louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05943860: Efficacy and Tolerability of Pantovigar® Vegan in Female Subjects With Diffuse Hair Loss
Official title: Efficacy and Tolerability of Pantovigar® Vegan in Female Subjects With Diffuse Hair Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diffuse Hair Loss in Females
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2023-07-13
Enrollment: 39
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intra-individual comparison
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the hair growth efficacy of a Food for Special Medicinal Purposes (FSMP) Pantovigar® vegan after 3 and 6 months of intake.


Eligibility criteria: Inclusion Criteria:

* Diffuse hair loss
* Modified Savin Score I to III
* Hair length of at least 2 cm

Exclusion Criteria:

* Pathological hair loss (like alopecia areata, universalis or totalis; scarring alopecias; androgenic alopecia; inflammatory conditions of the scalp)
* Symptomatic diffuse alopecia due to pathological low iron concentration or thyroid gland disorder
* Acute telogen effluvium
* Recent or concomitant treatment with any drugs that may cause hair loss
* Concomitant diseases that can cause hair loss

Primary outcomes:
measure: Self-assessment questionnaire for product acceptance by subjects
timeFrame: Months 3
measure: Self-assessment questionnaire for product acceptance by subjects
timeFrame: Months 6
Secondary outcomes:
measure: Effect on hair growth assessed by phototrichogram analysis
timeFrame: Baseline up to month 6
measure: Change from baseline of blood parameters: Ferritin
timeFrame: Baseline up to month 6
measure: Change from baseline of several blood parameters: Vitamin B1
timeFrame: Baseline up to month 6
measure: Change from baseline of several blood parameters: Biotin
timeFrame: Baseline up to month 6
measure: Change from baseline of several blood parameters: Folic acid
timeFrame: Baseline up to month 6
measure: Change from baseline of several blood parameters: Hematocrit
timeFrame: Baseline up to month 6
measure: Change from baseline of several blood parameters: Pantothenic Acid
timeFrame: Baseline up to months 6
measure: Occurrence of treatment-emergent adverse reactions and treatment-emergent serious adverse reactions
timeFrame: Baseline up to months 6
Other outcomes:
Locations:
city: Schenefeld
country: Germany
facility: proDerm
Study officials:
affiliation: Merz Therapeutics
name: Merz Medical Expert
role: STUDY_DIRECTOR
References:
Clinical trial NCT03151460: Dopaminergic Modulation of Declarative Memory
Official title: Dopaminergic Modulation of Declarative Memory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All PD patients were examined in two conditions: following the standard dopamineric medication ("on") and following a 12-18 hours of treatment wash-out ("off"). Normal controls were examined twice with no drug assumption.
Primary purpose: TREATMENT

Brief summary: The study investigates the effect of dopaminergic stimulation over declarative memory functions in Parkinson's disease (PD) patients. At this aim, 20 PD patients will receive declarative memory tasks in two different conditions: after 12-18 hours of dopaminergic stimulation withdrawal ("off" condition) and after the first daily dose dopaminergic therapy ("on" condition). 20 healthy controls will also administered the two tasks in two conditions with the same inter-session delay as PD patients, but without taking drugs.

Detailed description: Parkinson's disease (PD) is frequently accompanied by declarative memory deficits. It has been hypothesized that these latter could be related to dopaminergic depletion within the fronto-striatal network. However, the nature of this relationship is not clearly understood. In this study we aim to assess the role of daily dopaminergic stimulation on the retrieval processes needed to perform different cognitive tasks. A group of PD patients will be administered declarative memory task both "on" (standard medication intake) and "off" (12/18 hours after the last medication intake). A group of comparable normal controls will also present with the same cognitive task twice, without any drug assumption. Understanding the effect of dopamine treatment on declarative memory processes will allow standard medication treatment to be adjusted in order to take into account both motor and cognitive features of Parkinson's disease.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic Parkinson Disease made by a neurologist according to the London Brain Bank criteria.

Exclusion Criteria:

* disease duration ≥ 5 years; diagnosis of dementia based on clinical criteria and confirmed by a Mini-Mental State Examination score \< 26; presence of other neurological and/or psychiatric illnesses in the patient's clinical history.

Primary outcomes:
measure: Performance on cognitive task
timeFrame: 60 min.
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione S. Lucia
Study officials:
affiliation: Fondazione S. Lucia
name: Giovanni Carlesimo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01397760: Retrospective Study for Description of The Use Of Omalizumab In Patients With Difficult To Control Asthma
Official title: Retrospective Study for Description of The Use Of Omalizumab In Patients With Difficult To Control Asthma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Keywords: DIFFICULT TO CONTROL ASTHMA
OMALIZUMABE
Lead sponsor: Fiks, Iara Nely, M.D.
Sponsor class: INDIV
First posted: 2011-07-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20 PATIENTS WITH difficult to treat asthma

Brief summary: The purpose of this study is do describe the experience in the use of omalizumabe, in a real life scenario, in uncontrolled severe asthmatic patients attended in specialist outpatient clinics, and its efficacy and safety. The efficacy of omalizumab in the population observed will be evaluated as reduction of uncontrolled asthma related events, i.e. exacerbations, emergency dept. visits, hospitalization and asthma-related treatment (decrease of asthma medication).

Detailed description: Omalizumab is indicated in children over 6 years of age, with diagnosis of difficult to control asthma, presenting a component of atopy demonstrated preferably positive skin tests (prick test) or in vitro reactivity (rast) allergens common inhalants. Patients must also present the total serum IgE levels between 30 and 700UI/mL. Children until 12 years the IgE level is between 30 and 300 IU/ml.

Eligibility criteria: Inclusion Criteria:

Patients on optimal asthma treatment, good compliance and no response to treatment according to asthma consensus (GINA/NAEEP and the Latinamerican Consensus for Difficult to treat Asthma)

Primary outcomes:
measure: Number of asthma hospitalization
timeFrame: ONE YEAR Of Omalizumab USE
Secondary outcomes:
measure: Decrease the doses of oral steroids
timeFrame: ONE YEAR Of Omalizumab USE
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Iara Nely Fiks
Study officials:
affiliation: pulmonary sao luiz hospital
name: iara n fiks, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04686760: Efficacy of Inhaled Nitroglycerin in Moderate to Critically Ill COVID-19 Patients
Official title: Efficacy of Inhaled Nitroglycerin in Moderate to Severe Cases of COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corona Virus Infection
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 278
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In current analysis moderate to severely ill Covid-19 infected patients will be nebulized with nitroglycerin, and they will be compared with the standard nebulization


Eligibility criteria: Inclusion Criteria:

Diagnosed admitted cases of Covid-19 degree of illness should be moderate to severe both male and female every age group

Exclusion Criteria:

allergic to nitroglycerin sudden drop in blood pressure not given consent

Primary outcomes:
measure: ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen
timeFrame: 5-7 days
measure: Oxygen demand
timeFrame: 5-7 days
Secondary outcomes:
measure: Duration of hospital stay
timeFrame: 15 days
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Bahria Town International Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT00307060: MK0954A-264 Filter Study (0954A-264)(COMPLETED)
Official title: A Randomized, Double-Blind, Parallel-Filter Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan-HCTZ Combination as Compared to Losartan Monotherapy in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mild to Severe Hypertension
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-03-27
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the blood pressure lowering efficacy, safety and tolerability of a combination drug to a single drug taken once daily in patients with uncontrolled blood pressure following a 4-week filter on the single therapy product.


Eligibility criteria: Inclusion Criteria:

* Male and female patients with mild to severe hypertension (SiDBP 90-120 mmHg)

Exclusion Criteria:

* Systolic BP \> 200 mmHg
* Secondary or malignant hypertension
* Taking more than 2 antihypertensive medications
* Hypertension induced by oral contraceptives
* Hx of cerebral vascular accident within 6 months
* Hx of angina, myocardial infarction, PCI, CABG, or decompensated CHF within 6 months
* Clinically significant AV conduction disturbance or potentially life threatening ventricular arrhythmias, valvular disease, cardiomyopathy, unexplained syncope
* History of angioedema
* Sensitivity to AII receptor antagonists or HCTZ, nephrotic syndrome,single kidney function
* Pregnancy or lactation.

Primary outcomes:
measure: Losartan-HCTZ 100-12.5 mg combination will be more effective in lower mean through sitting diastolic blood pressure (SiDBP) than losartan 100 mg monotherapy after 6 weeks of treatment.
timeFrame: 6 Weeks
Secondary outcomes:
measure: Losartan-HCTZ 100-12.5 mg combination will be more effective in lowering mean through sitting systolic blood pressure (SiSBP) after 6 weeks of treatment compared to losartan 100-mg monotherapy, and will be safe and tolerable.
timeFrame: 6 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Gleim GW, Rubino J, Zhang H, Shahinfar S, Soffer BA, Lyle PA, Littlejohn TW 3rd, Feig PU. A multicenter, randomized, double-blind, parallel-group trial of the antihypertensive efficacy and tolerability of a combination of once-daily losartan 100 mg/hydrochlorothiazide 12.5 mg compared with losartan 100-mg monotherapy in the treatment of mild to severe essential hypertension. Clin Ther. 2006 Oct;28(10):1639-48. doi: 10.1016/j.clinthera.2006.10.014.
Clinical trial NCT00728260: 36-Month Post-marketing Surveillance and Analysis of Menactra Vaccine in 2-10 Year Olds
Official title: Post-licensure Safety Surveillance Study of Routine Use of Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Recipients 2 to 10 Years of Age.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningitis
Meningococcal Disease
Keywords: Meningitis
Meningococcal disease
Menactra vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-08-05
Enrollment: 1421
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Past receipt of Menactra vaccine

Brief summary: To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.


Eligibility criteria: Inclusion Criteria:

* Receipt of Menactra vaccine during the study period.

Exclusion Criteria:

* None

Primary outcomes:
measure: Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.
timeFrame: Day 0 up to Day 30 post-vaccination
measure: Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.
timeFrame: Day 31 up to Day 180 post-vaccination
Secondary outcomes:
Other outcomes:
measure: Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined
timeFrame: Day 0 up to 6 months post-vaccination
Locations:
city: Oakland
country: United States
state: California
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Hansen J, Zhang L, Eaton A, Baxter R, Robertson CA, Decker MD, Greenberg DP, Bassily E, Klein NP. Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MenACWY-D) in infants and children. Vaccine. 2018 Apr 12;36(16):2133-2138. doi: 10.1016/j.vaccine.2018.02.107. Epub 2018 Mar 14.
Clinical trial NCT03901560: Music Therapy: Sickle Cell and Pain Crisis
Official title: The Effect of Music Therapy on Pediatric Patients Admitted to the Hospital for Sickle Cell or Pain Crisis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Crisis
Functional Abdominal Pain
Patients Followed by the Pain Team
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: The Children's Hospital at OU Medical Center
First posted: 2019-04-03
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between the ages of 5-17 who either have sickle cell, are on the pain team, or functional abdominal pain

Brief summary: This study will assess whether participants who receive music therapy during inpatient care report a decrease in pain and whether music therapy influences factors such as family satisfaction.

Detailed description: The purpose of this study is to determine if music therapy services can serve as a viable, necessary, and beneficial aspect of inpatient pain management, distraction, and coping for pediatric patients in the acute care hospital setting. The investigator will note the effect of music therapy services in conjunction with pain scores reported by the participant and an increase in self and family reported coping skills during hospitalization.

Participants will be referred by providers from pain management service, oncology/hematology service, or the gastrointestinal (GI) service for functional and abdominal pain. Participants who meet the criteria for inclusion will be selected. The study will be explained to parents and a consent form will be left for the family to review and sign at their convenience. Participants will provide a pain scale level and vitals before completing the music therapy intervention. Once the music therapy intervention is completed, the pain scale and vitals will be repeated.

Eligibility criteria: Inclusion Criteria:

* 5-17 years of age
* Admitted for sickle cell crisis, functional abdominal pain, or whom the pediatric pain management team is following.

Exclusion Criteria:

* Non-English speaking
* Under 5 years old and over 17 years old
* Patients who are unable to hear or have a hearing disability
* Developmentally unable to self-report pain levels

Primary outcomes:
measure: How does music therapy affect perceived pain in hospitalized pediatric patients?
timeFrame: 30 minutes
measure: How does music therapy influence factors such as family satisfaction and length of stay at the time of discharge?
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00092560: Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)
Official title: Evaluation of the Efficacy and Safety of Fenofibrate and Ezetimibe Coadministration in Patients With Mixed Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Hypertriglyceridemia
Keywords: mixed hyperlipidemia
high cholesterol
high triglycerides
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 587
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the cholesterol lowering effectiveness and safety of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).

Detailed description: The duration of treatment is 18 weeks.

Eligibility criteria: Inclusion Criteria:

* High cholesterol and high triglycerides

Exclusion Criteria:

* Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study

Primary outcomes:
measure: Plasma LDL-C vs. fenofibrate for 12 weeks.
Secondary outcomes:
measure: All plasma lipid parameters vs. ezetimibe; all non-LDL lipid parameters vs. fenofibrate; safety and tolerability.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Farnier M, Freeman MW, Macdonell G, Perevozskaya I, Davies MJ, Mitchel YB, Gumbiner B; Ezetimibe Study Group. Efficacy and safety of the coadministration of ezetimibe with fenofibrate in patients with mixed hyperlipidaemia. Eur Heart J. 2005 May;26(9):897-905. doi: 10.1093/eurheartj/ehi231. Epub 2005 Mar 21.
citation: Farnier M, Dong Q, Shah A, Johnson-Levonas AO, Brudi P. Low incidence of paradoxical reductions in HDL-C levels in dyslipidemic patients treated with fenofibrate alone or in combination with ezetimibe or ezetimibe/simvastatin. Lipids Health Dis. 2011 Nov 16;10:212. doi: 10.1186/1476-511X-10-212.
Clinical trial NCT03030560: Longterm Postoperative Analgesia, Intravenous Lidocaine Infusion
Official title: Effect of Intravenous Lidocaine Infusion on Long Term Postoperative Pain After Spinal Fusion Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spinal fusion is a painful surgery, and control of postoperative pain is difficult. Several studies have indicated that appropriate pain treatment protocols reduce postoperative morbidity, improve the results of the surgery, and decrease hospital costs

Detailed description: Forty four patients were randomly allocated into two groups of equal size to receive either lidocaine infusion (Lidocaine group) or 0.9% sodium chloride infusion (Control group).

Randomization: was performed using Lidocaine group and Control group registers, which was placed in sealed envelopes prior to study initiation and opened prior to anesthesia by a physician who prepared the intravenous solution and identified it with the patient number, according to the envelope drawn. The solution was handed to another physician, blind to the prepared solutions' content, who was responsible for the anesthesia. The solution volume was equal. The responsible investigator was remained blind to the chosen group until the end of the study.

Eligibility criteria: Inclusion Criteria:

Age \> 18 years American Society of Anesthesiologists 1-3 status Patients undergoing spinal fusion or fixation

Exclusion Criteria:

1. Previous spinal fusion surgery.
2. Morbid obesity (BMI \> 40)
3. Diagnosis of spinal metastatic cancer
4. Allergy to an amide local anesthetic or morphine sulfate
5. History of renal dysfunction, liver dysfunction or congestive heart failure
6. History of substance abuse disorder.
7. Chronic opioid use.

Primary outcomes:
measure: numerical rating scale (NRS), pain score.
timeFrame: Postoperative 3 months
Secondary outcomes:
measure: opioid consumption.
timeFrame: Postoperative 24 h
measure: Serum cortisol.
timeFrame: Postoperative 24 h
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university faculty of medicine
Study officials:
affiliation: Assiut University
name: Mohamed G Abdelraheem, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Oliveira CM, Issy AM, Sakata RK. Intraoperative intravenous lidocaine. Rev Bras Anestesiol. 2010 May-Jun;60(3):325-33. doi: 10.1016/S0034-7094(10)70041-6.
Clinical trial NCT04444960: Precision Therapy in Complex High-risk Coronary Artery Disease
Official title: Prospective Registry of the Intracoronary Physiology and Imaging-guided Precision Therapy in Complex High-risk Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Coronary heart disease patients with complicated clinical conditions and/or complex coronary lesions.

Brief summary: This is a prospective registry to enroll complex high-risk coronary heart disease patients.

The purpose of this study is to compare intracoronary physiology and imaging-guided intervention strategy and angiography-guided intervention strategy for clinical outcomes and health economics.


Eligibility criteria: Inclusion Criteria:

* Bifurcation lesions with branch diameter ≥2.5mm;
* Chronic complete occlusion (occlusion duration ≥3 months);
* Left main disease;
* Long lesions (≥38mm);
* Multi-vessel percutaneous coronary intervention (simultaneous treatment of ≥2 epicardial vessels during one operation);
* Multi-stent implantation (≥3 stents);
* In-stent restenosis;
* Moderate to severe calcification on radiography;
* Intermediate lesion;
* Thrombotic lesions;
* Creatinine clearance rate \< 60ml/min) or on dialysis ;
* Left ventricular ejection fraction \<40% ；
* History of cerebral hemorrhage or massive hemorrhage of gastrointestinal tract.

Exclusion Criteria:

* Informed consent cannot be obtained;
* Life expectancy \< 1 year.

Primary outcomes:
measure: Composite ischemic events
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Xin Huang, phD
role: PRINCIPAL_INVESTIGATOR
References: