary outcomes:
measure: Onset of sepsis of a total of 23 burn patients during their treatment in the ICU
timeFrame: five days
Other outcomes:
Locations:
Study officials:
affiliation: RWTH Aachen University
name: Norbert Pallua, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03027479: Skeletal Muscle Energy Metabolism in Women With Weight Loss and Ovarian and/or Endometrial Cancer With Weight Loss
Official title: Study of Differences in Skeletal Muscle Energy Metabolism Alterations in Women With Weight Loss and Ovarian and/or Endometrial Cancer Based on the Body Mass Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Ovarian Carcinoma
Endometrial Carcinoma
Keywords: weight loss
ovarian cancer
endometrial cancer
energy metabolism
Body mass index
obesity
muscle energy
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Inserm U1069 - Team Nutrition, Growth and Cancer
First posted: 2017-01-23
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: the aim is to study skeletal muscle metabolism alterations métaboliques associated with weight loss in women with ovarian and/or endometrial cancer according to BMI.


Eligibility criteria: Case group selection criteria:

Inclusion Criteria:

* Women aged 18 years old and more
* Ovarian and/or endometrial cancer
* weight loss related to cancer (weight loss \> 5% weight in one month or 10% in 6 months)
* Indication to therapeutic surgery
* Women affiliated to social security scheme
* Women who can understand French and able to sign Informed consent

Exclusion Criteria:

* Unbalanced Diabetes
* Chronic neuromuscular disorder
* Any severe uncontrolled medical condition

Control group selection criteria:

Inclusion Criteria:

* Women aged 18 years and more
* Surgery Indication for a benign endometrial and/ or ovarian disease
* Patient affiliated to social security scheme
* Women who can understand French and able to sign Informed consent

Exclusion Criteria:

* Unbalanced Diabetes
* Chronic neuromuscular disorder
* Any severe uncontrolled medical condition

Primary outcomes:
measure: Measurement of muscle mitochondrial bioenergetics according to BMI
timeFrame: muscle biopsy realized during surgery
Secondary outcomes:
measure: on muscle biopsy
timeFrame: muscle biopsy realized during surgery
measure: on white adipose tissue
timeFrame: adipose tissue samples taken during surgery
measure: on ovarian cancer tumor samples
timeFrame: ovarian tumor biopsies realized during surgery
measure: on computerized tomography
timeFrame: 1 day of abdominal CT scan imaging procedure performed at diagnosis
Other outcomes:
Locations:
city: Tours
country: France
facility: Gynecology Department, University Teaching Hospital, Tours
Study officials:
affiliation: University Teaching Hospital of Tours
name: Lobna OULDAMER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04792879: Assessment of Peripheral Veins Doppler Ultrasound for Diagnosis of Acute Right Heart Failure in Suspicion or Follow-up of Pulmonary Hypertension
Official title: Assessment of Peripheral Veins Doppler Ultrasound for Diagnosis of Acute Right Heart Failure in Suspicion or Follow-up of Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Right Heart Failure
Pulmonary Hypertension
Peripheral Veins Doppler Ultrasound
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Occurrence of acute right heart failure (ARHF) remains common during pulmonary hypertension (PH). Right atrial pressure (RAP) invasive measurement is the gold standard to diagnose ARHF in order to improve diuretic treatment management. Existence of indirect signs of ARHF on venous Doppler ultrasound waveform has long been described, but correlation with RAP has not been properly established yet. It is the aim of our study in order to obtain an additional tool to manage ARHF.


Eligibility criteria: Inclusion Criteria:

* Adult patient (age ≥ 18 years old)
* Patient referred to the cardiology department for a right heart catheterization with measurement of RAP, regardless of the indication.
* Free subject, without guardianship or curatorship or subordination
* People affiliated to or beneficiary of a social security schemes
* Informed consent signed by the patient after clear and fair information about the study.

Exclusion Criteria:

* Minor patient (age \< 18 years)
* Refusal to participate in the study
* Patient with hemodynamic instability, unable to tolerate a delay in treatment caused by the ultrasound examination.
* Patient requiring diuretic treatment within the next 4 hours
* Patient with a life expectancy of less than 24 hours.
* History of proximal deep venous thrombosis involving the inferior vena cava and/or common iliac veins and/or femoral veins.
* History of extrinsic venous compression on the inferior vena cava and/or common iliac veins and/or femoral veins.
* Persons who do not benefit from a Social Security scheme or who do not benefit from it through a third party.
* Persons benefiting from reinforced protection, namely minors, pregnant and nursing women, persons deprived of liberty by a judicial or administrative decision, persons staying in health or social institutions, adults under legal protection and finally patients in emergency situations.

Primary outcomes:
measure: Sensitivity, specificity, positive and negative likelihood ratios of venous stasis index
timeFrame: Inclusion day within 4 hours before the right heart catheterization
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
References:
Clinical trial NCT05121779: Head-to-head Comparison of Diagnosis Value of Pulmonary Fibrosis on 68Ga-FAPI-04 and 18F-FDG PET-CT
Official title: Head-to-head Comparison of Diagnosis Value of Pulmonary Fibrosis on 68Ga-FAPI-04 and 18F-FDG PET-CT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pulmonary Fibrosis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 68Ga-fibroblast activating protein inhibitors(FAPI) has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation,such as inflammatory bowel disease. And it might be more sensitive than FDG in detecting a certain type of inflammations according to our preliminary research. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of Pulmonary fibrosis than 18F-FDG PET/CT.

Detailed description: Pulmonary fibrosis is a prototype of chronic, progressive, and fibrotic lung disease.Healthy tissue is replaced by altered extracellular matrix and alveolar architecture is destroyed, which leads to decreased lung compliance, disrupted gas exchange, and ultimately respiratory failure and death.Pulmonary fibrosis is diagnosed by identification of a pattern of usual interstitial pneumonia on the basis of radiological or histological criteria in patients without evidence of an alternative cause. Activated fibroblasts are crucial for fibrotic processes in Pulmonary fibrosis. 68Ga-FAPI has been developed as a tumortargeting agent as fibroblast activation protein is overexpressed in cancerassociated fibroblasts and inflammation. Recently，a study shows that FAPI-PET/CT imaging is a promising new imaging modality for Pulmonary fibrosis.This head-to-head comparisons aims to evaluate the severity of pulmonary fibrosis and the therapy response of 68Ga-FAPI-04 compared with 18F-FDG in the same group of pulmonary fibrosis patients.

Eligibility criteria: Inclusion Criteria:

* suspected or confirmed pulmonary fibrosis patients;
* signed written consent.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* known allergy against FAPI
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance

Primary outcomes:
measure: Diagnostic value
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: FAPI expression and SUV
timeFrame: through study completion, an average of 1 year
measure: therapy response
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Zhaohui Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References: