linjc16/ctgov huggingface dataset:
Efficacy of Fish Oil Supplementation on Cognition in MCI Patients and the Influence of the APOE4 Allele

Study Overview
=================
Brief Summary
-----------------
To study the short term effects of a pharmacological dose of fish oil on cognitive performance and on cerebral blood flow. Furthermore, we want to investigate whether carriers of the APOEε4 allele respond differently to fish oil treatment compared to non-carriers.

Official Title
-----------------
Challenge Study: The Efficacy of Fish Oil Supplementation on Cognitive Performance in MCI Patients and the Influence of the APOE-epsilon4 Allele

Conditions
-----------------
Mild Cognitive Impairment

Intervention / Treatment
-----------------
* Dietary Supplement: fish oil
* Dietary Supplement: placebo, sunflower oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women Diagnosed as having amnestic MCI: based on specific memory disturbances (cut-off of 1 sd, single or multiple domain amnestic MCI, according to Busse A et al37) Presence of a principal caregiver willing to assist for a successful participation Informed consent signed Exclusion Criteria: Current or recent (<4 weeks) use of fish oil supplements Consumption of fish more than 2 times/week Current use of dementia (Alzheimer) medication Current use of acenocoumarol or other anti-thrombotic drugs (because of the high dose of fish oil) Serious liver disease Use of more than 4 glasses of alcohol per day Unable to participate as judged by the responsible medical physician Allergy to fish(oil) Swallowing problems Participation in another clinical trial less than 2 months before the start of the trial or at the same time
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>3 g EPA-DHA | Dietary Supplement: fish oil<br>* 3 g fish oil (3078 mg) total EPA 1512 mg and total DHA 1026 mg<br>|
| Placebo Comparator: 2<br>Placebo: sunflower oil | Dietary Supplement: placebo, sunflower oil<br>* 3 g of sunflower oil<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive performance |  | baseline and after 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood flow-velocity in the middle cerebral arteries (assessed with TCD) and cortical tissue oxygenation, cerebral autoregulation, cerebral blood volume (assessed with NIRS |  | baseline and after 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mild cognitive impairment
Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is determine whether this drug will improve your insomnia in terms of decreasing your time to fall asleep and allowing you to stay asleep longer. The drug will be compared against placebo in order to determine if there's a difference.

Official Title
-----------------
A Double-Blind, Placebo Controlled, Randomized, Cross-Over Polysomnographic Study of MK0928 15 mg in Adult Patients With Primary Insomnia

Conditions
-----------------
Primary Insomnia

Intervention / Treatment
-----------------
* Drug: MK0928 / Duration of Treatment : 8 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Primary Insomnia Patient is willing to stay overnight at a sleep laboratory for a total of 7 nights Patient is willing to avoid alcohol on PSG visits Patient will avoid napping during the course of the study Patient's bedtime is between 9pm and 1am Exclusion Criteria: History of substance abuse, bipolar disorder or psychotic disorder Difficulty sleeping due to other medical condition History of narcolepsy, circadian rhythm sleep disorder, parasomnia, sleep apnea, periodic limb movements or restless legs syndrome History of neoplastic malignancy within the last 5 years Positive alcohol breath test during the screening visits

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0928 / Duration of Treatment : 8 Weeks|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wake after sleep onset and Latency to persistent sleep |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective total sleep time and subjective time to sleep onset |  |  |
Teduglutide in Short Bowel Syndrome Patients

Study Overview
=================
Brief Summary
-----------------
A retrospective analysis was performed using data of patients suffering from non-malignant SBS-IF. They were treated with teduglutide in a multidisciplinary SBS-IF program at a single university medical center between June 2016 and June 2020.

Official Title
-----------------
Teduglutide in Short Bowel Syndrome Patients - A Way Back to Normal Life?

Conditions
-----------------
Short Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: Teduglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SBS-IF Exclusion Criteria: < 18 years Incompliance < 6 months of treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Teduglutide|effect of teduglutide on intestinal rehabilitation|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| enteral autonomy | percentage of patients reaching complete discontinuation of parenteral support | at least 6 months of teduglutide treatment |
Myorelaxation Practice in Paediatric Anesthesia

Study Overview
=================
Brief Summary
-----------------
In retrospective data search the investigators will identified the percentage of patients with muscle relaxants administered during perioperative period. The block reversal, typ of drug, percentage of cases with and without reversal will be identified.

Detailed Description
-----------------
The actual percentage of surgeries with the muscle relaxants administered during perioperative period in paediatric patients remain unclear because many surgeries are being performed without muscle relaxation. In this retrospective study, the anesthesiology perioperative data from January 2016 till December 2016 in the tertiary center od Pediatric anesthesia will be searched for the percentage of surgeries with muscle relaxants administered. Type of surgery, age, weight, duration u surgery, muscle relaxants drug and percentage of block reversal will be identified.

Official Title
-----------------
Myorelaxation Practice in Paediatric Anesthesia: Retrospective Study

Conditions
-----------------
Neuromuscular Blockade

Intervention / Treatment
-----------------
* Drug: Neuromuscular Blocking Agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: paediatric patients the study period (1/2016-12/2016) neuromuscular blocking agent administration during surgery Exclusion Criteria: surgery without neuromuscular blockade

Ages Eligible for Study
-----------------
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with neuromuscular block<br>Neuromuscular blocking agent administrated during surgery to the paediatric patient | Drug: Neuromuscular Blocking Agent<br>* Administration of neuromuscular blockers during anesthesia<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of neuromuscular block reversal | The actual percentage of paediatric patients with perioperative neuromuscular blockade with active pharmacology block reversal at the end of surgery | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of surgeries without muscle relaxant administration | Paediatric surgeries without neuromuscular blocking agent administration | 1 year | 
| Type of neuromuscular blocking agent in paediatric anesthesiology practice | Actual type of neuromuscular blocking agent used in paediatric anesthesiology practice in predefined period. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuromuscular blockade, muscle relaxation, muscle relaxant
Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients

Study Overview
=================
Brief Summary
-----------------
With potential antiviral effects on severe acute respiratory syndrome (SARS) and as a methyl-xanthine derived inhibitor of phosphodiesterase-4, pentoxifylline basically functions as a hemorrheologic agent for a better circulation and oxygenation and exerts unique effects on immune modulation, inflammation and oxidative stress. As the main regulator of cAMP metabolism, posphodiesterase-4 plays a key role in proinflammatory and immune cells. Pentoxifylline plays its anti-inflammatory role by reducing the production of proinflammatory cytokines such as TNF-a, IL-1 and IL-6. Given its unique impacts on immune modulation, homeostasis and fibrinolysis and its supportive effects on oxidative stress and organ failure, pentoxifylline can constitute a multipurpose and generally-safe adjuvant therapy for COVID-19 patients.

Official Title
-----------------
Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients

Conditions
-----------------
COVID

Intervention / Treatment
-----------------
* Drug: Pentoxifylline
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive COVID-19 test Age >/= 18 y.o. Exclusion Criteria: Allergic reaction to Pentoxifylline Ongoing anticoagulation History of GI bleeding History of Seizures Cardiac or other vascular stents History of severe renal disease History of intracranial hemorrhage.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>100 patients will receive standard treatment plus placebo | Drug: Placebo<br>* Placebo tablet<br>|
| Experimental: Pentoxifylline group<br>100 patients will receive standard treatment plus pentoxifylline 1200 mg/day | Drug: Pentoxifylline<br>* Pentoxifylline 400 mg SR tablet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome | Number of Participants need hospitalization | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory infection | Incidence of any acute respiratory infection | 7 days | 
| Serious Adverse Events | Absolute and relative frequencies of Serious Adverse Events | 7 days |
Study to Evaluate the Clinical and Radiographic Outcomes of the BEE® HA Cage for Anterior Cervical Discectomy and Fusion

Study Overview
=================
Brief Summary
-----------------
Observational data collection of information after undergoing standard Cervical spine fusion surgery.

Official Title
-----------------
A Prospective, Non-randomised, Multi-centre, Post-market Clinical Follow-up Observational Study to Evaluate the Clinical and Radiographic Outcomes of the BEE® HA Cage for Anterior Cervical Discectomy and Fusion.

Conditions
-----------------
Cervical Disc Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects aged 18 years of age or older (≥ 18 years) and are skeletally mature. Subjects with discopathy, disc hernia with radiculopathy and/or myelopathy, or stenosis of the foramen and spinal canal with or without cervical radiculopathy/myelopathy, at one or two contiguous levels from C3 to C7, and confirmed by imaging studies (CT and/or MRI will be taken according to standard local procedures and confirmed by the Investigator that imaging represents the indication for surgery). Subjects with a documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated. Subjects who are indicated for surgical treatment with the BEE® HA Cage with RESORBA® Synthetic Bone injectable bone substitute (RESORBA Medical GmbH). Subjects who have completed at least 6 weeks of conservative non-operative treatment without obtaining adequate symptomatic relief. Exclusion Criteria: Subjects who have undergone previous spinal surgery either anterior or posterior. Subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than two years. Subjects with a known allergy to the material used in the instrumentation. Subjects with evidence of an active infection and/or with any condition that would compromise their participation and follow-up in this clinical study. Subjects who have known osteoporosis or severe osteopenia as determined by the Investigator. Subjects who have any conditions outlined as contraindicated in the Instructions for Use.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index (NDI) Questionnaire | Set of questions given to the subjects about experiencing pain during activities that are marked on a scale of 0-5 - whereby 0 is no pain and 5 is the worse pain. Maximum score for the questionnaire of 50 is possible. | 24 months |
Expanded Access [Ga-68] PSMA-11 PET Imaging

Study Overview
=================
Brief Summary
-----------------
In this expanded access IND study, Mayo Clinic in Rochester MN offers [Ga-68] PSMA-11 PET/CT or PET/MR imaging to patients who meet criteria.

Detailed Description
-----------------
[Ga-68] PSMA-11 PET/CT and PET/MR imaging has been shown to allow for accurate detection of metastatic prostate cancer at the time of initial diagnosis and staging of patients with high-risk prostate cancer and at the time of biochemical recurrence. In addition, available data show superiority of metastatic lesion detection with [Ga-68] PSMA-11 PET over conventional imaging. This improved lesion detection has a direct impact on selection of anti-cancer therapy and thus may improve patient outcomes. Under expanded access IND, enrolled patients will receive a clinical [68Ga] PSMA-11 PET/CT or PET/MR for evaluation of their cancer. Imaging exams must be deemed clinically indicated by a referring provider. Patients will be responsible for the cost of the imaging exam. Access is limited.

Official Title
-----------------
Expanded Access [Ga-68] PSMA-11 PET Imaging

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: [Ga-68] PSMA-11 PET/CT
* Diagnostic Test: [Ga-68] PSMA-11 PET/MR


Participation Criteria
=================
Eligibility Criteria
-----------------
Participant Groups There are two participant groups; please refer to the inclusion details below: Group 1: Untreated High-Risk prostate cancer group (must meet at least one of the following inclusion criteria): Serum prostate-specific antigen (PSA) concentration of 20 ng/mL or more Pathologic criteria of International Society of Uropathology (ISUP) grade group 3-5 (ISUP grades 3-5 are equivalent to pathologic Gleason scores of 4+3, 8, 9 or 10) Local staging of T3 or worse (Indicating that cancer has invaded into tissues outside of the prostate gland, as seen at either CT or MRI) Biochemically Recurrent prostate cancer group (must meet one of the criteria): In patients who have undergone a prostatectomy, PSA > 0.2 ng/ml on 2 consecutive tests In patients who have undergone definitive prostate radiation, PSA rise ≥ 2 ng/mL above the nadir PSA Exclusion Criteria: Current exclusion criteria for both groups includes: Patients unable to sign informed consent Patient with a life expectancy less than 6 months Additional exclusion criteria may be added based on demand

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: [Ga-68] PSMA-11 PET/CT|Imaging scan|
|Diagnostic Test: [Ga-68] PSMA-11 PET/MR|Imaging scan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Cortical Pharyngeal Area: Excitability, Facilitation and Plasticity in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The aims of this study are in four experimental sessions. The aims are: to characterize the excitability of the cortical pharyngeal area with pharyngeal pressure and electromyograms (EMGs), at rest, in awake healthy subjects; to study its facilitation by inspiration and deglutition; and to study its plasticity by respiration and swallowing.

Official Title
-----------------
Cortical Pharyngeal Area: Excitability, Facilitation and Plasticity in Healthy Subjects

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Exclusion Criteria: Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
swallowing, ventilation, pressure, EMG, cortical magnetic stimulation, Brain Mapping
A Prospective Study of Surgical Treatment Strategies for Chordoma

Study Overview
=================
Brief Summary
-----------------
Chordoma is a rare but locally invasive cancer that arises from the embryonic notochord. Total resection is challenging in mobile spine because of the complex anatomy and bone invasion.

Official Title
-----------------
A Prospective Study of Surgical Treatment Strategies for Chordoma

Conditions
-----------------
Chordoma of Spine, Surgery

Intervention / Treatment
-----------------
* Procedure: Resection surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 18 and 70 ys, With a diagnosis of chordoma confirmed by pathology, Undergone surgical treatment in our hospital, Available for clinical follow-up and agree to long-term clinical follow-up and sign informed consent. Exclusion Criteria: Suffer from other tumors, Suffer from cardiovascular disease, cerebrovascular disease, or immune system disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chordoma Patients<br>Chordoma Patients | Procedure: Resection surgery<br>* Patients undergo resection surgery in our hospital.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excision Extension | Clinical and radiographic assessments of excision extension of tumor. | 1 week after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS (Overall Survival) | Overall Survival of patient underwent surgery. | 2 years | 
| PFS (Progression-Free Survival) | Progression-Free Survival of patient underwent surgery. | 2 years | 
| DFS (Disease Free Survival) | Disease Free Survival of patient underwent surgery. | 2 years | 
| ORR (Objective Response Rate) | Objective Response Rate of patient underwent surgery. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chordoma