louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01521026: Cognitive Training for Patients With Schizophrenia
Official title: Cognitive Training for Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Other Primary Psychotic Disorders
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2012-01-30
Enrollment: 69
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: This research on cognitive training addresses the following questions:

1. Does cognitive training lead to improved cognition, functional abilities, psychiatric symptoms, treatment adherence, or quality of life in patients with psychoses?
2. What are the neurocognitive and non-cognitive factors that predict good outcomes following cognitive rehabilitation? In addition to verbal learning and memory, immediate verbal memory, vigilance, and executive functioning, the cognitive training intervention attempted to improve prospective memory ability (i.e., the ability to remember to do things in the future, such as take medications or attend a doctor's appointment).


Eligibility criteria: Inclusion Criteria:

* Primary psychotic disorder (including schizophrenia, schizoaffective disorder, psychotic mood disorder, or psychosis NOS)
* Age 18 or older
* Fluency in English

Exclusion Criteria:

* Dementia
* Neurological conditions affecting cognition
* Mental retardation
* Substance use disorder within the past month
* Participation in other intervention trials

Primary outcomes:
measure: UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity)
timeFrame: 3 months
Secondary outcomes:
measure: Hopkins Verbal Learning Test Percent Retained
timeFrame: 3 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Outpatient Psychiatric Services
state: California
Study officials:
affiliation: UCSD
name: Elizabeth W Twamley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Twamley EW, Vella L, Burton CZ, Heaton RK, Jeste DV. Compensatory cognitive training for psychosis: effects in a randomized controlled trial. J Clin Psychiatry. 2012 Sep;73(9):1212-9. doi: 10.4088/JCP.12m07686. Epub 2012 Aug 7.
Clinical trial NCT00219726: Safety and Efficacy of Imatinib in Chronic Myelogenous Patients in Relapse After Stem Cell Transplantation
Official title: Phase II Trial to Study the Tolerability and the Effectiveness of Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase in Relapse After Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Myeloid Leukemia
Keywords: CML
Imatinib mesylate
Stem cell transplantation
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2005-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase who are in relapse after stem cell transplantation.

Detailed description: Patients will received Imatinib at a dose of 400mg daily. The tolerability of Imatinib given at a daily dose of 400mg will be assessed. The hematologic, cytogenetic and molecular responses will be evaluated at various check points.

Donor/recipient chimerism during Imatinib therapy will be assessed. Survival will be estimated.

Eligibility criteria: Inclusion Criteria:

* CML Ph+ (assessed by cytogenetic or FISH)
* Age ≥ 18 year at inclusion
* PS grade 0 to 2 (ECOG)
* previous allogeneic stem cell transplantation
* molecular, cytogenetic or haematological relapse in chronic phase after transplantation
* Immune therapy for graft versus host disease stopped within 2 months from inclusion
* Adequate and organ function, defined as the following: total bilirubin \<3x uln, sgpt \<3x uln, creatinine \<2x uln.
* informed consent sign up

Exclusion Criteria:

* Age less than 18 y
* accelerated or blastic phase
* previous therapy with imatinib
* active malignancy other than CML or non-melanoma cancer of the skin
* current treatment with another investigational agent

Primary outcomes:
measure: - to assess the tolerability of Imatinib given at a daily dose of 400mg
measure: - to evaluate the hematologic, cytogenetic and molecular responses at various check points.
Secondary outcomes:
measure: - to assess donor/recipient chimerism during Imatinib therapy
measure: - to evaluate the survival
Other outcomes:
Locations:
city: Poitiers
country: France
facility: University Hospital
Study officials:
affiliation: Department of Oncology Hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
name: François GUILHOT, MD
role: STUDY_CHAIR
affiliation: University Hospital "Saint-Louis" - Department of Hematology and Oncology - 75475 PARIS Cedex 10 (FRANCE)
name: Agnès DEVERGIE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01982526: Role of Anti Mullerian Hormone for Ovarian Reserve Determination of Preoperative and Postoperative Endometrioma Patients
Official title: Role of Anti Mullerian Hormone for Ovarian Reserve Determination of Preoperative and Postoperative Endometrioma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrioma
Surgery
Keywords: Ovarian reserve
Antimullerian hormone
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 30
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 42
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females who are administring gynecology clinic suffering from symptomatic benign ovarian cysts.

Brief summary: Ovarian reserve influenced by many factor but especially cysts like endometrioma. Anti mullerian hormone is recent marker for ovarian reserve. The investigators are searching ovarian reserve pre and post operatively by using antimullerian hormone of endometrioma patient who are operated for their cysts.

Detailed description: long term results of the postoperative follow up for the endometrioma patients

Eligibility criteria: Inclusion Criteria:

* Ultrasonographical symptomatic and benign cysts which has surgery indication.

Exclusion Criteria:

* Over 42 years old, systemic endocrine disorder, history of ovarian surgery

Primary outcomes:
measure: Long term postoperative ovarian reserve outcomes of endometrioma patients by examining antimullerian hormone.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Education and Research Hospital
Study officials:
References:
Clinical trial NCT06333626: Effects of an Oral Multi-vitamin Carbohydrate Beverage on Intraoperative Nausea and Vomiting
Official title: Effects of an Oral Multi-vitamin Carbohydrate Beverage on Intraoperative Nausea and Vomiting in Women Converted From Vaginal Delivery to Cesarean Section
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nausea and Vomiting, Aspiration, Intraoperative
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Nausea and vomiting are common and unpleasant symptoms for pregnant women during cesarean section, which can lead to aspiration, a serious complication that can cause pneumonia. Our study aimed to evaluate the effects of oral multi-vitamin carbohydrate beverage on maternal intraoperative nausea and vomiting by gastric ultrasound.


Eligibility criteria: Inclusion Criteria:

* at least 37 weeks pregnant, had not eaten for at least 4 h before entering the delivery room, converted from vaginal delivery to cesarean section

Exclusion Criteria:

* gestational diabetes mellitus or gastroesophageal reflux disease, cesarean section performed under general anesthesia

Primary outcomes:
measure: Gastric antrum area
timeFrame: one hour after eating, two hours after eating, and before entering operating room
Secondary outcomes:
measure: vomiting
timeFrame: During the cesarean section
measure: The pH of vomiting fluid
timeFrame: During the cesarean section
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00448526: Effect of Low Protein Diet in Preventing the Progression of Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Nephropathies
Keywords: Low protein diet, type 2 Diabetic nephropathy
Comparing the effect of Low protein Diet on diabetic nephropathy to that of normal protein diet
Lead sponsor: Kanazawa Medical University
Sponsor class: OTHER
First posted: 2007-03-19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Diabetic nephropathy is the leading cause of chronic kidney disease all the world in spite of progress in new treatment for diabetes and anti hypertensive drugs. Additional treatments are thus needed to arrest the progression of diabetic nephropathy. Although there is insufficient evidence to suggest that a low-protein diet improves renal dysfunction, it is recommended as a mainstay of nutritional management. We here assessed the role of low protein diet in renal function as well as albuminuria in type 2 diabetic patients with nephropathy for a median of 5 years.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Urinary protein excretion 1-10 g/day
* Serum Cr \<2.0 mg/dl
* With diabetic retinopathy \> SDR
* Normal protein intake instruction
* Patients whose consent is obtained at \>20 or age =\<65

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* Non-diabetic nephropathy
* Urinary tract infection
* Congestive heart failure
* Unstable angina
* Myocardial infarction
* Stroke
* Severe hepatopathy
* Life threatening disease such as malignant tumor
* Patients on ACE-I and or ARB treatment
* Patients on instruction of low protein diet
* BW\< 80% of IBW
* Pregnant, lactating, and probably pregnant patients
* Patients judged as being inappropriate fir the subjects

Primary outcomes:
measure: annual change of GFR
measure: annual change of Ccr
measure: annual change of 1/Cr
measure: incidence rate of the doubling of sCr
measure: time to the doubling of sCr
Secondary outcomes:
measure: urinary albumin and protein excretion
measure: % change of urinary albumin and protein excretion from baseline
Other outcomes:
Locations:
Study officials:
affiliation: Shiga University of Medical Science
name: Ryuichi Kikkawa, M.D.
role: STUDY_DIRECTOR
References:
citation: Koya D, Haneda M, Inomata S, Suzuki Y, Suzuki D, Makino H, Shikata K, Murakami Y, Tomino Y, Yamada K, Araki SI, Kashiwagi A, Kikkawa R; Low-Protein Diet Study Group. Long-term effect of modification of dietary protein intake on the progression of diabetic nephropathy: a randomised controlled trial. Diabetologia. 2009 Oct;52(10):2037-45. doi: 10.1007/s00125-009-1467-8. Epub 2009 Aug 4.
Clinical trial NCT04238026: Distal Radial Artery Approach to Prevent Radial Artery Occlusion (DAPRAO)
Official title: Distal Radial Artery Approach to Prevent Radial Artery Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radial Artery Occlusion
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two randomized groups, one receiving traditional radial access and the other receiven distal radial access
Primary purpose: PREVENTION

Brief summary: The main complication of transradial intervention is radial artery occlusion (RAO). This is relevant because it limits the radial approach for future interventions and disables this conduit for coronary bypass grafts and arteriovenous fistula. Observational studies suggest that distal radial access could reduce RAO incidence.

The primary endpoint of our study is to compare the efficacy of the distal and proximal transradial approaches in terms of RAO incidence. The safety endpoint is the incidence of complications between these two methods.


Eligibility criteria: Inclusion Criteria:

* Perceptible radial artery pulse
* Diagnostic or interventional procedure feasible to be performed with radial access.

Exclusion Criteria:

* Myocardial infarction with ST segment elevation in time for primary angioplasty.
* Cardiogenic shock or hemodynamic instability.
* Clinical, plethysmography or ultrasound suggestive of occlusion of the radial artery
* Prior recent radial artery access (1 month)

Primary outcomes:
measure: The primary endpoint of our study is to compare the efficacy of the distal and proximal transradial approaches in terms of RAO incidence.
timeFrame: The RAO will be evaluated 24 hours after the procedure by ultrasound examination and was defined as the absence of both color pattern and pulsed wave registry.
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Institute of Cardiology
Study officials:
References:
Clinical trial NCT03862326: Pilot Study - Patient Education and Pelvic Strength Exercises in Elderly Women With Incontinence.
Official title: The Effect of Group-, Individual-, and Ultrasound Guided Pelvic Floor Training on Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: University College of Northern Denmark
Sponsor class: OTHER
Collaborators: name: Aalborg Municipality
First posted: 2019-03-05
Enrollment: 46
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 arms, one with group exercises, one with individual exercises and one with ), Individual exercises guided by ultrasonography imaging
Primary purpose: SUPPORTIVE_CARE

Brief summary: It will be investigate if women with a diaper grant in Aalborg Municipality can reduce diaper size and thus costs for diapers in the municipality through meetings with a incontinence nurse and pelvic floor exercises.

Detailed description: Incontinence is a world wide challenge especially in elderly women. The participation in pelvic floor exercises can to some extent help women with urinary incontinency. In the Municipality of Aalborg in Denmark, the citizens can get a diaper grant, if they are incontinence. The project will be recruiting women with diaper grants and randomly allocate the women to 3 different groups 1) Group training (usual care), 2) Individual training and 3) Individual training with biofeedback in the form of ultrasound. All groups will receive the same incontinence education from the incontinence nurses and physiotherapists. The Women will be offered 6 individual or 10 group base trainings, with increased time between trainings, to increase the participants independency and rely more on home based exercises.

Eligibility criteria: Inclusion Criteria:

Diaper grant

* Urinary incontinency Living in own home in Aalborg Municipality

Exclusion Criteria:

* Dementia Inability to transport herself to the training facility neurological diseases inability to understand Danish or bring a translator

Primary outcomes:
measure: Pelvic floor strength
timeFrame: Change compared to baseline after 12 week intervention
measure: Pelvic floor strength
timeFrame: Change compared to baseline 3 months after end of intervention.
Secondary outcomes:
measure: Change in life quality - UDI-6
timeFrame: after 12 weeks of exercise and 3 months follow-up
measure: Change in life quality IIQ-7
timeFrame: after 12 weeks of exercise and 3 months follow-up
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Signe Refsgaard Bech
Study officials:
affiliation: University College of Northern Denmark
name: Signe R Bech, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05634226: Simple Non-invasive Breathing Device to Improve Pulmonary Flow Pusatility in Single Ventricle Post Fontan
Official title: Oral Positive Pressure Device (oPEP) Effect on Flow Pulsatility in the Fontan Circuit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Single-ventricle
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 15
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a pilot study using a novel, minimal risk, portable, hands-free oral-positive pressure device (oPEP) in patients with Fontan palliation that will examine whether using this device in both the acute and chronic phase will alter Fontan hemodynamics and create pulsatility in the Fontan circuit and thereby increasing cardiac output. This device is easy to use and poses no significant risk to human subjects. The investigators will measure this through echocardiographic measures including pulsatility in different aspects of the Fontan circuit including IVC, hepatic veins, the Fontan conduit, and pulmonary arteries and aortic blood flow measurements. After demonstration of how to use the device appropriately, the investigators will have patients use the device after their clinical echocardiogram for their clinic appointment. The investigators will ask them to use the device at home 3-4 times a day for 10-15 mins and have them return in approximately 4 weeks to have another echocardiogram done with the same measurements.

Detailed description: The aortic VTI secondary outcome was inadvertently left out of the initial registration and is now reported

Eligibility criteria: Inclusion Criteria:

* Patients with single ventricle with Fontan palliation
* Over the age of 8 years who would be cooperative with breathing through the oPEP device

Exclusion Criteria:

* Patients with Fontan palliation under the age of 8 years
* Patients who have interrupted inferior vena cava
* Patients with abnormal pulmonary artery anatomy

Primary outcomes:
measure: Change in Pulmonary Pulsatility Index
timeFrame: The change is between enrollment echocardiogram and echocardiogram after 4 week use of the device
Secondary outcomes:
measure: Aortic Valve VTI
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital Pittsburgh
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00670826: Comparison Study of Intraoperative Patient Warming Systems
Official title: Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHEAT Temperature Management System(vH2)With the Arizant Bair Hugger System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthopedic Surgery
General Anesthesia
Keywords: Patient warming
Lead sponsor: Dynatherm Medical Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-02
Enrollment: 100
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: Medications used to put people to sleep during surgical procedures also cause changes in the body's ability to control its temperature. These changes can make a person's temperature drop below normal. To minimize this drop in body temperature, different types of body warming products are used during surgery. This study is designed to compare the the temperatures of people under general anesthesia after 60 minutes of warming with each product. The study hypothesis is that the people warmed with the Dynatherm Medical vitalHEAT vH2 System will decrease less in the first 60 minutes of warming time than people warmed with the Arizant Bair Hugger System.


Eligibility criteria: Inclusion Criteria:

* Pts undergoing orthopedic surgical procedure with expected duration 2-3 hrs
* General anesthesia required
* ASA physical status I-III

Exclusion Criteria:

* General anesthesia plus epidural anesthesia required
* Skin abrasions/trauma to extremity selected as application site
* History of peripheral vascular disease
* History of malignant hyperthermia
* Unwilling/unable to give consent

Primary outcomes:
measure: Compare esophageal temperatures after 60 minutes of warming with each system
timeFrame: 60 minutes of patient warming
Secondary outcomes:
measure: Compare esophageal temperature trends during surgical procedures
timeFrame: Every 15 minutes during procedure
measure: Compare sublingual temperatures of patients in PACU
timeFrame: Within 10 minutes of arrival in PACU
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Kent P Weinmeister, MD
role: PRINCIPAL_INVESTIGATOR
References: