louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00592254: Screening Protocol for Adults With ADHD
Official title: A Screening Protocol for Adults With Attention Deficit Hyperactivity Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ADHD
Keywords: ADHD
Adults
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-01-14
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with symptoms of ADHD

Brief summary: The objective of this protocol is to establish a comprehensive screening process to evaluate the eligibility of potential adult subjects for appropriate ADHD clinical research studies

Detailed description: To address the needs of the large number of adults who contact the Adult ADHD Program at Massachusetts General Hospital annually, we have sought approval for several research studies aimed at evaluating critical components of the needs of this population. Potential participants for those studies present with a widely varied set of complaints not always discernable in a telephone screening interview. This state of affairs often makes it difficult to ask subjects to sign a specific protocol's consent form without obtaining additional clinical information. Because of this, we have potential subjects consent to undergo an in-depth clinical assessment that will allow them to be screened by a clinician for eligibility to a diverse clinical research program available to them.

Eligibility criteria: Inclusion Criteria:

1. Males and females ages 18-55
2. Subjects must have a DSM-IV or DSM-V diagnosis of ADHD, as determined by a clinical evaluation based on DSM-IV or DSM-V criteria

Exclusion Criteria:

1. History of head trauma with loss of consciousness, organic brain disorders, seizures, or neurosurgical intervention.
2. Any significant medical condition, in the judgment of the investigator
3. Mental retardation
4. Pregnancy of lactation
5. Subjects with a known recent history (within the past 6 months) of illicit drug or alcohol dependence
6. Sensory difficulties such as deafness or blindness

Primary outcomes:
measure: Screening Protocol
timeFrame: Sreening
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joseph Biederman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02916654: Sucrosomial Iron in Patients With Celiac Disease and IDA
Official title: Sucrosomial Iron Supplementation in Anaemic Patients With Celiac Disease Not Tolerating Oral Ferrous Sulfate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Celiac Disease
Iron Deficiency Anemia
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sucrosomial iron (Sideral® Forte) is a preparation of ferric pyrophosphate conveyed within a phospholipid membrane associated with ascorbic acid, is a new-generation oral iron which shows a high gastrointestinal absorption and high bioavailability with a low incidence of side effects due to lack of any direct contact with intestinal mucosa. In comparison with the other standard oral iron preparations, sucrosomial iron seems to be a promising new strategy of iron replacement in CD patients.


Eligibility criteria: Inclusion Criteria:

* proven celiac disease
* iron deficiency anemia

Exclusion Criteria:

* other autoimmne diseases
* pregnancy psychiatric disorders

Primary outcomes:
measure: Hemoglobin
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda
state: MI
Study officials:
References:
Clinical trial NCT01186354: Understanding of Genetic Risk Information for Type 2 Diabetes
Official title: Implications of Health and Genetic Literacy for Genomic Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
health literacy
genetic literacy
genetic risk
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-08-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This research study is being conducted to learn about how health and genetic literacy (i.e., how well a person understands health and genetic information) affects a person's ability to understand genetic risk information for Type 2 diabetes and whether that person chooses to change their lifestyle and health behaviors to reduce their risk. The investigators also want to learn if the manner in which the genetic risk information is communicated affects the level of understanding and potential behavior changes. Participants will be tested for genetic risk of developing Type 2 diabetes and will received results either via a web-based computer program, or in-person from a genetic counselor.


Eligibility criteria: Inclusion Criteria:

* Ages 18 or older
* Speak fluent English
* Have an email address and access to the internet
* Not diagnosed with type 2 diabetes

Exclusion Criteria:

-

Primary outcomes:
measure: Accurate understanding of genetic risk information
timeFrame: assessed at follow-up 1 week, 3 months and 6 months after receiving results
Secondary outcomes:
measure: Impact on behavior change
timeFrame: assessed upon follow-up (3 mon, 6 mon)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University Medical Center, Institute for Genome Sciences and Policy
name: Susanne B Haga, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mills R, Powell J, Barry W, Haga SB. Information-seeking and sharing behavior following genomic testing for diabetes risk. J Genet Couns. 2015 Feb;24(1):58-66. doi: 10.1007/s10897-014-9736-1. Epub 2014 Jun 14.
citation: Haga SB, Barry WT, Mills R, Svetkey L, Suchindran S, Willard HF, Ginsburg GS. Impact of delivery models on understanding genomic risk for type 2 diabetes. Public Health Genomics. 2014;17(2):95-104. doi: 10.1159/000358413. Epub 2014 Feb 27.
citation: Haga SB, Barry WT, Mills R, Ginsburg GS, Svetkey L, Sullivan J, Willard HF. Public knowledge of and attitudes toward genetics and genetic testing. Genet Test Mol Biomarkers. 2013 Apr;17(4):327-35. doi: 10.1089/gtmb.2012.0350. Epub 2013 Feb 13.
citation: Waxler JL, O'Brien KE, Delahanty LM, Meigs JB, Florez JC, Park ER, Pober BR, Grant RW. Genetic counseling as a tool for type 2 diabetes prevention: a genetic counseling framework for common polygenetic disorders. J Genet Couns. 2012 Oct;21(5):684-91. doi: 10.1007/s10897-012-9486-x.
Clinical trial NCT03947554: Ginseng HRG80 in Stress and Fatigue
Official title: Study of the Efficacy of Panax Ginseng Herbal Preparation HRG80 for Prevention and Mitigation of the Symptoms of Stress in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Psychological Stress
Keywords: Panax ginseng
Red ginseng
Korean ginseng
Adaptogen
Lead sponsor: EuroPharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Botalys SA
First posted: 2019-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study evaluates the effects of a specific herbal preparation of Panax ginseng in preventing symptoms of stress in healthy individuals.

Detailed description: HRG80 is an herbal preparation of Panax ginseng with a higher concentration of bioavailable ginsenosides than typical Korean ginseng. This study will test whether HRG80 is effective at preventing symptoms of stress, such as fatigue, impaired memory, difficulty in concentration, attention deficit, restlessness, and irritation related to daily work situations of healthy individuals in comparison to placebo and a standard Pananx ginseng with a lower concentration of ginsenosides.

Eligibility criteria: Inclusion Criteria:

* Individuals experiencing at least one symptom of stress and fatigue during 8 hours of mental work with a computer.
* Men and women ages 18-65 (all races and ethnicities)
* Able to understand and participate in an 11-week study

Exclusion Criteria:

* Taking medicine or dietary supplements which may have potential effects on cognitive function
* Consuming more than 1 cup of coffee daily (in the morning).

Primary outcomes:
measure: Change in Perceived Stress Scale (PSS) from baseline to the last day of treatment
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: Sports Medicine and Anti-Doping Service Republican Centre
Study officials:
affiliation: Sports Medicine and Anti-Doping Service Republican Centre
name: Areg Hovhannisyan, PhD, Dr Sci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002354: A Study of Indinavir Sulfate Given Together With Stavudine to HIV-Positive Patients
Official title: One Year Study in HIV-1 Seropositive, AZT-Experienced Patients to Evaluate the Safety and Efficacy of MK-639 Administered Concomitantly With Stavudine (d4T)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Stavudine
HIV Protease Inhibitors
Indinavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: 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 indinavir sulfate plus stavudine to HIV-infected patients who have already been treated with zidovudine.


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Prophylaxis with aerosolized pentamidine, topical antifungals, TMP / SMX, dapsone, or isoniazid.

Patients must have:

* HIV infection.
* CD4 count 50 - 500 cells/mm3.
* Prior AZT use for more than 6 months OR documented intolerance to AZT with more than 6 months use of another anti-HIV therapy other than d4T or any protease inhibitor.
* No active opportunistic infection or visceral Kaposi's sarcoma.

NOTE:

* Patients with hemophilia may be enrolled at discretion of investigator.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Symptomatic neuropathy.
* Acute hepatitis.

Concurrent Medication:

Excluded:

* Antiretrovirals other than specified in protocol.
* Chronic therapy for an active opportunistic infection.
* Immunosuppressive therapy.

Prior Medication:

Excluded:

* Any prior protease inhibitor or d4T.
* Any nucleoside analogs within 2 weeks prior to study entry.
* Investigational agents or immunomodulators within 30 days prior to study entry.

Required:

* More than 6 months of prior AZT unless intolerant, in which case more than 6 months of another anti-HIV therapy (other than protease inhibitors or d4T).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Whitehouse Station
country: United States
facility: Merck & Co Inc
state: New Jersey
Study officials:
References:
Clinical trial NCT04228354: A Research Study Looking at the Comparability (Bioequivalence) of Two Versions of Semaglutide
Official title: A Trial to Demonstrate Bioequivalence Between Semaglutide Drug Product Concentrations 0.68 mg/mL and 1.0 mg/mL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Overweight
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2020-01-14
Enrollment: 28
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: The study will look at how two different versions of semaglutide reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different versions. Participants will get both versions of semaglutide. The order in which participants receive the versions is decided by chance. Participants will get the medicines as an injection under the skin of the belly with the use of a pen-injector. The study will last for about 11 to 17 weeks. Participants will have 27 visits with the study doctor. At 2 visits, participants will stay in the clinic for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body mass index between 20.0 and 27.0 kg/m\^2 (both inclusive).

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods.
* Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.

Primary outcomes:
measure: Area under the semaglutide plasma concentration curve from 0 to tz
timeFrame: 0-840 hours
measure: Maximum semaglutide plasma concentration
timeFrame: 0-840 hours
Secondary outcomes:
measure: Area under the semaglutide plasma concentration curve
timeFrame: 0-840 hours
measure: Time to Cmax for semaglutide
timeFrame: 0-840 hours
measure: Terminal elimination half-life
timeFrame: 0-840 hours
measure: Total apparent clearance of semaglutide
timeFrame: 0-840 hours
measure: Apparent volume of distribution of semaglutide
timeFrame: 0-840 hours
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor & Disclosure (1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00173654: Mutation Analysis of 17βhydroxysteroid Dehydrogenase 3 Deficiency
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pseudohermaphroditism
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: To disclose the molecular pathology of our 3 families with 17βHSD3 deficiency.

Detailed description: 17βhydroxysteroid dehydrogenase 3 (17βHSD3) deficiency is a rare cause of male pseudohermaphroditism. The incidence is reported to be 1: 147,000 in the Netherlands. Fewer than one hundred affected 46, XY males were reported in the literature, and no such case has been reported in Taiwan before. The 46, XY patients have ambiguious or complete female external genitalia. They are mostly unrecognized at birth and reared as female. They often draw medical attention when they receive operation for inguinal hernia or during puberty, clitoromegaly and musculization were noticed. However, the homozygous or compound heterozygous genetic females are asymptomatic. The 17βHSD3 catalyze the conversion of androstenedione to testosterone, the last step in the synthesis of testosterone. Therefore, the serum levels of androstenedione are elevated and testosterone or dihydrotestosterone are in the low range in these affected 46, XY individuals. The clinical diagnosis is made by HCG stimulation test, because androstenedione-to-testosterone ratio is abnormally elevated in these patients. But the molecular basis of 17βHSD3 deficiency was not determined till recent decade.

The HSD17B3 gene was elucidated in 1994, and composed of 11 exons. Several missence mutation and splice mutation were identified. But the precise action and tissue distribution of 17βHSD3 still need to be clarified. The Wölffian ducts virilze normally in the embryonic stage and the serum concentration of testosterone achieve to the normal range in the pubertal stage. The exact mechanism is not understood clearly and peripheral conversion under other isozymes was suggested in some studies.

The purpose of this study is to disclose the molecular pathology of our 3 families with 17βHSD3 deficiency.

Eligibility criteria: Inclusion Criteria:

* Patients with 17β-hydroxysteroid dehydrogenase 3 deficiency and their family

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yi-Ching Tung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04865354: Clinical Comparison of Two Daily Disposable Contact Lenses
Official title: Clinical Comparison of Two Daily Disposable Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: Contact Lenses
Disposable
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2021-04-29
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the clinical performance of PRECISION1™ contact lenses to Clariti® 1 day contact lenses.

Detailed description: Subjects will be expected to attend 3 study visits and wear the study lenses daily for at least 10 hours per day. On the day prior to Visits 2 and 3, subjects will be expected to wear the study lenses for at least 16 hours. The total duration of subject participation will be up to 22 days.

Eligibility criteria: Key Inclusion Criteria

* Successful wearer of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
* Possess spectacles and willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
* Willing to wear contact lenses for at least 16 hours on one of the days (day prior to each week 1 visit).
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Habitual PRECISION1, Clariti 1-Day, and DAILIES TOTAL1 contact lens wearers.
* Any monovision and multifocal lens wearers.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Least Squares Mean Distance VA (logMAR) With Study Lenses
timeFrame: Day 8, each study lens type
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Alcon Investigator 8106
state: California
city: Maitland
country: United States
facility: Alcon Investigator 6565
state: Florida
city: Tallahassee
country: United States
facility: Alcon Investigator 6418
state: Florida
city: Franklin Park
country: United States
facility: Alcon Investigator 6614
state: Illinois
city: Shawnee Mission
country: United States
facility: Alcon Investigator 6645
state: Kansas
city: Medina
country: United States
facility: Alcon Investigator 6402
state: Minnesota
city: Granville
country: United States
facility: Alcon Investigator 8046
state: Ohio
city: Wichita Falls
country: United States
facility: Alcon Investigator 8028
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: CDMA Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT00822354: Tadalafil for the Treatment of Raynaud's
Official title: Tadalafil for the Treatment of Secondary Raynaud's Phenomenon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Raynaud
Keywords: Secondary Raynaud's Phenomenon
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2009-01-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators propose that tadalafil will increase digital blood flow and improve the symptoms and signs of secondary Raynaud's phenomenon.

Detailed description: The primary goal of our study is to decrease the frequency, duration and severity of vasospastic attacks in patients with secondary Raynaud's. The secondary goal is to document increased blood flow and lessened capillary dysfunction in these patients. Both of these goals are to be achieved using a course of treatment with Tadalafil.We anticipate a decrease in the frequency, duration and severity of Raynaud's attacks. Improved digital blood flow and digital blood pressures, and a decrease in digital capillary dysfunction.

Eligibility criteria: Inclusion Criteria:

* active Raynaud's Phenomenon
* stable disease and medication requirements over the previous 2 months
* subjects willing and able to participate in study assessments
* ability to understand and sign informed consent
* ages 18 to 65, both sexes
* a diagnosis of diffuse or limited cutaneous sclerosis, MCTD using the American College Rheumatology criteria

Exclusion Criteria:

* uncontrolled HTN, DM, unstable disease, angina or using oral nitrates
* smoking, active alcoholism, drug abuse within 5 years
* abnormal renal function
* ulnar arterial occlusive disease as shown by a positive Allen Test
* Pregnant or breast feeding or considering preg. in next 4 months
* past or present major psych. illness
* allergy or sensitivity to tadalafil
* subject unable to understand protocol or give informed consent
* part. in another study trial within 30 days
* taking sildenafil

Primary outcomes:
measure: Number of Raynaud's Phenomenon Attacks Per Day
timeFrame: 9 weeks
measure: Duration of Raynaud's Phenomenon Attacks
timeFrame: 9 weeks
measure: Raynaud Severity Visual Analog Score (VAS)
timeFrame: 9 weeks
measure: Raynaud's Condition Score (RCS) Visual Analog Scale (VAS)
timeFrame: 9 weeks
Secondary outcomes:
measure: Digital Blood Pressure
timeFrame: 9 weeks
measure: Capillary Diameter
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Anne Laumann, MBChB, MRCP
role: PRINCIPAL_INVESTIGATOR
References: