linjc16/ctgov huggingface dataset:
Clinical Value of Homeopathic Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
recurrent symptomatic urinary tracts infections (UTI) in persons with spinal cord injury are a frequent problem, leading to significant morbidity and to a decreased quality of life. until today, there is no effective prophylaxis for UTI for patients with spinal cord injury. homeopathy has been shown to be an effective treatment option in several chronic diseases study hypothesis: the addition of homeopathic assessment and treatment to a standard prevention strategy for recurrent UTI will significantly reduce the number of symptomatic UTI per year in this group of patients compared to standard prevention alone

Official Title
-----------------
Clinical Value of Homeopathic Assessment and Treatment for Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury

Conditions
-----------------
Symptomatic Urinary Tract Infection, Spinal Cord Injury

Intervention / Treatment
-----------------
* Other: individual homeopathic treatment
* Other: standard treatment without homeopathy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neurogenic bladder dysfunction treated by intermittent catheterization recurrent (>3/year) symptomatic urinary tract infections Exclusion Criteria: inability to speak German already under homeopathic treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Active Comparator: individual homeopathic treatment<br>participants receive homeopathic treatment in addition to standard prevention measures for UTI | Other: individual homeopathic treatment<br>* participants are diagnosed by a trained homeopath and receive individualized homeopathic treatment in addition to standard UTI prophylaxis<br>|
| Other: standard prophylaxis<br> | Other: standard treatment without homeopathy<br>* participants receive standard UTI prophylaxis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of symptomatic urinary tract infections |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of symptomatic urinary tract infections compared to the previous year |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary tract infection, spinal cord injury, homeopathy, prevention
EP4-receptor Antagonism and Prostaglandin E2 (PGE2) in a Human Headache Model

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether EP-4 receptor antagonist can prevent the headache expected during a Prostaglandin E2 infusion.

Official Title
-----------------
EP4-receptor Antagonism and Prostaglandin E2 (PGE2) in a Human Headache Model

Conditions
-----------------
Headache, Migraine

Intervention / Treatment
-----------------
* Drug: BGC20-1531


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: Tension headache All other primary forms of headache Cardiovascular, Central Nervous system (CNS) and autoimmune diseases Gastrointestinal disease Previous or clinical signs of mental illness or substance abuse. Participation in a clinical study of a medicinal product without regulatory approval or marketing authorisation within 1 month prior to this trial Pregnancy/nursing Daily intake of medication (except oral contraceptives)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BGC20-1531 200mg<br> | Drug: BGC20-1531<br>* oral administration followed by Prostaglandin E2 infusion<br>* Other names: EP-4 receptor antagonist;|
| Placebo Comparator: sugar pill<br> | Drug: BGC20-1531<br>* oral administration followed by Prostaglandin E2 infusion<br>* Other names: EP-4 receptor antagonist;|
| Active Comparator: BGC20-1531 400mg<br> | Drug: BGC20-1531<br>* oral administration followed by Prostaglandin E2 infusion<br>* Other names: EP-4 receptor antagonist;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rCBF, blood flow, diameter of STA/RA, HR, BP |  | in-hospital |
Evaluation of PET-CT Using Somatostatin Agonists Labeled With Gallium68 in Neuroendocrine Tumors

Study Overview
=================
Brief Summary
-----------------
Gastro-Entero-Pancreatic tumors (GEPs) are a subset of Neuroendocrine tumors (NETs) derived from the primitive gut and include digestive and bronchial NETs. Historically, the gold standard in their functional exploration is the conventional somatostatin receptors scintigraphy (SRS) labeled with Indium-111 (Octreoscan®). This reference imaging is complementary to Tomography (CT) and liver MRI. However SRS sensitivity is moderate (60 %), because of its intrinsic detection limits, which could delay the diagnosis or lead to inappropriate therapy. The use of somatostatin agonists (DOTATOC, DOTATATE, DOTANOC), radiolabeled with gallium-68 (68Ga) enables targeting of Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of TNE with a gain in sensitivity of over 20% compared to SRS. Furthermore, patient irradiation and imaging protocol are significantly reduced.

Official Title
-----------------
Evaluation of PET-CT Using Somatostatin Agonists Labeled With Gallium68 in Neuroendocrine Tumors

Conditions
-----------------
Gastro-Entero-Pancreatic Tumors (GEPs)

Intervention / Treatment
-----------------
* Other: PET-CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Age ≥ 18, Patient with one of the following situations : suspicion of GEP, initial staging of non-metastatic GEP, GEP with unknown primary tumor, Restaging of GEP justifying focused therapeutic approach Reference imaging within the last 3 months: multiphasic thoracoabdominal CT scan, liver MRI and SRS (SPECT/CT). Exclusion Criteria: Pregnant or breast-feeding woman Other cancer disease GEP with grade 3 tumours Non GEP TNE (paragangliome, medullar thyroid cancer)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: assesment by 68Ga-DOTATATE PET-CT<br> | Other: PET-CT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interest of the realization of 68Ga-DOTATATE PET-CT in the detection of tumor sites in TNE diagnosis, staging and restaging |  | 12-15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| therapeutic impact of 68Ga-DOTATATE PET-CT in addition to reference imaging (SRS, CT, MRI): we will document the rate of changes in treatment options induced by PET-CT |  | 12-15 months |
A Trial to Reduce Pneumonia in Nursing Home Residents

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effectiveness of an enhanced oral hygiene protocol in preventing pneumonia among nursing home residents.

Official Title
-----------------
A Randomized Controlled Trial to Reduce Pneumonia in Nursing Home Residents

Conditions
-----------------
Pneumonia, Lower Respiratory Tract Infection

Intervention / Treatment
-----------------
* Other: Enhanced Oral Care
* Other: Usual oral care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: long term care resident of nursing home residents age >65 residents of nursing home for at least one month residents having at least one of two modifiable risk factors for pneumonia (i.e., impaired oral hygiene, swallowing difficulty) Exclusion Criteria: residents housed in nursing home for short term rehabilitation residents who receive nourishment by tube feeding residents who have a life expectancy < 3 months residents who have been diagnosed with pneumonia within the previous 6 weeks residents who are currently using oral chlorhexidine residents who have previously been enrolled in the study residents, or their designated proxies, who are unwilling to give informed consent residents who have tracheostomy residents who are non-english speaking residents who the administrator leadership of the home felt were not appropriate for the study

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: enhanced oral care<br> | Other: Enhanced Oral Care<br>* oral brushing plus oral chlorhexidine plus upright feeding positioning<br>|
| Active Comparator: Usual care<br>The usual oral care provided at the nursing home | Other: Usual oral care<br>* Usual oral care and feeding positioning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumonia | The number of participants that recorded a 'first pneumonia' during the 2.5 years timeframe. | 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower Respiratory Tract Infection Other Than Pneumonia | The number of participants that recorded a 'lower respiratory tract infection other than pneumonia' during the 2.5 years timeframe. | 2.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumonia, Lower respiratory tract infection, Lower respiratory tract infection other than pneumonia
24-Hour Intraocular Pressure (IOP) Control With Travoprost/Timolol Fixed Combination

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the short-term (8 week) mean 24-hour intraocular pressure control and safety of TravTim fixed combination given once in the evening with placebo once in the morning versus TravTim given once in the morning with placebo once in the evening in patients with open-angle glaucoma.

Official Title
-----------------
24-Hour Intraocular Pressure (IOP) Control With Travoprost/Timolol Fixed Combination

Conditions
-----------------
Primary Open Angle Glaucoma, Exfoliation Syndrome

Intervention / Treatment
-----------------
* Drug: travoprost/timolol fixed combination
* Drug: placebo (artificial tears)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: POAG Exfoliation syndrome Exclusion Criteria: Advanced glaucoma

Ages Eligible for Study
-----------------
Minimum Age: 29 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: travoprost/timolol fixed combination|nan|
|Drug: placebo (artificial tears)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
ABC Survey - do we Meet the Needs of Patients With Advanced Breast Cancer?

Study Overview
=================
Brief Summary
-----------------
The study will follow a descriptive design involving a survey. Data collection will involve paper based questionnaires. The questionnaires have been developed in conjunction with breast cancer support groups associated with the Irish Cancer Society and patients.

Detailed Description
-----------------
The purpose of the study is to identify and categorise the need of Metastatic Breast Cancer (MBC) patients in Ireland with particular focus on; quality of life, symptom burden and access to and value of support available. The study also aims to evaluate future service developments that will provide support to these patients.

Official Title
-----------------
ABC Survey: Are we Meeting the Needs of Patients With Advanced Breast Cancer (ABC) in Ireland? A Nationwide Survey

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent Clinical diagnosis of MBC Female aged 18 years or older Able to complete the questionnaires independently Exclusion Criteria: Any patient who does not meet the above mentioned inclusion criteria.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Metastatic Breast Cancer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Needs of MBC patients in Ireland | The needs of MBC patients to be identified and categorised with particular focus on; quality of life, symptom burden and access to and value of available support | Following analysis of the questionnaires completed by the patients, estimated 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Future service developments | Evaluation of future service developments that will provide support to these patients | Following analysis of the questionnaires completed by patients, estimated 24 months |
Expanded Access to Entrectinib for Cancers With NTRK1/2/3, ROS1, or ALK Gene Fusions

Study Overview
=================
Brief Summary
-----------------
Expanded access to entrectinib will be given to patients with cancers harboring NTRK1/2/3, ROS1, or ALK gene fusions who do not qualify for participation in, or who are otherwise unable to access, an ongoing clinical trial for entrectinib.

Official Title
-----------------
Expanded Access to Entrectinib (RXDX-101) for the Treatment of Cancers With NTRK, ROS1, or ALK Gene Fusions

Conditions
-----------------
Cancers With NTRK, ROS1, or ALK Gene Fusions

Intervention / Treatment
-----------------
* Drug: Entrectinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of advanced cancer with an NTRK1, NTRK2, NTRK3, ROS1, or ALK gene fusion Unable to participate in an ongoing entrectinib (RXDX-101) clinical trial Willing and able to provide written, signed informed consent Medically suitable for treatment with entrectinib (RXDX-101) Exclusion Criteria: Currently enrolled in an ongoing clinical study with any other investigational agent
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Entrectinib|Open-label expanded access, capsules|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Measurement of Cardiac Output and Blood Volumes Using Transonic Ultrasound Dilution Technology

Study Overview
=================
Brief Summary
-----------------
Measurement of the amount of blood pumped by the heart (cardiac output) and blood volumes in sick patients is important for doctors to better treat these patients. Current procedures available demand difficult invasive procedures and hence these parameters are not measured with enough frequency and are also limited to certain patients. The new COstatus system is capable of using the already existing arterial and venous lines placed in critically ill patients and thus provides an opportunity to measure these parameters less invasively and with enough frequency. The purpose of this study is to measure cardiac output and blood volumes using ultrasound dilution technology (COstatus system)in post cardiac surgery adult patients and compare the cardiac output measurements with a current clinical reference method, thermodilution.

Official Title
-----------------
Measurement of Cardiac Output and Blood Volumes Using Transonic Ultrasound Dilution Technology - Clinical Evaluation and Validation

Conditions
-----------------
Post Cardiac Surgery Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post cardiac surgery adult patients Patients with heart catheter and arterial catheter Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
Expression of Molecular Markers Before and After Neo-adjuvant Chemoradiotherapy in Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether markers on tumor tissue may be an indicator for good response to neoadjuvant chemoradiotherapy in patients with rectal cancer.

Conditions
-----------------
Rectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: locally advanced rectal cancer uT3 or uT4 no distant metastasis neoadjuvant radiochemotherapy required Exclusion Criteria: rejection of radiochemotherapy
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rectal cancer with neoadjuvant treatment, standardized clinical tests, tumor markers on tumor tissue
MRI STUDY OF THE LPEC

Study Overview
=================
Brief Summary
-----------------
Cricoid pressure is still considered as a standard of care in order to prevent the gastric regurgitation in full stomach surgery1. However, this attitude has been challenged in several case reports as oesophageal rupture, difficult intubation, and even failing to occlude the oesophagus. Moreover, in a large prospective randomized study , this maneuver has failed to show a definite benefit2. The lateral deviation to the left of the oeso deviate to the left side3,4 has led to the description of a new maneuver to compress directly the oesophagus at the low left paratracheal level. This maneuver has been shown to prevent gastric air insuflation during the ventilation. In the present study, the investigators aim to asses with an magnetic resonance imaging the compressibility of the oesophagus.

Official Title
-----------------
Evaluation in MRI of the Impact of the Sellick Manoeuvre or Para-tracheal Compression of the Cervical Esophagus on the Displacement of the Laryngeal Mass and the Visualization of the Vocal Cords

Conditions
-----------------
MRI

Intervention / Treatment
-----------------
* Procedure: mobilization of the larynx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults Volunteers Exclusion Criteria: Pregnancy Claustrophob Thyroid goiter

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mobilization of the larynx<br>we aim to asses with an magnetic resonance imaging the compressibility of the oesophagus with LPEC | Procedure: mobilization of the larynx<br>* we aim to asses with an magnetic resonance imaging the compressibility of the oesophagus with LPEC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oesophagus compressibility | Analysis of the position of the Oesophagus is obtained in the three groups in a upper position ( C5-6) and lower position (C8-T1). The upper position is the first view were the oesophagus is clearly identified: In fact, the pressure exerted during the cricoid maneuver is in fact applied in the area of the hypopharynx above the osophagus. The oesophagus is quoted relatively to the vertebral body as Medial (80% facing the vertebral body) Medio-lateral , lateral (20% facing the vertebral body). | End of the MRI |