louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02624596: Understanding How Ketamine Brings About Rapid Improvement in OCD
Official title: NMDAR Modulation As a Therapeutic Target and Probe of Neural Dysfunction in OCD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of Connecticut
First posted: 2015-12-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to understand how ketamine brings about rapid improvement in Obsessive-Compulsive Disorder (OCD) symptoms.

Detailed description: Obsessive-Compulsive Disorder (OCD) is a chronic and disabling disorder that costs the economy over $2 billion annually and represents a significant public health problem. This study aims to build on our discovery that a potent NMDA receptor antagonist, ketamine, has rapid (in hours) and robust therapeutic effects in OCD. The proposed projects test the acute mechanism of action of ketamine at the level of molecules, circuits, and network synchrony to determine how NMDA receptor antagonism modifies the underlying pathology of OCD to relieve repetitive thoughts and behaviors.

Eligibility criteria: Inclusion Criteria for participants with OCD:

* age 18-65
* Primary diagnosis of OCD
* Sufficient severity of OCD symptoms
* ability to tolerate a treatment-free period
* capacity to provide informed consent

Inclusion criteria for healthy controls:

* ages 18-65
* capacity to provide informed consent

Exclusion criteria for participants with OCD:

* Psychiatric or medical conditions that make participation unsafe
* pregnant or nursing females
* concurrent use of any medications that might increase the risk of participation (e.g. drug interactions)
* presence of metallic device or dental braces

Exclusion criteria for healthy controls:

* any current or lifetime psychiatric diagnosis
* pregnant or nursing females
* major medical or neurological problem
* presence of metallic device or dental braces

Primary outcomes:
measure: improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: Up to 6 months
Secondary outcomes:
measure: Regional gamma-aminobutyric acid, glutamate/glutamine levels derived from 3T Magnetic Resonance Spectroscopy
timeFrame: up to 90 minutes
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Carolyn I Rodriguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bandeira ID, Lins-Silva DH, Cavenaghi VB, Dorea-Bandeira I, Faria-Guimaraes D, Barouh JL, Jesus-Nunes AP, Beanes G, Souza LS, Leal GC, Sanacora G, Miguel EC, Sampaio AS, Quarantini LC. Ketamine in the Treatment of Obsessive-Compulsive Disorder: A Systematic Review. Harv Rev Psychiatry. 2022 Mar-Apr 01;30(2):135-145. doi: 10.1097/HRP.0000000000000330.
Clinical trial NCT03123796: Effects of Proton Pump Inhibitors on Kidney Transplant Recipients
Official title: Effects of Proton Pump Inhibitors on Kidney Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transplant Dysfunction
Magnesium Disorder
Keywords: chronic rejection
transplant outcome
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney transplant recipients.

Brief summary: Use of proton pump inhibitors (PPIs) is quite common among renal transplant recipients and reduced kidney functions and hypomagnesemia with the use of PPIs have been reported. In this study, investigation of the effects of PPI use on the outcome of kidney transplant recipients is aimed.

Detailed description: Use of proton pump inhibitors (PPIs) is frequent among renal transplant recipients due to the common use of glucocorticoids in immunosuppresive regimens after transplantation. Reduced kidney functions and hypomagnesemia with the use of PPIs have been reported in various patient populations. However, few studies examined the effects of PPIs on kidney transplant recipients. Therefore, the aim of this study is to investigate the effects of PPI and/or histamine H2 receptor antagonist use on serum magnesium levels, allograft functions and survival in kidney transplant recipients.

Eligibility criteria: Inclusion Criteria:

* Kidney transplant recipients who used only proton pump inhibitors and did not use histamine H2 receptor antagonists (Only PPI).
* Kidney transplant recipients who used histamine H2 receptor antagonists and did not use proton pump inhibitors (Only H2RA).
* Kidney transplant recipients who used both proton pump inhibitors and histamine H2 receptor antagonists (PPI and H2RA).
* Kidney transplant recipients who used neither proton pump inhibitors nor histamine H2 receptor antagonists (No Acid Suppressive Treatment).

Exclusion Criteria:

* Patients who are unwilling or unable to consent.

Primary outcomes:
measure: Graft survival
timeFrame: 5-10 years
Secondary outcomes:
measure: Graft rejection
timeFrame: 5-10 years
Other outcomes:
measure: Serum magnesium levels
timeFrame: 5-10 years
Locations:
city: İstanbul
country: Turkey
facility: Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
Study officials:
affiliation: Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
name: Yasar Caliskan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lazarus B, Chen Y, Wilson FP, Sang Y, Chang AR, Coresh J, Grams ME. Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease. JAMA Intern Med. 2016 Feb;176(2):238-46. doi: 10.1001/jamainternmed.2015.7193.
citation: van Boekel GA, Kerkhofs CH, van de Logt F, Hilbrands LB. Proton pump inhibitors do not increase the risk of acute rejection. Neth J Med. 2014 Feb;72(2):86-90.
Clinical trial NCT03533296: Individualized Positive End-expiratory Pressure Evaluation Using the Intratidal Compliance-volume Profile in Children
Official title: Individualized Positive End-expiratory Pressure Evaluation Using the Intratidal Compliance-volume Profile in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Compliance
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 47
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators assess the changes in respiratory compliance according to different levels of positive end expiratory pressure (PEEP) in children under general anesthesia. In addition, the investigators evaluate the intratidal compliance-volume profile at each PEEP level and determine the optimal PEEP level during anesthesia.


Eligibility criteria: Inclusion Criteria:

* Children undergoing surgery more than 1 hour under general anesthesia
* American Society Anesthesiologist physical status I, II

Exclusion Criteria:

* History of lung resection
* History of bronchopulmonary dysplasia or respiratory distress syndrome
* Abnormalities in chest radiography
* Laparoscopic surgery
* Abdominal surgery

Primary outcomes:
measure: Mean respiratory compliance
timeFrame: During 15 minutes after applying each level of PEEP
Secondary outcomes:
measure: Compliance profile
timeFrame: During 15 minutes after applying each level of PEEP
measure: Airway resistance
timeFrame: During 15 minutes after applying each level of PEEP
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital, Seoul National University College of Medicine
name: Jin-Tae Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JH, Ji SH, Lee HC, Jang YE, Kim EH, Kim HS, Kim JT. Evaluation of the intratidal compliance profile at different PEEP levels in children with healthy lungs: a prospective, crossover study. Br J Anaesth. 2020 Nov;125(5):818-825. doi: 10.1016/j.bja.2020.06.046. Epub 2020 Jul 15.
Clinical trial NCT05506696: Vitamin D Supplementation Study
Official title: A Feasibility Study of Perioperative Vitamin D Supplementation in Patients Undergoing Colorectal Cancer Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Vitamin D Deficiency
Keywords: colorectal
vitamin D
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Patients with colorectal cancer will be recruited to undergo vitamin D supplementation in the peri-operative period. Vitamin D levels (25OHD) will be measured to assess response to supplementation.

Detailed description: Patients with a new diagnosis of colorectal cancer will be recruited from colorectal outpatient clinics after confirmation of eligibility. Potential participants will be identified by their healthcare team comprising of clinical nurse specialist or surgeon and co-enrolment with portfolio studies including ALLEGRO and Prepare-ABC will be permitted. Patients undergoing neo-adjuvant therapy, already established on supplementary Vitamin D or with contra-indications to vitamin D supplementation will be excluded. After informed consent participants will undergo blood sampling at baseline (for 25OHD level and DNA) and given 3200IU cholecalciferol (Fultium) per day to take until the time of surgery (median time from pre-operative clinic 4 weeks). Further blood sampling will be performed on the day of surgery, in the early post-operative period (1-2 days, 3-5 days, 6-9 days) and at the first post-operative clinic appointment. Where possible surplus serum from clinically indicated blood tests will be collected to assay 25OHD and reduce need to additional venesection.

Eligibility criteria: Inclusion criteria -

* All participants will be aged 16 years or over.
* Participants must be resident in the United Kingdom.
* Undergoing bowel cancer surgery

Exclusion criteria

* Patients who may be at increased risk from Vitamin D supplementation including:
* Kidney disease
* High levels of calcium in the blood
* Atherosclerosis
* Sarcoidosis
* Histoplasmosis
* Over-active parathyroid gland (hyperparathyroidism)
* Lymphoma
* Currently taking thiazide diuretics, digoxin or other cardiac glycosides
* Known allergy to nuts (as peanut oil contained within vitamin D preparations)
* Female subjects of child bearing age who are not taking effective contraception during the period of the trial

Primary outcomes:
measure: 25OHD level
timeFrame: Peri-operative, up to 4 weeks post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
Study officials:
affiliation: University of Edinburgh
name: Malcolm Dunlop
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06407596: HILT or Conventional Combined Physical Therapy, in the Management of Hemiplegic Shoulder Pain
Official title: High-intensity Laser Therapy (HILT) or Conventional Combined Physical Therapy in the Management of Hemiplegic Shoulder Pain ; Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Shoulder Pain
Hemiplegia
Physical Therapy
High Intensity Laser
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 42
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: Background: Hemiplegic shoulder pain is one of the most common complications after a stroke. There are many treatment strategies for this complication. High-intensity laser therapy (HILT) is a new treatment option, and we aimed to compare the effectiveness of conventional electrotherapy agents and HILT in this study.

Patients and methods: Participants (N = 42) were randomized into the HILT (n = 21) and TENS+US (n = 21) groups. Group 1 received 3 sessions of HILT per week for 3 weeks in addition to a therapeutic exercise program that performed 5 sessions per week for 3 weeks. Group 2 received conventional physical therapy and a therapeutic exercise program for HSP of 5 sessions per week for 3 weeks. Patients were assessed before and after treatment on the on the 6th week for radiological evaluation with ultrasonography and for clinical parameters with VAS, AMAT, MRS, and FIQ scores.


Eligibility criteria: Inclusion Criteria:

* Diagnosed case of HSP,
* Age ≥18,
* First-ever unilateral stroke,
* Visual analog scale (VAS) ≥30 mm,
* Time since stroke ≥6 months,
* Time since last local intervention treatment \>6 months.

Exclusion Criteria:

* A history of shoulder pain prior to stroke;
* An unstable medical condition or uncontrolled systemic diseases (such as respiratory failure, congestive heart failure, liver and kidney dysfunction, or any other disorders affecting neuromuscular function);
* Bilateral hemiplegia;
* Cardiac pacemakers;
* Disturbance of awareness, severe visual and cognitive impairment, Mini-Mental State Examination score: \<23 points

Primary outcomes:
measure: visual analog scale
timeFrame: before treatment(baseline), after treatment
measure: arm motor ability test
timeFrame: before treatment(baseline), after treatment
measure: functional indepandance measures
timeFrame: before treatment(baseline), after treatment
measure: modified ranking scale
timeFrame: before treatment(baseline), after treatment
Secondary outcomes:
measure: ultrasonographic imaging
timeFrame: before treatment(baseline), after treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
state: Çankaya
Study officials:
References:
Clinical trial NCT01637896: A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation
Official title: A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation: the ELICOPTER Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Myocardial Ischemia
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 125
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: The purpose of this study is to evaluate the efficacy of predilation with paclitaxel-eluting balloon and bare metal stent implantation VS conventional balloon and drug-eluting stent implantation in terms of restenosis


Eligibility criteria: Inclusion Criteria:

* age\> 18 years
* angina or stress test positive for ischemia
* de novo coronary stenosis\>50%

Exclusion Criteria:

* recent myocardial infarction (\<72h)
* severe chronic kidney disease
* allergy to Paclitaxel
* contraindication for combined antiplatelet treatment
* life expectancy \<1 year
* hypersensitivity or contraindication to one of the study drugs
* lack of consent

Primary outcomes:
measure: angiographic binary re-restenosis
timeFrame: 9 months
Secondary outcomes:
measure: Late luminal loss
timeFrame: 9 months
measure: major adverse cardiac events
timeFrame: 12 months
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Cardiovascular Department, Ospedale S.Donato
state: AR
Study officials:
affiliation: San Donato Hospital
name: Leonardo Bolognese, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02069496: Drug Use Investigation for Arepanrix® (H1N1)
Official title: Drug Use Investigation for Arepanrix® (H1N1)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-02-24
Enrollment: 3405
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese subjects who receive Arepanrix® intramuscular injection for the first time

Brief summary: This post-marketing surveillance study is designed to collect safety information such as post-vaccination adverse events and adverse reactions from recipients of Arepanrix® (H1N1) Intramuscular Injection.

The following items will be investigated as priority investigation items. \<Priority investigation items\>

1. Allergic reactions
2. Anaphylaxis


Eligibility criteria: Inclusion Criteria:

* Subjects who receive Arepanrix® intramuscular injection for the first time

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: The number of recipients who have adverse reactions after injection
timeFrame: 29 days
measure: The number of recipients who have post-vaccination adverse events after injection
timeFrame: 29 days
measure: The number of recipients who have allergic reactions after injection
timeFrame: 29 days
measure: The number of recipients who have anaphylaxis after injection
timeFrame: 29 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Suminobu Ito et al. (2013) Post-marketing Surveillance of AS03-adjuvanted Influenza (H1N1) Vaccine in Japan. Pharma Medica. 31(4):135-141.
Clinical trial NCT00523796: InPractice Survey on the Treatment of Hypercholesterolemia
Official title: InPractice Survey on the Treatment of Hypercholesterolemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Keywords: dyslipidemia
in practice survey
Vietnam
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-09-03
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care

Brief summary: This is a multi-centre survey of patients who are currently on lipid-lowering pharmacological treatment. Data collection for each patient will take place at one visit.


Eligibility criteria: Inclusion Criteria:

* Subject must be 18 years of age or older of either sex.
* Subject is on lipid-lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.

Exclusion Criteria:

* Subjects who are unwilling or unable to provide informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Research Site
Study officials:
affiliation: Vietnamese Cardiovascular Association
name: Pham Gia Khai, Prof
role: STUDY_CHAIR
affiliation: Vietnamese Cardiovascular Association
name: Nguyen Manh Phan, Prof
role: STUDY_CHAIR
affiliation: AstraZeneca
name: Than Trong Son, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06748196: Awareness Among Physiotherapists About Effectiveness of Sensory Integration Therapy on Cerebral Palsy Population.
Official title: Awareness Among Physiotherapists of Khyber Pakhtunkhwa About the Effectiveness of Sensory Integration Therapy on Cerebral Palsy Population.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy (CP)
Keywords: Cerebral Palsy
Sensory Integration Therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Physical Therapists of Khyber Pakhtunkhwa

Brief summary: The study is to interrogate the awareness level of physiotherapists that are working in the region of KHYBER PAKHTUNKHWA, to access whether they know about sensory integration therapy or they use it for the patients of cerebral palsy in their treatment plan or not.

Detailed description: The study title is ''AWARENESS AMONG PHYSICAL THERAPISTS OF KHYBER PAKHTUNKHWA ABOUT THE EFFECTIVENESS OF SENSORY INTEGRATION THERAPY ON CEREBRAL PALSY POPULATION.' it is a cross-sectional study that will be conducted in the province of Khyber Pakhtunkhwa, Pakistan. The data will be conducted by 110 physical therapists on a self designed tool, that will allow us to know about the awareness among the physical therapist of this particular region to know if they are using sensory integration therapy in the treatment plan of the children suffering from cerebral palsy to know whether the sensory issues are being addressed over there by this therapy or not. Another purpose of this study is to make the therapists aware about sensory integration therapy and its efficacy in treating sensory processing and sensory integration issues present in the children that are suffering from cerebral palsy. The data will be collected by the physical therapists that are currently working in various hospitals of Khyber Pakhtunkhwa located in different regions of the province.

Eligibility criteria: Inclusion Criteria:

* Physical Therapists working across Khyber Pakhtunkhwa representative of all divisions of the province.
* Physical Therapists working as clinicians or working in healthcare vicinities from at least 2 years.

Exclusion Criteria:

* Non practicing Physical Therapists
* Freshly graduated Physical Therapists
* Physical Therapists working in areas other than Khyber Pakhtunkhwa

Primary outcomes:
measure: Survey tool awareness of Physical Therapists about sensory integration therapy
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International Lahore
name: Muhammad Shafique Akhtar, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Warutkar VB, Krishna Kovela R. Review of Sensory Integration Therapy for Children With Cerebral Palsy. Cureus. 2022 Oct 26;14(10):e30714. doi: 10.7759/cureus.30714. eCollection 2022 Oct.