louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00057291: Effect of Improving Caregiving on Early Mental Health
Official title: Effect of Improving Caregiving on Early Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development Disorders
Keywords: Orphanage
Caregiving
Training
Child development
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2003-04-01
Enrollment: 1521
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the effect on children and caregivers of providing training in warm, sensitive, responsive caregiving to caregivers in three orphanages in St. Petersburg, Russia. The study also assesses the effectiveness of having more consistent care from fewer caregivers in a family-like environment.

Detailed description: This project will provide experimental evidence that warm, sensitive, responsive caregiving and structural changes that promote more consistent and fewer caregivers will lead to better physical, mental, social, and emotional development of young children. Structural changes are designed to facilitate a more family-like environment and include smaller group sizes, more consistent caregiving from fewer caregivers, integration by age and disability status, and establishing two daily 60-minute Family Hours in which children and caregivers interact together. The project also attempts to demonstrate that training caregivers can be beneficial to both caregivers and children.

All caregivers and children in three orphanages for children under 4 years old in St. Petersburg, Russia will participate in this study. One orphanage will implement both training and structural changes. A second orphanage will receive training only. The third orphanage will serve as a control, receiving neither training nor structural changes. Caregivers are assessed annually for attitudes to and problems with their jobs; anxiety and depression; coping styles; traditional versus progressive attitudes toward caregiving; sensitivity to children's emotions; values; and perceptions of their own relationships. Children are assessed at 3, 6, 9, 12, 18, 24, 36, and 48 months for physical growth, chronic and acute disorders, functional abilities, and mental, motor, social, and emotional development.

Eligibility criteria: Inclusion Criteria

* All caregivers and children in three Baby Homes in St. Petersburg, Russia, who remain in the Baby Homes for at least 4 months.

Primary outcomes:
measure: children's physical growth
timeFrame: 4 to 9+ months
measure: Children's development (mental, motor, social and emotional)
timeFrame: 4 to 9+ months
Secondary outcomes:
Other outcomes:
Locations:
city: St. Petersburg
country: Russian Federation
facility: Baby Home #13
state: Canal Gnboedora 98
Study officials:
affiliation: University of Pittsburgh
name: Robert B. McCall
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01700491: Pilot Study: Paravertebral Analgesia vs Epidural Analgesia After Thoracotomy
Official title: Pilot Study: A Non-Inferiority Trial of the Analgesic Effect of Paravertebral Analgesia to Epidural Analgesia for the Management of Post-Operative Pain After Thoracotomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hypotension
Keywords: Paravertebral Catheter
Epidural Catheter
Analgesia
Hypotension
Analgesia,Epidural
Analgesia,Paravertebral
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Paravertebral analgesia is non-inferior to epidural analgesia for pain control and superior to epidural analgesia in terms of the main complication of hypotension.

Detailed description: There is some evidence that paravertebral analgesia is similar to epidural analgesia in efficacy but superior in maintenance of blood pressure. This is a double blind, randomized control trial comparing paravertebral catheters to epidural catheters for the management of post thoracotomy analgesia. Both groups will undergo placement of a pre-induction epidural catheter as well as a surgically placed paravertebral catheter. Patients will also receive PCA morphine. The primary outcome will be daily morphine use measured in milligrams. The co-primary outcome will be time spent with a systolic blood pressure below 90mmHg. Outcomes will be measured during the first five postoperative days.

Eligibility criteria: Inclusion Criteria:

* Open thoracotomy
* Age \> 18 yo
* Able to use a patient controlled analgesia device

Exclusion Criteria:

* Previous thoracotomy
* Previous spine surgery
* Chronic pain condition
* Ongoing narcotic use
* Prior narcotic abuse
* Active chest infection
* Chest trauma
* Anticoagulation
* Other contraindication to epidural catheter placement
* Allergy to local anesthetic or narcotic

Primary outcomes:
measure: Analgesic Effect
timeFrame: At postoperative day 5
Secondary outcomes:
measure: Hypotension
timeFrame: At postoperative day 5
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Sadeesh Srinathan, MD, FRCS C-Th, FRCS(C)
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Stephen Kowalski, MD, FRCP
role: STUDY_CHAIR
affiliation: University of Manitoba
name: Rob Brown, MD, FRCP
role: STUDY_DIRECTOR
affiliation: University of Manitoba
name: Purnima Rao, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01300091: Burden and Outcome of Shoulder Disorders in Primary Health Care
Official title: Burden and Outcome of Shoulder Disorders in Primary Health Care
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Shoulder Pain
Shoulder Mobility Impairment
Keywords: Shoulder
Pain
Range of Motion
Disability Evaluation
Function
Sick Leave
Primary Health Care
Visual Analog Scale
Visual Analog Pain Scale
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form
Lead sponsor: Central Finland Hospital District
Sponsor class: OTHER
First posted: 2011-02-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients consulting a general practitioner due to shoulder disorder during the recruitment period are included. The study population consists of two public health centres with a population of 120 000 individuals and two occupational medicine clinics with a population of 15 000 individuals. The population of health centres and occupational health clinics overlap partially.

Brief summary: Consumption of medical care and outcome of shoulder pain and disability in primary care.

Detailed description: Shoulder pain and impairment are common in primary health care. The prognosis of several individuals consulting for a new episode of shoulder problem is surprisingly poor. The objectives are to characterize the consumption of medical care and outcome of shoulder pain and disability in primary health care.

A composite questionnaire consisting of demographic information and ASES questionnaire was used to measure the shoulder function. The patients were sent a second questionnaire after one year.

Eligibility criteria: Inclusion Criteria:

* All individuals suffering from shoulder pain or impairment

Exclusion Criteria:

* No

Primary outcomes:
measure: Consumption of medical care
timeFrame: one year
Secondary outcomes:
measure: Development of the ASES score
timeFrame: one year
Other outcomes:
Locations:
city: Jyvaskyla
country: Finland
facility: Central Finland Hospital District
Study officials:
References:
citation: Dorrestijn O, Greving K, van der Veen WJ, van der Meer K, Diercks RL, Winters JC, Stevens M. Patients with shoulder complaints in general practice: consumption of medical care. Rheumatology (Oxford). 2011 Feb;50(2):389-95. doi: 10.1093/rheumatology/keq333. Epub 2010 Nov 2.
citation: Reilingh ML, Kuijpers T, Tanja-Harfterkamp AM, van der Windt DA. Course and prognosis of shoulder symptoms in general practice. Rheumatology (Oxford). 2008 May;47(5):724-30. doi: 10.1093/rheumatology/ken044. Epub 2008 Apr 14.
Clinical trial NCT03303391: Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration
Official title: Using Intradialytic Systolic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients: A Validation Study and Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: ESRD
Extracellular Fluid Alteration
Hypertension
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2017-10-06
Enrollment: 14
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: TREATMENT

Brief summary: This study is an open label randomized clinical trial that comparing intradialytic blood pressure slope-based ultrafiltration prescriptions to standard care in the chronic fluid management of maintenance hemodialysis patients. It also includes a cross sectional component evaluating the associations between intradialytic blood pressure slopes ascertained over 2 week periods with measurements of extracellular water/body weight obtained with multifrequency bioimpedance spectroscopy.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* End Stage Renal Disease on Maintenance Hemodialysis
* Hypertension defined as systolic blood pressure \> 140 mmHg pre-dialysis or \>130 mmHg post dialysis

Exclusion Criteria:

* Hemodialysis Vintage \< 1 month
* Pregnancy
* Nadir Systolic Blood Pressure \< 95 mmHg
* Pre or Post dialysis systolic blood pressure \> 180 mmHg
* Decrease in systolic blood pressure \>60 mmHg from pre to post dialysis
* Ultrafiltration rate \>13 mL/kg/hr
* Peridialytic Midodrine Use
* Intradialytic Clonidine use
* Documented Antihypertensive Medication Non-adherence

Bioimpedance will not be peformed on patients with

* amputated arms or legs
* cardiac defibrillator or pacemaker
* presence of metal prostheses

Primary outcomes:
measure: Change in Mean Ambulatory Systolic Blood Pressure
timeFrame: Baseline, 4 months
Secondary outcomes:
measure: Change in Extracellular Volume/Body Weight Ratio
timeFrame: Baseline, 4 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Davita Dialysis
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Peter Van Buren, MD, MSCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01400191: The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1
Official title: The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1 (OCT1) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pharmacogenetics of Metformin
Keywords: Metformin
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Gluconeogenesis
Pharmacodynamics
Pharmacogenetics
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
First posted: 2011-07-22
Enrollment: 37
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: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of the study is to evaluate the pharmacodynamic impact of metformin in healthy Caucasian volunteers with and without single polymorphisms M420del or R61C in OCT1, thus the study hypothesis is that metformin only affect the hepatic gluconeogenesis in healthy volunteers with functional OCT1-transporters.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Written consent
* Genotyped in OCT1 for (M420del and R61C)

Exclusion Criteria:

* Daily medication
* Alcohol abuse
* Pregnancy
* Breastfeeding

Primary outcomes:
measure: Endogenous glucose production
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Clinical pharmacology, Institute og public health, University of Southern Denmark
Study officials:
affiliation: Department of Public Health, Clinical Pharmacology, University of Southen Denmark
name: Mette Marie H Christensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christensen MM, Hojlund K, Hother-Nielsen O, Stage TB, Damkier P, Beck-Nielsen H, Brosen K. Endogenous glucose production increases in response to metformin treatment in the glycogen-depleted state in humans: a randomised trial. Diabetologia. 2015 Nov;58(11):2494-502. doi: 10.1007/s00125-015-3733-2. Epub 2015 Aug 14.
Clinical trial NCT00746291: Heart Rate Variability (HRV) Among Children With Brain Damage
Official title: Assessment of Autonomic Nervous System With Analysis of Heart Rate Variability in Children With Brain Damage.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Brain Injury
Cerebral Palsy
Lead sponsor: Alyn Pediatric & Adolescent Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 80
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to investigate the function of the autonomic nervous system in children with with post traumatic brain injury and children with cerebral palsy through an analysis of heart rate variability (HRV) occurring with walking performance.

Detailed description: 40 children with brain damage (20 with post TBI and 20 with CP)and 40 typically developed children will be participate in this study. ECG signals during rest and walking (for 6 minute and during step climbing) will be recorded.

Eligibility criteria: Inclusion Criteria:

* able to walk independently

Exclusion Criteria:

* can not follow simple commands

Primary outcomes:
measure: HRV parameters
timeFrame: during the assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Alyn Pediatric and Adolescent Rehabilitation Center
Study officials:
affiliation: Alyn Hopspital Jerusalem
name: Hemda Rotem
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01340391: Safety Study on a Wood-plastic Composite Cast
Official title: A Wood-plastic Composite Cast - a New Ecological Splinting Method
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Radius Fracture
Keywords: cast, radius fracture
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2011-04-22
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An ecologically friendly and biodegradable wood-plastic composite-cast is studied. Patients, who has sustained a distal radius fracture in need of splinting are requested to participate in the study.


Eligibility criteria: Inclusion Criteria:

* distal radius fracture not older than 14 days
* age 17-90 years
* mother tongue finnish or swedish

Exclusion Criteria:

* open fracture
* other fractures or a previous fracture
* a previous or simultaneous tendon-, nerve- or vascular injury to the upper extremity
* a multiple injured hand
* decreased co-operation of the patient
* malignancy
* an illness affecting the general health

Primary outcomes:
measure: How well will the material fulfil the demands of a splinting material
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Central Hospital- Helsinki University
name: Nina C Lindfors, MD, PhD, MSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00169091: Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia
Official title: Clozapine or Haloperidol in First Episode Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Clozapine
Haloperidol
Schizophrenia
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Dartmouth-Hitchcock Medical Center
name: Commonwealth Research Center, Massachusetts
name: Novartis
First posted: 2005-09-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the physical responses brought on by clozapine and haloperidol in people experiencing their first episode of schizophrenia.

Detailed description: This is a longitudinal double blind, 2- 5 year study of the clinical, neuroendocrine and biochemical response to clozapine (CLOZ) and haloperidol (HAL) in a group of "first episode" schizophrenic (RDC) patients. Within the protocol, we compare the differential effects of the two drugs over the short term (12 weeks) and the long-term (2-5 years); we evaluate the relationship between change in prolactin level and clinical response of the patients; and we search for biochemical predictors and correlates of clinical response. To achieve the study aims, we employ a drug-washout period, a 12-week acute treatment period; and an 88 - 260 week follow-up period.

Eligibility criteria: Inclusion Criteria:

* RDC diagnosis of schizophrenia
* Men and women, without regard to race/ethnicity,
* Aged 18-45
* Acutely psychotic with a score of at least 3 on one of the psychotic scale items of the Brief Psychiatric Rating Scale (BPRS) (hallucinations, delusions, conceptual disorganization) and a total BPRS of \> 21 (on a 0 - 6 scale);
* Require treatment with neuroleptic drugs on a clinical basis;
* The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent;
* Be within the first episode of a psychotic disorder;
* Have a history of neuroleptic treatment of \< 12 weeks;
* Likely to remain in the study for 2 years.

Exclusion Criteria:

* Substance dependence in the last six months
* History of seizure or blood dyscrasia
* Major medical illness
* Pregnancy or Lactation

Primary outcomes:
measure: Brief Psychiatric Rating Scale
timeFrame: Weekly during the Acute Treatment Phase and every two weeks in Follow-Up
Secondary outcomes:
Other outcomes:
Locations:
city: Jamaica Plain
country: United States
facility: Commonwealth Research Center
state: Massachusetts
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Alan I Green, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Green AI, Schildkraut JJ. Should clozapine be a first-line treatment for schizophrenia? The rationale for a double-blind clinical trial in first-episode patients. Harv Rev Psychiatry. 1995 May-Jun;3(1):1-9. doi: 10.3109/10673229509017159.
Clinical trial NCT05960591: Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures
Official title: Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures: a Monocenter Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fractures, Bone
Osteosynthesis
Lead sponsor: SLAM Ortho B.V.
Sponsor class: INDUSTRY
Collaborators: name: Erasmus Medical Center
First posted: 2023-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized in either the control group (bore depth measurement with the manual depth gauge) or in the intervention group (bore depth measurements with the ADEPTH sensor).
Primary purpose: OTHER

Brief summary: The goal of this monocenter randomized pilot study is to investigate the usability of the ADEPTH sensor for bore depth measurements in plate osteosynthesis procedures. The main question it aims to answer is:

- What is the usability score of the ADEPTH sensor for bore depth measurements during plate osteosynthesis procedures? Participants will receive either bore depth measurements with the ADEPTH sensor or with the manual depth gauge.

Detailed description: To assess the usability score of the ADEPTH sensor for bore depth measurements in plate osteosynthesis procedures. The surgeon and OR-assistant will fill in one survey after performing 3 operations with the ADEPTH sensor and one survey after performing 3 operations with the manual depth gauge.

Eligibility criteria: Inclusion Criteria:

* Elective plate osteosynthesis procedure (clavicula, humerus, radius, ulna, femur, tibia, fibula, malleoli) (incl. delayed union, nonunion, malunion)
* Needed surgical instrument net: 2.4 / 2.7 / 3.5-4.0 / 4.5-5.0-6.5
* Adults (≥ 18 years)
* Written informed consent by patient

Exclusion Criteria:

* Bone disease (dysplasia's, sarcomas, chondroma's, osteolysis, osteomyelitis)
* Variable angle plates
* Corrective surgery after previous plate osteosynthesis procedure or hardware removal

Primary outcomes:
measure: Usability score of the ADEPTH sensor for bore depth measurements in plate osteosynthesis
timeFrame: Surgeon and OR assistant fill in the SUS after 3 operations in each study group. Anticipated study duration is 6 months.
Secondary outcomes:
measure: Duration in seconds of the fixation process per screw during plate osteosynthesis
timeFrame: In both study groups the operation will be recorded. Anticipated study duration is 6 months.
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
References: