louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01325740: A Study to Assess the Tolerability of a Single Dose of STX107 in Adults With Fragile X Syndrome
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of STX107 in Adults With Fragile X Syndrome
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Fragile X Syndrome
Lead sponsor: Seaside Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-30
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will consist of a Screening period (up to 14 days), a Treatment period, and a Follow-Up period. Sixteen subjects will be enrolled into two sequential dose cohorts - 10 or 30 mg (or matching placebo) across four study centers.


Eligibility criteria: Inclusion Criteria:

* Male subjects 18 to 50 years of age, inclusive.
* Molecular documentation of the full fragile X mutation.

Exclusion Criteria:

* Subjects with a history of seizure disorder who are, in the opinion of the Investigator and Medical Monitor, not currently considered to be well controlled.
* Subjects currently being treated with psychoactive medications (including stimulants and anxiolytics).
* Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. 4. Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
* Subjects who, in the Investigator's opinion, might not be suitable for the study

Primary outcomes:
measure: Adverse events will be monitored for tolerability
timeFrame: 1 day
Secondary outcomes:
measure: Blood levels of STX107 will be measured to define pharmacokinetics
timeFrame: 1 day
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California-Los Angeles Neuropsychiatric Institute
state: California
city: Sacramento
country: United States
facility: University of California-Davis, M.I.N.D. Institute
state: California
city: Aurora
country: United States
facility: University of Colorado Denver, Children's Hospital
state: Colorado
city: Decatur
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT03046940: The Influence of Doctor-patient Communication on Patients' Willingness to Take Medication
Official title: The Influence of Doctor-patient Communication on Patients' Willingness to Take Medication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The experiment aims at investigating whether the doctor-patient communication has an influence on patients' willingness to take medication. Patients' attitude towards the medication is manipulated via a critical film sequence. Afterwards patients of the two experimental groups have a communication with one of the investigators of the study. Patients are told that the investigator is a medical doctor. The "doctors" either communicate in a patient-centered or doctor-centered style with the patient. Patients in the control group do not have the possibility to talk to a "medical doctor". Afterwards patients are offered the aforementioned pill that is supposed to be a cognitive enhancer (actually placebo pill). Pill intake is voluntary. The investigators hypothesize that patients in the experimental group with the patient-centered style of communication are more likely to take the pill than patients in the experimental group with the doctor-centered style of communication or patients in the control group.


Eligibility criteria: Inclusion Criteria:

* female
* between 18 and 35 years
* healthy
* adequate ability to see
* fluent in German (reading and writing)

Exclusion Criteria:

* regular intake of cognitive enhancers/medication that enhances concentration
* intake of psychotropic drugs
* medical or pharmacy students, advanced psychology students
* participants who know the investigators

Primary outcomes:
measure: Pill intake
timeFrame: Within 10 minutes after doctor-patient communication
Secondary outcomes:
measure: Willingness to take medication (VAS)
timeFrame: Within 10 minutes prior to watching the film sequence, directly (within 5 minutes) after the film sequence, directly (within 10 minutes) after doctor-patient communication
measure: Critical attitude towards the medication (VAS)
timeFrame: Within 10 minutes prior to watching the film sequence, directly (within 5 minutes) after the film sequence, directly (within 10 minutes) after doctor-patient communication
measure: Influence on concentration (Concentration task)
timeFrame: Directly (within 10 minutes) after the pill was offered
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg
Study officials:
affiliation: Philipps University Marburg
name: Winfried Rief, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05080140: Investigate the Effect of Ezetimibe, Simvastatin, and Omega 3- Fatty Acids on Dyslipidemia Patients: a Pharmacokinetics Based Study
Official title: Investigate the Effect of Ezetimibe, Simvastatin, and Omega 3- Fatty Acids on Dyslipidemia Patients: a Pharmacokinetics Based Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperlipidemia; Mixed
Lead sponsor: Misr University for Science and Technology
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: least 80 adult patients both sexes suffering from mixed dyslipidemia with high triglyceride level admitted at Sauad Kaffafi Hospital, Misr University for science and technology.

Brief summary: This randomized controlled pharmacokinetic based study will be carried out on patients with both sexes and various ages, plasma triglycerides levels, clinical health disorders and using different agents for treatment of their hyperlipidemia in order to access the optimal drug therapy with best cost effectiveness in the elderly cases under investigation.


Eligibility criteria: Inclusion Criteria:

* Patients of dyslipidemia with high triglyceride level (200 to 499 mg/100 ml).
* Total cholesterol level more than 200 mg/100 ml
* Male and female
* Age 35 - 70 years

Exclusion Criteria:

* - Hypersensitivity of drugs
* Liver toxicity
* -Patients suffering from renal dysfunction

Primary outcomes:
measure: Reduction of Total cholesterol
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Misr University for science and technology
Study officials:
References:
Clinical trial NCT00878540: Short-term Metabolic Effects of Mirtazapine in Healthy Subjects
Official title: Phase 1 Study of Mirtazapine in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: mirtazapine
metabolism
depression
Healthy males
Lead sponsor: Max-Planck-Institute of Psychiatry
Sponsor class: OTHER
First posted: 2009-04-09
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine metabolic changes upon a 7 day medication of 30 mg mirtazapine per day in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Male sex
* Age 20-25 years
* Somatically and mentally healthy
* Normal body weight (body mass index (BMI)18.5-25)

Exclusion Criteria:

* Smoking within the last 6 months
* Medication within last 6 months
* Current or former psychiatric illness
* Positive family history (first grade relatives) for metabolic diseases
* Alcohol abuse
* Current or former illicit drug abuse
* Current or former drug abuse
* Known intolerance to, or former prescription of study medication
* Participation in other clinical trials at the same time or participation in clinical trials associated with administration of a drug within the last 6 months
* Homelessness
* Shift work within last 12 months
* Known hypersensitivity to mirtazapine or other components of the drug given
* Known epilepsy; glaucoma; liver, kidney, or heart disease; urinary dysfunction; hypotonia; diabetes or any other metabolic disease
* Known hematologic disease, especially agranulocytosis or leukopenia
* Blood donation within last 6 months prior to the begin of the study
* Hemoglobin below 13.5 mg/dL

Primary outcomes:
measure: Metabolic changes upon a 7 day medication of 30 mg mirtazapine per day
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Max Planck Institue of Psychiatry
Study officials:
affiliation: Max Planck Institute of Psychiatry, Munich
name: Florian Holsboer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hennings JM, Heel S, Lechner K, Uhr M, Dose T, Schaaf L, Holsboer F, Lucae S, Fulda S, Kloiber S. Effect of mirtazapine on metabolism and energy substrate partitioning in healthy men. JCI Insight. 2019 Jan 10;4(1):e123786. doi: 10.1172/jci.insight.123786.
citation: Fulda S, Kloiber S, Dose T, Lucae S, Holsboer F, Schaaf L, Hennings J. Mirtazapine provokes periodic leg movements during sleep in young healthy men. Sleep. 2013 May 1;36(5):661-9. doi: 10.5665/sleep.2622.
Clinical trial NCT00882440: A Study to Investigate the Efficacy and Safety of Different Doses of Losartan Potassium (MK0954-011)
Official title: A Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Investigate the Antihypertensive Efficacy and Safety of Different Doses of DuP 753 (MK0954)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-04-16
Enrollment: 576
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the antihypertensive efficacy of different doses of losartan compared to placebo and enalapril, in patients with supine diastolic blood pressure of 100-115 mmHg.


Eligibility criteria: Inclusion Criteria:

* Patient has been diagnosed with mild to moderate hypertension, with supine diastolic blood pressure of 100 to 115 mmHg
* Patient has no active medical problems other than essential hypertension that might affect blood pressure
* Patient has received no drug therapy that might affect blood pressure

Exclusion Criteria:

* Prior exposure to losartan
* History of stroke
* History of myocardial infarction
* Atrial flutter or atrial fibrillation
* History of congestive Heart failure
* Known Sensitivity to ACE inhibitors
* Known positive test for HIV/AIDS or Hepatitis B
* Patient is being treated for acute ulcer disease
* History of chronic liver disease
* Actively treated diabetes mellitis
* Any known bleeding or platelet disorder
* Absence of one kidney
* Women of childbearing potential or who are breastfeeding
* Patient is abusing or has a history of alcoholism or drug addiction

Primary outcomes:
measure: Mean Change From Baseline in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8
timeFrame: 24 hours post dose at Baseline and Week 8
Secondary outcomes:
measure: Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8
timeFrame: 24 hours post dose at Week 8
measure: Mean Change From Baseline in Peak Supine Diastolic Blood Pressure (SuDBP) at Week 8
timeFrame: 6 hours post dose at Baseline and 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Gradman AH, Arcuri KE, Goldberg AI, Ikeda LS, Nelson EB, Snavely DB, Sweet CS. A randomized, placebo-controlled, double-blind, parallel study of various doses of losartan potassium compared with enalapril maleate in patients with essential hypertension. Hypertension. 1995 Jun;25(6):1345-50. doi: 10.1161/01.hyp.25.6.1345.
Clinical trial NCT05906901: Effects of Osteopathic Treatment in Patients With Tension Type Headache
Official title: Effects of Osteopathic Treatment in Patients With Tension Type Headache
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tension-Type Headache
Lead sponsor: Escola Superior de Tecnologia da Saúde do Porto
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 30
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: TREATMENT

Brief summary: The aim of this study is to evaluate the effects of the suboccipital muscles inhibition technique on patients suffering from tension-type headaches.

Detailed description: The tension-type headache is a recurrent condition with a high financial repercussion in Portugal. Their side effects often impact daily activities, reducing the quality of life of the patients.

In several studies, the excessive tension of the suboccipital muscles are usually referred as a cause of tension-type headache, since they can exert tension on the dura mater through the myodural bridge.

Eligibility criteria: Inclusion Criteria:

They must have tension-type headache, that is, a headache with:

* a duration of at least 30 min to days, with or without an break;
* must have at least two of the following four characteristics:

  1. bilateral location
  2. pressure or squeezing quality (non throbbing)
  3. weak or moderate intensity
  4. not aggravated by routine physical activity such as walking or climbing stairs;
* must have both of the following criteria:

  1. only one of the following: photophobia, phonophobia, or mild nausea
  2. absence of moderate or severe nausea or vomiting.

Exclusion Criteria:

* They can't be on antibiotics, antivirals, or antidepressants;
* They can't have neurological problems;
* They shouldn't have any absolute contraindication for the osteopathic maneuvers;
* They can't have acute pathologies (ex: infection) or serious (ex: cancer);
* They can't have fractures in the skull, cervical spine or high dorsal spine (up to D4);
* They can't be pregnant.

Primary outcomes:
measure: Frequency
timeFrame: One month after first intervention
measure: Intensity
timeFrame: One month after first intervention
measure: Impact on quality of life questionnaire
timeFrame: one month after first intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Escola Superior da Saúde do Porto
Study officials:
affiliation: Escola Superior da Saúde do Porto
name: Natália MO Natália
role: PRINCIPAL_INVESTIGATOR
References:
citation: Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
Clinical trial NCT03468101: Characterization of Professional COPD Related to Exposure to Organic Dust - Mean Follow up at 6 Years
Official title: Characterization of Professional COPD Related to Exposure to Organic Dust - Mean Follow up at 6 Years
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: COPD
Exposure Occupational
Keywords: COPD
Dairy farmers
Exposure Occupational
FEV1
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 90
Sex: ALL
Minimum age (years): 46
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who participated to BALISTIC 1 and who had been diagnosed with COPD, belonging to either the "dairy farmers COPD" group or the "non farmers COPD" group.

Brief summary: The main objective of the BALISTIC research program is to characterize COPD related to organic particles (of which the model is agricultural COPD) in comparison with tobacco-related COPD, at the clinical, functional (at rest and exercise), inflammatory and physiopathological level.

The cross-sectional step BALISTIC 1 made it possible to include 400 patients between 2011 and 2015, and to identify approximately 100 dairy farmers COPD and 100 non-dairy farmers COPD (tobacco COPD). Preliminary results, as well as those of an ancillary study that included a group of subjects exposed to mineral dust and fumes, suggest that agricultural COPD is a predominantly non-emphysematous or essentially bronchial disease with IgE-mediated allergic mechanisms.

The current project BALISTIC 2 proposes to conduct a comparative study at + 6 years on average of the two groups of COPD subjects identified in BALISTIC 1 in order to specify the phenotype of COPD in dairy farmers by, in particular, the study of the rate of decline of resting and exercise respiratory function parameters, its computed tomography presentation and its genetic and epigenetic profile.

The prospects of this work are to improve the management of COPD in any cause by setting up preventive and curative therapeutic approaches in order to provide answers to the progression of a disease that makes part of the few major public health problems of the 21st century.


Eligibility criteria: Inclusion Criteria:

* Patients who participated to BALISTIC 1 and who had been diagnosed with COPD, belonging to either the "dairy farmers COPD" group or the "non farmers COPD" group.

Exclusion Criteria:

-

Primary outcomes:
measure: Annual change in FEV1 judged by two spirometry performed on average at 6-year intervals and expressed in ml per year.
timeFrame: two spirometry performed on average at 6-year
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References:
Clinical trial NCT02893501: Infant Microbiome in Diaper Rash
Official title: An Exploratory Study to Evaluate the Microbial Consortia of Infants (9-12 Months) Experiencing Diaper Rash and When Healthy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaper Rash
Lead sponsor: Kimberly-Clark Corporation
Sponsor class: INDUSTRY
First posted: 2016-09-08
Enrollment: 25
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample of male and female infants with mild to moderate diaper rash

Brief summary: The objective of this study is to evaluate the microbiome composition of infant's (9-12 month) skin experiencing diaper rash in order to determine if the onset and severity of erythema associated with diaper rash is influenced by the type of bacteria colonizing the skin.


Eligibility criteria: Inclusion Criteria:

* Infants aged 9-12 months with mild to moderate diaper rash

Exclusion Criteria:

* Use of topical or oral antibiotics or antifungals within the past 4 weeks.
* Use of zinc-containing diaper rash creams within 48 hours first sample
* Immunocompromised

Primary outcomes:
measure: Operational Taxonomic Units (OTUs) of microbes present on skin
timeFrame: Change from Baseline at Day 14
measure: Relative abundance of microbes present on skin measured in picograms of DNA
timeFrame: Change from Baseline at Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
Study officials:
affiliation: Midwest Children's Health Research Institute
name: Sahra Niazi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Costello EK, Lauber CL, Hamady M, Fierer N, Gordon JI, Knight R. Bacterial community variation in human body habitats across space and time. Science. 2009 Dec 18;326(5960):1694-7. doi: 10.1126/science.1177486. Epub 2009 Nov 5.
citation: Le Lamer M, Pellerin L, Reynier M, Cau L, Pendaries V, Leprince C, Mechin MC, Serre G, Paul C, Simon M. Defects of corneocyte structural proteins and epidermal barrier in atopic dermatitis. Biol Chem. 2015 Nov;396(11):1163-79. doi: 10.1515/hsz-2015-0141.
citation: Sakabe J, Kamiya K, Yamaguchi H, Ikeya S, Suzuki T, Aoshima M, Tatsuno K, Fujiyama T, Suzuki M, Yatagai T, Ito T, Ojima T, Tokura Y. Proteome analysis of stratum corneum from atopic dermatitis patients by hybrid quadrupole-orbitrap mass spectrometer. J Allergy Clin Immunol. 2014 Oct;134(4):957-60.e8. doi: 10.1016/j.jaci.2014.07.054. No abstract available.
citation: Adalat S, Wall D, Goodyear H. Diaper dermatitis-frequency and contributory factors in hospital attending children. Pediatr Dermatol. 2007 Sep-Oct;24(5):483-8. doi: 10.1111/j.1525-1470.2007.00499.x.