linjc16/ctgov huggingface dataset:
Study of FK463 for the Treatment of Invasive Aspergillosis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and efficacy of FK463 in patients with proven or probable invasive infections due to Aspergillus species.

Detailed Description
-----------------
This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.

Official Title
-----------------
An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis

Conditions
-----------------
Aspergillosis

Intervention / Treatment
-----------------
* Drug: FK463


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Has proven or probable systemic infection with Aspergillus species Exclusion Criteria Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal Has bronchopulmonary aspergillosis, aspergillomas, sinus aspergillosis or external otitis but does not have histologic evidence of tissue invasion Has life-expectancy judged to be less than 5 days

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FK463|nan|

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
-----------------
Aspergillus, Anti-Fungal
Thyroid Dysfunction in Patients With Type 2 Diabetes With Early Diabetic Nephropathy.

Study Overview
=================
Brief Summary
-----------------
Diabetes Mellitus is the most common disorder seen. The impact of this disease on the quality of life, and on morbidity and mortality through the complications that affect the small and large vessels resulting in retinopathy, nephropathy, neuropathy, and ischemic heart disease has been emphasized by the findings of the national commission (USA) on diabetes . So, there was curiosity to understand and learn the association of this disorder with another common endocrine gland function that is thyroid gland . The association between these two disorders has long been recognized although the prevalence of thyroid dysfunction in diabetic population varies widely between studies. With insulin and thyroid hormone being intimately involved in cellular metabolism and thus excess or deficit of these hormones result in functional derangement of the other . Diabetic patients have higher prevalence of thyroid disorder when compared with the normal population. Diabetic women are more frequently affected than men and hypothyroidism is more common than thyrotoxicosis. As Hyperthyroidism impairs glycemic control in diabetic subjects, while hypothyroidism may increase susceptibility to hypoglycemia thus complicating diabetes management so Severe diabetic complications where noted in patients with sub- clinical hypothyroidism . Sub-clinical hypothyroidism is an independent risk factor for development of diabetic nephropathy.

Detailed Description
-----------------
Recognition and treatment of thyroid dysfunction in diabetic patients will benefit glycemic control and improve general well-being Diabetic nephropathy, a major microvascular complication of type 2 diabetes mellitus, is an important cause of chronic kidney disease. It results from interactions between hemodynamic and metabolic factors.

Official Title
-----------------
Thyroid Dysfunction in Patients With Type 2 Diabetes With Early Diabetic Nephropathy.

Conditions
-----------------
Evaluation Thyroid Functions in Diabetic Patient

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus and with diabetic nephropathy. Exclusion Criteria: 1) Insulin dependent diabetes 2) Patients with: Gestational diabetes mellitus. Steroid induced Diabetes. 3) Thyroid disease

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>case control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of patients progress to advanced diabetic nephropathy |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
evaluation of thyroid function in diabetes patients
Medical Clowning: Needs Assessment and Implication for Hospitalized Children With Cancer/Blood Disease

Study Overview
=================
Brief Summary
-----------------
Hospitalized children who undergo painful procedures are more susceptible than others to experiencing iatrogenic effects, such as anxiety, pain, and severe stress. Clowns in clinical setting have been found to be effective in reducing children's experiences of these effects during hospitalization and before procedures. This article provides an overview of clowning in health care settings; reviews major studies conducted on clowning for hospitalized children, discussing evidence that clown interventions decrease pain and distress in pediatric patients; and concludes with a discussion of health care clowning as a profession.

Official Title
-----------------
Medical Clowning: Needs Assessment, Implication, and Evaluation for Children and Adolescents With Cancer Using Child Friendly Healthcare

Conditions
-----------------
Blood Disease, Cancer, Friendly Healthcare in Children, Medical Clown, Hospitalized Children

Intervention / Treatment
-----------------
* Behavioral: Medical Clowning for children


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 4-18 children with cancer/blood disease and parents of children aged 0-18 years with cancer/blood disease Exclusion Criteria: older than aged 18
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 |
| --- | --- |
| children and their parents<br>aged 4-18 children with cancer/blood disease and their parents | Behavioral: Medical Clowning for children<br>* Clowns in clinical setting have been found to be effective in reducing children's experiences of these effects during hospitalization and before procedures.<br>|
| Dr. Clowns<br>they will perform shows for children and parents | Behavioral: Medical Clowning for children<br>* Clowns in clinical setting have been found to be effective in reducing children's experiences of these effects during hospitalization and before procedures.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| experience and influence from medical clowning for children and their parents | Children with cancer/blood disease and their parents would use self-report to complete the questionnaire after medical clowning. Using Face Rating Scale (1=very unhappy to 5=very happy) for measuring emotion state (pre-emotion for before medical clowning and post-emotion for after medical clowning). It can understand whether their emotion state change before/after medical clowning or not. | 1 year |
Ultraviolet Light Therapy for Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the mechanisms of ultraviolet A-1 light therapy in patients with systemic lupus erythematosus and normal controls.

Detailed Description
-----------------
PROTOCOL OUTLINE: Treatment with ultraviolet A-1 light is administered 5 days a week for 6 weeks, at the lowest dose or frequency required to maintain a response. The dose and frequency are progressively decreased over the next 9 weeks.

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Procedure: ultraviolet A-1 light treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Patients ages 15 to 70 with symptomatic systemic lupus erythematosus meeting American Rheumatism Association criteria and normal controls --Prior/Concurrent Therapy-- No requirement for tetracycline or other photosensitizing drugs

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: ultraviolet A-1 light treatment|nan|

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
-----------------
arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus
Source Profiling of Biohazardous Aerosols in Hospitals

Study Overview
=================
Brief Summary
-----------------
To characterise the physical parameters (number concentration, size distribution and their trajectories) of aerosols (droplets) generated in high risk procedures.

Official Title
-----------------
Source Profiling of Biohazardous Aerosols in Hospitals

Conditions
-----------------
Respiratory Tract Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (>18 years old) that can give valid consent URTI: with symptoms such as coryza, sore throat, nasal discharge, cough and sputum +/- fever. Amongst these, cough should be a major complaint. LRTI (CAP): acute lower respiratory illness of no other known cause which is usually associated with fever, symptoms and signs of the chest and abnormalities on the CXR. (BTS 1993). Exclusion Criteria: Pneumonia developed at or after 48 hours, or history of hospital admissions within 1 month of the present admission (to exclude hospital-acquired infections) Patients who are unable to cooperate with the study protocols (such as mentally confused, dementia) or are physically unable to sit or stand independently to carry out the tests optimally. Patients with TOCC associations with infections such Avian Flu or SARS (travel to endemic areas, at-risk occupations, close contacts with index cases, especially with compatible clinical features) or NPA revealed positivity of influenza A/B Patients who are clinically or haemodynamically unstable, such as the need for inotropes, oxygen supplement of >2L/min, any types of shock, etc. Underlying diseases that might affect the coughing effort (such as musculoskeletal diseases, or severe kyphoscoliosis)

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

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

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
-----------------
Healthy subjects, Lower Respiratory Tract Infections, Upper Respiratory Tract Infections
The Study of Using Esophageal Pressure to Guide the PEEP Setting in Abdominal Hypertension Patients Who Undergoing Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
Intra-abdominal hypertension can increase the pleural pressure, and then end-expiratory transpulmonary pressures will be turn to negative, Pulmonary atelectasis/acute lung injury/acute respiratory distress syndrome will appear. In the group of people who suffering intra-abdominal hypertension, the investigators use the pressure of esophagus to speculate the Intrathoracic pressure, and to setting PEEP in order to decrease the happening of ALI/ARDS, which may decrease morbidity in this population.

Official Title
-----------------
the Study of Using Esophageal Pressure to Guide the PEEP Setting in Abdominal Hypertension Patients Who Undergoing Mechanical Ventilation

Conditions
-----------------
ARDS, Intra-abdominal Hypertension

Intervention / Treatment
-----------------
* Device: titrated setting peep


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intra-abdominal hypertension mechanical ventilation sedation Exclusion Criteria: underlying pulmonary disease age older than 60 years and younger than 18 years vital signs were not stable non voluntary

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: esophageal pressure ,titrated setting<br> | Device: titrated setting peep<br>* titrated setting peep according to esophageal pressure in experimental group; setting peep on the patient's PaO2 and FiO2 in control group.<br>|
| Other: ARDSNet recommendations,peep<br> | Device: titrated setting peep<br>* titrated setting peep according to esophageal pressure in experimental group; setting peep on the patient's PaO2 and FiO2 in control group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilator-free days | Comparison of two groups the duration of ventilation-free in 28d,ventilator-free day include weaning from mechanical ventilation more than 24h. | 28d | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | 28-Day mortality include patients who giving up treatment due to critical condition | 28d | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mechanical ventilation, Intra-abdominal hypertension, positive end-expiratory pressure
Lactobacillus Farciminis and Hyperalgesia

Study Overview
=================
Brief Summary
-----------------
We want to analyse a possible effect of o dialy consumption of Lactobacillus farciminis on a hyperalgesia on response to thermal stimulation. A comparaison of results before and after three weeks of treatment will be made.

Official Title
-----------------
Effect of a Dialy Consumption of a Probiotic (Lactobacillus Farciminis) on Hyperalgesia in Response to Thermal Stimulation

Conditions
-----------------
Inflammation, Pain

Intervention / Treatment
-----------------
* Drug: Lactobacillus farciminis
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers Exclusion Criteria: consumption of yogurts

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>24 healthy volunteers consuming L.farciminis during three weeks | Drug: Lactobacillus farciminis<br>* 1 capsule per day. Each capsule containing 4*109 CFU<br>|
| Placebo Comparator: 2<br>24 healthy volunteers consuming placebo during three weeks | Drug: Placebo<br>* 1 capsule per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the mchanical pain threshold in primary and secondary areas by using a punctate stimulus. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of cutaneous temperature of hyperalgesia areas |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammation, Pain
Tampa Associating Microwave Liver Ablation With Portal Vein Ligation for Staged Hepatectomy (TAMLAPS)

Study Overview
=================
Brief Summary
-----------------
This is a study following the outcomes and survival of patients undergoing the TAMLAPS hepatectomy at Florida Hospital Tampa by Dr. Iswanto Sucandy

Official Title
-----------------
Complete Robotic Tampa Associating Microwave Liver Ablation With Portal Vein Ligation

Conditions
-----------------
Liver Cancer, Liver Tumor, Hepatocellular Carcinoma, Hilar Cholangiocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients scheduled to undergo the TAMLAPS procedure by Dr. Iswanto Sucandy. Exclusion Criteria: Subjects with history of noncompliance. Subjects with physical health, substance abuse, or mental health problems that will limit the subject's ability to meet study requirements

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth of the Future Liver remnant | 1. Liver growth determined by measuring the kinetic growth rate obtained from pre-operative and post-op stage one CT evaluations of the FLR volume | 2 weeks |
Evaluation of Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers

Study Overview
=================
Brief Summary
-----------------
This study was designed to evaluate the clinical benefits and safety of OrCel in the treatment of venous ulcers. OrCel and standard care were compared to standard care alone. Standard care consisted of currently accepted compression therapy. Patients were treated for 12 weeks. Patients with healed ulcers were followed for an additional 12 weeks to assess durability of the healed wound.

Official Title
-----------------
A Pivotal Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (OrCel) for the Treatment of Venous Ulcers

Conditions
-----------------
Venous Leg Ulcer, Venous Stasis Ulcer

Intervention / Treatment
-----------------
* Device: Bilayered Cellular Matrix (OrCel)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any race, between 18 and 85 years of age Male or female Chronic venous insufficiency Ulcer size between 2 and 20 sq cm, inclusive Ulcer present for at least one month ABI >0.7 Exclusion Criteria: Decrease in wound size >35% during Screening Phase Infection at the ulcer site Uncontrolled diabetes mellitus Previous treatment with excluded medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Bilayered Cellular Matrix (OrCel)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator assessment of wound healing |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Planimetric assessment of wound healing |  |  | 
| Photographic assessment of wound healing |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Venous leg ulcer, OrCel, Compression therapy
Contraceptive Counselling: Impact on Awareness of the Risk of Unwanted Pregnancy and on the Appeal of Contraception

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that the generalisation of minimal contraceptive advice in general medical consultations among women of childbearing age in Reunion Island who do not use contraception but who have sexual relations and do not wish to become pregnant within the year could induce an awareness of the risk of unwanted pregnancy and lead to a change in behaviour with regard to contraceptive methods.

Official Title
-----------------
Le Conseil Minimal Autour de la Contraception : Quel Impact Sur la Prise de Conscience du Risque de Grossesse Non désirée et Sur l'Attrait à la Contraception

Conditions
-----------------
Contraception

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women from 18 to 50 years old Consulting in a general practice in Reunion Island French or Creole speaking Not having any contraceptive means Having sexual intercourse Not having any desire to become pregnant within the year Collection of non-opposition Exclusion Criteria: Consultation for a desire or follow-up of a pregnancy Consultation for an abortion Consultation for a contraceptive method Known infertility Inability to answer the telephone (hearing impaired, mute) Severe cognitive disorder (mental retardation, dementia, active psychosis) Women under guardianship or curatorship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of a minimal councelling regarding the contraception awareness of risk of unwanted pregnancy | Change of Proportion of women with no contraception and having sexual relations without a desire of pregnancy | between Day 1 and Month 1 |