linjc16/ctgov huggingface dataset:
Predictive Factors of Acute Oral Mucositis Induced by Chemo-radiotherapy for Local Advanced Nasopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
This is a prospective, observational study to analyze the clinical and dosimetric factors about the radiation oral mucositis caused by radical chemo-radiotherapy for nasopharyngeal carcinoma patients and try to find the indicators for acute radiation oral mucositis.

Detailed Description
-----------------
All patients received 1 - 3 concurrent chemotherapy during the intensity modulated radiotherapy. Before radiotherapy, three types of mouth mucosa are contoured in all treatment plans. Oral mucosa grades are recorded before and during treatment. Dose-volume Histograms are got to analyze the associated factors.

Official Title
-----------------
Predictive Factors of Acute Oral Mucositis Induced by Intensity-Modulated Radiation Therapy With Concurrent Chemotherapy for Local Advanced Nasopharyngeal Carcinoma

Conditions
-----------------
Nasopharyngeal Neoplasms, Stomatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically conformed Initial nasopharyngeal carcinoma Patients can feed through the mouth. ECOG (Eastern Cooperative Oncology Group) : 0-1. No history of chemo-radiotherapy, immuno-therapy or biotherapy. Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function). Informed consent signed. Exclusion Criteria: History of malignant tumors. Any severe complications contraindicated chemotherapy or radiotherapy. Medical history of central nervous system, cognitive or psychological diseases; Pregnant or nursing women. Patients with mental disease cannot complete the questionaire. Patients refused the informed consent.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gradings of oral mucositis |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiotherapy, oral mucositis,oral mucosa protection
Evaluating the Efficacy of CPAP Therapy for the Treatment of Fatty Liver

Study Overview
=================
Brief Summary
-----------------
We are doing this research study to evaluate whether continuous positive airway pressure (CPAP), a treatment for sleep apnea, will also help treat fatty liver disease. Sleep apnea is a disease where a person has interruptions in their breathing while they are sleep. This can lead to low oxygen levels in the blood. CPAP is a mask that delivers oxygen at high pressure to the lungs to prevent a decrease in blood oxygen levels. CPAP is a known treatment for sleep apnea.

Official Title
-----------------
Evaluating the Efficacy of CPAP Therapy for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)

Conditions
-----------------
Non-alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Device: CPAP
* Behavioral: LIfestyle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 18 years of age or older with a previous liver biopsy showing NASH and at least grade 2 steatosis Obstructive sleep apnea diagnosed by sleep study. Exclusion Criteria: Other causes of chronic liver disease cirrhosis less than 33% steatosis identified on magnetic resonance spectroscopy (MRS) Alcohol use >2 units per day for women or >3 units per day for men Intolerance to or refusal of CPAP therapy overnight desaturation (more than 10% of the sleep time with oxygen desaturation below 85%) underlying sever sleepiness (Epworth scale more than 15) uncontrolled hypertension Severe heart failure (ejection fracture less than 30%) cardiac arrhythmias (atrial fibrillation or history of ventricular tachycardia) those who are commercial drivers

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP<br>Subjects in this arm with receive treatment with CPAP for fatty liver disease. | Device: CPAP<br>* Subjects in the intervention arm will be treated with continuous positive airway pressure (CPAP) device at night.<br>|
| Active Comparator: Lifestyle Intervention<br>Subjects in the lifestyle arm will undergo 12 weeks of dietary counseling. | Behavioral: LIfestyle<br>* Subjects will undergo 12 weeks of dietary counseling.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steatosis by MRS | Subjects will undergo baseline and 12 week magnetic resonance spectroscopy to assess the impact of CPAP or diet on fatty liver. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-alcoholic fatty liver disease, Obstructive sleep apnea
Safety and Efficacy of Recombinant Adeno-Associated Virus Containing the CFTR Gene in the Treatment of Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the improvement in pulmonary function and cytokine levels observed in the recently completed multidose aerosol study for the treatment of Cystic Fibrosis (CF).

Detailed Description
-----------------
Cystic Fibrosis is an autosomal recessive disorder with an incidence of approximately 1 in 33000 live births. It is due to defects in the CFTR gene, which is located on chromosome 7. Gene Therapy holds the promise of addressing the primary defect in CF by reconstituting the CFTR function in the lung. tgAAVCF, which has been genetically engineered to contain the CFTR gene, has been extremely well tolerated following single and multiple dose administrations to the nose, sinus, and lung. Dose-dependent gene transfer has been demonstrated. Although vector gene expression has not been detected, evidence consistent with biological activity was observed in maxillary sinus study, and statistically significant changes in the FEV1 and IL-8 levels were observed in the recently completed multidose aerosol study. These findings are worthy of further investigation.

Official Title
-----------------
A Multicenter, Double-Blind, Placebo Controlled, Phase II Study of Aerosolized tgAAVCF for the Treatment of Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Genetic: tgAAVCF


Participation Criteria
=================
Eligibility Criteria
-----------------
Eligible subjects will be randomized to two aerosolized doses of either tgAAVCF or placebo 30 days apart. Subjects will undergo pulmonary function testing every two weeks during the active portion of the study (three months) and will be followed for safety for a total of seven months.

Ages Eligible for Study
-----------------
Minimum Age: 12 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

| Intervention/Treatment |
| --- |
|Genetic: tgAAVCF|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
-----------------
Gene Transfer, Pulmonary function
Observational Study on Intubation in Septic Shock

Study Overview
=================
Brief Summary
-----------------
Septic shock is common in intensive care and its mortality remains high. While new treatments have not improved survival, optimization of known and widely used techniques has allowed reduction in mortality. Thus improving care given to patients starts with making better use of existing resuscitation techniques. Among these practices, mechanical ventilation is widespread in the management of patients with septic shock. In large studies published in recent years in Europe and North America, 40 to 85% of patients receive invasive mechanical ventilation. It therefore appears that a significant proportion of patients are never intubated during treatment and management of their septic shock. There is no specific recommendation from critical care societies concerning mechanical ventilation in the treatment of septic shock. Apart from indisputable situations such as impaired consciousness or acute respiratoire distress, the decision whether to ventilate mechanically or not is left to the discretion of the physician. The aim of this study is to analyze intubation practice in septic shock patients and its impact on 28-day survival. This multicentric and observational study will be conducted in 30 French ICUs.

Conditions
-----------------
Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years old Admitted in the ICU for septic shock Introduction of vasopressors ( norepinephrine or adrenaline ) in the ICU or within 24 hours of ICU admission Suspected or proven infection Exclusion Criteria: Intubation before the introduction of vasopressors Decision of withdrawing or withholding care at admission Pregnant woman Patient not affiliated to the social security insurance Refusal of participation in the study

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 |
| --- | --- |
| Patients with septic shock<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death |  | 28 days after ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of organ support | mechanical ventilation, vasopressors, renal replacement therapy | 28 days | 
| impact of intubation delay on outcome |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Outcome, Septic shock, Endotracheal intubation
HDDO-1756 Bio Equivalence Study

Study Overview
=================
Brief Summary
-----------------
For healthy adult volunteers, safety and pharmacokinetic properties are compared between the two formulations in the case of HDDO-1756 alone administration and HDDO-17561/HDDO-17562 combined administration.

Official Title
-----------------
A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Fixed-dose Combination of HDDO-1756 or Loose Combination of HDDO-17561/HDDO-17562 in Healthy Adult Volunteers

Conditions
-----------------
Hyperlipidemias

Intervention / Treatment
-----------------
* Drug: HDDO-1756
* Drug: HDDO-17561/HDDO-17562


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult volunteers aged 19 or older during screening A person who weighs more than 50.0 kg and has a BMI of 18.0 kg/m2 or less and 30.0 kg/m2 or less. ☞ BMI (kg/m2) = Weight (kg) / {Long (m)}2 A person who has no chronic disease or medical treatment and has no pathological symptoms or findings as a result of an internal examination; A person who has been determined to be eligible for a clinical trial according to the characteristics of the drug during screening, such as serum tests, hematologic tests, hematological tests, urine tests, urine tests, etc. and vital signs (physical tests) and 12-lead ECG tests. Exclusion Criteria: Current or past history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, urinary system, cardiovascular system, digestive system, musculoskeletal disease, or mental illness, as well as those with the following symptoms or history: Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Persons with a history of gastrointestinal diseases (cron disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of drugs;

Ages Eligible for Study
-----------------
Minimum Age: 19 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br> | Drug: HDDO-1756<br>* single dose<br>|
| Active Comparator: group B<br> | Drug: HDDO-17561/HDDO-17562<br>* single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic evaluation variables | Cmax | 0 96 hours | 
| pharmacokinetic evaluation variables | AUC | 0 96 hours |
V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)

Study Overview
=================
Brief Summary
-----------------
This study evaluated the long-term safety of quadrivalent Human Papillomavirus (HPV) types 6, 11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese women.

Official Title
-----------------
A Phase IV Open-Label, Descriptive Study to Evaluate the Safety and Effectiveness on the Incidence of HPV 6, 11, 16 and 18 Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 26-Year-Old Japanese Women

Conditions
-----------------
Cervical Cancer, Cervical Intraepithelial Neoplasia, Adenocarcinoma in Situ

Intervention / Treatment
-----------------
* Biological: V501


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Japanese females Not pregnant at Screening and agree to use effective contraception through Month 7 of the study Lifetime history of 0 to 4 male or female sexual partners No oral temperature ≥37.5 centigrade within 24 hours prior to injection Exclusion Criteria: Received a marketed HPV vaccine Prior abnormal Papanicolaou smear (PAP) or biopsy showing CIN Known history of positive test for HPV Known history of genital warts Received immune globulin or blood products within 6 months prior to first injection or plan to receive any through Month 7 of the study History of splenectomy, known immune disorders, or receiving immunosuppressives Immunocompromised or diagnosed as having human immunodeficiency virus (HIV)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 26 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V501<br>Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6 | Biological: V501<br>* HPV types 6, 11, 16, and 18 vaccine 0.5 mL by intramuscular injection at Day 1, Month 2, and Month 6<br>* Other names: Gardasil™;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 | The endpoint included pathology panel consensus diagnosis of CIN 2 or 3, adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix, and HPV type 6, 11, 16, or 18 detected in an adjacent section from the same tissue block. The point estimates and exact 95% confidence intervals for incidence rate were based on the Poisson distribution. | Up to Month 48 |
Registry-based Stroke in Tunisia

Study Overview
=================
Brief Summary
-----------------
Study the prevalence of strokes in the emergency department (ED) and their possible eligibility for thrombolysis.

Detailed Description
-----------------
The diagnosis and management of strokes represent a great emergency that requires multidisciplinary teams and an organization of the care chain from the collection of patients at the site of the stroke to follow-up care. That is why it is necessary to identify the prevalence of stroke in the ED in Tunisia and to evaluate their eligibility for thrombolysis.

Official Title
-----------------
Registry-based Stroke Research in Tunisia: Multicenter Study

Conditions
-----------------
Stroke, Ischemic, Strokes Thrombotic, Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with stroke symptoms. Exclusion Criteria: Refusal of inclusion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Stroke prevalence | After entering the ED , the patient will have a radiological and biological screening to establish his right diagnostic and then we have stroke prevalence in the ED. | 1day | 
| Modified Rankin Scale (MRS) score change | After discharge from ED, patients were called back in order to know information about the quality of life and the search for persistent complications. | After a month , six month , 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, thrombolysis, Tunisia
Rehabilitation Treatment of Anterior Cruciate Ligament Rupture

Study Overview
=================
Brief Summary
-----------------
The purpose with this present study is to investigate the effect og a non-surgical regime in patients with an Anterior Cruciate ligament injury. The effect will be measured by patient reported outcome scores, level of function and how many of the patients are converting to operative treatment.

Official Title
-----------------
Rehabilitation Treatment of Anterior Cruciate Ligament Rupture

Conditions
-----------------
ACL Injury

Intervention / Treatment
-----------------
* Other: Rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anterior cruciate ligament injury where rehabilitation regime is selected as treatment. Exclusion Criteria: Other knee ligament instability Rheumatoid arthritis Morbus Bechterews Disease

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Rehabilitation|Non-surgical interventions to patients with an Anterior cruciate ligament injury. Rehabilitation regime is the regime provided by the physician at the rehabilitation clinic.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in patient reported outcome score (IKDC) | The International Knee Documentation Committee (0-100) | Baseline - 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in patient reported outcome score (KOOS) | Knee injury and Osteoarthritis Outcome Score (0-100) | Baseline - 2 Years | 
| Changes in patient reported outcome score (KNEES-ACL) | Knee Numeric-Entity Evaluation Score (0-100) | Baseline - 2 Years | 
| Changes in patient reported outcome score (TEGNER) | Activity scale (0-10) | Baseline - 2 Years |
Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen Repository

Study Overview
=================
Brief Summary
-----------------
Hidradenitis suppurativa (HS) is a common and debilitating skin disease that is poorly understood and understudied. As a result, little is known about disease prognosis and few effective treatments exist for this condition. This prospective observational cohort study aims to comprehensively characterize the clinical and biological features of HS. The results of this research will provide a basis for the development of an HS clinical classification system and identification of potential treatments for HS.

Official Title
-----------------
Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen Repository

Conditions
-----------------
Hidradenitis Suppurativa

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥ 10 years of age Diagnosis of HS by a dermatologist or practitioner experienced in making a diagnosis of HS Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. Exclusion Criteria: 1. Inability to give informed consent or unavailability of a parent/guardian who is able and willing to give informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- | --- |
| Primary Objective | The primary aim of this study is to identify clinical and biologic characteristics of hidradenitis suppurativa. | 2019-2029 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Objective | Secondary aims include correlating alterations in clinical and biological characteristics with disease status, and identifying genetic variants that predict disease progression or response to therapy. | 2019-2029 |