louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03612102: Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism
Official title: Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Selective Mutism
Keywords: Selective Mutism
Treatment
Anxiety
Intensive Treatment
CBT
Group Treatment
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: American Psychological Association (APA)
First posted: 2018-08-02
Enrollment: 29
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Families of children with selective mutism will be randomly assigned to receive either immediate intensive group behavioral treatment (IGBT) or to a waitlist with psychoeducational materials, and then IGBT.
Primary purpose: TREATMENT

Brief summary: This goal of this study is to evaluate an intensive group behavioral treatment (IGBT) program for children with selective mutism, a low base-rate childhood anxiety disorder. 29 children between the ages of 5 and 9 will be randomly assigned to participate in a 5-day IGBT over the summer or to a waitlist control condition, with the opportunity to participate in IGBT 4 weeks later. All children that participate in treatment will be followed up 8 weeks into the following school year.


Eligibility criteria: Inclusion Criteria:

* Meets diagnostic criteria for selective mutism
* Verbal with at least 1 parent or caregiver
* Child fluent in English

Exclusion Criteria:

* Any mental health difficulty significantly more impairing than selective mutism

Primary outcomes:
measure: Clinical Global Impressions Scales - Improvement (CGI-I)
timeFrame: 5 minutes
Secondary outcomes:
measure: Anxiety Disorders Interview Schedule for Children (ADIS)
timeFrame: 2 hours
measure: Selective Mutism Questionnaire (SMQ)
timeFrame: 10 minutes
measure: Children's Global Assessment Scale (CGAS)
timeFrame: 5 minutes
measure: Child Behavior Checklist (CBCL)
timeFrame: 30 minutes
measure: School Speech Questionnaire (SSQ)
timeFrame: 5 minutes
measure: Impairment Rating Scale (IRS)
timeFrame: 8 minutes
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
References:
Clinical trial NCT00224302: Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine
Official title: Treatment of Major Depressive Episodes During the Course of Psychotic Disorders With Duloxetine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psychotic Disorders
Keywords: Schizophrenia,
schizoaffective disorder,
major depressive episode,
combination,
duloxetine
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We evaluate the efficacy and tolerability of duloxetine in the treatment of major depressive episodes during the course of psychotic disorders

Detailed description: Major depressive episodes (MDE) frequently occur during the course of schizophrenic psychoses, both as as "post-psychotic" depressions, and also independently from psychotic episodes. A number of clinical studies reported the application of different antidepressive substances, such as Imipramine, Reboxetine or Venlafaxine. In general, the treatment of schizophrenic patients with antidepressive drugs can be considered as necessary and save, resulting in therapeutic guidelines of different psychiatric societies. However, since 5 to 10 % of the schizophrenic patients commit suicide, there is still much effort necessary in order to improve the treatment of affective symptoms in schizophrenic psychoses.The recently introduced antidepressive substance Duloxetine selectively inhibits as a SSNRI the reuptake of serotonine and noradrenaline from the synaptic cleft. Duloxetine was proven as antidepressive, anxiolytic and analgetic in a series of multi-centre, placebo-controlled investigations. Based on these considerations and on successful experiences in single case reports we aim to investigate the therapeutic effects of duloxetine in patients with lifetime diagnoses of the schizophrenic spectrum.

Eligibility criteria: Inclusion Criteria:

* Major depressive episode, Severity: CDSS at least 8 points or HAMD at least 15 points, indication for the treatment with duloxetine
* Lifetime diagnosis of a psychotic disorder (PANSS positive scale below 15 points)
* Age between 18 and 65,
* Informed consent

Exclusion Criteria:

* No informed consent,
* Contraindications with respect to duloxetine,
* Gravidity or missing anticonceptive safety
* Substance dependance (excluded nicotin)

Primary outcomes:
measure: CDSS, HAMD, PANSS, SANS
Secondary outcomes:
measure: PANSS, SANS, Serum levels of antipsychotic substances, Body weight, EPMS,Prolactin, blood pressure, heart rate
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Central Institute of Mental Health, Department of Psychiatry,
state: BW
Study officials:
affiliation: Central Institute of Mental Health, Department of Psychiatry, Mannheim, Germany
name: Mathias Zink, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05101902: A Study to Determine Eligibility for CAH-301 (A Study of Gene Therapy for Classic Congenital Adrenal Hyperplasia (CAH) [NCT04783181])
Official title: Pre-screening Study to Identify Adult Participants with Classic Congenital Adrenal Hyperplasia Due to 21-Hydroxylase Deficiency Who May Be Eligible for Treatment in the CAH-301 Trial with BBP-631, an Adeno-associated Virus (AAV) Serotype 5-Based Recombinant Vector Encoding the Human CYP21A2 Gene
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Adrenal Hyperplasia
Keywords: CAH
Lead sponsor: Adrenas Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2021-11-01
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants diagnosed with classic CAH due to 21-OHD

Brief summary: This pre-screening study is designed to determine potential eligibility of adults with classic CAH due to 21-hydroxylase deficiency (21-OHD) for participation in the CAH-301 \[NCT04783181\] gene therapy trial with BBP-631.

Detailed description: Adult participants diagnosed with classic CAH due to 21-OHD and who are taking glucocorticoids as treatment for CAH will undergo assessments to determine their potential eligibility for participation in the adult CAH-301 treatment trial with BBP-631.

Eligibility criteria: Inclusion Criteria:

* Adult male and non-pregnant females with classic CAH (simple virilizing or salt-wasting) due to 21-OHD
* Screening/baseline 17-OHP levels \> 5-10 × ULN
* Is on a daily regimen of glucocorticoid
* Naïve to prior gene therapy or AAV-mediated therapy

Exclusion Criteria:

* Positive for anti-AAV5 antibodies
* History of adrenalectomy and has no significant liver disease

Primary outcomes:
measure: Number of Participants Potentially Eligible for CAH-301 Study
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Science37
state: California
Study officials:
References:
Clinical trial NCT03695302: Knowledge , Attitude and Practice (KAP) of Fifth Year Undergraduate Dental Students on Post Exposure Prophylaxis
Official title: Knowledge , Attitude and Practice (KAP) of Fifth Year Undergraduate Dental Students on Post Exposure Prophylaxis: An Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Occupational Exposure
Keywords: knowledge/attitude/practice/questionnaire/post-exposure
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fifth year undergraduate dental students in Faculty of Dentistry , Cairo University

Brief summary: Considering the increasing number of HIV and HBV cases, the aim of this study is to evaluate the knowledge,Attitude and practice of fifth year undergraduate dental students regarding post-exposure prophylaxis.

Detailed description: needle stick injury is inevitable. Needle stick injury is deﬁned as penetration of a sharp instrument into the body of a healthcare professional, exposing them to high-risk body ﬂuids.

Cutaneous injuries are the most common cause of infection transmission from patient to dentist. The causes of such injuries have been reported as 37% from dental burs , 30% from syringes , 6% from orthodonticwires , 3% from suture needles, 1% from blades and 2% from other sharp instruments .

Since high-risk exposure is unavoidable, dentists should be aware of post-exposure protocols to prevent infection .

Eligibility criteria: Inclusion Criteria:

* All Fifth Year dental students in Faculty of Dentistry ,Cairo University at the time of the study

Exclusion Criteria:

* Refusal of participation from the students.

Primary outcomes:
measure: Knowledge,Attitude and Practice questionnaire of fifth year undergraduate dental students on post exposure prophylaxis
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02100202: Efficacy and Safety Study of Dietary Supplements in Chronic Smokers Having Mild to Moderate Hyperlipidemia
Official title: Efficacy and Safety Study of Dietary Supplements (BioTurmin, BioTurmin-WD and MaQxan) on Cotinine Level and Oxidative Stress Marker in Chronic Smokers Having Mild to Moderate Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Smokers
Hyperlipidemia
Keywords: Dietary supplements
Cotinine level
Malondialdehyde
Chronic smokers
Hyperlipidemia
Lead sponsor: Olive Lifesciences Pvt Ltd
Sponsor class: INDUSTRY
First posted: 2014-03-31
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the efficacy and safety of dietary supplements (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in chronic smokers having mild to moderate hyperlipidemia after 30 days of intervention.

Detailed description: In a randomized, double-blind, placebo control trial, the efficacy and safety of dietary supplements (BioTurmin, BioTurmin-WD and MaQxan) will be investigated in chronic smokers having mild to moderate hyperlipidemia. Sixty subjects will be randomly assigned to receive the dietary supplements and placebo for 30 days. The efficacy of the supplements will be measured by estimating cotinine and malondialdehyde level.

Eligibility criteria: Inclusion Criteria:

Men \> 20 years

Chronic cigarette/ beedi smoker (2-3 packets/day since last 3 years or more) with mild to moderate hyperlipidemia (LDL ranging 160-189 mg/dL, TC \>200 mg/dL and/or HDL-C \<40 mg/dL)

Being mentally competent and able to understand all study requirements and sign the informed consent form.

Exclusion Criteria:

Patients with Chronic obstructive pulmonary disease (COPD)

Women

Patients with severe liver, renal, cardiac or brain diseases.

Unable to complete follow up.

Subjects on any medication like diuretics.

Allergic to any medication.

With a history of alcohol and/or drug abuse.

Primary outcomes:
measure: Change in urine cotinine and serum oxidative stress marker levels
timeFrame: Baseline and on day 30
Secondary outcomes:
measure: Change in serum lipid profile
timeFrame: Baseline and on day 30
Other outcomes:
measure: Safety and tolerability (composite measure)
timeFrame: Baseline and on day 30
Locations:
city: Bangalore
country: India
facility: Sreenivasa Clinic Diabetic Research Center
state: Karnataka
Study officials:
affiliation: Sreenivasa Clinic Diabetic Research Center
name: Venkateshwarlu K, MD (Ayur)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01638702: Study of Complication Rates Associated With PICC for Left vs Right
Official title: Assessment of Impact of Choice of Arm for Access on Rate of Complications in Peripherally Inserted Central Venous Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Infections
Keywords: Catheterisation, Central Venous
Catheters, Indwelling
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2012-07-12
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Peripherally inserted central catheter (PICC) are catheters that are placed mainly in the arms, but which pass in the veins to beside the heart. They are associated with occasional complications due to infection or blockage of the vein that they are in. The investigators want to investigate whether PICCs in the right arm have lower complications than those in the left. This difference in complication rates has been noticed in most other forms of central venous access.


Eligibility criteria: Inclusion Criteria:

* Referral for in-patient PICC placement at centre carrying out study.

Exclusion Criteria:

* Out of hospital referrals for PICC placement; previous PICC placement; previous long term central catheter/pacemaker; unable to give valid consent; presence of pre-existing medical preventing randomisation.

Primary outcomes:
measure: Line infection rate
timeFrame: From insertion to line removal, an estimated time of 4 weeks
Secondary outcomes:
measure: Effect of number of lumens
timeFrame: From insertion to time of removal, an estimated average time of four weeks.
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Richard Lindsay, MB Bch BaO
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: France Paquet, BS(N) MS(N)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04470102: Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy
Official title: A Randomised Controlled Pilot Trial: Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertrophic Obstructive Cardiomyopathy
Keywords: edge-to-edge repair
mitral valve plastic (MVP)
Septal myectomy
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2020-07-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized clinical trial comparing mitral valve repair using the edge-to-edge technique for surgical treatment of hypertrophic cardiomyopathy
Primary purpose: TREATMENT

Brief summary: Objective of the study: to evaluate whether edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.

Detailed description: A randomised controlled pilot trial to evaluate whether edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy. Patients with proven hypertrophic cardiomyopathy and resting left ventricle outflow tract obstruction underwent septal myectomy. If patients were suitable for both surgical techniques, they were randomized to septal myectomy + edge-to-edge mitral valve repair or isolated septal myectomy. All surgeons were experienced at least 50 related procedures.

Eligibility criteria: Inclusion Criteria:

* Provide written informed consent (either from the patient or a substitute decision-maker)
* Indications for surgical treatment (septal myectomy) of hypertrophic cardiomyopathy

Exclusion Criteria:

* indications for mitral valve replacement
* Patient failure at any stage of the study

Primary outcomes:
measure: Left Ventricular Outflow Tract (LVOT) gradient
timeFrame: 12 months in the medium-term follow-up
Secondary outcomes:
measure: Systolic anterior motion of the mitral valve
timeFrame: 12 months in the medium-term follow-up
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: "E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation
Study officials:
affiliation: E.Meshalkin National medical research center
name: Alexander V. Bogachev-Prokophiev, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05334602: The Effect of Use of Dermal Fat Graft as a Barrier Membrane
Official title: The Effect of Use of Dermal Fat Graft as a Barrier Membrane in Unilateral Alveolar Cleft Grafting. (A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilateral Cleft Lip
Keywords: Alveolar cleft grafting
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 40
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

Brief summary: a study conducted to assess the use of dermal fat graft use as barrier membrane over grafted bone

Detailed description: The study has two group in which the study will have in addition to the conventional bone grafting addition of dermal fat graft to protect the bone. The control will have just normal graft

The results are assessed using computed tomography to assess the quality of the grafted bone.

The Chisquare test was used to asses the results significance.

Eligibility criteria: Inclusion Criteria:

Patients having age range of 8-14ys who performed for 2ry alveolar cleft grafting at the CCC using adipose fat graft in conjunction with ACBG Boys or girls. Unilateral or bilateral cleft alveolus. Accepts Healthy Volunteers has not been entered.

Exclusion Criteria:

Younger patients requiring 1ry grafting. Older patients requiring 3ry grafting.

Primary outcomes:
measure: Incidence of oronasal fistula
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams University
Study officials:
affiliation: Ain Shams University
name: Marwa EL Kassaby
role: STUDY_CHAIR
References:
Clinical trial NCT00525902: Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis
Official title: An Open-label, Multicenter, Phase II Trial of Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uveitis
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
name: The Cleveland Clinic
First posted: 2007-09-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of Adalimumab in uveitis.


Eligibility criteria: Inclusion Criteria:

1. Patients with vision-threatening autoimmune uveitis.
2. Failure to respond to prednisone and at least one other systemic immunosuppressive (such as methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, cyclophosphamide, or chlorambucil), or intolerance to such medications due to side effects.

Exclusion Criteria:

1. Serious concomitant illness that could interfere with the subject's participation in the trial.
2. Previous or current use of cyclophosphamide.
3. Unable or unwilling to undergo multiple injections.

Primary outcomes:
measure: Cumulative Endpoint
timeFrame: 10 weeks
measure: Cumulative Endpoint
timeFrame: 50 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Eric B Suhler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: James T Rosenbaum, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05904002: Effect of Incentive Spirometery on Asthmatic Pregnant Women
Official title: Effect of Incentive Spirometery on Asthmatic Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthmatic
Pregnant With Complication
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of the incentive spirometer on asthma during pregnancy.

Detailed description: This study will provide an evidence basis for obstetricians and physical therapist for women's health about the effect of spirometry on asthma during pregnancy.

Eligibility criteria: Inclusion Criteria:

The patients will have the following criteria:

1. Their age will range from 30 to40years old.
2. Body mass index (BMI) will range from 25-29.9 kg/m2.
3. All patients will be clinically and medically stable.

Exclusion Criteria:

Patients will be excluded from the study if they have the following:

1. Diabetes mellitus.
2. Severe hypertension.
3. Neurological and neuromuscular disorders.
4. Blindness.
5. Developed moderate and severe degree of pleural effusion.
6. Cardiovascular instability.
7. Chronic chest disease.

Primary outcomes:
measure: Assessing the change in lung functions
timeFrame: at baseline and after 6 weeks of intervention
measure: Assessing the change in symptoms of asthma
timeFrame: at baseline and after 6 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Outpatient clinic faculty of physical therapy cairo university
Study officials:
References: