linjc16/ctgov huggingface dataset:
Pulsed Dye Laser Treatment of Onychomycosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, or nail fungus. Hypothesis: Complete nail clearance will occur in approximately half of patients after 3 laser treatments.

Detailed Description
-----------------
10 patients will participate nationally. The investigators hope to enroll all 10 patients at Jefferson. Involvement in the study will last about 8-12 weeks for the subject. The entire study will take about 12 months to complete.

Official Title
-----------------
Pulsed Dye Laser Treatment of Onychomycosis

Conditions
-----------------
Onychomycosis

Intervention / Treatment
-----------------
* Device: Pulsed Dye Laser for the treatment of nail fungus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18-65 years old Diagnosis of onychomycosis based on positive fungal culture for dermatophyte and positive PAS from toenail clipping Exclusion Criteria: HIV/immunosuppression Candidal toenail infection Prior PO antifungal therapy within last 6 months Personal history of psoriasis, lichen planus, or significant photosensitivity disorder Any serious generalized medical condition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Pulsed Dye Laser for fungus treatment<br>The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, a common nail fungus. | Device: Pulsed Dye Laser for the treatment of nail fungus<br>* The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, a common nail fungus.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Nail Clearance | After 3 laser treatments, the subject should experience clinical clearance. | approximately 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
onychomycosis, nail, fungus
Pneumoproteins Expression in the Organ Donor

Study Overview
=================
Brief Summary
-----------------
Primary graft dysfunction, a form of reperfusion pulmonary edema that occurs early after lung transplantation, shares key clinical and pathological features with acute lung injury and its more severe form, the acute respiratory distress syndrome. However, in contrast to acute lung injury/acute respiratory distress syndrome, in which biomarkers in plasma, urine and lung edema fluid have prognostic and pathogenetic value, the role of biomarkers in primary graft dysfunction has been less thoroughly explored. We will try in this study de determine the rule of pneumoproteins in the donor organ on the pulmonary edema in the recipient.

Official Title
-----------------
Pneumoproteins Expression in the Organ Donor

Conditions
-----------------
Primary Graft Dysfunction

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the organ donors for lung grafts. Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 70 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 |
| --- | --- |
| NHBD<br>Non Heart Beating Donors | Other: no intervention<br> <br> |
| BDD<br>Brain death donors | Other: no intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Recipient with primary graft dysfunction |  | one year |
Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.

Official Title
-----------------
An Open-label Phase IIIb Study of Riociguat in Patients With In-operable CTEPH, or Recurrent or Persisting PH After Surgical Treatment Who Are Not Satisfactorily Treated and Cannot Participate in Any Other CTEPH Trial

Conditions
-----------------
Hypertension, Pulmonary

Intervention / Treatment
-----------------
* Drug: Adempas (Riociguat, BAY63-2521)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery Exclusion Criteria: All types of pulmonary hypertension other than Dana Point Classification Group 4 Operable patients listed for PEA (Pulmonary Endarterectomy)

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Adempas (Riociguat, BAY63-2521)|Individual dosing of riociguat between 0.5 and 2.5 mg three times daily based on patient's well being and blood pressure. (The individual optimal dose should be determined during the initial 8-week titration phase based on patient's monitoring of systolic blood pressure and well-being.)|

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
-----------------
Chronic thromboembolic pulmonary hypertension
Molecular Predictors of Pemetrexed and Carboplatin Response in Malignant Pleural Mesothelioma (MPM) Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to investigate the molecular predictors of pemetrexed and carboplatin response in tumor samples of a series of MPM patients extracting the DNA and genotyping for the TSER polymorphism.

Detailed Description
-----------------
Malignant pleural mesothelioma (MPM) is an aggressive tumor that usually has a poor prognosis. The combination of cisplatin and pemetrexed has recently become the standard of care in the first-line treatment of MPM. For patients who are unfit to receive a cisplatin-based chemotherapy, pemetrexed alone [7] or combined with carboplatin [8] has been proposed as an alternative treatment choice. The identification of molecular predictors of effective therapy is important for maximizing therapeutic efficacy and minimizing useless treatment in cancer patients.

Official Title
-----------------
Pharmacogenetics of Pemetrexed and Carboplatin in Malignant Pleural Mesothelioma Patients

Conditions
-----------------
MALIGNANT PLEURAL MESOTHELIOMA

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MPM diagnosis Availability of tumor tissue to perform analysis Exclusion Criteria : Other primary diagnosis No archival tissue available

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 |
| --- | --- | --- |
| Evaluate the expression and allelic variants of a panel of candidate genes involved in the resistance to drugs, the genome wide copy number changes in patients treated with drugs combination in the first line |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate retrospectively the correlation between gene expression and polymorphisms in candidate genes and array-CGH data, immunohistochemistry data, and clinical data. |  | one year |
Evaluation of Antibacterial Soap for Treatment of Lymphedema in a Filariasis-Endemic Area

Study Overview
=================
Brief Summary
-----------------
Introduction. Lymphatic filariasis is a devastating mosquito-transmitted parasitic disease that causes lymphedema or elephantiasis of the leg in 15 million persons, the majority of whom are women. In these persons, frequent bacterial infections (acute attacks) of the legs adversely affect physical health, economic well-being, and quality of life. Prevention of bacterial infections through hygiene and skin care can result in significant improvements in lymphedema and patient well-being. Methods. To determine the extent to which antibacterial soap can help reduce the incidence of acute bacterial infections of the lower limbs in persons with filarial lymphedema, 200 patients of the Ste. Croix Hospital lymphedema treatment clinic in Leogane, Haiti randomly assigned to receive either antibacterial (Safeguard) or placebo (Camay) soap and acute attacks monitored monthly for 12 months. Both groups received specific instructions on washing and skin care.

Official Title
-----------------
Evaluation of Antibacterial Soap for Treatment of Lymphedema and Elephantiasis in an Area Endemic for Lymphatic Filariasis

Conditions
-----------------
Lymphedema, Cellulitis

Intervention / Treatment
-----------------
* Drug: antimicrobial agent in soap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients eligible for participation include those who are currently enrolled in the lymphedema treatment program in Leogane who 1) have been trained in the techniques of self-care, 2) who live in a 10-km radius of the hospital, and 3) for whom we have adequate data on incidence of acute bacterial infections, risk factors for infection, and ability to comply with the treatment protocol (particularly hygiene). - Exclusion Criteria: Don't meet inclusion criteria. -
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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: antimicrobial agent in soap|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bacterial acute attacks, assessed monthly. |  |  | 
| Reported or observed severity of these acute attacks. |  |  | 
| Duration of acute attacks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Process measures |  |  | 
| Number of bars of soap used per patient per month. |  |  | 
| Demonstrated knowledge and ability to wash leg appropriately during home visits. |  |  | 
| Reported patient satisfaction with soap. |  |  | 
| Reported frequency of leg washing. |  |  |
Impact of Naloxone on the Analgesic Effect of Paracetamol in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to check if Naloxone induce an inhibiting effect on the analgesic effect of paracetamol in healthy volunteer, using evoked potentials.

Detailed Description
-----------------
Double Blind, cross-over study in healthy volunteers.

Official Title
-----------------
Impact of Naloxone on the Analgesic Effect of Paracetamol in Healthy Volunteers

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Naloxone and paracetamol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men between 18 and 40 years old written consent given Exclusion Criteria: Naloxone or paracetamol hypersensibility Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania Concomitant medication

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Naloxone and paracetamol|to check if naloxone induce an inhibiting effect on the analgesic effect of paracetamol in healthy volunteer, using evoked potentials|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of amplitude of the N2P2 cerebral wave (before and after administration of Naloxone) induced by thermal stimulus applied on the arm. |  | before and after administration of Naloxone | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow up of pain's evaluation using analogical visual scale. Follow up of pain's evaluation using analogical visual scale |  | following the pain's evaluation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain,, sensitization,, analgesia
Effect of Rotatory Upper Cervical Manipulation on Reflex Cervical Vertigo

Study Overview
=================
Brief Summary
-----------------
Cervical reflex vertigo is a non-common cause of vertigo, caused by decreased afferent input from the upper three cervical segments to vestibular nuclei.

Official Title
-----------------
Effect of Rotatory Upper Cervical Manipulation on Reflex Cervical Vertigo in Chronic Mechanical Neck Pain Patients

Conditions
-----------------
Vertigo

Intervention / Treatment
-----------------
* Procedure: upper cervical manipulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cervical pain vertigo Exclusion Criteria: severe osteoporosis blood circulation problem

Ages Eligible for Study
-----------------
Maximum Age: 60 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: traditional physical therapy program<br> | Procedure: upper cervical manipulation<br>* rotatory upper cervical manipulation to both sides. The treatment program was conducted for twelve sessions (three sessions per week). Assessment procedures were performed before and after treatment through visual analogue scale (VAS)<br>|
| Experimental: rotatory upper cervical manipulation to both sides<br> | Procedure: upper cervical manipulation<br>* rotatory upper cervical manipulation to both sides. The treatment program was conducted for twelve sessions (three sessions per week). Assessment procedures were performed before and after treatment through visual analogue scale (VAS)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity seems to be improved | Assessment procedures were performed before and after treatment through visual analogue scale (VAS) | 3 monthes | 
| vertigo seems to be significantly improved | Dix-Hallpike test was used to asses the vertigo degree and improvement within and after the treatment programme | 3 monthes |
Eye Screening in German Secondary Diabetes Care Centers

Study Overview
=================
Brief Summary
-----------------
In patients with confirmed diagnosis of diabetes, an eye examination and a comprehensive survey are conducted after recruitment in secondary diabetes care centers. All patients undergo a comprehensive eye examination including wide-angle fundus photograph and ocular cohaerence tomography. A questionnaire assesses the characteristics (history: diabetes duration, type of treatment), knowledge and personal attitudes of the persons affected. The relevant lab findings were collected from the electronic files. Main focus of the study is the concordance to the national screening recommendations (last eye exam, presence of retinopathy).

Official Title
-----------------
OCT Screening of Diabetes Patients: Health Care Research in Secondary Diabetes Care Centers

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Device: OCT examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - diabetes Exclusion Criteria: mental handicap in the case of blindness absence of a caregiver

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 |
| --- | --- |
| DiabCheck ophta OCTplus<br>persons with diabetes undergoing OCT examination | Device: OCT examination<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of diabetic retinopathy |  | day |
Cytokine and Eicosanoid Mediators in Coronavirus Disease 2019 (COVID-19)

Study Overview
=================
Brief Summary
-----------------
This study is a prospective, single center, observational, cohort study of patients to (1) describe the kinetics and temporal relationship of changes in eicosanoid and cytokine mediators in patients with severe COVID-19 admitted to the hospital; and (2) correlate the dynamic changes in eicosanoid mediators with available patient clinical status, including measures of severity of illness, routine laboratory tests, and outcomes.

Official Title
-----------------
Dynamic Changes in Cytokine and Eicosanoid Mediators Among Hospitalized Patients With Coronavirus Infectious Disease 2019 (COVID-19)

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to a hospital with symptoms suggestive of COVID-19. Confirmed infection with SARS-CoV-2 as determined by polymerase chain reaction (PCR) or other commercial or public health assay in the 72 hours prior to hospital admission or any time during hospital admission. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. Understands and agrees to comply with planned study procedures. Agrees to the collection of whole blood samples. Exclusion Criteria: Inability to obtain informed consent. Anticipated transfer to another hospital which is not a study site within 48 hours. Inability to obtain sequential blood samples due to patient's characteristics (i.e. difficult vascular access). Obstetric patients. Prisoners.

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 |
| --- | --- | --- |
| Changes on eicosanoid lipid mediators | Temporal changes on eicosanoid lipid mediators over a course of 10 days (or until discharge) in COVID-19 patients requiring hospitalization | 10 days | 
| Changes on plasma levels of a panel of 40 human cytokines and chemokines | Temporal changes on the levels of 40 human cytokines, chemokines and growth factors included in a commercially available panel (Bio-Rad, Human Chemokine Panel, 40-Plex #171AK99MR2) over a course of 10 days (or until discharge) in COVID-19 patients requiring hospitalization. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe clinical outcome | Severe clinical outcome defined as need for ICU admission and/or need for mechanical ventilation and/or multi-organ failure and/or death during hospitalization | Through study completion, an average of 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronavirus Disease 2019, SARS-CoV-2, Eicosanoids, Eicosanoid storm, Cytokine storm