louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01327586: Abstinence-Linked Money Management Multisite
Official title: Abstinence-Linked Money Management Multisite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dual Diagnosis
Cocaine Abuse
Cocaine Dependence
Polysubstance Abuse
Keywords: disability
substance abuse
cocaine abuse
dual diagnosis
representative payee
HIV risk reduction
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-04-01
Enrollment: 108
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: Randomized clinical trial comparing a money management-based intervention involving storage and management of client funds, substance abuse counseling, and risk reduction counseling to individualized drug counseling.


Eligibility criteria: Inclusion Criteria:

* Enrolled in ambulatory psychiatric treatment at one of the participating clinics
* Receives SSI or SSDI payments
* Able to provide written informed consent
* Cocaine use within the last 60 days as evidenced by either a positive toxicology screen or self-reports

Exclusion Criteria:

* Has a conservator of person
* A history of violence towards clinical providers or predatory violence
* Suicidal plans or intent; homicidal plans or intent. Suicidal or homicidal ideation will not be exclusion criteria
* Physiological dependence on alcohol, illicit opiates or illicit sedatives as evidenced by a history of four weeks of daily use of these substances; and either tolerance or withdrawal (as defined by DSM IV-TR). The "standard withdrawal scales" referred to in DSM IV-TR will be the CIWA-AR (Sullivan et al., 1989) and the Clinical Opiate Withdrawal Scale (Wesson and Ling, 2003), with P.I. review because signs on the CIWA-AR such as "aware of sounds around you" may reflect psychiatric illness, not withdrawal
* Will not be able to complete the twelve months of the study because of anticipated incarceration or move
* Had been enrolled in the ongoing study
* Unable to speak and understand English

Primary outcomes:
measure: Proportion of Urine toxicology tests without cocaine
timeFrame: Month 0,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Secondary outcomes:
measure: Unprotected sexual encounters
timeFrame: Month 0, 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: Greater Bridgeport Mental Health Center
state: Connecticut
city: Hartford
country: United States
facility: Capitol Region Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Marc I Rosen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03645486: Lentiviral Gene Therapy for CGD
Official title: Lentiviral Gene Therapy for Chronic Granulomatous Disease (CGD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Granulomatous Disease
Keywords: Chronic granulomatous disease
Lentiviral vector
Lead sponsor: Shenzhen Geno-Immune Medical Institute
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase I/II clinical trial of gene therapy for treating Chronic Granulomatous Disease using a high-safety, high-efficiency, self-inactivating lentiviral vector TYF to functionally correct the defective gene. The objectives are to evaluate the safety and efficacy of the TYF-CGD gene transfer clinical protocol.

Detailed description: Chronic granulomatous disease (CGD) is a rare disorder caused by inherited defects in the NADPH oxidase multienzyme complex. It is associated with severe and life-threatening bacterial and fungal infections. Approximately two-thirds of all CGD cases result from mutations within the X-linked gp91phox gene (CYBB), followed by the autosomal recessive forms of CGD, with defects in the gene coding for p47phox (NCF1) accounting for 10-30% of all CGD cases.

The primary objectives are to evaluate the safety of the advanced self-inactivating lentiviral vector TYF-CYBB and TYF-NCF1, the ex-vivo gene transfer clinical protocol and the efficacy of immune reconstitution in patients overcoming frequent infections present at the time of treatment, assessment of vector integration sites, and finally the long-term correction of immune dysfunctions.

Eligibility criteria: Inclusion Criteria:

1. CGD patients \>= 0 years of age
2. Molecular diagnosis confirmed by DNA sequencing and supported by laboratory evidence for absent or significantly reduced biochemical activities of the NADPH-oxidase
3. Karnofsky-Index \> =70%
4. At least one prior, ongoing or refractory severe infection and/or inflammatory complications requiring hospitalization despite drug intervention
5. Written informed consent for adult patient, and assent for pediatric subjects seven years or older

Exclusion Criteria:

1. Contraindication for leukapheresis (anaemia Hb \<8g/dl, cardiovascular instability, severe coagulopathy) or for administration of conditioning medication
2. Female patients who are pregnant or lactating as determined by history and/or positive pregnancy test

Primary outcomes:
measure: Overall survival
timeFrame: 15 year follow up
measure: Gene marking in bone marrow cells
timeFrame: 15 year follow up
Secondary outcomes:
measure: Change in infection frequency
timeFrame: 1 year after treatment by clinical history, complete physical examination, haematological and microbiological tests
measure: Recovery of immune function
timeFrame: 1 year follow up
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Geno-immune Medical Institute
state: Guangdong
Study officials:
References:
Clinical trial NCT01310686: Genetics Study of Wet Age-Related Macular Degeneration (AMD) Non-Responders to Vascular Endothelial Growth Factor (VEGF) Therapy
Official title: Genotypic Evaluation of Chronic Exudative Macular Degeneration Despite Monthly Anti-Vascular Endothelial Growth Factor (VEGF) Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wet AMD
Keywords: wet AMD anti-VEGF
Genetic analysis of patients with Wet AMD who have not responded fully to anti-VEGF treatments
Lead sponsor: West Coast Retina Medical Group, Inc.
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2011-03-08
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Wet Age-Related Macular Degeneration

Brief summary: To obtain a genotypic analysis of patients with chronic exudative age-related macular degeneration noted to have subretinal or intraretinal edema despite continuous monthly Anti-VEGF therapy.


Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent for participation in this study
* Subjects diagnoses of neovascular AMD who are on a monthly anti-VEGF regimen (have had \>10 or more ranibizumab and/or bevacizumab injections within the last year) and who still have intra-retinal or subretinal fluid as confirmed by the Investigator

Exclusion Criteria:

* Subjects with a Pigment Epithelial Detachment Exclusively
* Subjects with Serous Pigment Epithelial Detachments
* Subjects with history of the following:

idiopathic polypoidal choroidal vasculopathy

* pathologic degenerative myopia
* central serous chorioretinopathy
* familial drusen
* adult onset foveal pattern dystrophy

Primary outcomes:
measure: Genetic analysis of patients with chronic wet age-related macular degeneration despite continuous anti-VEGF treatment
timeFrame: This is a one time only blood draw.
Secondary outcomes:
measure: To evaluate demographic and clinical characteristics in patients treated with anti-VEGF therapy who fail to respond completely.
timeFrame: This is a one time only blood draw and assessment of clinical characteristics.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: West Coast Retina Medical Group, Inc.
state: California
Study officials:
References:
Clinical trial NCT01310465: The Effect of Zoledronic Acid to Bone Fusion and Bone Metabolism of Patients With Lumbar Degenerative Disease After Lumbar Interbody Fusion
Official title: The Effect of Zoledronic Acid to Bone Fusion and Bone Metabolism of Patients With Lumbar Degenerative Disease After Lumbar Interbody Fusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Image Changes of Lumbar Fusion
Bone Turnover Markers
Bone Mineral Density
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2011-03-08
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many patients who have lumbar degenerative disease suffer from osteoporosis or reduced bone mass or low bone mineral density. Among patients with lumbar degenerative disease, some need fusion surgery. But conditions of osteoporosis or low bone mineral density slow down the rate of bone fusion, reduce the success of bone fusion, and ultimately affect the overall effectiveness of surgery. Zoledronic acid is an effective anti-osteoporotic. Many researchers dispute if zoledronic acid can promote the healing of long bone fractures. But few researchers focus on the effect of zoledronic acid to lumbar fusion. In this study, we select patients with lumbar degenerative disease who have had lumbar interbody fusion surgery. Three days postoperatively, the patients were randomized to either one infusion of zoledronic acid or sodium chloride intravenously. We follow all these patients for 6 months. During this time, we detect bone metabolism and bone fusion of these patients. At last, we can tell if zoledronic acid can modify bone metabolism and promote bone fusion.


Eligibility criteria: Inclusion Criteria:

* Patients with lumbar degenerative disease who have had lumbar interbody fusion surgery
* Age 50-70 years old
* Willing to sign informed consent

Exclusion Criteria:

* Application of strontium ranelate, sodium fluoride or parathyroid hormone
* Application of bisphosphonates more than 8 weeks during 2 years preoperatively
* Suffering from bone fracture during 3 months preoperatively
* Urinary creatinine clearance rate less than 35mL/min
* Serum calcium concentrations greater than 2.75mmol/L or less than 2.00mmol/L
* Pregnancy or breast-feeding women
* Suffering from cancer or other diseases that may be expected to live less than a year

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital of Fudan university
state: Shanghai
Study officials:
References:
citation: Colon-Emeric C, Nordsletten L, Olson S, Major N, Boonen S, Haentjens P, Mesenbrink P, Magaziner J, Adachi J, Lyles KW, Hyldstrup L, Bucci-Rechtweg C, Recknor C; HORIZON Recurrent Fracture Trial. Association between timing of zoledronic acid infusion and hip fracture healing. Osteoporos Int. 2011 Aug;22(8):2329-36. doi: 10.1007/s00198-010-1473-1. Epub 2010 Dec 9.
Clinical trial NCT06944366: Comparing Exposure v Imagery Rescripting in People With OCD: a SCED
Official title: Comparing Exposure v Imagery Rescripting in People With Obsessive Compulsive Disorder (OCD): a Single Case Experimental Design (SCED)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder (OCD)
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 10
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: Individuals with OCD may experience intrusive future orientated thoughts and images, which are extremely distressing and interfering in life. This project aims to explore whether imagery rescripting or exposure may be a more effective intervention for individuals with OCD experiencing such images.


Eligibility criteria: Inclusion Criteria:

* 18 years or over
* Main diagnosis of OCD (assessed by the Structured Clinical Interview for ICD11)
* Must report future orientated images that are distressing and ego-dystonic

Exclusion Criteria:

* Psychosis, bipolar disorder, or trauma disorder
* Current stimulant or hallucinogenic misuse, alcohol or substance misuse or dependence
* Intellectual disability, dementia, serious cognitive impairment, or organic brain disorder
* Personality Disorder as the main problem
* Active suicidality
* Concurrent engagement in other psychotherapy
* A patient may be taking anti-depressant medication so long as the dose has been stable for 6 weeks and there is no plan to increase the dose.

Primary outcomes:
measure: Obsessive Compulsive Inventory (OCI).
timeFrame: From the start of treatment until the end of treatment at 12 weeks.
measure: Yale-Brown Obsessive-Compulsive scale (Y-BOCS).
timeFrame: From the start of treatment until the end of treatment at 12 weeks.
measure: The Impact of Future Events Scale (IFES).
timeFrame: From the start of treatment until the end of treatment at 12 weeks.
measure: The Florida Obsessive Compulsive Inventory (FOCI).
timeFrame: From the start of treatment until the end of treatment at 12 weeks.
measure: Visual Analogue Scales (VAS).
timeFrame: From the start of treatment until the end of treatment at 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Centre for Anxiety Disorders and Trauma
Study officials:
References:
Clinical trial NCT05459766: Effects of a Perioperative Action Observation and Motor Imagery Training in Patients Undergoing Total Knee Arthroplasty
Official title: Effects of a Perioperative Action Observation and Motor Imagery Training in Patients Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Knee Arthoplasty
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is aimed at investigating the effects of action observation and motor imagery training in patients undergoing total knee arthroplasty. Fifty participants will be enrolled during hospital admission and randomized into 2 groups (AO+MI and CTRL groups). AO+MI will undergo 12-minute AO+MI intervention for 3 days (preoperative day, first and second postoperartive days), whereas CTRL group will undergo usual care. At baseline, first and third postoperative days, participants will be assessed for mobility, pain, range of motion, quadriceps acrivation failure and patient's bady-pain representation by a blinded operator.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for total knee arthroplasty
* age greater or equal to 18 years old
* ability to walk independently.

Exclusion Criteria:

* previous total knee arthoplasty on the contralateral side
* revision surgery
* dementia
* musculoskeletal and neurological disorders influencing functional recovery
* visual or auditory deficits.
* postoperative complications
* weight bearing restrictions
* lack of walking independency within the second postoperative day.

Primary outcomes:
measure: Changes in functional mobility
timeFrame: At baseline, at 1 day and 3 days after surgery
Secondary outcomes:
measure: Changes in active and passive knee range of motion
timeFrame: At baseline, at 1 day and 3 days after surgery
measure: Changes in perceived pain
timeFrame: At baseline and 3 days after surgery
measure: Changes in body pain representation at the level of the knee joint
timeFrame: At baseline and 3 days after surgery
measure: Changes in quadriceps activation failure
timeFrame: At baseline, at 1 day and 3 days after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03816566: Validation of a Wearable Non-invasive Device (the Patch)
Official title: Validation of a Wearable Non-invasive Device (the Patch) to Aid in Diagnosing Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea
Lead sponsor: BresoTEC Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: BresoTEC has designed and developed a standalone wearable device (the patch), that can record tracheal sounds with a microphone attached just above the suprasternal notch of the subject.

Detailed description: The patch also has a 3-dimensional accelerometer to record body position. Furthermore, the patch records oxygen saturation using an FDA cleared pulse oximeter, Nonin 3150 WristOx2® with Bluetooth Low Energy. We have developed advanced signal processing algorithms to detect apneas and hypopneas. Many of these techniques for analyzing breathing sounds and detecting apneas and hypopneas have been published in peer-reviewed journals.

The goal of this study is to validate the patch against polysomnography (PSG) for use as an aid in the diagnosis of sleep apnea for adult patients. Our primary objective is to assess whether the estimated apnea-hypopnea index (AHI) calculated by the patch agrees with the results of an in-laboratory PSG.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria are men and women 18 years and above, who are referred to either the University Health Network (UHN), Toronto Rehabilitation Institute (TRI) or Toronto General Hospital sleep laboratories for overnight PSG because of a suspicion of a sleep disorder. It is intended for the general outpatient population.

Exclusion Criteria:

* Exclusion criteria are patients with suspected complicated co-morbidities including in-hospital patients and those who self-report diagnosis of heart failure, recent stroke, neuromuscular disorders, renal failure, obesity hypoventilation, COPD, or other severe lung diseases.

Primary outcomes:
measure: Estimation of AHI
timeFrame: 8 months
Secondary outcomes:
measure: Estimation of body position
timeFrame: 8 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Toronto General Hospital & Toronto Rehabilitation Institute
name: Clodagh Ryan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01966965: Efficacy and Safety Study for PIOLIN® Shampoo
Official title: Phase 3 Efficacy and Safety Study for PIOLIN® Shampoo to Treat Pediculosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: PEDICULOSIS
Keywords: PIOLIN®, PEDICULOSIS, EFFICACY, SAFETY, PHYTOMEDICINE,
ARRUDA, RUTA
Lead sponsor: Phytopharm Consulting Brazil
Sponsor class: NETWORK
Collaborators: name: Laboratório Saúde Ltda - principal e único patrocinador
First posted: 2013-10-22
Enrollment: 212
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to demonstrate the therapeutic efficacy and safety of Shampoo PIOLIN ® in the treatment of human pediculosis. Will be treated 212 patients aged 2-60 years with the infestation, along with the people in your family life. All will be submitted to the dosing regimen recommended in the package insert. 100% of the sample shall be subjected to clinical evaluation through comb, pre and post treatment and monitored after thirty days for evaluation of safety and possible adverse effects that may arise related to any of the components of the formula.

The efficacy study is active comparator, non-inferiority.


Eligibility criteria: Inclusion Criteria:

* Volunteers healthy female and male ;
* Children between 2 and 17 years ;
* Increased from 18 years;
* Availability of volunteer to maintain a stable weight during the study period (ranging from less than 2 kg) ;
* Displays lice infestation on clinical examination ;
* Voluntary participation ;
* Signing the consent form and / or Free and Informed Consent ;
* Willingness to comply with study procedures ;
* Complying that researchers can make use of all the information nameless , including publication and comply with the use and storage of all information confidential .

Exclusion Criteria:

* Use paint or other chemicals on the hair in the last four weeks that precede the study ;
* Concomitant Therapy ;
* Women who are pregnant or intend to become pregnant during the study ;
* Infants ;
* Volunteers not willing to sign and adhere to the Statement of Consent ;
* Known hypersensitivity to the product ;
* Participation in any other clinical study ;
* Any other condition that the investigator decides that might interfere with the results or involving a risk to the volunteer study

Primary outcomes:
measure: EFFICACY
timeFrame: 17 DAYS
Secondary outcomes:
measure: SAFETY
timeFrame: 30 DAYS
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Ubs Fatima
state: RS
Study officials:
affiliation: UCPEL-UNIVERSIDADE CATÓLICA DE PELOTAS
name: MONICA M MENDES, MD MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: INDEPENDENT
name: ACHILLES GENTILINI NETO, MD
role: STUDY_CHAIR
References: