louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04996082: Skin Fibrosis Analysis by Raman Spectroscopy in Systemic Sclerosis
Official title: Skin Fibrosis Analysis by Raman Spectroscopy in Systemic Sclerosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Validation of Raman Spectroscopy Usefulness in Systemic Sclerosis
Keywords: Systemic sclerosis
Raman spectroscopy
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with or without systemic sclerosis, according to ACR criteria, older than 18-years-old

Brief summary: Systemic sclerosis (SSc) is a rare connective tissue disease characterized by a high clinical heterogeneity with unpredictable evolution that could engage functional and life-threatening prognosis. Most of patients develop skin fibrosis gradually spreading. Two clinical distinct forms are described according to the extension of skin fibrosis: limited (lSSc) and diffuse (dSSc) SSc. It is now admitted that a spreading of skin fibrosis is associated with poor prognosis. This disease can be complicated by pulmonary arterial hypertension (PAH), interstitial lung disease (ILD) and scleroderma renal crisis (SRC) representing the main causes of death in SSc. Usually, PAH is associated with lSSc, and ILD and SRC are associated with dSSc. Prognosis is also different regarding skin phenotype with a higher mortality rate in dSSc.

An easy score, called modified Rodnan skin score, is commonly used in clinical practice to evaluate the spreading and severity of skin fibrosis, but this score is hardly reproducible. Ultrasound can be used to measure skin thickness and is more reproducible than the Rodnan skin score. Nevertheless, non-invasive analysis of fibrosis composition in different areas is not possible with these two technics.

Thus, in this study we will investigate Raman spectroscopy, a non-invasive technic based on the interaction of a low-intensity laser with matter.

Detailed description: Raman spectroscopy will be performed on patients with SSc, according to the ACR criteria, and control patients without SSc, on 3 different areas of the skin. Patients with SSc and controls will be matched by gender and age. These measures will be performed at 6 months, 12 months, 24 months and 36 months.

Eligibility criteria: inclusion criteria :

* patients with SSc, according to ACR criteria
* older than 18-years-old exclusion criteria :
* younger than 18-years-old
* patient protected by law

Primary outcomes:
measure: Raman spectroscopy
timeFrame: at 6 months
measure: Raman spectroscopy
timeFrame: at 12 months
measure: Raman spectroscopy
timeFrame: at 24 months
measure: Raman spectroscopy
timeFrame: at 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
Clinical trial NCT00820482: Comparing Highly Purified hMG With Recombinant FSH + Recombinant LH in Women Undergoing Intrauterine Insemination.
Official title: A Prospective, Randomized, Controlled Trial Comparing Highly Purified hMG With Recombinant FSH + Recombinant LH in Women Undergoing Intrauterine Insemination: Ovarian Response and Clinical Outcomes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ovarian Stimulation Preceding Intrauterine Insemination
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2009-01-12
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aims to elucidate if the FSH and LH activity contained in hMG preparations is comparable to the recombinant FSH and LH administration in a 1:1 ratio. The mean outcome is the corresponding ovarian response in terms of oestradiol increase during stimulation and number of mature follicles the day of hCG administration. The patients will be included and randomized into two groups and stimulated either by HMG injections started on day 3 at a dose of 75 IU every day and fixed for the first 5 days, and in the second group, rFSH and rLH injections be started on day 3 at a dose of 75 UI/day of rFSH + 75UI/day of rLH. Serum estradiol levels will be measured on stimulation day 1, day 6 and the day of hCG injection. All follicles greater than 14 mm of diameter will be recorded on hCG day Intrauterine insemination is performed during two consecutive days starting the day after the human chorionic gonadotrophin (Ovitrelle) injection. Secondary outcomes are Days of stimulation, Total doses of gonadotrophins administrated, Clinical pregnancy , Ongoing pregnancy and Miscarriage rate, and Cancellation rate.


Eligibility criteria: Inclusion Criteria:

* Esterility \> 1 year duration
* \< 39 years old
* REM \> 3 millions/ml
* 1 or 2º IUI cycle

Exclusion criteria:

* Ovarian policystic syndrome
* Severe Endometriosis
* Uterine disease (polyps, myomas, intracavitarios, malformations...)

Primary outcomes:
measure: The present study aims to elucidate if the FSH and LH activity contained in hMG preparations is comparable to the recombinant FSH and LH administration in proporción 1:1. Mean outcome: - Ovarian response according to the protocol used.
timeFrame: one month
Secondary outcomes:
measure: Secondary outcomes: - Days of stimulation - Total doses of gonadotrophins administrated - Clinical pregnancy , ongoing pregnancy and miscarriage rate - Cancellation rate
timeFrame: one cycle
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI Valencia
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
affiliation: IVI Valencia
name: Elena Labarta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03498482: Adressing PTSD Symptoms and Aggressive Behavior in Vulnerable Children in Burundi
Official title: Treating Posttraumatic Stress Disorder and Reducing Aggressive Behavior in Street Children and Vulnerable Children in Burundi Using Narrative Exposure Therapy for Forensic Offender Rehabilitation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Aggressive Behavior
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: Vivo international e.V.
name: Psychologues sans Frontières Burundi
name: Université Lumière de Bujumbura
First posted: 2018-04-13
Enrollment: 19
Sex: ALL
Minimum age (years): 8
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Children either living in the streets of Bujumbara or that are similarly affected by extreme poverty or violence are regularly exposed to traumatic events. Additionally, they often find themselves in situations where engaging in violent behavior appears to be useful or even necessary for survival. The Narrative Exposure Therapy for violent offenders (FORNET) aims to reduce both PTSD symptoms and aggressive behavior. It helps the children to anchor fearful experiences and potential positive emotions linked to violent behaviour in the past. Additionally, visions for the future are developed in order to enable reintegration into the family.

The investigators want to provide evidence, that FORNET effectively reduces PTSD symptoms and ongoing aggressive behavior which in change facilitates reintegration into society.


Eligibility criteria: Inclusion Criteria:

* High degree of symptoms of posttraumatic stress disorder according to UCLA PTSD Reaction Index

Exclusion Criteria:

* Psychotic symptoms

Primary outcomes:
measure: Change of load of traumatic symptoms measured via the UCLA Adolescent PTSD Index (PTSD scale administered by Clinicians)
timeFrame: baseline; 5 months follow-up; 9 months follow-up
Secondary outcomes:
measure: Change of number of aggressive acts measured via an adaption of the Domestic and Community Violence Checklist
timeFrame: baseline; 5 months follow-up; 9 months follow-up
measure: Change of experienced shame measured via the Shame Variability Questionnaire
timeFrame: baseline; 5 months follow-up; 9 months follow-up
Other outcomes:
Locations:
city: Bujumbura
country: Burundi
facility: vivo international & Psychologues sans Frontières mental health center
state: Bujumbura Mairie
Study officials:
References:
Clinical trial NCT06169982: A Multiple Dose Study of LY3209590 in Participants With Type 2 Diabetes
Official title: A Phase 1, Open-Label, Multiple-Dose Study to Investigate Steady-State Pharmacokinetics and Pharmacodynamics During a Euglycemic Clamp of LY3209590 in Participants With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: Clamp
Diabetes, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-12-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to measure the activity and insulin time action of LY3209590 at steady state in participants with type 2 diabetes mellitus. The total study duration is approximately 182 days.


Eligibility criteria: Inclusion Criteria:

* Participants with Type 2 Diabetes (T2DM).
* Participants who are insulin naive or receiving basal insulin \[NPH (neutral protamine Hagedorn) once or twice daily, once-daily insulin glargine U100 or U300, once-daily insulin degludec, or insulin detemir once or twice daily\] for fewer than 5 years prior to screening.
* Have glycated hemoglobin (HbA1c) of ≥7.0 percent (%) to ≤9.5%, HbA1c of ≥6.5% to ≤9.5% for participants on treatment with sulfonylureas and/or Sodium-Glucose Transport Protein 2 inhibitors who require washout.
* Have a body mass index between 27 and 40 kilograms per meter square.
* Male or female participants who are willing to comply with the contraception requirements consistent with local regulations.
* Be willing to allow blood sample collection, reliable and to be available for the duration of the study as required for the study protocol.

Exclusion Criteria:

* Have known or suspected allergic reactions to study drugs, related compounds, excipients, and devices used in the study.
* Have a specific type of diabetes other than T2DM.
* Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
* Participants with a history of kidney complications.

Primary outcomes:
measure: Pharmacokinetics (PK): Area under the concentration curve during one dosing interval at steady state (AUCss) of LY3209590
timeFrame: One dosing interval at steady state from 0 to 168 hours after last dose
Secondary outcomes:
measure: PK: Total amount of glucose infused during one dosing interval at steady state (Gtot,SS) of LY3209590
timeFrame: One dosing interval at steady state from 0 to 168 hours after last dose
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung
state: Nordrhein-Westfalen
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01426282: The Effects of Health Education in Cardiovascular Diseases Prevention and Treatment
Official title: The Effects of Health Education Given by Nurse on Out-patient Compliance in Cardiovascular Diseases Prevention and Treatment in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Out-patient Compliance
Nurse, Heath Education
Cardiovascular Diseases
Treatment and Prevention
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2011-08-31
Enrollment: 5
Sex: ALL
Minimum age (years): 30
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the effects of health education given by nurse on out-patient compliance in cardiovascular diseases prevention and treatment.


Eligibility criteria: Inclusion Criteria:

* first diagnosis cardiovascular disease

Exclusion Criteria:

* Severe liver and kidney disease or cancer
* Limb movement disorder
* Cognitive impairment
* History of malignant arrhythmia or severe heart failure patients have a high risk of sudden death
* Diabetes
* Cerebrovascular disease
* History of atherosclerotic disease hospital

Primary outcomes:
measure: blood pressure
timeFrame: 1 year
measure: lipid
timeFrame: 1 year
measure: Adherence drug administration
timeFrame: 1 year
measure: Hospitalization
timeFrame: 1 year
Secondary outcomes:
measure: Exercise time(hours/week)
timeFrame: 1 year
measure: smoking
timeFrame: 1 year
measure: body weight
timeFrame: 1 year
Other outcomes:
Locations:
city: Harbin
country: China
facility: the first college of Harbin Medical University
state: Heilongjiang
Study officials:
References:
Clinical trial NCT05937282: Hemodynamic Responses of Dexmedetomidine, Lidocaine or Propofol Infusions During Laparoscopic Cholecystectomy
Official title: Comparative Study Between the Hemodynamic Responses of Dexmedetomidine, Lidocaine or Propofol Infusions During Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hemodynamic Responses
Laparoscopic Cholecystectomy
Dexmedetomidine
Lidocaine
Propofol
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be carried out to compare the efficacy of dexmedetomidine, propofol or lidocaine infusions in attenuation of hemodynamic responses to pneumoperitoneum during adult laparoscopic cholecystectomy using electrical cardiometry.

Detailed description: Many drug infusions have been used to control hemodynamic responses to laparoscopic surgeries like propofol, fentanyl, esmolol with varying degrees of success.

Dexmedetomidine has sedative and analgesic properties seems to be appropriate enough to control the sympathetic response as well as provide a stable hemodynamics

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists I patients.
* Patients between the ages of ≥ 20 and ≤ 60 years of both sexes.

Exclusion Criteria:

* Hypersensitivity to dexmedetomidine, propofol or lidocaine.
* Diabetic patients (Hemoglobin A1C ≥ 7).
* Hypertensive patients (Blood presssure ≥ 140/90 mmHg) or patients on medications that affect hemodynamics as clonidine, methyldopa, β blockers and calcium channel blockers.
* Impaired liver function (serum albumin ≤ 3.5 g/dl, International normalized ratio≥ 1.3, total bilirubin \>1mg/dl).
* Impaired renal function (serum creatinine \>1.2 mg/dl, blood urea \>20mg/dl).
* Morbidly obese patients with body mass index ≥ 40.
* Patients with acute cholecystitis or active infection.
* Patients taking medications that may impair cognition.
* History of seizures.

Primary outcomes:
measure: Noninvasive mean blood pressure
timeFrame: Intraoperatively
Secondary outcomes:
measure: Intraoperative rescue drugs
timeFrame: Intraoperatively
measure: Post extubation sedation
timeFrame: 24 hour postoperatively
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia University
state: Menoufia
Study officials:
References:
Clinical trial NCT01011582: Characteristics and Outcomes of Intensive Care Unit Patients Admitted With Novel H1N1 Influenza or Seasonal Influenza
Official title: Human Subjects Registry of Characteristics and Outcomes of Intensive Care Unit Patients Admitted With Novel H1N1 Influenza or Seasonal Influenza
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: H1N1 Influenza
Seasonal Influenza
Keywords: To evaluate biomarkers that cause critical illness in patients with novel H1N1 influenza and with seasonal influenza.
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2009-11-11
Enrollment: 4
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the medical intensive care unit at Virginia Commonwealth University Medical Center, Richmond, Virginia.

Brief summary: The purpose of this research study is to collect information on problems that patients with the novel H1N1 influenza and/or the seasonal influenza experience. Novel H1N1 flu is also called the swine flu. Seasonal influenza is also called the regular flu. The purpose of this study is to collect information from patients who are infected with either the novel H1N1 or the seasonal flu and to determine what makes patients critically ill with these infections. The goal is to develop a registry that will aid investigators in determining specific markers that lead to development of severe illness in these infections.

Detailed description: Patients admitted to the medical intensive care unit with either novel H1N1 infection or seasonal influenza infection may be eligible for participation.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to the medical intensive care unit with a diagnosis of novel H1N1 influenza infection or with a diagnosis of seasonal influenza infection.

Exclusion Criteria:

* Prisoners
* Refusal of study participation.

Primary outcomes:
measure: The primary outcome is to contrast patients infected with novel H1N1 influenza to those infected with seasonal influenza.
timeFrame: Patients will be evaluated until May 31, 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center (formerly known as Medical College of Virginia)
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Marjolein de Wit, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02046382: RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Cesarean Pain Relief
Official title: Randomized Control Trial of IV Acetaminophen for Post Cesarean Delivery Pain Relief
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section
Pain, Postoperative
Keywords: IV Acetaminophen
Cesarean Section
Pain, Postoperative
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is being done to evaluate the scheduled use of intravenous (IV) acetaminophen among cesarean section patients. The study hopes to find out if patients who receive scheduled IV acetaminophen for 48 hours following delivery have lower self-reported pain scores and use less narcotic pain medication than patients who do not receive IV acetaminophen.

Detailed description: See Brief Summary

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Scheduled cesarean section delivery
* Patient of TriHealth's Faculty Medical Center or Tri-State Maternal Fetal Medicine Associates
* Singleton pregnancy
* Term delivery (greater than or equal to 37 weeks)
* Spinal/epidural anesthesia with epidural analgesia (duramorph)
* Use of pfannenstiel incision

Exclusion Criteria:

* Weight less than 50 kg
* Allergy to study drugs (acetaminophen, oxycodone, duramorph, NSAIDS)
* Multiple gestation pregnancy
* Cesarean section for pre-term delivery (less than 37 weeks)
* Fetal anomalies
* Inability to use epidural duramorph at time of procedure
* General anesthesia used
* Vertical skin incision
* Opioid addiction
* Liver dysfunction (hepatitis, HELLP (hemolysis, elevated liver enzymes, and low platelet count), preeclampsia)

Primary outcomes:
measure: Total Oxycodone (mg)
timeFrame: approximately 2 - 7 days
Secondary outcomes:
measure: Number of Participants With Narcotic Associated Side Effects
timeFrame: 2-7 days
measure: Length of Stay
timeFrame: 2-7 days
Other outcomes:
measure: Total Amount of Ibuprofen During Inpatient Stay
timeFrame: 2-7 days
Locations:
city: Cincinnati
country: United States
facility: TriHealth Good Samaritan Hospital
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Donna Lambers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Altenau B, Crisp CC, Devaiah CG, Lambers DS. Randomized controlled trial of intravenous acetaminophen for postcesarean delivery pain control. Am J Obstet Gynecol. 2017 Sep;217(3):362.e1-362.e6. doi: 10.1016/j.ajog.2017.04.030. Epub 2017 Apr 25.