louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05107570: The Effect of Cold Exposure on Energy Expenditure
Official title: Cold-induced Thermogenesis in Adults From Siberia and Western Europe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cold Exposure
Keywords: Cold exposure
Energy expenditure
Lead sponsor: Maastricht University
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Cold-induced thermogenesis, or the increase in energy expenditure upon cold exposure, indicates metabolic stress, as such, cold-induced thermogenesis may signal an appropriate stimulus to improve metabolic health. Cold acclimation may alter cold-induced thermogenesis due to changes in (non)shivering thermogenesis and blood flow. The main aim of this research is to compare the energy expenditure responses, during a standardised cold stress (\~ 9°C air temperature, maximum 1 hour), of Siberian adults with Western European adults. The subjects will be individually matched for age, sex, body mass and height. It was hypothesised that cold-induced thermogenesis will be reduced in the Siberian population.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Western European origin or of Siberian origin
* BMI between 18.5 and 35 kg/m2
* Generally healthy (determined by dependent physician)

Exclusion Criteria:

* Smoking
* Active, uncontrolled cardiovascular disease or cancer
* Raynaud's disease
* Participation in another biomedical study within 1 month before the first study
* Cold-acclimated (Western European group), such as takes daily extended cold baths, works in a refrigerated environment, or regular cold-water swimming within 1 month of starting the study
* Medication use known to hamper subject's safety during study procedures
* Abuse of alcohol or drugs

Primary outcomes:
measure: Cold-induced thermogenesis
timeFrame: 30 min before and during the cold exposure (maximum 1 hour)
Secondary outcomes:
measure: Skin temperature
timeFrame: 30 min before and during the cold exposure (maximum 1 hour)
measure: Core temperature
timeFrame: 30 min before and during the cold exposure (maximum 1 hour)
measure: Shivering activity
timeFrame: 30 min before and during the cold exposure (maximum 1 hour)
measure: Substrate oxidation
timeFrame: 30 min before and during the cold exposure (maximum 1 hour)
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University
name: W. van Marken Lichtenbelt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04116970: Endobronchial Ultrasound-Guided Transbronchial Needle-Aspiration With Suction in Obtaining Samples From Patients With Suspected Nodal Metastatic Lung Cancer
Official title: Prospective Trial to Analyze Endobronchial Ultrasound-Guided Transbronchial Needle-Aspiration (EBUS-TBNA) Samples Obtained With and Without Suction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 50
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: This trial studies how well endobronchial ultrasound-guided transbronchial needle-aspiration (EBUS-TBNA) with suction works in obtaining samples from patients with suspected lung cancer that has spread to the nodal. EBUS-TBNA samples obtained with additional suction may help to improve material-amounts and decrease blood contamination in the samples.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate if suction applied with a vacuum syringe during EBUS-TBNA sampling helps to obtain more material for molecular analyses.

OUTLINE:

Patients undergo bronchoscopy with EBUS-TBUA first without and then with applied vacuum.

Eligibility criteria: Inclusion Criteria:

* Computed tomography (CT)-scan finding suspicious for lung cancer with nodal metastases
* Clinically stable to undergo diagnostic workup by bronchoscopy with endobronchial ultrasound

Exclusion Criteria:

* Pregnant female
* Minors
* Prisoners
* Patients with contraindication for EBUS such as non-reversible anticoagulation

Primary outcomes:
measure: Number of samples collected via endobronchial ultrasound-guided transbronchial needle-aspiration with suction
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Peter Kneuertz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03881670: On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours
Official title: On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperopia
Myopia
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2019-03-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The current study aims to systematically investigate the diurnal variation in the optical quality of soft contact lenses on eye throughout the day. Subject reported quality of vision will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Habitual prescription +5.00 D to -6.00 D
* 18-35 years of age
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* Vertex corrected refractive cylinder must be -0.75 or less.
* Visual acuity best correctable to 20/25 or better for each eye
* The subject must read and sign the Informed Consent form.
* Mesopic pupil size \>5.00 mm.

Exclusion Criteria:

* active condition that would prevent contact lens wear
* history of issues of eye alignment or binocularity by self-report
* doctor diagnosed, self-reported accommodative or binocular vision issues
* doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment

Primary outcomes:
measure: Higher Order Aberrations
timeFrame: 0-12 hours
Secondary outcomes:
measure: Subjective Stability of Vision Rating
timeFrame: 0-12 hours
measure: Image Quality Metrics
timeFrame: 0-12 hours
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University Clinical Optics Research Lab
state: Indiana
Study officials:
References:
Clinical trial NCT04961970: HAIC With FOLFOX Versus Systemic Chemotherapy With GP for Unresectable ICC
Official title: Hepatic Arterial Infusion Chemotherapy of Oxaliplatin, 5-Fluorouracil and Leucovorin Versus Systemic Chemotherapy of Gemcitabine and Cisplatin for Unresectable Intrahepatic Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Intrahepatic Cholangiocarcinoma
Keywords: intrahepatic cholangiocarcinoma
systemic chemotherapy
hepatic artery infusion chemotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 188
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 purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin compared systemic chemotherapy of gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma.


Eligibility criteria: Inclusion Criteria:

* The diagnosis of ICC
* Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
* With no previous treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* Without distant metastasis, but intrahepatic lymph node metastasis is allowed
* The following laboratory parameters:

Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease

Primary outcomes:
measure: Overall survival
timeFrame: 12 months
Secondary outcomes:
measure: Progression free survival
timeFrame: 12 months
measure: Time to progression
timeFrame: 12 months
measure: Number of adverse events.
timeFrame: 30 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT06870370: Role of Non-Selective Beta-Adrenergic Blocker in Severe TBI
Official title: Role of Non-Selective Beta-Adrenergic Blocker in Severe Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Traumatic Brain Injury (TBI) Patients
Intracranial Pressure
Intensive Care Unit
Mortality
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 60
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: PREVENTION

Brief summary: The role of nonselective beta adrenergic blocker as antistress agent in severe traumatic brain injury

Detailed description: The primary injury occurs at the time of trauma. secondary injury is caused by complications of the primary insult and caused by processes such as hypoxia, cerebral edema and ischemia.

Severe traumatic brain injury is associated with increased intracranial pressure, activation of the sympathetic nervous system and catecholamine response and major morbidity and mortality .

β-blockade is just one pharmacologic strategy to reduce sympathetic hyperactivity. In the Intensive care unit patients with severe traumatic brain injury associated with restlessness and agitation are frequently sedated and intubated in order to reduce the workload of the brain. This hyperactive response is called sympathetic storming which occurs within 24 hours of brain injury or weeks later . It occurs due to acceleration in sympathetic nervous system activity in the central nervous system which results in loss of cortical control due to downregulation of autonomic balance in the brain injury .

A Non-Selective beta-adrenergic antagonist propranolol, is one of the most customarily used treatments in the case of paroxysmal sympathetic hyperactivity.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 18and 65 years old
* Patients who have Severe traumatic brain injury
* Glascow outcome scale ≤ 8

Exclusion Criteria:

* Patients have pre-existing heart disease.
* If there are contraindications to β blocker.
* penetrating traumatic brain injury.
* pre-injury brain dysfunction.
* β-blocker or α2-agonist use before trauma.

Primary outcomes:
measure: Mortality
timeFrame: 7 days
Secondary outcomes:
measure: Glascow outcome scale extended
timeFrame: 7 days
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
Study officials:
affiliation: Tanta University
name: Huda Elkallaf, Resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03053570: Study Comparing Pulmonary Vein Isolation With the Cryoballoon and Radiofrequency Energy(Contact Force) in the Treatment of Persistent Atrial Fibrillation (AF) (Cryo Vs CF in PerAF)
Official title: Study Comparing Pulmonary Vein Isolation With the Cryoballoon and Radiofrequency Energy(Contact Force) in the Treatment of Persistent Atrial Fibrillation (PerAF)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: Cryoballoon
Contact Force
Persistent Atrial Fibrillation
Lead sponsor: China Cardiometabolic Registries
Sponsor class: NETWORK
First posted: 2017-02-15
Enrollment: 200
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 purpose of this study is to perform a prospective, randomised study investigating the safety and efficacy of cryoballoon catheter ablation compared with radiofrequency ablation(contact force), in the treatment of persistent AF.

Detailed description: The hypotheses for this study is that cryothermal energy is as effective and safe as using radiofrequency energy in the treatment of persistent AF and is associated with a better long term outcome.

Eligibility criteria: Inclusion Criteria:

* persistent Atrial Fibrillation; Intolerant to antiarrhythmic medication; Both male or female; Age from 18 to 75 years old.

Exclusion Criteria:

* Acute myocardial infarction; Coronary artery stent history; Acute severe stroke; Abnormal liver and renal function.

Primary outcomes:
measure: Number of participants with successful Pulmonary Vein Isolation
timeFrame: in one year
Secondary outcomes:
Other outcomes:
Locations:
city: Urumqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
affiliation: First Affiliated Hospital of Xinjiang Medical University
name: Baopeng Tang
role: STUDY_CHAIR
References:
Clinical trial NCT00002170: A Study of Viracept in AIDS Patients With Mycobacterium Avium Complex Disease (MAC)
Official title: A Pilot, Phase II, Randomized, Placebo-Controlled Study to Determine the Effects of Viracept on the Clinical Outcome of Disseminated Mycobacterium Avium Complex Disease (MAC) in AIDS Patients Who Are Receiving Standard Acute Treatment for This Opportunistic Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mycobacterium Avium-Intracellulare Infection
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Placebos
Mycobacterium avium-intracellulare Infection
Acquired Immunodeficiency Syndrome
HIV Protease Inhibitors
Nelfinavir
Anti-Infective Agents
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to give Viracept to AIDS patients who are being treated for MAC.


Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV infection
* New diagnosis of MAC bacteremia and \< 7 days of therapy.

Prior Medication:

Allowed:

Patients no more than 7 days of therapy for MAC disease.

Exclusion Criteria

Prior Medication:

Excluded:

Prior therapy (or less than 2 weeks) with protease inhibitors other than saquinavir.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Univ of California / San Diego Treatment Ctr
state: California
city: Torrance
country: United States
facility: Harbor UCLA Med Ctr
state: California
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Boston
country: United States
facility: Boston VA Med Ctr / 151
state: Massachusetts
city: Houston
country: United States
facility: Baylor Univ
state: Texas
Study officials:
References:
Clinical trial NCT04930770: Study About the Response to the Administration of a Third Dose of mRNA-1273 Vaccine (COVID-19 Vaccine Moderna) in Renal Transplants With Immunological Failure Initial to Vaccination
Official title: Study About the Response to the Administration of a Third Dose of mRNA-1273 Vaccine (COVID-19 Vaccine Moderna) in Renal Transplants With Immunological Failure Initial to Vaccination
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Covid19
Keywords: vaccine
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective will be to analyze the development of cellular and humoral immunity against SARS-CoV-2 after administration of a third dose of mRNA-1273 (Moderna) vaccine in patients who have remained seronegative after the full standard (two-dose) regimen.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years;
2. Male or female sex;
3. Renal transplant with stable renal function in the last 2 months prior to study inclusion.
4. Had received a full schedule of vaccination for SARS-CoV-2 with mRNA1273 vaccine (Moderna) and remained seronegative at 2 weeks after the second dose.
5. Patient giving written informed consent.

Exclusion Criteria:

1. Renal transplantation \< 3 months;
2. Pregnancy or lactation status;
3. Rejection treated within the last 6 months;
4. Presence of humoral immunity to SARS-CoV-2 defined as the presence of specific IgM/IgG.

Primary outcomes:
measure: Number of patients with development of cellular and humoral immunity against SARS-CoV-2
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of patients with development of cellular and humoral immunity against SARS-CoV-2
timeFrame: 4 months
measure: patient characteristics associated with biological non-response to vaccination
timeFrame: 4 months
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02663570: Effects of Melatonin in PCOS Women
Official title: Effects of 6 Months of Melatonin Treatment on Clinical, Endocrine ed Metabolic Features in Women Affected by PCOS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of our study is to investigate the effects of a treatment with melatonin on clinical, endocrine and metabolic features in women affected by PCOS. The study group included 40 patients treatend with 2 mg of melatonin daily for six months. Menstrual pattern, anthropometric parameters, hirsutism score, ultrasound ovarian volume and antral follicular count, an oral glucose tollerance test and hormonal assays are evaluated before and after therapy.


Eligibility criteria: Inclusion Criteria:

* women with PCOS in accordance with Rotterdam criteria

Exclusion Criteria:

* pregnancy
* past history of cardiovascular diseases
* diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)
* hypertension
* significant liver or renal impairment
* other hormonal dysfunction (hypothalamic, pituitary, thiroidal or adrenal)
* neoplasms

Primary outcomes:
measure: Number of cycles in six months of therapy
timeFrame: 6 months
Secondary outcomes:
measure: hirsutism score
timeFrame: 6 months
measure: testosterone levels
timeFrame: 6 months
measure: insulin levels
timeFrame: 6 months
measure: total cholesterol
timeFrame: 6 months
measure: HDL cholesterol
timeFrame: 6 months
measure: LDL cholesterol
timeFrame: 6 months
measure: tryglycerides
timeFrame: 6 months
measure: androstenedione levels
timeFrame: 6 months
measure: free androgen index
timeFrame: 6 months
measure: AMH levels
timeFrame: 6 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic university of Sacred Heart
Study officials:
References:
Clinical trial NCT00242970: Hypertrophic Scarring After Facial Burn
Official title: Hypertrophic Scarring After Facial Burn: A Pilot, Observational Study of Static and Dynamic Measurements of Facial Scars With the 3-D Scanner Through the Scar Maturation Process
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burn
Lead sponsor: Legacy Health System
Sponsor class: OTHER
Collaborators: name: Total Contact
First posted: 2005-10-21
Enrollment: 15
Sex: ALL
Minimum age (years): 4
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population includes patients with burn injuries to their face and or neck.

Brief summary: Subjects with a burn to the face and/or neck will be enrolled into the study and a Three-Dimensional scanner used to see if it can objectively measure scar color and volume and measure the effect of scar on motion of the face and neck.

Detailed description: Subjects will have 11 clinic visits over a 2-year period. An initial scan of the subject's head and neck will be made. Ten reproducible landmarks on the face and neck will be determined. The subject will return for follow up scans at Day 14, Day 28 and Month 2,6,9,12,18 and 24.

Eligibility criteria: Inclusion Criteria:

* Face and/or Neck Burn

Primary outcomes:
measure: Scar maturation
timeFrame: 5.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Legacy Emanuel Hospital and Health Center
state: Oregon
Study officials:
affiliation: Legacy Health System
name: Helen Christians, ORT/L
role: PRINCIPAL_INVESTIGATOR
References: