louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04498078: Creatine Supplementation in Autism Spectrum Disorder
Official title: The Effects of Creatine Supplementation in Autism Spectrum Disorder: a Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University of Novi Sad, Faculty of Sport and Physical Education
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Autism Spectrum Disorder (ASD) is accompanied by reduced levels of total creatine in right temporal-parietal junction and other brain regions of interest, and addressing this deficit by exogenous administration of creatine may have beneficial effects on brain metabolism and disease-specific clinical symptoms in patients suffering from ASD.


Eligibility criteria: Inclusion Criteria:

* Age 10 years and above
* Informed consent signed by a parent or legal guardian or legal representative
* Diagnostic and Statistical Manual of Mental Disorders-IV criteria for ASD.

Exclusion Criteria:

* Pregnant or nursing female patients
* Non-pharmacologic therapy
* Current diagnosis of other mental disorder

Primary outcomes:
measure: Brain creatine change
timeFrame: Change from Baseline Brain Creatine Levels at 6 Months
Secondary outcomes:
measure: Brain N-acetylaspartate change
timeFrame: Change from Baseline Brain N-acetylaspartate Levels at 6 Months
measure: Autism Treatment Evaluation Checklist (ATEC) score
timeFrame: Change from Baseline ATEC Scores at 6 Months
Other outcomes:
measure: Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities
timeFrame: Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities at 6-Month Follow-up
measure: Maximal oxygen uptake change
timeFrame: Change from Baseline Cardiorespiratory Capacity at 6 Months
Locations:
city: Novi Sad
country: Serbia
facility: FSPE Applied Bioenergetics Lab
state: Vojvodina
Study officials:
affiliation: Faculty of Sport and PE
name: Nebojsa Maksimovic, PhD
role: STUDY_CHAIR
References:
citation: Edmondson DA, Xia P, McNally Keehn R, Dydak U, Keehn B. A Magnetic Resonance Spectroscopy Study of Superior Visual Search Abilities in Children with Autism Spectrum Disorder. Autism Res. 2020 Apr;13(4):550-562. doi: 10.1002/aur.2258. Epub 2020 Jan 7.
Clinical trial NCT02073578: Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia
Official title: Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achalasia
Keywords: achalasia
POEM
peroral endoscopic myotomy
myotomy
Heller myotomy
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2014-02-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat 20 patients.

Detailed description: This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat or attempt to treat 20 patients. Patients for whom a POEM has been attempted but not completed (conversion to open or laparoscopic surgery, POEM surgery aborted and not re-attempted). Patients who proceed to study treatment will undergo ten years of follow-up as part of this study.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Achalasia
* Age 16-80
* ASA Class 1-3

Exclusion Criteria:

* Pregnancy
* Any prior surgical or endoscopic treatment for achalasia -- first eight subjects.

After eight subjects have been treated as part of this study, this exclusion criteria no longer applies

* Patients who are taking immunosuppressive medications or are immunocompromised
* Patients on anticoagulant medications or abnormal coagulation tests
* Patients with severe medical comorbidities, in the judgment of the treating surgeon

Primary outcomes:
measure: Safety and Efficacy of POEM Procedure
timeFrame: Intraoperative to one year follow-up
measure: Long-term patient-reported quality of life
timeFrame: Baseline to one year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Kyle M Perry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02932878: An Open Label, Safety Study to Assess the Potential for Adrenal Suppression
Official title: An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS Topical Product in Patients With Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2016-10-13
Enrollment: 16
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment with DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Plaque Psoriasis

Detailed description: To evaluate the potential of DSXS to suppress HPA axis function in patients with mild to moderate plaque psoriasis.

To evaluate the efficacy parameters and adverse event (AE) profile of DSXS administered to patients with mild to moderate plaque psoriasis.

Eligibility criteria: Inclusion Criteria:

* Male or non pregnant, non lactating females

Exclusion Criteria:

* Patients under 2 years of age

Primary outcomes:
measure: Proportion of Patients in the Study With HPA Axis Suppression
timeFrame: 28 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Hawthorne
country: United States
facility: Taro Pharmaceuticals USA Inc.
state: New York
Study officials:
affiliation: http://www.novumprs.com/contact
name: Novum Pharmaceutical Research Services
role: STUDY_CHAIR
References:
Clinical trial NCT03857178: SABINA INTERNATIONAL
Official title: A Multi-country Study on the Prescription Patterns of Short Acting Beta-2 Agonist (SABA) and Its Potential Effects on Asthma Control: A Cross-Sectional Study on SABA Use in Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-02-27
Enrollment: 8617
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The selection of sites and investigators will be made with the aim to achieve representativeness in the way asthma is managed in each participating country. The study will include patients from either primary care centres, or specialist centres involved in the management of asthma, or a mix of both within a country to ensure representativeness.

Brief summary: The aim of the study is to describe the prescribing pattern of the different types of medications which are used to treat asthma, across multiple countries.


Eligibility criteria: Inclusion Criteria:

1. Male and female patients ≥12 years-old
2. Documented diagnosis with Asthma as per medical records.
3. Have had ≥3 consultations with the HCP at study start date
4. After full explanation, a patient or legal guardian must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

1. Patient with a diagnosis of chronic obstructive pulmonary disease or other chronic respiratory disease different from Asthma.
2. An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in this study

Primary outcomes:
measure: The main outcome will be a categorisation of SABA prescription in asthma patients.
timeFrame: 12 months retrospective from index date
Secondary outcomes:
Other outcomes:
Locations:
city: San Salvador
country: Argentina
facility: Research Site
Study officials:
References:
citation: Alzaabi A, Al Busaidi N, Pradhan R, Shandy F, Ibrahim N, Ashtar M, Khudadah K, Hegazy K, Samir M, Negm M, Farouk H, Al Khalidi A, Beekman M. Over-prescription of short-acting beta2-agonists and asthma management in the Gulf region: a multicountry observational study. Asthma Res Pract. 2022 Jul 7;8(1):3. doi: 10.1186/s40733-022-00085-5.
citation: Bateman ED, Price DB, Wang HC, Khattab A, Schonffeldt P, Catanzariti A, van der Valk RJP, Beekman MJHI. Short-acting beta2-agonist prescriptions are associated with poor clinical outcomes of asthma: the multi-country, cross-sectional SABINA III study. Eur Respir J. 2022 May 5;59(5):2101402. doi: 10.1183/13993003.01402-2021. Print 2022 May.
Clinical trial NCT00115778: Intravenous Immunoglobulin (IVIG) in Lung Transplantation
Official title: IVIG for Acquired Immunodeficiency in Lung Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypogammaglobulinemia
Lung Transplantation
Keywords: Hypogammaglobulinemia
Lung Transplantation
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Grifols Therapeutics LLC
First posted: 2005-06-27
Enrollment: 11
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent bacterial infections in lung transplant patients with low serum levels of immunoglobulin.

Detailed description: An increased risk of infection despite intensive antimicrobial prophylaxis is a well-recognized complication of lung transplantation. Recent evidence suggests that immunosuppressive therapy after solid organ transplantation may lead to humoral immunodeficiency due to hypogammaglobulinemia (HGG). In lung transplant recipients with HGG, IVIG therapy offers the potential to significantly decrease the incidence and severity of infections, thereby reducing morbidity and potentially mortality.

Comparison: The investigators are conducting a randomized clinical trial of IVIG versus placebo for lung transplant patients with severe HGG to see if IVIG decreases the number of bacterial infections in these patients.

Eligibility criteria: Inclusion Criteria:

* Lung transplant recipients \> 3 months after transplant surgery
* Immunoglobulin G (IgG) \< 500 mg/dL
* Stable medical regimen

Exclusion Criteria:

* Acute rejection
* Active infection
* Contraindication to IVIG
* Pregnancy
* Recent thrombotic event

Primary outcomes:
measure: Number of Clinically Diagnosed Bacterial Infections During the Treatment Period
timeFrame: 3 month
Secondary outcomes:
measure: Number of Clinically Diagnosed Viral Infections
timeFrame: 3 month
measure: Number of Hospital Admissions
timeFrame: 3 month
measure: Number of Antibiotic Initiation
timeFrame: 3 month
measure: Number of Clinically Diagnosed Fungal Infection
timeFrame: 3 months
measure: Number of Lymphocytic Bronchiolitis
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital Lung Transplant Program
state: New York
Study officials:
affiliation: Columbia University
name: Selim M Arcasoy, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lederer DJ, Philip N, Rybak D, Arcasoy SM, Kawut SM. Intravenous immunoglobulin for hypogammaglobulinemia after lung transplantation: a randomized crossover trial. PLoS One. 2014 Aug 4;9(8):e103908. doi: 10.1371/journal.pone.0103908. eCollection 2014.
Clinical trial NCT00539578: Treatment of Patients With Anxiety Disorder (0777-022)
Official title: A Double-Blind, Mulitcenter, Placebo-Controlled, Flexible-Dose Replicate Study of MK0777 Gel Extrusion Module (GEM) 3 mg B.I.D. to 8 mg B.I.D. in the Treatment of Outpatients With Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Generalized Anxiety Disorder
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-04
Enrollment: 270
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: The purpose of the study is to examine the safety and efficacy of MK0777 during treatment for Generalized Anxiety Disorder.


Eligibility criteria: Inclusion Criteria:

* Male and Female patients ages 18 to 70

Exclusion Criteria:

* Women who are breastfeeding or pregnant
* Positive result at prestudy on urine drug screen for illicit drugs
* History of alcohol or drug abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04692571: EMG-Based Hand-Wrist Control: Study B Mirrored
Official title: EMG-Based Hand-Wrist Control: Study B: Comparison of Contralateral (Mirrored) EMG-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Amputation
Amputation; Traumatic, Hand
Amputation, Congenital
Prosthesis User
Keywords: prosthesis
electromyography
EMG
sEMG
control
myo
regression
transradial
terminal device
electrodes
Lead sponsor: Liberating Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Worcester Polytechnic Institute
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Transradial limb-absent vs able-bodied subjects tested in sequence.
Primary purpose: BASIC_SCIENCE

Brief summary: Study assessing four-channel prosthesis controller, that compares contralateral (mirrored) EMG-force training to ipsilateral EMG-target training with both limb-absent and able-bodied subjects

Detailed description: System identification models relating forearm electromyogram (EMG) signals to phantom wrist radial-ulnar deviation force, pronation-supination moment and/or hand open-close force (EMG-force) are hampered by lack of supervised force/moment output signals in limb-absent subjects. In able-bodied and unilateral transradial limb-absent subjects, we studied three alternative supervised output sources in one degree of freedom (DoF) and 2-DoF target tracking tasks: (1) bilateral tracking with force feedback from the contralateral side (non-dominant for able-bodied/ sound for limb-absent subjects) with the contralateral force as the output, (2) bilateral tracking with force feedback from the contralateral side with the target as the output, and (3) dominant/limb-absent side unilateral target tracking without feedback and the target used as the output.

Eligibility criteria: Inclusion Criteria:

* Limb-absent subjects: unilateral trans-radial limb absence or amputation
* Be capable of completing the requested contractions on the affected dominant side

Exclusion Criteria:

* Past injuries to the upper limbs that would limit their ability to complete the requested contractions
* Scars that would impede the use of surface electrodes

Primary outcomes:
measure: EMG-Force Models
timeFrame: 1 day visit
Secondary outcomes:
Other outcomes:
Locations:
city: Holliston
country: United States
facility: Liberating Technologies, Inc
state: Massachusetts
city: Worcester
country: United States
facility: Worcester Polytechnic Institute
state: Massachusetts
Study officials:
References:
Clinical trial NCT03686371: Evaluation of Pain Following Scoliosis Surgery.
Official title: Evaluation of Pain Following Scoliosis Surgery.- RACHIDOL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Scoliosis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 51
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adolescent with scoliosis surgery for idiopathic scoliosis

Brief summary: The main objective of this study was to evaluate acute pain following scoliosis surgery in adolescent.


Eligibility criteria: Inclusion Criteria:

* adolescent from 10 to 18 years of age
* idiopathic scoliosis
* posterior surgery for spinal arthrodesis
* non opposition children and parents

Exclusion Criteria:

* complication following surgery needing reoperation
* secondary intervention
* anterior surgery
* non idiopathic scoliosis

Primary outcomes:
measure: Visual Analog Score for pain (EVA)
timeFrame: 3 days after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Anne DEFONTAINE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03415971: Electromyographic Estimation of Neuro-muscular Coordination of Masticatory Muscles in Patients Treated With Implants (D-2012-057)
Official title: Electromyographic Estimation of Neuro-muscular Coordination of Masticatory Muscles in Patients Treated With Implants (D-2012-057)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous
Teeth Replacement
Bounded Edentulous Space
Lead sponsor: North-Western State Medical University named after I.I.Mechnikov
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The result of the study will demonstrate that the functional activity of maxillofacial area with edentulous posterior bounded spaces recovers more effectively in patients treated with restorations on implants comparing to patients treated with fixed dentures.

Detailed description: All patients will be provided with electromyographic research before denture treatment, in a month and three months after the termination of treatment.

Eligibility criteria: Inclusion Criteria:

* Partially edentulous bounded space in dental arch (not more that 3 teeth absent)
* Patients ages 20-45 y.o.

Exclusion Criteria:

* Chronical third-degree cardiac failure
* Connective tissue diseases
* Decompensated diabetes
* Neoplastic processes
* Strokes

Primary outcomes:
measure: The signals were averaged over 25 ms, with muscle activity assessed as the root mean square (RMS) of the amplitude (µV). sEMG signals were recorded for further analysis.
timeFrame: up to 3 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05895071: Comparison of Topical 5%Potassium Hydroxide vs Liquid Nitrogen in the Treatment of Plane Warts
Official title: Comparative Efficacy of Topical 5%Potassium Hydroxide vs Liquid Nitrogen in the Treatment of Plane Warts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Plan Warts
Lead sponsor: Combined Military Hospital Abbottabad
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ABSTRACT Objective: To study the efficacy while comparing Potassium hydroxide 5% with liquid nitrogen in treatment of plane warts.

Study design: Randomized-controlled trial (RCT), (Double-blind). Study setting and duration: Dept dermatology, CMH-Abbottabad, Nov-2022 / April-2023.

Methodology: The sample size of 60 patients (children and adults aged 4 to 30 years) was calculated using Openepi app sample size RCT calculator, after informed consent by using non-probability consecutive sampling technique. Patients randomly assigned into two groups i.e. In group-A 30 patients were given topical 5%-potassium hydroxide solution on affected area once at night upto 4 weeks and in group-B 30 patients treated with cotton bud method of cryotherapy with liquid nitrogen once every two weeks. Patients were reassessed at every two weeks and final assessment was done at 12th week whereas followed up for 3 months to monitor recurrence. Demographic information and frequency percentages were calculated for qualitative variables by using SPSS26. To determine statistical significance taking p-value \<0.05 as significant, and χ2-square test was used.


Eligibility criteria: Inclusion Criteria:

* Age 4-30 years
* Both males and females
* Greater than 3 number of warts

Exclusion Criteria:

* Pregnancy
* Breast feeding
* Those who are taking immunosupressive drugs

Primary outcomes:
measure: Comparative Efficacy of topical 5% Potassium hydroxide and liquid nitrogen in the treatment of plane warts
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottabad
country: Pakistan
facility: Sana aslam
state: Khyber Pakhtun Khwaa
Study officials:
References: