louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01850537: Prospective Study To Assess The Safety and Efficacy of the PROW LIF Procedure
Official title: Prospective Study To Assess The Safety and Efficacy of the PROW LIF Procedure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Degenerative Disc Disease
Keywords: DDD
PROW
FUSION
eSPIN
Cage
IBF
Discectomy
Lumbar Fusion
TLIF
MIS
Lead sponsor: NLT Spine
Sponsor class: INDUSTRY
First posted: 2013-05-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-arm, open-label, non-randomized study. The aim of the study is to assess the safety and efficacy of the Prow LIF procedure in Transforaminal Lumbar Interbody Fusion (TLIF) procedures for the treatment of subjects with symptomatic degenerative disc disease (DDD).

Detailed description: Primary endpoints:

* Safety: Incidence of device-related anticipated and unanticipated serious adverse events (SAE). However, ALL complications and adverse events (AE) will be monitored and recorded.
* Primary radiographic effectiveness outcome parameter: evaluations of fusion rate.

Eligibility criteria: Inclusion Criteria:main Inclusion Criteria

1. Male and female between 18-65 years of age (skeletally mature).
2. Subjects suffering from degenerative disc disease (DDD) accompanied by back pain with leg pain at a single level between L2 and S1 confirmed by history and radiographic studies and that are scheduled for a fusion operation. DDD is determined to be present if one or more of the following are noted:

   1. instability (defined as angulation ≥ 5° and/or translation ≥ 4mm on flexion/extension radiographs);
   2. osteophyte formation;
   3. decreased disc height;
   4. ligamentous thickening;
   5. disc degeneration/herniation; or
   6. facet joint degeneration.
3. A pre-op Oswestry Low Back Pain Disability Questionnaire (ODI) score of 35 % or more;
4. Be non-responsive to non-operative treatment for at least 6 months;

   -

Exclusion Criteria:

1. The Antero-Posterior (AP) diameter (at midline) of the involved level is \<31mm.
2. Any previous spinal surgery at the involved level;
3. Spondylolisthesis \> grade I;
4. Ankylosed segment at the affected level;
5. History or radiographic evidence of osteoporotic fractures in the spine;
6. Paraparesis;
7. Progressive neurologic conditions;

   -

Primary outcomes:
measure: Fusion rate
timeFrame: 24 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Spine Surgery Department, Meir Hospital, Israel
Study officials:
affiliation: Head of the Spine surgery department, Meir Hospital
name: Joseph Leitner, MD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00787137: Single Dose PG102 in Patients With Active Psoriatic Arthritis
Official title: A Randomised, Double Blind, Placebo Controlled, Single Ascending Dose, Phase I Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PG102 (Anti-CD40 Monoclonal Antibody) In Patients With Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Arthritis, Psoriatic
Lead sponsor: PanGenetics UK Limited
Sponsor class: INDUSTRY
First posted: 2008-11-07
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the safety and tolerability of a single intravenous dose of PG102 in patients with psoriatic arthritis. The secondary objectives are to evaluate how PG102 moves around the body and to explore its effects on the disease.


Eligibility criteria: Inclusion Criteria:

* Arthritis that meets Classification of Psoriatic Arthritis (CASPAR) criteria
* Plaque psoriasis for at least 6 months prior to study enrollment

Exclusion Criteria:

* Clinically significant psoriasis flare
* Unstable doses of pain relief medication
* Treatment with systemic corticosteroids other than prednisone ≤ 10 mg/day or equivalent
* Treatment with any biologic therapy
* Treatment with immunosuppressive agents or disease modifying anti-rheumatic drugs (DMARDs) other than methotrexate
* Treatment with lithium, any anti-malarial, chlorambucil, cyclophosphamide or therapies for psoriasis other than low potency topical corticosteroids on intertriginous and groin areas, tar or salicylate preparations on the scalp, and emollients and moisturisers
* Family history of multiple thrombotic events or a personal history of any venous or arterial thrombotic event
* Clinically significant result for anti-cardiolipin, Activated protein C resistance test, Protein C, Free Protein S, Antithrombin III, Factor V Leiden, Prothrombin variant, Homocysteine, Lupus anticoagulant, Prothrombin time, Activated partial thromboplastin time, Fibrinogen, Thrombin time, Factors IX and XI
* Currently smoking ≥ 10 cigarettes per day or equivalent
* Active tuberculosis or other infection
* Current or previous malignancies
* Clinically significant abnormality on physical examination, laboratory testing, vital signs or 12-lead electrocardiogram

Primary outcomes:
measure: The Number of Reported Adverse Events
timeFrame: Three months
measure: The Percentage of Participants With Adverse Events
timeFrame: Three months
measure: The Number of Episodes of Change in Vital Signs
timeFrame: Three months
measure: The Number of Episodes of Change in Electrocardiogram
timeFrame: Three months
measure: The Number of Episodes of Change From Screening in Laboratory Assessments
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Professor Nemanja Damjanov
Study officials:
affiliation: Institute of Rheumatology, Belgrade, Serbia
name: Nemanja Damjanov, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01019837: Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases (IBD) Treated Immunomodulators and Biologics
Official title: Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases Treated With Immunomodulators and Biologics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Influenza H1N1
Keywords: Vaccine
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-11-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The spread of Influenza H1N1 has prompted the development of vaccines against this virus. IBD patients are at increased risk of developing complications of Influenza H1N1. The efficacy and safety of H1N1 vaccination have not been evaluated in this population of patients. We would like to estimate the efficacy and safety of vaccination against influenza H1N1 in patients with IBD who treated with immunomodulatory drugs.

Detailed description: 200 patients with IBD and 200 healthy subjects will participate in the study. All the subjects will be vaccinated with Focetria (Novartis) and will be evaluated the day of vaccination and 4 weeks later.

The evaluation will include:

Efficacy of the vaccine: Blood will be drawn on day 0 and 4 weeks later and tested for the presence of antibodies against A/California17/2009/H1N1 by hemagglutination inhibition test.

Safety of the vaccine:

* Records of adverse event
* Assessment of disease activity : CDAI and MAYO score

Eligibility criteria: Inclusion Criteria:

1. Patients suffering from IBD (inflammatory bowel disease): UC/ CD
2. Able to firm an informed consent
3. Aged - 18-65
4. Candidates to receive vaccination against H1N1, according to the recommendation of the Ministry of Health
5. patients who treated with immunomodulators and biologics

Exclusion Criteria:

1. Allergy to eggs
2. Known allergy to seasonal influenza vaccine
3. Pregnant women
4. Patients who inoculate another vaccine in the past 3 weeks (except vaccine fot seasonal influenza
5. Patients without worsening in their disease condition (stable condition)

Primary outcomes:
measure: Proportion of patients who will achieve a titer of antibodies above 1/40 within the groups of patients in comparison with healthy subjects
timeFrame: 4 weeks
Secondary outcomes:
measure: Safety of the vaccine with regard to disease activity by changes in Crohn's Disease Activity Index (CDAI) and MAYO score
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Iris Dotan, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03991637: Non-Invasive Blood Test Cross-Validation Study
Official title: Remote Sensing Comprehensive Metabolic Panel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reproducibility of Results
Safety Issues
Lead sponsor: Concord Medical Technology Corporation
Sponsor class: INDUSTRY
Collaborators: name: University of North Dakota
First posted: 2019-06-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study considers a cross-validation approach to determine the effectiveness of a non-invasive comprehensive metabolic panel (NICMP), relative to the venipuncture method. The NICMP machine learned powered device utilizes a light sensor to capture readings from either palm. The study (n=90) proves an agreement and strong correlation with respect to the NICMP and venipuncture blood draw.


Eligibility criteria: Inclusion Criteria:

* Undiagnosed population

Exclusion Criteria:

* Diagnosed population, pregnant women, mental heath/disabled, prisoners, fetus or deceased

Primary outcomes:
measure: Performance of Non-Invasive Comprehensive Metabolic Panel
timeFrame: 2-minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: Altru Health System
state: North Dakota
Study officials:
References:
Clinical trial NCT05014737: External Validation of the Apfel Risk Score and Koivuranta Score to Predict Postoperative Nausea and Vomiting in Patients With Liver Cancer
Official title: External Validation of Two Models to Predict Postoperative Nausea and Vomiting (PONV) in Patients With Liver Cancer in Chinese Hospital Setting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Nausea and Vomiting
Hepatobiliary Surgery
Prediction Model
Keywords: Postoperative Nausea and Vomiting
hepatobiliary surgery
assessment tool
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving hepatobiliary surgery will be consectively invited, and PONV will be assessed within 24 hours after surgery．

Brief summary: Postoperative nausea and vomiting (PONV) is a common complication among surgical patients. The incidence ranging from 20% to 50% depends on different population studied. Clinical practice guidelines recommend routine PONV screening before surgery using the Apfel simplified risk score OR Koivuranta score. However, these two scores haven't been translated into Chinese version and tested for psychometric qualities. Therefore, this study aim to externally validate two PONV prediction models in the Chinese hospital setting for PONV assessment.


Eligibility criteria: Inclusion Criteria:

* patients receiving hepatobiliary surgery

Exclusion Criteria:

* patients receiving chemothreapy；patients with cognitive disorders; patients unwilling to participate.

Primary outcomes:
measure: postoperative nausea and vomiting
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT04886037: Evaluation of Sestrin Levels in Patients With Endometriosis
Official title: The Sestrin Levels in Patients With Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: sestrin
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The serum sestrin level of women between the ages of 18-45 who have been diagnosed with endometriosis by surgery or ultrasound will be compared with the level of women of the same age.

Brief summary: Serum sestrin levels of endometriosis patients are compared with a group of healthy volunteers of the same age.

Detailed description: Serum sestrin levels are compared with 45 endometriosis patients and 45 healthy volunteers of the same age. The energy metabolism of the endometriosis group and its possible relationship with the endometriosis stage will be compared since sestrin gives information about the energy metabolism of the people.

Eligibility criteria: Inclusion Criteria:

* diagnosed with endometriosis (Surgery or ultrasound)
* Women without endometriosis

Exclusion Criteria:

* Women without endometriosis
* women who are only suspected endometriosis

Primary outcomes:
measure: Serum sestrin levels in women with endometriosis
timeFrame: 6 months
Secondary outcomes:
measure: Comparison of the relationship between serum sestrin level and endometriosis stage
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pinar Yalcin Bahat
state: İ̇stanbul
Study officials:
References:
Clinical trial NCT04765137: Evaluate the Effect of Atorvastatin on Cerebrovascular Reactivity in Mild Cognitive Impairment (MCI)
Official title: Targeting Cerebrovascular Reactivity for Precision Medicine: Pilot Trial of Atorvastatin
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Mild Cognitive Impairment
Keywords: Cerebral Vascular Reactivity
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: The Richman Family Precision Medicine Center of Excellence in Alzheimer Disease
First posted: 2021-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label study with atorvastatin 40 mg
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of atorvastatin on brain vessel reactivity and with it on blood flow in people with mild cognitive impairment.

Detailed description: Participants are first being informed about potential benefits and risks of the study and are required to give written consent. After that participants will undergo detailed phone screen to determine eligibility for study entry. At week 0, participants who meet eligibility requirements will be prescribed atorvastatin (40 mg, once in the evening) in an open-label manner.

Eligibility criteria: Inclusion Criteria are chosen to include participants with MCI, enriched for vascular risk factors:

* MCI defined by Clinical Dementia Rating (CDR) of 0.5 or 1.0.
* Memory, processing speed, executive function, language - cognitive scores \> 1.5 standard deviations below age-education norms.
* Not demented by history.
* Not taking statins currently or in the last 6 months.
* Cognitive/functional impairment not likely due to another neurological disease or delirium.

Exclusion Criteria:

* Taking a statin currently or have taken a statin in the last 6 months.
* Contraindications to taking a statin.
* Transplant patient taking cyclosporine.
* Unable to undergo MRI procedures (such as having an implanted pacemaker or defibrillator or stimulator or having non MRI compatible metal).
* Diagnosis of dementia by history.
* Current diagnosis of substance abuse.
* History of stroke or myocardial infarction in past 6 months.
* History of HIV.

Primary outcomes:
measure: Change of MRI whole brain cerebrovascular reactivity (wbCVR)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in plasma exosomes
timeFrame: Baseline and 12 weeks
measure: Change in cognitive function (global neurocognitive measure)
timeFrame: Baseline and 12 weeks
measure: Change in cognitive function (domain-specific neurocognitive measure)
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University, Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Paul Rosenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01541137: NSAIDs With Morphine-PCA Compared to Epidural Analgesia in Thoracotomy Pain
Official title: NSAID With IV-PCA Morphine is an Alternative to Thoracic Epidural Analgesia in Post-thoracotomy Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: thoracotomy
pain
NSAID
PCA
TEA
chronic
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Academy of Finland
First posted: 2012-02-29
Enrollment: 30
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 investigators investigated whether a strictly controlled pain management with patients participating in a clinical study can attenuate persistence of post-thoracotomy pain. The investigators also wanted to find out whether NSAID + intravenous patient-controlled analgesia with morphine is an efficacious alternative to thoracic epidural analgesia.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective thoracotomy for lung surgery

Exclusion Criteria:

* Contraindication to any of the study drugs or an epidural catheter,
* Significant liver, renal or cardiac disease
* Peptic ulcer
* Regular use of analgesics
* Re-thoracotomy, and the patient´s inability to understand the use of PCA/patient controlled thoracic epidural analgesia (PCEA).

Primary outcomes:
measure: pain intensity 6 months after surgery
timeFrame: 6 months
Secondary outcomes:
measure: consumption of PCA-morphine
timeFrame: 4 days
measure: pain intensity while coughing
timeFrame: 4 days
measure: adverse effects
timeFrame: 1-7 days
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Elina Tiippana, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06604637: Effectiveness of Vagus Nerve Stimulation in Individuals With Tension-Type Headache
Official title: Effectiveness of Vagus Nerve Stimulation in Individuals With Tension-Type Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tension-Type Headache
Keywords: Tension-Type Headache
Vagus Nerve Stimulation
Lead sponsor: Bitlis Eren University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
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: It is planned to examine the effect of Vagus Nerve Stimulation on headache symptoms in individuals with tension-type headache.

Detailed description: Tension-type headache is the most common primary headache, usually bilateral, characterized by oppressive and squeezing pain of mild or moderate intensity, unchanged by physical activity. It affects approximately 80% of the population and has a point prevalence of 42% in the general population.

There are various pharmacological and non-pharmacological treatment methods for tension-type headache. One of the non-pharmacological treatment methods may be Vagus Nerve Stimulation (VNS). VNS can affect healing processes by regulating the autonomic nervous system and reduce symptoms in tension-type headache.

Eligibility criteria: Inclusion Criteria:

* Individuals with tension-type headache according to the International Classification of Headache Disorders (ICHD-3) criteria,
* Individuals between the ages of 18-65,

Exclusion Criteria:

* History of trauma or surgery to the head and neck region,
* Presence of lesions or metal implants in the application area,
* Uncontrolled hypertension/abnormal ECG results/history of myocardial infarction/pacemaker and similar cardiovascular disease history/suspicion,
* Pregnancy or suspicion,
* Other primary and secondary headache types,
* Individuals who received physiotherapy in the last 6 months,

Primary outcomes:
measure: Pain intensity
timeFrame: Change from baseline at 4 weeks
measure: Pain duration
timeFrame: Change from baseline at 4 weeks
measure: Number of days of pain for 1 month
timeFrame: Change from baseline at 4 weeks
measure: Heart rate variability
timeFrame: Change from baseline at 4 weeks
Secondary outcomes:
measure: Headache Impact Scale
timeFrame: Change from baseline at 4 weeks
measure: Depression Anxiety Stress Scale (DASS-21)
timeFrame: Change from baseline at 4 weeks
Other outcomes:
Locations:
city: Bitlis
country: Turkey
facility: Bitlis Eren Üniversitesi
Study officials:
References: