louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00759772: The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa
Official title: The Role of PTH in Low Bone Mass in Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anorexia Nervosa
Osteoporosis
Keywords: Anorexia Nervosa
Disordered Eating
Osteoporosis
Parathyroid Hormone
Bone
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2008-09-25
Enrollment: 23
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Decreased bone strength is a common and serious medical problem present in many women with anorexia nervosa, or disordered eating. Women with decreased bone strength are more likely to suffer broken bones than women with normal bone strength.

We are investigating whether a hormone that is naturally produced by the human body -- parathyroid hormone (PTH) -- can help strengthen the bones of women with anorexia nervosa.

Detailed description: Anorexia Nervosa affects 0.5-1% of college-age women in the US and is associated with a number of significant medical conditions including bone loss. A majority of women with anorexia nervosa have bone loss and 50% have bone mineral density measurements greater than 2 standard deviations below normative means. Bone loss in anorexia nervosa is characterized by a decrease in bone formation, therefore therapy with an anabolic agent may be an effective treatment approach. In a randomized, single-blinded, placebo-controlled trial, we will study the effects of parathyroid hormone on low bone mass in anorexia nervosa, specifically looking at the effects of parathyroid hormone on bone mineral density (primary outcome).

Eligibility criteria: Inclusion Criteria:

* Anorexia Nervosa
* Women, age 30-70 years
* Osteoporosis or history of clinical fractures (spine, wrist, hip or ribs)

Exclusion Criteria:

* Diseases known to affect bone metabolism
* Hyperparathyroidism
* Medications known to affect bone metabolism in last 12 weeks (or bisphosphonate use in last 1 year)
* Pregnant and/or breastfeeding
* Diabetes mellitus
* History of malignancy involving or affecting the bone, any active malignancy, and/or radiation therapy to the bone
* Fractures of a bone other than a finger or toe in last 1 year

Primary outcomes:
measure: Percent Change in Lumbar Spine Bone Mineral Density
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Pouneh K Fazeli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06014372: Envafolimab Monotherapy or Envafolimab + CAPEOX as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer
Official title: A Prospective, Single-center, Multi-cohort Study of Envolimab Monotherapy or Envafolimab in Combination With CAPEOX as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Colon Cancer
Neoadjuvant Therapy
Immunotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There exists substantial evidence suggesting that patients diagnosed with MSI-H/dMMR colorectal cancer can derive benefits from immunotherapy in the management of advanced colorectal cancer. In cases of locally advanced colorectal cancer exhibiting microsatellite instability (dMMR/MSI-H), patients exhibit low responsiveness to neoadjuvant chemotherapy, resulting in minimal rates of complete tumor remission and downstaging. Nevertheless, initial exploratory studies, characterized by modest sample sizes, reveal a favorable therapeutic effect of neoadjuvant immunotherapy in this particular patient population. Envafolimab monoclonal antibody, the first PD-L1 antibody developed and manufactured in China, possesses noteworthy practical and societal value in the context of exploratory clinical research on neoadjuvant immunotherapy for locally advanced MSI-H/dMMR colorectal cancer patients. The objective of this study is to evaluate the safety and efficacy of envafolimab monoclonal antibody (PD-L1) as neoadjuvant therapy for locally advanced MSI-H/dMMR colorectal cancer through a prospective, multi-cohort phase II clinical trial. Additionally, this study aims to investigate the effectiveness and safety of envafolimab monoclonal antibody in combination with CAPEOX as a neoadjuvant treatment regimen for locally advanced pMMR colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Pathological confirmed rectal cancer
* Clinical stage T3-4 or T any N1
* With or without MRF positivity, with or without EMVI positivity
* R0 resection is estimated
* Age ranged from 18 to 70

Exclusion Criteria:

* Clinical stage T1-2 N0
* Distance metastasis
* Multiple primary tumor
* Cachexy

Primary outcomes:
measure: Rate of pCR
timeFrame: Time Frame: One week after surgery
Secondary outcomes:
measure: DFS
timeFrame: 3 years
Other outcomes:
measure: OS
timeFrame: 5 years
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT04701372: Clinical Outcomes From NOCD Treatment of Obsessive-Compulsive Disorder Using Exposure and Response Prevention
Official title: Clinical Outcomes From NOCD Digital Behavioral Health Treatment of Obsessive-Compulsive Disorder Using Exposure and Response Prevention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obsessive-Compulsive Disorder
Keywords: exposure and response prevention
digital behavioral health
remote treatment
video therapy
Lead sponsor: NOCD
Sponsor class: INDUSTRY
First posted: 2021-01-08
Enrollment: 2069
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a naturalistic sample of children, adolescents, and adults with obsessive-compulsive disorder (OCD) who sought treatment for OCD from NOCD, LLC, a digital behavioral health company.

Brief summary: This is a naturalistic, observational study of individuals with obsessive-compulsive disorder who were treated with exposure and response prevention via video teletherapy, augmented with between-session support with text messaging and an online community forum.


Eligibility criteria: Inclusion Criteria:

* obsessive-compulsive disorder

Exclusion Criteria:

* none

Primary outcomes:
measure: Dimensional Obsessive-Compulsive Scale
timeFrame: change from pre-treatment to post-treatment (after 11 weeks)
Secondary outcomes:
measure: Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) OCD severity scale
timeFrame: pre-treatment, after 4 weeks, and post-treatment (after 11 weeks)
measure: Depression Anxiety and Stress Scale (DASS-21)
timeFrame: pre-treatment, after 4 weeks, and post-treatment (after 11 weeks)
measure: Quality of Life Enjoyment and Satisfaction Questionnaire -- Short Form (QLES-Q)
timeFrame: pre-treatment, after 4 weeks, and post-treatment (after 11 weeks)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Nocd, Llc
state: Illinois
Study officials:
References:
Clinical trial NCT02544672: Function Benefits of a Myoelectric Elbow-Wrist-Hand Orthosis
Official title: Function Benefits of a Myoelectric Elbow-Wrist-Hand Orthosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebrovascular Accidents
Lead sponsor: Myomo
Sponsor class: INDUSTRY
First posted: 2015-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The objective of this study is to evaluate the functional benefits of a myoelectric Elbow-Wrist-Hand orthosis for persons with upper limb paralysis caused by a cerebrovascular accident (CVA).

Detailed description: The objective of this study is to evaluate the functional gains provided by a myoelectric Elbow-Wrist-Hand orthosis for CVA patients with hemiparesis. The subjects will be fit with the device, provided general training in the operation of the EMG-controlled technology, and then guided through a series of standard clinical outcome measures used routinely as part of stroke rehabilitation medicine. The outcome measures employed in this study include the Fugl-Meyer assessment, the Box and Blocks test, and a battery of common functional tasks and activities. These outcome measures will allow the researchers to approximate the changes in the subjects' ability to successfully perform functional tasks with and without the MyoPro device.

Eligibility criteria: Inclusion Criteria:

* Adults over 18 years.
* Upper limb impairment caused by any stroke (CVA)
* Minimum of trace MMT (1/5) in Biceps and/or Triceps
* Full Passive range of motion in elbow, forearm, wrist, and hand
* Active shoulder flexion of at least 30 degrees of shoulder abduction of at least 20 degrees
* Score of at least 20 on the Mini Mental Status Examination.
* Ability to read and comprehend the English language.
* Ability to generate consistent, detectable EMG signal from the upper arm and forearm sensor sites with wrist in neutral or flexed positions.

Exclusion Criteria:

* Fixed upper limb contractures on affected side.
* Subjects with severe spasticity or tone (defined as 3 or more on the Modified Ashworth Scale).
* Inability to follow three step directions.
* Severe shoulder subluxation, pain or shoulder dislocation.
* Passive shoulder range of motion less than 45 degrees in flexion and abduction.
* Pain or hypersensitivity in the arm(s)

Primary outcomes:
measure: Fugl-Meyer Assessment Upper Extremity (FMA-UE)
timeFrame: 2 hours
measure: Modified Ashworth Scale
timeFrame: 2 hours
measure: Box and Blocks Test
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chardon
country: United States
facility: GRE Chardon
state: Ohio
Study officials:
References:
Clinical trial NCT01631968: Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement
Official title: Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection After Primary Total Knee Arthroplasty
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 2948
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: Prospective randomized study in cemented primary total knee arthroplasty. In one group the cement used was standard cement, without any antibiotics and in the other group the cement used was loaded with 0.5 g of erythromycin and 3 million units of colistin in 40 g of cement. In all cases intravenous antibiotics prophylaxis against infection was used. In both groups the cement was mechanically mixed in a vacuum. One deep drain tube was placed for 24 hours in all cases. The main variable was the presence of infection according to the Center of Disease Control criteria with a minimum of 12 months follow-up.


Eligibility criteria: Inclusion Criteria:

* Primary total knee replacement. Both genders. No age limits.

Exclusion Criteria:

* Allergy to erythromycin or colistin. Previous infection in the knee.

Primary outcomes:
measure: Infection
timeFrame: The minimum follow-up is 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Esperanza.
Study officials:
References:
citation: Hinarejos P, Guirro P, Leal J, Montserrat F, Pelfort X, Sorli ML, Horcajada JP, Puig L. The use of erythromycin and colistin-loaded cement in total knee arthroplasty does not reduce the incidence of infection: a prospective randomized study in 3000 knees. J Bone Joint Surg Am. 2013 May 1;95(9):769-74. doi: 10.2106/JBJS.L.00901.
Clinical trial NCT01699568: Stability of Implants With Different Surface Treatment: Randomized Clinical Trial
Official title: Stability of Implants With Different Surface Treatment: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Edentulous Jaws Partially
Keywords: dental implant stability
dental implant surface treatment
resonance frequence analysis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 42
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Objectives: To compare the stability of implant surface treated by dual acid etching (Porous)and implants with anodized surface (Vulcano) over a period of 16 weeks after installation.

Methods: it will be a clinical study with individuals with missing teeth requiring rehabilitation with dental implants in the maxilla and that fulfill the study inclusion criteria. The research sites will be randomized into two groups: the control group patient's sites receive implant surface treated by dual acid (AR Torque Porous, Connection Implant Systems, Aruja, Brazil) and in the test group implants with anodized surface (AR Torque Vulcano-Actives, Connection Implant Systems, Aruja, Brazil). The evaluation of the stability of the implants will be made over 16 weeks, through resonance frequency analysis with Osstell (Integration Diagnostics AB, Gothenburg, Sweden). Data will be analyzed using descriptive statistics and comparative.


Eligibility criteria: Inclusion Criteria:

* patients who have missing teeth in the maxilla,
* over 30 years old and under 60 years old,
* the implant sites with at least 3 months of healing after extraction,
* the implant sites with width and length to installation of an implant of 4 mm x 10 mm.

Exclusion Criteria:

* patients who experience any of the following conditions:
* general contraindications for surgical procedures,
* uncontrolled diabetes,
* severe bruxism or clenching,
* pregnant and lactating women,
* active periodontal disease,
* smoker and user of alcohol or drugs.

Primary outcomes:
measure: implant loss
timeFrame: 4 months
Secondary outcomes:
measure: ISQ analysis
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculdade de Odontologia da USP
Study officials:
affiliation: Student of doctoral program
name: Érico Fraga Moreira, Master of Science
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00526968: The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain Function
Official title: A Double Blind, Placebo Controlled Study to Investigate the Role of NMDA Receptor NR2B Subunit Selective Antagonism on Cognitive Functions and Neurophysiology in Healthy Subjects as Measured With MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Volunteers
Lead sponsor: Evotec International GmbH
Sponsor class: INDUSTRY
Collaborators: name: Richmond Pharmacology Limited
First posted: 2007-09-10
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the neurophysiological changes following single doses of EVT 101 using fMRI during rest and during cognitive tasks in young healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy Male volunteers
* Body Mass Index between 19 and 29

Exclusion Criteria:

* Subjects who received any prescribed medication within 5 half lives or 14 days of the first dose administration whichever is the longer
* Subjects who have received any prescribed CNS medication or any medication known to chronically alter drug absorption or elimination processes within 30 days of first dose administration
* Participation in a clinical trial of an investigational drug within the past 4 months or of a marketed drug within the past 3 months
* History of allergy to NMDA antagonists or other clinically significant drug allergy
* Supine blood pressure and heart rate of higher than 140/90 mmHg and 90 bpm respectively or lower than 80/40 mmHg and 40 bpm
* Consumption of more than 21 units of alcohol per week or history of alcoholism or drug/chemical abuse
* Smokers of more than 5 cigarettes or equivalent per day
* Subjects who cannot complete the neuropsychological test battery
* Any clinically significant health deficit

Primary outcomes:
measure: Change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks
timeFrame: 2-hours post dose
measure: Change in regional cerebral blood flow (determined with ASL-MRI)after drug compared with placebo
timeFrame: 2-hours post dose
measure: Performance scores in the cognitive tests
timeFrame: 2-hours post dose
Secondary outcomes:
measure: Safety, tolerability, adverse events, safety laboratory tests, ECG, vital signs
timeFrame: Up to 24 hours post dose and 5-7 days post last dose
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Centre for Neuroimaging Science, Box 089, Institute of Psychiatry
Study officials:
affiliation: Department of Clinical Neurosciences, Institute of Psychiatry
name: Nigel Leigh, BSc MBBS Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04962568: Ultrasonographic Evaluation of the Diaphragm During NHF Versus NIV Use in Respiratory Failure
Official title: Ultrasonographic Evaluation of the Diaphragm During NHF Versus NIV Use in Respiratory Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diaphragm Issues
Respiratory Failure With Hypoxia
Respiratory Failure With Hypercapnia
Non-invasive Mechanical Ventilation
Lead sponsor: Klinikum Emden
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will describe influence of NHF or NIV to different ultrasonographic parameters of the diaphragm. Therefor subjects will be randomized to the sequence NHF and than NIV or NIV and than NHF. In all subjects same parameters will be evaluated.


Eligibility criteria: Inclusion Criteria:

* acute or chronic respiratory failure, hyperemic or hypercapnic
* age \> 18 yrs
* written consent

Exclusion Criteria:

* critical disease (intubation, heart failure, lung edema,..)
* no compliance
* metabolic acidosis

Primary outcomes:
measure: Changes in DTEE
timeFrame: 10 minutes
Secondary outcomes:
measure: Changes in DTEI
timeFrame: 10 minutes
measure: Changes in Dex
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig
Study officials:
References:
Clinical trial NCT03190668: Skeletal Muscle and Adipose Tissue Study
Official title: Skeletal Muscle and Adipose Tissue Concentrations of Cefazolin Comparing Two Different Dosing Regimens During Pediatric Posterior Spinal Fusion Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Idiopathic Scoliosis
Keywords: tissue microdialysis
spinal fusion
surgical site infection
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Simple randomization will be used with each patient has probability 0.5 to be assigned in Group I or Group II. Computer program will generate a uniform random variable between 0 to 1, with subject assigned to Group I if the value is less than 0.5 and assigned to Group II if the value is greater than 0.5.
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to compare the current standard of care for prophylactic Cefazolin administered every 3 hours intravenously with continuous infusion of Cefazolin during pediatric spinal surgery.

Detailed description: Determine the skeletal muscle and adipose tissue disposition of prophylactic Cefazolin using microdialysis sampling in a cohort of patients diagnosed with idiopathic scoliosis undergoing posterior spinal fusion (PSF) for administration of Cefazolin by either continuous infusion or intermittent bolus.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic scoliosis
* Planned posterior spinal fusion surgery (PSFS)
* Age: 12-20 years old
* American Society of Anesthesiology status I or II undergoing posterior spinal fusion for at least 6 levels
* No known allergy to cefazolin

Exclusion Criteria:

* Known allergy to cefazolin
* Anatomical or other abnormalities that precluded insertion of a microdialysis catheter into the selected paraspinal muscle
* Known renal or hepatic insufficiency or failure

Primary outcomes:
measure: Unbound Cefazolin Concentration in Skeletal Muscle
timeFrame: Changes from baseline (pre-op) up to end of surgical procedure
measure: Unbound Cefazolin in Adipose Tissue
timeFrame: Changes from baseline (pre-op) up to end of surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Christoph Seubert, MD
role: PRINCIPAL_INVESTIGATOR
References: