linjc16/ctgov huggingface dataset:
Monoclonal Antibodies Elimination in Breast Cancer Patient

Study Overview
=================
Brief Summary
-----------------
This Study evaluates covariables being able to potentially influence the elimination of the monoclonal antibodies (trastuzumab, bevacizumab and denosumab).

Detailed Description
-----------------
Monoclonal antibodies are very widely used in cancer treatment . Certain patients benefit from these antibodies for several years and it is conceivable to wonder about the evolution of the pharmacokinetics of these antibodies.

Official Title
-----------------
Study of the Relative Impact of the Neonatal Fc Receptor (FcRn) and the Therapeutic History on Monoclonal Antibodies Elimination. Proof of the Concept on Patients Treated by Bevacizumab or Trastuzumab in Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: additional blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosed cancer patient treated by bevacizumab or trastuzumab Life expectancy of at least 3 months For the women: menopausal women for at least 24 months, sterilized surgically, or, for the women old enough to procreate, use a method of effective contraception (oral contraceptives, contraceptive injections, intra-uterine devices, method of the double barrier, the contraceptive patches). This contraception will have to be pursued during 6 months after the end of the treatment by bevacizumab or by trastuzumab. Exclusion Criteria: For Patients treated by trastuzumab: Dyspnoea of severe rest in touch with complications due to the disease or requiring an oxygen therapy. Hypocalcemia severe untreated

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab<br>Bevacizumab in monotherapy or in association to other anticancer agents pharmacokinetic assessment with blood sample with additional blood sample | Other: additional blood sample<br>* blood sample every 3 weeks<br>|
| Experimental: Trastuzumab<br>Trastuzumab in monotherapy or in association to other anticancer agents pharmacokinetic assessment with blood sample with additional blood sample | Other: additional blood sample<br>* blood sample every 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clearance of the bevacizumab |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clearance of the trastuzumab |  | 9 months |
Screening of Athletes

Study Overview
=================
Brief Summary
-----------------
Athletes have to participate in screenings in order to reduce injuries. Up-to-now most screenings are purely clinically based. Literature, however, indicates the importance of knowledge on deviant movement patterns as possible risk factors for injuries. From this perspective, the current project aims to measure movement patterns, gait and running in young athletes to optimise training and prevent injuries. 2D- and 3d registration methods, force plate data and pressure plate data will be used to document the performance of the athletes.

Official Title
-----------------
Screening of Athletes for Prevention of Injury and Optimisation of Performance

Conditions
-----------------
Individual Differences, Motor Activities

Intervention / Treatment
-----------------
* Other: Advice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Selected by the Flemish Athletics League Level: B1, B2 en C Age categories: 16-22 years No injuries at lower back and lower extremities in the past 6 months Signing informed consent Exclusion Criteria: Not selected by the Flemish Athletics League Injuries at lower quadrant

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 22 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| training advise<br> | Other: Advice<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinematic and kinetic data | Angles at different joints will be investigated with 3D movement analysis methods. Kinetic data (joint moments) will be calculated with 3D movement analysis methods. Center of pressure measures will be calculated on the basis of force plate data. Gait, running, jumps, postural balance will be investigated. Plantar pressure parameters will be calculated on the basis of plantar pressure measurements. | March - June 2014 (3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2 D parameters | Video analysis methods (Dartfish) will be used to calculate joint angles during jumps | March - June 2014 (3 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Athletes
Bone Fixation of Mpact Double Mobility Cup

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate long term fixation of the Mpact Double Mobility cup trough IMAGIKA technology.

Official Title
-----------------
Etude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte Pour l'évaluation de la Fixation Osseuse d'Une Cupule hémisphérique, le Mpact® Double Mobilité

Conditions
-----------------
Total Hip Replacement

Intervention / Treatment
-----------------
* Device: Mpact Double Mobility cup


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary hip replacement patients 18 to 80 years old patients who accept the follow-up schedule Exclusion Criteria: femoral neck fracture patients requiring grafts progressive local or systemic infections patients presenting muscular deficiency, neuromuscular disease or vascular insufficiency of the involved limb patients suffering from diseases that can compromize the recovery to independent mobility patients with BMI > 40 patients with cognitive diseases that can compromize their participation in the study patients living in geographical area not allowing the clinical follow-up to be performed patients participating in other biomedical research patients <18 years old patients > 80 years old pregnant or breast feeding women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Mpact Double Mobility cup|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implant fixation trough IMAGIKA | implant fixation trough IMAGIKA | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score | Harris Hip Score | preop, 3 months, 1, 2, 5, 10 years | 
| complications | complications | intraop, immediate postop, 3 months, 1, 2, 5, 10 years | 
| penetration of femoral head in the polyethylene insert trough IMAGIKA | penetration of femoral head in the polyethylene insert trough IMAGIKA | 3 months, 5 and 10 years | 
| implant stability trough standard x-ray | implant stability trough standard x-ray | 3 months, 1, 2, 5, 10 years | 
| implant survival trough Kaplan-Meier curve | implant survival trough Kaplan-Meier curve | 3 months, 1, 2, 5, 10 years | 
| implant fixation trough IMAGIKA | implant fixation trough IMAGIKA | 3 months and 5 years |
Effect of ANI on Intraoperative Opioid Consumption

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the analgesic nociception index (ANI), which is used to determine the dose of analgesic agent needed in the intraoperative period, with the conventional method in patients with erector spinae block who underwent gynecological surgery under general anesthesia.

Official Title
-----------------
Intraoperative Analgesia Management in Gynecological Surgery With Erector Spinae Block

Conditions
-----------------
Analgesia, Nociceptive Pain, Nerve Block, Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II-III risk group Patients who underwent gynecological surgery under general anesthesia, who underwent erector spina block, and whose pain was followed by analgesia nociception index or conventional methods for intraoperative pain monitoring Patients whose informed consent was read and consent was obtained from them and their guardians Exclusion Criteria: cardiac rhythm disorder central-autonomic nervous system disease neuropsychiatric disease receiving opioid therapy Use of drugs that will affect cardiac autonomic regulation Known allergy to the drugs to be applied Contraindicated for ESP block Patients who do not agree to participate in the study will not be included in the study. Patients who were administered drugs to stabilize the patient's hemodynamics during the operation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group ANI<br> | |
| Group Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative opioid consumption | Effect of ANI monitoring on intraoperative opioid consumption | during the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emergence time | time between last suture and extubation | at the end of the surgery | 
| VAS pain scores | pain scores in the recovery unit | during her stay in the recovery unit | 
| duration of stay in recovery room | time between entering and exiting the recovery unit | at the end of the surgery | 
| nausea and vomiting i | incidence of nausea and vomiting in recovery room | during her stay in the recovery unit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Analgesia nociception index, Pain monitoring, Analgesia
Observational Non-interventional Study (Anwendungsbeobachtung) With Telmisartan in High-risk Hypertensives

Study Overview
=================
Brief Summary
-----------------
This observational non-interventional study will assess (under conditions of clinical practice in daily routine) the antihypertensive efficacy of telmisartan treatment with or without active promotion of lifestyle changes in hypertensive patients at high cardiovascular risk

Detailed Description
-----------------
Study Design:

Official Title
-----------------
TOP -Study Telmisartan - Therapy of Hypertension and Life-style Changes in Cardiovascular Risk Patients

Conditions
-----------------
Hypertension, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with essential hypertension aged >/= 18 years with one of the following risk factors: history of coronary artery disease or stroke/TIA or peripheral artery disease or diabetes mellitus. Exclusion Criteria: according to SPC

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 |
| --- | --- | --- |
| Blood pressure reduction |  | 4 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in metabolic parameters Safety |  |  |
Cardiac Computed Tomography (CT) Scan Compared to Transesophageal Echocardiogram (TEE) in Endocarditis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness of cardiac CT versus TEE in endocarditis patients.

Official Title
-----------------
A Novel Modality of Cardiac CT in Characterization of Acute Infective Endocarditis

Conditions
-----------------
Endocarditis

Intervention / Treatment
-----------------
* Procedure: CT Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute endocarditis with positive TEE Exclusion Criteria: Renal failure Contrast dye allergy Beta-blocker allergy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 98 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CT scan<br>CT Scan for endocarditis patients. All patients receive intervention. | Procedure: CT Scan<br>* Cardiac CT with special attention to valves in Endocarditis patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Difference in CT versus TEE images in Endocarditis |  | Upon CT Scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity |  | 4 weeks & 6 months post CT scan |
Feasibility of a Wireless Patch System (WPS) to Measure Gastrointestinal Motility and Gastric Emptying

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the utility of a new device - an external wireless patch system (WPS) - to measure gastric motility and to compare this external wearable device with the most commonly used test to measure stomach emptying, the nuclear medicine gastric emptying scan (also called gastric scintigraphy).

Official Title
-----------------
A Pilot Study to Assess the Feasibility of a Wireless Patch System (WPS) to Measure Gastrointestinal Motility and Gastric Emptying

Conditions
-----------------
Gastric Emptying

Intervention / Treatment
-----------------
* Diagnostic Test: Scintigraphic gastric emptying scan
* Device: Wireless patch system (WPS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referred to the nuclear medicine department for a scintigraphic gastric emptying scan. Exclusion Criteria: Have had prior gastric or esophageal surgery. Have had surgery to the GI tract within the last 60 days (e.g., appendectomy, cholecystectomy). Are on chronic opioids or other medications known to affect gastric emptying (e.g., GLP-1 agonists, high dose tricyclic agents). Have been recently hospitalized for complications of diabetes or have a HgbA1c > 10. Have severe psychological distress preventing study participation. Unable to read or understand the consent form.

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wireless patch system (WPS)<br>Subjects scheduled for a gastric emptying scan will have a wireless patch system (WPS) placed. | Diagnostic Test: Scintigraphic gastric emptying scan<br>* Nuclear medicine scan that provides an assessment of gastric motility<br>Device: Wireless patch system (WPS)<br>* Wireless wearable patches applied to the abdomen after 3 small areas of the abdomen that connect to a recording device for a total of 6 days and subjects will track mealtimes, bowel movements, and sleep using an iPhone app.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject willingness to wear a wireless patch system (WPS) | Number of subjects to wear a wireless patch system (WPS) to evaluate upper gastrointestinal symptoms | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scintigraphy
Low Fiber Diet for Bowel Preparation for Colon Capsule Examination

Study Overview
=================
Brief Summary
-----------------
A prospective randomized controlled investigator-blinded study to compare efficacy of low fiber diet for 5 days versus regular diet, both as adjunct to one day clear liquid diet and standard bowel preparation for colon capsule examination

Official Title
-----------------
A Prospective Randomized Controlled Investigator-blinded Study of Low Fiber Diet for Bowel Preparation for Colon Capsule Examination

Conditions
-----------------
Colon Preparation

Intervention / Treatment
-----------------
* Other: low fiber diet
* Other: regular diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 and <75 Colon study indicated for colo-rectal carcinoma screening After colonoscopy for any indication failed due to technical causes Patients who decline an indicated colonoscopy Exclusion Criteria: Significant heart failure (NYHA grade III-IV) Renal failure (Creatinine > 1.2 mg/dl) Known or suspected intestinal strictures Known or suspected mesenteric adhesions History suggestive of bowel obstruction Vomiting and/or aspirations Symptoms of dysphagia Pace-maker or AICD implanted Known allergy or intolerance to any of the study drugs Pregnancy Illicit drug abuse or alcoholism Inability to provide an informed consent

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Low fiber diet for 5 days prior to procedure | Other: low fiber diet<br>* Low fiber diet for 5 days prior to colon capsule<br>|
| Active Comparator: 2<br>regular diet | Other: regular diet<br>* Regular diet until 1 day before colon capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colon cleanliness |  | one week from capsule examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of preparations |  | within 1 day of completing preparation |
An Observational Study Based on Endometrial Cancer Risk Screening Model

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to test the efficiency of our endometrial cancer risk screening calculator, and improve the endometrial cancer risk screening model to form a stable and reliable non-invasive auxiliary diagnostic tool with high sensitivity and specificity in healthy women.The main question it aims to answer is: ·the efficiency of our endometrial cancer risk screening calculator Participants will be collected demographic information, as well as ultrasound, blood routine test and other test results, which will be entered into the endometrial cancer risk screening calculator to obtain high-risk or low-risk prediction results.

Official Title
-----------------
An Observational Study Based on Endometrial Cancer Risk Screening Model

Conditions
-----------------
Endometrial Neoplasms

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18-70; The annual update of questionnaire information required by the calculator can be completed, and the gynecological examination, gynecological B-ultrasound and blood test can be evaluated once a year, and the follow-up can be at least 1 year; The patient or family members can understand the research scheme and are willing to participate in the study, and provide e-book informed consent. Exclusion Criteria: Endometrial cancer or precancerous lesions have been diagnosed; Previous or current malignant tumor, currently receiving radiotherapy and chemotherapy, endocrine, targeted and immunotherapy; History of endometrial resection or total hysterectomy; Pregnant or lactating women; The patient or family member could not understand the conditions and objectives of this study.

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

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|There is no intervention in this study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obtained endometrial pathological specimens due to any factors | The study object was obtained endometrial pathological specimen within one year due to any factor. | 1 year | 
| No endometrial cancer or precancerous lesions | The study object did not show B-ultrasound and clinical symptoms which indicate endometrial cancer or precancerous lesions. | 1 year |