louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02377375: Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD): Improving Targeting Precision
Official title: Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD) in the Bed Nucleus of the Stria Terminalis (BNST): Improving Targeting Precision
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Deep Brain Stimulation
OCD
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: When comparing targeting precision between DBS in parkinsonian patients and OCD patients, an unexpected deviation from the planned targets was discovered in OCD patients (Nuttin et al., 2013). The objective of this trial is to investigate whether the use of a micro-electrode assisted technique improves targeting precision in DBS at the BNST.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD (300.3).
* Failure of documented trials of pharmacotherapy, following an appropriate treatment algorithm for OCD.
* Failure of documented trial of cognitive and behavioural therapy
* Duration of illness: min. 5 year
* Y-BOCS (Yale-Brown Obsessive Compulsive Scale) at least 30/40.
* Age: 20-65 year

Exclusion Criteria:

* DSM-IV diagnosis on axis 2 of severe personality disorder in cluster A or B, especially in the case of heightened risk for acting-out behavior.
* DSM-IV diagnosis on axis 3 of organic brain pathology or significant abnormalities on MRI.
* Present or past history of psychotic symptoms.
* Present substance abuse, or instable remission of substance abuses (i.e. no substance abuse during the last 12 months).
* Any disorder affecting cognitive functioning, other than motor tics and Gilles de la Tourette's Syndrome
* Mental retardation. A minimum threshold of cognitive skills is needed for adequate reporting on questionnaires and evaluation, and for technical handling of the instruments in a later faze.

Primary outcomes:
measure: Millimeter difference in position between planned and actual target
timeFrame: 4 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Bart Nuttin, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nuttin B, Gielen F, van Kuyck K, Wu H, Luyten L, Welkenhuysen M, Brionne TC, Gabriels L. Targeting bed nucleus of the stria terminalis for severe obsessive-compulsive disorder: more unexpected lead placement in obsessive-compulsive disorder than in surgery for movement disorders. World Neurosurg. 2013 Sep-Oct;80(3-4):S30.e11-6. doi: 10.1016/j.wneu.2012.12.029. Epub 2012 Dec 23.
Clinical trial NCT05316675: Impact of Isotretinoin in Different Doses on Quality of Life
Official title: Impact of Different Protocols of Systemic Isotretinoin in Acne Treatment on Quality of Life Among Egyptien Patients:Avalidity and Reliability Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Cardiff Acne Disability Index is a short five-item questionnaire derived from the longer Acne Disability Index.It is designed for use in teenagers and young adults with acne. It is self explanatory and can be simply handed to the patient who is asked to complete it without the need for detailed explanation( .Abdelrazik etal., 2021).

.

Detailed description: Lower doses of isotretinoin can be effective in terms of cost and decreasing systemic side effects. Therefore, other regimens may be used instead of daily conventional dose as alternate, pulse and low doses of oral isotretinoin in acne vulgaris( Agarwal et al., 2011).

To study the impact of different protocols of systemic isotretinoin in acne treatment on quality of life among egyptian patients using Cardiff Acne Disability Index (CADI) and dermatology life quality index (DLQI)questionnaires.

To assess validity and reliability of the translated Arabic version of CADI. To compare the clinical efficacy and tolerability of different protocols of systemic isotretinoin in acne treatment.

Eligibility criteria: Inclusion Criteria:

Patients with clinically diagnosed acne vulgaris older than 18 years of age

-

Exclusion Criteria:

Patients having personal or family history of hyperlipidemia. Pregnancy and lactation. Newly married female desiring to get pregnant or using temporary method of contraception.

Patients with a history suggestive of any psychic disturbance -

Primary outcomes:
measure: To study the impact of different protocols of systemic isotretinoin in acne treatment on quality of life among egyptian patients using Cardiff Acne Disability Index
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06261775: Effect of Minimally Processed Animal Protein on Biomarkers for Cognitive Decline
Official title: Effect of Minimally Processed Animal Protein on Biomarkers for Cognitive Decline
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Lifestyle
Lead sponsor: South Dakota State University
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Minimally processed animal protein is a premier source of essential macro and micronutrients in the diet and is important, especially to older adults who are at increased risk of nutritional deficiency and age-related physiological changes. Our central hypothesis is that adding lean animal protein within a healthy diet following macronutrient recommendations for Americans will enhance nutrient adequacy and attenuate markers of cognitive decline. This is a retrospective study leveraging samples collected from the feeding trial NCT05581953. PI for both studies are the same.


Eligibility criteria: Inclusion Criteria:

* Generally, good health status based on one routine physical in the past 15 months, current health status
* Normal HbA1C, weigh 110 lb or more
* Age 65 years or more, generally healthy, all races and both sexes
* Generally practicing a meat-based dietary pattern, do not have any special dietary requirements, and
* Willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.

Exclusion Criteria:

* Medication usage, probiotic, long-term antibiotic, and tobacco/drug/alcohol use
* Not on any special diet within 3 months of recruitment, and do not intend to lose weight
* Impaired kidney functions
* Active history of cancer, diabetes, heart, liver, and kidney diseases
* Major gastrointestinal disorders in the past 3 months
* History of heart attacks or stroke
* Unable to meet in-person visit requirements for dining, picking up meals, and tests
* Any mental health condition affecting the ability to provide written informed consent
* If they had not had a routine health checkup 12 months before recruitment.
* If they were unwilling to abstain from taking nutritional supplements, alcohol, non-study foods, and beverages during the study period.

Primary outcomes:
measure: Concentration of phosphatidylcholine in blood
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Brookings
country: United States
facility: South Dakota State University, Wagner Hall 416
state: South Dakota
Study officials:
affiliation: South Dakota State University
name: Moul Dey, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01109875: Screening for Fabry Disease Among Young Stroke Patients in an Israeli Stroke Clinic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fabry Disease in the Young Stroke
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-04-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the incidence of Fabry Disease in young stroke patients in an Israeli stroke clinic.


Eligibility criteria: Inclusion Criteria:

diagnosis of stoke or TIA Time period within last 5 years -

Exclusion Criteria:

Known diagnosis of stroke or index event due to trauma

-

Primary outcomes:
measure: positive screening of fabry disease
timeFrame: past 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Neurology Dept. Edith Wolfson Medical Center
Study officials:
References:
Clinical trial NCT05243875: Lupus Education Alliance Program
Official title: Lupus Education Alliance Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Systemic Lupus Erythematosus
COVID-19
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: Ochsner Health System
name: Louisiana State University Health Sciences Center in New Orleans
First posted: 2022-02-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm study in which participants are randomized to an experimental (navigator) or comparison (education only) group.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the evaluate the effect of education-only vs. navigation interventions on COVID-19 testing and vaccination for people with systemic lupus erythematosus.


Eligibility criteria: Inclusion Criteria:

* Living with systemic lupus erythematosus (SLE),
* At least 18 years of age,
* Ability to speak and understand English, and
* Live, work, or seek care in Alabama or Louisiana

Primary outcomes:
measure: Incidence of COVID testing
timeFrame: 2 months
measure: Incidence of COVID-19 Vaccination
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
Study officials:
References:
Clinical trial NCT04147975: Assessment of Assay for Rapid Identification of Bloodstream Infections From Whole Blood
Official title: Assessment of Assay for Rapid Identification of Bloodstream Infections From Whole Blood
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bacteremia
Candidemia
Lead sponsor: HelixBind, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-01
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who are culture positive for bacterial or fungal bloodstream infection.

Brief summary: The purpose of this study is to assess the effectiveness of RaPID/BSI by testing its performance compared to blood cultures collected prospectively from consented subjects.


Eligibility criteria: Inclusion Criteria:

* Determined to have a positive blood culture.

Exclusion Criteria:

-

Primary outcomes:
measure: Sensitivity and Specificity compared to Blood Culture (comparator method)
timeFrame: Up to 24 hours following blood collection
Secondary outcomes:
Other outcomes:
Locations:
city: Marlborough
country: United States
facility: HelixBind Inc.
state: Massachusetts
Study officials:
References:
Clinical trial NCT00741975: Affect Management Intervention for Early Adolescents Wtih Mental Health Problems
Official title: Affect Management Intervention for Early Adolescents With Mental Health Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV prevention
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2008-08-27
Enrollment: 138
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Adolescents are at risk for HIV because of sexual and drug use behavior initiated during early adolescence, and those with mental health problems appear to be particularly susceptible. Problems with managing emotions may make it difficult for early adolescents to make good decisions about sexual and substance use behaviors. This project will develop and evaluate interventions for early adolescents with mental health issues. An intervention focused on teaching affect management skills will be compared to an intervention addressing a variety of health topics to determine which intervention best reduces risk behavior among this at-risk population.


Eligibility criteria: Inclusion Criteria:

* Seventh graders identified by counselors at participating public school

Exclusion Criteria:

* Adolescent is HIV positive
* Adolescent is developmentally delayed
* Adolescent in pregnant
* Adolescent has a history of sexual crime

Primary outcomes:
measure: Adolescent-reported sexual activity
timeFrame: 1 year
Secondary outcomes:
measure: Adolescent-reported condom use
timeFrame: 1 year
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Christopher D Houck, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07019675: A Study of SKB518 in Patients With Lung Cancer
Official title: A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of SKB518 in Patients With Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Lung Carcinoma
Lead sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB518 in patients with lung cancer. Eligible subjects will receive SKB518 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 75 years old at the time of signing the informed consent form, applicable to both males and females.
2. Non-small cell lung cancer (NSCLC) or small cell lung cancer(SCLC) confirmed by histology or cytology, who have failed first-line standard therapy.
3. At least one measurable tumor lesion per RECIST v1.1.
4. Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
5. Expected survival period ≥ 12 weeks.
6. The function of important organs meets the requirements of the protocol.

Exclusion Criteria:

1. Symptomatic or uncontrolled cardiovascular disease
2. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD;
3. Subjects with the disease that requires systemic corticosteroid therapy (prednisolone or equivalent dose of similar drugs at a dose of \>10 mg/d) or other immunosuppressive therapy within 14 days before the first dose.
4. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
5. The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.

Primary outcomes:
measure: AE
timeFrame: Up to 24 months
measure: ORR
timeFrame: Up to 24 months
Secondary outcomes:
measure: PFS
timeFrame: Up to 24 months
measure: DOR
timeFrame: Up to 24 months
measure: OS
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science
Study officials:
References:
Clinical trial NCT00123175: Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)
Official title: Levonorgestrel Containing Intrauterine Device in the Treatment of Endometrial Hyperplasia Without Atypia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Endometrial Hyperplasia
Keywords: Endometrial Hyperplasia without atypia
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Center for Research on Women and Newborn Health
First posted: 2005-07-22
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to determine the effectiveness of the intrauterine device (IUD) called Mirena when compared to the Provera tablets used in treating this condition.

Detailed description: Endometrial hyperplasia without atypia is a condition usually caused by excessive stimulation of the uterine lining (endometrium) by estrogens, and may cause irregular bleeding as a presenting symptom, but rarely may progress to endometrial cancer, which makes treatment important. The only treatment approved so far is medroxyprogesterone acetate tablets (progesterone), also known as Provera.

Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis of simple or complex endometrial hyperplasia without atypia
* Normal pap smear within one year

Exclusion Criteria:

* Diabetes
* Family history of endometrial cancer
* Contraindications for the intrauterine device

Primary outcomes:
measure: Pathologic examination of the specimens obtained by endometrial biopsy to determine the regression of endometrial hyperplasia without atypia compared to Provera
timeFrame: 90 days
Secondary outcomes:
measure: Side effects
timeFrame: 90 days
measure: Bleeding profile
timeFrame: 90 days
measure: Estradiol and progesterone levels
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Penn State University College of Medicine
name: Richard Legro, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02569775: Outcomes of Stem Cells for Cerebral Palsy
Official title: Outcomes of Autologous Bone Marrow Mononuclear Cells for Cerebral Palsy: A Self-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Stem Cells
Lead sponsor: Vinmec Healthcare System
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in patients with cerebral palsy.

Detailed description: The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in 40 patients with cerebral palsy at Vinmec International Hospital, Hanoi, Vietnam.

Eligibility criteria: Inclusion Criteria:

* Cerebral palsy of any types caused by oxygen deprivation.

Exclusion Criteria:

* Epilepsy
* Hydrocephalus with ventricular drain
* Coagulation disorders
* Allergy to anesthetic agents
* Severe health conditions such as cancer, failure of heart, lung, liver or kidney
* Active infections

Primary outcomes:
measure: Change in Total Score of Gross Motor Function Measure (GMFM)-88
timeFrame: 3 months and 6 months after transplantation
measure: Change in Gross Motor Function Measure (GMFM)-66 Percentile
timeFrame: 3 months and 6 months after transplantation
Secondary outcomes:
measure: Change in Muscle tone
timeFrame: 3 months and 6 months after transplantation
measure: Number of adverse events
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vinmec International Hospital
Study officials:
affiliation: Vinmec Healthcare System
name: Liem T Nguyen, MD., PhD.
role: STUDY_CHAIR
References:
citation: Sharma A, Sane H, Gokulchandran N, Kulkarni P, Gandhi S, Sundaram J, Paranjape A, Shetty A, Bhagwanani K, Biju H, Badhe P. A clinical study of autologous bone marrow mononuclear cells for cerebral palsy patients: a new frontier. Stem Cells Int. 2015;2015:905874. doi: 10.1155/2015/905874. Epub 2015 Feb 18.
citation: Nguyen LT, Nguyen AT, Vu CD, Ngo DV, Bui AV. Outcomes of autologous bone marrow mononuclear cells for cerebral palsy: an open label uncontrolled clinical trial. BMC Pediatr. 2017 Apr 12;17(1):104. doi: 10.1186/s12887-017-0859-z.
Clinical trial NCT04777175: A Retrospective Study: Evaluation of the Efficacy of Immunotherapy With Rare Mutations in Non-small Cell Lung Cancer
Official title: A Retrospective Study: Evaluation of the Efficacy of Immunotherapy With Rare Mutations in Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
Collaborators: name: Hunan Province Tumor Hospital
First posted: 2021-03-02
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced non-small-cell lung cancer carrying KRAS, ALK, ERBB2, MET, RET, BRAF mutation.

Brief summary: In advanced non-small cell lung cancer, there will be some rare mutations, such as ALK, KRAS, etc. The efficacy of these immunotherapies on these different rare mutations has not been reported. Therefore, we conducted this retrospective clinical study to explore the efficacy of immunotherapy for different rare mutations.


Eligibility criteria: Inclusion Criteria:

* 1.Diagnosed as advanced non-small cell lung cancer
* 2.Confirmed as KARS, ALK, ERBB2, MET, RET, BRAF mutation

Exclusion Criteria:

* The patient is diagnosed with small cell lung cancer

Primary outcomes:
measure: PFS
timeFrame: January 2021- January 2021 (1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer hospital
state: Hunan
Study officials:
References: