linjc16/ctgov huggingface dataset:
Studying Biomarkers in Urine Samples From Younger Patients With Wilms Tumor

Study Overview
=================
Brief Summary
-----------------
This research study is looking at biomarkers in urine samples from patients with Wilms tumor. Studying samples of urine from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To characterize the urinary metabolite signature of 10 stage III, favorable-histology, Wilms tumor patients from the Cooperative Human Tissue Network (CHTN) Databank, as distinct from 10 normal controls. II. To characterize and compare the urinary metabolite profile in 50 randomly selected, stage III, favorable-histology, Wilms tumor patients enriched with an additional 30 stage III Wilms tumor patients who have relapsed. III. To establish if the potential poor outcome (defined as relapse) in the favorable-histology group has a specific metabolite signature. IV. To characterize the urinary metabolite signature of Wilms tumor in patients with unfavorable histology (diffuse anaplasia) and compare it to those with favorable histology. OUTLINE: Archived urine samples are analyzed for specific metabolite patterns by nuclear magnetic resonance (NMR) spectroscopy and principal component analysis (PCA). Tumor tissue may also be examined by NMR and PCA.

Official Title
-----------------
Observational - Characterization of Urinary Metabolite Profiles in Wilms Tumor

Conditions
-----------------
Recurrent Wilms Tumor and Other Childhood Kidney Tumors, Stage III Wilms Tumor

Intervention / Treatment
-----------------
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with stage III, favorable-histology Wilms tumors and patients diagnosed with stage III, favorable-histology Wilms tumors who have relapsed Tumor samples available from both groups Urine samples from the CHTN bank Control urine samples Urine samples from patients with unfavorable histology Not specified Not specified
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>Archived urine samples are analyzed for specific metabolite patterns by nuclear magnetic resonance (NMR) spectroscopy and principal component analysis (PCA). Tumor tissue may also be examined by NMR and PCA. | Other: laboratory biomarker analysis<br>* Correlative studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of metabolomic markers in urine that would assist in identifying higher risk of relapse of Wilms tumor in otherwise lower-risk stratified patients as assessed by NMR spectroscopy and PCA |  | Baseline |
A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
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The purpose of this study is to investigate similarity between NI-071 and infliximab(the comparator) in terms of efficacy in patients with Rheumatoid Arthritis not adequately responding to Methotrexate.

Official Title
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A Phase 3 Clinical Study of NI-071 in Patients With Rheumatoid Arthritis -A Double-blind, Active Drug-controlled Study and Long-term Study-

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

Intervention / Treatment
-----------------
* Biological: NI-071
* Biological: Infliximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of RA as defined by the American College Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria (ACR/EULAR 2010) Patients who received MTX treatment (6- 16mg/week) for 2 weeks for at least 12 weeks prior to the screening visit Exclusion Criteria: Patients with a following past History or concomitant diseases Other Connective tissue disorders which may interfere the efficacy assessment Chronic or recurrent infectious disease Demyelinating disease Congestive heart failure lymphoproliferative disorder or myelodysplastic syndrome Malignancy Interstitial lung disease Patients with active or latent tuberculosis or history of tuberculosis

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NI-071<br> | Biological: NI-071<br>* 100mg/vial<br>|
| Active Comparator: Infliximab<br> | Biological: Infliximab<br>* 100mg/vial<br>* Other names: Remicade;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy : Changes in DAS28-ESR |  | week 0 to week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy : Changes in DAS28 |  | week 0 to week 54 | 
| Efficacy : Changes in ACR20, 50, 70 |  | week 0 to week 54 | 
| Efficacy : Changes in ACR core-set |  | week 0 to week 54 | 
| Safety : Long term safety (Adverse Events, Immunogenicity, etc.) |  | to 54 weeks |
Observational Feasibility Study of Home-based Training With Therabands in PAD-patients

Study Overview
=================
Brief Summary
-----------------
The study is an observational feasibility study to evaluate the feasibility of a combined aerobic+resistance training program in patients with IC.

Official Title
-----------------
Observational Feasability Study of Home-based Training With Therabands in PAD-patients - Addressing the Uncertainty of Acceptance, Satisfaction and Usability of a Home-based, Tele-monitored Program Combining Aerobic and Resistance Components in PAD-patients.

Conditions
-----------------
Peripheral Artery Disease, Intermittent Claudication

Intervention / Treatment
-----------------
* Behavioral: aerobic+resistance exercise training program


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: age ≥ 50 yrs; ankle-brachial index (ABI) ≤ 0.9 in one or two legs; Fontaine stage II (Rutherford I 1-3) of PAD (new onset or conservatively treated); body mass index <35 kg/m 2 ; resting systolic blood pressure (BP) <160 mmHg and diastolic BP <105 mmHg; ability to walk at least 2 min at 2.0 mph; ability to undertake an incremental treadmill test; decrease of at least 15% in ABI after a maximal treadmill test; not currently engaging in any regular exercise program. Exclusion Criteria: exercise induced signs of myocardial ischemia or complex ventricular arrhythmias; no access to laptop or internet; no medical clearance for exercise

Ages Eligible for Study
-----------------
Minimum Age: 50 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
Intervention Model: Single Group Assignment
Interventional Model Description: Patients enrolled in the study receive a novel physiotherapy program.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise intervention<br> | Behavioral: aerobic+resistance exercise training program<br>* Personalized exercise program based on the inclusion testing and patient screening will be provided to the patient. The program will consist of a gradual walking program as well as a gradual resistance training program using therabands.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| user satisfaction | self-developed questionnaire based evaluation of user satisfaction | 4 weeks | 
| walking distance | pain free and maximal walking distance are recorded using the Gardner treadmill protocol. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Physical activity, defined total active energy expenditure (kcal) is obtained from objective measurement of physical activity during 7 consecutive days using the Sensewear device. | 2 months |
Clinical Survey of Oticon Medical Healing Cap

Study Overview
=================
Brief Summary
-----------------
This study investigates the use of a new healing cap which, through altered design and choice of material, has been improved when it comes to minimizing the risk of it falling off as well as increasing patient comfort.

Detailed Description
-----------------
This study will primarily investigate the use of a new healing cap, Healing cap II. The new healing cap has the same function as previous healing caps, but it soft instead of hard. Due to this, the healing cap is anticipated to not fall off as easily, but at the same time does not risk transferring larger forces than previously to the implant. Secondly, the patients will start using the sound processor 1-2 weeks after surgery. The implant stability will be monitored before and after loading by the use of resonance frequency analysis, an established method to evaluate and monitor osseointegrated implants.

Official Title
-----------------
C51 - Clinical Survey of Oticon Medical Healing Cap

Conditions
-----------------
Conductive Hearing Loss, Mixed Hearing Loss, Unilateral Partial Deafness

Intervention / Treatment
-----------------
* Device: Healing cap II


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients eligible for treatment with a bone anchored hearing aid 18 years or older Exclusion Criteria: Inability to participate in follow-up Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.

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: Use of Healing cap II<br>Single arm study using a new healing cap as intervention | Device: Healing cap II<br>* Healing cap II is used instead of the traditional healing cap as part of the surgical dressing after bone anchored hearing aid implant surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin reactions according to Holgers | Focus is on healing, post-operative complications and skin reactions after the first 7-14 days after surgery. | At time of sugical follow up visit (visit window of 7-14 days after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fitting of sound processor at surgical follow-up visit | Implant stability is monitored before and after sound processor fitting through ISQ and clinical assessments. | At time of surgical follow up visit (visit window of 7-14 days after surgery) |
Tumor Markers in Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine if DCAMLK1 can be measured in the endobronchial biopsy specimens and bronchial washings from patients with lung cancer.

Detailed Description
-----------------
DCAMLK1 is a Ca2+ - ca/modulin (CaM) - dependent protein kinase that is a marker of stem cells in colonic crypts. Mutations within the stem cell population are thought to be responsible for the development of most colorectal carcinomas and studies have shown that DCAMLK1 is highly expressed in these tumors. Since the lung is an embryological development of the foregut, we speculate that DCAMLK1 will also be upregulated in lung cancers. The aim of this pilot study is to determine if DCAMLK1 can be measured in the endobronchial biopsy specimens and bronchial washings from patients with lung cancer. This is a prospective study in 10 patients with lung masses suspected to be malignant who are scheduled for diagnostic bronchoscopy. Patients with lung masses scheduled for diagnostic bronchoscopy will be included if they can give informed consent to participate and the diagnostic portion of the bronchoscopy has been uncomplicated. Patients considered to be at high risk during bronchoscopy because of either abnormal blood gases (Pco2 > 50 mmHg or PaO2 < 70 mmHg on oxygen) or coagulopathy (platelets <100,000 or INR > 1.5) will be excluded. If the preliminary results indicate this is feasible, we will then propose a larger study to examine DCAMLK1 distribution in normal and cancerous tissue as well as the predictive value of this biomarker.

Official Title
-----------------
Tumor Markers in Lung Cancer

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: abnormality on chest x-ray that requires diagnosis and physically capable of undergoing bronchoscopy Exclusion Criteria: <45 years Patients with severe abnormalities in blood gases and/or a coagulopathy will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- | --- |
| Identification of DCAMLK1 in BAL and lung biopsy specimens. |  | After collection and analysis of specimens. |
Serotonin, Leptin and Adiponectin Level in Patients With Postpartum Depression: Controlled Study

Study Overview
=================
Brief Summary
-----------------
After vaginal delivery, all of the participants will evaluate by using Edinburg depression scale and venous blood sample will obtain. Postpartum depression will consider the result of scale 13 and above according to Turkhish translate. Then leptin, adiponectin and serotonin level will compare between depressed and nondepressed women.

Official Title
-----------------
Serotonin, Leptin and Adiponectin Level in Patients With Postpartum Depression: Controlled Study

Conditions
-----------------
Postpartum Depression

Intervention / Treatment
-----------------
* Other: leptin, serotonin and adiponectin level
* Other: leptin,serotonin, adiponectin level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women who gave birth Exclusion Criteria: women with previously diagnosed depression and any psychiatric disorders women with previously take antidepressan and antipshycothic women giving birth to children with anomalies women with undertake surgery for peripartum hemorrhage

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| Women with postpartum depression<br> | Other: leptin, serotonin and adiponectin level<br> <br> |
| Women without postpartum depression<br> | Other: leptin,serotonin, adiponectin level<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood level (ng/ml) ELİSA |  | 1 month |
Use of a Vibrotactile Sensory Prosthesis in Patients With Postural Imbalance and Spatial Disorientation

Study Overview
=================
Brief Summary
-----------------
The investigators propose to explore the hypothesis that vibrotactile channels for indicating spatial orientation can be exploited as a sensory prosthesis. The specific research applications will be used for guiding visual orientation, to provide alternative feedback to vision and vestibular signals for controlling balance, and for directional and lateralisation cueing in patients with neglect syndromes. The programme will study whether vibrotactile feedback improves performance and also if it speeds rehabilitation when used as an adjunct to conventional therapy.

Official Title
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Evaluation of a Vibrotactile Sensory Aid Developed by the US Navy to Combat Pilot Disorientation as a Prosthesis in Patients With Postural Imbalance and Spatial Disorientation

Conditions
-----------------
Vestibular Diseases, Peripheral Neuropathies, Proprioceptive Disorders, Hemispatial Neglect

Intervention / Treatment
-----------------
* Device: Vibrotactile feedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sensory impairments Unsteadiness Exclusion Criteria: High strokes

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Vibrotactile feedback|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time reaction to the perturbation with the feedback |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemineglects
Prosthetic Valve and Graft Endocarditis With Mycobacterium Chimaera

Study Overview
=================
Brief Summary
-----------------
Mycobacterium chimaera infections have occurred in post-cardiac surgery patients in association with contaminated cardiac bypass heater-cooler devices. So far optimal therapeutical concepts are not clear. At the University Hospital Basel Mycobacterium chimaera- infected protheses are replaced to decrease pathogenic burden and to support antibiotic long- term treatment. This study is to analyze the efficacy of this therapeutic approach.

Official Title
-----------------
Prosthetic Valve and Graft Endocarditis With Mycobacterium Chimaera: Diagnosis, Course of Disease, and Therapy Recommendations

Conditions
-----------------
Mycobacterium Chimaera Infections

Intervention / Treatment
-----------------
* Other: data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Mycobacterium chimaera infections after cardiac surgery at University Hospital Basel Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: data collection|retrospective analysis of perioperative data collected from patient medical charts and from a telephone enquiry|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| summary of disease course in patients with Mycobacterium chimaera- infections after cardiac surgery | Descriptive statistical analysis of disease course in patients with Mycobacterium chimaera- infections after cardiac surgery | at baseline | 
| summary of therapeutic interventions in patients with Mycobacterium chimaera- infections after cardiac surgery | Descriptive statistical analysis of therapeutic interventions in patients with Mycobacterium chimaera- infections after cardiac surgery | at baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac bypass heater-cooler devices, cardiac surgery
Comparison of Hypotension During Spinal Anaesthesia for C-section

Study Overview
=================
Brief Summary
-----------------
Maternal hypotension during C section has been reported due to aortocaval compression (ACC) by full term uterus in supine position. This study aimed at reporting the effect of left tilt on maternal hemodynamics.

Detailed Description
-----------------
C-section is usually done in either general anesthesia or regional (epidural or spinal) anesthesia. The choice lies with the mother. In spinal anesthesia the anaesthetic agent is injected into the subarachnoid space. Hypotension in supine position that is associated with full term gravid uterus has been explained by compression of inferior venacava (IVF) and aorta. This aortocaval compression (ACC) can also cause hypotension during C- section after spinal block. The aim of our study was to study the effect of left tilt on systolic (SBP) and diastolic blood pressure (DBP), heart rate and the frequency of phenylephrine used to maintain the blood pressure in normal range.

Official Title
-----------------
To Tilt or Not to Tilt?: Comparison of Severity of Hypotension Between Supine and Left Tilt Position During Spinal Anesthesia for Elective C-section

Conditions
-----------------
Hypotension, Cesarean Section, Aortocaval Compression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants ≥ 18 years, undergoing Elective Caesarean Section for term singleton pregnancy, ASA I/II, were included after their consent for the participation of the study. Exclusion Criteria: Participants with co-morbidities (Hypertension, diabetes mellitus, cardiovascular or cerebrovascular disease and a history of coagulation disorders), any contraindication to spinal anesthesia, with multiple pregnancy, pre-eclampsia, obesity (body mass index > 30 kg.m2), intrauterine growth were excluded from the study.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Supine group<br>Spinal anaesthesia was administered in sitting position and then supine position was maintained. | |
| Left tilt group<br>Spinal anesthesia was administered in sitting position was then maintained on supine position until full anesthetic effect (motor and sensory loss) and then table was tilted 15 degrees to the left. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Group 1 - Supine Group | Systolic blood pressures decreased significantly in the supine group | December 2021 to February 2022 | 
| Group 2 - Left tilt Group | The decrease in the diastolic blood pressure was marginally significant in the left tilt group. | December 2021 to February 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypotension, Cesarean Section, Aortocaval Compression, Left titl