louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01315080: Efficacy of Percutaneous Injection of Triamcinolone in the Treatment of Mammillary Fistula
Official title: Efficacy of Percutaneous Injection of Triamcinolone in the Treatment of Mammillary Fistula
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mammillary Fistula
Keywords: mammillary fistula
triamcinolone
ultrasound management
percutaneous treatment
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
First posted: 2011-03-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with mammillary fistula

Brief summary: The investigators recently proposed a new hypothesis on the pathogenesis of mammillary fistulae (MF) suggesting that occlusion of hair follicles by keratinous plugging may relevantly contribute to the development of MF. The investigators believe that the pathogenesis of MF mimics the behaviour of hidradenitis suppurative, as both clinical entities manifest themselves as a chronic, suppurative and recurrent inflammatory process. This new proposal has led to the present suggestion of a therapeutic alternative for MF.

Detailed description: To compare the results from a prospective observational database with two groups of patients:

1. patients with MF treated by percutaneous drainage and saline solution.
2. patients with MF treated by percutaneous drainage and saline solution plus percutaneous triamcinolone.

These patients are treated following usual clinical practice in our Department. All the procedures are made through an ultrasound-guided way. During the follow-up of these cases (clinical and with ultrasound) resolution rate will be registered by the same investigator.

The follow-up will be at least 6 months.

Eligibility criteria: Inclusion Criteria:

* mammillary fistula
* older than 18 years
* patient acceptation to the recruitment

Exclusion Criteria:

* diabetes mellitus
* arterial hypertension
* immunodepression
* peptic ulcer
* chronic bowel inflammatory diseases

Primary outcomes:
measure: Resolution of mammillary fistula
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Virgen de la Arrixaca University Hospital
Study officials:
affiliation: Virgen de la Arrixaca University Hospital
name: Juan D Berna, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04810780: Safety and Efficacy of DUO Extended Set: Combined Glucose Sensor and Infusion Set.
Official title: Safety and Efficacy of DUO Extended Set: Combined Glucose Sensor and Infusion Set.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Medtronic
First posted: 2021-03-23
Enrollment: 10
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: TREATMENT

Brief summary: The study will follow subjects for 28 days while using an DUO extended infusion set combined with glucose sensor. the objective is to evaluate saftey and efficacy of the set in adult patient with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes for at least one year
2. Using a MiniMed™ 670G or 640G Insulin pump with Guardian sensor
3. Age 18 to 80 years
4. Hemoglobin A1c level less than or equal to 10%
5. Not currently known to be pregnant, nor planning pregnancy during the study.
6. Willingness to follow the protocol and sign the informed consent

Exclusion Criteria:

1. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
2. Pregnant or lactating females
3. Subject has Glycosylated hemoglobin (HbA1c) \> 10 % at time of screening.

Primary outcomes:
measure: Primery Effectivness Endpoint
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: amir Tirosh, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04968080: A Study to Validate Comparability of an Infrared Thermographic Camera Versus Oral, Forehead, and Ear Thermometers When Determining Body Temperature in Adult Participants
Official title: Prospective, Observational, Single-Arm Study to Validate Comparability of an Infrared Thermographic Camera Versus Oral, Forehead, and Ear Thermometers When Determining Body Temperature in Anonymous Adult Participants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temperature Change, Body
Keywords: Infrared Thermal Camera
IRT
Lead sponsor: Infrared Cameras Incorporate
Sponsor class: INDUSTRY
First posted: 2021-07-20
Enrollment: 887
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: Adult participants entering the PRA Health Sciences - Early Development Services (PRA-EDS) Salt Lake City business location who agree to receive anonymous infrared thermal camera (IRT) Class 1 device temperature scan while undergoing routine temperature surveillance.

Brief summary: The primary objective of this study is to determine if the Infrared Cameras, Inc (ICI) FMX 400 infrared (IR) Class 1 infrared thermal camera (IRT) system is comparable to oral, forehead, and ear thermometers for determining human body temperature.


Eligibility criteria: Inclusion Criteria:

1. Participants must be able to provide opt-out consent.
2. Participants must agree to have temperature recorded noninvasively using an infrared thermal camera (IRT) Class 1 device, oral thermometer, forehead thermometer, and ear thermometer.

Exclusion Criteria:

1. Participants who opt out of participating; ie, participants who do not agree to have temperature recorded noninvasively using an IRT Class 1 device, oral thermometer, forehead thermometer, and ear thermometer.
2. Participants who are not able to understand that their temperature will be recorded, or who are otherwise unwilling to participate.

Primary outcomes:
measure: Infrared Thermal Camera (IRT) Calculated Human Body Temperature
timeFrame: Up to Week 4
measure: Average Oral Thermometer Body Temperature
timeFrame: Up to Week 4
measure: Forehead Thermometer Body Temperature
timeFrame: Up to Week 4
measure: Average Ear Thermometer Body Temperature
timeFrame: Up to Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRA Health Sciences - Early Development Services
state: Utah
Study officials:
References:
Clinical trial NCT04779840: Retrospective Study on the Incidence and Management of Anemia in Oncology
Official title: Retrospective Study on the Incidence and Management of Anemia in Oncology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Cancer
Lead sponsor: Weprom
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 349
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with cancer and justifying continuous hospitalization for more than one night regardless of pattern.

Patient informed and not having expressed opposition to the study.

Brief summary: The incidence of anemia ranges from 20 to 75% depending on the type of cancer. It is often present at diagnosis and increases with specific treatments. It has an impact on overall survival and quality of life. Its origins are multiple (pure iron deficiency or functional, malnutrition, dyserythropoiesis, insufficiency renal, hemolysis, chemotherapy, radiotherapy, targeted therapies).

Transfusion is the most common treatment offered in the management of anemia. The incidence of anemia and its consequences are often underestimated during cancer management.

Recommendations were published in 2012. An inventory of the incidence of anemia before and after the publication of these recommendations are proposed in order to assess their impact on daily practice.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old,
* Follow-up for cancer justifying hospitalization,
* Presenting anemia defined by a hemoglobin level \<11 g / dL,
* Patient not having objected to the collection of his data after oral and written information.

Exclusion Criteria:

* patients with a hemoglobin level ≥ 11 g / dL,
* adult patients under guardianship, curatorship or deprived of liberty,
* pregnancy or breast-feeding in progress at the time of hospitalization.

Primary outcomes:
measure: Incidence of anemia
timeFrame: 2 years
Secondary outcomes:
measure: Assessment of transfusion prescriptions
timeFrame: 2 years
measure: Assessment of erythropoiesis stimulating agents (EPO) prescriptions
timeFrame: 2 years
measure: Assessment of iron prescriptions
timeFrame: 2 years
measure: Time between last transfusion and date of death
timeFrame: 2 years
measure: overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Jean Bernard - Clinique Victor Hugo
Study officials:
affiliation: Centre Jean Bernard/Clinique Victor Hugo - LE MANS
name: Katell LE DÛ, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01726140: CPAP Reduces Hypoxemia After Cardiac Surgery
Official title: CPAP Reduces Hypoxemia After Cardiac Surgery (CRHACS Trial). A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Respiratory Failure Requiring Reintubation
Keywords: intubation
respiratory failure
cardiac surgery
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: Agenzia Italiana del Farmaco
First posted: 2012-11-14
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of study is to evaluate whether the application of a continuous positive airway pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate.

Detailed description: We want to test the hypothesis that the application of a continuous positive airway pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate.

Primary end point: to reduce the rate of re-intubation.

Secondary end point: to reduce the incidence of atelectasis, pneumonia, sepsis, the mortality rate, the intensive care unit (ICU) and hospital length of stay.

Eligibility criteria: Inclusion Criteria:

* patients undergoing cardiac surgery on cardiopulmonary bypass
* PaO2 /FiO2 \< 200 after extubation
* extubation time \< 24 h.

Exclusion Criteria:

* patients \< 18 years old
* extracorporeal membrane oxygenation
* severe cardiac dysfunction (FE\<25%)
* mechanical ventilation before the intervention
* severe COPD (patients on oxygen therapy, with a FEV1\< 50%)
* heart or lung transplantation
* lack of consent.

Primary outcomes:
measure: rate of re-intubation
timeFrame: at 28 days
Secondary outcomes:
measure: incidence of atelectasis
timeFrame: at 28 days
measure: incidence of pneumonia
timeFrame: at 28 days
measure: incidence of sepsis
timeFrame: at 28 days
measure: mortality rate
timeFrame: at 28 days
measure: the intensive care unit length of stay
timeFrame: at 28 days
measure: hospital length of stay
timeFrame: at 28 days
Other outcomes:
Locations:
city: Turin
country: Italy
facility: University of Turin - Department of Anesthesia and Intensive Care Medicine
Study officials:
affiliation: University of Turin, Italy
name: Vito Marco VM Ranieri, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03098940: A Bioavailability Study on Dronabinol
Official title: A Two Part, Open Label, Randomized, Four Period Cross-over Study to Compare the Bioavailability of Two Different Dronabinol Formulations in Healthy Male and Female Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: THC
Lead sponsor: Axim Biotechnologies
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is a two part study

Detailed description: This study is a two part, open label, randomized, four periods cross-over study with a washout of at least 1 week between subsequent dosing occasions

Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking male and female subject, aged between 18 and 55 year of age (inclusive) with a BMI ≥18.0 kg/m2 and ≤ 30.0 kg/m2.

Exclusion Criteria:

* Smokers

Primary outcomes:
measure: Bioequivalence
timeFrame: up to 48 hours post-dose
measure: Bioequivalence
timeFrame: up to 48 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03312140: Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis
Official title: Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis Liver Disease
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study to evolve the effect ot the treatment by comparing data before and after the treatment within the same patients
Primary purpose: TREATMENT

Brief summary: Pilot study to investigate the effect of choline chloride in cystic fibrosis patients with liver steatosis by comparing their status before and after the intervention

Detailed description: Within this single arm pilot study patients with cystic fibrosis and liver steatosis receive choline chloride (2x0.5 gram three times a day) as a food supply for 88 days. D9-choline metabolism is measured before and after the intervention phase. Hypothesis of the study is, that supplying choline augments the secretion of phosphatidyl choline and lipoprotein (VLDL) from the liver and therefore results in a measurable reduction of the triglyceride storage of the liver.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* male
* Cystic fibrosis is verified
* pancreatic insufficiency
* Decline of plasma phosphatidylcholine and steatosis of the liver
* informed consent is given

Exclusion Criteria:

* cirrhosis of the liver
* Hyperreactivity to choline containing food
* allergic bronchopulmonary aspergillosis or other acute exacerbations of pulmonary infections
* FEV1 \< 40%
* smoker
* chronic alcohol consume
* clinically relevant diseases (for example thyroid dysfunction, disturbance of lipid metabolism, renal diseases, significant left or right ventricular functional restriction) which will change the lipid metabolism of the liver
* Implants or other reasons which make magnetic resonance examinations impossible

Primary outcomes:
measure: Measurement of D9-Methyl-Choline Kinetic
timeFrame: 3 months
Secondary outcomes:
measure: Lipid storage of the liver
timeFrame: 3 months
measure: Augmentation of creatinine concentration within the calf muscle
timeFrame: 3 months
measure: FVC
timeFrame: 3 months
measure: FEV1
timeFrame: 3 months
measure: MEF25
timeFrame: 3 months
measure: MMEF
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Klinik für Kinder- und Jugendmedizin Tübingen
name: Joachim Riethmüller, PD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05507372: Treatment for Post Acute COVID-19 Syndrome
Official title: Treatment for Post Acute COVID-19 Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus, Subjective
Lead sponsor: Applied Biology, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Jupiter Wellness, Inc.
First posted: 2022-08-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blinded, placebo controlled parallel assignment randomised study
Primary purpose: TREATMENT

Brief summary: Post-acute COVID-19 tinnitus has not been treated successfully. As tinnitus may be related to SARS-CoV-2 neurological manifestations. This study aims to investigate if the dopamine receptor antagonists can be used effectively treat COVID-19 induced tinnitus.

Detailed description: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative viral pathogen leading to the COVID-19 pandemic. In 2022, after three successive waves of the pandemic, the majority of the human population has been exposed to the SARS-CoV-2 virus. During the two years since the pandemic ensued, multiple reports emerged of patients experiencing COVID-19 emergent symptoms lasting longer than 4 weeks since onset. Up to 15% of patients recovering from COVID-19 experience post-acute COVID-19 induced tinnitus .

To-date, post-acute COVID-19 tinnitus has not been treated successfully. As tinnitus may be related to SARS-CoV-2 neurological manifestations. This study aims to investigate if the dopamine receptor antagonist Pimozide can be used effectively treat COVID-19 induced tinnitus.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with subjective tinnitus post COVID-19
2. Tinnitus persists for at least 4 weeks
3. Prior history of mild or no tinnitus
4. 18 years or older
5. Any gender
6. Females of child bearing age must be on contraception

Exclusion Criteria:

1. Pregnant
2. Patients who participated in any interventional studies in the past 6 months
3. Patients with severe hepatic impairment on admission (alanine aminotransferase higher than fivefold the upper limit)
4. Patients taking any dopamine receptor antagonists
5. Patient having history of hypersensitivity to Pimozide
6. Patients unable to comply with the study schedule
7. Actively using cortiocosteroids

Primary outcomes:
measure: Tinnitus Handicap Inventory (THI)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: DEPT.OF PHARMACOLOGY, RURAL MEDICAL COLLEGE, PIMS- DU (DU), LONI, PIN: 413736
name: RAHUL RAJENDRA KUNKULOL, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06659640: A Study to Evaluate ALN-6400 in Adult Healthy Volunteers
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-6400 in Adult Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: siRNA
RNAi therapeutic
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-10-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-6400 in healthy volunteers.


Eligibility criteria: Inclusion Criteria -

* Is a healthy adult volunteer

Exclusion Criteria -

* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> upper limit of normal (ULN)
* Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection
* Has an estimated glomerular filtration (eGFR) of \<90 mL/min/1.73m\^2 at screening
* Is not willing to comply with the contraceptive requirements during the study period

Note: other protocol defined inclusion / exclusion criteria apply

Primary outcomes:
measure: Frequency of Adverse Events
timeFrame: Up to 36 weeks
Secondary outcomes:
measure: Concentrations of ALN-6400 in Plasma
timeFrame: Predose and up to 2 days postdose
measure: Change from Baseline in the ALN-6400 Target in Plasma
timeFrame: Predose and up to 36 weeks postdose
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinical Trial Site
Study officials:
affiliation: Alnylam Pharmaceuticals
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02727140: Yoga as a Supportive Therapy for Patients With Hypertension
Official title: Yoga as a Supportive Therapy for Patients With Hypertension: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study aims to investigate the feasibility, effectiveness, and perceived benefit of a supportive hatha yoga intervention for patients with hypertension using antihypertensive drugs. Patients will be randomized into 3 groups comparing hatha yoga with yoga postures, breathing and relaxation techniques to a hatha yoga intervention without yoga postures (only breathing and relaxation techniques) as well as to a wait list control group.


Eligibility criteria: Inclusion Criteria:

* essential Hypertension
* stable antihypertensive medication during the next 6 months

Exclusion Criteria:

* pregnancy or breast feeding
* simultaneous participation in further clinical intervention trials
* regular yoga practice in the past 12 months
* serious mental illness (severe depression, severe addiction, psychosis)
* manifest coronary heart disease that has been treated in the past 3 months or myocardial infarction, embolism of pulmonary arteries or stroke in the past 3 months
* heart failure ≥ state 1 New York Heart Association (NYHA)
* peripheral arterial occlusive disease ≥ state 1
* renal insufficiency \> state 2, glomerular filtration rate \< 60 ml/min/1,73m² according to he National Kidney Foundation (NKF)

Primary outcomes:
measure: 24 h mean value of systolic and diastolic blood pressure
timeFrame: 12 weeks
Secondary outcomes:
measure: 24 h mean value of systolic and diastolic blood pressure
timeFrame: 28 weeks
measure: Health-related Quality of Life
timeFrame: 12 weeks
measure: Health-related Quality of Life
timeFrame: 28 weeks
measure: Emotional Distress
timeFrame: 12 weeks
measure: Emotional Distress
timeFrame: 28 weeks
measure: Subjective Stress
timeFrame: 12 weeks
measure: Subjective Stress
timeFrame: 28 weeks
measure: Nutrition habits
timeFrame: 12 weeks
measure: Nutrition habits
timeFrame: 28 weeks
measure: Physical activity
timeFrame: 12 weeks
measure: Physical activity
timeFrame: 28 weeks
measure: Adverse Events
timeFrame: 12 weeks
measure: Adverse Events
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Study officials:
References: