louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02010619: Internet Delivered CBT for Body Dysmorphic Disorder
Official title: Internet Delivered Cognitive Behavior Therapy for Body Dysmorphic Disorder - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Dysmorphic Disorder
BDD
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 94
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: To evaluate if Internet delivered cognitive behavior therapy is an efficacious treatment when compared to a control group consisting of supportive therapy.


Eligibility criteria: Inclusion Criteria:

* outpatient
* ≥ 18 years
* primary diagnosis of BDD according to the DSM-5
* BDD-YBOCS ≥20
* regular access to a computer with Internet access and skills to use the web.

Exclusion Criteria:

* psychotropic medication changes within two months prior to the treatment,
* completed CBT for BDD within the last 12 months,
* other primary axis I diagnosis
* current substance dependence
* lifetime bipolar disorder or psychosis
* suicidal ideation
* Axis II diagnosis that could jeopardize treatment participation,
* other current psychological treatment that could affect BDD symptoms
* A serious medical illness that precludes participation in the study

Primary outcomes:
measure: Body Dysmorphic Disorder Modification of the Y-BOCS (BDD-YBOCS)
timeFrame: Change in BDD-YBOCS from baseline (week 0) to post-treatment (week 12)
Secondary outcomes:
measure: The Montgomery Åsberg Depression Rating Scale - self report (MADRS-S)
timeFrame: Change in MADRS-S from baseline (week 0) to post-treatment (week 12)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst
state: Huddinge
Study officials:
References:
citation: Enander J, Andersson E, Mataix-Cols D, Lichtenstein L, Alstrom K, Andersson G, Ljotsson B, Ruck C. Therapist guided internet based cognitive behavioural therapy for body dysmorphic disorder: single blind randomised controlled trial. BMJ. 2016 Feb 2;352:i241. doi: 10.1136/bmj.i241.
citation: Flygare O, Enander J, Andersson E, Ljotsson B, Ivanov VZ, Mataix-Cols D, Ruck C. Predictors of remission from body dysmorphic disorder after internet-delivered cognitive behavior therapy: a machine learning approach. BMC Psychiatry. 2020 May 19;20(1):247. doi: 10.1186/s12888-020-02655-4.
citation: Enander J, Ljotsson B, Anderhell L, Runeborg M, Flygare O, Cottman O, Andersson E, Dahlen S, Lichtenstein L, Ivanov VZ, Mataix-Cols D, Ruck C. Long-term outcome of therapist-guided internet-based cognitive behavioural therapy for body dysmorphic disorder (BDD-NET): a naturalistic 2-year follow-up after a randomised controlled trial. BMJ Open. 2019 Jan 15;9(1):e024307. doi: 10.1136/bmjopen-2018-024307.
Clinical trial NCT06229119: Vault Evaluation After ICL Implantation
Official title: Vault Evaluation After Implantation of an Implantable Collamer Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nearsightedness
Lead sponsor: Carolina Eyecare Physicians, LLC
Sponsor class: OTHER
Collaborators: name: Science in Vision
First posted: 2024-01-29
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects were implanted with the EVO ICL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the lens vault after implantation of an implantable collamer lens (ICL). The ICL is designed to be implanted in front of the eye, without removing the natural lens. Because of this, it is also known as a phakic IOL. The ICL has already been approved by the U.S. Food and Drug Administration (FDA) to treat mid to high degrees of refractive errors such nearsightedness (also called myopia) with or without astigmatism. Once the artificial lens is implanted, a space between the ICL and the crystalline lens is created, which is called vault.

Detailed description: The ICL will be implanted in both eyes of study subjects. Diagnostic instrumentation will be used to measure the vault between the ICL and the crystalline lens.

Eligibility criteria: Inclusion Criteria:

* Gender: Males and Females.
* Age: 21 to 45 years of age
* Willing and able to provide written informed consent for participation in the study
* Willing and able to comply with scheduled visits and other study procedures.
* Scheduled to undergo ICL implantation in both eyes within 1 to 30 days between surgeries.
* Subjects who require an ICL power in the range of -3.00 to -15.00 D.

Exclusion Criteria:

* Patients who do not qualify for an ICL according to the Direction For Use (DFU)
* Unstable or worsening myopia
* Use of any systemic or topical drug known to interfere with visual performance.
* Irregular astigmatism.
* History of retinal detachment.
* Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
* Pigment dispersion
* Previous intraocular surgery.
* Previous refractive surgery.
* Previous keratoplasty
* Pupil abnormalities
* Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
* Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.

Primary outcomes:
measure: Mean Difference Between Predicted and Actual Central Vault at 1-month After ICL Implantation
timeFrame: 1-month
Secondary outcomes:
Other outcomes:
Locations:
city: Mount Pleasant
country: United States
facility: Helga Sandoval
state: South Carolina
Study officials:
affiliation: Carolina Eyecare Physicians
name: Kerry Solomon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00825019: Efficacy and Safety of One Single Dose of SR58611 Compared to Placebo and Paroxetine
Official title: A Double-Blind, Multicenter Study Evaluating the Efficacy and Safety of One Fixed Dose of SR58611A (700 mg/Day) Versus Placebo and Paroxetine (20 mg/Day) in Patients With a Recurrent Major Depressive Episode.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorders
Keywords: Depression
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-01-19
Enrollment: 306
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: Primary objective is to demonstrate the antidepressant efficacy on the Hamilton depression rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment of patients with a recurrent major depressive episode (MDD).

Secondary objective is to assess the safety profile of amibegron 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.


Eligibility criteria: Inclusion Criteria:

* patients suffering from a recurrent major depressive episode of at least moderate intensity (DSM-IV)
* patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months.
* the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration.

Primary outcomes:
measure: change from baseline of the total score of the HAM-D 17 items
timeFrame: 6 weeks
Secondary outcomes:
measure: HAM-D subscores, HAMD responders and remitters, HAM-A total score and subscores
timeFrame: 6 weeks
measure: Montgomery-Asberg Depression Rating Scale (MADRS) total score
timeFrame: 6 weeks
measure: clinical global impression (CGI) severity and improvement scores
timeFrame: 6 weeks
measure: patient global impression (PGI) improvement score
timeFrame: 6 weeks
measure: social and occupational functioning assessment scale (SOFAS) score
timeFrame: 6 weeks
measure: AEs, Arizona Sexual Experience Scale (ASEX),
timeFrame: 6 weeks
measure: laboratory parameters, physical examination findings, ECG parameters, change of vital signs, body weight
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05792319: Clinical Profile and Out Come of Children With Wilson's Disease
Official title: Clinical Profile and Out Come of Children With Wilson's Disease :A Single Tertiary Center Study .
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Clinical Outcome in WILSON Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The aim of this study to describe the clinical profile of children diagnosed as Wilson's disease who were admitted to A.U.C.H and explore the out come of these patients either they receive the chelation therapy or not along a period of one year

Brief summary: Clinical profile and out come of Children with Wilson's disease :A single tertiary center study

Detailed description: Wilson disease (WD) is an autosomal-recessive disorder of copper metabolism caused by mutations in the ATP7B gene . It presents in childhood, adolescence or adulthood with a wide range of clinical manifestations. The disease prevalence has previously been estimated as 1 in 30,000 , but some recent analyses have suggested a genetic prevalence of 1 in 7,000 . Copper is absorbed from the stomach and duodenum, taken up by the liver, and secreted by the liver into the systemic circulation bound to ceruloplasmin ATP7B transports copper through the trans-Golgi network in hepatocytes before it is incorporated into apoceruloplasmin which is secreted as holoceruloplasmin.

ATP7B is also essential for biliary excretion of copper when cytoplasmic levels are high. Dysfunction of ATP7B therefore leads to accumulation of copper in the liver giving rise to cellular damage and disease, and the release of nonceruloplasmin bound copper into the systemic circulation. Copper also accumulates and is associated with cellular damage and disease in other organs mostly in the brain Typical presentation of WD is in adolescence to early adulthood, but it may occur at any age . Clinical presentation can vary widely in terms of type and severity, but the key features are various degrees of liver disease,

Eligibility criteria: Inclusion Criteria:

* All patients aged 1-18 years
* fulfill the criteria for diagnosis of Wilson's disease according to Wilson's score

Exclusion Criteria:

1. persistent neonatal jaundice.
2. Patients presented with Acute and chronic liver disease rather than Wilson's e.g

   1. Autoimmune hepatitis
   2. Hepatitis C virus ,
   3. Hepatitis B virus infection ,(d)Hepatic focal lesions and(e) Metabolic liver disease e.g Gauchier ,glycogen storage disease and Niemman pick .

Primary outcomes:
measure: COC in WILSON disease
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Tryambak S, Sumanta L, Radheshyam P, Sutapa G. Clinical profile, prognostic indicators and outcome of Wilson's disease in children: a hospital based study. Trop Gastroenterol. 2009 Jul-Sep;30(3):163-6.
Clinical trial NCT03659019: Implanted Phrenic Nerve Stimulator Database.
Official title: Follow-up Database of Patients Who Are Candidates for Implanted Phrenic Nerve Stimulator and Implanted Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: External Mechanical Ventilatory Support
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Neuroresp, Reference centre Syndrome d'Ondine
First posted: 2018-09-06
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients adressed to the Respiratory and Medical Resuscitation Unit of the Pitié-Salpêtrière Charles Foix Hospital Group for the search for an indication of SPi in the context of central ventilatory paralysis or central hypoventilation, whether or not the indication is retained at the end of the balance sheet; this population is essentially made up of adults, some but not all of whom benefit from a protection regime; it may occasionally include minors;

Patients addressed to the adult branch of the Rare Disease Reference Center for Congenital Central Venous Hypoventilation, located within the hospital group Pitié-Salpêtrière Charles Foix, for the assessment and monitoring of their disease. By definition, this population consists solely of adults.

Brief summary: Phrenic nerve stimulation is a neurostimulation technique that allows patients who are dependent on external mechanical ventilatory support to regain their breathing autonomy. This study aim at long term following of patients who may be candidates for permanent implanted phrenic nerve stimulator.

Detailed description: During 10 years, the study will be conduct to obtain the quality of life evolution and medical complications in patients candidates but not implanted, and in patients candidates then implanted with the phrenic nerve stimulator.

Eligibility criteria: Inclusion Criteria:

* Patients with central respiratory paralysis (medullary lesions or supramedullary lesions, whatever their causes) or patients with congenital central hypoventilation (including Ondine syndrome by Phox2B mutation) or acquired (whatever the cause), with permanent hypoventilation or related to sleep.

Exclusion Criteria:

* Patient not affiliated to the social security system
* Patient unable to oppose his participation in research
* Patient not understanding French

Primary outcomes:
measure: Score at the Medical Outcomes Study Short-Form General Health Survey (SF-12) scale in patients with implanted phrenic nerve stimulator
timeFrame: 10 years
Secondary outcomes:
measure: Number of evolving episodes involving care, whether pathology events or intercurrent events
timeFrame: 10 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Thomas SIMILOWSKI
state: Ile De France
Study officials:
References:
Clinical trial NCT00895219: Physiotherapy and Dysfunctional Breathing
Official title: A Comparison of the Effects of Respiratory Physiotherapy Alone and Respiratory Physiotherapy Combined With Musculoskeletal Techniques in the Management of Dysfunctional Breathing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hyperventilation
Keywords: Hyperventilation
Dysfunctional breathing
Physiotherapy
Musculoskeletal techniques
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-05-08
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Traditionally, the physiotherapy management of people with dysfunctional breathing or hyperventilation syndrome is breathing re-training. There is increasing clinical evidence that structural and functional changes develop in the muscles and connective tissues of the chest wall, abdomen and back when the upper chest accessory pattern of breathing is used over time. When treatment includes breathing techniques only it is difficult for a person with chronic hyperventilation, who has developed muscle and connective tissue changes, to revert to using the normal lower chest diaphragmatic breathing pattern. In clinical practice when the problems which have developed in the musculoskeletal system are addressed, the patient reverts more quickly to the lower chest pattern of breathing but there is as yet little evidence to support this clinical finding.


Eligibility criteria: Inclusion Criteria:

* diagnosis of dysfunctional breathing (Nijmegen score of more than 23)

Exclusion Criteria:

* active metastatic disease
* osteoporotic disease
* dysfunctional breathing as a consequence of respiratory or cardiac disease

Primary outcomes:
measure: Nijmegen Questionnaire
timeFrame: 0, 2, 4, 8, 12 and 26 weeks
Secondary outcomes:
measure: Six-minute walking test
timeFrame: 0, 2, 4, 8, 12 & 26 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Margaret E Hodson, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04830319: Pilates Method in People With HAM/TSP
Official title: Therapeutic Effect of the Pilates Method in People With HAM/TSP: a Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HAM/TSP
HTLV-1 Secondary Myelopathy
Balance
Gait Balance
Functional Mobility
Lead sponsor: Pedreira, Érika, M.D.
Sponsor class: INDIV
First posted: 2021-04-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Individuals with HTLV-1 secondary myelopathy (HAM/TSP) may have motor and sensory alterations, which may result in reduced functional performance and consequent risk of falls. The aim of the study is to verify the therapeutic effect of a Pilates exercise program on functional performance and risk of falls, when compared to task-oriented training, of people with HAM / TSP. This is a randomized, crossover clinical trial performed with individuals with HAM / TSP who are attended at a referral center who is able to perform gait whether or not to use a walking aid. Amputees, with psychiatric disorders, rheumatic or orthopedic diseases and other associated neurological disorders, which could influence the balance and functional mobility, as well as pregnant women, were excluded. Participants will be submitted to the initial evaluation of functional mobility, balance, gait balance, fatigue, gait endurance, sphincter changes and questioned about the occurrence of falls in the last three months and will answer a semi-structured questionnaire about their conjugality. They will be allocated randomly to two groups. One will perform the Pilates Method protocol and the other task-oriented training. The first group, called test-control group (GTC), will initiate the protocol with exercises of the Pilates method; the control-test group (GCT) will initiate the task-oriented training protocol. A p \<0.05 will be considered a statistically significant difference.


Eligibility criteria: Inclusion Criteria:

* individuals with probable and/or defined diagnosis of HAM / TSP, according to WHO criteria, of both sexes, aged 18 to 64 years.

Exclusion Criteria:

* individuals with lower limb amputation, pregnancy, psychiatric disorders, rheumatic or orthopedic diseases, other associated neurological disorders, and those who have difficulty understanding the assessment instruments.

Primary outcomes:
measure: Balance
timeFrame: 15 minutes
measure: Functional Mobility
timeFrame: 3 minutes
measure: Gait Balance
timeFrame: 10 minutes
measure: Balance
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Universidade Católica do Salvador
state: Bahia
Study officials:
References:
Clinical trial NCT01551719: Clinical Usefulness of Mic/Breakpoint Ratio and Penetration in Tissues. A Prospective Study of Clinical Validation
Official title: Clinical Usefulness of Mic/Breakpoint Ratio and Penetration in Tissues. A Prospective Study of Clinical Validation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infection of Skin and/or Subcutaneous Tissue
Keywords: Bacterial infection of skin or soft tissues
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The general objective of the study is to assess whether the implementation of the antibiotic essay with the Breakpoint/MIC ratio and data on penetration of the antibiotic in the site of infection may improve the outcome of infections compared to using only the standard procedures.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Bacterial infections, with microbiological isolation, in one of the following tissues: skin, soft tissue or surgical wound infections

Exclusion Criteria:

* Age \< 18 years
* Inability to sign informed consent

Primary outcomes:
measure: Complete recovery rate from infection
timeFrame: At the end of treatment (an expected average of 10 days)
Secondary outcomes:
measure: Time to recovery from infection.
timeFrame: At the end of treatment (an expected average of 10 days)
measure: Partial response
timeFrame: At the end of treatment (an expected average of 10 days)
measure: Rate of non responders
timeFrame: At the end of treatment (an expected average of 10 days)
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
affiliation: Federico II University
name: Guglielmo Borgia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05060419: Meropenem-FL058 Phase 2 Study in the Treatment of Complicated Urinary Tract Infections
Official title: Phase Ⅱ, Randomized, Double-Blind,Double-Dummy Study Evaluating Safety,Tolerability,Efficacy of Meropenem-FL058 in Adult Patients With Complicated Urinary Tract Infections, Including Acute Pyelonephritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Complicated Urinary Tract Infection
Acute Pyelonephritis
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 2, randomised, double-blind,double-dummy study in hospitalised adults with complicated urinary tract infection (cUTI), including acute pyelonephritis.Treatment duration for each cohort was 7 to 14 days. Patients were not permitted to switch to oral therapy.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients, aged 18 \~ 75 years (inclusive);；
2. Acute pyelonephritis or other complicated urinary tract infection.

Exclusion Criteria:

1. Patients needing concomitant systemic antimicrobial agents in addition to those designated in the various study treatment groups;
2. Fungal urinary tract infection;
3. History of allergic to any carbapenem, cephalosporin, penicillin, other β -lactam drugs or other β -lactamase inhibitors;
4. Pregnant or breastfeeding women;
5. Inability to tolerate intravenous fluids, due to medical reasons, of 1050 mL per day required for study drug administration;
6. Unable or unwilling, in the judgment of the Investigator, to comply with the protocol.

Primary outcomes:
measure: Proportion of patients in the Microbiological Modified Intent to Treat (m-MITT) Population who achieve overall treatment success at Test Of Cure (TOC).
timeFrame: 5 to 9 days post-End of Treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Huashan Hospital
name: Huang Haihui, Professor
role: PRINCIPAL_INVESTIGATOR
References: