linjc16/ctgov huggingface dataset:
The Situation of Re-infection of Helicobacter Pylori After Successful Eradication

Study Overview
=================
Brief Summary
-----------------
The patients who accept the quadruple eradication program of the helicobacter pylori and success to eradicate helicobacter pylori will be followed-up to observe the situation of re-infection of helicobacter pylori.

Detailed Description
-----------------
The patients with helicobacter pylori accepted he quadruple eradication program of the helicobacter pylori.They will be followed-up from 1 year to 5 years to observe the situation of re-infection of helicobacter pylori.The rate of the re-infection will be described by frequency and percentage.

Official Title
-----------------
The Situation of Re-infection of Helicobacter Pylori After Successful Eradication

Conditions
-----------------
Helicobacter Pylori

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test. Exclusion Criteria: Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| The rate of re-infection | The rate of re-infection will be described by the frequency and percentage. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The influence factors of the rate of re-infection | The chi-square test will be used to compare the influence factors of the rate of re-infection. | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Re-infection
Treatment of Plantar Warts

Study Overview
=================
Brief Summary
-----------------
This study is to compare the efficacy and safety of topical 30% potassium hydroxide solution and topical 45% hydrogen peroxide solution in treatment of plantar warts.

Official Title
-----------------
Comparative Study Between Topical30%Potassium Hydroxide Solution and Topical 45% Hydrogen Peroxide Solution in Treatment of Plantar Warts

Conditions
-----------------
Plantar Wart

Intervention / Treatment
-----------------
* Drug: Topical 30%Potassium hydroxide solution
* Drug: Topical 45% hydrogen peroxide solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed diagnosis by clinical and dermoscopic examination of plantar warts Exclusion Criteria: history of hypersensitivity to any component used in this study pregnancy and breastfeeding patients who receive immune suppressive therapy patients who received any wart treatments during the last 2 months before enrollent in the study patients who refused participation in the study

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Potassium hydroxide group<br>Patients with plantar warts will apply topical 30% potassium hydroxide solutions on warts | Drug: Topical 30%Potassium hydroxide solution<br>* Patients will apply the solution every day under occlusion for 3 months<br>|
| Active Comparator: Hydrogen peroxide group<br>Patients with plantar warts will use topical 45% hydrogen peroxide solution on warts | Drug: Topical 45% hydrogen peroxide solution<br>* Patients will apply the solution every day under occlusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the size of the plantar warts | Decrease in the size of warts measured by a ruler | 12 weeks after end of treatment |
A Study of Xeloda (Capecitabine) in Combination With XELOX (Oxaliplatin) in Patients With Metastatic Nasopharyngeal Cancer.

Study Overview
=================
Brief Summary
-----------------
This single arm study will assess the efficacy and safety of Xeloda + oxaliplatin when given as first line treatment for patients with metastatic nasopharyngeal cancer. Patients will receive Xeloda (1000mg/m2 bid orally from day 1 to day 14, followed by a rest period of 7 days) plus oxaliplatin (130mg/m2 iv infusion on day 1 of each 21 day cycle) for 6-8 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Official Title
-----------------
An Open Label Study of First Line Chemotherapy With Xeloda in Combination With Cisplatin on Treatment Response in Patients With Metastatic Nasopharyngeal Cancer

Conditions
-----------------
Nasopharyngeal Cancer

Intervention / Treatment
-----------------
* Drug: Oxaliplatin
* Drug: capecitabine [Xeloda]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-75 years of age; history of nasopharyngeal cancer and distant metastases; no previous chemotherapy in past 6 months; recovery from previous radiotherapy; ability to swallow and retain oral medication. Exclusion Criteria: previous cytotoxic chemotherapy; radiotherapy within 4 weeks of treatment start; history of another malignancy within the last 5 years; clinically significant cardiac disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Oxaliplatin<br>* 130mg/m2 iv on day 1 of each 3 week cycle<br>Drug: capecitabine [Xeloda]<br>* 1000mg/m2 po bid on days 1-14 of each 3 week cycle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | Event driven | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression or death, survival time, duration of response, complete response rate. |  | Event driven | 
| AEs, laboratory parameters. |  | Throughout study |
Detection Of Monocytes/Macrophages Function And Tim-3 Expression In Septic Patients

Study Overview
=================
Brief Summary
-----------------
The imbalance between anti- and pro-inflammation often occurs in patients with sepsis. And continuous such imbalance could lead to immunoparalysis, which is characterized by loss of delayed type hypersensitivity, failure of primary infections eradication, and a predisposition of secondary nosocomial infections development. However, in which phase of sepsis does immunoparalysis occur is still unknown. So this study aims to tentatively understand this problem by checking monocytes/macrophages' antigen presentation and cytokine secretion，and by checking monocytes/macrophages' expression of Tim-3 (the T cell transmembrane, immunoglobulin, and mucin-3), which is an inhibitory regulatory molecule, in sepsis patients' peripheral blood mononuclear cells.

Conditions
-----------------
Sepsis, SIRS(Systemic Inflammatory Response Syndrome)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 years old; Fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 ℃ or lower than 36 ℃ (b)respiratory rate above 20/min, or carbon dioxide partial pressure below 32 mmHg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/μl or lower than < 4,000/μl or less than 10% of bands. Clinically suspected infection; Exclusion Criteria: were under 18 years of age; were refused by the patients or his/her familiality; were suffering from acquired immunodeficiency syndrome,viral hepatitis,autoimmune diseases and hematology; use medicine which can affect immune system,such as Glucocorticoid and Immunosuppressant died within 24h after being taken into the ICU, or refused to get involved in the study, or gave up treatment during the period of observation

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SIRS,sepsis,normal<br>SIRS (1) temperature > 38 centigrade or < 36 centigrade; (2) pulse rate > 90 beats/min; (3) ventilation rate > 20 breaths/min or hyperventilation with a partial pressure of arterial carbon dioxide (PaCO2) < 32 mmHg; (4) white blood cell (WBC) count >1 2,000/μL or < 4000/μL , or > 10% immature cells. sepsis SIRS + infection. normal not SIRS and have no infection. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systemic inflammatory response to infection with organ dysfunction, hypoperfusion, or hypotension |  | within 24 hours after enter experimental group |
Physiologic Effects of CPAP After Vascular Surgery

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate, with a case-crossover design, the effects of a short course of preventive CPAP administered in the immediate postoperative period in patients at high-risk of developing postoperative pulmonary complications undergoing major vascular surgery.

Official Title
-----------------
Physiologic Effects of CPAP After Vascular Surgery

Conditions
-----------------
Postoperative Complications, Respiratory Failure

Intervention / Treatment
-----------------
* Device: Postoperative preventive CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Open or endovascular surgery on the abdominal aorta Surgical procedure requiring general anaesthesia and invasive intraoperative mechanical ventilation Intermediate-high risk of postoperative pulmonary complications (ARISCAT score ≥ 26) Exclusion Criteria: Prolonged post-operative invasive ventilation Invasive or non-invasive ventilation or oxygen therapy in the last month ASA class IV or V Emergency procedures Pneumothorax or active pulmonary infection Any contraindication to CPAP Prolonged bed rest Patient refusal to participate or to receive preventive CPAP

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 |
| --- | --- |
| Major open vascular surgery<br>Surgical procedures on the abdominal aorta requiring median abdominal incision | Device: Postoperative preventive CPAP<br>* Administration of a course of 2 hours of CPAP with 7.5 cmH2O pressure and 0.30 FIO2<br>|
| Endovascular aortic repair<br>Abdominal aortic repair with endovascular approach | Device: Postoperative preventive CPAP<br>* Administration of a course of 2 hours of CPAP with 7.5 cmH2O pressure and 0.30 FIO2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2/FIO2 ratio | Increase of the PaO2/FIO2 ratio compared to the baseline value | Two hours after the administration of CPAP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal pressure-time product (PTPes) | Increase of the PTPes compared to the baseline value | Two hours after the administration of CPAP |
Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Techniques in Spain.

Study Overview
=================
Brief Summary
-----------------
Non-comparative, observational, ambispective post-authorisation study (EPA-SP).

Official Title
-----------------
Ambispective Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Techniques in Spain.

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: r-hFSH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged ≥ 18 years Currently undergoing an IVF or ICSI cycle or are oocyte-donors Have completed controlled ovarian stimulation Have received at least 5 doses of Bemfola® Are pituitary suppressed with a GnRH antagonist Have undergone oocyte retrieval Have signed the Informed Consent Form Exclusion Criteria: Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients listed Presence of tumours of the hypothalamus or pituitary gland

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: r-hFSH|As per standard practice|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of oocytes retrieved |  | 34-36 hours after hCG administration and after a maximum 16 days of r-hFSH treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of fertilised oocytes |  | 1 day after ovum pick-up | 
| Quality of oocytes |  | At Day 4-5 | 
| Number and quality of transferred embryos |  | Day of embryo transfer, either 2,3 or 5 days after oocyte retrieval | 
| Fertilization and implantation rate |  | 5 to 6 weeks after oocyte retrieval | 
| Incidence of serious adverse events, including moderate-to-severe OHSS |  | From Day 1 of stimulation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bemfola, r-hFSH, ART, Oocytes, OHSS, Pregnancy
Hispanic and White Women's Cardiovascular Health

Study Overview
=================
Brief Summary
-----------------
To elucidate the influence of ethnicity and socioeconomic status (SES) on women's cardiovascular health, using recently completed risk factor and mortality data from the Stanford Five-City Project.

Detailed Description
-----------------
DESIGN NARRATIVE: Two data sets were used to evaluate the specific aims: (1) survey risk factor data (e.g., blood pressure, cholesterol, blood lipids, smoking, etc.) on over 4500 girls and women; and (2) surveillance mortality data on over 1800 women.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Impact of Neutrophil Extracellular Traps (NET) on Thrombolysis in Acute Phase of Cerebral Ischemia

Study Overview
=================
Brief Summary
-----------------
Cerebral infarcts represent a major cause of morbidity/mortality in spite of therapeutics for a premature recanalisation (intravenous recombinant tissue plasminogen activator (rt-PA) and thrombectomy). Thrombolysis failure by the administration of rt-PA is frequent, in particular in proximal occlusion. Experimental studies suggest that neutrophils could play an important role in the thrombus development via the organization of a network (NET) within the thrombus. Targeting this network of NET could, in addition to the fibrinolysis, increase the rate of recanalisation and thus improve the neurological prognostic after a cerebral infarct. The aim of the research is to Study of the biochemical and histological composition of the stemming thrombi of cerebral thrombectomies with in vitro analysis of the sensibility in the thrombolysis induced by rt-PA +/- Desoxyribonuclease I (DNase I).

Official Title
-----------------
Impact of Neutrophil Extracellular Traps (NET) on Thrombolysis in Acute Phase of Cerebral Ischemia

Conditions
-----------------
Cerebral Infarct

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 Having a cerebral infarct consecutive to a wide calibre arterial occlusion taken care for mechanical thrombectomy Exclusion Criteria: Patient benefiting from a legal protective measure Pregnant or breast-feeding woman Opposition of the patient to participate 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation coefficient between biochemical and histological composition of the thrombus and the sensibility in the in vitro fibrinolysis and the origin of the thrombus. |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neutrophil Extracellular Traps
Study the Effect of Danggui Buxue Tang on Menopausal Symptoms

Study Overview
=================
Brief Summary
-----------------
This study is to examine the effect and safety of the study drug,Danggui Buxue Tang, on menopausal symptoms of hot flushes and sweating and to determine whether the patient's quality of life will be improved.

Official Title
-----------------
A Randomized, Double-Blind, Placebo Controlled Study of the Effect of Danggui Buxue Tang on Menopausal Symptoms and Quality of Life in Hong Kong Chinese Women

Conditions
-----------------
Menopause

Intervention / Treatment
-----------------
* Drug: DBT-Danggui Buxue Tang


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Follicle stimulating hormone (FSH), luteinizing hormone (LH), oestradiol in the menopausal range (FSH>18 IU/L, LH>12.6 IU/L, and E2< 361 pmol/l). Patients with amenorrhoea for more than 12 months Exclusion Criteria: Patients with a history of using any form of hormonal replacement therapy within 8 weeks Patients with a history of using Chinese medicine or other therapies which may affect the outcome within 8 weeks Patients who in the judgment of the investigator will be unable to comply with protocol requirements Patients with significant** gastrointestinal, renal, hepatic, bronchopulmonary, neurological, cardiovascular, breast or endometrial carcinoma, or allergic diseases Patients with uncontrolled hypertension Patients with undiagnosed vaginal bleeding Patients with a history of significant drug hypersensitivity

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

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

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 |
| --- |
|Drug: DBT-Danggui Buxue Tang|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Changes in severity and frequency of hot flushes and sweats. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Changes in score of the Menopause Specific Quality of Life and the values of various markers of risk for cardiovascular disease. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menopausal, Traditional Chinese Medicine
Drug Use Investigation for XYZAL®

Study Overview
=================
Brief Summary
-----------------
This post-marketing surveillance study (PMS) is conducted to collect safety and efficacy data among subjects with allergic rhinitis, urticaria, eczema, dermatitis, skin irritation, prurigo or pruritus cutaneous who have never been treated with levocetirizine tablets before.

Official Title
-----------------
Drug Use Investigation for XYZAL

Conditions
-----------------
Rhinitis, Allergic, Perennial and Seasonal

Intervention / Treatment
-----------------
* Drug: Levocetirizine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be the first time for taking levocetirizine tablet Exclusion Criteria: As this is PMS study, there are no exclusion criteria.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects prescribed levocetirizine tablets<br>Subjects prescribed levocetirizine tablets for treatment of allergic rhinitis, urticaria, eczema, dermatitis, skin irritation, prurigo or pruritus cutaneous | Drug: Levocetirizine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse events in Japanese subjects treated with levocetirizine tablets |  | 4 weeks |