louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01648673: Pilot Evaluation of the JHI Platform
Official title: Pilot Evaluation of the Janssen Healthcare Innovation Integrated Cardiovascular Rehabilitation Management Platform (JHI PLATFORM).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Cardiac Rehabilitation
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiology services.

Brief summary: The main purpose of this pilot study is to evaluate an impact of JHI CR Platform on patient referral, recruitment and retention rates and overall patient satisfaction in cardiovascular rehabilitation programs at the HFHS.


Eligibility criteria: Inclusion Criteria:

* Men and women age 18 years old (inclusive) and older
* Recent hospitalization at HFHS Main Campus hospital with one of the following diagnosis
* Stable angina with medical management
* Myocardial infarction (MI)/Acute coronary syndrome
* Percutaneous Coronary Intervention (PCI)
* Coronary Artery Bypass Graft (CABG) surgery
* Heart valve surgical repair or replacement
* Patients must be attending outpatient CR program at the HFHS Detroit location.
* Willingness to participate in the study and follow study requirements
* Willingness to respond to several surveys at the baseline and periodically during the study

Exclusion Criteria:

* Active substance abuse per medical record
* Unstable psychiatric condition
* Inability to exercise
* Unstable medical condition that would prevent safe and regular exercise training
* Uncorrected Severe Aortic Stenosis or Severe Mitral Stenosis
* Inpatient referring physician feels that exercise in contra-indicated due to safety reasons or is ill advised due to other patient specific factors
* LVAD, Heart Transplant. Although these patients qualify for CR, HFHS is not recruiting them due to difficulty in coordinating with surgical patients and their providers. In addition, there may also be surgical issues (infection, wound dehiscence, bone healing etc) that may reasonably interfere with exercise.

Primary outcomes:
measure: Patient referral, recruitment and retention rates and overall patient satisfaction.
timeFrame: Beginning, middle, and end of participation.
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Steven J Keteyian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04140773: The Effect of D-serine as add-on Therapy in Recent-onset Psychosis
Official title: The Effect of D-serine as add-on Therapy in Recent-onset Psychosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Psychotic Disorder
Lead sponsor: Psychiatric Hospital of the University of Basel
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In psychotic disorders, negative symptoms and cognitive impairment are difficult to treat with antipsychotics, which are mostly effective for positive symptoms. However, it is important that negative symptoms and cognitive impairment are treated as well, as they both play a large part in the acute episode and long-term course of schizophrenia outcome. Previous studies have used D-serine as add-on treatment in patients with psy-chotic disorders and high-risk patients, with positive results. So far, no study has investigated the effects in a sample of recent-onset psychosis patients.

Therefore, this study will include 30 patients (18-50 years old) with recent-onset psychosis. In addition to their regular treatment, patients will receive either D-serine (2 g/d) or placebo for 6 weeks. D-serine is an amino-acid naturally occurring in the brain which is prescription-free available as nutritional supplement.

The primary outcome measure is total score on the Positive and Negative Syndrome Scale (PANSS). Secondary measure-ments include PANSS subscales, neurocognitive tests, (f)MRI, and EEG


Eligibility criteria: Inclusion Criteria:

* Age 18-50
* Recent onset psychosis (\< 5 years of overt psychotic symptoms)
* Able to read and understand study procedures and participant's information

Exclusion Criteria:

* Clozapine use
* Suicidal ideation
* Psychotic disorders and symptoms associated with general medical conditions or substance abuse
* BMI \> 30
* Renal impairment (history and creatin levels (\< 80 ug/L for woman and \< 97 ug/L for men))
* Hearing impairment
* Current or past (\< 6 months) enrolment in another clinical trial with the primary outcome to improve symptoms
* Pregnant or lactating women (pregnancy test)

Primary outcomes:
measure: Total symptom severity
timeFrame: change from baseline to 6 weeks
Secondary outcomes:
measure: Subscales symptom severity
timeFrame: change from baseline to 6 weeks
measure: Symptom severity and treatment response
timeFrame: change from baseline to 6 weeks
measure: Resting-state microstates
timeFrame: change from baseline to 6 weeks
measure: Mismatch Negativity (MMN)
timeFrame: change from baseline to 6 weeks
measure: Intelligence
timeFrame: change from baseline to 6 weeks
measure: Attention and processing speed
timeFrame: change from baseline to 6 weeks
measure: Executive functioning
timeFrame: change from baseline to 6 weeks
measure: Memory
timeFrame: change from baseline to 6 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: UPK Basel
state: Basel-Stadt
Study officials:
References:
Clinical trial NCT06068673: The Potential Impact of Clindamycin on Neurosurgery Patients.
Official title: The Potential Impact of Clindamycin on Neurosurgery Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurologic Complication
Neurosurgery
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All enrolled 44 patients will be divided into two groups; Group I are patients who will receive clindamycin added-on therapy. Group II patients will be managed with the standard regimen.
Primary purpose: SUPPORTIVE_CARE

Brief summary: A prospective, open-label, single center, controlled trial. 44 patients that underwent neurosurgery or presented meningitis signs, for whom Clindamycin add-on therapy to assess its effect on neurological complication in relation to Neuron-specific enolase (NSE) and Neurotensin biomarkers levels.

Detailed description: 1. This is a prospective, open-label, single center, controlled trial. 44 patients that underwent neurosurgery or presented meningitis signs, for whom Clindamycin add-on therapy is prescribed (900 - 1200 mg twice daily) will be recruited from Alexandria University Main Hospital.
2. Whole blood samples will be collected for Analyses of Neuron-specific enolase (NSE) and Neurotensin will be detected by ELISA.
3. All patients will be assessed for complete blood count (CBC), kidney function, liver function, Methodology

   * Patients will be enrolled if they underwent surgery or presented with clinical signs of meningitis.
   * All enrolled 44 patients will be divided into two groups; Group I are patients who will receive clindamycin added-on therapy. Group II patients will be managed with the standard regimen.
   * Complete physical, laboratory, and radiological assessment will be done for all patients
   * All patients will be followed up during 2 weeks period.
   * Serum samples will be collected for measuring the biomarkers.

Eligibility criteria: Inclusion criteria

1) Adult patients will be enrolled if they underwent neurosurgery or presented with clinical signs of meningitis.

Exclusion criteria

1. Age lower than 18.
2. Females with a positive pregnancy test.
3. Known congestive heart failure or ischemic heart disease.
4. Any injury that disturbs the examination (high cervical cord injury or locked-in syndrome, could be a source of bias).
5. Severe brain disease (For example CVA history or brain tumor).
6. Renal failure with GFR lower than 60 ml/min.
7. Patients with unknown identity.

Primary outcomes:
measure: Neuron-specific enolase (NSE) Blood Concentration
timeFrame: 2 weeks
measure: Neurotensin Blood Concentration
timeFrame: 2 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University Hospital
Study officials:
affiliation: Damanhour University
name: Rehab H Werida, Ass Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT03264573: Role of Stem Cells, Platelet Rich Plasma in Treatment of Scars
Official title: Role of Stem Cells, Platelet Rich Plasma and Combination of Them in Treatment of Scars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrophic Scar
Keywords: Atrophic scar
PRP
ADSCs
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: M.A. Eloteify
name: Ahmed Kamal Osman
name: G.M. Hafsa
First posted: 2017-08-29
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The Objectives of this randomized controlled trial aiming to establishing a protocol of post scar revision care and to Study the effect of PRP and/or Adipose derived Mesenchymal Stem cell injection in improvement of atrophic scar after scar revision.

Detailed description: Forty patients with atrophic scar since one to five years including 25 males and 15 females with ages ranging from ten to 35 years with main age of 22.68 will be divided into four groups each included ten patients. One group will be treated with scar revision only (control group or group I), 2nd group will be injected with PRP after scar revision, 3rd group will be injected with ADSCs after scar revision and the 4th group will be injected with a combination of PRP and ADSCs after scar revision. All groups were assisted pre-operative and six months post-operative. Complications, Scar width, Vancouver scar scale (VSS), surgeon assessment scar scale and patient assessment scar scale will be considered the outcome measurements.

Eligibility criteria: Inclusion Criteria:

* Patient with atrophic scar.
* Age group: 5 years up to 35 years.
* No previous medications, surgeries or laser therapy.

Exclusion Criteria:

* Patient with hypertrophic or pigmented scar.
* Patient with any blood disease.
* Patients with lipodystrophy.

Primary outcomes:
measure: Patient satisfaction (Patient Assessment Scar Scale)
timeFrame: 6 months
Secondary outcomes:
measure: Doctor satisfaction (Vancouver Scar Scale)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00517673: To Evaluate Safety, Tolerability, Pharmacokinetics, And Food Effect Of Single Doses Of GSK945237 In Healthy Subjects
Official title: A Two-Part Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Escalating Oral Doses of GSK945237 and the Effect of Food on Single Oral Doses of GSK945237 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Infections, Bacterial
Keywords: Healthy Volunteer
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-08-17
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: GSK945237 is the first molecule of a new chemical class that is being developed for treatment of respiratory tract and other infections such as skin and soft tissue. This study drug has been tested in animals but has never been given to humans. This is a two part study. The purpose of the first part is to study the side effects of this drug in humans, and to study how much of the drug gets absorbed in the blood stream The second part of this study will compare absorption of the study drug in the blood stream when given with food and when given under fasting conditions


Eligibility criteria: Inclusion Criteria:

* Healthy male and female adults between 18 and 60 years of age.
* Body weight proportional to height.
* Female subjects must be of non-childbearing potential.
* QTc less than 450 msec at screening

Exclusion Criteria:

* Any clinically relevant abnormality identified on the screening history and physical, or on laboratory evaluations or the 12-lead surface electrocardiogram at screening or pre-dose.
* A positive pre-study alcohol/urine drug screen.
* Use of nicotine-containing products.
* A positive pre-study HIV antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody result.
* Recent participation in another study, use of certain medications, consumption certain fruits, juices, or red wine

Primary outcomes:
measure: Safety and tolerability
timeFrame: Day 1 to follow-up visit
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: Day 1 to Day 5
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: GSK Investigational Site
state: South Australia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04145973: Evaluation of Prognostic Monitoring for Breast Cancer Patients With Recurrence and Metastasis After Surgery
Official title: Evaluation of Prognostic Monitoring for Breast Cancer Patients With Recurrence and Metastasis After Surgery Via Analysis of Immunoinflammation-related Protein Complexes in Blood
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 200
Sex: FEMALE
Minimum age (years): 36
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with recurrence and metastasis of breast cancer

Brief summary: The relationship between immune inflammation-related protein complexes in blood and recurrence or metastasis of breast cancer with completed standard treatment will be studied.

Detailed description: 200 patients with breast cancer and recurrence or metastasis after surgery will be followed up. Peripheral venous blood was collected every 3 to 6 months. Change regularity of breast cancer-specific immune inflammation-related protein complexes in blood at different follow-up time points will be studied. The relationship between disease-specific protein complexes and pathological state of patients will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Female
* invasive breast cancer patients confirmed by postoperative pathology after surgery for breast lump
* Breast cancer-related chemotherapy and radiotherapy completed
* breast cancer patients with recurrence and metastasis after surgery

Exclusion Criteria:

* Male
* Aged above 60
* Breast Carcinoma in situ
* Women in pregnancy or breastfeeding
* Suffering from other malignant tumors
* Non-compliant patient

Primary outcomes:
measure: immune inflammation-related protein complexes
timeFrame: 2 years
measure: blood markers
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Chang Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00780273: Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in Anterior Part of Mandible and Restored With Fixed Prostheses
Official title: Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in the Anterior Part of the Mandible and Restored With Fixed Prostheses: a Randomized, Split-mouth, Masked, Prospective, Open, Comparison, Monocenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Edentulism
Keywords: subjects with edentulous mandible
Lead sponsor: Dentsply Sirona Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-27
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Change in crestal bone level implants at 5% significance level.


Eligibility criteria: Inclusion Criteria:

* age 18 to 80
* male or female (female non-pregnant)
* sufficient oral hygiene
* no inflammation/disorder in the area of implant site
* edentulous mandible and sufficient prosthetic and conservative
* sufficient width and height of bone to place implants with diameters of 4.8mm and length of 11 mm
* provide written informed consent

Exclusion Criteria:

* demonstrate a need for pre-surgical bone or soft tissue augmentation in planned implant areas
* exhibit angulation requirements of restoration exceeding 15 degrees
* systemic metabolic disorder that would compromise post-operative tissue regeneration or osseointegration
* taking medication that would compromise post-operative healing and/or osseointegration
* bone disorders such as osteoporosis, hyperparathyroidism, Paget's disease, diabetes mellitus
* oncology treatment
* oral infection
* acute gingivitis and/or periodontitis
* local bone defects in the area of planned implantation
* disorders of oral mucosa (e.g., leukoplakia, oral lichen, pemphigoid lesions)
* received investigational drug within 30 days
* history of illicit drugs or alcohol abuse
* history of addiction to medication
* allergic to dental materials
* nicotine abuse (\> 20 cigarettes/day)
* pregnant or nursing
* clinical significant or unstable medical or physiological conditions that would compromise participation in study
* unable or unwilling to return for follow-up visits for a period of 24 months

Primary outcomes:
measure: Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
timeFrame: 6 months after surgery
measure: Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
timeFrame: 12 months after surgery
measure: Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
timeFrame: 24 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester, Eastman Dept of Dentistry
state: New York
Study officials:
affiliation: University of Rochester
name: George Romanos, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02565173: Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma
Official title: Phase III Multi-center, Randomized, Double-masked, Active- and Placebo-controlled Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Open-Angle Glaucoma (POAG)
Ocular Hypertension (OHT)
Keywords: glaucoma
primary open-angle glaucoma
ocular hypertension
adenosine agonist
eye drop
trabodenoson
trabecular meshwork
Lead sponsor: Inotek Pharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2015-10-01
Enrollment: 303
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: Phase III trial involving topical application, in both eyes, of trabodenoson ophthalmic formulation 3.0% or 6.0% once per day or 4.5% twice per day, placebo twice per day, or timolol 0.5% twice per day for 12 weeks in adult subjects with Ocular Hypertension or Primary Open-Angle Glaucoma.

All subjects who meet the study's enrollment criteria following Screening will undergo washout of all prohibited medications, including their routine glaucoma medications. During the Placebo Run-In Period, placebo is administered twice daily to both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes for a total of 12 weeks followed by an Observation Period of approximately 7 days wherein no study eye drops are instilled.

The purpose of the study is to assess the efficacy, tolerability, and safety of binocular topical application of trabodenoson ophthalmic formulation 3.0% or 6.0% QD or 4.5% BID for 12 weeks.

Timolol is being included in the trial in order to have an active control to ensure the integrity of the trial from an efficacy perspective; the primary comparator for all statistical purposes is the placebo arm.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG)
* Mean Intraocular pressure (IOP) of ≥24 and ≤34

Exclusion Criteria:

* Significant visual field loss or any new field loss within the past year
* Cup-to-disc ratio \>0.8
* Central corneal thickness \<490 µm or \>610 µm
* A recent (acute) or chronic medical condition that might obfuscate the Subject's study data

Primary outcomes:
measure: Mean Intraocular Pressure (IOP)
timeFrame: Three Months
Secondary outcomes:
Other outcomes:
measure: Safety Parameters, including treatment emergent adverse events, to assess tolerability and safety.
timeFrame: Through Study Completion, up to 13 weeks.
Locations:
city: Lexington
country: United States
facility: Inotek Pharmaceuticals Corporation
state: Massachusetts
Study officials:
affiliation: Inotek Pharmaceuticals Corp.
name: Cadmus C Rich, MD,MBA,CPE
role: STUDY_DIRECTOR
References:
Clinical trial NCT00511173: Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm
Official title: Warfarin Dosing: Pharmacogenetic Algorithm Compared to Pharmacist's Dosing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Pulmonary Embolism
Deep Vein Thrombosis
Keywords: mechanical valve
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2007-08-03
Enrollment: 102
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective comparison of clinician dosing and a pharmacogenetic algorithm in diagnosed patients requiring warfarin therapy.

Detailed description: Diagnosed patients with atrial fibrillation, pulmonary embolism, or deep venous thrombosis requiring warfarin therapy will be consented and a tube of blood for DNA analysis will be drawn. The clinician dosing group will not be eligible to obtain the pharmacogenetic results and the algorithm group will have their warfarin pharmacogenetic SNPs performed and integrated into the algorithm and the warfarin dose will be calculated. Outcomes of patients receiving both methods will be gathered and statistically analyzed.

Eligibility criteria: Inclusion Criteria:

* Diagnosed patients with atrial fibrillation, deep venous thrombosis, or pulmonary embolism requiring warfarin therapy

Exclusion Criteria:

* Patients with atrial fibrillation, deep venous thrombosis, or pullmonary embolism requiring warfarin therapy who do not consent to participate

Primary outcomes:
measure: In Patients Receiving Warfarin, a Pharmacogenetic Algorithm Dose Was Compared to Clinician Dosing (mg/wk).
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Creighton University
name: Christopher J. Destache, Pharm. D.
role: PRINCIPAL_INVESTIGATOR
References: