louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02181777: Group Training for Social Skills in Psychosis
Official title: Exploring the Feasibility of Social Skills Training in People With Psychosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Keywords: Psychosis
Schizophrenia
Social Skills
Therapy
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: South London and Maudsley NHS Foundation Trust
First posted: 2014-07-04
Enrollment: 48
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 purpose of this study is to assess the feasibility of a social skills training group for people with psychosis.

Detailed description: This study is assessing the feasibility of a psychological intervention targeting social cognition problems in people with psychosis. The intervention is a group psychological treatment facilitated by a clinical psychologist. The group therapy takes advantage of audiovisual material and practical exercises to illustrate strategies and thinking styles that may help participants overcome difficulties in social settings.

A second objective of this study is to test a new method to measure social cognition by using portable devices. These devices will be carried by participants in their everyday life and will ask about their social activity levels at random times and record activity levels.

Eligibility criteria: Inclusion Criteria:

* Diagnosis part of the psychosis spectrum (according to DSM-IV or DSM-V or ICD-10)
* Good command of the English language
* Social engagement problems as evidenced by care coordinator report and number of hours spent in social activities per week lower than 10.

Exclusion Criteria:

* Primary diagnosis of substance abuse disorder
* Change in antipsychotic medication in the last six weeks
* Significant learning difficulties (premorbid IQ lower than 70)

Primary outcomes:
measure: Therapy drop-out rate
timeFrame: 8 weeks post randomisation
measure: Number of therapy session attended
timeFrame: 8 weeks post randomisation
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Kings College London
Study officials:
affiliation: Institute of Psychiatry
name: Matteo Cella, DClinPsy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Penn DL, Roberts DL, Combs D, Sterne A. Best practices: The development of the Social Cognition and Interaction Training program for schizophrenia spectrum disorders. Psychiatr Serv. 2007 Apr;58(4):449-51. doi: 10.1176/ps.2007.58.4.449.
Clinical trial NCT02176577: Study to Determine the Pharmacokinetics of Product 0405
Official title: An Open-Label, Multi-Center Study to Determine the Pharmacokinetics of Product 0405 in the Treatment of Atopic Dermatitis in Adolescent Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Fougera Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-27
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the Pharmacokinetics of Product 0405 in the Treatment of Atopic Dermatitis in Adolescent Subjects.

Detailed description: Treament medication will be administered topically twice daily for 28 days.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Atopic Dermatitis
* Good health with the exception of Atopic Dermatitis
* Percent body surface area minimums

Exclusion Criteria:

* Subject who are nursing, pregnant or planning a pregnancy

Primary outcomes:
measure: Phamacokinetic sampling
timeFrame: 28 days
Secondary outcomes:
measure: Laboratory tests, vital signs, adverse events and local skin safety signs
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Fougera Pharmaceuticals Inc.
name: Angela C Kaplan
role: STUDY_DIRECTOR
References:
Clinical trial NCT06886477: Sickle Cell, Pain and Mediterranean Diet
Official title: Exploring the Mediterranean Diet As a Promising Approach for Alleviating Chronic Pain in Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sickle Cell
Sickle Cell Disease
Sickle Cell Disease Without Crisis
Mediterranean Diet
Keywords: sickle cell
sickle cell disease
sickle cell pain
diet
Mediterranean diet
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 30
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 goal of this study is to compare pain levels in individuals with Sickle Cell Disease while following the Mediterranean Diet to pain levels while following their usual diet.

Detailed description: This is an exploratory, randomized, crossover-controlled feeding study of a 4-week Mediterranean Diet or usual diet control among 24 adults with sickle cell disease and chronic pain (30 will be recruited, with an estimated 24 participants completing the study).

Eligibility criteria: Inclusion Criteria:

* Sickle Cell Disease Diagnosis
* Chronic non-vaso-occlusive pain experienced on average ≥ 3 days per week for \> 6 months (based on a response of "Most days," "Every day," or "Some days" and not "Never" to the question "In the past 6 months, how often have you had pain?")
* Ability to speak, read, write, and understand English
* A Mediterranean Eating Pattern for Americans (MEPA-III) score \<13, indicating that they do not follow a Mediterranean diet.

Exclusion Criteria:

* Having taken systemic antimicrobials (to treat an infection in the previous 4 weeks)
* History of colon cancer or inflammatory bowel disease (given potential untoward effects on the gut microbiome)
* History of Clostridium difficile infection in the preceding 12 weeks; (4) unable to agree to maintain physical activity at the current level for the duration of the study
* Currently following a Mediterranean diet, vegan diet, or dietary restrictions (e.g., religious, food intolerance/allergy) that preclude adoption of a Mediterranean diet
* Lack of access to a space to safely store and reheat food items
* Living in a facility that provides meals.

Primary outcomes:
measure: Serum and Fecal Short Chain Fatty Acids
timeFrame: Baseline and day 27 or 28 of each diet
measure: Serum and Fecal Bile Acid Metabolites
timeFrame: Baseline and day 27 or 28 of each diet
Secondary outcomes:
measure: Gut Microbiota Composition
timeFrame: Baseline and day 27 or 28 of each diet
measure: Chronic Pain
timeFrame: Baseline and day 27 or 28 of each diet
measure: Diet adherence
timeFrame: Daily up to 4 weeks during the Mediterranean diet intervention
measure: Diet adherence
timeFrame: Daily up to 4 weeks during the Mediterranean diet intervention
measure: Diet adherence
timeFrame: Baseline and day 27 or 28 of each diet
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05108077: Treatment of Metastatic Tumors of the Urogenital Area With Cytokine-induced Killer Cells
Official title: Treatment of Metastatic Tumors of the Urogenital Area (Bladder Cancer, Renal Cancel) With Cytokine-induced Killer Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Bladder Cancer
Renal Cancer
Keywords: Bladder Cancer
Renal Cancer
CIK
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
Collaborators: name: Belarusian State Medical University
First posted: 2021-11-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of metastatic tumors of the urogenital area with cytokine-induced killer cells

Detailed description: Treatment of metastatic tumors of the urogenital area using autologous cytokine-induced killer cells

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of pTa metastatic tumors of the urogenital area;
* Patient who require repetitive transurethral resection;
* Expression of muc-1/wt-1 by the tumor;
* EGOC 0-3;

Exclusion Criteria:

* any medical condition which can be associated with the high risk for the patient;
* pregnancy/lactation;
* chronic infections, including hepatitis B/C, tuberculosis, HIV

Primary outcomes:
measure: The relapse-free survival
timeFrame: 1 year
measure: The relapse-free survival
timeFrame: 2 year
measure: The relapse-free survival
timeFrame: 3 year
measure: Adverse effects associated with the therapy
timeFrame: 1 month
measure: Adverse effects associated with the therapy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study officials:
affiliation: the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
name: Andrei Hancharou
role: STUDY_DIRECTOR
affiliation: Belarusian State Medical University
name: Alexander Prokhorov, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT02107677: Specificity Study of Diagnostic for Early Detection of Dengue Infection
Official title: Determination of Estimated Specificity of DENV Detect NS1 ELISAs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious Diseases
Lead sponsor: InBios International, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Human males and females of varying ages and geographical locations where dengue fever is non-endemic. We will use retrospective (archived) human serum samples, not collected specifically for this study and not individually identifiable to the Investigators. These samples will fall under the category of "leftover" specimens as described by FDA guidance. These archived samples will have been collected from patients within 7 days after onset of symptoms consistent with Dengue infection.

Brief summary: This study assesses the specificity of DENV Detect™ NS1 ELISA versus standard reference tests (e.g. PCR or viral culture) for dengue diagnosis in the US.

DENV Detect™ NS1 ELISA serves as an aid in the clinical laboratory diagnosis of early stages of Dengue infection in patients with clinical symptoms consistent with Dengue infection. This test is intended to be used on sera obtained within the first 7 days of symptoms. DENV Detect™ NS1 ELISA and rapid test results (positive or negative) must be confirmed by testing with a reference standard test.

This study will use archived, leftover human serum samples that have been sequentially collected from areas non-endemic for Dengue infection. Each specimen must have been collected within the first 7 days of symptoms, and must be accompanied by clinical data demonstrating that the individual had symptoms consistent with Dengue infection. The samples will have no personally identifiable information.

ELISAs and reference tests will be performed by different operators who are laboratory staff members. These staff members, blinded to each other's results, will evaluate the samples from each method independently.


Eligibility criteria: Inclusion Criteria:

* All age groups and both sexes.
* Serum samples collected within 1- 7 days of onset of symptoms consistent with Dengue virus infection.
* Information must be available about symptoms, age, and sex of patients from which samples are collected.

Exclusion Criteria:

* Any sample(s) with linked personal identifiers or any sample for which personal information can be discovered will be excluded.

Primary outcomes:
measure: number of subjects with negative result
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: State of Florida Dept. of Health Bureau of Laboratories Virology
state: Florida
Study officials:
References:
Clinical trial NCT00914277: SAR407899 Single-dose in Treatment of Mild to Moderate Erectile Dysfunction
Official title: Randomized, Double-blind, Placebo and Active Controlled Study of the Activity of SAR407899A Single-dose on the Ability to Increase Duration of Penile Rigidity, Under Experimental Condition, in Patients With Mild to Moderate Erectile Dysfunction (ED).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erectile Dysfunction
Keywords: Rho-kinase inhibitor
male impotence
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this clinical trial is to study the ability of SAR407899 to increase the duration of penile erection in male patients with mild-moderate Erectile Dysfunction.

The secondary objectives of this clinical trial are to study the ability of SAR407899 to shorten increase the time to erection duration of penile erection in male patients with mild-moderate Erectile Dysfunction and to determine the overall safety and tolerability of SAR407899 in these patients.


Eligibility criteria: Inclusion Criteria:

* male with mild to moderate erectile dysfunction for at least 6 months
* written informed consent

Exclusion Criteria:

* diabetes mellitus
* orthostatic hypotension
* hypogonadal testosterone level

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Duration of penile rigidity during sexual stimulation
timeFrame: 4 hours following drug administration
Secondary outcomes:
measure: Time to onset of penile rigidity
timeFrame: 4 hours following drug administration
measure: Blood pressure
timeFrame: 12 hours following drug administration
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: SGS Aster Life Science Services - Paris-France
name: Lionel HOVSEPIAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04140877: Choroidal Changes Post Short Term Exposure To Virtual Reality Devices
Official title: Choroidal Changes Post Short Term Exposure To Virtual Reality Devices
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Myopia
Keywords: Choroidal thickness
Virtual reality
Lead sponsor: Visu, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-28
Enrollment: 0
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, contralateral eye study
Primary purpose: PREVENTION

Brief summary: This is a prospective, randomized, controlled, contralateral eye, clinical study. The objective of the study is to determine the impact of Virtual Reality (VR) usage on choroidal thickness when viewed through a test display compared to a control (standard) VR display. The hypothesis is that there will be less choroidal thinning in the eye viewing the test VR screen compared to the eye viewing the control VR screen.


Eligibility criteria: Key Inclusion Criteria:

* Is at least 13 years of age and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Visual Acuity of +0.20 logMAR or better in each eye;
* Is willing and able to follow instructions and maintain the appointment schedule.

Key Exclusion Criteria:

* Is participating in any concurrent clinical or research study;
* Has any known active ocular disease and/or infection;
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
* Is amblyopic in either eye;
* Has a colour vision abnormality;
* Commonly experiences motion sickness.

Primary outcomes:
measure: Choroidal thickness
timeFrame: 2 hours
Secondary outcomes:
measure: Choroidal thickness
timeFrame: 3 months
measure: Axial length
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Centre for Ocular Research and Education
name: Lyndon Jones, PhD, FCOptom
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00379977: Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of Age
Official title: Open, Primary Vaccination Study to Assess Safety and Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Administered to Healthy Chinese Infants at 3, 4 and 5 Months of Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tetanus
Haemophilus Influenzae Type b
Acellular Pertussis
Diphtheria
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 90
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will evaluate the safety and reactogenicity of GSK Biologicals' Diphtheria Tetanus acellular Pertussis/Haemophilus influenzae type b vaccine given to Chinese infants at 3, 4 and 5 months of age.


Eligibility criteria: Inclusion Criteria:

* A male or female between, and including, 90 and 120 days of age at the time of the first vaccination Written informed consent obtained from the parent or guardian of the subject

Exclusion Criteria:

* subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate, subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b (Hib) diseases can not participate.

Primary outcomes:
measure: Occurrence of solicited symptoms during the 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events
Secondary outcomes:
Other outcomes:
Locations:
city: Nanning
country: China
facility: GSK Investigational Site
state: Guangxi
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03876977: Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia
Official title: Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Robotic Decompression
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary purpose:

Show the pain improvement 3-month after robotic laparoscopic pudendal nerve decompression for pudendal neuralgia.

Primary outcomes:

Pain evaluated on a VAS before surgery and 3-month after surgery or surveillance Improvement is considered if pain decreased by at least 3/10 points on the VAS.

Secondary purposes:

* improvement of quality of life
* study of MRI performance to predict pudendal nerve entrapment topography
* show the feasibility and safety of robotic pudendal nerve decompression


Eligibility criteria: Inclusion Criteria:

* Age 18 - 70 years old
* Pudendal neuralgia according to Nantes criteria
* pudendal nerve entrapment reachable with robotic transperitoneal approach

Exclusion Criteria:

* bilateral pain
* history of pain ≥ 18 months

Primary outcomes:
measure: Collection of the maximum pain intensity on a numerical scale (EN), calculated on 10 points. (0 no pain -10 extreme pain )
timeFrame: 3-months after surgery or surveillance
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'urologie
Study officials:
References:
Clinical trial NCT04619277: Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion
Official title: Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Drug-coated Balloon
Lead sponsor: Ulsan Medical Center
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: It is a international multicenter registry study conducted at 4 centers (Queen Elizabeth Hospital II, Peking Shougang Hospital, Ulsan Medical Center, and Ulsan University Hospital) expert in patients with de novo coronary lesion who received DCB treatment.

Brief summary: This study is the international multicenter registry for drug-coated balloon treatment for de novo coronary lesion.

Detailed description: There is lots of evidence that DCBs result in lower rates of restenosis, thrombosis, and better long-term outcomes when used for PCI of in-stent restenosis (ISR) compared to plain old balloon angioplasty (POBA) or additional stenting with drug-eluting stent (DES). DCB-only approach studies for de novo coronary lesion cases are scarce, but a recent registry data suggested it was a feasible and well-tolerated treatment method if the pre-dilation result is good. Therefore, the aim of this study was to evaluate the safety and efficacy in terms of angiographic and clinical outcomes of a DCB-only approach for de novo coronary lesions.

Eligibility criteria: Inclusion Criteria:

- de novo coronary artery disease

Exclusion Criteria:

* unstable hemodynamics at presentation
* life expectancy \<1 year

Primary outcomes:
measure: Major adverse cardiac events at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Angiographic and clinical outcomes
timeFrame: 12, 24, 36 months
Other outcomes:
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan Medical Center
Study officials:
affiliation: IRB
name: Soo-Jin Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jun EJ, Shin ES, Teoh EV, Bhak Y, Yuan SL, Chu CM, Garg S, Liew HB. Clinical Outcomes of Drug-Coated Balloon Treatment After Successful Revascularization of de novo Chronic Total Occlusions. Front Cardiovasc Med. 2022 Apr 13;9:821380. doi: 10.3389/fcvm.2022.821380. eCollection 2022.
citation: Kun L, Shin ES, Jun EJ, Bhak Y, Garg S, Kim TH, Sohn CB, Choi BJ, Hui L, Yuan SL, Zhi W, Hao J, Zhentao S, Qiang T. Sex-Related Outcomes of Successful Drug-Coated Balloon Treatment in De Novo Coronary Artery Disease. Yonsei Med J. 2021 Nov;62(11):981-989. doi: 10.3349/ymj.2021.62.11.981.
citation: Hui L, Shin ES, Jun EJ, Bhak Y, Garg S, Kim TH, Sohn CB, Choi BJ, Kun L, Yuan SL, Zhi W, Hao J, Zhentao S, Qiang T. Impact of Dissection after Drug-Coated Balloon Treatment of De Novo Coronary Lesions: Angiographic and Clinical Outcomes. Yonsei Med J. 2020 Dec;61(12):1004-1012. doi: 10.3349/ymj.2020.61.12.1004.