linjc16/ctgov huggingface dataset:
Intra-arterial Measurement of pO2 in Walking Induced Transient Hack Profiles

Study Overview
=================
Brief Summary
-----------------
Confirm with invasive measurement the presence of a Walking-Induced Transient Hack (WITH) profile

Detailed Description
-----------------
Arterial PO2 and body temperature measurements during exercise

Official Title
-----------------
Intra-arterial Measurement of pO2 in Walking Induced Transient Hack (WITH) Profiles

Conditions
-----------------
Claudication

Intervention / Treatment
-----------------
* Other: Arterial sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: walking induced transient Hack (WITH) tcpO2 profile Exclusion Criteria: rejection by patient
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: Patients with walking limitation<br>Patients with claudication and Walking-Induced Transient Hack (W.I.T.H.) tcpO2 profiles are tested on treadmill with invasive pO2 arterial sampling and body temperature recording | Other: Arterial sampling<br>* Arterial pO2 (ABL5) Body Temperature (Vitalsens Cortemp) tcpO2 TCM400<br>* Other names: All material is CE marked and approved for huamn use;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial pO2 |  | 2 months (time required to organise the test) |
Airway Response to Repeat Allergen Challenge and the Effect of Ibuprofen in Mild Atopic Asthma

Study Overview
=================
Brief Summary
-----------------
The study will assess airway responses in mild atopic asthmatics undergoing repeat allergen challenge testing and will investigate whether ibuprofen changes the response.

Official Title
-----------------
Assessment of Repeated Allergen Challenge and the Effects of Ibuprofen on the Inflammatory Process

Conditions
-----------------
Atopic Asthma

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of mild asthma, currently well controlled requiring only a bronchodilator (e.g. salbutamol) as needed and infrequently has allergies that trigger asthma responds to methacholine challenge at 16mg/ml or less has FEV1 > 69.5% predicted Exclusion Criteria: respiratory illness within 4 weeks other medical condition assessed by the principal investigator that would put the participant at risk or influence the integrity of the data pregnant or lactating females hypersensitivity to ibuprofen

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen<br>400mg (2X200mg) ibuprofen single dose once | Drug: ibuprofen<br>* 2x 200mg ibuprofen, single dose, blinded in 00 capsules<br>* Other names: Advil;|
| Placebo Comparator: Placebo<br>identical appearing lactose capsules single dose 2 capsules once | Drug: Placebo<br>* lactose filled 00 capsules to match appearance of ibuprofen intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway response to inhaled allergen | area under forced expiratory volume in one second versus time curve; 0-3hours (early response) and 3-7 hours (late response) | at time of allergen inhalation challenge and for 7 hours after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway response to inhaled methacholine | delta log methacholine PC20 (provocative concentration of methacholine causing a 20% decrease in the forced expiratory volume in one second) | day before allergen inhalation challenge and 8 hours after allergen inhalation challenge |
Advanced MRI in Major Depression

Study Overview
=================
Brief Summary
-----------------
Depression is the most common psychiatric disorder. 3-5% of a given population has major depression. Less than 50% of the depressed in Denmark are diagnosed with major depression. 25-50% of the depressed have a relative with major depression-underlying brain pathology? The purpose of this study is to use MRI to evaluate cerebral morphology and function in ambulant patients with major depression

Detailed Description
-----------------
Previous studies within major depression, have often included hospitalized patients with severe symptoms and imaging have been performed with PET and SPECT, which uses ionizing radiation. This study focus on ambulant patients(with or without medication/ECT treatment), to find patients in an earlier stage. Cerebral perfusion with the MR sequence Arterial Spin Labelling, concentrations of different metabolites with MR spectroscopy and brain volumetry with BRAVO 3D T1 ax will be performed. MR protocol: T2 sag, T2 FLAIR ax, ASL ax, MRS and 3D T1 ax. Scan time 45 min.

Official Title
-----------------
Advanced MRI at 3T for the Evaluation of Ambulant Patients With Major Depression

Conditions
-----------------
Depressive Disorder, Major

Intervention / Treatment
-----------------
* Other: Magnetic Resonance Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who fulfil ICD-10´s criteria for major depression, found within the ambulant psychiatric sector and who has a HAM-D ≥ 18 Exclusion Criteria: If the patient has pacemaker or other magnetic devices Pregnancy Has had an operation in the brain bipolar disorder

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- |
| A<br>Ambulant patients with major depression | Other: Magnetic Resonance Imaging<br>* Morphological sequences Arterial Spin Labelling (Perfusion) Spectroscopy: anterior cingulate cortex Naa, Cho, Cr, Myo-inositol, glutamate TE 30 Reference voxel in Parietal white matter<br>* Other names: 3 Tesla GE Scanner HDx;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in morphological and functional cerebral MRI findings in patients suffering from major depression |  | 6 months from first MRI in each patient | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, Perfusion, brain
Clinical Manifestations and Long-Term Outcome in Early Lyme Neuroborreliosis

Study Overview
=================
Brief Summary
-----------------
In this retrospective cohort study of patients with early Lyme neuroborreliosis (LNB), clinical and microbiologic characteristics and long-term outcome of definite vs. possible LNB were evaluated at a single university medical center in Slovenia. Severity of acute disease and long-term outcome during a 12-month follow-up were assessed using a composite clinical score based on objective clinical findings and subjective complaints.

Official Title
-----------------
Clinical Manifestations and Long-Term Outcome in Early Lyme Neuroborreliosis According to Diagnostic Certainty

Conditions
-----------------
Lyme Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: early Lyme neuroborreliosis Exclusion Criteria: Not fulfilling study criteria for definite or possible Lyme neuroborreliosis Alternative diagnosis during follow-up Concomitant tick-borne encephalitis Clinical symptoms/signs present for >6 months Data not available

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| definite LNB<br>patients with definite early Lyme neuroborreliosis | |
| possible LNB<br>patients with possible early Lyme neuroborreliosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite clinical score | Composite clinical score based on objective clinical findings and subjective complaints. The sum of subjective complaints and objective findings scored as 0=absent or 1=present represent severity of disease on admission or clinical outcome at follow-up, respectively. Maximum total score=31 | follow-up for 12 months-post-treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lyme neuroborreliosis, post-Lyme borreliosis symptoms, antibiotic therapy
Pruritus and Melanoma and Cutaneous Carcinomas Treated With Immunotherapy

Study Overview
=================
Brief Summary
-----------------
Immune checkpoint inhibitors (ICIs) are commonly used in the therapeutic arsenal of metastatic melanoma, Merkel cell carcinoma and cutaneous squamous cell carcinoma, thanks to their inhibiting effects on cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA4) and anti-programmed death-1 (anti-PD1) respectively. These treatments can induce numerous cutaneous and non-cutaneous adverse effects that are mainly due to their immunological action. Their most frequent adverse effects are dysthyroidism, autoimmune hepatitis, colitis and skin disorders. Among those, pruritus is frequently reported as a side effect of these treatments. Its incidence has been estimated between 11% and 47%. Pruritus can deeply affect the patient's quality of life and may lead to treatment discontinuation. Until now, ICI-related pruritus has been poorly studied and it is not understood. In the literature, data on the presence and characteristics of pruritus in patients treated by ICIs were provided, without analyzing the causes of this pruritus. Indeed, it is not known if the occurrence of pruritus is related to direct or indirect effects of ICIs. Some authors reported a correlation between the occurrence of cutaneous adverse events under ICIs and the survival. The principal aim of our study was to analyze the putative causes of pruritus occurring in patients treated with ICIs for melanomas and cutaneous carcinomas. The other objectives were to assess the association between the occurrence of pruritus and survival, and between the other adverse events and pruritus.

Official Title
-----------------
Pruritus and Melanoma and Cutaneous Carcinomas Treated With Immunotherapy (PRURICHECKPOINT)

Conditions
-----------------
Pruritus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 years and older, treated with ICIs (nivolumab, pembrolizumab, ipilimumab, cemiplimab) for melanoma, squamous cell carcinoma or Merkel cell carcinoma not having formulated any opposition Exclusion Criteria: age under 18 years, adults not legally competent, presence of pruritus at the inclusion, participation refusal

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 |
| --- | --- | --- |
| putative causes of pruritus | questionnaire | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of other side effects | questionnaire | through study completion, an average of 1 year | 
| survival | questionnaire | through study completion, an average of 1 year |
Phase 2 Study to Evaluate PVX-410 + Pembrolizumab + Chemotherapy for Metastatic, PD-L1+ Triple-Negative Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Evaluating the combination of the investigational, multi-peptide cancer vaccine PVX-410 in combination with pembrolizumab and chemotherapy in treatment naive patients with metastatic, triple negative breast cancer who are PDL1 and HLA A2 positive.

Official Title
-----------------
A Single-Arm, Open-Label, Multi-Center Phase II Study to Evaluate the Combination of PVX-410 + Pembrolizumab + Chemotherapy for Frontline Therapy of Metastatic, PD-L1+ Triple-Negative Breast Cancer (TNBC) in HLA-A2-Positive Patients

Conditions
-----------------
Metastatic Triple-Negative Breast Carcinoma

Intervention / Treatment
-----------------
* Drug: PVX-410


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - HLA A2 Positive PDL1 Positive Treatment naive, triple negative breast cancer Exclusion Criteria: -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PVX-410/pembrolizumab/chemotherapy<br> | Drug: PVX-410<br>* PVX-410 in combination with pembrolizumab and chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 8 months |
Inova Cardiogenic Shock Registry (INOVA SHOCK)

Study Overview
=================
Brief Summary
-----------------
To collect retrospective clinical outcomes related to acute decompensated heart failure cardiogenic shock, acute myocardial infarction cardiogenic shock and compare current versus historical survival rates. To collect Inova Heart and Vascular Institute (IHVI) site specific outcomes before and after initiation of the Cardiogenic Shock team on January 1, 2017. To collect outcomes related to implementation of mechanical circulatory support versus no circulatory intervention and type of intervention (extracorporeal membrane oxygenation (ECMO) versus intracorporeal axial-flow (Impella). • Assess survival at three time points.

Detailed Description
-----------------
Any patient with cardiogenic shock, whether inpatient or transferred from another facility, treated at the Inova Heart and Vascular Institute shall be included in this registry. This includes adults with and without decision making capacity over the age of 18 years old. The primary investigator (PI) will designate the data points to be included in the database in order to assess the efficiency of procedures and protocols in the treatment of cardiogenic shock at the IHVI as administered by the Shock team, to identify relationships between treatment and negative morbidity and mortality outcomes, and to monitor and improve quality of care delivered.

Official Title
-----------------
Implementation of a Cardiogenic Shock Team and Clinical Outcomes (INOVA-SHOCK Registry)

Conditions
-----------------
Cardiogenic Shock

Intervention / Treatment
-----------------
* Procedure: Cardiogenic Shock team activation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients at the IHVI with documented Cardiogenic Shock team intervention for acute decompensated heart failure cardiogenic shock, or acute myocardial infarction cardiogenic shock. Exclusion Criteria: -Patients under the age of 18 will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cardiogenic Shock team activation|Any patient with cardiogenic shock, whether inpatient or transferred from another facility, treated at the Inova Heart and Vascular Institute by the designated Cardiogenic Shock Team.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective review of Cardiogenic shock patients outcomes | To create an archive of retrospective clinical outcomes (acute decompensated heart failure cardiogenic shock, or acute myocardial infarction cardiogenic shock) and compare current versus historical survival rates. | 1 Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiogenic, shock
Effect of Elite Soccer Training on Routine Laboratory Parameters

Study Overview
=================
Brief Summary
-----------------
Repeated blood sampling within a regular soccer season of German first league clubs shall serve to define soccer-specific reference values for routine parameters determined from venous blood. It was hypothesized that only for a minor number of parameters common reference values will have to be adapted for soccer players during their competitive season.

Detailed Description
-----------------
It is often difficult to discern exercise-induced changes in laboratory parameters from pathological changes in elite athletes during the regular training process. This is particularly true in soccer players who compete more often than many other athletes. Therefore, soccer players of the first two German soccer leagues (all professional athletes) are recruited for repeated blood sampling during the season (4 sampling times, one of them immediately before training commences in the summer, the other ones in October/November, February/March, and April/May). Among other standardizing requirements, it is mandatory that precisely one training session (not zero, not two, no competition) takes place the day before sampling. Several confounders for the interpretation of laboratory results are verified by means of a questionnaire. Phases of high competitive stress are compared with those of low stress. The course of the parameters as well as confidence intervals for given times during the season are of main interest.

Official Title
-----------------
Laboratory Values in Elite Soccer Players

Conditions
-----------------
Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being employed as player by a club of the first two German soccer leagues healthy Exclusion Criteria: chronic disease interfering with one or more of the determined parameters

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| soccer players<br>players of the first two German soccer leagues | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete blood count |  | August 2008 until May 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numerous serum parameters from venous blood |  | August 2008 until May 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
soccer, laboratory, reference, exercise, variability, season, elite athletes, Define reference blood parameters in elite athletes
A Rehabilitation With Virtual Reality in Patients After Hip Arthroplasty Surgery (VRRS2018)

Study Overview
=================
Brief Summary
-----------------
.Assessing efficacy of rehabilitation with virtual reality exercises compared to traditional rehabilitation in the patient's operated hip arthroplasty

Detailed Description
-----------------
Randomized controlled clinical study: Comparison of clinical efficacy between rehabilitation with virtual reality (VRRS) and traditional physiotherapy in post-surgical rehabilitation treatment in hospital. Motor clinical evaluations will be carried out in both groups. Vrrs Arm: 32 subjects will undergo a virtual motor-reality training during the post-surgical rehabilitation period. Physiotherapist's arm: 32 subjects with demographic characteristics similar to the subjects of the Vrrs arm will undergo the habitual rehabilitative physiotherapy. According to normal clinical practice, both groups perform a co-intervention in addition to the assigned group; Manual therapy with exercises and functional activity (walk and stairs).

Official Title
-----------------
A Rehabilitation With Virtual Reality in Patients After Hip Arthroplasty Surgery (VRRS2018)

Conditions
-----------------
Hip Disease

Intervention / Treatment
-----------------
* Other: rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - hip arthroplasty Exclusion Criteria: patient with resence of neurological and psychiatric disorders minor patient

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Parallel Assignment
Interventional Model Description: randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional rehabilitation<br>32 subjects will undergo a virtual motor-reality training during the post-surgical rehabilitation period with VRSS | Other: rehabilitation<br>* rehabilitation<br>|
| Experimental: Rehabilitation with virtual reality<br>32 subjects with demographic characteristics similar to the subjects of the Vrrs arm will undergo the habitual rehabilitative physiotherapy. | Other: rehabilitation<br>* rehabilitation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disability measurement | WOMAC (Western Ontario and McMaster University) Osteoarthritis index | on the 21st day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain measurement | visual analoge scale VAS | on the 10st day |