linjc16/ctgov huggingface dataset:
IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.

Detailed Description
-----------------
The purpose of this observational study is to collect data regarding the population of patients whit a Zephyr™ pacemaker implanted, models 5826 and 5820, and active or passive fixation leads , when the Algorithms Acap Confirm, which automatically regulates the Atrial Pulse Width, is enabled.

Official Title
-----------------
Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.

Conditions
-----------------
Sinus Bradycardia, Sinus Node Disease, Atrio-ventricular Block

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has an indication for implantation of a dual-chamber pacemaker; Patient is older than 18 years of age Patient has signed the study specific Informed consent document. Primo implant. Exclusion Criteria: Patient is pregnant or nursing Patient is less than 18 years of age Patient is in New York Heart Association (NYHA) class III and IV. Patient has a pacemaker replacement; Patient is unable to attend the follow-up visits;

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

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 |
| --- | --- | --- |
| Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients in Whom ACap™ Confirm Algorithm is Recommended at a Pulse Width of 0.4 Milliseconds (ms) During All Follow-ups (Implant, Staples Removal, 3, 6, 9 and 12 Months). |  | 12 months |
Agreement and Accuracy of Different Devices Corneal Measurements

Study Overview
=================
Brief Summary
-----------------
To compare repeatability, reproducibility and agreement of both, AS- OCT and Scheimpflug imaging, for the measurement of corneal curvature and corneal thickness in patients with keratoconus.

Official Title
-----------------
Agreement and Accuracy of Different Devices for the Measurement of Corneal Thickness and Corneal Curvature in Patients With Keratoconus

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Device: Pentacam® (Oculus, Inc., Wetzlar, Germany)
* Device: Casia II (Tomey Germany, Nürnberg)
* Device: Spectralis Anterion (Heidelberg Engineering, Heidelberg, Germany)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged between 18 and 99 years Presence of keratoconus Signed informed consent Exclusion Criteria: Contact lens history within 5 days Pathologic changes of the lid or conjunctiva on slit-lamp examination History of corneal ocular surgery/Previous corneal cross-linking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with keratoconus<br> | Device: Pentacam® (Oculus, Inc., Wetzlar, Germany)<br>* Scheimpflug imaging<br>Device: Casia II (Tomey Germany, Nürnberg)<br>* Anterior segment optical coherence tomography<br>Device: Spectralis Anterion (Heidelberg Engineering, Heidelberg, Germany)<br>* Anterior segment optical coherence tomography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum K-value |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simulated minimum and maximum K-value |  | 1 day | 
| Mean K-values |  | 1 day | 
| Central Corneal thickness |  | 1 day | 
| Thinnest corneal point |  | 1 day |
Bariatric Surgery and Pharmacokinetics of Metoprolol

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on metoprolol are investigated.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics of Metoprolol: BAR-MEDS Metoprolol

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Metoprolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Metoprolol|Patients are tested for their normal prescription metaprolol medication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metaprolol concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Metoprolol
Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
This clinical study is designed as an open, single group, multi-center, phase 4 clinical study to assess the safety of Nimotuzumab in the treatment of nasopharyngeal carcinoma and to provide a more reasonable basis for clinical drug programs.

Detailed Description
-----------------
This clinical study is designed as an open, single group, multi-center, phase 4 clinical study to assess the safety of Nimotuzumab in the treatment of nasopharyngeal carcinoma and to provide a more reasonable basis for clinical drug programs. Subjects who meet the inclusion/exclusion criteria are administered of Nimotuzumab based on medication instructions or adjusted by clinicians according to the treatment. In case of the progression of disease, unacceptable toxicity, withdrawal of the consent, or judgment by investigator that the treatment needs to be stopped, the treatment of Nimotuzumab is stopped.

Official Title
-----------------
Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma

Conditions
-----------------
Nasopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Drug: Nimotuzumab Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically or cytologically confirmed nasopharyngeal carcinoma Sex and age without limiting Treatment without limiting Subjects with reproductive potential (males and females) willing to use reliable means of contraception Able and willing to give written informed consent and comply with the requirements of the study protocol Exclusion Criteria: Patients with severe allergies or idiosyncratic constitution Women who are pregnant (determined by urine pregnancy test)or breast feeding Any other severe complications or functional disorder of organ systems, which will affect the evaluation of safety of patients or will interfere with the test drug according to the researcher's point of view
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: Nimotuzumab Injection<br>200mg,Once a week，Intravenous infusion over 60 minutes | Drug: Nimotuzumab Injection<br>* patients receive nimotuzumab injection for 200mg/w,intravenous infusion over 60 minutes.Doctor adjust the dosage of nimotuzumab and choose other treatment options according to the actual situation of patients.<br>* Other names: Taixinsheng;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety of the treatment with Nimotuzumab(NCI Common Terminology Criteria for Adverse Events v4.03) |  | up to 30 months |
Safety and Efficacy of Meloxicam Compared to Other Nonsteroidal Antiinflammatory Drugs (NSAIDs) in an Observational Cohort Study of Patients With Rheumatoid Arthritis, Osteoarthritis, Lumbago, Scapulohumeral Periarthritis, Neck, Shoulder and Arm Syndrome

Study Overview
=================
Brief Summary
-----------------
Study to assess the safety profile of meloxicam by comparing incidence of gastrointestinal adverse events of meloxicam with that of NSAID in the routine daily therapeutic situation.

Official Title
-----------------
Safety and Efficacy of Meloxicam (MOBIC) Compared to Other NSAIDs in Approved Therapeutic Dosages and Routes of Administration in an Observational Cohort Study of Patients With Rheumatoid Arthritis, Osteoarthritis, Lumbago, Scapulohumeral Periarthritis, Neck, Shoulder and Arm Syndrome

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Drug: Meloxicam
* Drug: Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Indications according to the package insert of the prescribed NSAID Exclusion Criteria: There is no exclusion criterion, because this Post Marketing Study is an observational study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Meloxicam<br> | Drug: Meloxicam<br> <br> |
| Other NSAIDs<br> | Drug: Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolac<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence for adverse event of gastrointestinal disorder |  | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence for adverse drug reaction of gastrointestinal disorder |  | up to 6 months | 
| Incidence of adverse events |  | up to 6 months | 
| Incidence of adverse drug reactions |  | up to 6 months | 
| Incidence of serious adverse events |  | up to 6 months | 
| Incidence for adverse events Perforation, Ulcer and Bleeding (PUB) in the upper gastrointestinal tract |  | up to 6 months |
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B. Part A is a randomized, double-blind, placebo-controlled study. In Part B, patients who safely complete participation in part A may be enrolled in an open-label extension.

Official Title
-----------------
Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder

Conditions
-----------------
Bipolar Depression

Intervention / Treatment
-----------------
* Drug: ITI-007 (Lumateperone)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Major Inclusion Criteria: male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of Bipolar I or Bipolar II disorder experiencing a current major depressive episode Major Exclusion Criteria: any subject unable to provide informed consent any female subject who is pregnant or breast-feeding any subject judged to be medically inappropriate for study participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 40 mg ITI-007 (Lumateperone)<br>40 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks | Drug: ITI-007 (Lumateperone)<br> <br> |
| Experimental: 60 mg ITI-007 (Lumateperone)<br>60 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks | Drug: ITI-007 (Lumateperone)<br> <br> |
| Placebo Comparator: Placebo<br>Placebo administered orally as visually-matched capsules once daily for 6 weeks | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Åsberg Depression Rating Scale (MADRS) |  | 6 weeks |
Search for Fragility Indicators Among People Aged 50+ With Chronic HIV Infection

Study Overview
=================
Brief Summary
-----------------
The frailty and frail elderly was defined in 2001 by Fried as a physiological state of heightened vulnerability to external shocks. 5 criteria for classifying the elderly in 3 categories: frail, pre-frail and not frail. The prevalence of frailty in the general population was estimated to be 7%, 10% and 20% for over 65 years and 45% for over 85 years. This concept is explored in some chronic diseases, in order to prevent the loss of autonomy and tailor the treatment. In the carrier population of HIV, a North American retrospective study showed the frailty syndrome manifested as early as 10 years before, than in the general population. Furthermore various studies show in this specific population, increased incidence of diseases linked to age, suggesting an accelerated and premature aging. objectives: The objective of this study is to determine the prevalence of frailty defined Fried syndrome in a population of subjects aged 50 and over Holders of chronic HIV infection.

Conditions
-----------------
Frail in HIV Population

Intervention / Treatment
-----------------
* Behavioral: Fried scale for frailty assessement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with HIV and followed in the southeastern France area Exclusion Criteria: In patient HIV infected patient HIV patient disabled (spastic) HIV infected for less than a year

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIV Patient population over 50 years old<br> | Behavioral: Fried scale for frailty assessement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of frailed patient among the HIV population folloxed in southeastern France area |  | one year |
Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate metabolic effects of a standardized green tea extract, containing a defined amount of epigallocatechin-3-gallate (EGCG), in multiple sclerosis patients.

Conditions
-----------------
Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
-----------------
* Dietary Supplement: Capsules with 160 mg Teavigo (at least 94% EGCG)
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with relapsing-remitting multiple sclerosis stable treatment with glatiramer acetate at least 6 months prior to inclusion Expanded disability status scale < 4.5 Normal weight, overweight Exclusion Criteria: Primary or secondary progressive forms of multiple sclerosis Clinically relevant heart, lung, liver, kidney diseases Habitual caffeine intake over 300 mg per day Habitual consumption of green tea Alcohol or drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Green tea extract<br> | Dietary Supplement: Capsules with 160 mg Teavigo (at least 94% EGCG)<br>* Daily intake of 600 mg EGCG for 3 months<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Daily intake of placebo capsules for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting and postprandial lipid oxidation in grams per hour, assessed by indirect calorimetry, after 3 months intake of green tea extract versus placebo |  | Three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple sclerosis, Green tea extract, Metabolism
ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER.

Study Overview
=================
Brief Summary
-----------------
Overall, only limited evidence exists regarding the clinical benefit of antithrombotic prophylaxis after laparoscopic surgery for cancer. Four studies reported on the incidence of venous thromboembolism (VTE) after laparoscopic surgery for cancer. These studies differ concerning study design, site of cancer, regimens for antithrombotic prophylaxis and reported incidence of VTE. The aim of this multicenter, randomized study is to assess the clinical benefit of extended (4 weeks) compared to short (one week) heparin prophylaxis after laparoscopic surgery for colorectal cancer.

Official Title
-----------------
ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS IN PATIENTS WITH COLORECTAL CANCER UNDERGOING LAPAROSCOPIC SURGERY: INCIDENCE OF VENOUS THROMBOEMBOLISM AND BLEEDING COMPLICATIONS. THE PRO-LAPS STUDY.

Conditions
-----------------
The Primary Study Objective is to Assess the Efficacy and, Safety of Extended 4-week Heparin Prophylaxis Compared to, Prophylaxis Given for 8±2 Days After Planned Laparoscopic, Surgery for Colorectal Cancer., The Clinical Benefit Will be Evaluated as the Difference in, the Incidence of VTE or VTE-related Death Occurring Within 30 Days, From Surgery in the Two Study Groups.

Intervention / Treatment
-----------------
* Drug: Heparin, Low-Molecular-Weight


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients who had planned laparoscopic surgery for colorectal cancer will be included in the study provided no exclusion criteria will be found Exclusion Criteria: age < 18 years surgery for non-cancer disease duration of surgery < 45 min other indication for anticoagulant therapy known cerebral metastases kidney or liver failure known hemorrhagic diathesis or high risk for bleeding history of intracerebral bleeding or neurosurgery within 6 months, history of heparin induced thrombocytopenia pregnancy or lactation refusal of informed consent.

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: short heparin<br> | |
| Experimental: extended heparin<br> | Drug: Heparin, Low-Molecular-Weight<br>* 4 weeks heparin prophylaxis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colon-rectal cancer, heparin, prophylaxis, laparoscopy