linjc16/ctgov huggingface dataset:
Role of MRI Diffusion in Differentiation Between Benign and Malignant Bony Lesions

Study Overview
=================
Brief Summary
-----------------
Bone tumors are categorized according to their tissue of origin into cartilagenous, osteogenic, fibrogenic, fibrohistiocytic, haematopoietic, vascular, and lipogenic tumors. Magnetic resonance imaging (MRI) is now indispensable for the preoperative workup and therapeutic follow-up of patients with musculoskeletal tumors. The application of DW-MRI in bone marrow is today an established examination technique that provides a unique contrast and that can help in the detection of bone-marrow pathologies and the differentiation of benign and malignant bone-marrow lesions. Diffusion MRI provides quantitative and qualitative assessments of tissue cellularity and cell-membrane integrity. It is widely used for tumour detection, characterisation, and monitoring during treatment. Diffusion MRI supplies functional information that complements the structural evaluation. In combination with standard structural MRI parameters, the ADC value improves tumour characterization. Diffusion MRI can also be used to monitor tumours during chemotherapy. Tumour necrosis results in loss of cell membrane integrity and in expansion of the extracellular compartment, leading to greater water-molecule diffusion with an increase in the ADC value.

Official Title
-----------------
Role of MRI Diffusion in Differentiation Between Benign and Malignant Bony Lesions

Conditions
-----------------
Efficacy of MRI Diffusion in Differentiation Between Benign and Malignant Bony Lesions

Intervention / Treatment
-----------------
* Device: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with bony lesions will be included in the study. Exclusion Criteria: Patient with cardiac pacemaker. Patients with metallic prosthesis in the region of examination. Patients with claustrophobia. Patient with recent history of surgical or imagining guided biopsy from the bony lesion.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>All patients with bony lesions | Device: MRI<br>* T1 weighted image. Fast spin-echoT2 weighted image. Short inversion recovery (STIR). T1-fat suppressed images. Diffusion weighted sequences with different b values 0-1000 s/mm2 with qualitative assessments by the different b values as well as quantitative assessment by measurement of the ADC values.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ADC value of MRI diffusion in benign and malignant bony lesions ( considering ADC value <1.2 ..malignant while ADC>1.2 ..benign) |  | 1 day |
Efficacy and Safety of Acupuncture for Dizziness and Vertigo in Emergency Department: a Clinical Control Trial

Study Overview
=================
Brief Summary
-----------------
Dizziness and vertigo account for roughly 4% of chief symptoms in the emergency department (ED). Pharmacological therapy is often solicited for these symptoms, such as vestibular suppressants, anti-emetics and benzodiazepines. However, every medication is accompanied with unavoidable side-effects. To the best of the investigators knowledge, no papers surveyed assess the feasibility of applying acupuncture as an emergent intervention means to the treatment of dizziness and vertigo. The investigators study targeted on filling in this gap by performing a clinical control trial to evaluate the efficacy and safety of traditional Chinese medicine - acupuncture - in treating patients with dizziness and vertigo in ED.

Conditions
-----------------
Dizziness, Vertigo

Intervention / Treatment
-----------------
* Procedure: acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Visit emergency department and stay in observation unit. Consult otolaryngologist and neurologist to rule in dizziness and giddiness, auditory vertigo, vertebrobasilar artery syndrome, and peripheral vestibular disorders - Ménière's disease, benign paroxymal peripheral vertigo, and vestibular neuritis. Exclusion Criteria: Serious comorbid conditions (for example, life-threatening condition or progressive central disorder). Patients who cannot communicate reliably with the investigator or who are not likely to obey the instructions of the trial.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Efficacy and safety of acupuncture for dizziness and vertigo<br>To evaluate the efficacy and safety of acupuncture in treating patients with dizziness and vertigo in ED. | Procedure: acupuncture<br>* Experiment group received acupuncture at Zusanli (ST36) and Neiguan (PC6) acupuncture points<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) of dizziness |  | after the first 30 minutes after acupuncture | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dizziness and vertigo, emergency department (ED), clinical trial, acupuncture
Diagnosis of Bacterial Vaginosis Comparing Modified Hay/Ison With Molecular Diagnosis

Study Overview
=================
Brief Summary
-----------------
Among 300 women that are scheduled a therapeutic abortion screening diagnopsis of BV are done using Gram stained vaginal smear and with a molecular test using PCR for 5 different bacteria.

Detailed Description
-----------------
The molecular test will test for Atophobium vaginae, Leopitrichia spp, Megasphaera Mobiluncus and BVAB2

Official Title
-----------------
Diagnosis of Bacterial Vaginosis Using Molecular PCR Test.

Conditions
-----------------
Infection, Bacterial

Intervention / Treatment
-----------------
* Diagnostic Test: molecuar test of BV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women scheduled a therapeutic abortion (Before 12th week) will be screened for gential infections such as chlamydia and Gc together with bacterial vaginosis Exclusion Criteria: women not pregnat

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: molecuar test of BV|diagnosis of BV|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of bacterial vaginosis comparing modified Hay/Ison with molecular diagnosis | Comparing the Gram stained vaginal smears using Hay/Ison (i.e. BV or normal) criteria with a molecular PCR method with 5 different bacterium and after an algoritm end up with the result (i.e. BV or normal). The number of women with the diagnosis of BV with each of the diagnostic test can be compared calculatitng a KAPPA index | 4 month |
Cross-Over Evaluation of Two Lubricating Eye Drops

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of two lubricating eye drops for the treatment of dry eye signs and symptoms.

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: Polyethylene Glycol 400 0.4%
* Drug: Propylene Glycol 0.3%
* Drug: 0.15% sodium Hyaluronate
* Drug: sodium chloride
* Drug: sodium phosphate monobasic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 yrs or older Males or females Any race or ethnic background Patients with present ocular surface discomfort and a SESoD score of at least 2 Exclusion Criteria: Corneal refractive surgery within 6 months of this study. Contact lens use on day of examination. Corneal ectasia. Current use of Restasis

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Polyethylene Glycol 400 0.4%|nan|
|Drug: Propylene Glycol 0.3%|nan|
|Drug: 0.15% sodium Hyaluronate|nan|
|Drug: sodium chloride|nan|
|Drug: sodium phosphate monobasic|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Gut Immune System During Immune Checkpoint Inhibitor Therapy

Study Overview
=================
Brief Summary
-----------------
This exploratory study aims to gain insight in gut immune system phenotypes before and after immunotherapy. After informed consent is obtained, sigmoidoscopies at baseline and during treatment with immunotherapy will be performed, During the endoscopies, biopsies from the sigmoid and rectum will be obtained. Subsequent immune cell analyses in these biopsies will be performed. Parallel to the sigmoidoscopies, venous blood samples will be obtained to monitor inflammatory markers.

Official Title
-----------------
Deep Phenotyping of the Gut Immune System During Immune Checkpoint Inhibitor Therapy - DEFENCE

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Procedure: sigmoidoscopies and and venous blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for treatment with anti PD1/PDL1 based immunotherapy Written informed consent Evaluable according to iRECIST v1.1 Exclusion Criteria: Concomitant, chronic or infectious illness in the past 6 months causing moderate to severe colitis Use of a medication in the past 6 months with an elevated risk of moderate to severe colitis Gastrointestinal resection or enterostomy Abdominal radiotherapy in the past 6 months

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Palliative treatment with immunotherapy<br> | Procedure: sigmoidoscopies and and venous blood sampling<br>* Sigmoidoscopies will be performed at baseline and during immunotherapy. During these procedures biopsies will be taken from the sigmoid and rectum. At the same timepoints, venous blood samples will be taken.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD8+ T cell count in the gut mucosa |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immune Checkpoint Inhibitor, Cancer, Gut Wall
Protocol for Women at Increased Risk of Developing Breast Cancer

Study Overview
=================
Brief Summary
-----------------
A pilot study to assess the effects of six months of letrozole on breast tissue risk markers in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer.

Detailed Description
-----------------
A pilot study of letrozole in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer. Subjects will have hyperplasia with atypia (or borderline Epithelial Hyperplasia/Atypical Hyperplasia) and evidence of Estrogen Receptor expression by random periareolar fine needle aspiration and baseline serum estradiol levels less than or equal to 150 pg/ml. The feasibility of performing RT-qPCR on breast specimens for aromatase expression will also be done at baseline.

Official Title
-----------------
Study of the Effect of Letrozole on Breast Biomarkers of High Risk Postmenopausal Women Receiving Hormone Replacement Therapy

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

Intervention / Treatment
-----------------
* Drug: letrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: evidence of hyperplasia with/without atypia upon random periareolar fine needle aspiration of breast on hormone replacement therapy postmenopausal increased risk of developing breast cancer based on personal or family history never have taken aromatase inhibitors or selective estrogen receptor modulators in last six months women who have a high risk of breast cancer older than 18 years Exclusion Criteria: anticoagulants marked breast tenderness pregnant or within twelve months of breast feeding/childbirth

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

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

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: 1<br>Oral Letrozole 2.5 mg daily for six months | Drug: letrozole<br>* Letrozole 2.5 mg daily<br>* Other names: Femara;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration. | Proliferation assessment by immunocytochemistry using Ki-67. Expressed as percent of cells staining positive for Ki-67. | Baseline, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast atypia, open label pilot study, letrozole, fine needle aspiration, high risk for breast cancer, breast epithelial hyperplasia, Ki-67, hormones plus chemoprevention, chemoprevention
Safety and Efficacy of the Therapeutic Vaccine GI-5005 Versus Placebo for the Treatment of Chronic Hepatitis C Infection

Study Overview
=================
Brief Summary
-----------------
The GI-5005 therapeutic vaccine or placebo will be injected under the skin of hepatitis C virus (HCV) subjects. Patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections.

Official Title
-----------------
A Phase 1 Double-Blind, Placebo Controlled, Dose-Escalation, Multi-center Therapeutic Trial of the Safety, Immunogenicity, and Efficacy of GI-5005; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing a Hepatitis C Virus NS3-Core Fusion Protein, in Patients With Chronic Hepatitis C Infection

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Biological: GI-5005


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic hepatitis C virus infection including treatment naive subjects as well as subjects who are partial responders and relapsers to prior interferon therapy >18 years of age Negative skin test for hypersensitivity to saccharomyces cerevisiae. Exclusion Criteria: Non-responders to previous interferon treatments Cirrhosis HCV treatment within 3 months Hepatitis B infection HIV infection

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: GI-5005|Heat-killed yeast cell transfected with NS3-Core fusion protien.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis, HCV, vaccine, Hepatitis C Infection
Negative Pressure Wound Therapy for Surgical Wounds of the Foot and Ankle

Study Overview
=================
Brief Summary
-----------------
Prophylactic use of Negative Pressure Wound Therapy (NPWT) on surgical wounds following lower extremity orthopedic trauma to prevent infectious complications.

Official Title
-----------------
Negative Pressure Wound Therapy for Surgical Wounds of the Foot and Ankle

Conditions
-----------------
Negative Pressure Wound Therapy, Vacuum Therapy, Closed Incisions

Intervention / Treatment
-----------------
* Device: PICO, Smith & Nephew


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥18 and ≤ 80 years Orthopedic (trauma) surgery to the foot and/or ankle Incision >3 cm Exclusion Criteria: Open fractures Antibiotic treatment at the time of the operation for a concomitant disease or infection Insufficient comprehension of the Dutch language Patients with immune-deficiencies Inability to address negative pressure wound therapy device Active infection

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Prophylactic negative pressure wound therapy | Device: PICO, Smith & Nephew<br>* Direct application of negative pressure wound therapy following Foot and Ankle surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number patients with postoperative wound infections (POWI) as classified bij the Centers for Disease Control and prevention (CDC)-criteria. | The number of POWI's within 30 days of surgery will be recorded. These will be classified in superficial and deep POWI's using the criteria as proposed by the CDC. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The American Orthopaedic Foot and Ankle Score (AOFAS) will be measured at six months | To asses functional outcome of the participants the AOFAS questionnaire will be used | 6 months | 
| EuroQol five dimensions questionnaire (EQ-5D)will be measured at six months | To asses the quality of life of the participants the EQ-5D questionnaire will be used | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NPWT
Effects of Inspiratory Muscle Training in COPD

Study Overview
=================
Brief Summary
-----------------
The additional effect of inspiratory muscle training as an adjunct to a general exercise training program in patients with COPD with inspiratory muscle weakness will be studied. The main hypothesis is that inspiratory muscle training combined with an exercise training program improves functional exercise capacity more than an exercise training program without the addition of an inspiratory muscle training program.

Official Title
-----------------
Effects of Inspiratory Muscle Training in Patients With Chronic Obstructive Pulmonary Disease - a Randomized Controlled Trial

Conditions
-----------------
COPD, Inspiratory Muscle Weakness

Intervention / Treatment
-----------------
* Procedure: Inspiratory Muscle Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with COPD Eligible to participate in a exercise training intervention of 8 weeks Pi,max <60cmH2O or <50% of the predicted normal value Exclusion Criteria: Major comorbidities preventing successful participation in an 8 week exercise training intervention

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspiratory Muscle Training<br>Inspiratory Muscle Training | Procedure: Inspiratory Muscle Training<br>* Three times daily inspiratory muscle training (2x30 breaths) at an intensity of >50% Pi,max<br>|
| Placebo Comparator: Sham IMT<br>Sham Inspiratory Muscle Training | Procedure: Inspiratory Muscle Training<br>* Three times daily inspiratory muscle training (2x30 breaths) at an intensity of >50% Pi,max<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-Minute Walking Distance |  | Baseline and 8 weeks follow-up |