louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00842309: D-Cycloserine Augmentation of Behavior Therapy for Individuals With Body Dysmorphic Disorder
Official title: A Randomized, Double-blind, Placebo-controlled Trial of D-cycloserine Augmentation of Behavior Therapy for Body Dysmorphic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Body Dysmorphic Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2009-02-12
Enrollment: 68
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: The purpose of the study is to conduct a double-blind, placebo-controlled study of D-cycloserine (DCS) augmentation of behavior therapy in individuals with Body Dysmorphic Disorder (BDD). Specifically, we intend to randomize 50 individuals with BDD to receive either DCS (n = 25) or placebo (n = 25) one hour prior to 8 of 10 behavior therapy sessions.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Primary diagnosis of Body Dysmorphic Disorder as determined by DSM-IV criteria
* BDD Yale-Brown Obsessive Compulsive Scale score greater than or equal to 24
* Females of childbearing potential must have a negative urinary beta-HCG test
* Subjects currently taking psychotropic medication must be on a stable does for at least two months prior to initiating study procedures

Exclusion Criteria:

* Pregnant or breastfeeding women will be excluded
* People taking medications that may interfere with DCS
* History of seizure disorder or other serious medical illnesses such as cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
* Comorbid psychiatric diagnoses (alcohol dependence, bipolar disorder, psychosis, borderline personality disorder, organic mental disorder, or development disorder). If subjects have any other comorbid disorder, the BDD symptoms have to be the primary concern.
* Persons taking medications that may lower seizure threshold, including clozapine, pethidine, and the following antibiotics in high dosage: penicillins, cephalosporins, amphotericin, and imipenem
* Those deemed to pose a serious suicidal or homicidal threat will be excluded
* Current psychotherapy or failure to benefit from ten or more sessions of previous ERP treatment is a rule-out

Primary outcomes:
measure: Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
timeFrame: Endpoint (post-treatment, week 11)
measure: Body Dysmorphic Disorder Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS)
timeFrame: Mid-treatment (week 6)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sabine Wilhelm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00665509: Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 08/09 Season.
Official title: Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Season 2008/2009. An Open-Label, Baseline-Controlled Multi-Center Study in Two Groups: Adult Subjects and Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Vaccine
CHMP criteria
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-04-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of healthy subjects: subjects aged \>= 18 and \<= 60 years and subjects \>= 61 years of age (elderly).


Eligibility criteria: Inclusion Criteria:

* Willing and able to give informed consent and able to adhere to all protocol required study procedures.
* Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination.
* Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria:

* Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
* A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
* Having received vaccination against influenza within the previous six months before study vaccination or planned vaccination during the study period.
* A history of Guillain-Barré syndrome or active neurological disease.

Primary outcomes:
measure: Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Influvac® 2008/2009
timeFrame: 2 and 3 weeks
Secondary outcomes:
measure: HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP)
timeFrame: 2 and 3 weeks
Other outcomes:
Locations:
city: Tessenderlo
country: Belgium
facility: Site 1
city: Hamburg
country: Germany
facility: Site 2
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT01234909: Asthma, Missed Immunizations, and Vitamin D Deficiency in Atopic Dermatitis
Official title: The Atopic Dermatitis Clinic as an Entry Point for Community Outreach in Asthma, Missed Immunizations, and Vitamin D Deficiency
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atopic Dermatitis
Vitamin D Deficiency
Asthma
Keywords: Missed immunizations
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Children's Hospital and Health System Foundation, Wisconsin
First posted: 2010-11-04
Enrollment: 98
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children's Hospital of Wisconsin Pediatric Dermatology clinic

Brief summary: Atopic dermatitis is a chronic skin disease with pruritus as one of its main features. Because of the symptomatic nature of their condition, pediatric patients with atopic dermatitis may preferentially seek care in the subspecialty dermatology clinic while falling behind in visits to their primary care provider. This cross-sectional study in patients attending the Dermatology Clinic at Children's Hospital of Wisconsin will screen for common conditions associated with atopic dermatitis and subsequently treat or refer patients for appropriate care. The investigators hypothesize that Milwaukee County pediatric patients with atopic dermatitis will have a high prevalence of asthma needing treatment, missed immunizations requiring catch-up, and vitamin D deficiency necessitating replacement therapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with atopic dermatitis by a Children's Hospital of Wisconsin (CHW) pediatric dermatologist
* Age 1- 18 years old
* Primary residence in Milwaukee County

Exclusion Criteria:

* Other chronic, systemic diseases other than asthma or environmental allergies
* Hyperimmunoglobulin E or Job syndrome
* Ichthyosis disorder other than ichthyosis vulgaris
* Prior systemic therapy or phototherapy for atopic dermatitis
* Ongoing or prior treatment for known Vitamin D deficiency
* On chronic systemic corticosteroids for asthma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Children's Hospital and Health System Foundation, Wisconsin
name: Yvonne Chiu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06398509: A Primary Care Based Intervention to Prevent Childhood Obesity Among Low-income Latino Children
Official title: Futuros Fuertes 2.0 A Primary Care Based Intervention to Prevent Obesity Among Low-income Latino Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-05-03
Enrollment: 576
Sex: ALL
Minimum age (years): 7
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to evaluate the impact of a primary care based intervention to promote optimal feeding, screen time and sleep practices among low-income Latino infants and toddlers. Infants and caregivers will receive brief health education and coaching sessions from health educators at primary care visits in the first two years of life as well as two text messages per week with health information and tips. Half of the participants will receive the Futuros Fuertes 2.0 intervention that includes health coaching and education on infant feeding, screen time and sleep (intervention group). The other half will receive health coaching and education on safety, home management of childhood illnesses, and promotion of language development (control group). We will look at the impact of the Futuros Fuertes 2.0 intervention on child BMI and various health behaviors.


Eligibility criteria: Inclusion Criteria:

* Parent/caregiver self identifies as Latino
* Parent/caregiver speaks Spanish or English
* Parent/caregiver intends to receive primary care for infant at participating clinic
* Infant gestational age of 37 weeks or greater
* Infant birthweight of 2600 grams or greater
* For multiples (twins, triplets), one sibling will be chosen at random to participate

Exclusion Criteria:

-Infant has a serious medical condition that affects feeding or growth

Primary outcomes:
measure: BMI Z-score
timeFrame: 24-months
Secondary outcomes:
measure: Breastfeeding
timeFrame: First year of life
measure: Screen time
timeFrame: 24-months
measure: Sleep duration
timeFrame: 24-months
measure: Fruit and vegetable intake
timeFrame: 24-months
measure: Sugar sweetened beverage and 100% fruit juice intake
timeFrame: 24-months
measure: Change in BMI Z-score
timeFrame: 6-months to 24-months
Other outcomes:
measure: Screen time
timeFrame: 6-months, 12-months and 18-months
measure: Sleep duration
timeFrame: 6-months, 12-months, 18-months
measure: Sugar-sweetened beverages and 100% fruit juice
timeFrame: 6-months, 12-months, 18-months
Locations:
city: San Francisco
country: United States
facility: Children's Health Center San Francisco General Hospital
state: California
city: Sunnyvale
country: United States
facility: Valley Health Center Sunnyvale
state: California
Study officials:
affiliation: University of California, San Francisco
name: Amy Beck, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004409: Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dupuytren's Contracture
Keywords: Dupuytren's disease
arthritis & connective tissue diseases
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 1999-10-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

Evaluate the safety and efficacy of collagenase in improving flexion deformity, range of motion, and grip strength in patients with residual Dupuytren's disease.

Detailed description: PROTOCOL OUTLINE: This is a randomized, investigator-blinded, placebo-controlled study.

Patients receive a single dose of either collagenase or placebo into the target finger on day 0. Patients who do not respond at the 1 month follow up visit may receive an injection of open label collagenase, if IgE antibody levels are no greater than 15 ng/mL.

Following treatment, patients use a nighttime extension splint for 4 months and perform finger flexion/extension exercises. Patients are followed at 1, 7, and 14 days, and at 1, 2, 3, 6, 9, and 12 months, for each joint treated.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Diagnosis of residual Dupuytren's disease with fixed flexion deformity of the fingers of at least 20-30 degrees caused by a palpable cord Positive table top test (inability to simultaneously place affected finger and palm flat against a table top) --Prior/Concurrent Therapy-- Surgery: At least 30 days since surgery for Dupuytren's disease Other: At least 30 days since prior investigational drug --Patient Characteristics-- Hematopoietic: No history of hematologic disease Hepatic: No history of hepatic disease Renal: No history of renal disease Cardiovascular: No congestive heart failure within 6 months No angina within 6 months No myocardial infarction within 6 months Pulmonary: No history of respiratory disease Other: HIV negative Not immunocompromised No history of significant illness, e.g., endocrine or neurologic disease No history of illicit drug abuse or alcoholism within 1 year No psychosis At least 2 weeks since infectious illness No chronic or debilitating disease No IgE antibodies to collagenase greater than 15 ng/mL No known allergy to collagenase or any of the inactive ingredients in the injection Not pregnant or nursing Fertile patients must use effective contraception

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Hospital
state: California
city: Stony Brook
country: United States
facility: State University of New York Health Sciences Center - Stony Brook
state: New York
Study officials:
affiliation: State University of New York
name: Lawrence C. Hurst
role: STUDY_CHAIR
References:
Clinical trial NCT06654609: Innovation of Custom-made Silicon Insoles for Diabetic Patient
Official title: Innovation of Custom-made Silicon Insoles for Diabetic Patient
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetic Foot
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 4
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: "Diabetic foot ulcers, caused by diabetes-related nerve and blood vessel damage, can lead to amputations. Silicone insoles help prevent ulcers but are often expensive. Affordable, customized insoles are available, making prevention more accessible.

Detailed description: This research aims to create affordable, locally manufactured silicone insoles for diabetic foot ulcers, reducing costs and improving accessibility. six-month study at the Pakistan.

Eligibility criteria: Inclusion Criteria:

* Adults aged patients,
* Both genders will be included
* Diagnosed with diabetic ulcers/diabetes
* Reporting pain and mild ulcers on foot,

Exclusion Criteria:

* Recent history of foot injuries
* Presence of other musculoskeletal conditions affecting the foot
* Inflammatory conditions such as rheumatoid arthritis or gout
* Neurological conditions affecting foot or leg functions

Primary outcomes:
measure: The American Orthopedic - AO
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Pakistan Rehablitation center Peshawar
Study officials:
References:
Clinical trial NCT05998109: PheCheck Feasibility Study
Official title: PheCheck Feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Phenylketonurias
Lead sponsor: Lumos Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: Aptatek Biosciences
First posted: 2023-08-18
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥ 10 years who are undergoing monitoring for Phenylketonuria (PKU)

Brief summary: The goal of this feasibility study clinical trial is to compare the accuracy of PheCheck™ for the rapid quantitative detection of phenylalanine (Phe) with the gold standard (HPLC amino acid analyzer), in patients with PKU.

The main aims are:

* Evaluate the accuracy of PheCheck as compared to the gold standard
* Evaluate ease of use by lay participants

Detailed description: The primary objective of this feasibility study is to evaluate the accuracy of the analyte concentration of PheCheck™ for the rapid, quantitative detection of phenylalanine (Phe) from capillary blood compared to the gold standard (HPLC amino acid analyzer) which quantitatively measures Phe in venous blood.

The study will enroll subjects into one study cohort. It will include patients 10 years or older, monitored for Phenylketonuria (PKU), hyperphenylalaninemia or PKU during pregnancy.

Eligibility criteria: Inclusion Criteria:

* 10 years of age or older
* Being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy Signed informed consent

Exclusion Criteria:

* Younger than 10 years of age
* Not being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy
* Lack of signed informed consent
* Previous enrollment in the study and has completed study visit 1 and 2

Primary outcomes:
measure: Concentration of phenylalanine (Phe) from PheCheck as compared to HPLC amino acid analyzer
timeFrame: 6-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00067509: Emergency Contraception (ECP): Reducing Unintended Pregnancies
Official title: A Second Chance With Emergency Contraception (ECP): Reducing Unintended Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Pregnancy
Keywords: Female
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2003-08-25
Enrollment: 1100
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Emergency contraception is a method of birth control that can be used up to three days after sexual intercourse. Emergency contraceptive pills (ECPs) can be given to a woman before she needs them (advance provision) or when she needs them (emergency provision). This study will compare these two methods of providing ECPs.

Detailed description: ECPs can give women a "second chance" to prevent an unintended pregnancy that might arise because of lack or improper/defective use of contraceptives. By using ECP, a woman can reduce her risk of pregnancy by at least 75%; however, there is little information on what distribution patterns and other factors are most likely to encourage ECP use. This study will compare the use and cost of two ECP distribution patterns: advance provision and emergency provision. It will also identify environmental, situational, and behavioral factors associated with ECP acceptance and use.

Participants in this study will be recruited from four family planning clinics in the Philadelphia area and five family planning clinics in the Pittsburgh area. Participants from the Philadelphia clinics will be given ECPs as part of a regular clinic visit (advance provision); participants from the Pittsburgh clinics will be given ECPs on an emergency basis (emergent provision). Each participant will complete a short intake form and will be issued a pager. Participants will be paged every month over an 18-month period as a reminder to respond to a short automated telephone survey on ECP, contraceptives, and pregnancy status. Approximately half of the participants will be randomly selected to participate in in-depth interviews at study entry and Months 9 and 18. Clinic visit data will augment the surveys to verify use of the clinic and contraceptive method and to develop cost data.

Eligibility criteria: Inclusion Criteria

* Patient at a participating clinic

Exclusion Criteria

* Pregnant
* Medical or surgical procedure preventing pregnancy (e.g., tubal ligation, hysterectomy)
* Norplant or IUDs
* Desires to become pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Family Planning Council
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Family Health Council
state: Pennsylvania
Study officials:
name: Paul G Whittaker, D.Phil.
role: PRINCIPAL_INVESTIGATOR
References: